title: Modified prescription-event monitoring studies: a tool for pharmacovigilance and risk management.
abstract: 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 10 000 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.
authors.affiliation: Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton, UK.
authors.forename: Deborah
authors.initials: D
authors.lastname: Layton
authors.forename: Lorna
authors.initials: L
authors.lastname: Hazell
authors.forename: Saad A W
authors.initials: SA
authors.lastname: Shakir
mesh_terms: D015331:Cohort Studies; D004363:Drug Utilization; D005194:Family Practice; D006801:Humans; D055553:Prescription Drugs / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011795:Surveys and Questionnaires; D006113:United Kingdom
chemical_list: D055553:Prescription Drugs
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