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Pharmaceutical Society of Ireland

Codes of Ethics & Practice


Code of Ethics for Pharmacists & Codes of Practice

Pharmaceutical Society of Ireland, 18 Shrewsbury Road, Ballsbridge, Dublin 4.

January 2005 Edition

Introduction
The Pharmaceutical Society of Ireland makes no representation, express or implied with regard to the accuracy of the information contained in this Booklet and cannot accept any legal responsibility or liability for any errors or omissions that may be made.

IMPORTANT NOTICE TO ALL READERS This Booklet does not contain legislation governing the practice of pharmacy and the sale and supply of medicines in Ireland, or summaries thereof. For summaries of the laws governing the sale and supply of medicines and practice of pharmacy in Ireland, please refer to the Guide to Irish Pharmacy Law, also published by the Pharmaceutical Society of Ireland. Regard should also be had to the full texts of the relevant Acts and Statutory Instruments, which are available to download on the Irish Government website www.irlgov.ie, the Irish Statute Book website, www.irishstatutebook.ie, or may be purchased from the Government Publications Sales Office, Sun Alliance House, Molesworth Street, Dublin 2. Readers should not use or rely on the information contained in this Booklet as a summary of the legislation governing the practice of pharmacy and sale and supply of medicines in Ireland. Where references are made in this Booklet to legislative provisions, the reader should always have regard to the full texts of the relevant Acts and Regulations, as such legislative provisions may have been superseded. This Booklet is not, and does not purport to be a legal interpretation of any of the Acts and Regulations governing the practice of pharmacy and the sale and supply of medicines in Ireland.

Copyright 2005 by the Pharmaceutical Society of Ireland. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means - electronic, mechanical, photocopying, recording or otherwise - without the prior written permission of the Registrar of the Pharmaceutical Society of Ireland.

Please notify the Society of any errors or omissions that come to light.

January 2005

Pharmaceutical Society of Ireland, 18 Shrewsbury Road, Ballsbridge, Dublin 4. Tel: 01 218 4000 Fax: 01 283 7678

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CODES OF ETHICS & PRACTICE


CONTENTS Page Number Section 1 1. 2. 3. Code

of

Ethics

for

Pharmacists...4

Background to the Code of Ethics...5


..

Legal Dilemmas faced by Pharmacists in the area of Addiction, are there8 any easy Answers? Section 2

1. 2. 3. 4. 5. 6. 7. 8. 9. 1

Good

Pharmaceutical for

..

Practice ...2 0 Prescriptions..2 3

Guidelines

Dispensing

Guidelines on Dealing with Errors ...3 .. 0 Code of Practice on the Use Computer. of Personal Information on3 2

General Guidelines on the Production and Implementation of Medicines3 Sales Protocols . 6 Code of Practice governing the Temporary Absence Clause of the Pharmacy4 Act, 1890.. 2 Council Statement on the use of Generic Medicines in Pharmaceutical4 Practice 4 Pregnancy Testing in Pharmacies...4 5 Cholesterol Testing in Pharmacies...4 . 6 Guidelines on Storage of Medicines in Community Pharmacies.4

0. 1 1. 1 2. 1 3. 1 4. 1 5. 1 6. 1 7.

7 dealing on with Requests by for Information .5 5 Pharmacists.5 7 Extemporaneous5 8 6 4

Guidelines Guidelines

on

Advertising

Guidelines On Dispensing .

Best Practice Guidelines On The Provision Of Pharmacy Services To Residential Homes By Community Pharmacies.

Best Practice Guidelines On Systems. Guidelines On The Treatment


.

The Of

Use

Of

Dosage

Compliance6 9

Opioid

Misusers .7 3 8 9

Revised Society Policy On The Use Of Child Resistant Containers (CRCs)


.

CODES OF ETHICS & PRACTICE


SECTION 1

Pharmaceutical Society of Ireland CODE OF ETHICS FOR PHARMACISTS

CONTENTS 1. 2. Code of Ethics for Pharmacists Background to the Code of Ethics

3. Legal Dilemmas faced by Pharmacists in the area of Addiction, are there any easy Answers?

Sect ion 1 Code of Ethics for Pharmacists

1. 1.1 Introduction

CODE OF ETHICS FOR PHARMACISTS

This code of ethics has been adopted by the Council of the Pharmaceutical Society of Ireland to provide a set of guiding principles by which the actions of every pharmacist should be judged. It is the ultimate standard of professional practice and is intended to embody the ideals which regulate each pharmacists own conduct. For specific guidance on individual practice issues pharmacists should consult the Codes of Practice issued by the Council of the Society. These are published on an ongoing basis and are collected in the Practice of Pharmacy Guide. To avoid unnecessary repetition of pronouns the masculine form only is used in this document. For any use thereof the feminine form may be construed as equivalent. 1.2 Code

Sect ion 1 Background to the Code of Ethics

2. BACKGROUND TO THE CODE OF ETHICS


In an effort to produce a code of ethics which reflects as closely as possibly the thoughts and feelings of pharmacists, the Pharmaceutical Society of Ireland published this article in the Irish Pharmacy Journal, April 1996 2.1 Introduction Printed at the end of this article is the draft code of ethics for pharmacists, which has been approved in principle by the Council of the Society. The code has not yet been officially approved as Society policy as it is felt that a matter of such fundamental importance should be discussed by the membership at large before being ratified by Council. The purpose of this article is to introduce the concept of ethics in general, to discuss ethics in pharmacy and to describe the way in which the current code was developed. Following from this, the Council would earnestly request that any pharmacist who has an opinion, comment, suggestion or criticism of the proposed code of ethics would make these known. Written submissions addressed to the Chairman of the Practice of Pharmacy Committee will be accepted at the Societys offices until Wednesday 30th April. In the interests of producing a code of ethics representative of pharmacists in general it is vital that the input of as many pharmacists as possible is considered. 2.2 The Theory of Ethics The concept of ethics is one of the oldest philosophical ideas, having its origins in the Golden Age of Greece. At the simplest level an ethic is a set of moral principles and ethics is the science of morals in human conduct, or the rules of conduct with which a particular society governs itself. Within this definition there are a myriad of different topics which may be discussed. However, as a general rule ethics are primarily aspirational, providing an ideal by which a person can judge their own conduct, and by which this conduct can be viewed by others. It is worth noting from this that ethics are an entirely different thing to law. Law is a rule enacted or customary in community, recognised as enjoining or prohibiting certain actions and enforced by the imposition of penalties. The distinction between law and ethics is often misunderstood, yet crucially important, and should be clearly drawn. One of the major difficulties in the theory of ethics is the absence of any empirical standard by which the validity of an ethical system can be measured. While it can be easily stated that there are true statements of fact, it is not so for statements of ethics. There can be no argument as to whether or not Amsterdam is the capital of the Netherlands, the question as to whether it is right for cannabis to be legally available in Amsterdam is another matter. In short, it is impossible to construct a completely objective system of ethics as there is no standard of good or bad other than what the person using these words desires. The extension of this concept is that the various codes of ethics proposed for a particular society or individual must compete on their merits, with the most suitable being eventually selected. Following this line of thinking to its logical conclusion leads to the uncomfortable, if not altogether uncommon, assertion that justice is nothing else than the interests of the stronger. This prickly dilemma may have been temporarily solved by the Platonic idea of the Good, which became incorporated into the Christian idea of God, but it is still a somewhat unanswerable question. For our purposes it will suffice to note that ethics is relative, not absolute. When considering a system of ethics the prevailing general opinion of the time is not the only consideration which is important. Major innovations, radical in their time, have contributed to codes of ethics and are now accepted norms.

Sect ion 1 Background to the Code of Ethics

When Jesus proclaimed that it was not wrong to pluck ears of corn on the Sabbath, but that it was wrong to hate your enemies, he was at odds with the views of the Jewish religion, which considered working on Sunday, even that necessary to keep body and soul together, to be sinful, but which was not overly concerned with hatred and revenge. To decide which system of ethics is most appropriate for a particular instance requires difficult decisions. These decisions must take account of many different variables, but for the purposes of this article the three points given below are as good a way to examine a proposed ethical system as any: Is the code of ethics self-consistent? Is it consistent with the remainder of the authors views? Does it give answers to ethical problems that are consonant to our own ethical feelings?

If the answers to question I or 2 are no, then the system is intellectually flawed. At best it is ill-conceived, or badly put together; at worst it is useless. If the answer to question 3 is no, then it is not correct to say that the system is wrong, only that we do not like what it says. Before moving on from the general to the more particular, a final point of note: the idea of moral worth, as introduced by the 18th century German philosophers, holds that moral worth only exists when a man acts from a sense of duty: it is not enough that the act should be such as duty might have prescribed. Put simply this means that there is no inherent worth in acts of kindness or honesty done out of self-interest. 2.3 Ethics and Pharmacy A common feature of all professions is an ethical code governing the actions of their members which is self-imposed and self-regulated. This need not be an official written document but can be a set of generally held principles which each member of the profession should abide by. Pharmacy is no different in this respect. There is a difference of degree, however, in the bewildering array of ethical dilemmas with which pharmacists are faced. Most of the other professions are only concerned, from the point of view of ethics, with the professional to client (or patient) relationship, the sanctity of which takes precedence over all their actions. This relationship also exists for pharmacists, but is complicated in that pharmacists also have an ethical obligation towards a third party, the general public who visit pharmacists. This notion of an ethical responsibility which is primarily to the patient, but equally to other pharmacy customers, is embodied in the proposed code of ethics. However, it should be noted that pharmacists responsibilities may quite properly end here. There is no point in speaking of the pharmacists responsibility to protect the public, or the public health. These may be laudable ideas, but they are well beyond the remit of the pharmacist. Pharmacists provide a clearly defined service, and their obligations are to the people who decide to avail of these services. As members of the community, pharmacists have obvious civic responsibilities, but these are different to their duties as pharmacists. Expanding on this can lead to something of an impasse. If a pharmacist is to abide by an ethical code imposed on him by his profession, there is a distinct possibility that this might contradict with the moral obligations of his particular societal situation. This can manifest itself in many ways, one common example being the conflict between a pharmacists duty to the patient and his views on sexual morality. The law of the land gives a specific exemption to healthcare professionals who have a conscientious objection to participation in the provision of family planning services.

Sect ion 1 Background to the Code of Ethics

Therefore, a pharmacist can quite legally refuse to dispense the oral contraceptive pill, but to do so would not seem to be in the best interests of the patient. If the welfare of the patient is the pharmacists primary concern, as the general consensus would have it, then a pharmacist would not be able to exercise the legal right to his moral objection. The only solution would seem to be in balancing the two alternatives and choosing the one we are most at ease with. Problems like this do not make it any easier to devise an ethical system for pharmacists, but by highlighting the difficulties inherent in such a selection, they underscore the need for a code of ethics which is as inclusive as possible. 2.4 Pharmaceutical Society of Ireland Code of Ethics The Royal Pharmaceutical Society of Great Britain produces a code of ethics for pharmacists which details their views on all aspects of pharmaceutical practice. The code is extremely detailed, and covers the whole spectrum of activity from the advertising of professional services to the sale of unlicensed medicines. As such it is an immensely useful guide for practising pharmacists, providing them with a reference manual where they can obtain guidance on varied aspects of pharmaceutical practice. Notwithstanding these obvious advantages, this type of ethical system has some inherent drawbacks. It is more like a procedural manual than a code of ethics. While the strengths of this system are obvious, it can never hope to cover every ethical problem faced by pharmacists. Constant updates and additions are required to keep such a code in line with current practices. Having carefully considered the merits and shortcomings of this type of system the Societys Practice of Pharmacy Committee decided to opt for the more aspirational and idealist code presented in draft form here following. The seven points of this code should form the basic tenets by which a pharmacists actions should be guided in all aspects of professional practice. As such, this type of code, which gives more freedom to individual pharmacists, is a reflection of the changing times. Pharmacists are no longer hidebound by absolute dependence on the instructions of others. The concept of professional judgement, which is explicitly referred to in the code, means that pharmacists are obliged, both legally and ethically, to exercise their own professional judgement when the best interests of the patient indicate that it would be necessary to do so. The importance of this, and other related advances, is that it is not possible for pharmacists to simply discharge their duties by slavishly following the instructions of others. It is with this in mind that the draft code of ethics has been designed. Reducing the written instructions to the seven points given in the code places the final responsibility for any ethical judgement on the individual pharmacists concerned. At the same time, the scope of the code has been broadened to reflect the feelings and opinions of all pharmacists, and it is this fusion of individual choice, predicated on the outlook of the profession as a whole, which will be the enduring strength of the Societys new code of ethics for pharmacists. 2.5 Some Ethical Questions Is it ethical for a pharmacist to use his influence to impede a colleague who is attempting to establish a new pharmacy or revitalise an existing one? Is it ethical for a pharmacist to charge money for dispensing methadone to drug misusers who are entitled to this free of charge on a GMS prescription? Is it ethical for a pharmacist to threaten or disparage a colleague who is intending to work in a pharmacy owned by a non-pharmacist?

Sect ion 1 Background to the Code of Ethics

Is it ethical for a pharmacist to dispense the wrong medication to a patient? Is it ethical for a pharmacist to attempt to cover this up when challenged? Is it ethical for a pharmacist to operate from a premises which is filthy, dilapidated or unsightly?

Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

3. LEGAL DILEMMAS FACED BY PHARMACISTS IN THE AREA OF ADDICTION, ARE THERE ANY EASY ANSWERS?
Text of the presentation given to the Societys Annual Conference, November 1996, by Mr Dominic Dowling, legal advisor to the Society 3.1 General legal principles which apply to the practice of community pharmacy (including the area of addiction) Nothing preoccupies people as much as their health or lack of it. I believe that this was as true a thousand years ago as it is now. It is not surprising therefore that almost 700 years ago, in 1316, a group of people who might then have called themselves pharmacists (if the word had been invented) came together and produced a code to prevent the adulteration and to monitor the purity of certain drugs. In the late 1540s, during the reign of Henry VIII, an act was passed which empowered certain physicians to visit Apothecaries shops in London in order to inspect the same and to destroy any medicines which were "defective, corrupted and not meet nor convenient to be ministered for the health of mans body." Legislation then progressed from the control of medicines per se to the control of the people who sold them and the places from which they were sold. In 1791 the Apothecaries Hall (which some would see as a predecessor of the Society) was established so that "no person shall open shop or practice the art and mystery of an apothecary within the Kingdom of Ireland until he shall have been examined as to his qualifications and knowledge of the business by the said Act prescribed." The Society's own founding legislation was enacted in 1875 and since then there has been a very considerable body of statutory law promulgated in the area of pharmacy. In the introduction to their book Medicines and Pharmacy Law in Ireland by Dr Peter Weedle and Michael J Cahill, it is stated "the legal control of medicines in Ireland has developed over many years into a patched together framework which is often difficult to follow legislation was enacted on a piecemeal basis and usually in response to a specific crisis rather than in a planned manner." The truth of this statement is obvious if one considers that the November 1996 syllabus for the licence examination requires the present examination candidates, for entry into your profession, to be familiar with the combined terms of 31 Acts of the Oireachtas and Statutory Instruments, 42 EU Directives, the Pharmacy Regulations 1977-1995 and the various guidelines made thereunder. I recall during the course of the debate whether solicitors should or should not be appointed to the benches of the higher courts, part of a speech which was given by our present Chief Justice, Liam Hamilton. He was talking to newly qualified solicitors on the day when they were presented with their parchments. On the topic of solicitors becoming judges he said "Everybody wants to go to heaven but nobody wants to die". I should like to translate this for you into the context of pharmacy referring to a paper which was read by Dr Peter Weedle at a conference which took place in 1994. In the course of his paper he stated: "It has been proposed that what is needed is a process of re-engineering of controlled supervision and counselling. This will require a fundamental change in the way the pharmacist demonstrates professional accountability to patients, to doctors and to his peers. This obviously covers all medicines transactions and not just the newly deregulated medicines. Put straight; pharmacists are trying to get an effective monopoly on medicines but this will not be tolerated by society if the pharmacist abdicates his professional responsibility."

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

In my opinion this is central to the way in which a community pharmacy must be conducted in the future with total professionalism. This professionalism must inform all areas of practice including those which relate to drug addicts and drug addictions. In addition to this enhanced professional responsibility which is referred to by Dr Weedle, a pharmacist may also be unique amongst the healthcare professionals in that he must combine professional services with commercial activity. It seems to me inevitable that during the course of his career a pharmacist must encounter a conflict of interest between these two aspects of practice. This can also make it more difficult effectively to operate in the area of addiction where not only is there little commercial gain, but in many instances the risk of commercial loss. It follows from the above that in addition to the responsibilities which attend on any person who operates a business in the commercial marketplace, the pharmacist must also be prepared to swallow the bitter pill of professional responsibility. Where then can one find the legal and professional responsibilities of a community pharmacist? In my view they are principally to be found in the following legal and paralegal areas: Statute Statutory instrument Common law Professional regulation Professional guidelines

As I stated earlier all pharmacists are expected to be familiar with the responsibilities and duties which are imposed upon them in four of the areas mentioned above. For this reason I do not propose to review the general statutory laws. I will take them as read. However, not all statutory obligations might have their roots specifically in pharmacy legislation. I am thinking here of the duties imposed on pharmacists by the: Safety Health & Welfare at Work Act, 1989 Safety at Work Regulations, 1993 The Sale of Foods and Supply of Services Act, 1980 The Liability for Defective Products Act, 1991

These are not pieces of legislation which would normally be found on a course of pharmaceutical study but they are very relevant to how you should conduct your business. I will say something more concerning these pieces of legislation as the paper progresses but for the moment it is enough to advert to their existence. 3.2 Common Law Because pharmacists are not obliged to be fully conversant with common law, I propose to deal at more length with their responsibilities and duties under this legal heading as opposed to under statute. There are two specific areas of the common law with which I wish to deal. The first is the law of contract and the second is the law of tort. Again I would stress and ask you to bear in mind that what I say here relates not only to the practice of community pharmacy in relation to the normal patient but also in relation to those with addiction problems. 3.3 Law of Contract Each time an individual patient comes into a pharmacy and purchases a product, a contract has been made and completed. In 99.9% of cases, the patient employs the product to therapeutic effect, the pharmacist lodges the money to his or her bank

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

account, (also to therapeutic effect) and that is the end of the matter. In the small minority of cases however, where the product purchased causes the patient harm, then the legal ramifications of what might have been a very straightforward and often financially small contract can be enormous. It would be impossible to deal with them exhaustively in this presentation but I would refer you to an article contained in the IPU Diary by Alex Schuster, director of the Irish Centre for European Law. The article is entitled Consumer Law and Product Liability Claims. In this article he adverts in particular to the strict liability which is imposed on a pharmacist by the Sale of Goods and Supply of Services Act of 1980. Under the provisions of this Act, it will not avail pharmacists to plead that the defect in an over-the-counter product was attributable to factors outside his control. The pharmacist is responsible for both patent and latent defects. Under Part IV of the same Act, prescription only medicines are subjected to the same high standards of quality demanded of over-the-counter products. The liability imposed by the Defective Products Act, 1991 captures the activities of retailers and importers who are included in the definition of a producer for the purposes of the Act. In so far as the average community pharmacist is concerned, if the producer of the product cannot be identified, then the pharmacist or the supplier will be treated as the producer with all the attendant liabilities that this may impose. This highlights the need for pharmacists to keep full and accurate records independently of those records which they are obliged by statute to keep anyway. More significantly in the area of contract law, there has been the recent introduction of the new Community Pharmacy Contractor Agreement for the provision of services under the Health Act, 1970. I am going to refer to this as the new GMS contract. The new GMS contract will be very relevant in the area of addiction because most pharmacists operating in that area will do so under the auspices of the contract rather than under private patient contracts. I am therefore going to deal with the GMS contract in some detail. Clause 1 of the contract sets out what the pharmacy contractor is obliged to do. Clause 1.1 states "the pharmacy contractor shall supply with reasonable promptness to such medicines as may be ordered". Clause 1(2) states "in the supply of a medicine on prescription under this agreement, the pharmacy contractor shall exercise his professional judgement and discretion as pharmacist such pharmacist shall exercise due diligence and care and shall satisfy himself/herself that the safety of the patient is paramountin exercise of his professional judgement and discretion the pharmacist shall where necessary, act in consultation with the practitioner who issued the prescription concerned". I draw your particular attention to the use of the word "shall" in the extracts which I have quoted above. The import of that word into the contract means that the pharmacist does not have any contractual discretion in respect of those matters which by the clauses recited, he is mandated to perform. You cannot refuse to supply. You cannot accept the word of a prescriber as gospel. In the difficult area of addiction, the patients safety must come first. Clause 1.3 of the contract provides for a situation where a pharmacist in the exercise of his professional judgment is obliged to depart from the strict terms of a prescription. Clause 4.3 provides "The pharmacy contractor shall ensure that the conduct of his practice in so far as the dispensing and compounding of medicines are concerned is in conformity with the standards of Best Pharmaceutical Practice as determined by the Pharmaceutical Society of Ireland from time to time".

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

Clause 5 is again a mandatory clause and deals with staff levels, accommodation, equipment, text, records and stocks. The most significant clause in the contract is of course Clause 9 which will not come into force for another two years. Under Clause 9 "the pharmacy contractor shall prior to the dispensing of each prescription and prior to the supply of the medicine, ensure that a pharmacist reviews the medicine therapy of the individual for whom the prescription is issued". Again I would ask you to remember that this Clause will apply equally, if not more so, in the area of addiction. The Clause then goes on to stipulate what matters could be included in such a review and provides at Clause 9 (5) "the pharmacists shall offer to discuss with the individual for whom the prescription is issued or with the carer of such person, such matters as the pharmacist in the exercise of his professional judgement deems significant including the following"In my opinion the articulation in the new GMS contract represents the single biggest catalyst for change in the profession for many years. In addition to defining the areas of responsibility the Contract also provides at Clause 24 thereof that "The pharmacy contractor shall ensure that his personal professional liability and that of anyone employed by him/her is adequately covered by indemnity insurance"What are the consequences of this mandatory requirement likely to be for the pharmacist who treats a high proportion of addicts? If as happened in the legal profession, the underwriters of such insurance build up a poor claims experience, then premiums will inevitably go up and the pharmacist will have no option but to pay them or abandon the new contract. In the book Medicine and Pharmacy Law in Ireland it is stated (page 150) that "a most important limitation to contract liability from the point of view of the pharmacist is that the supply of a medicine on a general medical services (GMS) prescription is not a sale either to the GMS or to the patient. A patient injured by medicine supplied under the GMS has no entitlement to the Sale of Goods or Supply of Service Act and therefore, must look elsewhere for lawful remedy". I am very loathe to disagree with this statement but the law like everything else, moves on and I believe that the pharmacist now does have a contractual and certainly a quasi-contractual liability directly to his patient in respect of the supply of GMS medicines. I am fortified in that view by the English cases of Pfizer Corporation V Minister of Health and Appleby V Sleep. In commenting on these cases, Alex Schuster in his article states "it is strongly arguable however, that even in the absence of a sale in the strict sense of the word, Irish courts might hold a retail pharmacist liable for a serious adverse effect. The courts have on other occasions extrapolated from the Sale of Goods legislation to analogous situations involving the transfer of materials without sale. Given that the Irish courts tend to be more consumer orientated than their UK counterparts, it is difficult to envisage a situation in which the victim of a dangerously defective drug would be denied a contractual remedy against the pharmacist because he is a medical care holder (as opposed to a private purchaser for value). There may also be a misconception abroad in the area of privity of contract. If for example, a mother purchases a product from a pharmacy for the benefit of her child it is sometimes argued that there is no privity of contract between the child and the pharmacist. This fails to take account of Section 5 of the Married Womens Status Act, 1957 which provides that if a contract is expressed to be for the benefit of the wife, husband or child of one of the contracting parties, then the contract will be enforceable by the third party in his or her own name. In the treatment, management and supply of addicts and their families bear in mind that you must, as a matter of contract law, comply with your obligations under the new contract. I believe that as pharmacists you should plan on the basis that contractual liability will attach to you in respect of GMS products and in respect of supplies to defined third parties.

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

3.4 Law of Tort Having dealt with some of the duties and responsibilities imposed on pharmacists under the law of contract, I wish now to turn to the law of tort. Tort is a civil (as opposed to a criminal) wrong in respect of which the courts will give a plaintiff a remedy. Torts generally fall into two categories; intentional and unintentional. Insofar as pharmacists are concerned, the relevant intentional torts will probably be defamation of character, false imprisonment, assault and battery. I should like to give you an example in this regard. It is 5.55pm on a Monday. The proprietor returns to her premises, which is trading under the care of her employee pharmacist. It is a big shop and as she walks towards the dispensing area she notices a woman whom she knows to be a drug addict with a small child. The young woman does not notice her. The young woman takes a bottle of a proprietary childs medicine, glances at the label, puts it into her bag and walks out of the shop. She stops in the queue at the bus stop which is just outside the pharmacy door and begins to talk to an acquaintance. The pharmacist follows her out and asks her to come back into the shop. The woman refuses and demands to know why. The pharmacist initially refuses to tell her but then accuses her of stealing the medicine. The young woman denies she stole anything. The pharmacist states that she will call the Gardai. She advises the young woman that if the young woman does not accompany her back into the shop that the Gardai will undoubtedly be calling to her home. The young woman and her child reluctantly accompany the pharmacist back into the shop where they are asked to wait in a back room. The pharmacist locks the door. The Garda are called but there is a delay before they arrive. The young woman requests that she be allowed leave. This request is refused. When the Garda arrive it transpires that the young woman had earlier paid the employee pharmacist for the product. She had indicated to the employee pharmacist that she would pick it up on the way out of the shop. She holds a valid receipt. The position at law is that this young woman has been defamed, falsely imprisoned and technically assaulted. The pharmacist will face a large claim in damages. I now turn to the more common torts - those which are unintentional. The principal tort in this area is that of negligence and breach of duty including breach of statutory duty. The principles of negligence were established in the case of Donohue V Stevenson (1931) AC. 562 that a person must "take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbour. Who then in law is my neighbour? The answer seems to be persons who are so closely and directly affected by my act that I ought reasonably to have them in contemplation as being so affected when I am directing my mind to the acts or omissions which are being called into question". To establish a claim in negligence, the plaintiff must satisfy the court that he or she is owed duty of care, that this duty of care has been breached and that they have suffered a foreseeable loss as a result therefore. In the overall tort of negligence, there is a sub-area of professional negligence. The duties imposed in negligence on professional people are often made much greater than the duties imposed on the lay person. It can readily be understood that a passer-by who goes to the aid of the victim of a road traffic accident could not possibly be expected to show the same degree of skill and expertise in treating the victim as would be required from a surgeon in a hospital. Since pharmacists sought and have been granted full professionals status, they must now accept the liabilities that go with such status and again I would stress that you bear in mind that these liabilities apply equally in the area of addiction. One of the most important recent cases in the area of medical negligence is that of Dunne (an infant) V National Maternity Hospital 1989 IR 91. The facts in that case are that the infant plaintiff was born on March 20, 1982 in the National Maternity Hospital. In the course of her

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

pregnancy with the plaintiff, his mother consulted with her doctor on a number of occasions and asked him to consider whether she might be pregnant with twins. He carried out a scan examination and was satisfied that this was so and that both twins were of equal size and in apparent good health. The plaintiffs mother was admitted to the labour ward of the hospital at 11.15am on March 20. The plaintiff was born naturally at 5.15pm and at 5.30pm the second twin was born dead. It became apparent that in the events which surrounded the birth of the twins, the plaintiff had suffered severe and irreversible brain damage. In a 15 day trial before judge and jury in the High Court for professional negligence, a succession of medical experts gave evidence for the parties. The decision of the High Court was appealed to the Supreme Court and it was held that: (a) A practitioner is negligent in diagnosis or treatment only if guilty of such failure as no other practitioner of equal specialist of general status and skill would be guilty of if acting with ordinary care. (b) A plaintiff establishes negligence against a medical practitioner by proving his deviation from the general and approved practice only upon proving also that the course taken was one which no other medical practitioner of like specialisation and skill would have followed when taking the ordinary care required for a person of his qualification. (c) A medical practitioner who establishes that he followed a practice which was general and approved by his colleagues of similar specialisation and skill is nevertheless negligent if the plaintiff thereupon establishes that such practice has inherent defects which ought to be obvious to any person giving the matter due consideration. The court then went on to state per curiam "the courts should ever have equal regard to the clear benefit to the common good of advancing medical science without the apprehended burden of frequent and unsustainable legal claims on the one hand and on the other hand the care required of medical attendants arising from the extent to which their patients must rely on their care and skill. This test has been applied in circumstances where it was alleged that the incorrect drugs were administered (Hughes V Staunton High Court February 16, 1990) and where it was alleged that the defendant doctors were negligent in the diagnosis of patients: Caffrey V North Eastern Health Board High Court February 10, 1995, Goonan V Dooley High Court March 23, 1994 and Lynksey V Jervis Street Hospital High Court April 23, 1993. All of these cases turned upon their facts and applied, without extending or developing, the test in Dunne.In my opinion the principles in relation to medical negligence as outlined above can be applied equally to pharmacists in the practice of their profession and you cannot do otherwise than heed them. I would refer you in particular to paragraph (c) above. The effect of this paragraph is that just because you have over the years adopted and followed the same pharmaceutical practice as everyone else does not mean you are protected from professional negligence. In the case of ODonovan V Cork County Council 1967 IR page 193 it was stated neglect of duty does not cease by repetition to be neglect of duty. A number of interesting aspects may be relevant to the circumstances in which the pharmacist finds himself. The first is the observation that the human body is not like an inert object, the reactions of which are predictable: Lindsay V Mid-Western Health Board (1993) 2 IR 147. The question must arise therefore as to what degree of liability can be imposed upon persons who have no opportunity of examining the person seeking to fill a prescription. It is true that, in certain circumstances, the court has considered the efficacy of diagnosis by observation (see for example Healy V North- Eastern Health Board High Court January 31, 1996) but this has been in the field of mental illness and the scope for its extension would appear to be limited.

