Presentation given by Margaretha Helling-Borda,
Director of WHO Action Programme on Essential Drugs

　

　　On behalf of the World Health Organization, I would like to thank The Nippon Foundation for their kind invitation and for providing this opportunity to present an important and topical subject: the rational use of drugs.

　

The rational use of drugs can be defined as safe and cost-effective drugs, prescribed and used in the right amounts and dosage forms for appropriately diagnosed conditions.

　　The appropriate use of pharmaceuticals is fully complementary to, and should be viewed as, an integral part of primary health care which contains as one of its eight elements, “access to essential drugs.” Improvements in access to essential drugs can be achieved by minimizing waste through better selection, prescription, and use of pharmaceuticals; these improvements translate directly into saved lives an reduced suffering.

　　The prescription, sale, and use of pharmaceuticals are influenced by a large variety of factors ranging from educational and cultural to economic, and to those associated with pharmaceutical product features and their presentation. Rational drug use therefore should be addressed within the context of a drug policy incorporated within a national health policy. Such a comprehensive national drug policy (NDP) is concerned with all aspects of the pharmaceutical sector such as drug selection, supply, quality assurance and financing.

　　WHO has, since 1975, been “convinced of the necessity of developing drug policies...” and has consistently strengthened its commitment to and advocacy of this concept throughout the years through its collaborative efforts with its Member States so as to ensure that providers and consumers have reasonable access to appropriate drugs. The WHO Expert Committee on National Drug Policies, which met in Geneva in June of this year to review and contribute to updating the WHO Guidelines for Developing National Drug Policies (first published in 1988), noted that “a policy on rational use is an extremely important part of an NDP,” and because diverse factors affect drug use, the concerted effort of all parties-- governments, industry, health workers, and consumers-- is required to improve drug utilization practices.¹

　

A. GLOBAL PERSPECTIVE AND ACTIVITIES

　

　　From the earliest days of the WHO Action Programme on Essential Drugs (DAP), rational drug use has been a major issue to tackle. Since the 1985 Nairobi Conference on the Rational Use of Drugs, however, it has received even greater attention on the global stage. This has further intensified in the last couple of years with the wave of privatization and free market economy advocacy which has hit many previously centrally planned and ruled countries which were not necessarily prepared for such rapid changes.

Rational drug use is one of DAP's four areas of technical intervention; the others are policy and management, supply and logistics, and quality assurance. In addition to these technical interventions, the Programme has also identified four underlying principles for cooperation: need driven, capacity building, decentralized responsibility, integrative approach; and four program areas of work: country support, development work, operational research, and program management. Together, these components form DAP/s 4+4+4 Framework for Action.

DAP's work in the area of rational drug use includes several programmatic and operational (interventional) elements such as drug selection, training programs, clinical pharmacology, educational material and campaigns, national health service level formularies and therapeutic guidelines, and research on drug use and self-medication.

　

B. DEVELOPMENT WORK INCLUDING TRAINING AND EDUCATION

　

National Formularies and Treatment Guidelines

　

　　The selection of essential drugs and the development of a regulatory mechanism are the first steps towards improving the rational use of drugs. The Use of Essential Drugs is the WHO publication which contains the Model List of Essential Drugs which countries can use as a starting point for developing their own national lists.

　　Common guides for prescribing that correspond to a country's essential drugs list contribute to the promotion of rational prescribing. The Action Programme has, therefore, supported the elaboration of many national formularies and treatment guidelines in WHO Member States, such as Colombia, Nigeria, the Philippines, and the Sudan. A guide for producing national drug and therapeutic information has been put together based on the development of publications in Malawi (Producing National Drug and Therapeutic Information).

　

Drug Information

　

　　Lack of access to noncommercial sources of drug information is a contributory factor to irrational drug use in many parts of the world. The Action Programme, in collaboration with the WHO Division of Drug Management and Policies, is currently developing a manual on how to set up small drug information centers in developing countries This manual will review experiences of different types of drug information centers in the developing world, discuss a range of potential functions of such centers, and provide step-by-step guidelines for setting up centers at different levels of operation.

