Pharmaceutical products post-marketing surveillance

The pharmaceutical industry presents many new challenges to such a person which include the interface with pharmacy and pharmacology, toxicological research, human volunteer studies, clinical trials and post-marketing surveillance to name just a few. Product safety is a factor which impacts on all of those endeavours and the pharmaceutical physician will be expected to work and provide advice within that framework. It will be clear to anyone that evidence of lack of safety in a medical product is not good news for the company concerned and that some level of protective action will often be required which in extreme circumstances may involve product withdrawal. It is, therefore, essential that the pharmaceutical physician should be absolutely clear what constitutes lack of safety in relation to the intended use of the product. 

There has never been any incentive for the pharmaceutical industry to pursue research along these lines even though, as in the case of Vioxx, the end results of neglecting adverse effects may be very costly. The aim of the industry has usually been to extend the market size irrespective of potential risk and attempts to implement effective post-marketing surveillance has received little enthusiasm. It is to be hoped that company medical departments and pharmaceutical physicians will continue to support the need for a broad range of safety evaluation studies to be conducted on new medicinal products. 

The National Pharmaceutical Administration is staffed by pharmacists who evaluate all applications for product licence, conduct GMP audits in the case of a local manufacturer, conduct post-marketing surveillance and also actively monitor adverse drug reaction reports. 

Promotion should not be disguised. Clinical assessments, post-marketing surveillance and experience programmes, and post-authorisation studies must not be disguised promotion. Such assessments, programmes and studies must be conducted with a primarily scientific or educational purpose. Material relating to pharmaceutical products and their uses, whether or not promotional in nature, that is sponsored by a company should clearly indicate by whom it has been sponsored. 

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