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

Furthermore, to what extent does a pharmacist, who has not examined his patient owe a duty to disclose the possible risks inherent in certain treatment? You must make your own judgments based on your own enquiries and considerations. This applies all the more in the area of addiction where new parameters and practices are only now being developed. My point is very vividly illustrated by the case of Devilez V Boots. Some of you may recall that the plaintiff bought a bottle of corn solvent from the defendants. He spilt some of the solvent on a most sensitive part of his anatomy and later suffered extreme pain and had to undergo plastic surgery. He sued Boots for negligence. Boots established that over the previous 30 years they had sold some 20 million bottles of the preparation using the same label and in a similar type of bottle. During that time they had received only a dozen minor complaints. Notwithstanding such a successful record Boots were held liable because they should have provided a safer bottle and a clearer warning. The other aspect of professional negligence of which the profession should be aware is that laid down in the case of Brogan V Bennett 1952 IR page 119. The effect of that decision is that if you hold yourself out to a member of the public as possessing a particular degree of skill and expertise then the court may well find that you ought to have exercised such skill and care as a person with co-measurate qualifications would have possessed. If you hold yourself out as an expert in the area of addiction or even if you acquire a reputation as being such an expert then you may well find that the law will require you to act to the same high standards as a genuinely qualified expert. If you do not then even though you act as any reasonable pharmacist might have done you may find yourself liable in negligence. At this stage I would refer back to the terms of the GMS contract which I have outlined above and in particular paragraphs 1(1), 1(2), 4(3) and 9 (to be introduced) thereof. I believe that in any future claim for professional negligence the legal advisers to the plaintiff will inevitably urge the court to accept that the stringent level of professional care and expertise to be exercised by and expected of a community pharmacist is evidenced inter aliaby the onerous obligations placed on community pharmacists by the new contract. As I have already stated a community pharmacist is obliged to conduct his practice in conformity with the standards of the best pharmaceutical practice as determined by the Pharmaceutical Society of Ireland from time to time. I do not propose to set out these standards and requirements which in practical and readable terms are probably best set out in the preregistration training manual which is supplied to pre-registration pharmacy graduates. 3.5 The Examination of Addiction in the Context of Legal Principals which apply to Community Pharmacy Having examined the legal duties and responsibilities imposed by the profession in relation to their practices in general I am now going to examine them with particular reference to the area of addiction. I will take as a working definition of addiction, a compulsion to use a substance which damages the physical or mental health of the user, his family, friends and society. It is much more difficult to describe an addict. The lay person would almost certainly think in terms of a young, impoverished, poorly educated, male who probably comes from a disturbed background, has a criminal record, is underweight and half dressed. I have no statistics but my instinct tells me that such people are probably (in terms of addicts) the tip of the iceberg. If an addict is functioning under a disability (whether self-induced or not) does the pharmacist owe him an additional duty of care because of his disability? If, for example, a pharmacist were dealing with a patient who was mentally or physically handicapped or of tender years then most people would accept that

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

pharmacist would owe special duty of care to such a person. I suspect that to the extent that a drug abuser is suffering from a disability the pharmacist cannot ignore such disability and treat them as he would a normal patient. He probably owes them a special duty of care. If a pharmacist owes a higher duty of care to a person who has an addiction problem how in the first instance does the pharmacist recognise the extent of a duty and how should the pharmacist then proceed? It seems to me that it is helpful answering this question for a pharmacist to examine the differing types of medicine and some of the manifestation of addiction which occur in relation thereto. I would propose adopting the traditional classification in respect of these medicines, namely over the counter medicines (OTCs), prescription only medicines (POMs) and controlled drugs. 3.5.1 Over-The-Counter Medicines As pharmacists you are all familiar with items such as: Codeine Cyclizine preparations Ephedrine preparations Phenylpropanolamine preparations Preparations which may be used for solvent abuse, especially pain relieving sprays. All these medicines are Schedule I Part I poisons and for this reason they can be sold under the supervision of a pharmacist from a pharmacy without a prescription. The Society recommends that all such products should be sold personally by the pharmacist. You will know from your own practices that the products which I have listed are capable of giving rise to dependency or causing serious side effects when abused. You must therefore meet these patients personally and where possible form a view on the likelihood of abuse. It is my opinion that you are under a legal duty to seriously consider refusing a sale of these and similar OTC products where you believe that there is anything other than a genuine need for the product. I do not propose to detail here the recommendations which the Society have made to you as a profession in respect of OTCs but again I would draw your attention to paragraph 4(3) of the new contract which, although it relates to POMs, requires that you conduct your practice in conformity of the standards of best pharmaceutical practice as determined by the Society. It would be illogical if the same criteria were not to apply to OTCs. The problem in relation to OTCs is compounded by the recent deregulation of a number of medicinal products under the Medical Preparations (Prescription and Control of Supply) Regulations, 1993 (replaced in 1996). Some of these products are being heavily advertised so as to create a consumer demand. If the pharmacist is not prepared to hand out the most recent OTC wonder drug then the patient may well go elsewhere. I would suggest that this is probably no bad thing. If you reasonably suspect that the patient has a problem with addiction or if in your professional opinion the medicine is inappropriate and if your judgment turns out to be correct then although you may have lost a small sale you have gained the peace of mind of knowing that you avoided a potential future action for substantial compensation. The fact that a medicine has been deregulated to OTC status has not really changed its inherent nature or in my opinion the standard of vigilance required from the pharmacist in relation to the supply thereof. 3.5.2 Prescription Only Medicines As a lay person in the area of pharmacy I am well aware of reported abuses of antibiotics and accusations of over dependence on antidepressants and anxiolytic medication. I do not think that any pharmacist with hand on heart could deny that there has been some over prescribing in these areas. What duties, if any, does the pharmacist have if faced with such possible abuses? Over and above your statutory

17

Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

requirements which you operate any way, it seems to me that the law would require more from you. The pharmacist in a community pharmacy is often the last and only bulwark between the marketing forces of large drug companies, the pressures on an over worked medical practitioner and an unwell patient. It was never my opinion that a pharmacist should or could act as a mere conduit in the supply of medicines and this is recognised by the Learned Intermediatory rule propounded in the case of Buchan V Ortho Pharmaceutical (Canada) Limited. In straight forward cases such as Dwyer V Roderick & Others 1983 127 Solicitors Journal where a pharmacist failed to notice a gross mis-direction in a prescription it was held that the pharmacist was also under a more rigorous duty to exercise independent judgment so as to ensure not only that the prescription was correctly dispensed but also that it was suitable for the patient. In the other case of Predergast V Sam & Dee Limited & Others 1989 Medical law Reports page 36 a pharmacist was found negligent for failing to pay sufficient attention to the prescription but not for misreading amoxil as daonil. It is interesting to note by way of aside that in an article entitled Dispensing with Error in the February 1992 issue of the Irish Pharmacy Journal there is a list of some 350 drugs and opposite each one of these is the name of another drug with which it could easily be mistaken. The combination of such similar names and the traditionally bad handwriting of medical practitioners makes for a lethal cocktail. In the area of prescription only medicines the significance of the new contract and in particular Sections 1(2) and 4(3) and 9 thereof cannot be underestimated. You can no longer simply dispense a medicine just because a patient presents a prescription which demands it. You must exercise your professional judgment. The same remarks as I made concerning OTCs apply here. You must bear in mind that in areas of addiction the law may require an even higher standard of care from you than would apply to you normal patients. 3.5.3 Controlled Drugs Controlled drugs are the heavy weights. As you know the Society and the Medical Council have agreed on a common approach to the matter of prescribing and dispensing controlled drugs. At the core of this common approach is the notion that controlled drugs should be prescribed by local medical practitioners for local patients and dispensed in local pharmacies. Controlled drugs tend to be more associated with the traditional view of the addict as outlined earlier. There are of course non-stereotypical abusers of controlled drugs such as doctors and pharmacists themselves. How should a pharmacist deal with a colleague or a medical practitioner whom he suspects may be abusing controlled drugs? The law relating to controlled drugs and the guidelines of the Society have been well set down and widely promulgated and I do not propose to take up time in this article in dealing with them. The area where the pharmacist may not have existing guidelines are the procedures which might be followed in participating in the maintenance and care of addicts under a methadone management programme. If the pharmacist becomes involved in such a programme what are his responsibilities to: (a) The patient in question? (b) His staff? (c) His other patients? (a) The patient in question I believe that the duty of the pharmacist to such a patient is governed by the same laws of contract and tort which have been outlined earlier. If there is imposed on the pharmacist any additional requirements by a local health board then clearly the

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

pharmacist must also comply with those requirements. The same would apply to any requirements imposed on him by the Society. The pharmacist must of course, be mindful of the fact that the patient whom he is treating is suffering under a disability and appropriate allowances must be made to ensure that patient understands: (a) The dosage form, the method a route of administration and duration of therapy (b) Any special directions and precautions for administration and use of the medicine (c) The importance of compliance with directions for use (d) Any common severe side effects and adverse reactions and interactions (e) Therapeutic contraindications that may be encountered including their avoidance (f) The action required should they occur (g) Techniques for self-monitoring during therapy (h) The need for patient compliance, proper storage of the medicine, action to be taken in the event of a missed dose (i) Methods for the safe disposal of the medicine in the event of the course of treatment not being completed. As you will have observed the points which I have made in paragraph (a) to (i) above come once again from the famous Clause 9 of the new contract. In so far as the patient is suffering under a disability it may in many cases be very difficult for the pharmacist to get this information across. This does not mean they should not try. It might be a sensible precaution to furnish the information in written form. I do not think this would act as a substitute but certainly as a sound aid. The pharmacist must do more than pay mere lip service to his obligations. Safe methadone dispensing practice I would like to bring to your attention something which at present can be referred to as no more than a practice. This practice is currently being operated to good effect by pharmacists who are engaged in methadone treatment programmes. It is based on two precepts. The first is that there must be an assumption of noncompliance on the part of the addict. The second is that the programme is based on an agreement or understanding with the addict. Under the regime the pharmacist lays down the rules based on the assumption of non-compliance. If the addict cooperates, the programme proceeds. If he does not it is terminated. It has been found that this system works even more effectively when there is close co-operation with the local medical practitioner. Some of the aspects covered by the agreement or understanding between patient and pharmacist would be: Present non-intoxicated An agreed time for the addict to present in the pharmacy Come alone No interference by the addict with other patients or staff No congregation outside The seal is broken on dispensation No broken bottle excuses Care of children Some pharmacists find it helpful to put these points (when agreed with the addict) in writing. The sanction for breach is no further supply.

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

(b) Duty to staff I referred earlier to the Safety Health and Welfare at Work Act 1989, the main purpose of which was to make provision for securing the safety, health and welfare of persons at work and to protect them against risks to safety or health arising out of or in connection with their activities at work. The Safety Health and Welfare at Work (General Application) Regulations 1993 were made pursuant to the 1989 Act. The general duties of employers are set out in the first schedule to the Act and include the avoidance of risks, the evaluation of unavoidable risks and the adaptation of the place of work to technical progress. The Regulations oblige employers to provide information to employees in relation to safety and health and protective and preventative measures and to consult and train employees on matters relating thereto. In this regard the employer must publish a safety statement. The booklet, issued by the Health and Safety Authority in 1994 entitled Guidelines on Safety Statements sets out how an employer should draw up a safety statement and publish it to his employees. I recommend that you should at all obtain a copy from the HSA. The safety statement must identify the hazards in the work place and specify the manner in which safety, health and welfare are to be secured. The employer must provide appropriate information, instruction and training for personnel and must identify hazards to them. A hazard is defined as anything which can potentially cause harm. The guidelines deal with biological agents and human factors and suggest regular health checks for employees where appropriate. It seems to me (although not on the basis of any statistical evidence which I have) that persons on methadone treatment are likely to have a high instance of hepatitis B or be HIV positive. If my assumption is correct then I believe that a pharmacist is under an obligation to educate, train and protect his staff against the manifest dangers which these and other conditions associated with unfortunate drug abusers can present to employees. If this means offering periodic testing facilities and where appropriate vaccinations then this is what you must do. Dealing with addicts may also involve setting up security precautions for your staff. This is perhaps something upon which expert advice should be taken. The area of employers liability is an area of law upon which whole text books have been written and there is no possibility of dealing with in any meaningful way in this paper. Suffice is to say that you as employers should acquaint yourselves with your obligations under the employment law and ensure compliance therewith. (c) Responsibility to patients I have outlined earlier in this paper the general duties and responsibilities which you have under contract and in tort your patients. In addition to those duties you, as the proprietors of a business and the owners of a premises have a further duty to ensure that your premises is safe and secure. You must take all necessary steps to ensure that they are so. If you do not and a patient is injured then you may be liable to them in damages. If in the course of your business you supply controlled drugs then it is inevitable that you will attract to your premises a proportion of drug damaged people. If an addict under the compulsion of his addiction bursts through the security lock on the front door of your premise and holds a blood-filled syringe to neck of one of your patients with the demand that you supply him with a controlled drug, what are your responsibilities to the patient? In another situation, what if you supply controlled drugs to an addict in a container which is not child proof and the drug is consumed by a child who is permanently brain damaged or dies? What are your responsibilities? I could go on posing questions in these areas all day but I cannot give you hard or fast answers. It would be dangerous to do so. Each case must be judged according

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

to the merits of its individual circumstances. The standards as enunciated by statute, at common law and by the Society must be applied thereto. Your conduct will then be judged by reference to how closely you have adhered to standards. If you have not even taken the trouble to find out what the standards are then it is inevitable that you will end in trouble. If the conduct of addicts who are habitually on or about your premises by your invitation is such that it constitutes a danger or threat to the safety of your patients and if you fail to take steps to protect your patients against such danger which subsequently manifests itself in the form of violence then you may well be held liable. In general a person is not responsible for the acts of another and cannot be made legally liable therefore. If for example, you are unlucky enough to be in a bank when it is raided then as a general rule you will not be compensated by the bank. The difference in this instance is of course that the raiders are not present with the consent of the proprietors. 3.6 Questions and Answers In the final part of the address given by Mr Dowling, he posed a series of questions which exhibited legal dilemmas which pharmacists could face in the course of the practice of their profession. He then provided his opinion on the various dilemmas posed. Q: Is a pharmacist allowed under law to refuse to dispense a correctly written prescription? Is this decision influenced by the fact of whether the prescription is private or GMS? A: Yes, the pharmacist is in all circumstances entitled to refuse to dispense a correctly written prescription where, in the exercise of his professional judgment, such dispensation would not be in the best interest of the patient. In this regard, I refer to Clauses 1(2) and 1(3) of the new GMS contract. I would go further and state that, in some instances, not only is the pharmacist permitted to refuse to dispense prescriptions but he or she must so refuse. In relation to whether the prescription is a private one or a GMS one, I do not think that this should affect the principles of good pharmacy practice in accordance with which the pharmacist is obliged to operate. In one sense, however, it might be easier for the pharmacist to refuse to dispense a GMS prescription because the pharmacist would be able to point to the terms of the GMS agreement which are quite clear in this regard. Q: If a pharmacist dispenses methadone to an addict he knows to be taking other drugs (i.e. because the patient is involved in a harm reduction course where he is allowed to use other drugs, or because he is visibly intoxicated) and the patient suffers an overdose could the pharmacist be seen to have been negligent and therefore partially or wholly responsible for any damage done to the patient? A: This question is almost a leading question. It is not the case that a pharmacist might be seen to have been negligent but whether the pharmacist is, in fact, negligent or not. In this regard, I would refer you to the general observations made in the previous article on the question of the negligence of pharmacists. As stated, a pharmacist is obliged to exercise particular care and attention when dealing with patients whom he or she knows to be taking drugs. Q: It is normally recommended that methadone be supplied in child resistant containers, but this is not legally required. Many instances of accidental overdoses of methadone have been reported, mainly in children. Would a

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

pharmacist be deemed to be negligent in this respect if he or she supplied methadone in an ordinary bottle which was later ingested by a child? A: I believe that a pharmacist would be deemed negligent if he or she supplied methadone in non child-resistant containers. In the circumstances described, the fact that there is no specific section in an act or statutory instrument requiring a pharmacist to use child-resistant containers is not in itself sufficient reason to absolve the pharmacist from liability in the matter. What must be looked at is best pharmaceutical practice which, I believe in this instance, would require the use of child-resistant containers. Q: Given that heroin addicts can have a higher incidence of diseases such as TB, Hepatitis and HIV, does this imply that pharmacists who agree to take on addicts for methadone maintenance therapy have additional responsibilities to their staff and other patient and customers who frequent the pharmacy? A: I believe that if a pharmacist decides to take on addicts in the circumstances described that there are indeed additional responsibilities attaching to him or her. In particular, regard must be given to the security arrangements which would be required to embark safety on such a programme. In this regard professional advice might have to be taken from a firm of security consultants. Furthermore, the pharmacist should also consult the Societys document containing its policy on drug abuse and which contains guidelines in this regard. The pharmacist should probably also introduce optional vaccination for members of staff (including part-time staff) who wish to avail of it. This would obviously have to be paid for by the pharmacist and not by the staff member. Q: Is the proposed new anti-discrimination legislation likely to cause problems for pharmacists who might in the past have refused to supply potentially addictive OTC medicines to potentially suspicious patients? Is the situation complicated by the fact that many pharmacists keep such medicines out of view in order to make it easy for them to refuse to sell them if necessary by claiming they are out of stock? A: I dont believe that the new legislation should cause any problems because the grounds upon which the pharmacist will refuse to supply would presumably be grounds relating to the patients welfare and not to their class, creed or colour. In relation to the second part of the question, I think that this a ruse which is used by pharmacists on occasion to avoid confrontation with patients. In essence, the pharmacist is telling an untruth which is always dangerous. If the pharmacist does not clearly state a genuine reason why he or she is refusing to supply, then their conduct is always open to interpretation at a later stage. The patient might in that situation be able to allege grounds of discrimination if the patient subsequently discovers that the pharmacist did in fact have the medicine in stock but out of view. Q: If a pharmacist becomes aware that a patient is frequently buying large quantities of OTC medicines (e.g. painkillers which contain codeine or laxatives which may he abused by young women who are dieting), does he or she have a duty to confront the patient regarding the possibility of addiction or is it acceptable to become suddenly out of stock of such medicines although this may mean that the customer will just go somewhere else instead? A: I believe that the pharmacist does have a duty not to confront but to consult with their patient in relation to those anxieties which the pharmacist has concerning the supply of these medicines. If the pharmacist, having made all reasonable enquiries, is satisfied with the replies which he or she receives from the patient then there is no harm done. If the pharmacist is not satisfied, then the pharmacist must refuse to supply.

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Sect ion 1 Legal Dilemmas faced by Pharmacists in the area of Addiction

I would refer you to Clause 9 of the new GMS contract which sets out very clearly what the duties of the pharmacist will be in relation to prescription only medicines. I think it would be irrational to assume that the same duties would not apply to the pharmacist in relation to OTC medicines as well. Q: Where does a pharmacist stand if they deliberately choose to sell large packs of paracetamol (e.g. 100 tablets) in breach of the PSI/IPU joint guidelines which state that not more than one pack of 24 tablets should be sold by pharmacists at any one time? A: If the pharmacist has chosen to act outside the PSI/IPU guidelines on paracetamol and, if a person suffers harm as a result, then I believe that there could be a prima facia case of negligence raised against the pharmacist. In any situation where the pharmacist is going to depart from these guidelines, the pharmacist should document in a permanent way this departure and the reasons therefore. If they do not do so, then they risk being confronted with a negligence action which they may afterwards be unable to defend. Q: If a pharmacist has very strong suspicion that a prescription, for a controlled drug is forged but cannot get firm proof of this because the supposed prescriber is uncontactable, how should he or she proceed? A: I think that a good rule of thumb here is if in doubt dont. In this regard I would refer you to Article 14 of the Misuse of Drugs Regulations, 1988 which states that a person should not supply a controlled drug unless he either is acquainted with the signature of the person by whom it purports to be issued and there is no reason to believe the signature is not genuine or has taken reasonably sufficient steps to satisfy himself that it is genuine. This may occasionally lead to a confrontation with a patient but each individual pharmacist will have to work out his or her own particular way of dealing with such a confrontation should it arise. Q: Where does a pharmacist stand if he or she continues to dispense benzodiazepines for a patient over a prolonged period in light of consistent recommendations in the medical and pharmaceutical literature that they should only be used short-term? Does he or she have a duty to ask the prescriber to review the patients therapy and what happens if the prescriber refuses to do so? A: In my opinion, if a pharmacist continues to dispense in the manner described they are acting in a way which would suggest prima facia negligence, for which they may be subsequently be made liable for damages. I believe that the pharmacist is under a heavy duty to ask the prescriber to review the patients therapy. I would even go further and say that even if they had good reason to disagree with the prescribers view, then they are under obligation to refuse to dispense, notwithstanding the fact that the prescribers view may be to the contrary. A pharmacist is not a mere conduit of medicines for a doctor. He or she must think for themselves and make judgments accordingly.

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CODES OF ETHICS & PRACTICE


SECTION 2

Pharmaceutical Society of Ireland CODES OF PRACTICE


CONTENTS 1. 2. 3. 4. Good Pharmaceutical Practice Guidelines for Dispensing Prescriptions Guidelines on Dealing with Errors Code of Practice on the Use of Personal Information on Computer 5. General Guidelines on the Production and Implementation of Medicines Sales Protocols 6. Code of Practice governing the Temporary Absence Clause of the Pharmacy Act, 1890 Council Statement on the use of Generic Medicines in Pharmaceutical Practice
7.

8. Pregnancy Testing in Pharmacies 9. Cholesterol Testing in Pharmacies 10.Guidelines on Storage of Medicines in Community Pharmacies 11.Guidelines on dealing with Requests for Information 12.Guidelines on Advertising by Pharmacists 13.Guidelines On Extemporaneous Dispensing 14.Best Practice Guidelines On The Provision Of Pharmacy Services To Residential Homes By Community Pharmacies 15. Best Practice Guidelines On The Use Of Dosage Compliance Systems
16. Guidelines On The Treatment Of Opioid Misusers 17. Revised Society Policy On The Use Of Child Resistant Containers (CRCs)

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Sect ion 2 Good Pharmaceutical Practice

1. GOOD PHARMACEUTICAL PRACTICE


1.1 Introduction This code of practice offers a generalised overview of the standards expected by the Society of all pharmacies. Detailed guidance on specific practice areas is available throughout the remainder of the Practice of Pharmacy Guide. 1.2 Appearance of Premises The external appearance of a pharmacy, including any window displays, should be dignified, tasteful and professional in character. Signs should be restrained in size, design and terms, and should not be associated with advertising. Titles or descriptions should be accurate and non-repetitive, and should not reflect on the status or competence of other pharmacists. The internal layout should be so designed as to enable the normal activities of a pharmacy to be carried out efficiently and with safety. The pharmacy should be sufficiently spacious to cope with the normal volume of business. Overall, the main impression should be one that is in harmony with the professional character of pharmaceutical services. 1.3 Suitability of Premises The pharmacist should satisfy himself that all areas of the pharmacy are suitable for the operations being carried out and should ensure that they are: Free of all sources of contamination. Maintained in a clean and tidy condition. adequately lit, heated and ventilated, and Generally kept at a high level of hygiene. The public area of the pharmacy should be so constructed that the public cannot have direct access to medicines or poisons. Medicines are not just like ordinary items of commerce, consequently, they should not be displayed on open self-selection shelves, gondolas or in dumper bins. Medicines and related medical or pharmaceutical stock should be kept separate from general merchandise. If possible, there should be two distribution points to complement the principle of separation. The needs of the customer should be taken into account by the provision of waiting facilities (seating) and a suitable area should be available for private consultations. A separate consultation area should be provided where it is feasible to do so. The dispensing department should be large enough to allow an efficient flow of work. It should be sited so as to enable the pharmacist to supervise, from there, all the activities of the pharmacy. Open dispensaries, where the public can observe what is happening, should not allow unauthorised access to medicinal preparations. The overall impression should be bright, cheerful, tasteful, clean and professional. A specific area, ideally completely separate from the dispensary, should be kept for office work.

