| Modified Prescription-Event Monitoring Studies: A Tool for Pharmacovigilance and Risk Management. | |
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MedLine Citation:
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PMID: 21997129 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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Deborah Layton; Lorna Hazell; Saad A W Shakir |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-10-12 |
Journal Detail:
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Title: Drug safety : an international journal of medical toxicology and drug experience Volume: - ISSN: 0114-5916 ISO Abbreviation: - Publication Date: 2011 Oct |
Date Detail:
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Created Date: 2011-10-14 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9002928 Medline TA: Drug Saf Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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1Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton, UK 2Associate Department of the School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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