Introduction to Pharmacy Ethics

Background
 Pharmaceutical care involves applied ethics in that it
consists of the practical application of moral standards to
specific ends.

 Pharmaceutical care practitioners should not only be

clinically competent, but must also adhere to the law and
ethical standards.

 The pharmaceutical care practitioner must learn to

recognize when his/her personal values (political views,
religious beliefs, or social expectations) interfere with
professional responsibilities and behaviors.

 As a general rule, clinical problems should be identified and

resolved first, followed by legal issues.
Background
 Pharmacists are the researchers, developers, producers,
people who are trusted to give advice on drugs to all health
professionals and persons who market drugs in the whole
world.

 The pharmaceutical industry is the most heavily regulated of

all industries.

 The law, as well as the professional regulation body and the

public, will require reasons for professional actions.

 Law and ethics are not static. This means that students, and
eventual practitioners, need to remain alert throughout their
professional life for changes and amendments to each and to
be aware of how these will affect and impact on their chosen
area of practice.
http://www.gallup.com/poll/1654/honesty-ethics-professions.aspx
Ethics
 Ethics is the study of the rightness or wrongness of human
conduct.

 Patient care involves applied ethics in that it consists of the

practical application of moral standards to specific ends.

 In pharmaceutical care, utilization of pharmaceuticals

should depend on using the essential knowledge that
should always accompany such clinical intervention.
Ethics
 Pharmaceutical care is dependent upon human interactions,
that include patients, family members, pharmaceutical care
practitioners, other clinicians, support personnel, managers,
and administrators.

 These individuals are likely to have different values, beliefs,

and preferences. Whenever two people with different value
systems interact, there is the potential for an ethical
problem to develop.

 Because ethical problems are common in practice it is

important that practitioners know how to identify and
resolve them when they arise.
Ethics
 There are three issues— clinical, legal, and ethical —
which can be so closely associated. It will be helpful if the
three issues can be separated, when possible, because a
successful resolution to each issue is arrived at slightly
differently.

 Each situation requires different knowledge for its

recognition and a somewhat different process for its
resolution.

 As a general rule, clinical problems should be identified and

resolved first, followed by legal issues, and if an ethical
problem remains, it can then be resolved effectively.
History
1906 Federal Food and Drug Act
 Enacted to stop the sale of inaccurately labeled drugs
 Manufacturers were required to put truthful information on
the label before selling the drug
 Manufacturers had to prove their drug’s effectiveness
1914 Harrison Narcotic Act
 Enacted because of the excessive number of opium addicts
in the United States
 People could no longer obtain opium without a prescription
1938 Food, Drug, and Cosmetic Act
 Enacted because the earlier Food and Drug Act was not
worded strictly enough and did not include cosmetics
 Required drug companies to include directions to the
consumer regarding use and package inserts on drugs
 All narcotics were required to be labeled “Warning: May be
habit-forming”
History
1951 Durham-Humphrey Amendment
Required the labeling ”Caution: Federal law prohibits
dispensing without a prescription”
Made certain drugs require a doctor’s order and supervision
Made the initial distinction between legend drugs (by
prescription only) and over-the-counter (OTC) medications
1962 Kefauver-Harris Amendment
 Enacted in an attempt to ensure the safety and effectiveness
of all new drugs on the market
Burden put on manufacturing companies to have good
manufacturing practices (GMP)
Prevented the sale of thalidomide in the United States
because children were born with birth defects after usage in
pregnancy
Issues of the law
 Pharmacy law consists of rules, regulations, and actions that
are disseminated by governments and are binding on its
constituents.
Example Should a pharmacist, based on his/her clinical
judgment at the time of an emergency, provide a patient with a
life-saving drug not authorized by a physician's prescription,
when technically he/she is breaking the law, but is perhaps acting
ethically?
 There are many laws that direct what practitioners may and
may not do with prescription drug products.

 In those relatively few situations where the law is not clear,

practitioners should always follow the professional and
ethical mandate to do no harm and when it is possible, to do
good for the patient.
Issues of the law
 Example Is it ethical to intentionally dose a patient with an
amount of drug that is so small to has little or no chance of
successfully treating the medical problem? If the pharmacist's
clinical judgment is that the patient's drug therapy problem is
that the dosage is too low, then it is legally necessary to
obtain the consent of the prescriber in order to increase the
dose.

 Being an active moral agent can conflict with the law and
often does.

 Ethical analysis requires critical examination of actions and

their consequences and are not so easily differentiated as
appropriate and inappropriate.
Legislation
 Legislation sets out the rules or structure for what we can
do and what we are not allowed to do and outlines the
consequences of breaking the rules.

 Every pharmacist has a duty to practise lawfully and the

sanctions for failing to do so can be harsh.