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Sect ion 2 Good Pharmaceutical Practice

In addition, proper storage facilities, away from the dispensary, should be available for the storage of surplus stock, cleaning equipment, coats etc. Food must not be consumed or stored in the dispensary area. The licence certificate of the supervising pharmacist should be prominently displayed in the pharmacy. Children should not be permitted in the dispensary for their own safety and also to avoid distracting those engaged in dispensing and other activities. This will also be of the benefit to patients who wish to consult privately with the pharmacist without disruption. Animals, other than guide dogs, should not be allowed in the pharmacy. All areas of the pharmacy should be designated no-smoking zones. The prohibition on smoking should include pharmacy staff as well as customers. Discrete background music is permitted but radio chat shows or loud music should not be played in the dispensary or other public areas of the pharmacy. Toilet facilities should be appropriately located and maintained. They should not be used for the storage of stock. Water for dispensing purposes must not be obtained from the toilet handbasin. 1.4 Suitability of Equipment & Reference Texts The pharmacist should satisfy himself that the equipment in his possession is adequate and suitable for the operations to be carried out. In this regard, each pharmacy should contain: a) A dispensing bench having a smooth, impervious & washable finish working top. It is recommended that there be at least 2 x 6 of clear space on the bench (note additional space should be provided for the computer, tablet counter, extemporaneous equipment, etc.) Such a bench should be used solely for the purposes of compounding and dispensing. All other work surfaces and shelving in the dispensary should be finished with a smooth impervious & washable material. b) A sink fitted with a good quality draining board and a supply of hot and cold water. c) A suitable range of equipment for extemporaneous dispensing including: (i) A dispensing balance, accurate to not more than 10mg, with a set of weights ranging from 10mg-60g. (ii) An accurate weighing scale balance having a capacity not exceeding 2.5kg, complete with a set of weights ranging from 5g-2kg. The pharmacist should ensure that each weighing apparatus in his possession and all weights and measures in use in his pharmacy are government stamped. (iii)A range of graduated glass measures, including pipettes, capable of accurately measuring volumes from 0.05ml-500ml. (iv)A suitable range of porcelain mortars and pestles including one set composed of glass. d) A refrigerator unit complete with thermostat having a selected temperature range from 0C to 15C for the storage of thermolabile medicinal products. Food must not be stored in the refrigerator.

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Sect ion 2 Good Pharmaceutical Practice

e) At least one locked cabinet, preferably concealed, the minimum standards for which are laid down in the Misuse of Drugs (Safe Custody) Regulations, 1982, as amended, for the safe keeping of controlled drugs in the pharmacy. The keys to this cabinet should be held solely in the custody of the pharmacist personally managing and conducting that pharmacy. f) A source of purified water BP. Care should be taken to ensure that all purified water is maintained in usable condition. g) A suitable range of tablet and capsule containers, to provide for the dispensing of quantities ranging from 10-500 unit dosage forms. [deleted by the Revised Society Policy on the Use of Child Resistant Containers, Oct 2003]
h)

i) A suitable range of plain containers for liquids to provide for the dispensing of volumes ranging from 10ml-500ml and suitable ribbed or fluted containers for poisons and non-oral preparations. j) A range of containers suitable for the dispensing of creams, ointments and pastes, not including cardboard boxes and cartons, to provide for the dispensing of quantities ranging from 5g- 500g. k) Returned containers or empty manufacturers tablet bottles should not be used for dispensing. l) A range of labels suitable for use with those containers specified above. All labels for dispensed medicines should be mechanically printed using a typewriter or computer labeller in order to ensure the clarity and legibility of the written instructions. m) An adequate supply of steel and non metallic spatulas, glass stirring rods, ointment slabs, tablet counting trays, dispensing date stamps, disposable rubbish containers and disposable hand towels. n) A bound prescription book which has numbered pages for the purpose of recording prescriptions; suitable methylated spirits, poisons, misuse of drugs and veterinary antibiotic registers. If a computer capable of maintaining patient records is in use, a printout of all private prescriptions is acceptable instead of recording in the prescription book, provided it is performed daily and duly signed by the pharmacist. Such printouts must be filed and retained for two years in the pharmacy. o) A library which should be adequately stocked with current reference books, journals and statutory regulations pertaining to the practice of pharmacy and to the sale and supply of medicines and poisons. Essential textbooks include Martindale (current edition), the British National Formulary (current edition) & the Data Sheet Compendium. Other recommended texts include reputable textbooks on pharmacology, drug interactions, minor illnesses, first aid, etc. p) A suitable means of counting tablets and capsules. Steps should be taken to avoid cross contamination particularly when using mechanical counters e.g. when counting uncoated tablets. q) Regular cleaning of such counters is essential. Direct contact between the operators hand and the dispensed product should be avoided.

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Sect ion 2 Good Pharmaceutical Practice

r) A suitable means of filing dispensed prescriptions, which must be retained for 2 years from the date of dispensing. s) A supply of disposable plastic cups and drinking water for patients who wish to consume medicines on the premises. t) The pharmacist should ensure that all equipment is thoroughly cleaned after each individual use and that it is stored in an orderly manner ready for the next task for which it may be required. u) A telephone.

1.5 Pharmacy Personnel The dispensing of medicines should be carried out by suitably trained personnel under the personal supervision of the pharmacist. All persons engaged in dispensing should observe high standards of personal cleanliness. Protective clothing (eg. white coat) is recommended and should be regularly laundered. Otherwise, staff should dress in a professional manner. No person with cuts or skin infections should be involved in the dispensing process. Identification badges bearing the name and qualification of pharmacy personnel are recommended eg. Mr J Kelly Ms M Smith Pharmacist Pharm. Technician 1.6 Dispensing Procedure A suitable procedure for the receipt of prescriptions and supply of dispensed medication should be in operation. An adequate checking system is essential. Care should be taken to positively identify the patient at the point of collection. Pharmacists should refer to the Societys guidelines entitled Guidelines for Dispensing Prescriptions. Only licensed medicines (i.e. those with product authorisations) should be used except where the product is being dispensed extemporaneously by the pharmacist. Where rotas currently exist, pharmacists are strongly recommended to participate. Otherwise, consideration should be given in emergency or urgent situations to the availability of medicines outside the normal opening hours of the pharmacy eg. by on-call arrangements. Pharmacists must at all times have regard to the laws and regulations applicable to pharmaceutical practice and maintain a high standard of professional conduct.

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Sect ion 2 Guidelines for Dispensing Prescriptions

2. GUIDELINES FOR DISPENSING PRESCRIPTIONS


2.1 Introduction When supplying a medicine on prescription the safety of the patient is paramount and must be secured by due diligence and care. Dispensing medicines is not something that can or should be done quickly or on autopilot but is a process which requires due consideration and attention to detail. Accordingly, a sequence should be followed which has built-in error control and enables the application of requirements for correct handling and use of drugs. When necessary the pharmacist should exercise professional judgement and discretion. Professional judgement is a concept which is central to the role of the pharmacist. The exercise of such judgement is essential from the moment the prescription is received. The pharmacist should be satisfied as to the appropriateness of each prescription rather than following the prescribers Instructions unquestioningly. This involves checking for interactions, overdose or misuse. When a query or problem arises the pharmacist must use professional judgement to decide on the course of action to be taken, taking heed of generally approved practice in the particular situation to hand. In order to facilitate this, a pharmacist should keep abreast of all developments relevant to the area of practice. The pharmacist should have access to sufficient reference material to make an informed judgement and be able to consult with colleagues where appropriate. Once the prescription is dispensed its delivery is of vital importance as it provides the opportunity for pharmacist counselling on all such matters as are important for the most effective use of the medicines. The pharmacist may need to balance the benefits of giving information on side-effects with the possibility that such information can lead to poor patient compliance. In summary, pharmacists are healthcare professionals and not mere conduits for the supply of medicines. They are ultimately responsible to their patients and should be ever mindful of this. 2.2 Receiving the Prescription 2.2.1Insofar as possible all prescriptions should be received by a qualified member of staff. 2.2.2The person receiving the prescription should ensure that they know who the prescription is for and that they can read the patients name and address or otherwise record same on the prescription. 2.2.3The pharmacist should record the patients telephone number where he considers this appropriate. 2.2.4In the case of a prescription for a child, the childs age should be ascertained and written on the prescription (if the prescriber has not already done so). 2.2.5When setting up a new Patient Medication Record a qualified member of staff should establish from the patient or messenger, where possible, if any allergic reactions or adverse drug reactions have occurred in the past. 2.3 Checking the Prescription

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Sect ion 2 Guidelines for Dispensing Prescriptions

2.3.1 The first requirement is that a prescription be legible. If it is ambiguous the prescriber should be contacted. Furthermore, there should be an alert at all times for forged prescriptions. Prescriptions presented by strangers or from unfamiliar prescribers for potential drugs of abuse must be appropriately screened before dispensing.
2.3.2

Where no labelling instructions are specified by the prescriber the pharmacist should first ascertain whether these have been verbally transmitted to and understood by the patient. If this is not the case then the prescriber should be contacted and the pharmacist should act in consultation with them. If the prescriber cannot be contacted then the pharmacist should proceed by exercising his professional judgement to decide whether to dispense the prescription and how best to label it appropriately.

2.3.3The prescription must comply with the following legislative requirements: 2.3.3.1 It should be written in ink. 2.3.3.2 It should be signed and dated by the prescriber. 2.3.3.3 It should clearly indicate the prescribers name & state whether he is a doctor or a dentist. 2.3.3.4 It should specify the patients name and address (and age if under 12 years). 2.3.3.5 Except in the case of health prescriptions, it should specify the address of the person issuing it. 2.3.3.6 A prescription which is deficient in one of the above requirements may be dispensed if the pharmacist, exercising due diligence and care, is satisfied that it is safe to do so. 2.3.4The prescription must be legally valid for dispensing in that: 2.3.4.1 It must have been written within the last six months. 2.3.4.2 Where neither the number of occasions on which nor the intervals at which an S1A preparation may be supplied are specified in a prescription, the prescription may be dispensed on one occasion only. 2.3.4.3 Where neither the number of occasions on which nor the intervals at which an S1B preparation may be supplied are specified, the prescription may be dispensed on such number of occasions within the period of six months after the date thereon as the pharmacist considers appropriate having regard to the specified rate of dosage. 2.3.4.4 Where the intervals at which an S1A preparation may be supplied are specified but not the number of occasions, the prescription may be dispensed on not more that three occasions. 2.3.4.5 Where the intervals at which an S1B preparation may be supplied are specified, the prescription may be dispensed at those, intervals within six months after the date thereon. 2.3.4.6 Where the number of occasions on which S1A or S1B preparation may be supplied are specified but not the intervals, the prescription may be dispensed at such intervals as the pharmacist considers appropriate having regard to the specified rate of dosage. 2.3.5Controlled drug prescriptions must comply with the following further legal requirements: 2.3.5.1 The prescription must be presented within 14 days of its date of issue. 2.3.5.2 It must be written out in full by the prescriber in his usual handwriting.

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Sect ion 2 Guidelines for Dispensing Prescriptions

2.3.5.3 It must bear a telephone number at which the prescriber may be contacted (not required for GMS prescriptions). 2.3.5.4 It must specify the following: 2.3.5.4.1 The name of the drug. 2.3.5.4.2 The dose to be taken. 2.3.5.4.3 The form in the case of preparations. 2.3.5.4.4 The strength (where appropriate). 2.3.5.4.5 The total quantity in both words and figures. 2.3.5.4.6 In the case of a prescription to be dispensed by instalments, it must specify the number of instalments and the intervals to be observed when dispensing. 2.3.6A pharmacist may supply a medical preparation otherwise than in accordance with a prescription where the following emergency supply conditions are met. 2.3.6.1 Emergency supply at request of practitioner: The pharmacist has been requested to supply the preparation for a particular patient by a registered medical practitioner or registered dentist who by reason of an emergency is unable to furnish a prescription immediately, and 2.3.6.1.1 The practitioner concerned has undertaken to furnish a prescription within 72 hours. 2.3.6.1.2 The preparation is supplied in accordance with the directions of the practitioner requesting it. 2.3.6.1.3 The preparation is not a controlled drug specified in Schedules 1, 2, 3, 4 to the Misuse of Drugs Regulations, 1988 (except methylphenobarbitone, phenobarbitone or phenobarbitone sodium for the treatment of epilepsy). 2.3.6.2 Emergency supply at request of patient: The pharmacist has interviewed the person requesting the preparation and has satisfied himself: 2.3.6.2.1 That there is an immediate need for the preparation to be supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay. 2.3.6.2.2 That treatment with the preparation has on a previous occasion been prescribed by a registered medical practitioner for the person. 2.3.6.2.3 That he can in the circumstances safely specify the appropriate dose of the preparation for the person. 2.3.6.2.4 No greater quantity of the preparation than will provide five days treatment is supplied except where the preparation is; an aerosol for asthma, an ointment or cream in which case the smallest container should be supplied; an antibiotic for oral administration in liquid form and the smallest quantity that provides a full course of treatment is supplied; or an oral contraceptive and a quantity sufficient for a full cycle is supplied. 2.3.6.2.5 The preparation does not consist of or contain a substance specified in the Fourth Schedule to the Medicinal Products (Prescription and Control of Supply) Regulations 1996, and is not a controlled drug specified in the Schedule 1, 2, 3 or 4 of the Misuse of Drugs Regulations 1988 (except methylphenobarbitone, phenobarbitone or phenobarbitone sodium for the treatment of epilepsy).

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Sect ion 2 Guidelines for Dispensing Prescriptions

2.4 Review of Medicine Therapy 2.4.1 The pharmacist must review the medicine therapy of the individual for whom the prescription is issued, this includes screening for any potential drug therapy problems which may arise out of the use of the medicines prescribed. 2.4.2 Where a generic equivalent is prescribed the pharmacist should check the patients history to ensure that the equivalent prescribed is appropriate, having regard to previous proprietary or other generic equivalents which the patient may have received in the past. Insofar as possible the patient should be maintained on the same generic preparation with which therapy was initiated. 2.4.3 If there is any change in a repeat prescription such change should be confirmed with the patient prior to dispensing the prescription. 2.4.4 In the case of infants or children the date of birth should be ascertained and entered in the new PMR. 2.4.5The pharmacist should retrieve the patients medication record or in the case of a new patient, establish a new record, and: 2.4.5.1 Check that the dosage and dosage interval of each preparation is within the limits set by the standard sources listed at 2.4.5.8 below. 2.4.5.2 Check that the duration of drug treatment is within the limits set by the standard sources listed at 2.4.5.8 below. 2.4.5.3 Check that the prescribed preparations will not lead to unintended therapeutic duplication. 2.4.5.4 Check for any known previous drug/allergy interactions. 2.4.5.5 Check for possible unwanted side effects in the standard sources listed at 2.4.5.8 below. 2.4.5.6 Check for clinical abuse and/or misuse. 2.4.5.7 Check for drug-drug interactions (including serious interactions with non-prescription or over-the- counter medication or foods) in the standard sources listed below. 2.4.5.8 The standard sources for the review of medicine therapy are: 2.4.5.8.1 The British National Formulary. 2.4.5.8.2 The Summary of Product Characteristics incorporated in a product authorisation granted under the Medical Preparations (Licensing and Sale) Regulations, 1996 (S1 No. 43 of 1996) or in an authorisation granted or renewed by the European Commission in accordance with EU Council Regulation number (EEC) 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products, as contained in data sheets for medicinal products. 2.4.5.8.3 Guidance notes published by the National Medicines Information Centre. 2.4.5.8.4 Martindale 2.4.6 When the review of medicine therapy reveals a problem the pharmacist should exercise professional judgement in order to evaluate its significance and decide on a course of action. When he deems it necessary, the pharmacist should act in consultation with the practitioner who issued the prescription. In a case where the prescriber cannot be contacted, or where such contact fails to solve the problem, the pharmacist should proceed by exercising his professional judgement to compare the consequences of supplying or not supplying the prescription. When a pharmacist must deviate from the prescribers instructions, whether through contacting the prescriber or researching the standard texts,

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Sect ion 2 Guidelines for Dispensing Prescriptions

this decision should be documented and communicated to the prescriber as soon as possible. 2.5 Dispensing Procedures 2.5.1 All medicines should be checked for expiry dates. 2.5.2 Each item to be dispensed should be collected with the prescription (preferably in a tray) on the dispensing bench. 2.5.3 Items of broken bulk should be stacked upon their original container for ease of identification. Loose tablets should be placed in an appropriate tablet phial while blister pack dispensed from bulk should be placed in a re-sealable sachet or an appropriate cardboard carton. 2.5.4 Where possible the pharmacist should strive for coherence in the quantities of different drugs dispensed, taking into account all the circumstances of the prescription. 2.5.5 Where no labelling instructions are specified by the prescriber the pharmacist should first ascertain whether these have been verbally transmitted to and understood by the patient. If this is not the case then the prescriber should be contacted and the pharmacist should act in consultation with them. If the prescriber cannot be contacted then the pharmacist should proceed by exercising his professional judgement to decide whether to dispense the prescription and how best to label it appropriately. 2.5.6 Preparations should be labelled with computer generated labels which must contain the following information: 2.5.6.1 The name of the person to whom the preparation is to be administered. 2.5.6.2 The name and address of the person by whom the preparation was supplied. 2.5.6.3 The date on which the preparation was dispensed. 2.5.6.4 Unless the prescriber otherwise directs, the name of the preparation. 2.5.6.5 Where the preparation is being supplied on foot of a prescription, such of the following particulars as the prescriber may specify: 2.5.6.5.1 Directions for use of the preparation and precautions relating to the use of the preparation. 2.5.6.5.2 Or where a pharmacist in the exercise of his professional skill and judgement is of the opinion that any of such particulars are inappropriate and has taken such steps as in all the circumstances are reasonably practicable to consult with the prescriber but has been unable to do so, particulars of the same kind as those requested by the prescriber as appear to the pharmacist to be appropriate. 2.5.6.6 Where the preparation is not being supplied on foot of a prescription, the directions for use and the words Emergency Supply. 2.5.6.7 The words Keep out of the reach of children. 2.5.6.8 Where the preparation is for external use only, the words For external use only. 2.5.6.9 Such of the cautionary and warning notices specified in the Sixth Schedule to the Medicinal Products (Prescription and Control of Supply) Regulations 1996 as are in the opinion of the pharmacist deemed to be necessary.

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Sect ion 2 Guidelines for Dispensing Prescriptions

2.5.7 When affixing labels the pharmacist should take care to ensure that no important information present on the manufacturers original pack is obscured. Furthermore, the label should not be affixed in such a way as to provide an impediment to any manual dexterity required in the use of the medicine. 2.5.8 Patients should always be advised to keep all medicines out of the reach of children. The Pharmaceutical Society of Ireland is seeking to make the use of Child-Resistant Containers (CRCs) mandatory for all dispensed oral medicines. Pending the introduction of the necessary regulation in this regard, all pharmacists should always use CRCs when dispensing any solid medicinal product for oral use that is not blister packed. Opaque blister packs are considered to be sufficiently child resistant. However, transparent blister packs are not and should always be supplied in an opaque outer e.g. a cardboard box to minimise the risk to children. Similarly, medicinal products in liquid form should only be dispensed in a CRC. Where a liquid preparation is supplied in the manufacturers original pack which is not a CRC, the pharmacist is expected to replace the closure with a child resistant one if at all possible. However, if the pharmacist cannot supply it with a child resistant closure, they are expected to advise the patient or their representative, that it does not have a child resistant closure and that it should be even more carefully stored, out of the reach of children at all times. In very exceptional circumstances, the pharmacist may use non-CRCs where in their professional judgement, the use of CRCs might pose excessive difficulty for the patient. However, before deciding to use a non-CRC, the pharmacist must review in full with the patient concerned the individual particular circumstances and be satisfied that the use of CRCs would: i cause the patient excessive difficulty on an on-going basis in getting the medication out of the container and ii be likely to compromise the safe, effective and compliant use of the medication. A full record of such an intervention should be made by the pharmacist in the patients medication record. When dispensing a medicinal product for oral use in a non-CRC, the pharmacist should advise the patient or their representative on each occasion of the need to ensure that the product is safely stored out of the reach of children at all times. [inserted by the Revised Society Policy on the Use of Child Resistant Containers, Oct 2003] 2.5.9 Under no circumstances should returned medicines be reused. Any medicines returned by patients or their agents to the pharmacy should be disposed of in the appropriate manner. 2.5.10 The pharmacist should include a patient information leaflet if one is available. 2.5.11 Before packaging or delivering the prescription, the dispensed medicine should be checked against the prescription by the people involved in the dispensing process. Both the person preparing each medicine and the pharmacist responsible for dispensing it should check that both the medicine and the label are correct. Both should also initial the label of the dispensed medicine. Particular attention should be paid to ensure that the correct labels are on the correct container and that the prescriptions instructions are interpreted correctly.

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Sect ion 2 Guidelines for Dispensing Prescriptions

2.5.12 The pharmacist responsible for dispensing the medicine bears the associated legal liability and professional responsibility. 2.6 Recording the Prescription 2.6.1 The prescription must be stamped and dated to indicate that it has been dispensed (also include prescription number). 2.6.2 If the prescription is to be returned to the patient, the pharmacist should clearly indicate the exact name and quantities of each prescription dispensed. (This is particularly important for generically written prescriptions). 2.6.3 The following information should be recorded in a prescription book or daily printout 2.6.3.1 The date on which the preparation was supplied. 2.6.3.2 The name, quantity and except where it is apparent from the name, the pharmaceutical form and strength of the preparation. 2.6.3.3 The name and address of the person for whom the preparation is prescribed. 2.6.3.4 The name and address of the prescriber and where it is not known to the pharmacist, his address. 2.6.3.5 The date of the prescription. 2.6.3.6 In the case of preparations dispensed on emergency supply pending a doctors prescription, the pharmacist must record the date on which the prescription is received. 2.6.3.7 Where the dispensing is on a second or subsequent occasion of a repeatable prescription, the pharmacist must record a reference to the first dispensing or where the supply on the last occasion was at another shop, the name and address of such shop and the reference to the entry in the aforementioned register for such shop in respect of such supply. 2.6.3.8 Where the dispensing is carried out under emergency supply regulations at the patients request, then the pharmacist must record the nature of the emergency, the name of the previous prescriber and where the supply on the previous occasion was at another shop, the name and address of such shop and the reference to the entry in the aforementioned register for such shop in respect of such supply. 2.6.4 Where an S1A and S1B medicine are both prescribed together and the S1A medicine dispensed, the prescription must be retained by the pharmacist. The patient must return to the pharmacy to have the S1B medicine repeated. Pharmacists must advise patients of the legal restrictions on S1A prescriptions prior to dispensing them. 2.6.5 When a prescription can no longer be repeated it should be retained by the pharmacist and kept on the premises for a minimum of two years. 2.6.6 If a Schedule 2 controlled drug or preparation is dispensed the transaction must be recorded in the Controlled Drug Register and the stock balance adjusted, at the time of dispensing, if possible, but no more than 24 hours later. 2.7 Delivery of Dispensed Medicines 2.7.1 The pharmacist should always deliver the dispensed medicine to the patient or his carer (who should be over 12).

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Sect ion 2 Guidelines for Dispensing Prescriptions

2.7.2 In order to ensure delivery to the correct patient, the individual(s) waiting for prescriptions who are unknown to the pharmacist should be asked for whose prescriptions they are waiting and the patients name and address should be called out if appropriate. The pharmacist should ensure that the correct medicine is delivered to the correct patient. 2.7.3 If there is any change in a repeat prescription the patient should be informed as this will invariably pre-empt a call back from the patient at a later stage. 2.7.4 The pharmacist should offer to discuss with the individual for whom the prescription is issued, or with the carer of such person, all such matters as the pharmacist in the exercise of his professional judgement, deems significant including the following: 2.7.4.1 The name and description of the medicine. 2.7.4.2 The dosage form, the method and route of administration and the duration of therapy. 2.7.4.3 Any special directions and precautions for the correct preparation, administration and use of the medicine(s). 2.7.4.4 The importance of compliance with the directions for use. 2.7.4.5 Any common severe side-effects and adverse reactions or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required should they occur. 2.7.4.6 Techniques for self-monitoring during therapy and the need for patient compliance. 2.7.4.7 Proper storage of the medicine. 2.7.4.8 Prescription repeat information (where necessary). 2.7.4.9 Action to be taken in the event of a missed dose. 2.7.4.10 Methods for the safe disposal of the medicine in the event of the course of treatment not being completed. 2.7.4.11 Any other matters which may be included or referred to in the patient information leaflet supplied with the medicine. 2.7.5 When a prescription is dispensed with less than the full amount required, the patient must be made aware of this. They should be given a suitable owings receipt, showing at least the following information. 2.7.5.1 The patient name. 2.7.5.2 The pharmacy name. 2.7.5.3 The item and quantity owed. 2.7.5.4 The date of issue. 2.7.6 A record containing full details against which the supply of the balance owing will be made must also be retained in the pharmacy. 2.8 Summary 2.8.1 Insofar as possible, all prescriptions should be received by a qualified member of staff who should check the patients name and address (and age in the case of a child). 2.8.2 If the prescription is ambiguous, the prescriber should be contacted. In a case where the prescriber cannot be contacted, or where such contact fails to solve the problem, the pharmacist should proceed by exercising his professional judgement to compare the consequences of supplying or not supplying the prescription.

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Sect ion 2 Guidelines for Dispensing Prescriptions

2.8.3 The prescription should be checked for compliance with all legal requirements including those for controlled drugs. 2.8.4 A medical preparation may be dispensed in the absence of a prescription if the emergency supply conditions are met. 2.8.5 The pharmacist should review the medicine therapy of the patient. This includes screening for any potential drug therapy problems which may arise out of the use of the medicine prescribed. Where a generic equivalent is prescribed the pharmacist should check the patients history to ensure that the equivalent prescribed is appropriate, having regard to previous proprietary or other generic equivalents which the patient may have received in the past. 2.8.6 The pharmacist should exercise his professional judgement in evaluating the significance of any problem revealed by the review of medicine therapy. If he deems it appropriate the pharmacist should act in consultation with the prescriber. 2.8.7 The items to be dispensed should be collected with the prescription on the dispensing bench with broken bulk items being stacked upon their original container for ease of identification. 2.8.8 All preparations should be labelled in accordance with legal requirements. 2.8.9 The dispensed medicines should be checked against the prescription by another member of staff and a patient information leaflet included if one is available. Both the pharmacist responsible for dispensing it and the person checking it should initial the label of the dispensed medicine. 2.8.10 The prescription should be stamped and dated indicating the quantities dispensed and the prescription reference number. 2.8.11 The legal requirements as regards records in a prescription book or daily printout should be observed. Controlled drugs should be entered in the register and the stock balance adjusted. 2.8.12 The pharmacist should always deliver the dispensed medicines to the patient and ensure correct delivery by calling out the patients name and address, if appropriate. 2.8.13 The pharmacist should offer to discuss with the patient or with the carer of such person all such matters as the pharmacist in the exercise of his professional judgement deems significant.

