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Risk Management Plans: are they a tool for improving drug safety?

Risk Management Plans: are they a tool for improving drug safety?,10.1007/s00228-010-0848-8,European Journal of Clinical Pharmacology,Serena Frau,Mari

Risk Management Plans: are they a tool for improving drug safety?   (Citations: 5)
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Purpose  In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-marketing safety issues. Methods  Of the 90 new Chemical Entities approved through a centralised procedure by the EMA during 2006 and 2007, 15 of them were selected and their safety aspects and relative RMPs analysed. All post-marketing communications released for safety reasons related to these drugs were also considered. Results  A total of 157 safety specifications were established for the drugs assessed. Risk minimisation activities were foreseen for 5 drugs as training activities. Post-marketing safety issues emerged for 12 of them, leading to 39 type II variations in Summary of Product Characteristics (SPC). Nearly half of such variations, 19 (49%), concerned safety aspects not envisaged by the RMPs. Besides this, 9 Safety Communications were published for 6 out of 15 drugs assessed. Conclusion  The present study reveals several critical points on the way RMPs have been implemented. Several activities proposed by the RMPs do not appear to be adequate in dealing with the potential risks of drugs. Poor communication of risk to practitioners and to the public, and above all limited transparency for the total assessment of risk, seem to transform RMPs into a tool to reassure the public when inadequately evaluated drugs are granted premature marketing authorisation.
Journal: European Journal of Clinical Pharmacology - EUR J CLIN PHARMACOL , vol. 66, no. 8, pp. 785-790, 2010
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    • ... for eliciting new, unexpected side effects, to quantify more reliable the real chance for a patient to experience side effects and to unearth determinants of adverse effects: when, how and why do they occur? Since November 2005, the EMA (European Medicines Agency) is requesting for almost all medicines it evaluates a proposal for a risk management plan, which the EMA has to approve, and it is part of the license to market a drug [2,7]...
    • ...Frau et al. (2010) [7] discuss similar concerns regarding the lack of publicly available data regarding the most significant aspects of the risk management plans...

    A. G. Vulto. Risk management of biosimilars in oncology

    • ...Academia should also be involved in the implementation—not very promising to date [3, 4]—of the risk management plan submitted by companies with their marketing authorisation application and of the post-authorisation safety studies demanded by the European Medicine Agency (EMA) for specific medicinal products requiring additional monitoring...

    Silvio Garattiniet al. Anything new in EU pharmacovigilance?

    • ...Even the recent proposal of risk management strategies by the EMA to monitor the postregistration life of molecules for which insufficient documentation is available epitomizes this discrepancy [14]...

    Veronica Scurtiet al. A plea for a more epidemiological and patient-oriented pharmacovigilan...

    • ...(2) the MAH writes the RMP, and the key pharmacovigilance (Pv) studies and risk minimisation activities are agreed upon with the Committee for Medicinal Products for Human Use (CHMP); (3) as the RMP is part of the dossier, it is reviewed by the...

    Andrew Herxheimer. Looking at EU pharmacovigilance

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