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 17 Treatment guidelines and formulary manuals Summary 17.2 illustrations 17.1 Need for local reference manuals 17.2 Figure 17-1 Sample page from WHO Model Formulary, Treatment guidelines • Formulary manual 2008 17.13 17.2 Treatment guidelines 17.3 Table 17-1 Summary of the standard treatment guideline Establishment of a guideline development committee • development process 17.6 Information in treatment guidelines • Use of treatment guidelines boxes Box 17-1 Potential benefits of standard treatment 17.3 Formulary manuals 17.10 guidelines 17.3 Information in a formulary manual • Developing Box 17-2 Cost-effectiveness analysis for choosing standard a formulary manual • Practical issues in formulary treatments 17.8 manual development • Hospital formularies Box 17-3 Using monitoring systems to evaluate the 17.4 Production and distribution issues 17.14 appropriateness of standard treatment 17.5 Implementing and maintaining treatment guidelines guidelines 17.10 and formulary manuals 17.14 Box 17-4 Information in a formulary manual 17.11 Assessment guide 17.16 country studies References and further readings 17.16 CS 17-1 Production and use of treatment guidelines 17.5 CS 17-2 Improving compliance with standard treatment guidelines in Indonesia 17.9 CS 17-3 Availability and knowledge of HIV/AIDS-related treatment guidelines in Rwanda 17.15 copyright © management sciences for health 2012 17.2 SELECTION SUMMARY Treatment guidelines are disease oriented and reflect a integrate technical advice from various disease programs consensus on the treatments of first choice for a range of into an overall training program. Treatment guidelines medical conditions. A formulary manual is drug oriented should be used as the basis for undergraduate medical and contains summary drug information on a selected and paramedical training, for in-service training, for number of medicines, sometimes combined with practi- supervision, and for medical audit. The range of medi- cal prescribing and dispensing information. They can cines included should be limited to those on the national both be developed for various levels of health care. list of essential medicines. The process of developing these publications (the for- A formulary manual, whether at a national or facility mulary process) is a continual effort, not limited to the level, should be developed by a formulary subcommittee one-time production of a set of treatment guidelines of the national drug committee or the facility’s drug and or a formulary manual. The process includes gaining therapeutics committee. Both committees should ensure acceptance of the concept, preparing a text on the basis of the full participation of prominent specialists and health wide consultation and consensus building, implementing opinion leaders in the process. One or two editors should an introductory campaign and training activities, and be commissioned to draft and edit the formulary manual. undertaking regular reviews and updates. To maintain the credibility of the information, a system Treatment guidelines can be made for one institution, for regular updates and for incorporation of accepted such as a hospital; for one level of care, such as all health amendments into the next edition is essential for both centers; or for a region or nation. Treatment guidelines formularies and treatment guidelines. are powerful tools to promote rational prescribing, pro- This chapter builds on concepts introduced in Chapter vided they are based on extensive involvement of the 16, which should be read first. end users. Their development is a good opportunity to 17.1 Need for local reference manuals guidelines for paramedical workers in rural areas to detailed protocols for tertiary health care centers in wealthy urban After standard treatment guidelines (STGs) for a country’s areas and teaching hospitals. common conditions and complaints have been agreed upon Standard guidelines benefit health officials, supply man- and adopted, the next step is the development of a national agement staff, health care providers, and patients (Box essential medicines list and a formulary manual. 17-1). Together with a national list of essential medicines, The procedures for developing an essential medicines list, treatment guidelines are powerful tools in promoting the a set of treatment guidelines, and a formulary manual are all rational use of medicines, and they are integral in strategies similar; together, they can be called the formulary process. to reduce antimicrobial resistance. They offer an opportu- Standard treatment guidelines are disease oriented, whereas nity to ensure that the training of health workers is based formulary manuals are very much drug-oriented docu- both on a logical approach to treatment and on a consensus ments. These two documents are the cornerstone of rational about the selection of essential medicines. Comprehensive medicine therapy. General information on the selection of treatment guidelines are a logical starting point for inte- medicines and the development and maintenance of a list of grated training and an excellent basis for pharmaceutical essential medicines is given in Chapter 16. In this chapter, supply in the public sector. Treatment guidelines should be the specific aspects of the formulary process are outlined in used for in-service training, supervision, and medical audit. relation to developing treatment guidelines or a formulary They can also assist in the standardization (and rationaliza- manual. tion) of prescribing patterns in countries with large numbers of foreign-trained medical graduates. STGs, when properly Treatment guidelines developed and implemented, will improve the patient’s clin- ical outcome at a lower total cost (Grimshaw et al. 2004). The terms standard treatment guidelines, treatment protocols, and clinical guidelines are all used to indicate systematically Formulary manual developed statements that help practitioners or prescribers make decisions about appropriate treatments for specific A formulary manual contains summary information on a clinical conditions. Treatment guidelines exist for vari- selected number of medicines. It is drug centered, and the ous levels of health care, ranging from general prescribing information is usually organized in therapeutic groups. In 17 / Treatment guidelines and formulary manuals 17.3 Box 17-1 Potential benefits of standard treatment guidelines For health officials • Makes medicine demand more predictable, so fore- casting is more reliable • Permits identification of cost-effective treatments for common health problems For health care providers • Provides basis for assessing and comparing quality • Provides expert consensus on most effective, eco- of care nomical treatment for a specific setting • Identifies most effective therapy in terms of quality • Gives providers the opportunity to concentrate on and combats antimicrobial resistance correct diagnosis • Provides information for practitioners to give to • Sets a quality-of-care standard patients concerning the institution’s standards of • Provides a basis for monitoring and supervision care • Is a vehicle for integrating special programs (control For patients of diarrheal disease, acute respiratory infection, • Encourages adherence to treatment through consis- tuberculosis, malaria, and so on) at the point of the tency among prescribers at all locations within the primary health care provider health care system For supply management staff • Ensures most cost-effective treatments are provided • Improves availability of medicines • Identifies which medicines should be available for • Improves treatment and outcomes the most commonly treated problems • Facilitates prepackaging of course-of-therapy quan- tities of commonly prescribed items most developing countries, the national formulary list is lim- available on its website and on CD-ROM. The WHO Model ited to medicines on the national list of essential medicines. Formulary presents independent information on the more A therapeutic formulary includes detailed and comprehen- than 300 medicines on the WHO Model List of Essential sive therapeutic information on each of the medicines listed Medicines and is updated periodically, along with the essen- and may also include guidelines on rational prescribing and tial medicines list. Each section of the formulary starts with dispensing; here, the distinction between a formulary and a comparative overview of various therapeutic alternatives, treatment guidelines becomes less clear, as is the case with while each medication entry has information on use, dosage, the British National Formulary (BNF). adverse effects, contraindications, and warnings. The for- Although there are several available reference texts that mulary is intended to be a model for national governments include comprehensive drug information, they may not be and institutions to use as a basis for developing their own appropriate for all settings. A national formulary manual national formularies. It is particularly relevant for develop- concentrates on medications relevant to a particular coun- ing countries, where commercial and promotional materials try. For example, it would exclude information on medicines are often the only available source of drug information to that are not available in the country