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European Commission Seeks Increased Awareness of Additional Monitoring System of Medicines

  • 21/11/2019
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The European Commission released on 15 November 2019 a report examining the effectiveness of amendments made in 2010 and 2012 to the pharmacovigilance rules governing medicines under additional monitoring (the Report, see, attached). These medicines are identified by the inclusion of a black inverted triangleand an explanatory note in the product information. The additional monitoring system applies to medicinal products for which enhanced post-authorisation data collection is needed to ensure that any new safety hazards are identified as promptly as possible and that appropriate action can be initiated immediately.

The 2013 Guidelines on additional monitoring drafted by the European Medicines Agency (EMA) (the Guidelines, see, attached) explain the general principles for assigning additional monitoring status to medicines. The additional monitoring status applies (i) for five years for products included solely on the basis of being a new biological medicine or containing a new active substance; or (ii) until the completion of all the conditions for inclusion in the additional monitoring list for other products. When medicines are no longer subject to additional monitoring, the inverted triangle is removed from the product information.

On the basis of a public survey conducted by EMA with a view to understanding awareness of reporting adverse reactions to medicines, including medicines under additional monitoring, EMA concluded that, as regards the entire set of respondents, made up of healthcare professionals, patients and other members of the public, only 36% showed an acceptable understanding.

EMA also inquired whether the inclusion of a medicine in the additional monitoring list had an effect on the reporting of adverse reactions. EMA discovered variations in that some products showed increases while others did not, and some products even showed a decrease. However, EMA noted that the study had several limitations (including a restricted data set and limited length of the observation period) and that reporting may also have increased due to factors other than inclusion in the additional monitoring list.

Overall, the Report concludes that more time and more communication activities are required to raise awareness of the additional monitoring system and of the reasons for inclusion of a medicine in the list. The Report acknowledges the inconclusive effect of inclusion of a product in the additional monitoring list and recommends that EU Member States and EMA should continue promoting the importance of reporting and sharing their experience to develop best practices.

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