Postmarketing surveillance: present activities and future possibilities in the Netherlands

Abstract

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Whenever a drug is approved for marketing, this does not ensure that a drug will be safe in subsequent prescribing practice: no effective drug is totally safe. The approval merely means that, at the time of approval, no hazards unacceptable to the regulatory agency have been identified. Because of the inherent shortcomings of preapproval research, postmarketing surveillance (PMS) is crucial for providing additional information that cannot realistically be collected before approval of the drug. Only by implementing a responsive and responsible PMS system can serious adverse drug events and unknown beneficial effects, if they exist, be detected in a timely fashion. Before setting up new PMS systems, one must have insight into the present PMS activities in the Netherlands and the interests of the parties involved. These aspects are discussed in this report. From this inventory it has become clear that there is no sole system, rather different activities are complementary to each other in providing the information needed by the different parties involved. The report concludes with proposals for the organizational structures of future PMS activities.