Document Detail


Modified Prescription-Event Monitoring Studies: A Tool for Pharmacovigilance and Risk Management.
MedLine Citation:
PMID:  21997129     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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:
Deborah Layton; Lorna Hazell; Saad A W Shakir
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-10-12
Journal Detail:
Title:  Drug safety : an international journal of medical toxicology and drug experience     Volume:  -     ISSN:  0114-5916     ISO Abbreviation:  -     Publication Date:  2011 Oct 
Date Detail:
Created Date:  2011-10-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
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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