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Sect ion 2 Guidelines on Dealing with Errors

3. GUIDELINES ON DEALING WITH ERRORS


3.1 Introduction If an error occurs in the dispensing of a medicine, either on prescription or overthe-counter, the pharmacist in charge has full responsibility for dealing with this. The error should be dealt with promptly, efficiently and professionally, as the manner in which the error is dealt with is of paramount importance and will be crucial in determining the eventual outcome of the situation. Pharmacists should recognise that a mistake need not be reflection on their competence, nor is it a criticism of their personal standards. If a mistake does arises, it should be dealt with in a professional manner such that the welfare of the patient is at all times assured. The pharmacist should endeavour, whenever possible, to retain the trust and confidence of the patient or client. When a mistake or error is suspected the following procedure should be observed, for errors arising from the dispensing of a medicine, either on prescription or over-the-counter. 3.2 Discovery 3.2.1 It should be established whether an error has occurred, and if so, the nature of the error. The dispensing procedure should be reviewed, and the original prescription and patient medication record checked, if appropriate. For a suspected error in the dispensing of an over-the-counter medicine any advice given, by the pharmacist or other staff, should be reviewed. 3.2.2 The pharmacist in charge should deal with the situation personally. 3.2.3 The patient should be contacted immediately. 3.3 Corrective action 3.3.1 The patient should be informed of the nature of the error with the pharmacist making every effort not to cause undue alarm or distress. 3.3.2 The pharmacist should express regret that the error occurred. 3.3.3 The pharmacist should exercise his professional judgement in deciding on the course of corrective action, for example, 3.3.3.1 Amend any labelling errors. 3.3.3.2 Replace incorrect medicines. 3.3.3.3 Refer to a GP or hospital. 3.3.3.4 Refer to the pharmacy where the previous error occurred. 3.3.4 The pharmacist should exercise his professional judgement to counsel the patient on any possible consequences. 3.3.5 A follow-up contact should be made where appropriate. 3.3.6 The patient should be assured that procedures have been implemented to prevent a repeat of the error. 3.3.7 The patient should not be at any financial disadvantage as a result of the error. 3.4 Follow-Up Action

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Sect ion 2 Guidelines on Dealing with Errors

3.4.1 Full details of all errors should be recorded accurately and comprehensively, including all actions taken. It should be recorded in the PMR or other appropriate place. 3.4.2 The reason or cause of error should be established. 3.4.3 Corrective action should be taken to avoid a repeat of the error, examples of this would be: 3.4.3.1 Poor handwriting contact GP. 3.4.3.2 Incorrect strength selected separate and distinguish more effectively on dispensary and overthe- counter shelves. 3.4.4 The dispensing procedures, any appropriate medicines sales protocols or staff training should be reviewed in light of the error. 3.4.5 Errors should be periodically reviewed. 3.4.6 The pharmacists professional indemnity insurers may need to be informed of any dispensing errors.

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Sect ion 2 Code of Practice for Pharmacists on the Use of Personal Information kept on Computer

4. CODE OF PRACTICE FOR PHARMACISTS ON THE USE OF PERSONAL INFORMATION KEPT ON COMPUTER
4.1 Code of Practice Summary Summary The Data Protection Act of 1988 imposes certain obligations on those keeping personal information on computer, and confers rights to persons on whom such information is kept. This code of practice should be followed to ensure that personal information held on computer is dealt with correctly. It should be brought to the attention of the public that certain information which they give to the pharmacist or other staff members may be held on computer. The purpose for which it is used and the persons to whom it may be disclosed should also be indicated. A statement of purpose for which computer information on patients is kept, should be prepared. The information should only be used as outlined in the statement of purpose. All computer held information should be kept safe. Only authorised staff should have access to it, and only in accordance with the statement of purpose. A regular back up procedure should be carried out and copies of back-up tapes kept at an off site location. All waste paper and printouts should be disposed of carefully. Procedures should be in place to ensure that information is kept both accurate and up to date. Any information held should be adequate, relevant and not excessive in relation to the purpose for which it is used. There should be a definite policy on the period of time for which the information is retained. On receipt of a written request a copy of any information kept on computer about a particular individual must be supplied to that person. It must be in a form which is clear and intelligible to an ordinary person. The information must be supplied within 40 days of request and should only be given to the person concerned, or to an authorised person acting on their behalf.

4.2 Explanation of the Code of Practice The code of practice gives an eight step outline of the procedures to be followed in the use of personal information held on computer, so that this use complies with the provisions of the Data Protection Act, 1988. The following article is intended to give a more detailed explanation of the code of practice. Examples and suggestions are given, but individual pharmacists are free to tailor these to suit their particular circumstances, provided they still meet the requirements of the code of practice. 4.2.1 It should be brought to the attention of the public that certain information which they give to the pharmacist or other staff may be held on computer This is to satisfy the provisions of the Data Protection Act which state that any information held is obtained fairly and that the person providing this information is aware of the identity of those collecting it. The data protection commission suggest that where customers or clients mostly call to the premises a notice displaying a statement to this effect should be displayed. A suitable notice of this type could read: SAMPLE DISPLAY NOTICE

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Sect ion 2 Code of Practice for Pharmacists on the Use of Personal Information kept on Computer

Personal information is held on computer in this pharmacy to provide an ongoing record of patient medication and factors which may influence this. Should you wish, your pharmacist will be able to tell you the purposes for which this information is used and will answer any questions you have on it. 4.2.2 The purpose for which it is used and the persons to whom it may be disclosed should also be indicated It is not necessary to provide an exhaustive description of the use to which this computer held information is put, nor the persons to whom it may be disclosed. The best solution would be a note (see sample display notice) that a complete explanation of the purpose, uses and access to personal information is available on request. Should a request for such an explanation be received the pharmacist should be able to give it in person. It is important to satisfy the concerns of people in relation to matters such as this. With stories of the information technology revolution scarcely out of the news people may feel personal details, once entered into a computer, are available to all manner of people, for all sorts of reasons. They should be assured that personal information held on pharmacy computer systems is treated with utmost respect and that confidentiality is strictly guarded. 4.3 Preparation of a Statement of Purpose The statement of purpose is an important concept. It is a requirement of the Act and is referred to throughout the remainder of this code of practice. A sample statement of purpose reads as follows: SAMPLE STATEMENT OF PURPOSE Personal information is held on computer at (insert name) Pharmacy in order to provide an ongoing record of medication and factors influencing in this for each individual patient. Such information is also kept to comply with Article 10 of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996. Access to this information is password protected and is restricted to (insert names). Following receipt of any new information which may have a bearing on patient health the records will be updated or amended as required. The information will be held for life of the patient but if the pharmacist deems appropriate it may be deleted after two years. Information will only be disclosed to the person to which it refers, a third party authorised by that person or medical professionals who require the information to assist in the treatment of that person. Subject to Article 24 of the Misuse of Drugs Act, 1977 certain information may be made available to the Garda. Information may be presented to the courts if required by statute but this information will only be available to the court and not to individual barristers or solicitors. Where the information may be used for other purposes, for example community health or scientific studies, taxation or accounting purposes or automatic stock ordering, these should also be stated. As mentioned in 4.2.2 above the statement of purpose need not be openly displayed but the pharmacist should he available to answer questions on it, as any individual is entitled to ask such questions. 4.4 Information should only be used as outlined in the Statement of Purpose

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Sect ion 2 Code of Practice for Pharmacists on the Use of Personal Information kept on Computer

The requirement that information should only be used in a manner compatible with the statement of purpose refers to both use and disclosure. Once the uses to which the information is put are outlined in the statement of purpose it is easy enough to adhere to these, but the matter of disclosure is more difficult. The Data Protection Act allows for disclosure of information in certain cases and these are given in the statement of purpose. Where requests for information on a particular person are made by persons other than those noted there the pharmacist may find himself in the complicated field of patient confidentiality. An article in the Irish Pharmacy Journal, July 1991, gives an excellent overview of this whole area of confidentiality and another in February 1994 gives a number of interesting case studies on the intricacies of patient confidentiality. 4.4.1 All computer held information should be kept safe The hardware and software systems used to store patient medication records should be adequately protected against damage or corruption of information held therein. This protection will normally be provided by the company supplying the computer equipment and will take the form of built in auxiliary power supplies, protection against electrical surges and virus check programmes. There are still a number of issues which the pharmacist will have to deal with. Cups of coffee or other drinks should not be left near the computer, as spillages could destroy the circuitry. Adequate space should be left for the fan at the back of the disc drive to properly ventilate the system. It is becoming increasingly important that all computer users take the necessary steps to protect their software from viruses. These are small self replicating sections of computer programmes which, like their medical counterparts, can either be harmless to, or wreak havoc on, their hosts. Anyone introducing software from outside sources into their systems should ensure that these have been checked for viruses, and anyone downloading any software or applications from the Internet should be especially careful and should ensure that they have a suitable built in virus check package.

4.4.2 Only authorised staff should have access to it, & only in accordance with Statement of Purpose All the professional staff will have to have access to the patient information records. Other staff who may use the computer for pricing or ordering should be limited to these functions, and should not be allowed access to personal information. All information should be password protected and no details displayed on screen should be visible to the general public. As detailed in 4.3 above staff should only use the personal information in the manner intended and in strict accordance with the statement of purpose. 4.4.3 Regular back-up procedure should be carried out & copies of back-up tapes kept off-site In order to avoid irrevocable loss of data due to a hardware or software malfunction it is essential that regular back-ups are carried out. All back-up tapes should be kept in a secure location off the premises. These back-up tapes should not be stored in controlled drug cabinets or money safes in the pharmacy. In the unfortunate event of a robbery it can happen that the entire contents of a safe are taken by the raiders who sort out what they want later. Back-up tapes are also subject to the Data Protection Act, and to the principles of patient confidentiality. Pharmacists should ensure that the handling and

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Sect ion 2 Code of Practice for Pharmacists on the Use of Personal Information kept on Computer

storage of these tapes is controlled and that unauthorised persons do not have access to them. 4.4.4 All waste paper & printouts should be disposed of carefully As with back up tapes, any documents generated from the personal information held on computer is subject to control. Waste paper and printouts, once they are no longer required, should be disposed of by incineration or shredding, and not via the general waste collection services. 4.5 Procedures should be in place to ensure that Information is kept accurate & up-to-date It is important that the information in patient medication records be updated each time new information becomes available and it hardly needs to be stressed that it be accurate. All details concerning a patients health such as allergies. Previous drug interactions, concomitant medications, should be recorded when they come to hand. Where the facility for recording repeat prescriptions exists the original prescription should be retrieved at each dispensing to ensure accuracy and to comply with the Medicinal Products Regulations. A standard form should be used to record prescription details so that duplication of patient records because of different spellings or punctuation is avoided. All authorised staff that use the system should be fully trained in its operation so that they do not alter or obliterate any information by mistake. 4.6 Information held should be adequate, relevant & not excessive in relation to its Purpose Since the pharmacy software packages currently in use do not allow for the storage of much more than the minimum information necessary they are adequate in respect of this point. It is hoped that future improvements will allow for more scope in the recording of personal information, but pharmacists should not keep excessive and unnecessary information about any person. 4.7 There should be a definite policy on the period of time for which information is retained Patient medication records should be maintained for the lifetime of the patient. After the two years required by the Medicinal Products Regulations information may be deleted if the pharmacist feels it appropriate to do so. Since the Data Protection Act does not apply to records of deceased persons these can be deleted, but may be required by the persons relatives or legal representatives for insurance or other purposes. 4.8 On receipt of a written request a Copy of any Information kept on computer regarding an Individual must be supplied to that Person This section applies to the rights of access granted to individuals under the data protection act. Any person can request a copy of personal information pertaining to him kept on computer. He must give any details (name, address, previous addresses) required to locate the information. A fee, not in excess of 5 may be charged for this. 4.8.1 It must be in a form which is clear and intelligible to an ordinary person

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Sect ion 2 Code of Practice for Pharmacists on the Use of Personal Information kept on Computer

Any codes, abbreviations explained to the person. income tax or insurance medication be omitted. possible.

or scientific terms appearing on a printout should be In some cases a person may require a printout for purposes, and might request that details of actual Such requests should be complied with wherever

4.8.2 The information should be supplied within 40 days of request and should only be given to the person concerned, or to an authorised person acting on their behalf. In practice printouts should be provided as soon as possible after a request is received. The pharmacist should be satisfied as to the identity of the person making the request, and if the information is to be given to a representative should further ensure that this representative is acting under instructions from the person concerned. There are a number of special rules on access dealt with in the Act. One of these is that people should be protected from hearing anything about themselves which might cause serious harm to their physical or mental health or emotional well-being. Bearing this in mind and the matters of patient confidentiality dealt with in 4.4, pharmacists should exercise caution and discretion when responding to requests for personal information printouts.

45

Sect ion 2 General Guidelines on the Production and Implementation of Medicines Sales Protocols

5. GENERAL GUIDELINES ON THE PRODUCTION AND IMPLEMENTATION OF MEDICINES SALES PROTOCOLS


5.1 Background The perceived need for the introduction of formal written medicine sales protocols in community pharmacy has arisen concurrent with legislative changes which allow an increasing range of medicines to be supplied by community pharmacists in the absence of a prescription. The continued transition from prescription-only to pharmacist supervised medicine sales, while broadly welcomed by the profession may well depend on the ability of pharmacists to demonstrate that they can be relied upon to sell medicines with appropriate professional advice. A further impetus for the drafting of medicine sales protocols has arisen, ironically, from consumer organisations lobbying for more unrestricted availability of certain medicines. Such groups have criticised pharmacists for not asking the appropriate questions of medicine purchasers and have claimed that pharmacists do not supervise medicine sales in a manner that demonstrates the benefit of their professional input. And thirdly, if a further reason is needed, the Report of the Commission of Inquiry into Pharmacy in Ireland (1990) has recommended that the sale of non-prescription medicines takes place in the context of clear guidelines issued by the Pharmaceutical Society. The Society, therefore offers the following guidance in relation to the production and implementation of medicine sales protocols for use in community pharmacies. This guidance is offered in a general way and only deals with factors which should be borne in mind in the production and implementation of the protocol. It is intended in the future that specific protocols, either for particular therapeutic conditions or for particular groups of medicines, will be produced in guidance form. 5.2 Before Starting 5.2.1 Staff involvement Medicine sales protocols are to be used by all members of staff in contact with the public in relation to these sales. Obviously, qualified and non qualified staff will apply the protocols at different levels and with different objectives in mind. Their raison detre is to assist staff in understanding their role in medicine sales, to recognise at what stage their involvement and responsibility ceases and at what point to refer a patient to the pharmacist. It is worthwhile, therefore, when drawing up procedures to consult with pharmacy support staff, to discuss the relevance of the proposed protocols and to examine current or established practices in order to resolve present areas of difficulty specifically to be clarified in the written protocol. There is little value in attempting to introduce protocols which staff find difficult to implement or with which they are uncomfortable. It is important to recognise that certain staff, especially senior or long term members, may have amassed considerable knowledge and experience on OTC medicines. There may be resistance to the implementation of new controls on the established practices of such staff. To address this issue successfully it is important to acknowledge the experience and ability of these people, whilst still bearing in mind that they are not fully qualified in or conversant with all the issues involved in OTC medication. A senior sales assistant might routinely refer patients to the pharmacist but might also sell medicines to other patients without seeking any information from them on concurrent medication or other important factors. Finally, it must be stressed that if senior members of staff are given more authority and scope within the framework of the protocols, more junior or inexperienced staff should not refer patients to them instead of to the pharmacist. All staff should receive training in

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Sect ion 2 General Guidelines on the Production and Implementation of Medicines Sales Protocols

relation to the operation of the protocol and further training should be ongoing in this regard. The protocol should be absolutely clear about the conditions of referral to the pharmacist and that non-qualified staff should not refer directly to the doctor. When a new person joins the pharmacy staff, their training should include the reading, understanding and interpreting of the written policies and procedures. Furthermore, all staff should revise the protocols every year or more often as necessary following the introduction of the protocols or their joining the staff, and certify that they have done so. 5.2.2 Patient involvement A substantial number of visitors to pharmacies are accustomed to purchasing their OTC medicine requirements on demand. Interviewing or questioning the patients choice may well be perceived as interference by the pharmacist or sales assistant. It is necessary therefore to educate the public on the reason for and value of such intervention. For the protocols to be successful, they must be understood to be helpful and informative rather than intrusive. In order to achieve this, the importance of tact should be explained to staff in addition to the need to recognise sensitivities. Finally, in the event of a particularly awkward or difficult customer, sales staff should know how to discontinue with the questions. Where medicine sales protocols are to be introduced for the first time, a sign alerting the public to some changes in the sales procedure or transaction, should be displayed. A typical notice might read: We want to help you to get the most from your medicines. To ensure that the medicine you are purchasing is used safely and effectively, we need to obtain certain information from you. We hope you will find this helpful and informative. If you are unsure or concerned about your medicine, do not hesitate to ask for advice. 5.2.3 Pharmacists involvement It is likely that with the introduction of medicine sales protocols, community pharmacists will spend a greater proportion of their time talking to patients. This is a necessary and desirable trend if pharmacists are serious in their commitment to be the principal suppliers of medicines. Consideration should be given to the reorganisation of certain functions within the pharmacy to allow pharmacists time to counsel customers. 5.2.4 Guidance notes on drafting your medicine sale protocols The fundamental purpose for introducing a medicines sales protocol in your pharmacy is to ensure that every customer purchasing a medicine or seeking advice on an ailment, is provided with relevant information and is offered appropriate professional advice. The protocols can be used in transactions involving all medicines sales, pharmacy confined medicines as well as those which are available from other retail outlets. There are many instances however, where medical preparations are purchased for use as food supplements or health/immune boosters and in these cases a series of questions about symptoms, etc. is inappropriate. All medicine sales should be adequately supervised by the pharmacist, however, S1P1 poisons or medicines deregulated from prescription-only status can only be legally sold or supplied under the direct supervision of a pharmacist. This means that the pharmacist must be aware of such transactions and be in a position to intervene if required. Protocols developed should reflect these facts. Further, newly deregulated medicines will require special attention in the protocol. To achieve the end result of the medicine sales protocol, ie. the safe and effective use of medicines by the public attending the pharmacy, sufficient relevant

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Sect ion 2 General Guidelines on the Production and Implementation of Medicines Sales Protocols

information must be obtained. Protocols are therefore based on a format of questions, the answers to which direct the course of action to be taken by patient or staff member. The following systems of questioning may prove useful when devising protocols for your pharmacy, however, depending on circumstances pertaining to your area or your clientele, a variation on these may be more appropriate. Three examples are given below. 5.3.1 W-WHAM W Who is the patient? W What are the symptoms? H How long have the symptoms been present? A Action already taken? M Medication taken? This is a very popular choice it gets the basic information, quickly and is memorable. It is appropriate for use by non qualified staff. 5.3.2 The ASMETHOD A Age/Appearance S Self/Someone else M Medication used for current condition E Extra medicines/other conditions T Time persisting H History O Other symptoms D Danger symptoms 5.3.3 Sit down Sir S Site or location I Intensity or severity T Type or nature D Duration O Onset W With other symptoms N Annoyed or aggravated by S Spread or radiation I Incidence or frequency pattern R Relieved by These last two may be more appropriate to use by the pharmacist or authorised person. As can be seen, the three different mnemonics prompt similar questions, with the second and third probing a little further into the nature of the symptoms. The first step then in drafting the protocols, is to list what questions your staff need to ask in order to obtain most relevant information. The protocols should then direct what action is to be taken based on the information received. For example, an obvious place to start is by asking for whom is the medicine intended. Then depending on the answer; an elderly patient, a pregnant woman, a three year old child, a 30-something man, a specified course of action should be set in train. It is important nonetheless to keep the protocols concise and easy to follow with clear directions in every instance. In particular, directions should be given when the patient is elderly, pregnant or very young, when medicine is sought for someone else, when symptoms persist, or when patient is on other medication. Local policies on medicines liable to abuse should also be incorporated into any set of medicine

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Sect ion 2 General Guidelines on the Production and Implementation of Medicines Sales Protocols

sale protocols. It is imperative that protocols be written down, reviewed and updated, if necessary, regularly. Protocols produced should be comprehensible and memorable by all staff. They should be easy to implement. Their operation at the counter should strive to be customer friendly. 5.4 Sample Pharmacy Protocol Document 5.4.1 Aims The aim of the following medicine sales protocols is to ensure that every customer purchasing a medicine or seeking advice on an ailment, is provided with relevant information and is offered appropriate professional advice. or alternatively The aim of the following medicine sales procedures is to ensure the safe and effective use of medicines sold or supplied from this pharmacy. 5.4.2 Contents (a) Notes for the supervising pharmacist (b) Sample Protocol 1 (c) Sample Protocol 2 (d) Sample Protocol 3. 5.5 For the Attention of Pharmacists 5.5.1 All medicine sales from this pharmacy, including those preparations available from any retail outlet, must be adequately supervised by the pharmacist on duty. This necessitates the presence of the pharmacist in the pharmacy at all times when the pharmacy is open to the public. Pay areas for medicines must be located close to that area of the pharmacy in which the pharmacist spends most of his or her time. 5.5.2 All sales of S1P1 poisons and scheduled medicines (i.e. deregulated medicines which are not poisons) must be carried out by or under the direct supervision of the pharmacist. To provide such direct supervision, the pharmacist on duty must be aware of the sale and be in a position to intervene if necessary. Medicines in this group should only be displayed in an area of the pharmacy to which the public has no access. All such medicines should be held displayed in an area of the pharmacy proximate to the dispensary section or where sales can be carried out in earshot of the pharmacist on duty. 5.5.3 Pharmacists should give consideration to the display areas in the medicines section for the various preparations available for sale without a prescription. In selecting the various levels of access to medicines, it is worthwhile distinguishing between the various levels of legal controls on OTC medicines as outlined below. 5.5.3.1 Medicines to which minimal controls apply, i.e. paracetamol products, aspirin preparations, vitamin and mineral preparations. 5.5.3.2 Pharmacy confined medicines or poisons, i.e. preparations included under the Poisons Regulations 1982, as amended, e.g. ibuprofen, codeine, antihistamines. 5.5.3.3 Pharmacist-supervised (PS), medicines which are de-regulated for a number of years, e.g. acyclovir, loperamide, topical imidazole creams, non-sedating antihistamines. 5.5.3.4 Medicines de-regulated to PS status more recently, eg. famotidine, Regaine 2%, nicotine patches, imidazole pessaries. The above

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Sect ion 2 General Guidelines on the Production and Implementation of Medicines Sales Protocols

classification should not alone decide display areas in pharmacies. The potential for misuse, duplication or interaction should also be considered. Furthermore, many of the newer OTC products are presented in special OTC packs with patient information leaflets while some of the older deregulated products, such as the topical imidazoles, have not had their packaging altered. It is likely, however, that when the Medical Preparations (Labelling and Package Leaflets) Regulations 1993, take full effect, greater written information will be available to patients even where special OTC packs are not introduced. Finally, certain preparations are more appropriately stored in the dispensary, e.g. Paramol Imidazole products Hydrocortisone preparations Preparations abused locally. 5.6 Protocol 1: Supply of a medicine requested by the patient, e.g. Twelve Nurofen please, May I have a bottle of Maalox?

NOTES: If the patient is a regular customer and has undergone the OTC protocol previously and requests the same preparation each month or couple of weeks ask how he/she is keeping, check to ensure that the requested preparation is safe for continuous use, then supply. Customer urgency may well prevent the full use of the protocol. It would be helpful to provide staff with preset form of words or a phrase which can quickly

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Sect ion 2 General Guidelines on the Production and Implementation of Medicines Sales Protocols

explain why questions are being asked; failing this and if the customer appears hurried and unwilling to answer questions, when supplying the preparation, alert him/her to its ingredients mention cautionary warnings with its use; advise against concurrent use of preparations with similar ingredients. You may have another opportunity to discuss his/her condition refer to pharmacist where there is persistent non co-operation. 5.7 Protocol 2: Patient seeking advice on an ailment, e.g.: I have this pain

5.8

Protocol 3: Protocol for individual therapeutic group

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Sect ion 2 General Guidelines on the Production and Implementation of Medicines Sales Protocols

NOTES: Irrespective of whatever protocols or procedures are used to elucidate information from patients, it goes without saying that staff trained to be alert to possible warning symptoms and to ask pertinent questions, will result in the most effective use of medicine sales protocols. Ideally, individual protocols should be drafted for the various therapeutic groups of OTC medicines, e.g. indigestion remedies, painkillers, etc. Implementation of the protocol The Society recommends that existing procedures be examined in light of this guide and adjusted as necessary. The Society recommends producing written protocols and at least annual, if not more frequent reviews. Brief notes should be kept of any alterations. The Society will endeavour to offer help and support through the inspectorate in elation to the protocols. Staff should be involved in all stages of production of the protocol as this will aid better quality implementation. Practical difficulties experienced by staff in implementation of the protocol should result in changes to the protocol. All new staff should be formally trained on the protocols in existence that pertain to that outlet.

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Sect ion 2 Code of Practice governing the Temporary Absence Clause of the Pharmacy Act, 1890

6. CODE OF PRACTICE GOVERNING THE TEMPORARY ABSENCE CLAUSE OF THE PHARMACY ACT, 1890
6.1 Introduction The agreement reached between the Pharmaceutical Society of Ireland and the Pharmaceutical Assistants Association which included a code of practice relating to temporary absence has now been in place since December 1994. At a meeting between the aforementioned bodies it was decided that it might be useful to restate the detailed provisions of the code of practice and elaborate on those areas which have given rise to queries in the intervening period. 6.2 Code of Practice Governing Temporary Absence Clause 6.2.1 The name of the pharmaceutical assistant shall appear in the current Register of Assistants to Pharmaceutical Chemists and he shall have paid the appropriate retention fee If the name of the pharmaceutical assistant does not appear in the Register of Assistants to Pharmaceutical Chemists (as reproduced in the current calendar), the pharmaceutical assistant should contact the Society to obtain information on how to seek restoration to the register. 6.2.2 The assistant who has not been employed in pharmacy practice during the preceding five years shall undergo a defined period of retraining as required and shall be restored to the register This provision is not currently being implemented in its entirety. The requirement to undergo a defined period of retraining will not come into force until the Pharmacy Act is passed. Pharmacists who have not been employed in pharmacy practice for a similar time period will also have to undergo such a period of retraining under the terms of the Act. In the interim, such assistants need only apply for restoration to the register. 6.2.3 The assistant who will be performing professional duties of the pharmacist in his temporary absence shall be employed in the pharmacy concerned on a permanent basis for not less than 15 hours per week An analysis of the annual statements of return (SOR) received from community pharmacies for the year 1995 indicate that a number of pharmacists who employ an assistant(s) for the required number of hours do not appear to employ them to work in their temporary absence or alternatively they omitted to fill out that particular section of the SOR form. Should such pharmacists wish to amend their statements in light of the foregoing we have provided a coupon below which should be sent to the Society giving the amended details. 6.2.4 The assistant shall be entitled to cover short absences, such as lunch hours, two half days or one day off per week and unscheduled short absences The Pharmaceutical Society of Ireland has been legally advised that the term unscheduled short absences would not be acceptable to the parliamentary draftsmen drawing up the new pharmacy Bill and therefore this will require further discussion. If a pharmacist employs more than one assistant for the requisite number of hours, i.e. 15 hours, he is still only entitled to one day off per week which can be covered by either of his assistants.

