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• What is the background which led to the development of the concept of essential drugs? • What is the definition of an essential drug? • What are the criteria for inclusion of a drug in the Essential Drugs List (EDL)? • How are drugs classified in the EDL? • Why are revisions of the EDL necessary? • What is the use of EDL to the Ministry of Health? • What was the role played by Professor Bibile in the development of the EDL? • What are the recommendations made by Professor Bibile towards optimizing use of pharmaceutics in Sri Lanka? • Know the essential medicine list of 2009 and be able to name the medicines in the list.
• • • • • • • • • • What are the recommendations on Drug procurement Distribution Education of prescribers Education of the public Explain the meaning of the term - Rational Drug Use (RDU) overuse, use, inappropriate use, polypharmacy. What is the Cosmetics, Devices and Drugs Act? What is a registered drug & What criteria are used when drugs are registered in this country? How are drugs scheduled? What is a drug dossier and what are its contents?
• The essential medicines concept was launched in 1977, and became one of the eight pillars of WHO's "Primary Health Care" strategy. • Initially country lists were a means to guide the procurement of medicines. • Initially was mainly for adults with some paediatric medicines included • Since 2007 paediatric list developed separately by a Subcommittee and included in the final WHO – ML • It is a global list
• Selection – on disease prevalence and – evidence on efficacy and safety and – comparative cost-effectiveness .Essential Medicines • Definition by World Health Organisation Essential medicines are MEDICINES that satisfy the priority health care needs of the population.
in the appropriate dosage forms. and at a price the individual and the community can afford . with assured quality and adequate information.Purpose of WHO essential medicines concept • Essential medicines are intended to be available at all times in adequate amounts.
never in the brand names . one calcium channel blocker is chosen from the several available • Medicines are listed only in generic name. one ACE inhibitor.Other principles • Only one member from a pharmacological group can be chosen – Example hypertension ONLY • one beta blocker.
WHO Model List of Essential Medicines • The is a model product and a model process • Updated every two years by an expert committee • In Sri Lanka the WHO list is used as a model • Exactly which medicines are regarded as essential remains our national responsibility .
WHO – EML • Medicines classified into – Core List – Complementary List Sri Lanka has also divided our list accordingly 9 .
safe and cost effective medicines for priority conditions • Priority conditions are selected on the basis of current and estimated future public health relevance 10 .Core list • List of minimum medicine needs for a basic health care system • Lists the most efficacious.
The complementary list • Consists of essential medicines for priority diseases which are efficacious. safe and cost-effective But • not necessarily affordable. 11 . or • for which specialized health care facilities or services may be needed.
Cost comparisons • Cost of the total treatment not only the unit cost of the medicine. not between treatment of tuberculosis and treatment of malaria. • The patent status of medicine is not considered in selecting medicines for the Model List if all main criteria are met. 12 . • Comparisons may be made among alternative treatments within the same therapeutic group for example high blood pressure but not be made between therapeutic categories for Eg. is considered.
• Examples of FDCs that have met these criteria include new formulations for HIV tuberculosis and malaria.Single medicines/ Fixed dose combinations (FDCs) Most essential medicines should be formulated as single c ompounds. safety or compliance over single compounds administered separately. • FDCs selected only when the combination has a proven ad vantage in therapeutic effect. 13 .
from annual health bulletin • Reliable and adequate efficacy AND safety data • Pharmacoeconomic data to determine comparative cost-effectiveness of available treatments 14 .Criteria for selection of Sri Lanka EML • Disease burden in Sri Lanka .
What is the use of EML to the Ministry of Health? • Used for procurement and supply of the priority medicines for the public sector • To accept donations in times of emergency • For local manufacture • Procurement for the state sector – state pharmaceutical corporation (SPC) • Who distributes and quantifies the needs – medical supplies division (MSD) .
Essential medicine list Sri Lanka • • • • • First EML published in 1988 Revised irregularly since then 1999. 2004 Now will be done every three years 2009 latest – you will be given a copy You should know the essential medicine list of 2009 and be able to name the medicines in the list and all the relevant information .
Role of Professor Senaka Bibile • First Professor of pharmacology in Colombo • In 1958 conceived the idea and produced a limited list (HFL) for poor countries to spend wisely • Recognized as the person who revolutionized management of pharmaceuticals in Sri Lanka In 1971 introduced and in the third world • In 1975 – 1976 WHO accepted the concept and essential medicines concept was born • Prof NDW Lionel was on the first expert committee of the WHO .
Reforms introduced in Sri Lanka in 1971 by SB • Set up a central procurement organization – SPC • Medicines requirement was quantified objectively and purchased through world wide / regional tender system • Ensured quality of medicines met specified standards • Introduced an efficient system for distribution of medicines through MSD • Restricted innovator branded products and introduced generic prescribing .
Trends in percentage expenditure on essential medicines: 2002-2006 90 Percentage of money spent 80 70 60 50 40 30 20 10 0 2002 2003 2004 Year 2005 2006 19 18 20 26 29 81 82 80 74 71 Essential medicines Non essential medicines .
DRUG REGULATION .
What is Drug Regulation The control of pharmaceuticals that is sold in a country. Includes – What drugs are available in the country – How they are used – How they are advertised – What their prices are Drug Regulation is an intrinsic sovereign right of a country as a part of the states duty in health .
Drug Regulation • Is done in every country • Only extent differs between the countries • In Sri Lanka drug regulation is carried out at the Medical Technology and Supplies division of the Ministry of Health .
