Authors’ reply to MacDonald and EtminanBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5523 (Published 17 September 2014) Cite this as: BMJ 2014;349:g5523
- Andrew Grey, associate professor1,
- Kirin Tan, medical student1,
- Keith J Petrie, professor2,
- Kate Faasse, postdoctoral fellow2,
- Mark J Bolland, associate professor1
- 1Department of Medicine, University of Auckland, Private Bag 92019, Auckland, New Zealand
- 2Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, New Zealand
MacDonald discusses the importance of the summary of product characteristics, a document prepared by companies seeking marketing approval for their drugs, to presentation of information about adverse drug reactions by a regulatory authority.1 2 The inclusion in this summary of any adverse reaction that could possibly be linked to the drug probably contributes to the large numbers of adverse reactions listed across a range of information sources and compromises the accuracy of the information. Such an approach has the potential to do harm.3 As we pointed out, evidence from meta-analyses of clinical trials refutes the associations between some drugs and their listed adverse reactions. Better presentation of the evidence underpinning the associations between drugs and adverse reactions would greatly help doctors and patients in making decisions about drug treatments.
Etminan’s call for improvements in design, analysis, and reporting of pharmacoepidemiological studies echoes recent suggestions for improvements in the same parameters in observational studies in general.4 5 Ultimately, however, observational studies of any type cannot prove causality. Consequently, greater emphasis on accurate, transparent, and complete reporting of adverse events data from randomised controlled trials is needed to improve the quality of information available to guide practice.
Cite this as: BMJ 2014;349:g5523
Competing interests: KJP and AG receive research funding from Pharmac (www.pharmac.health.nz/), the New Zealand government’s pharmaceutical management agency.