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Sect ion 2 Code of Practice governing the Temporary Absence Clause of the Pharmacy Act, 1890

6.2.5 In the event of the temporary absence caused by illness of the pharmacist 6.2.5.1 The Society shall be notified as soon as possible, but not later than one calendar week from the date of first absence. 6.2.5.2 If the pharmacist has been absent for a second calendar week the Registrar shall be so informed and the direction of the Registrar in relation to the continuation of cover shall be acted upon by the pharmaceutical assistant who has been covering in the event of such an illness. The operation of this clause in the agreement has proceeded very smoothly since its implementation and no major queries have arisen in respect of same. 6.2.6 In the event of the temporary absence caused by the pharmacists holiday entitlements 6.2.6.1 The pharmaceutical assistant shall be entitled to cover the period of annual leave as recommended for the employee pharmacist by the Irish Pharmaceutical Union (currently two working weeks per annum). 6.2.6.2 The maximum number of days which the pharmaceutical assistant can cover shall not exceed 14 calendar days in any single absence. Again this particular provision has not caused any problems to date. This provision is however very specific in relation to the entitlements of the pharmacist who is using an assistant to cover such an absence and problems are not anticipated in this regard. 6.2.7 The pharmacist retains full personal responsibility for the supervision and management of the pharmacy. This provision in the code is extremely specific and no pharmacist can abdicate his responsibility for the supervision or management of the pharmacy under any circumstances. 6.3 General Comments Where a pharmacist employs more than one pharmaceutical assistant and each of the assistants work the minimum number of hours required in the pharmacy, i.e. 15 hours, the pharmacist can nominate each of the assistants as persons who are entitled to cover in his temporary absence. It was never the intention of the agreement to ask a pharmacist to select one assistant over another or to dismiss an assistant on such a basis. However, no matter how many assistants are employed in a particular pharmacy the pharmacist is only entitled to one day off per week (or two half days per week) with an assistant covering that temporary absence period. The entitlement whereby the assistant can cover short absences still remains. The SOR forms submitted to the Society have shown that in several instances an assistant is working in more than one outlet and covering the temporary absence of the pharmacist in each outlet. This situation is acceptable provided that the assistant works the required minimum number of hours in each of the pharmacies involved (i.e. 15 hours per pharmacy). If the circumstances prevailing at a particular pharmacy do not appear to be covered by the exact terms of the code of practice detailed above we recommend that the pharmacist concerned should contact the Society and outline the details of the individual case. This will then be examined in detail by both parties to the

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Sect ion 2 Code of Practice governing the Temporary Absence Clause of the Pharmacy Act, 1890

agreement who shall endeavour to offer some practical guidelines on the matter.

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Sect ion 2 Council Statement on the Use of Generic Medicines in Pharmaceutical Practice

7. COUNCIL STATEMENT ON THE USE OF GENERIC MEDICINES IN PHARMACEUTICAL PRACTICE


The community pharmacist has a complete responsibility for dispensing a prescription accurately and in accordance with the prescribers instructions. In normal circumstances, where a doctor specifies a particular brand, the pharmacist is not entitled to substitute a generic equivalent, or even another branded product deemed to be equivalent, without the doctors approval. In an emergency, where the prescriber is not readily contactable, the pharmacist may exercise his professional judgment in the best interest of the patient. In the hospital situation, the same general principles apply. However, there may be an agreed policy concerning the normal range of products the pharmacy should have in stock, or in relation to substitution in clearly defined circumstances. Therapeutic committees can be cost effective without posing any danger to the patient. Such committees have an official or quasi-official status and usually include representatives of the medical, pharmaceutical, nursing and administrative staff. Where a pharmacist uses an agreed brand or generic product in such circumstances, he must be satisfied that the prescriber has given approval for the substitution. Special attention must be given to those products where there is a difficulty in establishing bio-equivalents. Any general instruction from hospital administration to give effect to a generic only policy should be directed to the medical staff. If doctors prescribe generically, no professional or ethical problems will arise for the pharmacists. Clearly, it would be most desirable that matters of this kind should be fully discussed and agreed by the drugs and therapeutic committee when a patients safety as well as the professional integrity of doctors and pharmacists must be taken into account. On discharge from hospital, patients should be issued with prescriptions that indicate the exact product to be used in continuing treatment. [In non-technical language, generic prescribing means ordering a medicine by its approved chemical name or active component rather than a manufacturers brand or proprietary name]. The Migril case in the UK has drawn attention once again the onerous responsibilities carried by pharmacists when dispensing any prescription. An English pharmacy owner was ordered by the High Court to pay heavy damages to a patient for injury she suffered from taking a prescribed medicine. The pharmacist had dispensed and labelled the medicine exactly in accordance with the prescribers instructions. Unfortunately, the dose specified was significantly larger than the manufacturer's recommendations. The important point is that a pharmacist can be held liable for injury to a patient even if the original error was that of the prescribing doctor. Hospital pharmacists, therefore, should be concerned about their position in the event of negligence action. The general rule is that the employer (master) is responsible for the negligent acts of the employee (servant) while the latter is acting in the course of his employment. It is often the case, nevertheless, that the employee is joined as a co-defendant in a negligence action. It would be important for hospital pharmacists to have written guarantees from their hospital authorities indemnifying them against possible awards of damages to patients arising from the use of medicines.

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Sect ion 2 Council Statement on the Use of Generic Medicines in Pharmaceutical Practice

In no circumstances should medicines be stocked or supplied unless they have been approved and authorised by the Irish Medicines Board. The policy of some companies of marketing a generic medicine under a brand name is confusing and undesirable. The absence of a national drug testing laboratory in Ireland capable of carrying out the full range of relevant tests on all medicines is a cause for concern. In summary, the Council advises that hospital pharmacists should insist on exercising their professional skill and judgment in this as in other matters and resist any attempts to make them carry out without question any administrative decisions which they feel are not in the best interests of patient safety.

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Sect ion 2 Pregnancy Testing in Pharmacies

8. PREGNANCY TESTING IN PHARMACIES


8.1 Introduction Pregnancy testing is a professional service offered by community pharmacists. 8.2 Confidentiality The pharmacist should keep all information provided by the patient and the result of the test confidential and disclose information only with the written consent of the patient. 8.3 Advertising Pregnancy testing as a professional service should not be advertised. However a suitable notice in the pharmacy advising patients of the availability of the service is acceptable. 8.4 Facilities for Carrying Out the Test A reliable method of testing should be used. It is important that care is taken to prevent contamination which can be caused by the handling of samples of urine. This can only be achieved by the use of a room separate from that used for dispensing. This should be maintained in a clean and tidy condition and all working surfaces should be finished with a smooth, impervious and washable material. Adequate lighting should be provided so that the results of the test can be read correctly. A separate sink should be provided. In no circumstances should the dispensing bench be used. Procedures which ensure that no confusion occurs between samples must be devised and followed. Persons carrying out tests should wash their hands before leaving the working area. All cuts and grazes on hands or on exposed parts of the body must be covered with waterproof dressings. 8.5 Request for a Pregnancy Test A signed and dated confirmation of the request should be obtained. The form on which confirmation is obtained should state the limits of accuracy of the test. All questions relating to the test should be asked by the pharmacist and the answers recorded in writing. 8.6 Records A written record of the result of the test, together with information provided by the patient and the type of test and batch number of the test materials, should be retained by the pharmacist for at least one year. Such records must be stored securely to preserve confidentiality. 8.7 Communication of the Result The result of the test should be provided in writing on a standard form. It is not recommended that the result be given over the telephone. The pharmacist should be satisfied that the person requesting the information is the person who requested the test. The form should be dated and give the name and address of the patient. The

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Sect ion 2 Pregnancy Testing in Pharmacies

result should be given as positive or negative with an explanation of such terms and the limits of accuracy of the test, e.g. research has shown the results of the test to be accurate in 98% of all cases. A positive result indicates a probable pregnancy. A copy of the form should be sent to the patients medical practitioner with her permission. Notwithstanding the result of the test, the patient should be strongly advised to consult her medical practitioner. 8.8 Insurance Pharmacists are advised to check that their professional indemnity insurance covers them before providing this service.

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Sect ion 2 Cholesterol Testing in Pharmacies

9. CHOLESTEROL TESTING IN PHARMACIES


9.1 Training Prior to providing a cholesterol testing service, pharmacists should undergo an approved training programme to ensure that they are competent to operate the equipment and to counsel patients appropriately. Once trained, pharmacists should keep abreast of all developments in cholesterol testing. 9.2 Registration Pharmacists providing the service should be registered for that purpose with the Pharmaceutical Society. [Registration will be dependent on an inspection to assess the suitability of the premises]. 9.3 Facilities Blood sampling, the test procedure and patient counselling should be undertaken in an area of the pharmacy appropriate for the purpose. The service should not be provided in the main public area. 9.4 Procedures Suitable procedures should be adopted for the disposal of waste, in particular, blood and blood contaminated materials. Pharmacists should cooperate in testing any samples provided by a laboratory on behalf of the supplier, or the registration body, to ensure that the equipment is operating consistently and accurately. In addition, they should make arrangements with a local laboratory for the regular testing of blind samples to validate their methodology and the equipment. Before providing the service, pharmacists should inform their local general medical practitioners. 9.5 Results The pharmacist, before commencing a test, should explain the procedure to the patient and obtain the patients permission in writing to carry out the test. The patient should be advised that the result will be forwarded to the patients general medical practitioner if it is found to be outside the normal range. If a patient withholds such agreement, a test should not be carried out. Results should be provided in writing with an appropriate explanation. Where a reading is above normal the patient should be counselled by the pharmacist, referred for medical attention and supplied with an information leaflet. A copy of the result should be filed and retained in the pharmacy for a period of two years. 9.6 Advertising Advertising a cholesterol testing service to the public should be avoided. However, a discrete notice in the pharmacy advising that such a service is available is acceptable.

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Sect ion 2 Guidelines on Storage of Medicines in Community Pharmacies

10. GUIDELINES ON STORAGE OF MEDICINES IN COMMUNITY PHARMACIES


10.1 Introduction The following guidelines have been prepared by the Practice of Pharmacy Committee of the Pharmaceutical Society of Ireland. They are applicable to all areas of practice, but are specifically designed for community pharmacy. Hospital, industrial or institutional pharmacists may read these in conjunction with more specific guidelines relating to their own area of practice. Any specific storage conditions imposed by the manufacturer or product authorisation holder for a particular product (with the exception of the stated case in Section 3.3), or by the Irish Medicines Board, should be observed at all times, and pharmacists should be aware that these may vary from time to time. The Pharmaceutical Society of Ireland are of the opinion that any change in the recommended storage conditions for a particular medicine should be notified to all pharmacists by the product authorisation holder in a circular letter prior to the change taking place. These guidelines do not take the place of specific requirements contained in the European Communities Directives on Good Manufacturing Practice (which refer to pharmaceutical manufacturers), the European Communities Guidelines on Good Distribution Practice (which refer to pharmaceutical wholesalers), or any other relevant Directives, Acts, Regulations or orders (which are legally binding), but should be read in conjunction with them. Although the guidelines refer mainly to the dispensary and shop areas of the pharmacy it should be noted that the guidelines in their entirety also apply to any storerooms or other areas where medicines may be kept. 10.2 General Conditions 10.2.1 Security All medicines should be stored in such a manner that they are secure from theft, tamper or accidental damage. Pharmacists should ensure that they have adequate security provisions appropriate to their particular circumstances and should also ensure that proper fire safety procedures are in place. 10.2.2 Accessibility 10.2.2.1 General All medicines should be stored such that they are only accessible to members of staff having responsibility for them. Further guidance on this is given in Sections 10.3.1, 10.3.3, 10.3.4, 10.4.1and 10.4.3. 10.2.2.2 Children Particular care should be taken to ensure that children do not have access to medicines. If children are present in the dispensary, or in any other area where potent medicines are to hand they must be supervised by adults at all times. This applies especially to children or young relatives of the pharmacy staff, who may be present in the pharmacy on a regular basis. It should be noted in relation to the latter that a pharmacy is not a suitable place for child care provision on a long-term or regular basis. Arrangements should be made to ensure that children are only present on the premises for the absolute minimum time. 10.2.2.3 Contractors Outside contractors, such as electricians, security personnel, cleaners etc. should only be allowed to work in the pharmacy under the

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supervision of the pharmacist or an appropriate staff member delegated by the pharmacist. While it might appear more convenient to allow such contractors to work outside normal opening hours when the pharmacy is empty, pharmacists must bear in mind that they will be responsible for any untoward events which might arise as a result of contractors having unrestricted access to pharmacy medicines and should therefore ensure that medicines are adequately supervised at these times. 10.2.2.4 Display of medicines Where medicines are used for display purposes, only empty containers or dummy packs should be used. 10.2.3 Environmental conditions 10.2.3.1 Temperature All pharmacies should have a documented temperature recording procedure. Maximum temperature and minimum temperature should be recorded daily, at a specified time, by a designated member of staff, and the results entered in a log in the format given in Appendix I. Alternatively a form of continuous recording may be used. All recording equipment must be calibrated as recommended by the equipment manufacturers. Recordings should be done, as a minimum, in the dispensary and the OTC area. For large pharmacies where there may be local area variations, it may be appropriate to vary the location in which temperature measurements are made, by moving the location of the recording device from time to time. Particular attention should be paid to areas of extreme temperature variation, such as areas near glass, heaters, lighting or cooling equipment. It may be appropriate to take temperature measurements in the vicinity of heaters or other localised areas which may be subject to temperatures higher than the norm. It should also be noted that seasonal variations may occur, with higher temperatures near display windows during the summer and near heaters in the winter. With regard to temperature variations near display windows the contents of Section 10.2.2.4 must be observed. For thermolabile medicines the requirements of Section 10.3.3must also be observed. 10.2.3.2 Humidity Measurements of relative humidity should also be carried out, in accordance with the requirements of Section 10.2.3.1. Pharmacists should note that steam, because of its intense heat and humidity, will cause severe degradation to any medicine with which it comes into contact. Kettles should only be used in a specific canteen area, well away from any medicines. Under no circumstances should the kettle be placed directly underneath a shelf containing medicines. 10.2.3.3 Light Care should be taken to store medicines out of direct sunlight, taking particular care with medicines which may be at risk from photodegradation, such as liquids, suppositories, drops, oily injections and volatile substances. It should also be noted that certain forms of artificial lighting can adversely affect medicines. Halogen lights in particular are extremely luminescent and also generate substantial heat in their immediate vicinity. 10.2.3.4 Water

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Sect ion 2 Guidelines on Storage of Medicines in Community Pharmacies

Care should be taken to ensure that water does not come into contact with medicines. Plumbing should be checked regularly, and any areas which are prone to moisture build-up or leaks should be attended to. Pharmacists in areas where seasonal flooding may occur should have special emergency procedures in place to deal with such eventualities. 10.2.4 Hygiene All staff, especially those dealing directly with medicines, must maintain a scrupulously high level of personal hygiene, to avoid accidental contamination of medicines. Medicines should not be stored in close proximity to areas where food or drink is stored, prepared or eaten. These activities should only take place in a specially designated area. Strong odours may attach themselves to medicines packaging and this may be a source of genuine concern for the patient to whom such a medicine is dispensed. Medicines should not be stored in the toilet or bathroom. 10.2.5 General housekeeping 10.2.5.1 Presentation Medicines dispensed to the patient should be presented in pristine condition. All stocks should be cleaned and dusted regularly to ensure this. Pharmacists should be aware that while they themselves may be satisfied that the medicine is entirely safe, the patient may be very worried if he s presented with a medicine in a container which is stained, yellowed, watermarked or dirty. Adequate procedures should be followed to ensure that packaging does not become damaged. It is quite proper for the patient to assume that the condition of the packaging reflects the condition of the medicine inside. If the packaging of a medicine has suffered any damage which has not adversely affected the contents, then the medicine should be repackaged before dispensing. This applies only to dispensary medicines. OTC medicines should not be repackaged from their original container, and any OTC medicine whose packaging is damaged or otherwise affected so as to render it unusable should be returned to the supplier. 10.2.5.2 Health and safety Medicines should be stored in accordance with correct health and safety procedures. They must not be left lying around the floor, piled precariously on top of each other, or overloaded onto shelves. Special care should be taken with glass bottles, heavy items, volatile, flammable or explosive items and injections. 10.2.5.3 Extemporaneous dispensing Medicines should not be kept in the area reserved for extemporaneous dispensing. 10.2.5.4 Shelving and storage equipment Any shelving or other storage system used should be adequate for its intended purpose, and should be easily cleaned. 10.3 Prescription-Only Medicines The following applies specifically to prescription-only medicines (POMs), but should be read in conjunction with the general conditions in Section 10.2. 10.3.1 Location

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All POMs should be kept in the dispensary area. They should be located so that customers or patients in the pharmacy cannot identify medicines which are being prepared for dispensing to other patients. 10.3.2 Organisation The particular method of organisation for dispensary medicines is up to the individual pharmacist. Most pharmacists prefer the method of alphabetical organisation, but there are other methods of categorisation which may also be used. The main alternatives are storage according to pharmacological classification, or by manufacturer. Whenever any new product information is published about a particular medicine, this should be noted on the area of the shelf reserved for that product, with a reference to where the original published information is to be found. Care should be exercised in the storage of different medicines presented in similar packaging. While it might appear appropriate to store these at a distance from each other, this may cause a problem where staff may think that a particular medicine is out of stock because it is not present in the location where it logically ought to be. It is considered more appropriate to address the problem of inadvertent dispensing of the wrong medicine due to similar packaging by educating staff as to the dangers inherent in this, and by making sure all members of dispensary staff are aware of the products which are likely to give rise to such misunderstandings. In addition the importance of adhering to the dispensing guidelines (Section 10.2 of this guide) when dispensing any medicine must be recognised. The system of checks and product verification contained in the dispensing guidelines should ensure that no dispensing errors arise from the accidental substitution of similarly packaged products. 10.3.3 Thermolabile medicines 10.3.3.1 General conditions Any medicine which is indicated as store between 2C and 8C, store in refrigerator or their equivalent must be stored in a refrigerator. The medicines on the Irish market which currently require refrigeration are listed in Appendix II. This list is correct at time of press and will be amended as the need arises. In the meantime pharmacists should observe any directions issued by product authorisation holders or the Irish Medicines Board on the reclassification of any product into or out of this category. This refrigerator must be reserved solely for the storage of medicines and food or drink should not, under any circumstances, be stored in a refrigerator which is used for medicines storage.

10.3.3.2 Temperature measurement Temperature measurement as described in Section 10.2.3.1 should be carried out, and the refrigerator should be serviced according to the manufacturers specifications. 10.3.3.3 Storage conditions within the refrigerator The refrigerator must be large enough to store all the medicines which will be kept in it such that there is still adequate airflow and uniform temperature in the interior. The refrigerator should not be overfilled, as this will reduce its ability to maintain the required temperature control. Medicines should not be stored in the door compartment of the refrigerator, as the required temperature cannot be guaranteed in this

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Sect ion 2 Guidelines on Storage of Medicines in Community Pharmacies

location. It is noted that special medicines refrigerators do not have any storage compartments on the door. Although some modern medicines refrigerators do not have an ice box or freezer compartment, these are not appropriate for pharmacies, as some products come with an ice pack which must be frozen before being placed along with the dispensed medicine, to maintain cold chain control during transportation to the patients home. Once again, care must be taken to ensure that the medicines do not come into direct contact with the ice pack during transport or storage. 10.3.3.4 Defrosting the refrigerator The refrigerator should be defrosted regularly, and care should be taken to ensure that no excess build-up of ice occurs, and especially, that medicines do not come into contact with any ice which might form. While the refrigerator is being defrosted the medicines should be removed, placed in a suitable sealed container and transferred to another refrigerator for the duration of the defrost cycle. It is permissible to store the medicines in a domestic refrigerator while the medicines refrigerator is being defrosted, once they are in a suitable sealed container throughout this time. 10.3.3.5 Deliveries of thermolabile medicines As soon as a delivery is received the invoice or delivery note should be checked to see if any thermolabile medicines are present. These should be removed immediately and placed in the refrigerator. Pharmaceutical wholesalers are required to maintain the cold chain during transport of thermolabile medicines. They are therefore responsible for the medicines until such time as they are received in the pharmacy. Pharmacists should satisfy themselves that the correct storage conditions are observed by their wholesalers. If not they should report any discrepancies to the wholesaler, who will then be obliged to rectify the matter.

10.3.4 Controlled Drugs Controlled drugs listed in Schedule 2 or Schedule 3 to the Misuse of Drugs Regulations, 1988 (as amended) must be stored in accordance with the terms of the Misuse of Drugs (Safe Custody) Regulations, 1982. The general provisions of these Regulations are summarised in Appendix III, and the main requirement is that Schedule 2and 3 drugs be kept in a safe. The medicines on the Irish market which are currently listed in Schedule 2 or Schedule 3 to the Misuse of Drugs Regulations, 1988 (as amended) are listed in Appendix IV. This list is correct at time of press and will be amended as the need arises. In the meantime pharmacists should observe any amendments to the Regulations issued by the Department of Health and Children. This safe must be locked at all times, and

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the key kept in the possession of the pharmacist, or a delegated member of the professional staff. Under no circumstances should unauthorised staff members have access to the contents of the safe, which preferably should not be used for the storage of money, computer backup tapes or other items. It is recommended that coins be kept in a secure location other than the safe. If the safe does not conform to the specific requirements of the Misuse of Drugs (Safe Custody) Regulations, 1982 then it may be certified as providing adequate equivalent protection by a Garda, who must be of a rank not below that of Superintendent. This certificate must be updated every two years. As soon as a delivery is received the invoice or delivery note should be checked to see if any controlled drugs are present. These should be removed immediately entered in the controlled drugs register where appropriate and placed in the safe. The controlled drugs delivery note should then be signed by the pharmacist and returned to the wholesaler.

10.4 Over-The-Counter Medicines The following applies specifically to the storage of over-the-counter medicines (OTCs), but should be read in conjunction with the general conditions in Section 10.2.The medicines sales protocols in Section 5 of this guide should also be read in conjunction with this section. 10.4.1 Medicines with a misuse potential There are many OTC medicines available which have the potential for misuse if used incorrectly. Pharmacists should decide which of these are relevant in their local area, in consultation with colleagues or other parties involved in the treatment of drug misuse, and take special steps to ensure that they are stored such that they are only available from a professional member of staff. They should be kept behind the counter, and consideration should be given to placing them out of sight so that they are only supplied to patients whose condition, in the opinion of the pharmacist, warrants their use. As mentioned above, the actual incidence of misuse varies greatly from area to area, but the following are examples of some medicines with a proven misuse potential:

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Preparations containing codeine, especially preparations Cough suppressants Slimming products, especially potent laxatives Paracetamol

multi-ingredient

liquid

10.4.2 Medicines requiring supervised sale Certain OTC medicines must be sold either by or under the personal supervision of a pharmacist. These are products which contain substances listed in Schedule 1 to the Poisons Regulations, 1982 (S1P1 Poisons) and/or covered by Articles 5(2) and 6 of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 (S1BE medicines). These must be stored in an area of the pharmacy to which the public does not have direct access, and must not be available to the public on a self-selection basis. Pharmacists should note that pharmaceutical companies on occasion produce special counter display units for some of these medicines, but these must not be used if the public can access the medicines contained in the unit. In this case the unit should be kept behind the counter. 10.4.3 Natural remedies, homeopathic medicines and other alternative treatments The recommendations of these guidelines apply equally to natural remedies, homeopathic medicines and other alternative treatments. The Society is of the opinion that all medicines should be treated in the same way, and the same level of supervision and control applied to their handling, storage and sale. 10.4.4 Other OTC medicines not subject to special control The Society would advise pharmacists to keep all medicines away from direct public access. However, given the physical layout of some pharmacies this might not always be possible. In this case consideration should be given to restricting access to medicines containing paracetamol, intended for children, or containing potent medication. While supervised sale of products not covered by the regulations referred to in Section 10.4.2 is not legally required, pharmacists should be aware that they have a professional responsibility to ensure that patients receive an appropriate treatment for their particular condition. While the direct involvement of the pharmacist is not required in the sale of these medicines pharmacists should nonetheless ensure that they have arranged adequate storage conditions for medicines which they feel would require some professional input prior to sale. 10.5 Other Medicines 10.5.1 Special storage conditions for substances listed in Schedule 2 to the Poisons Regulations, 1982 These substances are listed in Appendix V, and must be stored: In a cupboard or drawer reserved solely for the storage of poisons or on a shelf reserved solely for the storage of poisons Where no food is kept directly underneath that shelf and the container of the poison is distinguishable by touch from other containers In a place partitioned off or separated from the rest of the pharmacy to which the public are not permitted to have access and where no food is kept 10.5.2 Medicines which pose a hazard under normal conditions of handling and storage All the drugs listed in Appendix VI are considered hazardous, from a health and safety viewpoint, and may constitute a material risk to staff involved in handling or reconstituting them. This appendix is not all inclusive, and the Practice of

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Sect ion 2 Guidelines on Storage of Medicines in Community Pharmacies

Pharmacy Committee hope to review it on an ongoing basis is more information becomes available. The list of drugs is taken from a paper in the American Journal of Health System Pharmacists. Any pharmacist who carries stocks of these drugs should familiarise themselves, and their staff, with the potential hazards involved in routine handling or preparation activities. The necessity for a proper safety statement, which details the procedures to be followed in minimising the risks posed by these, or any other hazards in the pharmacy cannot be underestimated. In general, it is advisable to keep these drugs separate from the main pharmacy stocks, and to perform any reconstitution or preparation activities according to the directions of the manufacturer contained in the data sheet, or other product information. As already stated, the Committee intend to review this list on a regular basis, but in the meantime pharmacists should be mindful of the potential risks posed by certain types of drugs, especially anti-cancer drugs and hormonal preparations. 10.6 Veterinary Medicines All the material referred to thus far applies equally to the storage of human and veterinary medicines, but the following should be observed as specifically applied to veterinary medicines. 10.6.1 Separation Veterinary medicines must be kept in a separate section of the pharmacy, which should be clearly identified as such. In the case of a pharmacy which only carries small animal medicines (cats, dogs etc.) this is not absolutely necessary, so long as the pharmacist and staff are aware that the veterinary medicines are kept in a certain area, and there is no danger of anyone mistaking an animal remedy for a human medicine. Special care should be taken with veterinary medicines, feed additives or other materials which might have a strong or lingering odour. 10.6.2 Thermolabile veterinary medicines All thermolabile medicines should be kept in an animal remedies refrigerator reserved solely for this purpose. Certain veterinary vaccines are live vaccines, and these should not be kept in close proximity to human medicines, or to food and drink, in case of contamination. 10.6.3 Veterinary implements Items like shears, knives, needles and syringes and other equipment or implements should be stored well out of reach of children, and in a manner such that there is no danger of them falling onto customers who may be examining products in the veterinary section of the pharmacy. 10.7 Non-Medicinal Pharmacy Items Care should also be exercised when storing potentially dangerous non-medicinal pharmacy items. Appropriate precautions should be taken with scissors, blades, electrical equipment and other such consumer durables, to ensure that they are kept out of reach of children, and do not pose a risk to customers in the pharmacy. Other items of concern would be rodenticides, pesticides, herbicides, bleaching agents, methylated spirits, solvents, acids, alkalis, or any other item which might be dangerous if not used correctly. These should all be stored away from public access, and should always be kept on the bottom shelf to minimise the risks from accidental spillage. Wherever possible such items should be kept in a separate, designated area

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of the pharmacy and caution exercised when handling them. Appropriate procedures for dealing with these products should be written into the pharmacys safety statement. 10.8 Appendices
Appendix 1 Monthly Temperature Recording Logs

Appendix II Medicines which must be stored in a refrigerator [Outdated Please refer to the relevant product Summary of Product Characteristics] Appendix III Schedule to the Misuse of Drugs (Safe Custody) Regulations, 1982 [Please refer to the Misuse of Drugs Regulations, 1982 S.I. 321 of 1982 or the Pharmaceutical Society of Ireland Forensic Pharmacy Manual Volume II Part 1] Appendix IV Drugs listed in Schedules 2 & 3 of the Misuse of Drugs Regulations 1988 as amended [Please refer to the Misuse of Drugs Regulations, 1988 1999 or the Pharmaceutical Society of Ireland Forensic Pharmacy Manual Volume II Part 1] Appendix V Drugs listed in Schedule 2 of the Poisons Regulations, 1982 as amended

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[Please refer to the Poisons Regulations 1982 2003 or the Pharmaceutical Society of Ireland Forensic Pharmacy Manual Volume II Part 1 and Weedle PB, Cahill MJ. Medicines and Pharmacy Law in Ireland Chapter 8 Poisons Acts and Regulations and Appendices 17 - 25]

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Sect ion 2 Guidelines on Dealing with Requests for Information

11. GUIDELINES ON DEALING WITH REQUESTS FOR INFORMATION


11.1 Introduction The purpose of these guidelines is to assist pharmacists who find themselves approached by someone who wishes to find out information on some aspect of a drug or medicine, who asks to have a substance, be it a proprietary medicine or a sample of some kind, identified, or who is seeking information on a patients medical history, their own or someone elses. 11.2 Information on or identification of a particular medicine The flow chart sequence given in Figure 1 (11.4) shows the type of questions you could ask of someone who presents at your pharmacy looking for information on a particular medicine or identification of a medicine formulation. This is only intended as a guide, and should prompt you to ask the right questions. It will not give you the answers for each particular request you may encounter. It must also be noted that the final step in each branch of the chart, answer, or refer the person to their GP, depending on their answers to the previous questions, requires you to make up your own mind whether to provide the person with the information they require, or refer them elsewhere. This may be a difficult decision to make, but no amount of guidance or set examples will give you the right answer for each individual case. You must exercise your professional judgement to decide the best course of action, bearing in mind the requirements of the person making the request, and the rights of any other individual who may be affected by this. The Drug Abuse Project Team (DAPT) intend to publish a series of case studies in order to give examples of the type of requests which pharmacists are routinely faced with. These should give a useful insight into how to deal with potentially tricky situations but are not intended as stock answers for set situations. They are only a learning guide. The final decision is yours alone, based on the points contained in this article, your experience and your professional judgement. 11.3 Before considering any requests you should bear in mind the following key points Do you feel the request is genuine, and there is no malicious intent to deceive? Is the medicine in question, or the information requested, for the person themselves, or for some other person? Patient information may only be divulged to the patient themselves, or to someone acting on their behalf, with written authorisation to this respect.

