Proposal for Publishing and Parallel Reporting of Case Reports on Adverse Drug Reactions to Authorities by Physicians

Abstract

For the safe use of medicinal products, it is important that physicians publish adverse experiences with a medicinal product—particularly regarding side effects—in the scientific literature. However, when searching applicable publications, we determined that adverse drug reactions (ADRs) are often published several months after their occurrence. In the context of patient safety, this is rather questionable as new and important information on ADRs is not available quickly enough to be considered in pharmacovigilance systems. This delay is also not acceptable on the background of the timelines—eg, European Union (EU) legislation requires that marketing authorization holders (MAH) report serious ADRs (SADRs) within 15 calendar days. The legal basis for ADR reporting by physicians and other healthcare professionals is specified in article 102 of the EU Directive 2001/83/ EC as amended (2010/84/EU).

For the safe use of medicinal products, it is important that physicians publish adverse experiences with a medicinal product—particularly regarding side effects—in the scientific literature. However, when searching applicable publications, we determined that adverse drug reactions (ADRs) are often published several months after their occurrence. In the context of patient safety, this is rather questionable as new and important information on ADRs is not available quickly enough to be considered in pharmacovigilance systems. This delay is also not acceptable on the background of the timelines—eg, European Union (EU) legislation requires that marketing authorization holders (MAH) report serious ADRs (SADRs) within 15 calendar days. The legal basis for ADR reporting by physicians and other healthcare professionals is specified in article 102 of the EU Directive 2001/83/ EC as amended (2010/84/EU).

According to this legislation, MAHs have the obligation to report cases of SADRs within 15 days and non-serious ADRs within 90 days to the competent authorities. This covers not only cases reported by patients or healthcare professionals but also cases published in the scientific or medical literature. Thus, the MAHs need to perform continuous literature searches in all relevant databases on a regular basis (weekly in the EU).

ADR reporting is based on the active substance—not on the product. In the case of generics with often hundreds of authorizations in the EU, the literature search procedure leads to unnecessary time- and cost-consuming parallel searches and repeated reporting of the same case, which needs to be identified and eliminated by the authorities.

The aim of the literature searches and reports to the authorities is to identify unknown risks for a defined medication, which may generate signals for specific ADRs.

Thus, in order to improve and accelerate the information flow, it is proposed to demand from the authors of case reports that they also report in parallel the ADR/SADR to the authorities. This will substantially improve patient safety. A proposal is that every scientific or medical journal to which a manuscript about a case report is submitted requests from the author a confirmation that the case was reported to the authorities.

It is state-of-the art when publishing controlled clinical trials to provide the registration number in clinical trial registries such as the National Institutes of Health (NIH) clinical trials register as part of the checklist for the electronic submission procedure to a journal as specified in the CONSORT (Consolidated Standards of Reporting Trials) statement. Most journals will not consider reports of clinical trials unless they were registered prospectively before recruitment of participants. If the registration was not performed and a registration number is not available, the manuscript cannot be published.

In a similar fashion, an additional item of this checklist could be established by the journals for a parallel ADR reporting by the authors/physicians to the authorities. This would enhance the safety of pharmaceutical products and also substantially reduce the time and costs associated with elaborate literature searches.