A well-functioning regulatory system that ensures the efficacy, safety and quality of drugs marketed is a prerequisite for policies to promote rational use. There are various regulatory strategies that support educational and managerial strategies to promote rational drug use. Most have already been discussed in Chapter 8.

Evaluation of drugs for market approval and scheduling

The critical evaluation and rational selection of drugs registered for marketing in the country are among the main vehicles for limiting the availability and irrational use of drugs in the private sector. Scheduling decisions about which drugs are available “over-the-counter” to consumers and which are available “on prescription only” are important in determining how drugs are used, provided that they are enforced (which is, unfortunately, very often not the case). Regulations may be used to allow certain types of drugs to be prescribed by trained paramedical workers, such as nurses and midwives.

Drug promotion

Rational use of drugs is dependent upon people understanding that medicines should be used only when needed, for the correct indications and in the required dosage. Drug promotion influences prescribers and consumers, and regulations to control it are vital to increasing rational drug use. The WHO Ethical criteria for medicinal drug promotion⁵⁸ can be used as a basis for developing such regulations. Promotion should be in line with national health policies, and comply with national regulations and any existing voluntary standards. For further information see Chapter 8.