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11.4 Flow chart for dealing with information or identification requests

11.5 Box 1: Who is asking the question?

11.6 Box 2: What are they requesting?

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Sect ion 2 Guidelines on Dealing with Requests for Information

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Sect ion 2 Guidelines on Advertising by Pharmacists

12. GUIDELINES ON ADVERTISING BY PHARMACISTS


It is considered unethical for pharmacists to advertise professional services, such as the dispensing of prescriptions or the sale of medicines. Exceptions to the general rule might include: a) Discreet local announcements concerning new pharmacy openings, transfer of location or extended opening hours. Notice of new openings, transfers or changes of opening hours may only appear in a local newspaper. The size of the announcement should be no larger than 2x 3. Such announcements may run for a maximum of one week, either prior to or during the week of the change in opening hours or the opening or transfer of business. Announcements concerning a visiting hear-aid specialist, optician, physiotherapist, chiropodist, etc. are permitted on a once-off basis, at the introduction of the extra service at the pharmacy. Provision of extra professional services, e.g. cholesterol testing, by the pharmacist should not be advertised in a newspaper, but highlighted in the pharmacy. Entries in telephone directories (such as the Golden Pages) or local services directories. Such entries may include the name and address of the pharmacy, hours of opening, and telephone number. No reference should be made to services provided or the provision of ethical or non-ethical goods. Appropriate factual announcements by groups of pharmacists at district level concerning rota services, special arrangements for holiday periods and the like. The use of restricted titles, e.g. Pharmacy, Chemist, or MPSI is unethical when used in association with advertisements for films, cameras, cosmetics and other goods. In certain circumstances, advertisers might be identified by name and address but without using titles.

b)

c)

d)

The Council considers it necessary to issue this statement because of the continuing practice by a minority who utilise their professional titles for purely commercial purposes. Such advertising makes it difficult for pharmacy as a whole to gain widespread acceptance of its primary role as a caring and responsible health profession. Breaches of these guidelines are brought to the attention of the Societys Law and Ethics Committee.

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Section 2 Guidelines on Extemporaneous Dispensing

13. GUIDELINES ON EXTEMPORANEOUS DISPENSING


Approved by the Council of the Pharmaceutical Society of Ireland in April 2003 Important Note: Extemporaneous compounding should only take place when the prescribed formulation of a product or suitable alternative cannot be obtained commercially. Proprietary products commercially available are preferable to compounded products because they are subject to formal quality control procedures.

13.1

Introduction

13.1.1 Extemporaneous Dispensing / Compounding is defined as the preparation and supply of a single unit of issue of a product which is intended for immediate use by a specific patient. The pharmacist should be satisfied that they can ensure the quality, safety and efficacy of the extemporaneously compounded product and the appropriateness of the formulation. 13.1.2 A pharmacist should dispense an extemporaneous preparation on foot of a prescription except where, in his professional opinion, to do so is not in the best interest of the patient. However, in such circumstances, the pharmacist should facilitate alternative arrangements for the patient concerned. 13.1.3 Extemporaneous Manufacture is the production of a batch of product consisting of a number of units of product, intended for supply over a period of time. Extemporaneous manufacture is not recommended unless it is performed by suitably trained personnel in premises licensed for such manufacture. 13.2 Scope

13.2.1 These guidelines apply to the compounding of a single unit of product involving the combination of a number of ingredients. The reconstitution of pre-mixed powders (such as antibiotic mixtures) is not considered extemporaneous preparation within the meaning of this guideline. 13.2.2 The compounding of products which require batch manufacturing, aseptic transfer, sterilisation, and cytotoxic precaution etc require specialised procedures and thus are not provided for in this general guideline. 13.3 Responsibilities

13.3.1 The pharmacist is responsible for ensuring that the product is compounded in a manner that guarantees its quality, safety and efficacy.
13.3.2

The pharmacist is also responsible for ensuring that extemporaneous compounding is documented fully, and that records of compounding are signed and dated and retained in the pharmacy for two years.

13.3.3 Extemporaneous dispensing should normally be done by the pharmacist. However, where the extemporaneous dispensing is carried out by a trained member of staff, the pharmacist must: Be satisfied as to the appropriate level of training and skill of the staff member

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Closely supervise and check the compounding at all stages of the process, check calculations and measurements and approve the product for release Ensure that the compounding has been appropriately documented and signed. 13.4 Cleanliness & Hygiene 13.4.1 The Pharmacist is responsible for ensuring that a high standard of hygiene and cleanliness is maintained during the compounding of extemporaneous preparations. All parts of the preparation area and associated equipment and apparatus must be cleaned regularly by appropriate trained staff using normal cleaning procedures. No preparation should be undertaken while cleaning is in progress. 13.4.3 There should be a written cleaning schedule and procedure appropriate to the extemporaneous dispensing facility. A cleaning record should be maintained.
13.4.2

13.4.4 All equipment used in compounding should be cleaned before and after compounding and maintained in good order.
13.4.5

Staff carrying out extemporaneous preparation should maintain a high level of personal hygiene and wash their hands before and after compounding.

Staff preparing extemporaneous products should wear clean protective clothing. Such protective clothing i.e. white coat, plastic apron etc. should be reserved for extemporaneous preparation only. Specialised clothing such as protective gloves and masks should be available and worn where appropriate. 13.4.7 Staff involved in extemporaneous preparation should report respiratory and other infections and skin lesions to the pharmacist. The pharmacist must assess the risk of contamination and if there are concerns the staff member should not be involved in the compounding process.
13.4.6

13.5

Extemporaneous Dispensing Area

13.5.1 Extemporaneous dispensing should occur in a clean area of the pharmacy conducive to pharmaceutical preparation and away from areas of high traffic or where routine dispensing, counselling or meetings occur. 13.6 Equipment

13.6.1 Essential equipment required for extemporaneous dispensing are as follows: Dispensing bench with a smooth, impervious and washable finish worktop Sink with draining board and a supply of hot and cold water Dispensing balance accurate to not more than 10mg, with a set of weights ranging from 10mg to 60mg Weighing scale balance having a capacity not exceeding 2.5kg complete with a set of weights ranging from 5g to 2kg. Both measuring apparatus should be calibrated and authenticated in accordance with the weights and measures requirements of the Legal Metrology Service. Weighing boats Range of graduated Type A glass measures and pipettes to measure volumes from 0.05ml to 500ml or range of syringes and syringe filters

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Suitable set of mortars and pestles including one glass set A suitable range of ointment jars including amber glass jars and suitable range of amber glass bottles Glass or marble ointment slab Glass stirrer and stainless steel spatula Face masks and disposal gloves to be used where appropriate 13.6.2 All instruments used for weighing or measuring should be calibrated at yearly intervals and records of date and particulars of equipment calibration should be maintained in the pharmacy. 13.7 Documentation

13.7.1 The compounding of a product should be documented in a manner that clearly shows the ingredients and the procedure used. 13.7.2 An extemporaneous compounding worksheet should be used to document all compounding. The following details should be included on the worksheet: Details of the patient, name address and age (in the case of a child) Ingredients (quantities, source, batch number & expiry date) Formulation & calculations Procedure Storage requirements Usage directions Duplicate label Number of labels generated Supplier details where difficulty was experienced in sourcing ingredients / formulae Pharmacy-assigned prescription number or preparation number Expiry date of final product All worksheets should be signed by the pharmacist who prepared or supervised the compounding and filed on the premises for future reference. 13.7.3 For products regularly prepared, pre-printed worksheets may be used to save time and avoid errors. 13.7.4 All records of the extemporaneous dispensing should be kept for at least two years. 13.8 Formulation

13.8.1 Where a pharmacist undertakes to extemporaneously prepare a product, the pharmacist must be satisfied as to the safety and appropriateness of the formula for the patient concerned and the pharmaceutical quality of the ingredients. 13.8.2 When pharmacists are faced with a request for an extemporaneous product they should adopt the following sequence in determining what formulation to be used: 13.8.2.1 If there a suitable formulation published in a reputable peerreviewed source such as formulary, journal or other source which has adequate information on physical, chemical and microbiological stability then this should be used.

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Section 2 Guidelines on Extemporaneous Dispensing

13.8.2.2 If no suitable formulation it may be advisable for the pharmacist to contact the prescriber to ascertain the indication and duration of treatment required to establish if there is a reasonable alternative commercial treatment available 13.8.2.3 If no published formulation is available the pharmacist should seek advice from local/other hospital pharmacy departments, National Medicines Information Centre, or product manufacturer. The pharmacist should endeavour to confirm the source of the formula, obtain information on the stability of the product, the compounding procedure and any other relevant information. 13.8.3 The compounding worksheet should detail the formulation used and the reference source. 13.8.4 In the case of extemporaneous preparation for children the pharmacist should make every effort to obtain up-to-date information on the correct therapeutic dosage range depending on the age of the child and also information on bioavailability of the extemporaneous product in children. 13.8.5 The pharmacist is responsible for either sourcing or preparing a suitable liquid preparation for the treatment of children. It is, in general, not appropriate for crushed tablets to be administered to children. 13.8.6 In extemporaneously preparing liquid preparations for the treatment of children, the pharmacist should have regard to the flavour of the preparation to aid compliance. 13.9 Ingredients

13.9.1 Pharmaceutical grade ingredients should be used in the extemporaneous preparation where possible. 13.9.2 All ingredients used in extemporaneous compounding must be used within the manufacturers specified shelf life. Where no expiry date is stated on the container, the pharmacist should check the expiry with the manufacturer. It is not advisable to use ingredients where no shelf life is specified. 13.9.3 The date on which a new container of ingredient is opened should be recorded on the container. 13.9.4 All ingredients used in extemporaneous compounding should be stored in accordance with the manufacturers specifications and in a way that minimises any potential for contamination. 13.9.5 Water used in extemporaneous preparation should be potable water, i.e. freshly drawn from a public water supply, safe and palatable for drinking, or Purified Water freshly boiled and cooled. Purified Water freshly boiled and cooled should be discarded 24 hours after preparation. 13.9.6 Hazardous substances should be handled according to the label and with due consideration of the health and safety of all staff. 13.10 Containers and Labelling

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13.10.1 The pharmacist should ensure that the extemporaneously compounded product is packaged in a suitable container to ensure its stability. 13.10.2 The extemporaneously compounded product must be labelled in accordance with the regulatory requirements. Labels should also include the expiry date of the extemporaneously prepared product, the strength of the product prepared, quantity supplied and storage requirements. 13.10.3 Products which are compounded in accordance with a published formulation such as a pharmacopoeial formulation should be labelled with the approved pharmacopoeial name. In all other situations the active ingredients and their quantities should be listed on the label where possible. 13.10.4 The name and strength of any preservative used in the formulation should be stated on the label. 13.10.5 A duplicate label should be affixed to the compounding worksheet. The number of labels printed should be recorded on the worksheet, and the pharmacist should be able to account for the location of each of the labels printed. 13.10.6 The pharmacist should ensure that an appropriate and specially adapted oral syringe is included with the extemporaneous preparation where it is intended for administration to a child. 13.11 Storage and Stability 13.11.1 The pharmacist should be satisfied as to the stability of the extemporaneously prepared product and that they can assign an expiry date to the product. 13.11.2 The label should state the date of manufacture and the date of expiry of the compounded product. 13.11.3 Where necessary, auxiliary storage labels (e.g. Refrigerate Do Not Freeze) should be used to indicate specific storage requirements. 13.11.4 Where a product is prepared in accordance with a published formulation the expiry date specified in the formulation should be used. Where no information is available regarding the stability of the extemporaneous product a short shelf-life should be assigned 13.12 Directions for Use 13.12.1 The product label should contain clear and correct directions for use of the compounded product. 13.12.2 Where necessary, auxiliary labels containing directions for use (e.g. External Use Only) or specific usage instructions (e.g. Shake the Bottle) should be used. 13.12.3 When labelling liquid preparations for administration to children the directions on the label should state the number of mls of liquid to be drawn up into the oral syringe followed by the dose in mgs in brackets afterwards e.g. 5mls (125mg) 13.13 Audit of the Extemporaneous Dispensing Processes

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13.13.1 An audit of the entire extemporaneous dispensing process should be conducted every six months. 13.13.2 When carrying out the audit the pharmacist should have regard to: 13.1.1.1 The training and performance of personnel involved in the compounding process 13.1.1.2 The adequacy and operation of the checking process by pharmacists 13.1.1.3 Cleanliness and hygiene standards i.e. that the cleaning schedule is sufficient and performed in compliance with the documented procedures 13.1.1.4 All required equipment is present in the pharmacy, in good working order and properly cleaned 13.1.1.5 Documentation of extemporaneous dispensing is complete and accurate 13.1.1.6 Ingredients used are stored and labelled appropriately, of appropriate quality and in date 13.1.1.7 Labels are prepared correctly and contain all necessary and relevant information 13.13.3 The pharmacist must ensure that outcomes of all audits are documented and action list is prepared of all issues which must be addressed in advance of next extemporaneous dispensing audit.
References: 1. Pharmaceutical Society of Australia. Australian Pharmaceutical Formulary and Handbook (17th Ed Canberra 2000) 2. Royal Pharmaceutical Society of Great Britain. Medicines, Ethics and Practice, a Guide for Pharmacists 3. Guild of Hospital Pharmacists, United Kingdom Guide to the Preparation of Extemporaneous Products, 28 November 2001

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Sample Compounding Worksheet


Pharmacy Name & Address Patient Name & Address Prescription No.

Prescription Details

Formulation & Reference Source (if applicable)

Working Formula Ingredients


Measure d Quantity Manufactur er Batch No. Measured by Checked by

Method & Notes

Usage Instructions

Label

Date of Preparation Expiry Date Storage Requirements No. of Labels Printed

Prepared by

Checked & Released by

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Section 2 Guidelines on the Provision of Pharmacy Services to Residential Homes by Community Pharmacies

14. BEST PRACTICE GUIDELINES ON THE PROVISION OF PHARMACY SERVICES TO RESIDENTIAL HOMES BY COMMUNITY PHARMACIES
Approved by the Council of the Pharmaceutical Society of Ireland in February 2004 14.1 Introduction The provision of pharmacy services by a pharmacist to a residential home ensures that its residents achieve the maximum therapeutic benefit from their medicines usage. It is the view of the Society that the pharmaceutical needs of those in residential homes is optimally served where a pharmacist is engaged on a full-time basis in the home concerned to provide pharmacy services to residents of the home. Such a pharmacist would manage and execute the ordering, dispensing to residents and safe storage of all medicinal products in the home and advise on their appropriate use. However, the Society acknowledges that it may not be practicable for every residential home to engage a pharmacist to provide pharmacy services in the home. In these circumstances, the pharmaceutical needs of the residents may successfully be provided by a community pharmacy. A number of community pharmacies provide pharmacy services to residential homes. The purpose of these guidelines is to set down best practice for community pharmacies providing pharmacy services to residential homes which do not have their own pharmacist, to ensure that persons in residential homes have the same opportunity and likelihood of accessing and receiving a high quality pharmacy service as a member of the public who is not resident in a residential home. For the purpose of these guidelines: 1. a residential home will be understood to mean any collective environment other than the usual home environment, where people are domiciled on either a temporary or permanent basis and includes homes for the elderly, those with a mental and /or physical disability, hospitals, prisons, remand centres and hostels; 2. a pharmacy service consists of and includes the following: i the dispensing, compounding, sale and supply of a medicinal product, either on foot of a valid prescription or otherwise, ii the provision of information and advice on the safe, effective and rational use of medicinal products in treating and preventing illness and improving health and well-being iii the monitoring and review of drug therapy use to ensure it is providing optimum benefit for the user iv any associated activities engaged in by a pharmacist in furtherance of (ii) and (iii) above 14.2 Supply of Medicinal Products 14.2.1 Ordering

14.2.1.1 Only a registered medical or dental practitioner can prescribe/order a medicinal product, be it prescription only or not, for use by a resident in a residential home.

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Nurses or other care staff cannot do so except in circumstances where: (i) that medicinal product has been prescribed by a registered medical practitioner/dentist and the nurse or other care worker is requesting the pharmacy to supply it on foot of that prescription (ii) they are acting on the direction of the resident concerned within the circumstances provided for in Section 2.1.8 below and medicinal product concerned is not a prescription only medicine. 14.2.1.2 A medicinal product for a resident in a residential home shall only be supplied on foot of a prescription written by a registered medical practitioner (or registered dental practitioner) in accordance with the statutory requirements prevailing at the time (currently the Medicinal Products (Prescription and Control of Supply) Regulations 2003 and in the case of a controlled drug, the Misuse of Drugs Regulations 1988-1993), except insofar as it concerns the supply of a non-prescription only medicinal product to a resident in accordance with the circumstances provided for in Section 2.1.8 below. 14.2.1.3 Where the Misuse of Drugs Regulations 1988-1993 are concerned, all of the usual statutory requirements for the supply from a pharmacy of a medicinal product controlled by these Regulations must be adhered to in full. 14.2.1.4 A residents patient chart does not constitute a prescription unless it is written in accordance with the statutory requirements prevailing at the time. 14.2.1.5 A copy of a prescription faxed to a pharmacy does not constitute a prescription under the current legal provisions and medicinal products must not be supplied by a pharmacy to a residential home on foot of a faxed copy of a prescription. The pharmacist is only entitled to dispense the medication when he is in possession of the original prescription for the resident concerned. 14.2.1.6 A medicinal product cannot be supplied to a residential home on foot of a telephone order, except in an emergency as currently provided for in law (Article 8(1) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 i.e. emergency supply at the request of a medical or dental practitioner). Here, the doctor or dentist, by reason of an emergency, is unable to supply a prescription and requests the pharmacist to supply a medicinal product for a particular person. The medical practitioner/dental practitioner must supply the pharmacist with a prescription within 72 hours thereafter. While it is good practice if possible to have a copy of the prescription faxed in support of the practitioners telephone instructions, a fax copy of a prescription is not sufficient and an original prescription must be still be furnished within 72 hours thereafter. The medical practitioner/dental practitioner must contact the pharmacist personally. No one can do so on his behalf e.g. a nurse or other carer. A medicinal product that is a controlled drug specified in Schedules 1,2,3 or 4 of the Misuse of Drugs Regulations 1988-1993 cannot be supplied in these circumstances. Supply by telephone order in these circumstances can only be in an emergency as that outlined above and it is not acceptable for it to become a routine means of supply to a residential home from the pharmacy.

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14.2.1.7 Supply of medicinal products on foot of a requisition or stock order form to a residential home is not appropriate. Where a medical practitioner requisitions a medicinal product, it is for use by him in his professional practice. The product should be delivered directly to the practitioner requisitioning it, who takes full responsibility for it thereafter. Unless a pharmacist can satisfy himself that a product being requisitioned for use in a residential home, is delivered directly to the practitioner requisitioning it and will be confined to the professional practice of the medical practitioner concerned in that home, then it should not be supplied. 14.2.1.8 A resident, either personally or another acting on their behalf, is entitled to be supplied with a non-prescription medicinal product for his personal use. Such requests should be considered by the pharmacist when attending the residential home (see No.3 below) and any supply shall be in accordance with a policy on self-medication by residents, which the pharmacist in the supplying pharmacy should agree with the management of the home and its associated medical, nursing and other care staff. 14.2.2 Dispensing of Medicinal Products

14.2.2.1 When dispensing a prescription for a resident in a residential home, the

pharmacist shall do so in compliance with all the prevailing legal and contractual requirements at the time. Furthermore, he shall do so in accordance with any professional and ethical guidelines issued by the Society for the dispensing of a prescription. 14.2.2.2 The dispensed medicinal products should be labelled in accordance with the prevailing legal requirements. Where the medicinal products are supplied in a dosage compliance system (DCS), then the usual labelling requirements must also be complied with. Where dispensing in a DCS, pharmacists should do so in accordance with the Societys guidelines on the supply of medicinal products in DCSs. Medicinal products which are a controlled drug specified in Schedules 2 and 3 of the Misuse of Drugs Regulations 1988-1993 should not be dispensed in any DCS being supplied for a resident in a residential home. Dispensing in DCSs for supply to residential homes where the practice is to have a permanent presence of registered nurses to administer the medicinal products is not justified and is not considered to be appropriate practice. 14.2.2.3 Depending on the number of residents in a residential home, the frequency of deliveries and the number of homes being serviced, the pharmacy shall ensure that the requirements in terms of pharmacist numbers, support staff, dispensing area, storage area, equipment and other facilities in the pharmacy are adequate to provide a high quality pharmacy service to the residential home(s) concerned. 14.2.2.4 There shall be sufficient pharmacist numbers available in the pharmacy at all times to ensure the proper and lawful supervision of the dispensing and supply of medicinal products to a residential home and to fulfil requirement in terms of pharmacists attendance at the home (see No.3 below) together with the proper supervision of the usual pharmacy services provided in any pharmacy keeping open shop in accordance with the Pharmacy Acts 18751977. 14.2.3 Delivery of Dispensed Medications

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14.2.3.1 The pharmacist who dispenses the medicinal products for the residents of the residential home in question should deliver the dispensed medicinal products to a designated person(s) at the home in question on a regular scheduled basis. Where the supplying pharmacy employs more than one pharmacist on a full-time basis and all its pharmacists are fully familiar with the pharmaceutical needs of the home and its residents, then it is acceptable for another of these pharmacists, other than the one who dispenses the medicinal products to deliver it, provided this pharmacist checks each dispensed product with the prescription and the pharmacys patient medication record before it leaves the pharmacy. Arrangements to have the delivery jointly verified and signatures of receipt obtained should be in place 14.2.3.2 Alternatively, the residential home can have its designated person(s) collect the dispensed medicinal products from the pharmacy, with arrangements to have the collection jointly verified and signatures of receipt obtained. 14.2.3.3 Where medicinal products which are controlled drugs specified in Schedules 2 and 3 of the Misuse of Drugs Regulations 1988-1993 are involved, the pharmacist should ensure that they are received or collected only by designated persons acting on behalf of the home and its residents. Under no circumstances, should they be received or collected by any other person. 14.2.3.4 Residents of a residential home should not experience any delay longer than that which could be reasonably expected for a person not in residential care, in having prescribed medicinal products available for them to take. A pharmacist agreeing to provide pharmacy services to a residential home should be in a position to guarantee, that any medicinal product required by a resident of the home, even in a emergency, will be available for that resident within a comparable time period to that which a person not resident in a residential home could reasonably expect to have the product available to him in similar circumstances. 14.2.4 Storage of the Medicinal Products

14.2.4.1 The pharmacist in the pharmacy providing pharmacy services to a residential home shall routinely advise on appropriate environmental storage conditions for all medicinal products in the residential home being supplied by him. The pharmacist should assist the residential home in ensuring that the medicinal products supplied by him are stored safely and in accordance with their storage requirements in the home pending their use by the residents. This applies equally to medicinal products supplied in the usual dispensing containers/original packs and in DCSs. 14.2.4.2 Additional storage and safe custody issues arise with medicinal products which are controlled drugs specified in Schedules 2 and 3 of the Misuse of Drugs Regulations 1988-1993. With such products, the pharmacist supplying them together with the management in the residential home shall ensure that they are stored in secure conditions with restricted access to designated persons in the home and that proper records as to their use in the home are maintained. 14.3 Attendance at the Residential Home

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14.3.1

The pharmacist in the pharmacy providing pharmacy services to a residential home will attend on a regular basis at the home at a frequency determined by the needs of the residents and as agreed with the home but not less than once per week. During such visits to the residential home, the pharmacist shall: 14.3.2.1 provide counselling to residents or where it is not appropriate, to the appropriate staff in the home, to encourage compliance with the prescribed drug regimen and the safe and effective of the medicinal products being prescribed; 14.3.2.2 review at least once every month, the medication charts of residents in the home and check against the patient medication record maintained by the pharmacy to ensure that the patient is being dispensed the proper medicinal products; 14.3.2.3 monitor at least once every month, the drug regimens for each resident for drug interactions, appropriate dosage, inappropriate prescribing etc; 14.3.2.4 ensure sufficient quantities of medication are being supplied and that there are no oversupplies and undersupplies of medicinal products; 14.3.2..5 ensure that appropriate arrangements are in place for the destruction of medicinal products no longer being used or are out-of-date; 14.3.2.6 takes reasonable steps to identify and report to the Irish Medicines Board any adverse drug reactions; 14.3.2.7 where he identifies discrepancies or inadequacies in a residents therapy, communicate with the medical practitioner concerned and the nurse or other carer directly responsible for the resident concerned as necessary. The pharmacist shall ensure that any issues identified are satisfactorily resolved in the best interests of the resident. 14.3.2.8 consider any personal self-medication requests with an Over-The Counter or other non-prescription medicinal product from residents and if so supplying, shall do so in accordance with a policy on selfmedication by residents, agreed with the management and medical, nursing and other care staff associated with the home.

