Abstract
Introduction: A periodic safety update report (PSUR), composed by marketing authorization holders and submitted to regulatory authorities on predetermined time points, provides an update of the worldwide safety experience of a pharmaceutical. Information is lacking on how PSURs contribute to safety related regulatory actions. Aim: The objective of the study is to analyze the contribution of PSUR evaluations to the initiation of safety related regulatory actions of biopharmaceuticals. Methods: We performed a retrospective analysis of all safety related type II variations of biological products centrally approved in the European Union (since 1995) for which ≥1 safety-related Direct Health Healthcare Professional Communication (DHPC) was issued until December 2009. An evaluation of the role of PSUR assessments in the initiation of safety associated regulatory actions was performed through an analysis of European Public Assessment Reports and updates of the Summary of Product Characteristics (SPC). We compared “urgent” variations, defined as variations accompanied by the distribution of a DHPC, with “less urgent” variations, i.e. safety related SPC variations for which no DHPC was distributed. For each variation we determined if any reference was made to the contribution of PSUR evaluations. We determined the data source and nature of the safety issues included in the variations. Each variation could include ≥1 safety issue and ≥1 data source could contribute in a single variation. Results: We identified 133 safety related type II variations for 15 biological products. Reference to PSUR evaluations was made in 2/24 (8.4%) of all urgent type II variations and 48/109 (44.0%) of the less urgent variations (x2, p<0.01). Data sources that contributed to the urgent variations were: 14 (58%) spontaneous reports, 9 (28%) clinical trials and 2 (8%) an analysis of pooled data. For the non-urgent variations, these were 53 (49%), 40 (37%) and 18 (17%) respectively. Overall, most of the variations concerned events from the System Organ Classes (SOCs) Infections and Infestations (32%), General Disorders and Administration Site Conditions (26%), Neoplasms (14%), Blood and Lymphatic System Disorders (14%) and Nervous System Disorders (14%). No differences in SOCs were observed between safety-related regulatory actions that did or did not result from PSUR assessments. Conclusions: The contribution of PSUR evaluations was lower in urgent safety related regulatory actions when compared with less urgent safety issues. Despite the modest role of PSURs, spontaneous reports contributed to the majority of the urgent safety related regulatory actions.
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