- Poster presentation
- Open Access
Usability and consistency of harm information in drug product descriptions: a matched comparison of data between the United States (US) and Europe
© Cornelius et al; licensee BioMed Central Ltd. 2015
- Published: 29 May 2015
- Neuropathic Pain
- Product Information
- Drug Agency
- Matched Comparison
- Product Description
Good information on the harm of a drug is vital to inform risk-benefit decisions and undertake robust cost effectiveness analysis. Clinical trials reported in peer-reviewed articles are not useful for this purpose [1, 2]. Regulators require pharmaceutical companies to produce product information documents (Europe:SmPC, US:USPI). These documents contain comprehensive and valuable publicly available information on the known harm of a drug and have the potential to inform important risk-benefit decisions. We reviewed the usefulness of the data presented and compared the harm profile reported in documents for brand drugs marketed in Europe and the US.
Inclusion: Antidepressants/antiepileptic brand drugs evaluated in randomised trials of neuropathic pain and marketed in the US and Europe. Documentation was obtained from the European Medicines Agency and Food Drug Agency.
Summary of number of harms by document
Median # harms reported (range)
Median # harms reported only in one document(range)
Median # median # of the same harms reported by both documents (range)
It is expected that the harm profile in the product information for the same drug should agree. This study found a lack of consistency for the same drug based on the same central data available to the pharmaceutical company, and demonstrates the overwhelming impact of using arbitrary rules for reporting and differing dictionaries to code harm data. This problem can only be exacerbated across drugs.
The development of CORE harm outcome sets by drug class would improve the usability of this information by facilitating comparison of harm profiles across drug which would support informed risk-benefit decisions and allow robust cost effectiveness analyses.
- Cornelius VR, Sauzet O, Williams JE, et al: Adverse event reporting in randomised controlled trials of neuropathic pain: considerations for future practice. Pain. 2013, 154 (2): 213-220. 10.1016/j.pain.2012.08.012.View ArticlePubMedGoogle Scholar
- Ioannidis JP: Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med. 2009, 169 (19): 1737-1739. 10.1001/archinternmed.2009.313.View ArticlePubMedGoogle Scholar
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.