14.3.2

14.4 Residents Rights 14.4.1 Prescriptions must be issued in the name of the individual resident. Therefore, it is the right of each individual resident to have that prescription dispensed in any pharmacy of their choice. Accordingly, each resident of the home should be provided with the details of the pharmacist and pharmacy (including its address) providing pharmacy services to the home and each resident should give their written consent to have that pharmacist and pharmacy dispense their prescriptions.

14.5 Quality Assurance 14.5.1 The authorities of the residential home and the pharmacist providing pharmaceutical services to that home should have a quality assurance programme in place to ensure systems are evaluated and demonstrated to be working well (or not) and that faults and areas for improvement are identified and remedies for them agreed. Suggested areas to be routinely reviewed in a quality assurance programme include:

14.5.2

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Ordering and delivery of medicinal products e.g. lag time between prescribing and receipt of prescription by pharmacist, lag time between receipt of prescription and availability of medicinal product for resident to take, availability of designated person for receipt of delivery/collection of medicinal products; Arrangements for storage and safe keeping of dispensed medicinal product at the residential home; Attendance at the residential home and the pharmacists involvement in patient counselling and review of drug therapy. 14.6 Education 14.6.1 The pharmacist in the pharmacy providing pharmacy services to the residential home shall provide the necessary education to the care staff in the home to ensure that they are in receipt of the necessary information on new drugs, drug information updates etc.

14.7 Contract of Services 14.7.1 The pharmacist in the pharmacy providing pharmacy services to a residential home will need to work in close co-operation with the management and medical, nursing and other care personnel associated with the home. To ensure that these staff, the management of the home and the pharmacist concerned fully understands the extent and standard of the service to be provided, and the responsibilities of the management and staff of the home in supporting the provision of pharmacy services, it is advised that a written contract between the pharmacy and the residential home is agreed. It is advised that this contract should include provision for all of the issues identified in these guidelines and their effective discharge. In particular, the contract should provide for the pharmacist to have access to the necessary patient information required for the proper discharge of his duties and responsibilities in respect of the provision of pharmacy services to the residential home. It is recommended that the contract address the issue of its termination so as to ensure that the standard and quality of pharmacy service provided to residents is not impaired in such circumstances. This contract should include all of the issues identified in these guidelines. In particular, the contract should identify the pharmacist who will be providing the pharmacy services and the key contact personnel in the home concerned, including the designated person(s) who will receive/collect the dispensed medicinal products from the pharmacy.

14.7.2

14.8 Inducements 14.8.1 It is unethical for any pharmacist to offer or accept any form of inducement relating to the provision, by that pharmacist or any pharmacy associated with him, of pharmacy services to a residential home.

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Section 2 Guidelines on the Use of Dosage Compliance Systems

15. BEST PRACTICE GUIDELINES ON THE USE OF DOSAGE COMPLIANCE SYSTEMS*


Approved by the Council of the Pharmaceutical Society of Ireland in February 2004 *Note: a number of different names have been used to describe such systems. They are commonly known as Monitored Dosage Systems however this term was considered an inappropriate description as monitored denotes that the use of the system is supervised by a carer. They are also referred to as Dosage Administration Aids and Compliance Aids and Multi-Compartment Compliance Aids 15.1 Introduction

15.1.1 Dosage compliance systems are compartmentalised boxes or blister-pack type devices used to aid the administration of solid, oral medications. 15.1.2 This guideline in no way suggests that the provision of medicines in a dosage compliance system is preferable to regular dispensing services. 15.2 Background

15.2.1 The use of a dosage compliance system can improve patient compliance in certain situations. However, it is important to note that there have been few published controlled studies of the use of dosage compliance systems as compliance aids, and the evidence regarding their effectiveness is conflicting 2. 15.2.2 Dosage compliance systems may not be suitable for all patients, home settings, or residential establishments. Their successful use will depend on the patient, their environment, the presence of carers and the patients own motivation, physical and cognitive abilities. 15.2.3 Dispensing in DCSs for supply to those in residential homes where the practice is to have a permanent presence of registered nurses to administer the medicinal products is not justified and is not considered to be appropriate practice 15.3 Scope

15.3.1 These guidelines are intended to cover the provision of a dosage compliance system service for regular oral medications, in order to facilitate the use of such medicines by patients in their homes and administration by carers to patients in nursing and residential care homes. 15.3.2 This guideline should be read in conjunction with the Guidelines for Dispensing Prescriptions and where appropriate, the Guidelines on the Provision of Pharmacy Services to Residential Homes by Community Pharmacies. 15.4 Responsibilities

15.4.1 The pharmacist is responsible for ensuring the overall quality, safety and appropriateness of a Dosage compliance system for the patient concerned. 15.4.2 The pharmacist is responsible for ensuring that the medication supplied in a dosage compliance system is: in accordance with the patients current medication regimen and total medication history suitable for issue in a Dosage compliance system
2

Nunney JM, Raynor DKT. How are multi-compartment compliance aids used in primary care? Pharm J 2001;267:784-789

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15.5

labelled in accordance with statutory requirements And that: the patient / carer is competent to independently manage the dosage compliance system Patient Suitability

15.5.1 A pharmacist should only fill and supply a dosage compliance system to a patient having received and recorded a request from the patient, carer, a health professional, or where having conducted an appropriate assessment, the pharmacist considers the patient may benefit from such a system. 15.5.2 In assessing patient suitability, the pharmacist should use their professional judgement to identify at-risk patients who will benefit from the use of a dosage compliance system. Criteria worthy of consideration in this assessment include: Patients who take five or more medications (including any over the counter medicines). Patients whose previous history suggests they have problems in managing their medication. Patients requiring a complex regimen of medications. Patients showing signs of cognitive or physical impairment which may impair their ability to effectively manage their medication.

15.5.3 The pharmacist should only supply a dosage compliance system where they have ascertained and ensured that the patient or their carer can effectively manage the dosage compliance system independently. 15.5.4 The developing practice of medicinal products for supply to residents in residential homes automatically being dispensed in dosage compliance systems is not appropriate. In residential homes where the practice is to have registered nurses available to administer the medicinal products to residents, the dispensing of those products in dosage compliance systems is neither justified or appropriate. 15.6 Personnel

15.6.1 The filling of the dosage compliance system must be conducted by or under the direct supervision of the pharmacist. 15.6.2 Where a non-pharmacist is involved in the tasks of filling the dosage compliance system, the pharmacist must ensure that they have the necessary training and practical experience to carry out their role. 15.6.3 All completed dosage compliance systems and documentation must be checked by the pharmacist and documentation must be signed by the pharmacist before issue. 15.7 Premises & Equipment

15.7.1 The filling of a Dosage compliance system must only be undertaken at a pharmacy. 15.7.2 The area assigned for this dispensing procedure should be clean and, where possible, free from interruption while the filling process is taking place. The

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area should be sufficiently large to allow for the orderly assembly of materials and to reduce the risk of error and cross contamination. 15.7.3 The storage area should be of sufficient capacity to allow orderly storage of the various products, packaging materials and finished products. 15.7.4 The pharmacy should have appropriate equipment for counting tablets and solid dosage forms to ensure that all hand contact with the medicine is avoided 15.7.5 For systems which are heat sealed, pharmacists must use an appropriate heat sealer as recommended by the Dosage compliance system supplier in order to safeguard the stability of the medicine. 15.7.6 The completed dosage compliance system should be stored in a cool, dry area and protected from light. 15.8 Product Suitability 15.8.1 Tablets or capsules which cannot be identified and readily distinguished from each other should not be placed together in a dosage compliance system. 15.8.2 Only medication free of incompatibilities (due to being in close contact with other medication) and medication whose removal from its original pack does not adversely affect its action shall be suitable for use in Dosage compliance systems. 15.8.3 Certain medications are unsuitable for packaging in a multi-dose pack and therefore should not be placed in a Dosage compliance system. These include: effervescent tablets dispersible tablets tablets for buccal use tablets for sublingual use significantly hygroscopic preparations solid dose cytotoxic preparations prn (as required) medicines 15.8.4 Uncoated tablets should not be placed in the same section as other uncoated tablets. 15.8.5 Consideration should be given to the effect of heat sealing the backing on some dose forms such as soft gelatin capsules 15.8.6 Labelling must enable identification of individual medicinal products to be made and must comply with regulatory requirements for dispensed medicines. 15.8.7 A controlled drug specified in Schedule 2 or 3 of the Misuse of Drugs Regulations 1988 as amended should not be dispensed in a dosage compliance system except in circumstances where the dosage compliance system is being supplied directly to persons or their representatives, for administration in the persons own home environment, not being a residential home. 15.9 Preparation of the Dosage Compliance System 15.9.1 The dispensing of medicines in a dosage compliance system should take place on receipt of an original prescription. The dosage compliance system should

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be filled with reference to the patients current prescription or medication regimen. 15.9.2 Medicines dispensed in a dosage compliance system should comply fully with statutory requirements governing dispensing. 15.9.3 In the patients medication history, the pharmacy should have a list of medications that are not delivered in the dosage compliance system and this list should be provided to the patient or their carer. 15.9.4 Tablets and capsules should not be removed from a manufacturers foil or blister pack until the dosage compliance system is being assembled, they should not be removed for the purpose of creating a bulk pack for dispensing. 15.9.5 Plastic trays or packaging in direct contact with the tablets or capsules should be discarded and should not be re-used. 15.9.6 All hand contact with solid dosage forms should be avoided 15.9.7 The pharmacist should ensure that re-usable dosage compliance system containers are cleaned and hygienic prior to reuse. Individual reusable dosage compliance systems should not be interchanged between different patients at any one time of their use. Use of such containers should be restricted to one particular person at any one time 15.9.8 After filling, the dosage compliance system should be protected from light and stored in a cool dry place. Packaging providing protection from light is preferred. 15.9.9 The containers and packaging used in a dosage compliance system should be such that any tampering between closure and sealing by the pharmacist, and time of administration, should be apparent. 15.9.10 Any unwanted medicines from the dosage compliance system should be returned to the pharmacy for safe disposal and should not be reused. 15.9.11 Patients should be advised to return all old / unused dosage compliance systems to the pharmacy in order to allow the pharmacist to monitor compliance.
15.10

Labelling

15.10.1 The dosage compliance system should be labelled in accordance with statutory labelling requirements. 15.10.2 The pharmacys name, address and telephone number and the patients name should be printed on the dosage compliance system label. 15.10.3 Labelling of the system must enable medicinal products to be made. identification of individual

15.10.4 Any appropriate ancillary labels should also appear on the dosage compliance system label. 15.11 Supply of the Dosage Compliance System

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15.11.1 To ensure that the medicines in the system are used correctly, pharmacists must advise the patient or carer on how to use the system and of the procedures to be followed regarding storage. 15.11.2 Notwithstanding Sections 2.3 and 5.4 above, where dosage compliance systems are supplied to a residential care facility the staff must be advised on procedures for storage, record-keeping, security etc. Their supply should be in accordance with the Societys Guidelines on the Provision of Pharmacy Services to Residential Homes by Community Pharmacies. 15.11.3 The pharmacist should also include with the dosage compliance system, the patients medications which are not delivered in the System as well as a list of these medications. 15.12 Documentation & Record-Keeping Procedures 15.12.1 The pharmacist is responsible for establishing and maintaining records of each dosage compliance system filled and that statutory requirements are fulfilled. 15.12.2 Dosage compliance system records should contain the following information: patients name & address date of provision details of medications provided cross-referenced to the prescription numbers where appropriate name of the pharmacist who filled / checked the system batch number and expiry date of medication used 15.12.3 Where feasible, written procedures should be maintained for the filling and supply of dosage compliance systems, particularly where filling is done on a rota by a number of pharmacists. Procedures should be systematically reviewed and audited at regular intervals. 15.12.4 Procedures should be clearly defined for dealing with issues that arise, such as as required or prn medication, changes to medication regimens (cessation or addition of a medication) supply of a controlled drug for a person in a residential home whose other medication is being dispensed in a dosage compliance system.. 15.12.5 The pharmacist should ensure that changes to medication in a dosage compliance system are made only under their supervision at the pharmacy and in accordance with statutory requirements. References:
Pharmaceutical Society of Australia. Australian Pharmaceutical Formulary and Handbook (17th Ed Canberra: Pharmaceutical Society of Australia, 2000) pp. 84-88 Pharmaceutical Society of Australia. Pharmacy Practice Handbook (Canberra: Pharmaceutical Society of Australia, 2000) pp. 96-99

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Section 2 Guidelines on the Treatment of Opioid Misusers

16. GUIDELINES ON THE TREATMENT OF OPIOID MISUSERS


Approved by the Council of the Pharmaceutical Society of Ireland in December 2004 CONTENTS Foreword
16.1. Introduction 16.1.1 Drug misuse in Ireland 16.1.2 Role of the Pharmacist 16.1.3 Harm reduction 16.1.4 Opioids 16.2. Community-pharmacy based treatment for opioid misusers 16.2.1. General services for opioid misusers 16.2.2. Specialist treatment services for opioid misusers 16.2.2.1. Methadone dispensing services 16.2.2.1.1. Methadone programmes in Ireland 16.2.2.1.2. Clinical information and training 16.2.2.1.3. Initiating methadone treatment under the Methadone Protocol Scheme 16.2.2.1.3.1. Recognising Stable Patients 16.2.2.1.3.2. Patient Registration & Methadone Treatment Cards 16.2.2.1.3.3. Pharmacy/Patient Agreements 16.2.2.1.4. Guidelines for dispensing and on-site administration of methadone 16.2.2.1.4.1. Dispensed methadone doses 16.2.2.1.4.2. On-site administration of methadone doses 16.2.2.1.4.3. Guidance for managing intoxicated patients 16.2.2.1.4.4. Guidance where patient has missed more than one methadone dose 16.2.2.1.4.5. Guidance where a patient's service is to be discontinued 16.2.3. Needle and syringe exchange 16.2.3.1. Staff training and in-house preparations 16.2.3.2. Operating a needle and syringe exchange scheme 16.2.4. Other pharmacological treatment options for opioid misusers 16.3. General issues 16.3.1. Safety and security issues 16.3.1.1. Procedure for pharmacy staff dealing with contaminated spillages 16.3.1.2. Procedure for dealing with needle stick injuries 16.3.2. Legal Issues 16.3.3. Professional and inter-disciplinary cooperation 16.4. References 16.5. Appendices

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16.6. Recommendations

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Foreword The Pharmaceutical Society of Ireland developed these guidelines at a time when the introduction and expansion of the Methadone Protocol has resulted in considerable changes to the nature and extent of treatment services for opioid misusers in Ireland since their Policy on Drug Abuse was published in 1996. They were published cognisant of the fact that there is, as yet, no formal national community pharmacybased needle exchange scheme. Furthermore, they were written shortly after the Irish College of General Practitioners produced its guidelines for GPs involved in the treatment of opioid misuse. In that context, it was felt that the Pharmaceutical Society of Ireland should revise and update its guidelines to provide support and advice for its members at this time. It should be noted that this document updates only one part of the Pharmaceutical Society of Ireland's Policy on Drug Abuse, as published in 1996. Further work is required to be undertaken to complete the update of this entire policy and guidance framework. In approaching this work, the Drug Abuse Project Team was conscious of a wide range of issues in this area of pharmacy practice. It recognised that this area of practice has a broad array of social and political dimensions. It was also aware of the necessity for close co-operation between the various health-carers involved in the provision of treatment services for opioid misusers. Methadone dispensing is regulated by both the Misuse of Drugs Regulations 1988-1993 and the Misuse of Drugs (Supervision of Prescription and Supply of Methadone) Regulations 1998. As a Schedule 2 controlled drug, methadone is subject to rigorous dispensing, storage and record-keeping requirements in the pharmacy and prescriptions for methadone must comply with Article 13 of the Misuse of Drugs Regulations 1988-1993. The Pharmaceutical Society of Ireland is aware that methadone prescriptions commonly fail to comply with these regulations, causing considerable difficulty for pharmacists. Optimal treatment of opioid misusers requires effective teamwork between the health care professionals involved, and prescribers must recognise that methadone prescriptions that are not written in accordance with the various statutory requirements are legally unacceptable and cannot be dispensed by the pharmacist. In its work, the Drug Abuse Project Team considered patient safety as the single most important responsibility of community pharmacists who treat drug misusers, and all aspects of these Guidelines aim to promote the continued safe, professional development and delivery of community pharmacy-based services for them. Members of the Drug Abuse Team: Mr.John Bourke (Chairman) Community Pharmacist & Council Member, PSI Dr William Boles Community Pharmacist & Council Member, PSI Ms. Noeleen Dargan Community Pharmacist Ms. Helen Johnston Pharmacy Co-ordinator, SEAHB Mr. Matthew Lynch Assistant Registrar, PSI Dr Sle O'Connor (Editor) Community Pharmacist Dr Denis O'Driscoll Pharmacy Co-ordinator, SWAHB Ms.Cicely Roche Community Pharmacist & Council Member, PSI Ms. Nihal Zayed Pharmacy Co-ordinator, NAHB

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16.1 Introduction 16.1.1 Drug Misuse in Ireland Drug Misuse has been defined as the use of any drug, legal or illegal, which damages some aspect of the user's life - whether it is their mental or physical health, their relationship with their family, friends or society in general, their vocational functioning as students or as workers, inside or outside the home (Corrigan 2003). The National Drug Task Force has identified four way of addressing the Irish drugs problem: (i) Treatment and rehabilitation (ii) Prevention and education (iii) Research and audit (iv) Supply reduction 16.1.2 Role of the Pharmacist The Pharmaceutical Society of Ireland recommends that community pharmacists make every reasonable effort to provide appropriate services for the drug misusing patients in their local communities. In this document the Pharmaceutical Society of Ireland provides practical guidelines for pharmacists involved in the treatment and rehabilitation of drugs misusers. While misuse has been associated with a wide range of drugs, these guidelines focus on opioidrelated drug misuse. 16.1.3. Harm Reduction The WHO describes harm reduction as an approach aimed at achieving intermediate goals as a halfway stage to achievement of the ultimate goal of freedom from drug dependence by using a variety of strategies to decrease the health and social risks and consequences of substance use (WHO 1998). Harm reduction strategies are pragmatic and non-judgemental and include substitute prescribing (e.g. methadone instead of heroin) and the supply of clean syringes and needles to injecting opioid misusers. Such initiatives are supported by the Pharmaceutical Society of Ireland. 16.1.4 Opioids The term opioids is used to include synthetically produced drugs in this class (e.g. methadone) as well as semi-synthetic and naturally occurring opiates (e.g. heroin). This ensures that the guidelines refer to the treatment of patients who misuse drugs in any of these categories. 16.2. Community Pharmacy-based Treatment for Opioid Misusers Community pharmacies offer two types of pharmaceutical service to opioid misusers: 16.2.1 General services, which are also utilised by other pharmacy patients 16.2.2 Specialist treatment services, used primarily by opioid misusers 16.2.1 General community pharmacy-based services for Opioid Misusers

Community pharmacists who are sensitive to the needs of their drug misusing patients can provide many useful generic health care services for them. Such services might include: Drug/medicines information Advice on the safe storage of medicine in the home

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Phased dispensing of benzodiazepines and other psychoactive medicines Information regarding all aspects of personal health and well-being e.g. nutrition, smoking cessation, wound management and dental care. Advice on accessing services dealing with testing, vaccination (where available) and treatment of various blood-borne diseases such as TB, HIV and hepatitis B & C. Safer sex information. Information on how to access local specialist services such as drug agencies or mental health services.

Pharmacists should not underestimate the impact they can have on the health of drug misusers, even if they do not dispense drugs such as methadone or enter into formal needle exchange arrangements. The care of drug misusers, as with all patients, extends far beyond their primary medical diagnosis. 16.2.2 Specialist treatment services for Opioid Misusers

Internationally, community pharmacy has been involved in the provision of a number of different specialist services for opioid misusers. These services can be broadly divided into three categories, which are described in detail below: (i) methadone dispensing, (ii) needle and syringe exchange and (iii) the dispensing of other medicines used in the treatment of opioid misuse. 16.2.2.1 Methadone Dispensing Services 16.2.2.1.1 Methadone Programmes in Ireland

In Ireland methadone is dispensed both in community pharmacies and in specialist drug treatment centres, most of which are located in the greater Dublin area. In addition, patients who are stable on methadone programmes generally continue to receive treatment if admitted to hospital or interned in prison. The introduction of the Methadone Protocol Scheme in 1998 enabled patients to receive free methadone treatment from their GPs and local community pharmacists, and the co-operation of pharmacists with the Scheme has been recognised and favourably acknowledged (Farrell et al 2000). As healthcare professionals, pharmacists have an important role to play in this harm reduction initiative and the Pharmaceutical Society of Ireland supports the involvement of community pharmacists in methadone dispensing under the Methadone Protocol Scheme. Methadone 1mg/ml is the formulation most commonly dispensed under the Methadone Protocol Scheme. A 10mg/ml formulation has been considered for use in the tertiary drug treatment centre setting, but due to the potential dangers associated with the concurrent use of two disparate formulations, further policy and protocols need to be in place before its use becomes routine. 16.2.2.1.2 Clinical information & Training

Pharmacists who are willing to participate in the Methadone Protocol Scheme should be provided with information on all aspects of methadone treatment. They should possess a sound understanding of the following: (i) the rationale behind methadone treatment (ii) the pharmacology of methadone (iii) the concept of harm reduction (iv) signs and symptoms of opioid withdrawal and opioid intoxication (v) psychosocial aspects of drug misuse

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Recommended reading in this area includes: Sheridan, J and Strang, J (Eds.) (2003) Drug Misuse and Community Pharmacy Taylor and Francis, London Tober G, Strang J, (eds), (2003). Methadone Matters: Evolving Community Methadone Treatment of Opiate Addiction. London: Martin Dunitz, 2003. Irish College of General Practitioners (2003) Working with Opiate Users in Community Based Primary Care. ICGP, 4/5 Lincoln Place, Dublin 2. 16.2.2.1.3 Initiating Scheme Methadone Treatment under the Methadone Protocol

16.2.2.1.3.1 Recognising Stable Patients The decision as to whether a pharmacy will provide a methadone dispensing service to a patient lies solely with the particular pharmacist in the pharmacy in question. It is advised that pharmacists exercise their own professional judgement in deciding whether or not to provide a methadone dispensing service for any prospective patient. A pharmacist when making their decision should consult with the pharmacy co-ordinator and get a firm indication from the co-ordinator as to the behavioural status of any prospective patient and whether their behaviour is considered to be sufficiently stable to allow them attend a community pharmacy to have their methadone dispensed. The pharmacy co-ordinator in assessing the suitability of patients for methadone dispensing in a community pharmacy should do so in accordance with the following criteria: optimally the patient concerned should be opioid free (excluding methadone) they should be committed to the harm reduction progress that they are undertaking optimally they should be cocaine/stimulant free and not have problem use of benzodiazepines or alcohol To assist the pharmacist in reaching their decision, the pharmacy co-ordinator must advise the pharmacist of the patients status in respect of the following: serious behavioural problems serious psychiatric conditions details of relevant criminal record and pending criminal proceedings against them childcare or housing issues in the case of female patients, whether they are pregnant or not age if under 18 The following additional matters should also be considered by the pharmacist when making their decision: whether the patient is living or working in the pharmacys usual catchment area the number of existing patients in receipt of methadone dispensing services at the pharmacy. A maximum of fifty patients for methadone dispensing services per pharmacy is recommended whether the proposed prescribing medical practitioner is known to the pharmacist and the pharmacist has access to a full range of contact details for that medical practitioner. (The pharmacy co-ordinator should provide the relevant contact details to the pharmacist). Once in receipt of the range of details identified above, the pharmacist can then make an informed decision as to whether they are satisfied to provide methadone dispensing services to a particular patient in the particular circumstances or not.

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It should be noted that initiating methadone prescribing is a specialist field and should only be carried out within a drug treatment centre or by a GP who has carried out supplementary (Level 2) training with the ICGP. 16.2.2.1.3.2 Patient Registration & Methadone Treatment Cards All patients being dispensed methadone for opioid dependence must be registered on a Central Drug Treatment List. This is a confidential register that can be accessed by doctors and pharmacists only. A pharmacist can check that a patient is registered by telephoning 01 - 648 8638 during office hours. Each registered patient is allocated to a methadone prescriber and a community pharmacy. If a community pharmacist agrees to dispense methadone for a patient, the pharmacy co-ordinator notifies the Central Drugs Treatment List and a treatment card (which is similar in appearance to a credit card) is posted to the community pharmacy. The treatment card carries the patient's name, photograph, date of birth, methadone treatment number and the name and contact number of the doctor prescribing their methadone. Treatment cards should be stored safely in the pharmacy and destroyed on expiry or discontinuation of treatment. Once the patient's methadone treatment card is received in the pharmacy, the pharmacist can legally dispense methadone to that patient on foot of a valid methadone prescription. Pharmacists should ensure that they are the necessary stocks of methadone available to dispense to the patient concerned when they present in the pharmacy. 16.2.2.1.3.3 Pharmacy/Patient Agreements It is important that pharmacists who dispense methadone take steps to prevent conflict arising between them and their patients on methadone. Written pharmacy/patient agreements can be useful in avoiding conflict as they: clarify the services that the pharmacy will provide outline the behaviour that is acceptable in the pharmacy, and detail the steps that will be taken should the agreement be breached. The Pharmaceutical Society of Ireland recommends that pharmacies introduce such agreements with individual patients in advance of commencing their methadone treatment. They can address a wide range of issues such as dispensing hours, privacy, confidentiality, practice protocols, and can emphasise key points e.g. methadone cannot ever be supplied without a valid prescription (Methadone is a controlled drug in Schedule 2 of the Misuse of Drugs Regulations 1988 as amended, therefore it cannot be supplied in accordance with the emergency supply provisions). In the interests of the patient, the treating doctor and the dispensing pharmacist should share relevant information regarding the patient being treated. Shared Information should include relevant clinical information such as urinalysis data, treatment plan details and changes in physical appearance and behaviour. Appropriate provision should be included in the Pharmacy/Patient Agreement for the sharing of relevant information so as to ensure that such disclosure is made with the knowledge and consent of the patient concerned. If necessary, specific details of the information to be shared may be specified in the agreement. Pharmacists should also ensure that in the pharmacys annual return to the Data Protection Commissioner, that the doctor of a patient is listed in the section of that return for disclosees. Agreements should be mindful of patients' rights and should take into account particular local/personal circumstances. A sample agreement is included in Appendix

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1 for guidance. In circumstances where it is not possible to have formal Pharmacy/Patient Agreements in place, it is recommended that the pharmacist bring to the attention of the patient any conditions in place for providing a methadone provision service to the patient. In particular, it is recommended that the pharmacist addresses the issue of shared information as referred to above. 16.2.2.1.4 Guidelines for dispensing and on-site administration of methadone

16.2.2.1.4.1 Dispensed methadone doses (i) "Take home" methadone doses should always be dispensed in plastic bottles with child-resistant tops and patients should be repeatedly reminded to store their methadone in a safe place beyond the reach of children. Plastic bottles should be used to avoid accidental breakages. (ii) Measuring devices of a suitable size should be made available to all patients who need them. Measures of 30 - 60mls are generally appropriate. Patients should be advised not to use babies' bottles when measuring methadone, due to associated risks of child poisoning. (iii) "Take home" methadone doses that are lost or stolen should not be replaced unless a new valid prescription is issued. Patient records should note the reason why a further supply was dispensed. (iv) It is recommended that the patient for whom the methadone is prescribed (and whose treatment card is held by the pharmacy) collects his methadone in person. However, it is acceptable in particular circumstances for the dispensed methadone to be supplied to a nominated representative of the patient, who collects it on his behalf. Such arrangements must be initiated with the agreement of the methadone prescriber, who should name the representative in writing on the methadone prescription. In such circumstances, the pharmacist should satisfy himself as to the identity of the nominated representative before any methadone is supplied. 16.2.2.1.4.2 On-site administration of methadone doses (i) The Pharmaceutical Society of Ireland recommends that a minimum of one methadone dose should be consumed under the supervision of the pharmacist at the pharmacy each week to improve patients' compliance with their prescribed dosage regimen. This is in accordance with international best practice, the ICGP's Guidelines (ICGP 2003) and with current practice in the statutory tertiary drug treatment centres. (ii) Community pharmacies, where methadone is consumed on-site, should have a quiet area which is used by all customers for confidential consultations, and can also be used to reduce visibility and increase privacy during methadone consumption. (iii) Methadone doses should be dispensed in advance and stored in the Controlled Drugs cabinet, to avoid undue delay when patients present for their methadone. (iv) The identity of each patient should be confirmed in advance of the administration of methadone using the patient's methadone treatment card. (v) Suitably sized disposable cups should be used for the administration of methadone doses on-site. All used containers should be discarded following self-administration. (vi) Methadone should be dispensed and consumed under the direct supervision of the pharmacist. Water consumed after the dose will guarantee that the methadone has all been swallowed.

