(2002; 28 pages) [French] [Spanish]
Promoting rational use
The selection of essential medicines is only one step to improve the quality of health care. It should be followed by the appropriate use of the selected medicines. Each individual should receive the right medicine, in an adequate dose for an adequate duration, with appropriate information, planning of treatment follow up, and at an affordable cost. In each country and setting, this is influenced by a number of factors, such as regulatory decisions, procurement, information, training, and the context where medicines are prescribed or recommended.
Training, education and the provision of medicines information
For the safe, effective and prudent use of essential medicines, relevant, reliable and independent medicines information should be available. Health care professionals should receive education about the use of medicines not only during their training but also throughout their careers. More highly trained individuals should be encouraged to assume a responsibility to educate those with less training. Health care providers and those responsible for dispensing medicines should take every opportunity to inform consumers about the rational use of these products, including those for self-medication, at the time they are dispensed.
Governments, universities and professional associations have a major responsibility to collaborate on improving undergraduate, postgraduate and continuing education in clinical pharmacology, therapeutics and medicines information issues. Problem-based pharmacotherapy teaching2 has been shown to be an effective strategy in this area.
2Guide to Good Prescribing. Geneva: World Health Organization, 1994. Document WHO/DAP/94.11
Appropriate medicines information that is well presented ensures that medicines are used properly and decreases inappropriate medicine use. Ministries of Health must take the responsibility for arranging for the provision of such information. Independent medicine information activities should be properly funded and if necessary financed through health care budgets. Electronic, readily accessible sources of medicines information are becoming available in many settings and can be the basis of reliable medicines information systems.
Standard clinical guidelines
Standard clinical guidelines are an effective tool for assisting health professionals to choose the most appropriate medicine for a given patient with a given condition. STGs should be developed at national and local level and updated on a regular basis. It is not sufficient to develop standard clinical guidelines without an education and training program to encourage their use.
Drugs and Therapeutic Committees
Drugs and Therapeutic Committees should play an important role in helping to develop and implement an effective essential medicines program. These committees should be encouraged to select products for local use from a national essential medicines list, to measure and monitor the use of medicines in their own environments and undertake interventions to improve medicines use. There is good evidence that involving Drugs and Therapeutic Committees and prescribers in guideline development can contribute to improving prescribing behaviour.
Measuring and monitoring use
Drug utilisation studies are those dealing with the development, regulation, marketing, distribution, prescription, dispensing, and use of medicines in a society, with special emphasis on the resulting medical, social and economic consequences. These studies can examine any level of the therapeutic chain, from medicines development to their actual use by people. They can provide consumption indicators in a given country, area or institution. Consumption can be quantified as economic expenditure (either in absolute terms or as percentage of total health budget), as number of units, or as defined daily doses3 (old reference 31). They can aim at describing the consumption of all medicines, or of particular groups of medicines or therapeutic areas. The Anatomical Therapeutic Chemical (ATC) classification is a useful tool for international comparisons on the use of medicines. Drug utilisation studies can be medicine-oriented (on the use of a particular medicine or group of medicines), or problem-oriented (on the treatment of a particular condition or disease).
3 Guidelines for ATC classification and DDD assignment, 5th ed. Oslo: WHO Collaborating Centre for Drug Statistics Methodology, 2001
The efficacy of a medicine is most reliably defined on the basis of randomised clinical trials, which, if well conducted, provide the most reliable estimates of the treatment effect of a new medicine. Clinical trials cannot be conducted in all possible populations or settings and their results should therefore be carefully translated into routine clinical practice. Drug utilisation studies aim at providing evidence on the use and the effects of medicines in routine conditions, and they thus can provide additional evidence for the evaluation of effectiveness.
Such studies are important tools for identifying those factors or elements of the therapeutic chain in need of improvement or change. The results should be taken into consideration when taking regulatory action, selecting medicines, information, training, and teaching. Institutional and local drug and therapeutic committees should set up drug utilisation studies and other methods for the surveillance of the use of medicines and of its effects.
Monitoring of drug safety and pharmacovigilance
The surveillance of the safety of medicines is part of the general surveillance of their use. The aims of the various forms of pharmacovigilance are to identify new, previously unrecognised adverse effects of medicines, to quantify their risks, and to communicate with drug regulatory authorities, health professionals, and, when relevant, with the public. Voluntary reporting of adverse effects of medicines, on which the International WHO Programme for Drug Monitoring is based, has been effective in Identifying a number of previously undescribed effects. Voluntary reporting schemes and other methods for assembling case series can identify certain local safety problems, and may be the basis for specific regulatory or educational interventions. The magnitude of the risk of adverse effects is generally evaluated with observational epidemiological methods, such as case-control, cohort, and case-population studies. Each country and institution should set up simple schemes aimed at identifying problems related with the safety of medicines.