　　Support for the development of national drug information capacity has also been a focus of the Programme's activities. One example is technical and financial support for new drug bulletins. Another is the development with la Trobe University of Australia of prototype audiovisual material to guide medical students in identifying and evaluating sources of drug information, with specific reference to WHO's Ethical Criteria for Medicinal Drug Promotion.

　　WHO's Division of Drug Management and Policies contributes to the available body of information on pharmaceuticals through the regular production of several newsletters, journals, and publications such as the WHO Pharmaceutical Newsletter, WHO Drug Information, and WHO Model Prescribing Information. In addition, several WHO disease control programs are also concerned with rational drug therapy and publish relevant material such as The Rational Use of Drugs in the Management of Acute Diarrhea in Children (by the Division of Diarrheal and Acute Respiratory Disease Control). DAP collaborates closely with these programs to ensure that, in the clinical management guidelines produced, the essential drugs concept prevails in proposed drugs selection and that these selections are made within the framework of a national drug policy.

　

Training

　

　　Because prescribers' attitudes drive the consumption patterns of consumers, the training of prescribers and other health workers must be pursued to tackle the problem of irrational use. Studies spanning several years and in diverse countries have demonstrated that between 41% and 91% of all antibiotic prescriptions in teaching hospitals were considered irrational.² Improving the education offered to medical students and health workers, particularly at an early stage of their training, will help ensure that they prescribe appropriately and that their positive training is subsequently passed on to others. Therefore, the Action Programme has collaborated in preparing learning material for health workers, guidelines for patient communication, and clinical pharmacology training programs. Some examples of this work are as follows:

　

Public Education

　

　　Effective education of the public in the rational use of drugs is not easy. There is still resistance on the part of prescribers to the “empowerment” of the consumer; human and financial resources for research and educational campaigns are scarce and little has been done to determine how such education can be evaluated and sustained. Yet, it is vital. Users' expectations can influence prescribing patterns and informed dialogue between patient and prescriber is essential if medicines are to be properly used.

　　In 1993, the Action Programme held an informal consultation to review the information, education, and communication support is provides to countries in the area of public education in the rational use of drugs. The report of this consultation is available as a DAP document, Public Education in Rational Drug Use.

　　Public education is a main activity of the Programme, and is the focus of a project which started in October 1994 in partnership with the Health Action International network. The direct output of the first stage of this project will be a state-of-the-art global review of drug education activities with a critical assessment of their effectiveness, a database of activities, and a reference collection of educational materials. The second stage of this project should result in the development of an illustrated manual to guide the planning, implementation and evaluation of drug education programs, and a set of criteria for assessment of these programs. A third stage will cover advocacy and support for public education activities with a range of partners using development an implementation strategies developed by the project.

　

　　Surprisingly little is known about the determinants that result in the spending of thousands of millions of dollars and that have profound social, health and economic consequences. In order to address effectively the educational needs of both prescribers and consumers, it is imperative that current social and economic conditions regarding the use of drugs be clearly identified and interventions devised to improve these specific areas.

　　The Action Programme on Essential Drugs has engaged in a variety of operational research studies on rational drug use, especially at the country level. This research has focused on such topics as prescribing patterns, economic pressures on prescribing and consumption, injection practices, self-medication, and community health workers and drugs. Some publications of particular interest are those which include indicators, i.e. How to Investigate Drug Use in Communities, How to Investigate Drug Use in Health Facilities, and the most recently published, Indicators for Monitoring National Drug Policies.

　

　　An important vehicle for transmitting the message that rational drug use is necessary is the Programme's newsletter, The Essential Drugs Monitor, which is produced about twice yearly in English, French, Russian, and Spanish, with a worldwide readership of more than 200,000 persons. The most recent issue (no.19) focuses on informed therapy and contains articles on the therapeutic guidelines, new drugs prescription and drug bulletins, and also provides a list of relevant bibliographic resources.

