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Managing Medicine Selection 17 Treatment Guidelines and Formulary Manuals Procurement Distribution Use

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Part I: Policy and economic issues Part II: Pharmaceutical management Part III: Management support systems Selection 16 Managing medicine selection 17 Treatment guidelines and formulary manuals Procurement Distribution Use chapter 16 Managing medicine selection Summary 16.2 illustrations 16.1 Introduction 16.2 Figure 16-1 The essential medicines target 16.7 Figure 16-2 Common health problems guide selection, training, 16.2 Practical implications of the essential medicines supply, and medicine use 16.9 concept 16.2 Figure 16-3 Sample form for proposing revisions in essential 16.3 Selection criteria 16.4 medicines lists 16.12 16.4 Use of International Nonproprietary (generic) Table 16-1 Advantages of a limited list of essential Names 16.5 medicines 16.4 Table 16-2 Example of level-of-use categories, Ethiopia 16.5 Essential medicines lists in context 16.6 Essential Drugs List, fifth edition, 2007 16.6 Lists of registered medicines • Formulary manuals • Table 16-3 Key factors in successfully developing Treatment guidelines and implementing an essential medicines 16.6 Approaches to developing essential medicines lists, program 16.14 formularies, and treatment guidelines 16.8 box 16.7 Therapeutic classification systems 16.10 Box 16-1 WHO criteria for selection of essential 16.8 Sources of information 16.13 medicines 16.5 16.9 Implementing and updating essential medicines lists 16.14 country studies Reasons for failure • Gaining acceptance of essential CS 16-1 Approaches to updating essential medicines and medicines lists • Authority of essential medicines lists formulary lists 16.10 Assessment guide 16.15 CS 16-2 Updating the National Essential Medicines List of Kenya 16.11 References and further readings 16.15 Glossary 16.16 copyright © management sciences for health 2012 16.2 selection SUMMARY The rationale for selecting a limited number of essen- The process of selecting essential medicines begins with tial medicines is that it may lead to better supply, more defining a list of common diseases for each level of health rational use, and lower costs. Essential medicines are care. The treatment of first choice for each health prob- those that are deemed to satisfy the health care needs of lem is the basis for the list of essential medicines, the the majority of the population and that should be avail- national formulary system, and the treatment guidelines. able in the appropriate dosage forms and strengths at The supply system should then supply the medicines that all times. Because selection of medicines has a consid- have been selected, based on this series of steps. erable impact on quality of care and cost of treatment, Essential medicines should be selected on the basis of it is one of the most cost-effective areas for interven- (1) relevance to the pattern of prevalent diseases, (2) tion. proven efficacy and safety, (3) adequate scientific data A list of essential medicines may be selected for use in and evidence of performance in a variety of settings, one or more health facilities or for the public sector as (4) adequate quality, (5) favorable cost-benefit ratio, a whole. In the latter case, the list usually indicates the (6) desirable pharmacokinetic properties, (7) possibili- level of the health care system where each medicine ties for local manufacture, and (8) availability as single may be used. It can also be considered a supply list. compounds. The drugs should be identified by the A formulary system is part of the medicine selection International Nonproprietary Name (INN), sometimes process. The system includes a formulary list, which referred to as the generic name. is ideally based on an essential medicines list, and a General acceptance of an essential medicines list can be formulary manual, which contains summary informa- promoted by wide consultation with senior specialists tion on each medication on the formulary list. Standard and experts, including professional organizations and treatment guidelines are systematically developed state- academic institutions, on the list’s development and use. ments that assist prescribers in deciding on appropri- An open and transparent system of regular updates is an ate treatments for specific clinical problems. Whereas absolute prerequisite for maintaining the authority and a formulary manual is medicine centered, treatment acceptance of an essential medicines list or formulary list. guidelines are disease centered, presenting treatment The essential medicines concept can be applied in any alternatives and recommending a treatment of first country, in the public and private sectors, and in rural choice. areas as well as at referral hospitals. 16.1 Introduction able, prescribers often find it impossible to keep their knowl- edge up-to-date and to compare alternatives. In addition, Pharmaceuticals may constitute as much as 40 percent of the variety of available products may contribute to inconsis- the health care budget in developing countries, yet large tent prescribing within the same health care system or even portions of the population may lack access to even the most in the health facility. With regard to procurement, purchas- essential medicines. The limited funds available are fre- ing power is significantly lessened by the large number of quently spent on ineffective, unnecessary, or even danger- duplicative and nonessential pharmaceutical products on ous medications. the market. As much as 70 percent of pharmaceuticals on the world In short, pharmaceuticals can provide great benefits, but market are duplicative or nonessential. Many are minor their cost is substantial. The selection of medicines has a variations of a prototype drug product and offer no thera- considerable impact on the quality of care and the cost of peutic advantage over other medicines that are already treatment, and it is therefore one of the areas where inter- available. Some are medications that show high toxicity rela- vention is most cost-effective. tive to their therapeutic benefit. In some cases, new medi- cines are released without sufficient information on efficacy or toxicity. Finally, new products often are for therapeutic 16.2 Practical implications of the essential indications not relevant to the basic needs of the population. medicines concept In all of these cases, the newer medicines are nearly always more expensive than existing medicines. The World Health Organization (WHO) has defined With so many different pharmaceutical products avail- essential medicines as those that satisfy the needs of the 16 / Managing medicine selection 16.3 majority of the population and therefore should be available system. Many international organizations, including the at all times. The rationale for the selection and use of a limited United Nations Children’s Fund (UNICEF) and interna- number of essential medicines is that it leads to an improved tional nonprofit supply agencies, have adopted the essential supply of medicines, more rational prescribing, and lower medicines concept for their supply systems. costs; in fact, the appropriate use of essential medicines is Third, when the limited list of essential medicines repre- one of the most cost-effective strategies a country can enact. sents prescribers’ consensus on pharmaceutical treatments The essential medicines concept is a global concept that of first choice, its use may improve the quality of care by can be applied in any country, in the private and public ensuring that patients receive the treatment of choice as sectors, in referral hospitals as well as primary health care well as similar treatment from different providers. It also units, and in both urban and rural areas. However, the deci- allows prescribers to become more familiar with a smaller sion about exactly which medicines should be considered number of medicines. This restricted number of possibili- as essential should be a national-level responsibility. By ties contributes to improved recognition of actual benefits 2007, 86 percent of countries had national essential medi- and limitations of specific medicine therapy, as well as to the cines lists, of which at least 69 percent had been updated in detection and prevention of adverse drug reactions. the previous five years. Some have state or provincial lists as Fourth, improved effectiveness and efficiency in patient well (Kathleen Holloway, personal communication, March treatment reduce health care costs. Therefore, lack of 2010). funds in developing countries is not the only reason to Under optimal circumstances, the registration of medi- limit treatment selection to essential medicines, nor does cines for the private and public sectors should be based such a policy necessarily compromise quality of care. In on an evaluation of efficacy, safety, and quality. In some fact, the essential medicines concept is increasingly being countries, cost and need are also criteria for medicine reg- accepted as a universal tool to promote both quality of istration. In such cases, the selection of essential medicines care and cost control. takes place during medicine evaluation, approval, and reg- Fifth, for public-sector supply programs, advantages exist istration and is therefore applicable to both the public and in concentrating procurement and logistics efforts on a lim- private sectors. ited number of medicines, including reduction in the num- More commonly, the selection and use of essential medi- ber of different products that must be stocked, distributed, cines are limited to public-sector health facilities. However, and monitored.
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