Improving the use of drugs by health workers and the general public is crucial both to reducing morbidity and mortality from communicable and non-communicable diseases, and to containing drug expenditure.

Ideally, therapeutically sound and cost-effective use of drugs by health professionals and consumers is achieved at all levels of the health system, and in both the public and the private sectors. A sound rational drug use programme in any country has three elements:

• Rational drug use strategy and monitoring - advocating rational drug use, identifying and promoting successful strategies, and securing responsible drug promotion.

• Rational drug use by health professionals - working with countries to develop and update their treatment guidelines, national essential drugs lists and formularies, and supporting training programmes on rational drug use.

• Rational drug use by consumers - supporting the creation of effective systems of drug information, and empowering consumers to take responsible decisions regarding health care.

WHO supports governments and organizations in carrying out each of these elements.

“...the rational use of drugs requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community.”

Conference of Experts on the Rational Use of Drugs, Nairobi, 1985. ⁶³

Component 10: Rational drug use strategy and monitoring

Support countries in implementing and monitoring a national strategy to promote rational use of drugs by health professionals and consumers

This component contains all the elements necessary to design and monitor a successful, comprehensive programme to promote rational drug use: advocacy of the concept of rational drug use, measurement tools to monitor the situation, and identification of successful intervention strategies. It also includes activities that concern health workers and the public alike: responsible drug promotion; provision of information on the use of traditional medicine; and efforts to contain antimicrobial resistance. Efforts specifically targeted at health workers and consumers are detailed in Components 11 and 12.

Progress

Since the 1985 Nairobi Conference on the Rational Use of Drugs, the concept of rational drug use has been widely disseminated by WHO, and is now incorporated in all drug policies and essential drugs programmes. Standardized indicators for investigating drug use in health facilities, have been developed by WHO and these are now the global standard. Qualitative and quantitative methods to measure drug use in communities have also been developed and are used extensively.

In terms of rational drug use training, more than 500 health professionals, mainly from developing countries, have been trained through an international course on promoting rational drug use, held once a year in Asia and once a year in Africa. The course materials were recently updated and are now available on the Internet and on CD-ROM.

Significant work has also been undertaken on actual rational drug use interventions. The first global International Conference on Improving the Use of Medicines, held in Thailand in 1997, reviewed all available evidence on the impact of rational drug use interventions in developing countries. This resulted in a global research agenda and an interagency research programme to research additional potential interventions in Asia, Africa and the Americas.

Challenges

Despite all the efforts made, however, irrational prescribing, dispensing and consumption of medicines remains widespread, especially in the private sector. A hazard to health, such irrational use can also be a major source of impoverishment for poor populations. It is a particularly serious problem in developing countries where between 50 and 90% of drug purchases are made in the private sector. ⁵

Drug promotion - effectively monitored in only 52 of 102 countries for which relevant data are available - is also of intense concern. Too often, medical representatives of pharmaceutical companies are the primary source of drug information for prescribers. ⁶⁴ In many countries, continuing education in good prescribing is unavailable, and if it is available it is often dominated by promotional messages from pharmaceutical companies rather than independent sources. Most prescribers are not trained to evaluate such information critically. ⁵⁰ This situation is not helped by the increasing blurring of the boundary between commercial and independent information.

Figure 20: Antibiotic resistance varies greatly: within countries, between countries, over time and in rate of change

Source: GASP, 1997. ⁶⁶

Traditional medicine is another area where much progress remains to be made in rational use. This is partly because the clinical efficacy of traditional remedies is as yet unproven. Consumers of traditional medicine products therefore risk wasting their money and even endangering their health.

Irrational use has particularly serious consequences if it involves antibiotics. Misuse of antibiotics is contributing to the worldwide increase in antimicrobial resistance that is now being observed for most common pathogens. Chloroquine resistance, for example, has been reported from 81 countries, and up to 98% of Neisseria gonorrhoea is resistant to penicillin. ⁶⁵ The costs of antimicrobial resistance are very high. Second-line treatment for resistant meningitis or malaria may be 50 - 90 times as expensive as the original drugs, while one years treatment of multidrugresistant tuberculosis costs US$ 8,000 - 12,000, compared with about US$ 40 for first-line treatment. Containing antimicrobial resistance is crucial if drug costs are to be affordable and common diseases to remain treatable.

