Post-marketing studies: The work of the Drug Safety Research Unit

The Drug Safety Research Unit (DSRU) is the centre for prescription-event monitoring (PEM) in England. PEM studies are noninterventional observational cohort studies which monitor the safety of newly marketed drugs. The need for post-marketing surveillance is well recognised in the UK and general pr...

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Bibliographic Details
Published in:Drug safety 1998-11, Vol.19 (5), p.343-353
Main Author: MACKAY, F. J
Format: Article
Language:English
Subjects:
Antipsychotic Agents - adverse effects
Biological and medical sciences
Clinical trial. Drug monitoring
Drug Prescriptions
Drug-Related Side Effects and Adverse Reactions
Epidemiologic Methods
Female
General pharmacology
Government Agencies
Humans
Male
Medical sciences
Pharmacology. Drug treatments
Product Surveillance, Postmarketing - methods
Risperidone - adverse effects
United Kingdom
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Summary:The Drug Safety Research Unit (DSRU) is the centre for prescription-event monitoring (PEM) in England. PEM studies are noninterventional observational cohort studies which monitor the safety of newly marketed drugs. The need for post-marketing surveillance is well recognised in the UK and general practice is an ideal source of data. PEM studies are general practitioner (community)-based and exposure is based on dispensed prescription data in England. To date, 65 PEM studies have been completed with a mean cohort size of 10 979 patients and the DSRU database has clinical information on over 700000 patients prescribed new drugs. Unlike spontaneous reporting schemes, PEM produces incidence rates for events reported during treatment. Comparative studies can be conducted for drugs in the same class. The DSRU aggregates outcome data for pregnancies exposed to new drugs. Data for children and the elderly can also be specifically examined. PEM data have a number of advantages over data from computerised general practice databases in the UK. PEM is the only technique within the UK capable of monitoring newly marketed drugs in such a comprehensive and systematic way.
ISSN:0114-5916
DOI:10.2165/00002018-199819050-00002