Essential Medicines Moderated by – Dr. Chetna Maliye

Framework Factors influencing the Use of Medicines The Concept of Essential Medicines Milestones of the Essential Medicines Concept Global and Indian scenario Management of the drugs Counterfeit medicines Strategy of Essential Medicine policy 2004-07 & 2007-13 Essential Medicines and MDG Quality control in Drug Sector in India Abhinav Aushadhi Yojana 1

Factors Influencing Use of Medicines 2

The concept of Essential medicines A limited range of carefully selected essential medicines lead to better health care, better drug management, and lower costs. Definition of essential medicines Essential medicines are those that satisfy the priority health care needs of majority of the population. (Report to WHO Executive Board, January 2002) 3

Description of essential drugs Selection criteria: Are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness Purpose: To be available within the context of functioning health systems at all times, in adequate amounts, in appropriate dosage forms, with assured quality & at a price the individual & community can afford. Implementation: Intended to be flexible and adaptable to different situations; which medicines are regarded as essential is a national responsibility. 4

Milestones –Essential Medicines Concept 1960—International organization of consumers union (IOCU) - 170 members. for the promotion of health and rational use of medicine coordinated with HAI (HEALTH ACTION INTERNATIONAL)—working for safe, rational and economic use of pharmaceuticals all over the world 1970— concept of essential drugs was launched with a selection of 200-250 essential drugs –sufficient to cater 90% morbidity in the country at low cost. 1975–-WHO expert advisory committee 5

Milestones –Essential Medicines Concept 1977—first model list of essential drugs (208d) 1981– establishment of WHO action programme on essential drugs 1982– second revision of WHO essential drugs 1985– Proposed to have access of drugs at a cost to majority of world’s people who live in developing countries . 1986 – HAI established ACTION FOR RATIONAL DRUGS in Asia 2007– 15th model list of essential drugs by WHO 2009- 16th model list of essential drugs by WHO 1995– 6th report 6

History of the WHO Model List of Essential Drugs 1977 First Model list published, ± 200 active substances List is revised every two years by WHO Expert Committee 2002 Revised procedures approved by WHO Last revision (April 2003) contains 315 active substances The first list was a major breakthrough in the history of medicine, pharmacy and public health Médecins sans Frontières, 2000 1

Use of the WHO Model List of essential medicines 156 countries have a national list of essential drugs Major agencies (UNICEF, UNHCR, IDA) base their catalogue on the WHO Model List Latest revision (April 2009) contains 315 active substances Sub-sets: UN list of recommended essential drugs for emergency relief (85 drugs) Emergency Health Kit (98 drugs for 10,000 consultations) Normative tools follow the Model List: WHO Model Formulary International Pharmacopoeia Basic Quality Tests and reference standards INDIA produced its NATIONAL ESSENTIAL DRUGS LIST in 1996 Revised it in 2003 and including 354 medicines 7

Use of the WHO Model List of essential medicines INDIA produced its NATIONAL ESSENTIAL DRUGS LIST in 1996 Revised it in 2003 and includes 354 medicines 27 categories The following level of care/facilities are listed with each drug- o U = Universal, (Primary, Secondary, Tertiary) o S = Secondary care facility o T = Tertiary care facility. The NEDL was formulated with the following objectives:- To ensure cost-effectiveness of t/t through suitable therapy, the use of generic drugs and cheaper alternatives, as per the existing health problems in the country Encourage rational use of drugs by avoiding over-prescribing and mis-prescribing. Make the healthcare system in the country more transparent. INDIA produced its NATIONAL ESSENTIAL DRUGS LIST in 1996 Revised it in 2003 and including 354 medicines 8

Number of countries with a national list of essential medicines National Essential Drugs List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) 9 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years

Percentage of population with regular access to essential medicines 10

The Essential Medicines Target National list of essential medicines Registered medicines All the drugs in the world Levels of use CHW c c dispensary Complementary medicines PHC CHC Referral hospital Private sector 11

Essential Medicine List Medicine list can be divided into CORE LIST : A list of minimum needs of a basic health care system listing most efficacious safe cost effective medicines for priority conditions (on the basis of current and future public health relevance) COMPLEMENTARY LIST : essential medicines for priority conditions for which specialized diagnostic or monitoring facilities or special medical care is required. 12

Symbols: Essential Medicine List Intended to indicate similar clinical performance within a pharmacological class. Therapeutic equivalence is indicated on the basis of reviews of efficacy and safety. The a symbol indicates that there is an age or weight restriction on use of the medicine Is placed next to the complementary list it signifies that the medicine(s) require(s) specialist diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training for their use in children. Is placed next to an individual medicine or strength of medicine it signifies that there is a specific indication for restricting its use to children. indicates that the medicine is endorsed as essential but has requested a review of the efficacy and safety to confirm this decision 13