 The consequences of breaking the rules of professional

practice can include criminal prosecution resulting in a fine
or, in more serious cases, imprisonment, as well as removal
of the right to continue to practise (removal from the
register).
Pharmacist and Legislation
 Pharmacists, are required to follow the requirements of the
Code of Ethics and other guidance and standards set out by the
professional regulator.

 When applying clinical knowledge in practice, patients and the

public will rightly wish to assume that the knowledge will be up
to date, relevant and safe.

 Early legislation relating to pharmacy was concerned with

prohibiting harmful practices associated with the supply of
medicines and restricting authority to a few types of practitioner.

 In UK, Pharmacists were all required to achieve a set standard of

education, to register with the Royal Pharmaceutical Society of
Great Britain and pay an annual retention fee in order to be able
to continue to practise.
Pharmacist and Legislation
 Other recent changes have allowed pharmacists to utilise their
clinical skills to become authorised prescribers as well as
dispensers or suppliers of medicines.

 A knowledge and understanding of pharmacy legislation are

therefore crucial to be able to practise.

 Pharmacy legislation sets out the framework of rules that govern

what we can do legally.
Pharmacist and Legislation
Accountable (responsible ) officer
 In Health Act 2006 which relates to the supervision, management
and use of controlled drugs. It introduces the concept of the
‘accountable officer’

 The aim was preventing patient deaths, take a systematic

approach to the early detection of practitioners who might be
misusing or abusing controlled drugs.

 The Health Act places a requirement on specified organisations

within the NHS to appoint an Accountable Officer for controlled
drugs.

 The role of this person is to ensure the safe use of controlled

drugs within his or her organisation.

 It also involves training, monitoring and assessment of people

involved in their management and use.
Medicines and Pharmacies
 The Health Act 2006 provides for powers in relation to
supervision of sales of medicines in registered pharmacy site.

 Replacing the term ‘personal control’ with ‘responsible

pharmacist’, referring to both registered pharmacy premises and
bodies corporate.

 Since the implementation of the Medicines Act 1968, every

registered pharmacy premises has been required to have a
pharmacist in ‘personal control’. ‘Personal control’ is the legal
term that has been replaced by the new term ‘responsible
pharmacist’
Medicines and Pharmacies
 The term ‘personal control’ meant that there had to be a
pharmacist within each pharmacy who was responsible for the
pharmacy’s systems and practices to ensure safe sale and supply
of medicines to patients and the public.

 Why is this control important? It meant that in every registered

pharmacy premises, even those pharmacy building that were part
of a body corporate and therefore had a manager pharmacist,
there was an individual pharmacist responsible for the immediate
running of each individual pharmacy.

 The pharmacist had to be personally available to intervene in

every sale or supply of a medicine whether in accordance with a
prescription.
Medicines and Pharmacies
 This requirement for a pharmacist to be present in the pharmacy
at all times, put pharmacists at variance from other professions
where supervision meant overseeing systems and/or practices of
groups of professionals rather than personal presence and
involvement.

 For example, a supervisor of midwives is a senior midwife with

professional responsibility. However, a supervisor of midwives
does not personally have to attend every birth or every clinic
visit undertaken by every member of his or her team of
midwives.
Medicines and Pharmacies
 In the early 20th century, the pharmacy was the place many
people went for advice about their healthcare. These were the
places where free advice was readily available from a healthcare
professional, but the National Insurance Act of 1911 changed
health provision for many – mostly men. With the introduction of
this Act of Parliament, employed men earning less than £170 per
annum became entitled to free medical care provided by doctors
who were ‘on the panel’. This meant the doctors were paid a
retainer fee to see and treat men covered by the Act.
Conclusion
 The art of pharmacy was first practiced in Ancient Babylon
around 2600 BC. In this era the priest, physician and pharmacist
was the same person. The Arabs were the first to separate the
art of pharmacy from physician and in the eight century they
establish the first private pharmacy in Baghdad.

 When the European countries were exposed to Arabian

influence, public pharmacies began to appear. However, it was
not until about 1240 A.D. that pharmacy was separated from
medicine.

 The role of the pharmacist is changing drastically with the

traditional activities such as compounding of medicines, and
pharmacist becoming more like a walking encyclopedia for
drugs, fulfilling the doctor’s needs by giving advice and
information on use of drugs, providing correct dosage forms,
assuring the efficacy and quality of the dispensed medicinal
products, formulating dosage forms and manufacturing drugs.
Conclusion
 Now the pharmacy profession is not only related to dispensing
and distribution of drugs or sometimes being regarded as a
“glorified store keeper”.

 Pharmacists now have a bigger role as global players and in the

adoption of global standards so as not to be left out or left
behind in the global race.