Expected outcomes for 2000-2003

10.1: Advocacy of rational drug use directed at national experts, government officials and international organizations, with a focus on the therapeutic and economic need for rational use of medicines.

• Work will include development of guidelines on how to develop a national programme to promote rational drug use, continuation of the annual WHO/International Network for Rational Use of Drugs training courses (in English) in Africa and Asia, and provision of these courses in French and Spanish in Africa and Latin America.

10.2: Identification and promotion of successful rational drug use strategies following operational research to identify cost-effective interventions to promote therapeutically sound and cost-effective drug use by health professionals and consumers, leading to production of global guidelines and training manuals to promote their application.

• WHO will support the global research agenda identified at the 1997 International Conference on Improving the Use of Medicines, but focus especially on expansion of activities into Latin America. Priority research topics will include rational use of malaria drugs and antibiotics, and drug use in hospital settings and in the private sector.

10.3: Responsible drug promotion encouraged through advocacy, promotion of adherence to the WHO Ethical Criteria for Medicinal Drug Promotion, and support for development of national guidelines for drug promotion and national measures to prevent and monitor perverse incentives for prescribers and dispensers.

• Work will include development of standardized tools to measure levels of drug promotion activities, continued expansion of a global database on the impact of promotional practices, and development of training materials for students, health workers and consumers on how to read and interpret promotional materials. Special efforts will be made to empower NGOs to monitor the impact of drug promotion.

10.4: Information support on use of traditional medicine with WHO acting as a “clearing house”.

• WHO will develop its own database on traditional medicine and a WHO web-site on traditional medicine. It will also make a collective analysis of national surveys on use of traditional medicine.

10.5: Antimicrobial resistance contained through better use of resistance surveillance information, and by ensuring timely and appropriate measures on the part of governments, professional bodies, industry, consumers and other stakeholders.

• WHO will develop a global strategy to contain antimicrobial resistance. Standardized measuring tools and practical guidelines to contain antimicrobial resistance will be developed for hospitals and for national governments, as will training materials for medical and pharmacy students on combating antimicrobial resistance.

Component 11: Rational drug use by health professionals

Develop national standard treatment guide-lines, essential drugs lists, educational programmes and other effective mechanisms to promote rational drug use by health professionals

Progress

Extensive research has shown that standard treatment guidelines, essential drugs lists and formularies promote rational prescribing of drugs by prescribers. ^{67, 68} Progress in developing each of these tools has been considerable. By the end of 1999, 156 countries had an essential drugs list, of which 127 were new or updated within the previous five years, with 94 divided according to level of care. In addition, 135 countries have developed national treatment guidelines, of which 112 have been updated in the last five years. There are now more than 100 national formularies, and by the end of 1999, 88 countries in all six WHO regions had introduced the essential drugs concept into curricula for medicine and pharmacy students.

The WHO Model List of Essential Drugs, and regional and international rational drug use courses, form a large part of ongoing WHO efforts to improve drug use by health professionals. The WHO Model List of Essential Drugs is generally updated every two years by the WHO Expert Committee on the Use of Essential Drugs. The 11th Model List - describing just over 300 drugs - was revised in November 1999 and published in December 1999. ⁶⁹ Training helps put the principles upon which the list is founded into practice. International training courses for university teachers in problem-based pharmacotherapy teaching are held every year in Europe, Africa and Latin America. Two randomized controlled trials with over ten centres in developed and developing countries have shown that the teaching methods transfer lasting skills in rational prescribing. ⁷⁰

Figure 21: The essential drugs concept is becoming global - 156 countries have a national list of essential drugs

The WHO Guide to Good Prescribing has proved to be another invaluable tool. Translated into 18 languages and now available on at least six different web-sites, it continues to be one of the Organization's most successful publications. Primarily intended for undergraduate medical students who are about to enter the clinical phase of their studies, it provides step-by-step guidance on the process of rational prescribing. ⁷⁰

The WHO Monographs on Selected Medicinal Plants are also doing much to promote rational drug use, but in the area of traditional medicine. Volume 1 was published in 1999 to guide Member States in the proper use of medicinal plants, to provide them with a model for the development of their own monographs, and to facilitate information exchange. A second volume was finalized in the same year. The Monographs were recently recommended by the European Commission to Member States as an authoritative reference.

