Postmarketing Surveillance: A Case Study
The need to develop new systems for detecting adverse effects of new drugs has been apparent since the thalidomide disaster in the early 1960s and received added impetus after recognition of the association between practolol and a serious muco-cutaneous syndrome (Nicholls, 1977) and hormone replacement therapy and uterine cancer (Ziel and Finkle, 1975). Since the mid-1960s various different approaches to detecting and evaluating adverse drug effects have been developed, ranging from the spontaneous reporting systems run by groups such as the Committee on Safety of Medicines in the UK (Inman, 1972), through cohort studies of drug recipients such as those conducted by the Boston Collaborative Drug Surveillance Program (Jick et al., 1970), to formalised case-control studies such as those undertaken by the Drug Epidemiology Unit at Boston University (Slone et al., 1977). In summarising the types of approaches in general use Lawson (1979) emphasised the fact that although much was now known about the hazards of preparations in use over a long period, there was an urgent need to develop systems which would enhance our ability to detect and, if possible quantify, adverse effects of new drugs in as short a period as possible after marketing. It is this type of study that is commonly referred to as a ‘Post Marketing Surveillance Study’. In their initial proposals for setting up such studies, Dollery and Rawlins (1977) suggested that release of new chemical entities onto the market should be restricted until an initial cohort of recipients had received the drug for some time without untoward effects. This however, would involve further, possibly substantial, delays in getting new chemical entities into widespread use and seemed on the part of isome workers (Lawson and Henry, 1977) to be unnecessarily restrictive in view of the remarkably low levels of toxicity seen with most new and established drugs in western society (Jick, 1974).
KeywordsComparison Subject Hospital Contact Post Market Surveillance Study Visit Practice Boston Collaborative Drug Surveillance Program
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- Dollery, C.T. and Rawlins, M.D., 1977, Monitoring adverse reactions to new drugs, Brit. Med. J., 1:96.Google Scholar
- Inman, W.H.W., 1972, Monitoring by voluntary reporting at national level, in: “Adverse Drug Reactions”, D.J. Richards and R.K. Rondell, ed., Churchill Livingstone, Edinburgh.Google Scholar
- Nicholls, J.T., 1977, The practolol syndrome - a retrospective analysis, Medico-Pharmacuetical Forum, Publication No. 7, 4–11.Google Scholar
- Rawlins, M.D., 1978, Monitoring newly-marketed drugs, in: “Modern Aspects of Beta Blocker Therapy”, Geigy Publications, p. 236.Google Scholar
- Slone, D., Shapiro, S., and Miettinen, O.S., 1977, Case-control surveillance, in: “Epidemiological Evaluation of Drugs”, Colombo, Shapiro, Slone, and Tognoni, eds., Elsevier/Holland.Google Scholar