4 Modern medicines have transformed the world, but the drugs within them are powerful chemicals which have potentially harmful adverse effects. Medicines and drugs can be misused (see Ch. 50), abused and when taken as an overdose, which may be intentional, can sometimes be fatal. Self-treatment of the wrong drug for the wrong condition or disease can have severe consequences. For these reasons, most governments or states control all aspects of medicines from their first trials in animals, through manufacture and distribution to post marketing pharmacovigilance: together with who can supply and/or prescribe the medicine. This chapter explains this process in more detail and describes the controls placed on large organizations, such as the pharmaceutical industry, as well as the legal controls placed on the medicines and the professionals acting as suppliers/prescribers. Most countries have legislation in place to regulate and control medicines: in the UK, this is the Human Medicines Regulations 2012. The legislation will be administered through the legal system and government departments. Examples of these departments include the Department of Health (DH), which is headed by the Minister for Health in the UK, the Department of Health and Ageing in Australia and the Department of Health and Human Services in the USA. These Departments create agencies, which are responsible for the day-to-day regulation and control of medicines. The Medicines and Healthcare products Regulatory Authority (MHRA) in the UK is responsible for ensuring that medicines and medical devices work, and are acceptably safe. In Australia, the Therapeutic Goods Administration regulates medicines. In the USA, the Food and Drug Administration (FDA) aims to protect consumers and enhance public health by maximizing compliance of FDA-regulated products. These regulated products include medicines and medical devices. The FDA also deals with veterinary products, as well as human medicines. Veterinary medicines are regulated by the Veterinary Medicines Directorate in the UK (see Ch. 28). In addition to the MHRA in the UK, advisory bodies have been set up including the Commission on Human Medicines, the Herbal Medicine Advisory Committee and the Advisory Board on Registration of Homeopathic Products. These advisory bodies have expert panels which advise the Minister of Health on matters relating to their specialist products. The vigilance of medicines, after their marketing, with regard to their safety and efficacy will be monitored by the regulatory authority. Any medicine found to have adverse effects, which give rise to concerns over safety, can be withdrawn from the market immediately and, concomitantly, the Marketing Authorization removed (see Ch. 22). The legal structure within a country will regulate the supply of medicines. Box 4.1 shows some of the controls on medicines. Thus, the legislation controls healthcare professionals and their staff (see Ch. 5) and their professional premises, such as community pharmacies. The legal classification used for medicines in a country will have a direct impact on how and where the general public can access their medicines. Some countries have a two-tier classification of drugs:
Control of medicines
Most countries place legal controls on their medicines
All stages in the development, manufacture and distribution of medicines are controlled
Medicines are classified to control their access to the general public
Introduction
Control of medicines
Post-marketing of medicines
Supply of medicines
Legal classification of medicines
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Control of medicines
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