Does Europe’s Additional Monitoring Scheme Generate Additional Evidence?


Applied Clinical Trials

Europe’s additional monitoring scheme hasn't been a roaring success, according to a recent report.

A scheme that Europe’s health authorities imposed three years ago to improve safety reporting on new medicines has not been a roaring success, to judge from a recent report on its performance.

The hope at the time was to promote a stream of real-world evidence about medicines authorized on the basis of limited clinical trials-where, for example, the number of patients is restricted and the available evidence has gaps or reservations. “Additional monitoring”-as the scheme is known-“aims to enhance adverse drug reaction reporting for medicines for which the clinical evidence base is less well developed,” notes the report.

But, “the evidence does not allow a conclusion on the impact of additional monitoring on the reporting or detection of adverse events,” the report concludes. An investigation tried to establish whether putting a medicine on the watch-list had any impact on the reporting of ADRs, but this, “was not conclusive.” Similarly, “it was also not possible to conclude on whether additional monitoring status has an impact on the number of signals validated and assessed (by the European Medicines Agency’s special pharmacovigilance committee, PRAC) or on signal outcome.”

The legislation had bold ambitions when it was introduced in 2010. Additional monitoring would apply to all new biologicals or medicines containing a new active substance, as well as to some specifically selected medicines. Companies were obliged to insert a black inverted triangle in the product information of these products, to flag them up as being under study. And in 2012 the scope was extended to include medicines required to conduct a post authorization safety study or granted only a conditional marketing authorization. The latest list for additional monitoring contains more than 2,000 medicines.

Scale of activity does not seem so far to have translated into measurable benefits. An EMA study conducted jointly with the heads of national medicines agencies concluded with the following  mix of the aspirational and the realistic, “If the analyses had shown marked and consistent increases in ADR reporting then it would be reasonable to conclude that additional monitoring was increasing the reporting for these products. However, the inconsistent and marginal results, combined with the known, disparate external influences on ADR reporting, suggest that even with a larger sample size and longer follow up, the potential to definitively demonstrate a causal link between AM and increased reporting, is unlikely.”

The scheme has not been universally popular either. Some member states questioned the value of including on the list all the medicines subject to a post authorization safety. This, they point out,  leads to many medicines which have been on the market for years, being subject to additional monitoring. There were also concerns over the possibility of misunderstanding of the black triangle-giving rise, for instance, to public fears over safety.

It is for the European Commission, which has ultimate responsibility for the legislation, to take the next steps. And with valiant determination in the face of perceptible disappointment, it is now recommending continued efforts, “to monitor the impact to strengthen the evidence base for future review of the scheme.” National authorities and EMA are, “encouraged to continue promoting ADR reporting and sharing their experience to further develop best practices.” And they are, “invited to continue to collect data regarding the implementation of additional monitoring to allow at a later stage further assessment of the understanding of additional monitoring and its impact.”

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