Actions in response to drug safety signals arising from a spontaneous reporting system: Retrospective study in The Netherlands

Article type: Research Article

Authors: Rolfes, Leàn^{a; b; *} | Kolfschoten, Judith^c | van Hunsel, Florence^{a; b} | Kooijman, Michel^d | van Puijenbroek, Eugène^{a; b}

Affiliations: [a] Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, The Netherlands | [b] Department of Pharmacy, Pharmacotherapy and Pharmaceutical Care, University of Groningen, Groningen, The Netherlands | [c] Department of Pharmacy, Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, The Netherlands | [d] Medicines Evaluation Board, Utrecht, The Netherlands

Correspondence: [*] Address for correspondence: Leàn Rolfes, Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237MH ‘s-Hertogenbosch, The Netherlands. Tel.: +31 73 6469700; Fax: +31 73 6426136; E-mail: L.rolfes@lareb.nl.

Abstract: BACKGROUND: There is limited information on actions taken in response to drug safety signals originating from a spontaneous reporting system (SRS) in pharmacovigilance. In The Netherlands the Pharmacovigilance Centre Lareb is an independent organization that works in close collaboration with the Dutch regulatory agency, the Medicines Evaluation Board (MEB). OBJECTIVE: The objective of this study is to gain insight in steps undertaken on signals originating from the SRS and disseminated by Lareb from 2008–2012. METHOD: For all signals the recommendations of Lareb and the following steps proposed by the MEB were analyzed. Secondary outcomes were prioritization of the signal, the year of dissemination and if Lareb published (inter)nationally about the signal. Pearson’s Chi-square (X2) and Mantel-Haenszel statistics were used for statistical analysis. RESULTS: Of all signals disseminated by Lareb from 2008–2012, 90,7% resulted in an action: in 87% a regulatory action and in 36% an (inter)national publication. Generally, Lareb’s recommendations correspond to steps undertaken by the MEB. CONCLUSION: This study found influence of signal prioritization on Lareb’s recommendations but not on the steps undertaken by the MEB. Trends over time were only seen for steps undertaken by the MEB. These differences are most probably due to responsibilities of the different EU member states of various drugs.

Keywords: Adverse drug reactions (ADRs), pharmacovigilance, signals, post marketing drug safety

DOI: 10.3233/JRS-160724

Journal: International Journal of Risk & Safety in Medicine, vol. 28, no. 2, pp. 115-123, 2016