Letters Drug safety reporting

A major rethink is needed on reporting adverse drug reactions

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e6379 (Published 24 September 2012) Cite this as: BMJ 2012;345:e6379
  1. Andrew Herxheimer, clinical pharmacologist1,
  2. Sunita Vohra, professor of paediatrics2,
  3. Jean-Louis Montastruc, professor of pharmacology3,
  4. Ralph Edwards, past president, International Society of Pharmacovigilance4
  1. 1UK Cochrane Centre, London N3 2NL, UK
  2. 2University of Alberta, Edmonton, AB, Canada T5K 0L4
  3. 3CHU de Toulouse, Université Paul Sabatier, 31000 Toulouse, France
  4. 4Uppsala Monitoring Centre, Box 1051, SE-751 40 Uppsala, Sweden
  1. a.herxheimer{at}ntlworld.com

We agree that spontaneous reporting systems are important but would like to emphasise that most suspected adverse drug reactions are not reported at all, and many reports have limited information.1

New guidelines are useful, but major problems everywhere, not only in the UK, are that the complex data analysis needed on safety is not open to public review and neither is the feedback to reporters and the public sufficiently encouraging to stimulate reporting. There is need for:

  • Transparency: regulators withhold details of individual reports to protect the identity of reporters and patients. But patients who report (they in principle own the data) are given no opportunity to allow bona fide researchers access to their reports

  • Feedback to reporters and follow-up: reporters never learn how their reports are interpreted or what is done with them; they just get a polite acknowledgment

  • Decentralisation of reporting: in the UK regional pharmacovigilance centres no longer have contact with reporters, and local discussions of adverse drug reactions have largely dried up. In some countries, such as France, Italy, and Spain, such local contacts are normal and valued, and encourage professionals to report possible adverse reactions. Centralisation of reports at the European Medicines Agency will make this worse, completely blocking personal communication and learning.

To enable comprehensive reporting of drug safety concerns for the benefit of all stakeholders, as the World Health Organization and Raine envisage, will require major rethinking to develop a user friendly way of reporting and linking to other databases. WHO and the Uppsala Monitoring Centre are piloting a web based patient reporting scheme, but much more work is needed to create a truly dynamic network that will actively involve all concerned.

Notes

Cite this as: BMJ 2012;345:e6379

Footnotes

  • Competing interests: AH and SV are co-convenors of the Cochrane Adverse Effects Methods Group; J-LM directs the Centre de Pharmacovigilance Midi-Pyrénées; RE is ex-director of the WHO-Uppsala (medicines) Monitoring Centre.

References

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