Challenges

Despite the growing body of knowledge on rational use interventions, numerous studies have documented the continuing widespread irrational prescribing of drugs, including the overuse of antibiotics in primary health care. One review, for instance, found that 25 to 75% of antibiotic prescriptions in teaching hospitals in a large number of developed and developing countries were inappropriate in terms of either indication, selection, dosage or duration, or a combination of these. ¹⁴

Popular and widespread in developing countries, injection therapy can also be an example of irrational drug use. One study showed that in some countries children have received 20 injections on average by the age of two. ⁷¹ Of all injections given, 5% or less were for immunization and 95% for curative purposes; most of the latter were unnecessary. Furthermore, over 50% of all injections given were unsafe, with increased risk of transmission of bloodborne pathogens such as hepatitis B and C, and HIV. ⁷²

The main challenge regarding rational drug use by prescribers is that knowledge alone is not enough to change behaviour, and that complex and multifaceted solutions are needed. Training programmes must therefore be complemented with other means, such as supervision, medical audit, regulatory measures, financial incentives and public education. For example, a conflict of interest occurs when prescribers also sell (and are therefore likely to overprescribe) drugs. A training course alone will not solve this problem since financial incentives may be a large part of the problem.

Many new drugs and second-line drugs are very expensive and accordingly unaffordable for many governments and consumers. This adds an economic dimension to the process of developing treatment guidelines and selecting essential drugs. Difficult decisions have to be made by health care managers concerning the recommended treatment for multidrugresistant tuberculosis and malaria, for HIV/AIDS and for other infectious diseases, so that treatment is available to all who need it.

Figure 22: 27 to 63% of patients in primary health care centres receive antibiotics perhaps twice what is clinically justified.

Source: Hogerzeil et al., 1993. ¹⁷

In developed countries drugs and therapeutics committees have been successful in promoting rational prescribing. ⁷³ However, ongoing studies suggest that such committees are more difficult to run in developing countries. Medical and pharmacy training in most developing countries is still very traditional, with much emphasis on drug knowledge and very little on public health, prescribing skills, drug management or patient care.

For traditional medicine, the major problem concerning rational use relates to the fact that few plant species that provide medicinal herbs have been scientifically evaluated for their possible medical application. Safety and efficacy data are available for even fewer plants.

Expected outcomes for 2000 - 2003

11.1: Development of national standard treatment guidelines and essential drugs lists will be supported, as will development of model prescribing information, a model formulary and model list of essential drugs. Additionally, global guidance on how to develop such materials at country or institutional level will be provided.

• WHO will develop a database containing all WHO standard treatment guidelines, review the development process of the WHO Model List of Essential Drugs, develop a WHO Model Formulary, and organize an annual training course on pharmacoeconomic analysis to support the process of drug selection.

11.2: Support for problem-based and skill-based in-service training programmes incorporating the essential drugs concept, learning objectives and problem-based learning methods.

• Work will include: continuation of the annual international training courses on problem-based pharmacotherapy, but with expansion into French-speaking Africa; finalizing of the Teacher’s Guide to Good Prescribing; and development of a Guide to Good Pharmaceutical Care to stimulate reform of pharmacy curricula in developing countries and countries in transition.

11.3: Drugs and therapeutics committees established and operating effectively at the hospital and primary care levels, and efforts to strengthen the role of the pharmacist in the treatment team.

• WHO will conduct operational research and pilot projects on the best means of promoting drugs and therapeutics committees, in order to develop and test practical guidelines for running such committees in developing countries.

11.4: International technical guidelines and standards on traditional medicine expanded, particularly for medicinal plants and acupuncture.

• WHO will publish the third volume of the WHO Monographs on Selected Medicinal Plants, WHO guidelines on methodology for research into and evaluation of traditional medicines, and a review of the clinical practice of acupuncture.

Component 12: Rational drug use by consumers

Establishing effective drug information systems to provide independent and unbiased drug information including on traditional medicine to the general public and to improve drug use by consumers

Progress

An extensive review by WHO of public education on drugs provided valuable insight into strategies used, and their strengths and weaknesses. ⁷⁴ Its findings - widely disseminated in English, French, Spanish and Russian - identified how different players could contribute to more effective approaches to such education.

