Intended for healthcare professionals

Rapid response to:

Letters Adverse drug reactions

Reporting guidelines for pharmacoepidemiological studies are urgently needed

BMJ 2014; 349 doi: (Published 17 September 2014) Cite this as: BMJ 2014;349:g5511

Rapid Response:

We fully agree with Etminan that guidelines are important to support the reporting of high quality data from pharmacoepidemiological studies and their appropriate evaluation.1 Etminan writes that new reporting guidelines are urgently needed. However, several guidelines already exist.

In Europe, the ENCePP Guide on Methodological Standards in Pharmacoepidemiology2 offers public electronic access to internationally agreed guidelines, such as the key and widely-adhered to Good Pharmacoepidemiology Practice guidelines from the International Society for Pharmacoepidemiology. A specific chapter describes communication issues, including reporting of results. The guide is updated annually and amended as necessary in response to comments received. The ENCePP Checklist for Study Protocols stimulates researchers to consider important principles when designing a pharmacoepidemiological study and writing a study protocol including a section for communication of study results.3 The PROTECT project is issuing recommendations to reduce inconsistencies between results of pharmacoepidemiological studies by developing methodological standards applicable to different safety issues using a range of data sources.4,5 In addition, the Good pharmacovigilance practices provide a set recommendations for the format and content of the study protocols and study reports.6 In the United States, similar efforts are underway and the US Food and Drug Administration (FDA) released guidance on the conduct and reporting of pharmacoepidemiology safety studies that use electronic healthcare data.7 Therefore, with existing guidance and checklists for reporting of epidemiological studies, including STROBE, researchers have good resources to design, conduct and report results of pharmacoepidemiological studies.

Etminan states that absence of reporting guidelines for pharmacoepidemiological studies may lead to poor quality data with inconsistent findings. We suggest that it is the full recognition and application of existing guidance, together with its regular updating based on feedback and experience that is needed, rather than development of new guidance.

1 Etminan M. Reporting guidelines for pharmacoepidemiological studies are urgently needed. BMJ 2014;349:g5511 doi: 10.1136/bmj.g5511 (17 September 2014).
2 The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Standards and Guidances.
3 The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Standards and Guidances.
4 The Pharmacoepidemiological Research on OuTcomes of Therapeutics by a European Consortium (PROTECT).
5 Abbing-Karahagopian V, Kurz X, de Vries F, van Staa TP, Alvarez Y, Hesse U, Hasford J, Dijk Lv, de Abajo FJ, Weil JG, Grimaldi-Bensouda L, Egberts AC, Reynolds RF, Klungel OH. Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project. Curr Clin Pharmacol. 2014 May;9(2):130-8.
6 European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 1).
7 US Food and Drug Administration. Guidance for Industry and FDA Staff: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data.

Competing interests: RR is an employee and shareholder of Pfizer, Inc. SP declares research grants, advisory roles and regulatory deliverables, mostly funded by pharmaceutical companies. XK, KB, LP, PA, OK and SP are members of ENCePP Steering Committe or working groups. XK, PA, OK and RR are members of PROTECT. XK, OK and RR are contributors to the ISPE Good Practice Guidance. RR was Member of FDA Panel that provided input for development of FDA Guidance. The views expressed in this letter are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

01 October 2014
Xavier Kurz
European Medicines Agency
Kevin Blake, Luis Prieto, Peter Arlett, Olaf H. Klungel, Robert Reynolds, Susana Perez-Gutthann
30 Churchill Place, Canary Wharf, London E14 5EU, United Kingdom