Office of MT&S Administration Unit Registration & Licensing Unit Directo r Deputy Director No of Pharmacist attached to NRA – 11 Pharmacologists . scientists – Permanent Nil University academics provide advice as a GMP Unit Pharmacovigilanc e Unit Law Enforcement Unit Control Substance Unit Post-Marketing Unit .
Bangaladesh 2008 . but in US only • Such poisonings still happens .main issue was safety.within the law • Beginning of drug regulation .US. Haiti 1995.Why should there be Drug Regulation? History • 1938 .Bangladesh 1992. diethylene glycol used as solvent • 107 children died • Company could not be prosecuted .
Drug Regulation in Sri Lanka • Legislative Framework for Pharmaceuticals • Cosmetics. Drugs and Devices Act 1980 and the regulations • Note .many reasons • Applies only to Western drugs • Excludes herbal.Cosmetics and Devices too • Comprehensive legislation but implementation patchy . ayurvedic & other drugs .
every drug must be registered in the Drug Regulatory Authority before being sold in the country • Drugs must be stored and sold in the manner defined in the act • Registration of pharmacies • Licence to bring in new drug samples • Advertisement of drugs must be in accordance with the regulations .Elements of the CDD Act • Registration .
IP.quality. USP. safety and efficacy • Quality Product must be registered in the country of manufacture Good manufacturing practices – guidelines given by WHO Conform to pharmacopoeia specifications – BP.Registration 1 • Criteria . Analytical reports on starting material and finished product Stability data throughout the proposed shelf life Testing by National drug quality assurance laboratory .
Registration 2 • Efficacy judged on clinical trial data (RCTs done in phase 3 studies) • Safety – data provided from clinical trials but post marketing surveillance for adverse drug reactions very important – done in our department • Doctors are requested to fill a ADR form if they suspect any ADRs .
Four classes of drugs • SCHEDULE 1 . paracetamol.original packing Advertisement to the public allowed . can be sold unsupervised.g.simple drugs with a wide therapeutic index. sell in original packing Medical Faculty canteen • No registered premises.Over The Counter • No licence. but in a defined manner . aspirin Basis . no registered person e.
g. registered person (pharmacist) • Basis .drugs which do not need prescription but need supervision • Cannot be advertised to public • Can be sold loose e. salbutamol / paracetamol .Pharmacy only Medicines • Registered premises (pharmacy). chlorphenamine.Four classes of drugs (2a) • SCHEDULE 2A .
only to prescribers • e.g.Four classes of drugs (2b) • SCHEDULE 2B .Prescription only Medicines • Registered premise (pharmacy).drugs which need prescription and supervision in dispensing • Cannot be advertised to public. propranolol . amoxicillin. registered person (pharmacist) on prescription • Basis .
drugs which need prescription. morphine. doctors need to keep a register.Four classes of drugs (3) • SCHEDULE 3 .g. e. pethidine Basis . supervision in dispensing and state control • Cannot be advertised to public .Dangerous Drugs • Drugs with a potential for dependence • Imported only by government • Distributed through Medical Supplies Division • Pharmacies.
leprosy reactions. thalidomide • Little relevance to medical practice • But now problem as thalidomide has re emerged for treatment of multiple myeloma.Banned Drugs • Considered too dangerous for use • LSD. cancer • ? Personal used licence .Four classes of drugs (4) • SCHEDULE 4 .
qualifications. supervision by Food and Drug Inspectors • Clinical trials • Storage of drugs • Distribution of drugs • Manufacture of drugs locally • Advertising – Committee in the drug regulatory authority goes through all drug advertisements before it is made public .Other areas of Drug Regulation • Registration of Pharmacies .
• CDD Act .Drug Advertisements • What is the object of advertising drugs? • To make the public aware of the product.negative statement • Consumer directed advertising of precription medicines prohibited in the act .OTC products • Main object .drugs must not be advertised in a false and misleading manner . NOT stimulate demand (reality?) • Therefore special rules and regulations for pharmaceutical advertising. so that it will be used when need arises .provide information about product.
Drug Advertisements (cont.. to support and encourage the improvement of health care through the rational use of medicinal drugs” • The SLMA has developed these criteria further (Both SLMA and WHO publications in FILM) • Specific points .. contraindications should be in an advertisement .generic name.. adverse effects. indications.) • How should drugs be advertised? • WHO Ethical Criteria for Medicinal Drug Promotion • “.
Definition of a innovator / generic product • Innovator is the first invented medicine authorized for marketing and is branded and patented by the company Example panadol • Generic product is a multisource interchangeable ( with the innovator) pharmaceutical product produced after the patent expires. example paracetol. may have a brand name or only the INN. paracetamol (SPC) .
in doses that meet their own individual requirements for an adequate period of time. and the lowest cost to them and their community. .Definition of Rational drug use WHO .Rational use of Drugs requires that patient receive medication appropriate to their clinical needs.
SUMMARY .EIGHT RIGHTS OF RATIONAL PRESCRIBING • • • • • • • • THE THE THE THE THE THE THE THE RIGHT RIGHT RIGHT RIGHT RIGHT RIGHT RIGHT RIGHT DRUG PATIENT TIME DOSE ROUTE INFORMATION MONITORING COST .
accessibility and affordabilty • Drugs are special unlike food and other consumer goods • Enormous potential for both harm & good • Stringent regulation is important . safety and cost important in selecting the right medicine • EML ensures availability.Summary 2 • A major consideration in selection of EML is prevalence of the diseases • Efficacy.
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