Additionally, the WHO guide to investigating drug use in the community has contributed to a growing body of knowledge on consumer understanding, attitudes and practices regarding drug use that is being used to strengthen future public education programmes. ⁷⁵ An updated edition, based on users' experience, provided the core research methodology for a new WHO course on promoting rational drug use in the community.

In parallel, efforts have continued to support independent sources of drug information. These are essential to enable consumers and others to become fully informed about the drugs available in their countries. Experiences with independent drug bulletins are being shared with developing countries through networks such as the International Society of Drug Bulletins, in which WHO participates.

Drug information centres - increasingly well established in developed countries - are another important source of independent drug information. Their number in developing countries is now beginning to grow, often with WHO support. Some also function as WHO Collaborating Centres. A global network of centres, linked electronically, is contributing to shared information and experience.

Figure 23: In Sri Lanka, self-medication is a major source of care for acute illness, with high risk of treatment failure

Source: World Health Organization, 1997. 32

Challenges

Improving consumers' drug use is equally or more important than improving the practice of health providers. Health professionals have a major influence on the overall use of medicines in a country. But it is the consumer, throughout the world, who takes the final decision about whether and where to seek health care, what medicine is actually taken, how much and when, and from what source. These decisions are influenced by knowledge, culture, drug promotion and personal finances. These factors operate even more strongly among communities whose primary source of modern medicines is not a trained health worker, but the local (often informal) drug seller. For example, in Sri Lanka, self-medication has been observed to be the primary source of care even in cases of acute illness (see Figure 23).

At the same time, independent drug information and public education about drug use have always been underserved and underfunded. The financial resources available for producing commercial, promotional information on drugs vastly outweigh those available for provision of comparative independent information, and for undertaking the assessments to make the necessary comparisons between therapies. Moreover, substantive community education interventions are complicated and costly. They are also problematic because their results are often incremental and difficult to measure. Funding and sustaining them can therefore be difficult. They also tend to be organized by NGOs. Since NGOs often work through informal networks, objective evaluation of interventions and publication of the results are not easily arranged.

In view of the lack of independent drug information and advice, rates of adherence to treatment are understandably low in both rich and poor countries. Worldwide, some 50% of people fail to take their medicines correctly. Part of the problem is that self-medication of “prescription” drugs is widespread. In observational studies of pharmacies in Asia, for example, about half of consumers bought only one or two tablets at a time, and 90% bought less than 10 tablets. ^{15, 16} This was doubtless partly linked to what the consumers could afford, but lack of awareness about appropriate treatment regimens was probably another important factor.

Furthermore, since most drug purchases in developing countries take place in the private sector, where prescribing and selling functions are often combined, consumers are often sold medicines with a higher profit margin, even though these may be no more or less effective than cheaper medicines. Concurrently, profit motives and pressure to please the patient can lead to over-treatment of mild illnesses, overuse of injections and misuse of anti-infective drugs. Money is wasted and risk of treatment failure is increased.

In short, the consumer is too often unaware of the potential problems surrounding prescribing and the price, quality and effectiveness of pharmaceuticals. Consumer empowerment to enable individuals to take responsible treatment decisions and better availability of independent drug information are sorely needed. Even though its resources are limited, WHO will try to support systems of effective, comparative and unbiased drug information. It will also rally and train core groups in developing countries to undertake and evaluate sustainable community education in the rational use of drugs.

Expected outcomes for 2000 - 2003

12.1: Effective systems of drug information that are accessible to all health workers and the general public, through provision of training materials and regional and national training courses, and technical support to international networks of drug information centres.

• WHO will continue to work with the International Society of Drug Bulletins, including on development of practical guidelines for establishing and running a drug information bulletin in a developing country.

12.2: Public education in ration-al drug use and consumer empowerment through operational research, and development and provision of new training materials and courses.

• Work will focus on developing an international training course on public education in rational drug use in developing countries, and establishing a network of national core groups undertaking interventions in public education in rational drug use. Standard research tools to assess drug use in communities will be updated.