Skip to main content
Log in

Post-Marketing Studies

The Work of the Drug Safety Research Unit

  • Leading Article
  • Published:
Drug Safety Aims and scope Submit manuscript

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 700 000 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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Rawson NSB, Pearce GL, Inman WHW. Prescription-event monitoring: methodology and recent progress. J Clin Epidemiol 1990; 43(5): 509–22

    Article  PubMed  CAS  Google Scholar 

  2. Rawson NSB. Post-marketing surveillance. In: Hansch C, Sammes PG, Taylor JB, editors. Comprehensive medicinal chemistry. Vol. 1. General principles. Oxford: Pergamon Press, 1990: 625–55

    Google Scholar 

  3. Dunn NR, Thorogood M, De Caestecker L, et al. Myocardial infarction and oral contraceptives, a retrospective case control study in England and Scotland (’MICA’ Study). Pharmacoepidemiol Drug Saf 1997; 6: 283–9

    Article  PubMed  Google Scholar 

  4. Joint Committee of ABPI, BMA, CSM and RCGP. Guidelines on post-marketing surveillance. BMJ 1988; 296: 399–400

    Article  Google Scholar 

  5. Waller PC, Wood SM, Langman MJS, et al. Review of company postmarketing surveillance studies. BMJ 1992; 304: 1470–2

    Article  PubMed  CAS  Google Scholar 

  6. Rawlins MD, Jefferys DB. United Kingdom product licence applications involving new active substances, 1987–1989: their fate after appeals. Br J Clin Pharmacol 1991; 302: 223–5

    CAS  Google Scholar 

  7. Pringle M, Hobbs R. Large computer databases in general practice. Of little use unless high quality data are collected. BMJ 1991; 302: 741–2

    Article  PubMed  CAS  Google Scholar 

  8. Meyboom RHB, Egberts ACG, Edwards R, et al. Principles of signal detection in pharmacovigilance. Drug Saf 1997; 16(6): 355–65

    Article  PubMed  CAS  Google Scholar 

  9. Waller PC, Coulson RA, Wood SM. Regulatory pharmacovigilance in the United Kingdom: current principles and practice. Pharmacoepidemiol Drug Saf 1996; 5: 363–75

    Article  PubMed  CAS  Google Scholar 

  10. Bem JL, Mann RD, Rawlins MD. Review of yellow cards 1986 and 1987. BMJ 1988; 296: 1319

    Article  PubMed  CAS  Google Scholar 

  11. Belton KJ, Lewis SC, Payne S, et al. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol 1995; 39: 223–6

    Article  PubMed  CAS  Google Scholar 

  12. Carson JL, Strom BL, Maislin G. Screening for unknown effects of newly marketed drugs. In: Strom BL, editor. Pharmacoepidemiology. 2nd ed. Chichester: John Wiley & Sons, 1994: 431–47

    Google Scholar 

  13. Freemantle SN, Pearce GL, Wilton LV, et al. The incidence of the most commonly reported events with 40 newly marketed drugs — a study by prescription-event monitoring. Pharmacoepidemiol Drug Saf 1997; 6 Suppl. 1: S1–S62

    Google Scholar 

  14. Mann RD. Prescription-event monitoring: its role in ensuring new drug safety. Prescriber 1996; 7(5): 102–4

    Google Scholar 

  15. Mann RD, Wilton LV, Pearce GL, et al. Prescription-event monitoring (PEM) in 1996 — a method of non-interventional observational cohort pharmacovigilance. Pharmacoepidemiol Drug Saf 1997; 6 Suppl. 3: S5–11

    Article  PubMed  Google Scholar 

  16. Mackay FJ, Wilton LV, Pearce GL, et al. Safety of long-term lamotrigine in epilepsy. Epilepsia 1997; 38(8): 881–6

    Article  PubMed  CAS  Google Scholar 

  17. Council for International Organisations of Medical Sciences in collaboration with the World Health Organization. International Ethical Guidelines for Biomedical Research involving human subjects: Geneva, 1993

  18. Dunn N, Freemantle S, Pearce G, et al. Galactorrhoea with moclobemide [letter]. Lancet 1998; 351: 802

    Article  PubMed  CAS  Google Scholar 

  19. Mackay FJ, Dunn NR, Wilton LV, et al. A comparison of fluvoxamine, fluoxetine, sertraline and paroxetine examined by observational cohort studies. Pharmacoepidemiol Drug Saf 1997; 6: 235–46

