(1994; 60 pages)
4.1 Regulatory control and drug management
Health and drug policy
Each ministry of health has a section dealing with pharmaceutical affairs. In view of the importance of drugs in government health services, and of the related expertise within the pharmaceutical section, it is important that the pharmaceutical affairs section should have equal prominence with other sections of the ministry. Pharmacists in administration participate in formulating health and drug policies, particularly those on the selection, procurement and distribution of drugs. They serve as sources of information for health care professionals and the public, and participate in the preparation of pharmacopoeias and other official documents. They cooperate with educators and the professional body of pharmacists in establishing and modifying the curricula of schools of pharmacy and continuing education programmes. In some countries, pharmacists have roles in environmental health control and in control of the quality of food and of cosmetics and medical devices.
Pharmacists do not perform these functions in all countries. A prerequisite to their widespread adoption is the involvement of pharmacists with the appropriate expertise in the determination and implementation of national health policy, which provides the context for policies related to drugs and pharmacy. In view of the special knowledge and expertise of pharmacists, they should be given the responsibility at a senior level for the determination and implementation of policy on drugs and pharmacy manpower and for the drafting and administration of legislation. Pharmacists in such senior positions should preferably have postgraduate training and a qualification in public health.
In some countries, potent medicines and related products may be supplied or dispensed by non-pharmacists and without the supervision or control of pharmacists. For the safety of the public, such transactions should be performed or supervised by pharmacists, to ensure the supply of correct medicines of acceptable quality.
In some countries the management of drug procurement and supply, and drug control, registration and enforcement, do not meet satisfactory standards. To achieve acceptable standards, pharmacists with suitable postgraduate training should be appointed to senior positions, and standards should be assured by comprehensive pharmaceutical legislation and its effective enforcement.
Government-employed pharmacists are responsible for drug management, which includes the selection of essential drugs, the determination of drug requirements, the procurement and distribution of drugs and their rational use, as well as the design and use of information systems. Also, they collect and collate data required by their national government agencies and by international bodies, such as the International Narcotics Control Board.
In some countries, tenders for the import and supply of drugs are awarded to non-pharmaceutical businesses. The management of such businesses is not capable of applying professional standards and is influenced solely by commercial considerations. Procedures for inviting, accepting and awarding tenders for the supply of pharmaceuticals should be separate from those for non-professional commercial tenders, and should be managed by pharmacists.
Pharmacists cooperate with educators in establishing and implementing policies with regard to undergraduate and continuing education, in-service training, and other aspects of manpower development.
Regulatory and enforcement agencies
Pharmacists are employed by regulatory agencies concerned with the approval, registration and quality control of drugs, cosmetics and medical devices, and with enforcement agencies, including customs departments, that control the distribution of drugs through licit and illicit channels, and as inspectors of the manufacture, importation, distribution and sale of drugs.
Professional registration authorities
Pharmacists are prominently engaged in agencies, such as boards of pharmacy, that establish criteria for the registration of pharmacists or licensing requirements, register pharmacies and pharmacists, and monitor the way pharmacies are operated and the professional conduct of pharmacists.
International agencies and professional bodies
Pharmacists employed in these bodies perform a variety of technical and administrative functions in professional bodies and in drug- and health-related agencies, e.g., the World Health Organization, the International Narcotics Control Board, the United Nations Division of Narcotic Drugs, the United Nations Commission on Narcotic Drugs, the United Nations Fund for Drug Abuse Control, Interpol, national pharmacopoeial committees, and pharmaceutical societies.