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Drug Safety

, Volume 34, Issue 12, pp e1–e9

A Tool for Pharmacovigilance and Risk ManagementFirst Online: 29 December 2012


Prescription-Event Monitoring PEM is a well established postmarketing surveillance technique designed to monitor the overall safety of newly marketed medicines as used in real-life clinical practice, usually in cohorts of at least 10000 patients.

At the Drug Safety Research Unit in the UK we are now moving towards a more targeted safety surveillance known as Modified PEM M-PEM. These studies combine the advantages of conventional PEM studies in monitoring general safety and identification of unexpected risks of a medicine with that of a more targeted safety study that addresses specific questions to better understand known or partially known risks with a medicine. Through the use of enhanced data collection questionnaires, M-PEM expands the range of applications of conventional PEM, which include more detailed characterization of real-life drug use, adherence to prescribing recommendations and targeted analysis of events requiring special monitoring by regulatory authorities. A particularly useful application is the evaluation of the safety of a medicine in special populations or subgroups e.g. patients switching from another therapy or patients with a particular risk factor or following important changes in the product’s lifecycle e.g. a licensing or formulation change. M-PEM studies therefore have an important contribution to make to pharmacovigilance and the risk management of medicines by providing valuable information on the use of new medications under real-life situations.

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Author: Deborah Layton - Lorna Hazell - Saad A.W. Shakir


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