Safe_Medicines

How can we be sure medicines are safe, effective and of good quality “Nothing of so great importance to human welfare is used more completely on faith than a medicinal product” (Taylor, 1947 cited in Sharp, 2002) The Webster’s-online-dictionary defines Medicines “as agents that treat, prevent or alleviate symptoms or diseases”. They are usually made up of the active drug substance plus other pharmaceutical ingredients (excipients, additives etc). Generally, people are unaware of what medicines contain, some do not even think about it. However, when ill, these medicines are taken without question, trusting that they will help restore them back to good health. The statement ‘all medicines are potential poisons’ was impressed on us as undergraduates. This is indeed true because medicines have beneficial effects when correctly made and taken, however, if not, they could result in dire consequences and may sometimes even result in the death of unsuspecting patients (Sharp, 2002) Some examples of such unfortunate incidences include: the Elixir Sulfanilamide Incident (1937) in USA where about 107 people died after taking Sulfanilamide dissolved in diethylene glycol, an antifreeze chemical, the Thalidomide Incident (late 1950s) in Europe, where the birth of about 5,000 babies born deformed was linked to Thalidomide a drug taken by pregnant women for nausea (GMP Institute, 2006) and the Devonport Incident (1972) in UK in which about 4 people died after receiving contaminated infusion fluid (Stone & Curtis, 2002) These incidences and the like have led to more stringent control of medicines in most countries around the world with the aim of ensuring that they are safe, effective and of good quality. This involves two major aspects – Drug regulation and the Pharmaceutical industries. Drug Regulation in the United Kingdom (UK) From the Ordinances of the Guild of Pepperers of Soper Lane (the earliest known written code of medicine control) in 1316 to the Poisons and Pharmacy Act of 1933, various legislations had been enacted to regulate some aspects of the quality of some medicines, but there was no regulatory body in place to control all aspects of all medicines. However, after the Thalidomide incident, the Committee on Safety of Drugs (CSD) was established in 1963 to assess new drugs. A few years later (1968), the Medicines Act was enacted to provide legal control of medicines (Mansel-Jones, 1970; Sharp, 2002) Presently, the government agency responsible for ensuring the safety of medicines in the UK is the Medicines and Healthcare Products Regulatory Agency (MHRA) which was set up in April 2003 (a merger of the Medicines Control Agency and Medical Devices Agency).  Its “primary objective is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy” (MHRA, 2006). This is done in various ways some of which include: Licensing: Issuance of licenses to companies involved in manufacture (Manufacturer’s License), new products still in development (Clinical Trials Authorisation), and medicines before they can be sold on the UK market (Marketing Authorisation) ➢ Inspection activities: Inspection of companies to ensure strict compliance with requirements for manufacture. This includes certification of Good Laboratory Practices, Good Manufacturing and Distribution Practices, and Pharmacovigilance. ➢ Medicines Testing: Testing of samples of selected medicines (licensed, unlicensed, herbal or Active Pharmaceutical Ingredients - APIs) on or intended for the UK market to confirm their quality. (MHRA,2006) The UK Pharmaceutical Industry Most of the medicines prescribed and used in the UK are produced by the UK pharmaceutical Industry. These companies invest a lot in terms of time, effort and money in the research, development, manufacture, testing and supply of medicines to guarantee the health of the people (RPSGB, 2006) In manufacturing, it is important that quality is built into products. This involves constant monitoring and reviewing of each stage of production. To accomplish this, pharmaceutical industries must have some processes in place which are often checked by the regulatory bodies. These include: Quality Assurance System: This is “the sum total of the organized arrangements made with the object of ensuring that products will be of the quality required by their intended use” (MCA, 2002). It includes all stages of the product life from its development through to its distribution and dispensing and involves the following processes – purchasing, warehousing, manufacturing, quality control, packaging, dispatching, operational protocols, training and validation. All these procedures and records of the processes must be documented (Winfield & Richards, 2004) Good Manufacturing Practice (GMP): This is “that part of quality assurance which ensures that medicinal products are consistently manufactured to a quality appropriate to their intended use” (MCA, 2002) It comprises both production and quality control. It specifically involves clear definitions, validation and review of manufacturing processes, ensuring the use of appropriate premises, qualified personnel, suitable equipments, correct materials/containers, suitable storage and transport (Good Distribution Practice), adequate training for personnel, recall procedures and handling of complaints (Winfield & Richards, 2004) It is mandatory that all pharmaceutical industries employ the services of a ‘Qualified Person’ who is responsible for releasing each batch of a product for use having ensured that it appropriately produced and tested (MCA, 2002) Quality Control: This is “that part of GMP which is concerned with sampling, specification and testing, and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out and that materials are not released for use or products released for sale/supply until their quality has been judged to be satisfactory” (MCA, 2002) It involves using various analytical test methods to ensure the quality of the product and ensuring Good Laboratory Practice. Tests are carried out on APIs, products during in-process production, and the finished products. Stability Testing: Since medicines are a combination of active drug substances and other components, they do not remain stable indefinitely, and tend to undergo degradation. This could be worsened by poor formulation, packaging or storage. Degradation may be physical, chemical or biological (Collett and Aulton, 1990). This is the reason why expiration dates are stated on medicines to act as a guide to the viability of that product. With adequate regulations, continuous monitoring by regulatory bodies, and in-house controls by the pharmaceutical industries, we can be sure that medicines are safe, effective and of good quality. References Taylor F.O. (1947), Quality Control, Journal of American Pharmaceutical Association III (3) in John Sharp (2002), Quality in the manufacture of medicines and other healthcare products, Pharmaceutical Press John Sharp (2002), Quality in the manufacture of medicines and other healthcare products, Pharmaceutical Press GMP Institute (2006), Food and Drug Legislation - The story behind the law. Date assessed 09/10/06 Patricia Stone and Stephen J Curtis (2002), Pharmacy Practice, 3rd edition, Pharmaceutical Press, 27-28 Mansel- Jones D. (1970), The role of the Committee on Safety of Drugs, British Medical Bulletin, 26, 3, 257-259 MHRA, 2006 (Online) date assessed 09/10/06 date assessed 09/10/06 date assessed 09/10/06 date assessed 09/10/06 RPSGB, 2006 (Online) date assessed 09/10/06 MCA 2002: Rules & Guidance for Pharmaceutical Manufacturers and Distributors 2002, 6th Edition, Medicines Control Agency London: TSO Winfield A.J & Richards R.M.E, (2004), Pharmaceutical Practice, 4th edition, Churchill Livingstone, 66-71, 113-114 Collett Diana M. & Aulton Michael E (1990), Pharmaceutical Practice, Churchill Livingstone, 45-50