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...