Symbols: Essential Medicine List 14

Criteria to Guide selection of an Essential Drug Adequate data on its efficacy & safety. It should be available in form in which quality, including bioavailability & stability on storage can be assured . Selection of drug depend upon pattern of prevalent diseases, availability of facilities & trained personnel financial resources, genetic, demographic & environmental factors. In case of two or more similar drugs ,choice should be made on the basis of their relative efficacy, safety, quality, price & availability. 15

Criteria to Guide selection of an Essential Drug Choices may be influenced by comparative pharmacokinetic properties and local facilities for manufacture and storage. The most essential drugs are single compound. Thus combination medicines are avoided from prioritizing as essential medicines. Selection of the drug should be a continuous process which should take into account changing priorities for public health action epidemiological condition as well as availability of better drugs formulation and progress in pharmacological knowledge 16

Access framework for Essential Medicines 17

Medicines management cycle 18

Essential Medicine List Also known as group purchasing, pooled procurement is defined as “Purchasing done by one procurement office on behalf of a group of facilities, health systems or countries. Group members agree to purchase certain drugs exclusively through the group.” 19

Classification Of Drugs ABC analysis of drugs. Based on their cost and expenditure. Category A – 10% of the total items consume 70% of the budget. Category B – 20% of the total items consumes 20% of the budget. Category C – 70% of the total items consumes 10% of the budget. 20

Classification Of Drugs 21

V E D Analysis – according to criticality in patient care V – Vital drugs. – 10% of the total , they are vital life-saving drugs and their absence cannot be accepted. They have got to be administered to the patients. No drugs are available as substitutes for these items. E – Essential drugs – Constituting 40% of the total items. And their absence can be tolerated for short stretches of time. They could be made available within a day or two and alternative medicines made available for use in their place. D – Desirable Drugs (N-Non essential items.) Constitute 50% of the items. And their non-availability can be tolerated for longer period of time. They may be required for treatment of chronic and less serious patients. Therefore every effort has to be made, at whatever cost to avoid out-of stock position for any of these items. 22

Basis and purpose of various Methods of Stores classification Therefore every effort has to be made, at whatever cost to avoid out-of stock position for any of these items. 23

Counterfeit Medicines WHO has defined as: ‘À counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/ or source. Counterfeiting can apply to both branded and generic products. Counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.’ Counterfeit medicine was first mentioned as à problem at the WHO Conference of Experts on Rational Drug Use in Nairobi, Kenya in 1985 Development of a system which helps in reporting counterfeit drugs, implementation of anti-counterfeiting technologies, enforcement of laws and regulations, and severe penalties on convicted offenders will help combating counterfeit drugs. 24

WHO Medicines Strategy 2004-2007: 5 priority Objectives: Policy, Access, quality & safety, rational use National medicines policies that focus on human rights, health-oriented approach to trade agreements & stronger ethical dimension Access to traditional medicine by protecting knowledge and access, expanding evidence base, ensuring safety. Access to essential medicines, with emphasis on HIV medicines, medicines for malaria, TB, childhood illness etc. Safer medicines through expanded safety monitoring and continued strengthening of quality assurance Rational use through education, initiatives linked to health insurance 25

Medicine related strategic objective and expected results for 2008-2013 Strategic Objective: To ensure improved access, quality and use of medical products and technologies Expected results: Formulation and monitoring of comprehensive national policies on access, quality and use of essential medical products and technologies International norms, standards and guidelines for the quality, safety, efficacy and cost-effective use of medical products and technologies developed and their national and/ or regional implementation Evidence-based policy guidance on promoting scientifically sound and cost effective use of medical products and technologies by health workers and consumers developed. 26

Strengths The concept of essential medicine is associated is well known and globally accepted. The concept of essential medicine is associated with equity cost-effectiveness, good governance and attention to the need of poor and disadvantaged. It has a solid track record and a reputation of technical excellence, sound scientific methods, expert staff and extensive global network. Access to medicines like HIV medicines, medicines for malaria, TB, etc has increased 27

Weaknesses Several countries have made substantial progress towards increasing access to essential medicines and treatments to fight HIV/AIDS, malaria and tuberculosis, but access to essential medicines in developing countries is not adequate. In countries for which there is information, the availability of medicines in the public sector is only 1/3rd , while private sector availability is 2/3rd of the requirement. The prices people pay for lowest-priced generic medicines vary from 2.5 times to 6.5 times international reference prices (IRPs) in these two sectors, respectively. Difficulty in assessing large and growing amount of medicine-related information and evidence that exists and lack of systematic planning at country level. There is inefficient involvement of private sector Several important components of the program are under-resourced and more than 75% of its contribution is from project based contribution while less than 15% is from assessed contribution 28

Availability of selected medicines in public and private health facilities between 2001 and 2007 29

Public per-capita expenditure on medicines, 2007 (dollars) 30

Margins between producer and consumer prices in public and private sector 30

Opportunities There is growing need for global quality standards for new essential medicines Medicine pricing surveys for over a 50 countries have generated a demand for policy advice on how to reduce prices and promote affordability, and how to ensure universal availability in situations where most medicines are paid for out-of-pocket. 31

