Intended for healthcare professionals

Letters Improving pharmacovigilance

Use of routinely collected data

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c2403 (Published 04 May 2010) Cite this as: BMJ 2010;340:c2403
  1. Mariam Molokhia, senior lecturer in epidemiology1,
  2. Vasa Curcin, research fellow2,
  3. Azeem Majeed, professor of primary care3
  1. 1Non-communicable Disease Epidemiology Unit, London School of Hygiene and Tropical Medicine, London WC1H 7HT
  2. 2Department of Computing, Imperial College, London SW7 2AZ
  3. 3Department of Primary Care and Public Health, Imperial College, London W6 8RP
  1. a.majeed{at}imperial.ac.uk

    Initiatives to improve pharmacovigilance in Europe1 are essential in improving the safety of health care because current approaches to detecting adverse drug reactions have major limitations.

    Databases derived from electronic patient records and hospital administration systems could help to improve detection.2 We used one primary care database to investigate the association of myopathy and myalgia with the use of statins and fibrates.3 This case crossover design (in which each patient acts as his or her own control) could have detected the association as early as 1996 (figure).

    Figure1

    Relative risk of myopathy and myalgia by year in case-crossover analysis of 16 591 patients using statins or fibrates during 1991-2005.3 Error bars are 95% confidence intervals

    Hospital episode statistics can identify admissions for adverse drug reactions. For example, during 1998-2005 the total number of hospital episodes in England increased by 14% but the number associated with adverse drug reactions increased by 45%.4 The increase in admissions associated with adverse drug reactions may have been due to improved record keeping, a rise in adverse reactions because of an increasingly elderly population, the introduction of new drugs, and polypharmacotherapy. More effective use of hospital episode statistics, and of similar systems elsewhere in Europe, could considerably improve surveillance, as well as allowing evaluation of interventions to improve the safety of prescribing.

    Health systems throughout Europe are investing substantially in information technology, which could improve pharmacovigilance.5 Coverage of larger populations than allowed by studies in a single country and using a single database increases study power, with the potential benefit of earlier and more effective detection of adverse drug reactions.

    Notes

    Cite this as: BMJ 2010;340:c2403

    Footnotes

    • Competing interests: MM is funded by an NIHR postdoctoral award and is an investigator for the EU-ADR FP7 and Serious Adverse Events Consortium (SAEC) projects on adverse drug reactions. The Department of Primary Care and Public Health at Imperial College London has support from the NIHR Biomedical Research Centre scheme and the NIHR collaboration for leadership in applied health research and care (CLAHRC) scheme.

    References