    Article  PubMed  CAS  Google Scholar 

  20. Wilton L, Pearce G, Martin RM, et al. The outcome of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol 1998; 105: 882–9

    Article  PubMed  CAS  Google Scholar 

  21. Turner S, Longworth A, Nunn AJ, et al. Unlicensed and off label drug use in paediatric wards: prospective study. BMJ 1998; 316: 343–5

    Article  PubMed  CAS  Google Scholar 

  22. Mackay FJ, Wilton LV, Pearce GL, et al. The safety of risperidone: results of a post-marketing surveillance study on 7684 patients. Hum Psychopharmacol Clin Exp 1998; 13(6): 413–8

    Article  CAS  Google Scholar 

  23. Coulter DM. Reasons for stopping drugs are monitored in New Zealand. BMJ 1996; 313: 756

    Article  PubMed  CAS  Google Scholar 

  24. Coulter DM, Edwards IR, McQueen EG. Post-marketing surveillance in the general population: New Zealand. In: Inman WHW, editor. Monitoring for drug safety. 2nd ed. Lancaster: MTP Press, 1986: 119–34

    Google Scholar 

  25. McAvoy BR, Kaner EFS. General practice postal surveys: a questionnaire too far? BMJ 1996; 313: 732–3

    Article  PubMed  CAS  Google Scholar 

  26. Sinclair J, Birtwhistle J, Baldwin D. The tolerability of venlafaxine. Rev Contemp Pharmacother 1998; 9: 333–44

    CAS  Google Scholar 

  27. Mackay FJ, Wilton LV, Pearce GL, et al. United Kingdom experience with alendronate and oesophageal reactions. Br J Gen Pract 1998; 48: 1161–2

    PubMed  CAS  Google Scholar 

  28. Stephens MBD, Wilton LV, Pearce Gl, et al. Visual field defects in patients taking vigabatrin [abstract]. Pharmacoepidemiol Drug Saf 1997; 6 Suppl. 2: S18

    Google Scholar 

  29. Martin RM, Dunn NR, Freemantle SN, et al. Risk of non-fatal cardiac failure and ischaemic heart disease with long acting β2 agonists. Thorax 1998; 53: 558–62

    Article  PubMed  CAS  Google Scholar 

  30. Pringle M, Ward P, Chilvers C. Assessment of the completeness and accuracy of computer medical records in four practices committed to recording data on computer. Br J Gen Pract 1995; 45: 537–41

    PubMed  CAS  Google Scholar 

  31. Jick H, Jick SS, Derby LE. Validation of information recorded on general practitioner based computerised data resource in the United Kingdom. BMJ 1991; 302: 766–8

    Article  PubMed  CAS  Google Scholar 

  32. Jick H, Terris B, Derby L, et al. Further validation of information recorded on a general practitioner based computerised data resource in the United Kingdom. Pharmacoepidemiol Drug Saf 1992; 1: 347–9

    Article  Google Scholar 

  33. Johnson N, Mant D, Jones L, et al. Use of computerised general practice data for population surveillance: comparative study of influenza data. BMJ 1991; 302: 763–5

    Article  PubMed  CAS  Google Scholar 

  34. Beardon PHG, McGilchrist MM, McKendrick AD, et al. Primary Non-compliance with prescribed medication in primary care. BMJ 1993; 307: 846–8

    Article  PubMed  CAS  Google Scholar 

  35. The general practice research database: information for researchers. London: Office for National Statistics on behalf of the GPRD Advisory Management Board, 1996

  36. Kane JM. Newer antipsychotic drugs: a review of their pharmacology and therapeutic potential. Drugs 1993; 46: 585–93

    Article  PubMed  CAS  Google Scholar 

  37. MacDonald TM, McDevitt DG. The Tayside Medicines Monitoring Unit (MEMO). In: Strom BL, editors. Pharmacoepidemiology. 2nd ed. Chichester: John Wiley & Sons, 1994: 245–355

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Fiona Jean Mackay.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Mackay, F.J. Post-Marketing Studies. Drug-Safety 19, 343–353 (1998). https://doi.org/10.2165/00002018-199819050-00002

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00002018-199819050-00002

Keywords

Navigation