Threats There is growing need for social health insurance and medicines reimbursement schemes for effective regulation with involvement of private sector. Increased need for programmes to combat counterfeit medicines and to promote good governance in pharmaceutical sector. 32

Essential Medicines and MDG GOAL 8: Developing global partnership for development Target 13- Address the special needs of least developed countries Target 17- In cooperation with pharmaceutical companies, provide access to affordable essential drugs, in developing countries. These targets are currently measured by the following indicator: Indicator 46: Proportion of population with access to affordable, essential drugs on a sustainable basis. Access is defined as having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population. Recent progress in a number of countries shows that access to essential medicines can be improved through stronger partnership among governments, pharmaceutical companies and civil society, including consumers, working together to ensure universal access to essential medicines. Several countries have made substantial progress towards increasing access to essential medicines and treatments to fight HIV/AIDS, malaria and tuberculosis, but access to essential medicines in developing countries is not adequate. In countries for which there is information, the availability of medicines in the public sector is only 1/3rd , while private sector availability is 2/3rd of the requirement. The prices people pay for lowest-priced generic medicines vary from 2.5 times to 6.5 times international reference prices (IRPs) in these two sectors, respectively. 33

Quality control in Drug Sector in India The Central Drugs Standard Control Organization (CDSCO) in the Directorate of Director General of Health Services along with Drug Control Organization in the states are responsible for safety, efficacy and quality of drugs, their import, manufacture, distribution, sale and standards. The CDSCOat Centre is headed by Drug Controller General (India)and DCO in states by State Drug Controllers appointed by state governments. The CDSCO has a network of four Zonal Offices located at Mumbai, Ghaziabad, Kolkata and Chennai and seven port offices for ensuring quality of imports. Recent progress in a number of countries shows that access to essential medicines can be improved through stronger partnership among governments, pharmaceutical companies and civil society, including consumers, working together to ensure universal access to essential medicines. Several countries have made substantial progress towards increasing access to essential medicines and treatments to fight HIV/AIDS, malaria and tuberculosis, but access to essential medicines in developing countries is not adequate. In countries for which there is information, the availability of medicines in the public sector is only 1/3rd , while private sector availability is 2/3rd of the requirement. The prices people pay for lowest-priced generic medicines vary from 2.5 times to 6.5 times international reference prices (IRPs) in these two sectors, respectively. 34

Abhinav Aushadhi Yojana in KHS ‘Abhinav Aushadhi Yojana’ has started in KHS since october 2010. It provides medicines to the needy poor patients at reasonable rates, much lower than the market prices. The medicines available not only contain antibiotics, antiemetics, analgesics and antipyretics but also contain antihypertensives, antidiabetics, emergency medicines like ASV, PAM, STK and Anticancer drugs. Recent progress in a number of countries shows that access to essential medicines can be improved through stronger partnership among governments, pharmaceutical companies and civil society, including consumers, working together to ensure universal access to essential medicines. Several countries have made substantial progress towards increasing access to essential medicines and treatments to fight HIV/AIDS, malaria and tuberculosis, but access to essential medicines in developing countries is not adequate. In countries for which there is information, the availability of medicines in the public sector is only 1/3rd , while private sector availability is 2/3rd of the requirement. The prices people pay for lowest-priced generic medicines vary from 2.5 times to 6.5 times international reference prices (IRPs) in these two sectors, respectively. 35

Saving lives with the right médicine…! Thank You..!

References Medicines, Medical Care and Drug Policy, Mira Shiva; VHAI New Delhi,2000. Guidelines For Developing National Drug Policies, WHO Geneva,1988. Guide to drug Financing Mechanism, WHO Geneva, 1998. Epidemiology and Management for Health Care for All, P V Sathe,3rd Edn. WHO (2005) Tech. Rep. Ser. No.993, The Selection and Use of Essential Medicines. WHO (2006), Fact Sheet M. 275, Counterfeit Medicines. WHO (2007), WHO Model List of Essential Medicines, 15th list, March 2007. WHO (2009), WHO Model List of Essential Medicines, 16th list, April 2009. Continuity and Change, Implementing the Third WHO Medicine Strategy, 2008-2013, WHO 2009. Surveys of medicine prices and availability using WHO/HAI standard methodology (available from http://www.haiweb.org/medicineprices/). Recent progress in a number of countries shows that access to essential medicines can be improved through stronger partnership among governments, pharmaceutical companies and civil society, including consumers, working together to ensure universal access to essential medicines. Several countries have made substantial progress towards increasing access to essential medicines and treatments to fight HIV/AIDS, malaria and tuberculosis, but access to essential medicines in developing countries is not adequate. In countries for which there is information, the availability of medicines in the public sector is only 1/3rd , while private sector availability is 2/3rd of the requirement. The prices people pay for lowest-priced generic medicines vary from 2.5 times to 6.5 times international reference prices (IRPs) in these two sectors, respectively.