On 19 May 2016 the European Medicines Agency (“EMA”) published a draft Reflection paper on non-spontaneous adverse event reports (peer-reviewed literature, internet and social media) (“the Draft Reflection Paper”) for veterinary products.
Adverse event reporting
Adverse event reporting is a series of actions following an adverse event which is required to be reported through a special system.
Topics of adverse event reports can be published in peer-review worldwide literature or on the internet. They are governed by Volume 9B of the Rules Governing Medicinal Products in the European Union (“EU”)(“Volume 9B”).
Volume 9B of “The rules governing medicinal products in the European Union” provides Pharmacovigilance guidelines for medicinal products for veterinary use. Guidelines were published by the European Commission in consultation with the EMA, Member States and interested parties in accordance with Article 77 of Directive 2001/82/EC as amended and Article 51 of Regulation (EC) 726/2004.
Substantial amounts of reliable information of structured and non-structured information are also available from interest groups on social media and the internet in general. Guidance on the use of this information is covered by the Draft Reflection Paper.
The Draft Reflection Paper
Regular performance of literature search is a part of the periodic update report (“PSUR”) for veterinary medicinal products. This Draft Reflection Paper provides guidance on limitations for searching the published literature in the following areas:
- Volume 9B provides that a marketing authorisation holder is only obliged to perform a product specific search. It is recommended to begin searches based on the literature relating to active substance which should then be narrowed down to the individual product. Searches of terms for adverse events should not be too restrictive. Other terms such as adverse reaction, side effect, and toxicity are advised to be used. The marketing authorisation holder is also expected to consider reports from other products, if the reaction of interest is related to the active substance and/or if the specific product cannot be identified. All reports which clearly relate only to competitor products are to be excluded.
- Volume 9B does not specify the databases for searches. However, databases such as Medline and Google Scholar may not necessarily capture all national veterinary journals and articles. It is preferable to ensure that a variety of databases and/or search engines are searched such as CAB Abstracts, Google Scholar, Medline, PubMed, Scopus.
For reports indicative of resistance to antimicrobials, databases on minimum inhibitory concentration (MIC) values are publically available in Denmark (Danmap), Norway (NORM-VET), Finland (FINRES), the Netherlands (MARAN) and Sweden (SVARM).
In the process of pharmacovigilance reporting marketing authorisation holder hosted websites are frequently used to report adverse events. Furthermore, they are encouraged to make use of social media to inform product users how and when to report adverse events.
Interest groups of animal owners
According to the Draft Reflection Paper it is noted that interest groups and breed organisations on social media platforms became a trusted source of new information for animal owners. Although information found on social media platforms may be important it is difficult to use it for surveillance purposes for the following reasons:
- The groups are often not well organised, making it time-consuming to scroll through all of the information available from these sites;
- The reports of adverse events are not made in a systematic way and product information may not be insufficient; and
- The events may go viral, starting a spur of several responses and discussion threads causing overrepresentation.
Marketing authorisation holders are not expected to search through the internet for potential adverse event reports. However, if a marketing authorisation holder becomes aware of a potential adverse event, every effort should be made to follow up on the reports. The focus is to obtain the minimum reporting criterion which has to be entered in the pharmacovigilance reporting system. In cases where the minimum criterion for a valid adverse event report is not met, after efforts to investigate the potential event, it is recommended to keep a record of the data available.
Although internet and social media are used often, the Draft Reflection Paper suggests they could be exploited better. Marketing authorisation holders may choose to make further use of the information on the internet and social media by capturing product and substance specific information. This could be done by following selected online meeting rooms on the internet or setting-up search profiles on social media platforms. The Draft Reflection Paper concludes that a regular search does not capture the most recent threads on the different online meeting rooms.
Information on regular monitoring of social media is encouraged to be noted in PSURs.