Presentation on theme: "Essential Drug List Dr. Paresh Koli Guide: Dr. Yashashri Shetty."— Presentation transcript:
Essential Drug List Dr. Paresh Koli Guide: Dr. Yashashri Shetty
Approach History & Definition Usefulness Economic Impact New Procedure in selection WHO Model List of Essential Medicines National List of Essential Medicines of India & its Weaknesses State Essential Medicine lists Price cap in Essential Medicines EDL & Rational Drug Use KEM Pharmacy Final Words
History & Definition 1975, the World Health Assembly requested the Director-General to advise Member States on “the selection and procurement, at reasonable cost, of essential drugs of established quality corresponding to their national health needs” First meeting held in 1977, the WHO Expert Committee on the Selection of Essential Drugs “are of utmost importance, and are basic, indispensable and necessary for the health needs of the population” 1982 – 1999 1999, Combine this description with the affordability concept
History & Definition (Cont.) WHO Secretariat, report to the Executive Board of January 2002 Description of essential medicines - include three components: Definition. Essential medicines are those that satisfy the priority health care needs of the population. Selection criteria. disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness. Purpose. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford.
History & Definition (Cont.) WHO Secretariat in its report to the Executive Board (2001) highlighted - need for countries and institutions to develop their own list of essential medicines. As stated by the Expert Committee at its meeting in 1999 essential drugs - flexible and adaptable to many different situations exactly which drugs are regarded as essential remains a national responsibility “disease prevalence” did not cover the use of preventive medicines and items for family planning and aspect of prevention be added to the “selection criteria” part of the description. recommended the replacement of “disease prevalence” by “public health relevance” in the section on selection criteria, and the addition of “with adequate information” to the section on purpose and “implementation of” to the last sentence.
Full description Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems 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. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility.
Previous Lists Before WHO Formulation of national drug lists - 1950s in countries such as Sri Lanka and Papua New Guinea, 1960s in Cuba and Peru 1970s in countries such as, Mozambique. The Scandinavian countries and Tanzania had both adopted lists of essential medicines Industrialised countries such as Canada and Australia practised selection of medicines ANTEZANA F, SEUBA X. THIRTY YEARS OF ESSENTIAL MEDICINES: THE CHALLENGE [Internet]. 1st ed. Farmamundi - Servicios Centrales en Valencia; [cited 30 January 2015]. Available from: http://haieurope.org/wp-content/uploads/2010/12/7-Dec-2009-Book-Thirty- Years-of-Essential-Medicines-EN.pdf
How it is Useful Most cost-effective elements in modern health care and their potential health impact is remarkable In 2013 there were 40 million deaths in developing countries, one-third among children under age five Ten million will be due to acute respiratory infections, diarrhoeal diseases, tuberculosis, and malaria All conditions for which safe, inexpensive, essential drugs can be life-saving Examples Simple iron-folate preparations can reduce maternal and child mortality from anaemia of pregnancy Treatment of STDs reduces transmission of the AIDS virus Treatment of hypertension reduces heart attacks and strokes
A global concept Concept of essential medicines is forward-looking Need to regularly update medicines selections to reflect new therapeutic options and changing therapeutic needs Need to ensure drug quality Need for continued development of better medicines, medicines for emerging diseases, and medicines to meet changing resistance patterns
Economic Impact Impact of pharmaceuticals is substantial -- especially in developing countries Spending on pharmaceuticals < 1/5th of total public and private health spending in most developed countries transitional economies - 15 to 30% developing countries - 25 to 66%
New Procedures in 2002 Term “essential medicines” instead of “essential drugs” More systematic approach to inviting and dealing with applications More transparent process - including a systematic analysis of the evidence Opportunities for interested parties to comment on both the application and its review to the Expert Committee Full involvement of different WHO departments Full scientific independence as it makes its final recommendations
New Procedures in 2002 Absolute cost of a medicine will not be a reason to exclude it from the Model List if it meets the stated selection criteria Cost-effectiveness comparisons must be made among medicines within the same therapeutic group (e.g. for identifying the most cost- effective medicine treatment to prevent mother-to-child transmission of HIV).
Essential Medicines Library
Information to be included with an application 1. Summary statement of the proposal for inclusion, change or deletion 2. Name of the focal point in WHO submitting or supporting the application (where relevant) 3. Name of the organization(s) consulted and/or supporting the application 4. International Nonproprietary Name (INN, generic name) of the medicine 5. Formulation proposed for inclusion; including adult and paediatric (if appropriate) 6. International availability - sources, of possible manufacturers and trade names 7. Whether listing is requested as an individual medicine or as an example of a therapeutic group 8. Information supporting the public health relevance (epidemiological information on disease burden, assessment of current use, target population) 9. Treatment details (dosage regimen, duration; reference to existing WHO and other clinical guidelines; need for special diagnostics, treatment or monitoring facilities and skills) 10. Summary of comparative effectiveness in a variety of clinical settings 11. Summary of comparative evidence on safety 12. Summary of available data on comparative cost and cost-effectiveness within the pharmacological class or therapeutic group 14. Availability of pharmacopoeial standards (British Pharmacopoeia, International Pharmacopoeia, United States Pharmacopoeia, European Pharmacopeia) 15. Proposed (new/adapted) text that could be included in a revised WHO Model Formulary
WHO Model List of Essential Medicines First published in 1977 & included 204 pharmaceuticals Updated every 2 years Since 2007, a separate list for children up to 12 years (WHO Model List of Essential Medicines for Children) has been released 18th edition for adults (30 cat.) and the fourth edition for children were released in April 2013 (with Amendments in Oct 2013) More than 130 countries have created national essential medicines lists based on the WHO's model list. These lists contain between 334 and 580 medications.
