Selection of essential medicines Suzanne Hill November 2008 Department of Essential Medicines & Pharmaceutical Policies TBS 2008

Outline What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments

Essential medicines The concept of essential medicines A limited range of carefully selected essential medicines leads 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 the population (Report to WHO Executive Board, January 2002)

Full description of essential drugs (Expert Committee Report, April 2002) Definition: Essential medicines are those that satisfy the priority health care needs of the population Selection criteria: Essential medicines are selected with due regard to 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. Implementation: 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.

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 March 2007 list contains 340 active substances Next revision 2009

The Essential Medicines Target National list of essential medicines Registered medicines All the drugs in the world Levels of use CHW S S dispensary Health center Supplementary specialist medicines Hospital Referral hospital Private sector

The essential drugs concept is nearly universal Countries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists.

So what? Evidence of impact – health outcomes Delhi state improved availability of supply studies of lack of essential medicines Evidence of impact – policy, advocacy Indirect evidence through impact of listing ARVs Linkage with pricing policies Linkage with import policies

Outline What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments

Process Expert Committee review and recommendation Application lodged Reviewed internally, published on web External expert review and comment WHO department comment Public comment Expert Committee review and recommendation

Recommendation based on… Public health need Evidence of comparative effectiveness and safety Global experience of use / suitability Cost (indicative prices only) NOT patent No formal cost-effectiveness assessment

Outline What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments

The ideal WHO treatment guideline developed Treatment recommendation made Proposal to update list to reflect new guideline Potential to influence practice

Outline What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments

Cochrane reviews Over 50% of medicines on the 14th list have a relevant Cochrane review Useful source of information Some reviews raise questions over inclusion on the list e.g. antacids, allopurinol

The WHO Essential Medicines Library: WHO Model Formulary (search) WHO Model List

The WHO Essential Medicines Library, status 2005 Selection WHO clusters WHO/EDM Clinical guideline Summary of clinical guideline RPS WHO/EC, Cochrane, Guideline Clearing House WHO Model Formulary Reasons for inclusion Systematic reviews Key references WHO Model List WHO/QSM MSH UNICEF MSF Statistics: - ATC - DDD Quality information: - Basic quality tests - Intern. Pharmacopoea - Reference standards Link to price information WCCs Oslo/Uppsala

Outline What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments

Essential medicines for children

Causes of death in under 5s World Health Report, 2005

EML 2005 Core Complementary Total Total No of medication listings 284 84 368 Listings not assessed 129 45 174 Listings assessed 155 39 194 PF indicated 119 28 148 PF not indicated 36 11 46 PF indicated and on the list 52 3 55 PF indicated and not on the list 67 25 93 PF indicated, not on the list, duplicate listings removed 59 23 83 PF indicated, not on list and available* 29 2 30 PF indicated, not on list and not available* 21 53

Paediatric formulation issues Technical difficulties of manufacturing Storage and preparation Impact of various climates Taste of the medication Local factors and practice

Liquids Short shelf lives Often require refrigeration Bulky and heavy (issue for storage and transport)

Powders for suspension Solid formulations Powders for suspension Mixed correctly with sterile fluids Affected by humidity Chewable tablet Tolerated by children two years and older Limited dose variation

Survey of 29 countries: Problems with Children's Medicines for Malaria, TB and HIV Lack of appropriate paediatric formulations Artemisinin derivatives in tablet form only No paediatric dose forms available for isoniazid, pyrazinamide, ethambutol, rifampicin Many countries no paediatric HIV medicines Cost of medicines ARV syrup formulations, artemisinin combinations Need for standard methods for adapting adult medicines for use in children Costs of special storage conditions for unstable products

Survey of 29 countries: Problems identified for other acute and chronic illnesses in childhood Availability of suitable formulations Vitamins & minerals, some antibiotics and anti-infectives, anti-epileptic medicines, cardiovascular medicines, cytotoxic drugs Costs of medicines Anti-infective agents, cytotoxic drugs, insulin pens, steroid inhalers for asthma, vaccines Other issues Lack of standardised dosing measures, breaks in cold chain for vaccines, storage costs for drugs, lack of paediatric guidelines and formulary

Are essential medicines for children available?

Source: International Drug Price Indicator Guide, 2005; median price

Terms of reference for sub committee (1)To prepare a list of medicines for children, based on their clinical needs and the burden of disease, that the WHO Expert Committee on the Selection and Use of Essential Medicines can use to revise and regularly update the WHO Model List of Essential Medicines to include missing essential medicines for children: (2) To determine suitability criteria for dosage forms of medicines for children, with particular attention to conditions prevailing in the developing countries: (3) To review the feasibility of manufacturing appropriate formulations for those priority medicines for which no dosage form for children currently exists, specifically considering requirements for use in resource‐limited settings and availability of data on efficacy and safety in the appropriate age groups: (4) To identify the clinical‐research gaps regarding safety and efficacy of essential medicines for children in order to improve suboptimal prescribing and dosing, and to facilitate regulatory approval of paediatric formulations: (5) To report to the Expert Committee on the Selection and Use of Essential Medicines in 2009.

Improving use of medicines

Lack of Human Capacity

stock outs Uhjin Kim, Nauru 2008

The WHO Model List of Essential Medicines is a model product, model process and public health tool Independent Membership of the Committee, careful consideration of conflict of interest Transparent process, standard application, web review Link to evidence-based clinical guidelines Systematic review of comparative efficacy, safety, cost-effectiveness and public health relevance Rapid dissemination, electronic access Regular review