　　In addition to activities in information, training, education, and advocacy, and in accordance with a need frequently expressed by international agencies engaged in emergency aid and by national recipients of aid, DAP is in the process of developing WHO Guidelines for Drug Donations.

　

　　Up to this point, I have mainly focused on WHO global support in addressing issues pertaining to rational drug use. Although this support is critical, it is finally at the country level where actions must be, and are in reality, taken. The fact that the essential drugs concept has been embraced by so many countries shows that the issue of proper drug use is of core concern.

　　The Programme cooperates with WHO Member States in elaborating and implementing comprehensive information, education and communication strategies for their national essential drugs programs. These strategies, drawn up for example in Malawi and the Sudan, typically involve a broad range of activities designed to share information, enhance knowledge, and also modify specific behaviors and practices with respect to rational drug use.

　　Collaborative efforts of countries to identify problems and solutions in the area of rational drug use which are appropriate in the socio-economic context of specific regions ar fully supported by DAP. For example, in 1993, the Action Programme with the Southeast Asia Regional Office of WHO sponsored a consultative meeting, “Promotion of the Rational Use of Drugs in the South-East Asia Region.” During this meeting a set of guidelines were suggested to promote rational drug use at the country level in the context of national programs on essential drugs.

　　Serious issues which prevent rational drug use at the country level shoultd be identified, through research or built-in supervisory methods, and prioritized. Common types of misuse are:

　

　

　　Personally, I believe that in countries with great public health problems such as diarrhoeal diseases, acute respiratory infections malaria, sexually transmitted diseases, tuberculosis, and HIV, priorities for the promotion of rational drug use should be given to interventions addressing drug misuse in the prevention and treatment of these diseases.

　　A joint forum with a participatory approach can be used to develop educational, managerial and/or regulatory strategies for priority interventions. The role of each interested group would be defined and presented either separately or jointly in a matrix for ease of reference. The various roles to be defined would be for example:

　

　

The interventions most suited to be carried out by each actor should then be determined. For example, who should carry out educational interventions through seminars and/or printed matter? Or, who should be concerned with regulatory actions such as scheduling the level of prescribing?

　　Systematic evaluation of the interventions taken to promote rational prescribing is very often missing or not built into health services procedures. It is for this reason that a country needs to identify more than the interventions and the parties to carry them out; it needs also to develop or identify suitable indicators which can be used to evaluate the outcomes. I have previously mentioned some WHO publications that can be used for this purpose (How to Investigate Drug Use in Countries, How to Investigate Drug Use in Health Facilities, and Indicators for Monitoring National Drug Policies). As improving rational drug use is a continuous effort, information from these evaluations should feed back into the process to indicate areas where further improvements are most necessary and where strategies need to be continued or modified.

　

　　Since the early 1990s, some countries have been experiencing deteriorating economic conditions, creating an uncertain environment for planners and decision makers. In economies which were centrally planned but are now moving to free market structures, health services traditionally provided by the public sector are increasingly becoming the domain of the private sector or are not being provided at all. Countries everywhere are exploring new ways to control health expenditure while still offering their citizens quality services.

　　The selection of essential drugs and the promotion of the rational drug use are powerful tools in achieving the ultimate goal of making drugs available to those who need them. These concepts continue to be-- in fact, are probably more now than ever-- vital and fundamental components of a comprehensive national drug policy.

　　Changing economic and social conditions, however, affect the dynamics which drive pharmaceutical demand and many change the actors or roles of the actors involved in the pharmaceutical sector. Approaches to improving the rational use of drugs must evolve in accordance with these changes if the issues facing individuals, communities, and countries are to be successfully addressed.

　　In a book I read some years ago was the question, “Will the essential drugs concept be only valid in health and development circles?” Let us work together so that we can eventually reply to this question with a resounding “no!”