16.2.2.1.4.3 Guidance for Managing Intoxicated Patients

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Pharmacists have a responsibility to satisfy themselves that the patient is intoxicated before administering or dispensing a dose of methadone. If intoxicated patient presents in the pharmacy, the pharmacist should outline safety issues to the patient and the patient should be advised to return to pharmacy after a number of hours, when the pharmacist can review the situation.

not an the the

If time does not allow for this procedure, no methadone should be dispensed and the patient should be referred back to the methadone prescriber (via the local drug treatment centre or pharmacy co-ordinator, where possible). Pharmacists who refuse to dispense methadone under these circumstances may be at risk due to the unpredictable nature of the intoxicated patient, and they may need to exercise professional discretion regarding balancing the safety of the patient versus the danger to themselves, their staff and other pharmacy users. 16.2.2.1.4.4 Guidance where Patient has missed more than one Methadone Dose Where a patient has missed two or more days' supply of methadone, his tolerance may have fallen and the supply of a previously safe methadone dose may endanger him. In the interest of patient safety, no methadone should be dispensed or administered on-site and the patient should be referred back to the doctor prescribing his methadone, for an immediate review. 16.2.2.1.4.5 Guidance where a Patient's service is to be discontinued The Methadone Protocol Scheme recognises that there may be conflicts with patients on methadone in community pharmacies, making it necessary for the patient's treatment in that pharmacy to be discontinued. All health boards that implement the Methadone Protocol Scheme must put structures in place to ensure that patients are expeditiously transferred out of a community pharmacy where conflict has arisen, to minimise risks to the pharmacist, pharmacy staff and other pharmacy users. 16.2.3 Needle and Syringe Exchange Schemes Needle and syringe exchange schemes provide clean injecting equipment for selfinjectors such as opioid misusers, while also facilitating the collection of their used returns. Some needle and syringe exchanges also offer other injecting paraphernalia such as citric acid, spoons and filters. The provision of free clean injecting equipment has been shown to reduce sharing behaviour among opioid misusers (Donoghue et al 1992), thereby reducing the incidence of physical complications such as endocarditis and abscesses, and the transmission of blood borne diseases such as HIV and hepatitis (Bastos 2000). Although needle and syringe exchange has been available in Ireland since 1989 (Dillon & O'Brien 2001) research suggests that current provision is inadequate and recommends community pharmacy involvement (Cox & Lawless 2000, Farrell et al 2000). Community pharmacy-based needle and syringe exchange schemes have been shown to attract opioid misusers who do not use other exchanges because they are anonymous and less stigmatised. The National Drugs Strategy 2001-2008 has required the Eastern Regional Health Authority (ERHA) to investigate the establishment of a community pharmacy-based needle and syringe exchange scheme within the ERHA region (Department of Tourism, Sport & Recreation 2001). In the pursuit of harm reduction, the Pharmaceutical Society of Ireland supports the principle of needle and syringe exchange and advocates the establishment of a national needle and syringe exchange scheme.

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16.2.3.1 Staff Training and In-House Preparations (i) All staff (including locum pharmacists) should be aware that the pharmacy operates a needle and syringe exchange. (ii) Vaccination against hepatitis A & B should be available to all staff in a pharmacy providing needle and syringe exchange facilities. (iii) A written operating procedure for the needle and syringe exchange should be readily available in the pharmacy (see sample operating procedure in Appendix 2). (iv) Appropriate training should be provided for those operating the needle and syringe exchange. Such training should include: The pharmacy's needle and syringe exchange operating procedure Instructions on safe practice and minimising the risk of needle stick injury Information on infection risk and surface decontamination Familiarity with various injecting equipment and paraphernalia supplied The concept of harm reduction as applied to needle and syringe exchange and safer sexual practices Addressing the importance of a professional, non-judgemental attitude Conflict resolution skills Knowledge of other local drug treatment agencies and needle and syringe exchange schemes Record-keeping requirements and confidentiality issues (v) A trained needle and syringe exchange operator should be available on-site at all times. Needles and syringes must never be supplied or exchanged by an untrained staff member. 16.2.3.2 Operating a pharmacy-based needle and syringe exchange scheme (i) (ii) (iii) At the first visit all relevant aspects of the operation of the needle and syringe exchange scheme including record keeping requirements should be explained to the service user. Needle and syringe exchanges can be made to persons over 18 years who have been referred by the local health board or under arrangements and conditions as set out and agreed. Community pharmacists should not knowingly exchange or supply injecting equipment to those aged less than 18 years. Unless personal identification can be used to verify a person's age, community pharmacists should refer those they suspect may be under 18 years old to the nearest health board needle and syringe exchange facility, where a protocol is in place for the management of minors. Service users should be encouraged to return used injecting equipment as the pharmacy offers an exchange as opposed to a supply service. However, the supply of clean equipment should not be on a strict one-for-one basis and service users should not be refused clean equipment if they do not bring returns. The service user must dispose of their own used equipment by depositing it directly into a sharps container in the pharmacy. Sharps containers should not be overfilled and suitable arrangements should be in place for the regular collection of full sharps containers from the pharmacy by the relevant health or waste management authority. Details of supply and exchange transactions may need to be recorded for research, evaluation or payment purposes. However, the pharmacy should endeavour to respect service users' confidentiality and to afford a level of privacy as would be appropriate for any sensitive healthcare transaction in the pharmacy.

(iv)

(v) (vi) (vii)

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(viii) If a person who is known to be currently prescribed methadone endeavours to use the needle and syringe exchange scheme, the community pharmacist must use his professional judgement and take whatever steps are deemed necessary in the best interest of the service user. 16.2.4 Other pharmacological treatment options for opioid misusers In addition to methadone, there are a number of drugs that can be used in the treatment of opioid misusers. These include buprenorphine, lofexidine, naloxone and naltrexone. Information on any of these drugs is available from the National Advisory Committee on Drugs at 01-6670760 or www.nacd.ie. The Pharmaceutical Society of Ireland recommends that all available pharmacological options are considered and used appropriately in an effort to expand the range of treatment services available to Irish opioid misusers. 16.3 General Issues in the provision of specialist services for opioid misusers There are three general professional issues relating to the provision of community pharmacy-based specialist treatment services for opioid misusers: 16.3.1 Safety and security concerns 16.3.2 Legal issues 16.3.3 Professional and interdisciplinary co-operation 16.3.1 Safety and Security Issues The security of pharmacy premises and the safety of pharmacy staff should be taken into consideration when providing specialist services for opioid misusers. The Pharmaceutical Society of Ireland recognises the particular risks associated with the management of opioid misusers in the community pharmacy. It has previously liaised with Garda authorities to secure assurances of their support and it will continue this liaison in order to regularly review community pharmacy-based services for opioid misusers, and address any safety and security issues arising therefrom. If a pharmacy is participating in the treatment of opioid misusers and methadone is being dispensed, the pharmacist should notify the local Garda and seek their advice on safety and security matters. Similarly, where other specialist services such as needle and syringe exchange are being provided to opioid misusers in a pharmacy, the local Garda should be notified to seek their guidance on security and protection. All staff working in pharmacies providing specialist care for opioid misusers should be offered vaccination against hepatitis A & B. Vaccines are available free of charge and can be sourced from the pharmacy co-ordinators or the local health board primary care teams. Pharmacy staff may on occasion be exposed to hazardous waste in providing services for opioid misusers. Suitable steps should be taken to ensure their safety is not compromised. Health carers who come in contact with body fluids may be exposed to hepatitis B, C or HIV infection. The highest risks are associated with needle stick injuries and mucocutaneous exposure (i.e. when infected fluids splash onto broken skin or mucous membranes). The most likely risk in the pharmacy relates to spillages of bodily fluids (e.g. vomit after taking methadone dose or blood spills from used injecting equipment). 16.3.1.1 Procedure for Pharmacy Staff dealing with Contaminated Spillages

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In instances where spillages occur, the Centre for Disease Control (RCN 1993, MMWR 1998) recommends the following procedures: Good hand washing technique Hands should be washed before and after dealing with spillage. Use water and an antiseptic solution and lather for 60 seconds. Safe decontamination of clinical spillage and the use of protective clothing A plastic apron and latex gloves must be worn throughout the decontamination process. If the spillage occurs on a non-porous surface, sufficient Presept granules (or a similar chlorine releasing agent) should be used to fully absorb the spillage. The granules should be left in place for 3 minutes, and wiped up using paper towels. The affected area should then be wiped with hot detergent water. If the spillage occurs on a carpeted area, the fluid spill should be wiped with paper towels. Then the area should be wiped clean with disposable wipes and hot detergent water. The spillage site should be cleaned with a hot water extractor machine if possible. If used injecting equipment is spilled, it should not be handled but must be placed into a sharps container with a forceps. Hands should be washed following the procedure outlined above and protective clothing and materials used to wipe the spill must be disposed of as clinical waste. 16.3.1.2 Procedure for Dealing with Needle Stick Injuries The wound should be encouraged to bleed and washed thoroughly with warm running water. The incident should be reported to the pharmacist if it involves another member of the pharmacy staff and the affected person should immediately go to the nearest hospital casualty department. The offending sharp should be kept for analysis. A report should be made in the pharmacy accident book and the pharmacy's insurance company should be notified. 16.3.2 Legal Issues Methadone The supply of methadone from the pharmacy is controlled by the Misuse of Drugs Regulations 1988-1993 and the Misuse of Drugs (Supervision of Prescription and Supply of Methadone) Regulations 1998. Methadone is listed in Schedule 2 of the Misuse of Drugs Regulations 1988-1993 and pharmacists involved in its supply are required to comply with the various provisions of these Regulations including those relating to the supply, storage and record keeping of CD2 drugs. The Misuse of Drugs (Supervision of Prescription and Supply of Methadone) Regulations 1998 set down a number of additional requirements controlling the supply of methadone, and pharmacists are required to also comply in full with them. Needle and Syringe Exchange Schemes There is no specific legal provision prohibiting the sale or supply of syringes, needles or paraphernalia in Ireland and a prescription is not required in order to supply them. Little evidence has been found in the

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literature on needle exchange to support the view that their provision in exchanges such as pharmacy based needle exchange promotes injecting drug use. However, where a community pharmacy is not participating in a structured needle and syringe exchange scheme, the Pharmaceutical Society of Ireland recommends that pharmacists should only supply clean injecting equipment in exceptional circumstances. In addition, pharmacists making such supplies should have a designated sharps container on the premises to facilitate the disposal of used injecting equipment, and they should actively encourage the return of used injecting equipment. 16.3.3 Professional and Interdisciplinary Co-operation and Communication It is essential that community pharmacists who provide specialist care for opioid misusers do not work in isolation but strive to cultivate good working relations with other health carers involved in the provision of drug treatment. The three health boards in the Eastern Regional Health Authority have employed pharmacy co-ordinators to support community pharmacists and they can be contacted as follows: NAHB: SWAHB: SEAHB: Ms. Nihal Zayed First Floor, Phibsborough Towers, Dublin 7 Tel: 087 225 2860

Dr Denis O'Driscoll Tel: 087 290 4852 Bridge House, Cherry Orchard, Dublin 10 Ms. Helen Johnston Tel: 086 854 3733 York Road, Dun Laoghaire, Co. Dublin

The Pharmaceutical Society of Ireland recommends that a national pharmacy co-ordinator be appointed to co-ordinate community pharmacy involvement in the Methadone Protocol Scheme at national level. This is particularly important in instances where prescribing and dispensing services are being provided in different health board regions. Additionally, so that those pharmacists involved in methadone dispensing can be fully involved in the treatment of opioid misusers, there needs to be proper measures put in place to support such pharmacists arranging appropriate professional cover for their pharmacies. This would allow them to attend relevant meetings and consultations with drug treatment centres, doctors and others who are involved in the treatment of opioid misusers. These meetings are often held during pharmacy opening hours and pharmacists often cannot attend because there is not another pharmacist available to replace them in the pharmacy. Methadone Community pharmacists who dispense methadone under the Methadone Protocol Scheme should work closely with their pharmacy co-ordinator and with the doctors who prescribe the methadone that they dispense. The pharmacist and doctor mutually concerned with the provision of treatment for individual drug misusers should maintain strong two-way communication links. Specifically, the dispensing pharmacist should be provided with a fixed or mobile telephone number for the prescribing doctor, where he can be contacted throughout pharmacy dispensing hours.

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Standard protocols (such as those outlined in 16.2.2.1.4) should be made known to the doctors involved to facilitate the management of patients on methadone. They should also be made aware of the content of any Pharmacy/Patient Agreement being used, including the steps that will be taken should the Agreement be breached (see Section 16.2.2.1.3.3). Needle and Syringe Exchange Schemes Where a national or regional network is in place, community pharmacists who operate needle and syringe exchange schemes should work in conjunction with the pharmacy co-ordinator (or needle and syringe exchange scheme co-ordinator), local outreach workers and medical and nursing staff at the local drug treatment centre. Co-operation at this level is vital if the community pharmacist is to be adequately supported in managing the service and so that referral links are established should service users require additional drug treatment services.

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16.4. References Bastos, F., Strathdee, S.A. (2000) Evaluating effectiveness of syringe exchange programmes: current issues and future prospects. Social Science and Medicine 51, 1771-1782 Corrigan, D. (2003) Facts About Drug Misuse in Ireland (Fourth Edition). Health Promotion Unit, Department of Health & Children, Dublin. Cox, G., Lawless, M. (2000) Evaluation of a Syringe Exchange Programme. Merchants Quay Project, Dublin. Department of Tourism, Sport and Recreation (2001). Building on Experience: National Drugs Strategy 2001-2008 (Action 63). Government Stationery Office, Dublin. Dillon, L., O'Brien, M. (2001). Drug- Related Infectious Diseases. In Moran, R. et al A Collection of Papers on Drug Issues in Ireland. Health Research Board, Dublin. Donoghue, M.C., Stimson, C.V., Dolan, K.A. (1992) Syringe exchange in England: An Overview. The Centre for Research on Drugs and Health Behaviour, London. Farrell, M., Gerada, C., Marsden, J. (2000) External Review of Drug Services for the Eastern Health Board. National Addiction Centre, Institute of Psychiatry, London. Irish College of General Practitioners (2003) Working with Opioid Users in Community Based Primary Care. ICGP, Dublin. Morbidity and Mortality Weekly Report (1998) Universal Precautions for the prevention of transmission of Human Immunodeficiency Virus, Hepatitis B virus and other blood-borne pathogens in the Health Care setting. Centre for Disease Control, Vol. 37, No.24. Royal College of Nursing (1993) Universal Precautions. Royal College of Nursing, UK. World Health Organisation Expert Committee on Drug Dependence (1998). WHO technical report series 873: treatment of drug dependence. World Health Organization, Geneva.

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APPENDIX 1: Methadone Protocol Scheme Pharmacy/Patient Agreement at NAME: Pharmacy DATE: / /

This agreement protects the interests of both the pharmacy staff and the person on methadone. It will help both you and your pharmacist. Please read in full before signing. PHARMACY STAFF 1. We agree to treat you with respect and dignity at all times. 2. We will dispense your prescriptions in accordance with your doctor's instructions, in the correct dose and at the proper intervals. 3. We will inform you if there is an interaction between your methadone and any other medication dispensed to you at this pharmacy. 4. We will provide you with any relevant drugs information that you need. 5. We will dispense your methadone to you as efficiently as possible and avoid any unnecessary delays in the pharmacy. 6. We will dispense your take-home methadone doses in child-resistant containers. 7. We will protect the confidentiality of your methadone treatment at our pharmacy. 8. We undertake to give you as much privacy as possible when you attend the pharmacy for your methadone, especially if you drink a dose on-site. 9. We will protect your health and safety by with-holding your methadone if you appear to be under the influence of alcohol or drugs. 10. If it is in your best interest, the pharmacist will share relevant information with other health carers such as doctors involved in your treatment. (Refer to 16.2.2.1.3.3 of Guidelines). SERVICE USER 1. I agree to treat the pharmacy staff with respect and dignity at all times. 2. I agree to collect my methadone prescription and I accept that no methadone can be dispensed without a valid prescription. 3. I agree that I am responsible for my methadone and I accept that it cannot be replaced if lost or stolen. 4. I agree to attend the pharmacy during the allocated time. 5. I understand that I may have to wait for my methadone to be dispensed if the pharmacy is busy. 6. I will attend the pharmacy alone. 7. I will not loiter outside the pharmacy. 8. I accept that my methadone will not be dispensed if I am intoxicated or if I have missed two or more daily doses. 9. I accept that the pharmacist and other health carers involved in my treatment may share relevant information in my best interest. (Refer to 16.2.2.1.3.3. of Guidelines). 10.I accept that violent, threatening or abusive behaviour is not appropriate and will result in the discontinuation of my treatment. I understand the above conditions and I am aware that the continuation of my treatment at this pharmacy depends on my abiding by them. Signed:________________________ (Patient)

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I agree to provide the above services to this patient under the Methadone Protocol Scheme. Signed:________________________ (Pharmacist)

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APPENDIX 2: SAMPLE PROTOCOL FOR OPERATING A COMMUNITY PHARMACY-BASED NEEDLE AND SYRINGE EXCHANGE SCHEME 1. General Guidelines The following staff are trained to operate the needle and syringe exchange scheme: ______________________________________________ ______________________________________________ (i) All queries regarding the syringes and needle exchange scheme operated in this pharmacy must be referred to the staff members listed above. (ii) Only those listed above can issue new injecting equipment or accept returned equipment. (iii) All staff must be polite and courteous when dealing with people using the needle and syringe exchange scheme, and must respect their right to confidentiality. 2. Returns procedures for used injecting equipment (i) Service users should always be encouraged to return used injecting equipment, ideally encasing it in a personal sharps container before arriving at the pharmacy. (ii) If a service user wishes to dispose of used injecting equipment, the pharmacy sharps container should be retrieved from its storage place by the trained staff member. It should be carried by the handle and held well away from the body (iii) The pharmacy sharps container should be placed on the counter and the service user should place all used equipment directly into it. The needle and syringe exchange operator must not touch the returned injecting equipment (iv) The trained staff member must wash his hands thoroughly using water and detergent after each exchange. (v) Sharps containers must not be overfilled. (vi) When full, the sharps container should be sealed and stored in a safe place, ready for collection (see below). (vii) If all sharps containers are full, used equipment must not be accepted. Service users should be referred to the following local needle and syringe exchange services: ________________________________ ________________________________ 2. Supply of new injecting equipment (i) Stocks of new equipment are stored in ______________________________. (ii) Additional needle and syringe exchange supplies can be ordered from __________________________________ (iii) If used injecting equipment is returned, a maximum of forty (40) syringes or needles can be supplied during any one transaction. (iv) Service users who do not return used equipment should not be refused supplies but may be given no more than six (6) syringes or needles. (v) Every opportunity should be taken to relay health promotion messages regarding injecting practices, drug misuse and safer sex when operating the needle and syringe exchange facility. 3. Storage of pharmacy sharps containers

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(i) (ii) (iii) (iv)

Sharps containers must be kept in a safe location to which the public does not have access. The sharps container currently in use is stored in ______________________ Additional pharmacy sharps containers are stored in ___________________ Full sharps containers which are awaiting collection for disposal are stored in _____________________________________________

4. Disposal of returned Needles and Syringes (i) The normal arrangements for the collection of full sharps containers are _____________________________________________ (ii) To organise an extra collection of full sharps containers, contact ____________________________________________ 5. Record keeping (i) Some records may be required of the volume and nature of the equipment supplied or returned to the needle and syringe exchange. (ii) All information recorded in the pharmacy needle and syringe exchange should be anonymous and confidential.

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5. Recommendations 5.1. 5.2. 5.3. 5.4. 5.5. The Pharmaceutical Society of Ireland recommends that community pharmacists make every effort to provide appropriate services for the drug misusing patients in their local communities. The Pharmaceutical Society of Ireland supports the involvement of community pharmacists in methadone dispensing under the Methadone Protocol Scheme. The Pharmaceutical Society of Ireland recommends that a national pharmacy co-ordinator be appointed to co-ordinate community pharmacy involvement in the Methadone Protocol Scheme at national level. The Pharmaceutical Society of Ireland recommends that pharmacies introduce Pharmacy/Patient agreements with individual patients in advance of commencing their methadone treatment. The Pharmaceutical Society of Ireland will continue to liaise with Garda authorities in order to regularly review community pharmacy-based services for opioid misusers, and address any safety and security issues arising therefrom The Pharmaceutical Society of Ireland recommends that a minimum of one methadone dose should be consumed under the supervision of the pharmacist at the pharmacy each week to improve patients' compliance with their prescribed dosage regimen. In the pursuit of harm reduction, the Pharmaceutical Society of Ireland supports the principle of needle and syringe exchange and advocates the establishment of a national needle and syringe exchange scheme. Where a community pharmacy is not participating in a structured needle and syringe exchange scheme, the Pharmaceutical Society of Ireland recommends that pharmacists should only supply clean injecting equipment in exceptional circumstances. The Pharmaceutical Society of Ireland recommends that all available pharmacological options are considered and used appropriately in an effort to expand the range of treatment services available to Irish opioid misusers.

5.6.

5.7. 5.8.

5.9.

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Section 2 Revised Society Policy on the Use of Child Resistant Containers

17. REVISED SOCIETY POLICY ON THE USE OF CHILD RESISTANT CONTAINERS (CRCS)
Approved by the Council of the Pharmaceutical Society of Ireland in October 2003 The Council of the Pharmaceutical Society of Ireland unanimously passed the following motion on the use of child resistant container (CRCs) for the dispensing of medicines: The Council of the Pharmaceutical Society of Ireland should seek the mandatory use of child resistant containers (CRCs) for all dispensed oral dose medicines by lobbying the Department of Health to introduce the necessary legislation as soon as possible. In the interim, the Pharmaceutical Society should actively promote the use of such containers to all pharmacists by every means at its disposal. On foot of it having adopted this motion, the Society has amended its Codes of Practice for both Good Pharmaceutical Practice and Guidelines for Dispensing Prescriptions as follows: In the Code of Practice for Good Pharmaceutical Practice, the statement at 1.4.8 as follows is deleted: The use of child resistant closures is recommended for particular classes of medicines including: Non-steroidal anti-inflammatory agents; iron preparations; antihistamines, including anti-tussives and decongestants; anti-convulsants; digoxin; theophylline and derivatives; sedatives; hypnotics and tranquillisers; tricyclic and other anti-depressants; opiate derivatives including preparations containing diphenoxylate; appetite suppressants; aspirin; paracetamol; and other analgesics. These medicines are most likely to be implicated in childhood poisonings. In the Guidelines for Dispensing Prescriptions, the statement at 2.5.8 as follows is also deleted Patients should be warned to keep all medicines out of the reach of children. Childresistant containers should always be used except where the professional judgement of the pharmacist indicates that this might pose excessive difficulty for the patient. All liquid oral medicines should be dispensed in containers fitted with suitable childresistant closures. All solid oral medicines should be dispensed in containers fitted with suitable child-resistant closures or in blister packs unless: 2.5.8.1 They are in a manufacturers original pack and transfer to another container would therefore be an unnecessary and retrograde step; 2.5.8.2. The patient specifically requests otherwise; 2.5.8.3 In the case of 2.5.8.2 above, the pharmacist should make a particular point of advising that the medicines be kept well out of the reach of children. A revised statement at 2.5.8 in the Guidelines for Dispensing Prescriptions has been agreed to replace that deleted as follows: Patients should always be advised to keep all medicines out of the reach of children. The Pharmaceutical Society of Ireland is seeking to make the use of Child-Resistant Containers (CRCs) mandatory for all dispensed oral medicines. Pending the introduction of the necessary regulation in this regard, all pharmacists should always use CRCs when dispensing any solid medicinal product for oral use that is not blister packed. Opaque blister packs are considered to be sufficiently child resistant. However, transparent blister packs are not and should always be supplied in an opaque outer e.g. a cardboard box to minimise the risk to children. Similarly, medicinal products in liquid form should only be dispensed in a CRC. Where a liquid preparation is supplied in the manufacturers original pack which is not a CRC,

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the pharmacist is expected to replace the closure with a child resistant one if at all possible. However, if the pharmacist cannot supply it with a child resistant closure, they are expected to advise the patient or their representative, that it does not have a child resistant closure and that it should be even more carefully stored, out of the reach of children at all times. In very exceptional circumstances, the pharmacist may use non-CRCs where in their professional judgement, the use of CRCs might pose excessive difficulty for the patient. However, before deciding to use a non-CRC, the pharmacist must review in full with the patient concerned the individual particular circumstances and be satisfied that the use of CRCs would: iii cause the patient excessive difficulty on an on-going basis in getting the medication out of the container and iv be likely to compromise the safe, effective and compliant use of the medication. A full record of such an intervention should be made by the pharmacist in the patients medication record. When dispensing a medicinal product for oral use in a non-CRC, the pharmacist should advise the patient or their representative on each occasion of the need to ensure that the product is safely stored out of the reach of children at all times. There is a significant body of evidence demonstrating the reduction in accidental childhood poisonings where child resistant containers are used for dispensed medicines. The Society would request that all pharmacists note its revised policy in this matter and ensure that they amend their dispensing practices where necessary in accordance with it.

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