The Interagency List of Essential Medicines for Reproductive Health Lack of consistency between various United Nations agencies UNFPA/UNAIDS/WHO lists 36 "discrepancy medicines" which figured on one list but not on another Published in 2006 Presents the current international consensus on rational selection of essential reproductive health medicines
National List of Essential Medicines of India By GOI and MOHFW First National Essential Drugs List in 1996 Revised in 2003 as the National List of Essential Medicines (NLEM) new section on medicines for HIV-AIDS new anti-cancer drugs 71 added and 3 removed in 2003 (compared to 1996) Changes in categories of drugs Allopurinol from NSAID to drugs to treat gout
NLEM 2011 The National List of Essential Medicines of India (NLEMI 2011) was revised recently by MOHFW & GOI, in June 2011, nearly eight years after the previous list, on the directions of the Supreme Court of India Preparation for the list started as early as 16 September 2009 Published in 2011 348 drugs in total (deleted is 47 and 43 added compared to 2003) Added new drugs indicated for Rx (cefixime, cetirizine) & removed older drugs (tetracycline) Revision of NLEM was also based on the two important national reference documents i.e., Indian Pharmacopeia 2010 and National Formulary of India, 4th Edition, 2010.
Weaknesses in NLEM 2011 Improper selection of medicines ‘Ether' as a general anesthetic – no longer used Pyridoxine as antianemic – idiopathic sideroblastic anemia (rare disorder) Including medicines of the same class which have no major advantages in efficacy and safety omeprazole and ranitidine - pantoprazole and famotidine cisplatin - oxaliplatin Non-alignment of the NLEMI with the National Health Programs and the National Formulary of India Non-inclusion of pediatric formulations (Indian Academy of Pediatrics List of Essential Medicines for Children of India – in collaboration with WHO, 134 medicines) Errors of medicine formulation strengths & Incomplete medicine information Gitanjali B, Manikandan S. National list of essential medicines of India: The way forward. Journal of Postgraduate Medicine. 2012;58(1):68.
State lists THE ESSENTIAL MEDICINES LIST, Government of NCT of Delhi 2013 (8 th edition with 152 medicines) Gujarat - Essential Drugs List Primary Health Care (PHC, Sub Centres and Others)-(249) Secondary Health Care (CHC & T.B. Hospitals)-(366) Tertiary Health Care (Districts, Sub-Districts & Medical Colleges)-(538) Chhattisgarh, Rajasthan, Madhya Pradesh, Uttarakhand, Orissa, Meghalaya No list for Maharashtra Delhi.gov.in. THE ESSENTIAL MEDICINES LIST Government of NCT of Delhi 2013 [Internet]. 2015 [cited 30 January 2015]. Available from:http://www.delhi.gov.in/wps/wcm/connect/37ff160040df3f158152eb7dfb3d6621/EML2013Book.pdf?MOD=AJPERES&lmod=29 6430078 Gmscl.gujarat.gov.in. Essential Drugs List [Internet]. 2015 [cited 30 January 2015]. Available from: http://gmscl.gujarat.gov.in/essential-drug-list.htm
Future Lists WHO - 20th Expert Committee on the Selection and Use of Essential Medicines WHO Headquarters, Geneva, 20-24 April 2015 India New list after NLEM 2011 Meeting in Nov. 2014
Price cap in Essential Medicines National Pharmaceutical Pricing Policy (NPPP) in 2012 Drugs Price Control Order (DPCO) 2013 mechanism for price fixing, the issue is still under the scrutiny of the Supreme Court National Pharmaceutical Pricing Authority (NPPA) All NLEM under price cap (60% of total sales) Ceiling price of an essential drug will be the simple average of all brands with a market share of at least 1 per cent.
EDL & Rational Drug Use Essential drug list – Twelve core interventions to promote more rational use of medicines Study in China National Essential Medicine System (NEMS) is a new policy in China launched in 2009 average number of drugs per prescription decreased from 3.64 to 3.46 percentage of prescriptions including antibiotics decreased from 60.26 to 58.48% Song Y e. The impact of China’s national essential medicine system on improvi... - PubMed - NCBI [Internet]. Ncbi.nlm.nih.gov. 2015 [cited 29 January 2015]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25344413
Other Countries In 2000 - Palestinian Ministry of Health introduced an essential medicines list Analysis of prescription patterns between 1997 and 2003 Effective in improving prescribing indicators of appropriate use of medicines average number of medicines prescribed per clinic visit decreased, percentage of all medicines prescribed that were antibiotics and injections percentage of all medicines included in the essential medicines list being prescribed increased by about 5% Hutchings J, Neroutsos K, Donnelly K. Making the List: The Role of Essential Medicines Lists In Reproductive Health. IPSRH. 2010;36(04):205-208.
KEM Pharmacy List of drugs for free 157 drugs 105 Tabs 22 mixtures 19 ointment, power, lotion, liniment 11 ENT preparation Out of stock New list
Final Words Revision of list like WHO Making drugs available KEM pharmacy Price control – Help patients