Presentation on theme: "Dr. Paresh Koli Guide: Dr. Yashashri Shetty"— Presentation transcript:
1 Dr. Paresh Koli Guide: Dr. Yashashri Shetty Essential Drug ListDr. Paresh KoliGuide: Dr. Yashashri Shetty
2 Approach History & Definition Usefulness Economic Impact New Procedure in selectionWHO Model List of Essential MedicinesNational List of Essential Medicines of India & its WeaknessesState Essential Medicine listsPrice cap in Essential MedicinesEDL & Rational Drug UseKEM PharmacyFinal Words
3 History & Definition1975, 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 – 19991999, Combine this description with the affordability concept
4 History & Definition (Cont.) WHO Secretariat, report to the Executive Board of January 2002Description 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.“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 criteriaMany additions
5 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 1999essential drugs - flexible and adaptable to many different situationsexactly 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.
6 Full descriptionEssential 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.
7 Previous Lists Before WHO Formulation of national drug lists s in countries such as Sri Lanka and Papua New Guinea,1960s in Cuba and Peru1970s in countries such as, Mozambique.The Scandinavian countries and Tanzania had both adopted lists of essential medicinesIndustrialised countries such as Canada and Australia practised selection of medicinesANTEZANA F, SEUBA X. THIRTY YEARS OF ESSENTIAL MEDICINES: THE CHALLENGE [Internet]. 1st ed. Farmamundi - Servicios Centrales en Valencia; [cited 30 January 2015]. Available from:
8 How it is UsefulMost cost-effective elements in modern health care and their potential health impact is remarkableIn 2013 there were 40 million deaths in developing countries, one-third among children under age fiveTen million will be due to acute respiratory infections, diarrhoeal diseases, tuberculosis, and malariaAll conditions for which safe, inexpensive, essential drugs can be life-savingExamplesSimple iron-folate preparations can reduce maternal and child mortality from anaemia of pregnancyTreatment of STDs reduces transmission of the AIDS virusTreatment of hypertension reduces heart attacks and strokes
9 A global concept Concept of essential medicines is forward-looking Need to regularly update medicines selections to reflect new therapeutic options and changing therapeutic needsNeed to ensure drug qualityNeed for continued development of better medicines, medicines for emerging diseases, and medicines to meet changing resistance patterns
10 Economic ImpactImpact of pharmaceuticals is substantial -- especially in developing countriesSpending on pharmaceuticals< 1/5th of total public and private health spending in most developed countriestransitional economies - 15 to 30%developing countries - 25 to 66%
11 New Procedures in 2002Term “essential medicines” instead of “essential drugs”More systematic approach to inviting and dealing with applicationsMore transparent process - including a systematic analysis of the evidenceOpportunities for interested parties to comment on both the application and its review to the Expert CommitteeFull involvement of different WHO departmentsFull scientific independence as it makes its final recommendationsterm “essential medicines” instead of “essential drugs” to reflect the common use of the term “medicines” to describe pharmaceutical preparations used in clinical health care practice
12 New Procedures in 2002Absolute cost of a medicine will not be a reason to exclude it from the Model List if it meets the stated selection criteriaCost-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).
14 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
15 WHO Model List of Essential Medicines First published in 1977 & included 204 pharmaceuticalsUpdated every 2 yearsSince 2007, a separate list for children up to 12 years (WHO Model List of Essential Medicines for Children) has been released18th 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.
16 The Interagency List of Essential Medicines for Reproductive Health Lack of consistency between various United Nations agencies UNFPA/UNAIDS/WHO lists36 "discrepancy medicines" which figured on one list but not on anotherPublished in 2006Presents the current international consensus on rational selection of essential reproductive health medicines
17 National List of Essential Medicines of India By GOI and MOHFWFirst National Essential Drugs List in 1996Revised in 2003 as the National List of Essential Medicines (NLEM)new section on medicines for HIV-AIDSnew anti-cancer drugs71 added and 3 removed in 2003 (compared to 1996)Changes in categories of drugsAllopurinol from NSAID to drugs to treat gout
18 NLEM 2011The 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 IndiaPreparation for the list started as early as 16 September 2009Published in 2011348 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.
19 Weaknesses in NLEM 2011 Improper selection of medicines ‘Ether' as a general anesthetic – no longer usedPyridoxine as antianemic – idiopathic sideroblastic anemia (rare disorder) Including medicines of the same class which have no major advantages in efficacy and safetyomeprazole and ranitidine - pantoprazole and famotidinecisplatin - oxaliplatin Non-alignment of the NLEMI with the National Health Programs and the National Formulary of IndiaNon-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 National diarrheal disease control program (as per IMNCI*) Dispersible zinc tablets 20 mg Zinc syrup 20 mg/5mlIMNCI guidelines for pneumonia Amoxycillin - tablet 150 mg and syrup 125mg/5ml Amoxycillin powder for suspension (125mg/5ml) Capsules 250 mg and 500 mgCetirizine Syrup 5 mg/ml (NLEM), 5 mg/5ml or 1 mg/ml (correct)Ondansetron Syrup 2 mg/ml, 2 mg/5ml(ORS) for which the strength is mentioned as ‘As per IP’. As there are many types of ORS (low osmolality, rice based and high osmolality), the exact constituents should be specifiedGitanjali B, Manikandan S. National list of essential medicines of India: The way forward. Journal of Postgraduate Medicine. 2012;58(1):68.
20 State listsTHE ESSENTIAL MEDICINES LIST, Government of NCT of Delhi (8th edition with 152 medicines)Gujarat - Essential Drugs ListPrimary 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, MeghalayaNo list for Maharashtra Delhi.gov.in. THE ESSENTIAL MEDICINES LIST Government of NCT of Delhi 2013 [Internet] [cited 30 January 2015]. Available from:http://www.delhi.gov.in/wps/wcm/connect/37ff160040df3f158152eb7dfb3d6621/EML2013Book.pdf?MOD=AJPERES&lmod=Gmscl.gujarat.gov.in. Essential Drugs List [Internet] [cited 30 January 2015]. Available from:
21 Future ListsWHO - 20th Expert Committee on the Selection and Use of Essential MedicinesWHO Headquarters, Geneva, April 2015IndiaNew list after NLEM 2011Meeting in Nov. 2014
22 Price cap in Essential Medicines National Pharmaceutical Pricing Policy (NPPP) in 2012 Drugs Price Control Order (DPCO) 2013mechanism for price fixing, the issue is still under the scrutiny of the Supreme CourtNational 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.
23 EDL & Rational Drug UseEssential drug list – Twelve core interventions to promote more rational use of medicinesStudy in ChinaNational Essential Medicine System (NEMS) is a new policy in China launched in 2009average number of drugs per prescription decreased from 3.64 to 3.46percentage of prescriptions including antibiotics decreased from to 58.48%Song Y e. The impact of China’s national essential medicine system on improvi... - PubMed - NCBI [Internet]. Ncbi.nlm.nih.gov [cited 29 January 2015]. Available from:
24 Other CountriesIn Palestinian Ministry of Health introduced an essential medicines listAnalysis of prescription patterns between 1997 and 2003Effective in improving prescribing indicators of appropriate use of medicinesaverage number of medicines prescribed per clinic visit decreased,percentage of all medicines prescribed that were antibiotics and injectionspercentage 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):
25 KEM Pharmacy List of drugs for free 157 drugs 105 Tabs 22 mixtures 19 ointment, power, lotion, liniment11 ENT preparationOut of stockNew list
26 Final Words Revision of list like WHO Making drugs available KEM pharmacyPrice control – Help patients