Evidence map›Paper›PMID 9825948›Full record

ArticleDrug safety1998

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

F J Mackay

Abstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 1998. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.4field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 32 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Pharmacovigilance: methods, recent developments and future perspectives.European journal of clinical pharmacology · 2008
    Review
  5. Review
  6. Review
  7. Antidepressants and the serotonin syndrome in general practice.The British journal of general practice : the journal of the Royal College of General Practitioners · 1999
    Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

1 author at 1 institution in 1 country.

F J MackayDrug Safety Research Unit, Southampton, England. drmann@dsru.u-net.com
Drug Safety Research Unit · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Drug PrescriptionsDrug-Related Side Effects and Adverse ReactionsAntipsychotic AgentsEpidemiologic MethodsFemaleGovernment AgenciesHumansMaleProduct Surveillance, PostmarketingRisperidoneUnited KingdomAntipsychotic AgentsRisperidone

Identifiers

PMID9825948
OpenAlexW2115624781

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.