The New Zealand Intensive Medicines Monitoring Programme in pro-active safety surveillance

Purpose - The purpose of this paper is to demonstrate the pro-active nature of the New Zealand Intensive Medicines Monitoring Programme (IMMP) and mak e an assessment of its effectiveness in postmarketing drug safety evaluatio n. Methods - The IMMP undertakes prospective observational cohort studies of s elected new drugs. Patient cohorts are established from prescription data r eceived from dispensing pharmacists nationwide. Adverse events are reported by doctors on prescription follow-up questionnaires or as spontaneous repo rts. The method of signal generation is reviewed with particular emphasis o n the review of individual event reports and their relationship to the medi cine. Signals reported over the last 10 years are assessed for timeliness i n advising the regulatory authority. Results - Mean cohort size is 10,964 patients and the mean study period for each drug was 58 months. A total of 153 signals were recorded from II drug s with 132 (86%) being notified to the regulatory authority prior to any pu blication in the literature. The use of 'incidents' in controlling for repo rting bias is illustrated and examples are given of data on safety in pregn ancy and lactation, the assessment of deaths, reassurance with drug scares, risk comparison and signal validation studies. Conclusion - PEM type methodology is effective and cost-efficient in pro-ac tive safety surveillance even with limited resources. Copyright (C) 2000 Jo hn Wiley & Sons, Ltd.