Compliance in European pharmacovigilance: How compliant is compliant?

The emergence of European requirements for safety reporting has resulted in systems geared towards the timely collection and submission of reports at the cost of the quality of the reports or their evaluation. This change in focus has been engendered by system audits concentrating on 'easy to measur e targets' such as time frames. The real purpose of pharmacovigilance. the identification and communication of potential safety concerns, may be lost in the effort to expedite. By common consensus there are certain safety iss ues that warrant special attention including serious unexpected events, cha nges in frequency of known adverse events, those involving special populati ons, overdosage. or potential drug-drug interactions. Rationalizing and pri oritizing workflow management during safety processing is required to optim ize the utilization of available resources. This paper provides a basis for discussion on suitable standards for the re ceipt, processing and distribution of safety reports and proposes possible benchmarks as a measurement of competent pharmacovigilance practice. Copyri ght (C) 2000 John Wiley & Sons, Ltd.