drug registration and essential drugs[1]

ESSENTIAL MEDICINES CONCEPT AND DRUG REGULATION IN SRI

LANKA

Prof Rohini Fernandopulle December 2010

Objectives 1 • 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.

Objectives 2• 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?

Background • 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

Essential Medicines• Definition by World Health Organisation

Essential medicines are MEDICINES that satisfy the priority health care needs of the population.

• Selection – on disease prevalence and– evidence on efficacy and safety and – comparative cost-effectiveness

Purpose of WHO essential medicines concept

• Essential medicines are intended to be

available at all times in adequate amounts, in

the appropriate dosage forms, with assured

quality and adequate information, and at a

price the individual and the community can

afford

Other principles • Only one member from a pharmacological

group can be chosen – Example hypertension ONLY

• one beta blocker, one ACE inhibitor, one calcium channel blocker is chosen from the several available

• Medicines are listed only in generic name, never in the brand names

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

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WHO – EML

• Medicines classified into

– Core List

– Complementary List

Sri Lanka has also divided our list accordingly

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Core list

• List of minimum medicine needs for a basic health care system

• Lists the most efficacious, safe and cost effective medicines for priority conditions

• Priority conditions are selected on the basis of current and estimated future public health relevance

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The complementary list

• Consists of essential medicines for priority diseases which are efficacious, safe and cost-effective But

• not necessarily affordable, or • for which specialized health care facilities or

services may be needed.

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Cost comparisons• Cost of the total treatment not only the unit cost of

the medicine, is considered. • 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. 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.

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Single medicines/ Fixed dose combinations (FDCs)

Most essential medicines should be formulated as single compounds.

• FDCs selected only when the combination has a proven advantage in therapeutic effect, safety or compliance over single compounds administered separately.

• Examples of FDCs that have met these criteria include new formulations for HIVtuberculosis and malaria.

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Criteria for selection of Sri Lanka EML

• Disease burden in Sri Lanka - from annual health bulletin

• Reliable and adequate efficacy AND safety data

• Pharmacoeconomic data to determine comparative cost-effectiveness of available treatments

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

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Essentialmedicines

Non essentialmedicines

Trends in percentage expenditure on essential medicines: 2002-2006

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 DirectorDeputy Director

Administration

Unit

Registration &

Licensing Unit

GM

P U

nit

Pharmacovigilance

Unit

Law Enforcem

ent U

nit

Control Substance U

nit

Post-Marketing

Unit

No of Pharmacist attached to NRA – 11Pharmacologists , scientists – Permanent NilUniversity academics provide advice as a voluntary service

Why should there be Drug Regulation?

History• 1938 - US, diethylene glycol used as solvent• 107 children died• Company could not be prosecuted - within the law• Beginning of drug regulation - main issue was safety, but

in US only• Such poisonings still happens - Bangladesh 1992, Haiti

1995, Bangaladesh 2008

Drug Regulation in Sri Lanka

• Legislative Framework for Pharmaceuticals• Cosmetics, Drugs and Devices Act 1980 and the

regulations• Note - Cosmetics and Devices too• Comprehensive legislation but implementation patchy -

many reasons• Applies only to Western drugs• Excludes herbal, ayurvedic & other drugs

Elements of the CDD Act

• Registration - 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

Registration 1• Criteria - quality, safety and efficacy• QualityProduct must be registered in the country of

manufacture Good manufacturing practices – guidelines given by

WHOConform to pharmacopoeia specifications – BP. USP.

IP. Analytical reports on starting material and finished

productStability data throughout the proposed shelf lifeTesting 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 - Over The Counter• No licence, sell in original packing

Medical Faculty canteen• No registered premises, no registered person e.g.

paracetamol, aspirin

Basis - simple drugs with a wide therapeutic index, can be sold unsupervised, but in a defined manner - original packing

Advertisement to the public allowed

Four classes of drugs (2a)

• SCHEDULE 2A - Pharmacy only Medicines• Registered premises (pharmacy), registered person

(pharmacist)• Basis - drugs which do not need prescription but need

supervision• Cannot be advertised to public• Can be sold loose

e.g. chlorphenamine, salbutamol / paracetamol

Four classes of drugs (2b)

• SCHEDULE 2B - Prescription only Medicines• Registered premise (pharmacy), registered person

(pharmacist) on prescription• Basis - drugs which need prescription and supervision

in dispensing• Cannot be advertised to public, only to prescribers to public, only to prescribers• e.g. amoxicillin, propranolol

Four classes of drugs (3)• SCHEDULE 3 - Dangerous Drugs• Drugs with a potential for dependence• Imported only by government• Distributed through Medical Supplies Division• Pharmacies, doctors need to keep a register. e.g.

morphine, pethidineBasis - drugs which need prescription, supervision in Basis - drugs which need prescription, supervision in dispensing and state controldispensing and state control

• Cannot be advertised to publicCannot be advertised to public

Four classes of drugs (4)• SCHEDULE 4 - Banned Drugs• Considered too dangerous for use• LSD, thalidomide• Little relevance to medical practiceLittle relevance to medical practice• But now problem as thalidomide has re emerged for But now problem as thalidomide has re emerged for

treatment of multiple myeloma, leprosy reactions, treatment of multiple myeloma, leprosy reactions, cancercancer

• ? Personal used licence? Personal used licence

Other areas of Drug Regulation

• Registration of Pharmacies - 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

Drug Advertisements • What is the object of advertising drugs?• To make the public aware of the product, so that it

will be used when need arises - OTC products• Main object - provide information about product,

NOT stimulate demand (reality?)• Therefore special rules and regulations for

pharmaceutical advertising.• CDD Act - drugs must not be advertised in a false

and misleading manner - negative statement • Consumer directed advertising of precription

medicines prohibited in the act

Drug Advertisements (cont.)

• How should drugs be advertised?• WHO Ethical Criteria for Medicinal Drug Promotion• “.... 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 - generic name, indications, adverse effects, contraindications should be in an advertisement

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, may have a brand name or only the INN. example paracetol, paracetamol (SPC)

Definition of Rational drug use

WHO - Rational use of Drugs requires that patient receive medication appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, and the lowest cost to them and their community.

SUMMARY - EIGHT RIGHTS OF RATIONAL PRESCRIBING

• THE RIGHT DRUG• THE RIGHT PATIENT• THE RIGHT TIME• THE RIGHT DOSE• THE RIGHT ROUTE• THE RIGHT INFORMATION • THE RIGHT MONITORING • THE RIGHT COST

Summary 2• A major consideration in selection of EML is

prevalence of the diseases• Efficacy, safety and cost important in selecting the

right medicine • EML ensures availability, accessibility and affordabilty• Drugs are special unlike food and other consumer

goods• Enormous potential for both harm & good • Stringent regulation is important

• Thank you