Cleaning Up the Drug Safety Record in Europe


Applied Clinical Trials

The European Union system for pharmacovigilance “is operating effectively and efficiently” concludes a report.

The European Union system for pharmacovigilance, “is operating effectively and efficiently for the promotion and protection of public health and to support innovation in pharmaceuticals such as the authorization of CAR-T cell therapies” concludes a report1-generated within the system itself-of its activities across the four years of 2015-2018.

The system is supporting innovation by ensuring that patients with unmet medical needs receive new products to fulfil those needs, it claims, instancing the advice offered on the design of post authorization data collection, or of risk minimization measures, and the use of real-world data, epidemiology methods, patient registries, and use of new data sources.

The report provides plenty of evidence to support its claim. It is a positive cornucopia of figures: it recounts that suspected ADRs reported increased by 19% in 2017 from around 1.2 to nearly 1.5 million reports, after the enhancement that year of the EudraVigilance system, and by a further 37% in 2018 to over 2 million reports, about half of which came from the 31 European countries covered. Serious reports increased from around 1.1 million in 2015 (290,000 from Europe) to about 1.4 million in 2018 (425,000 from Europe).

The pharmacovigilance network that has conducted the work and compiled the report is a cooperation between 28 national authorities and the European Medicines Agency. The measurements it has carried out on its performance suggest, it says, that “more rapid decisions are being made, based on better evidence”. Improvements have been brought about, according to the report, by enhancements to the EudraVigilance database, and simplification of the handling of periodic safety update reports. And during the period under review, the first public hearings were held on safety issues, for valproate-containing medicines in 2017 and for quinolone and fluoroquinolone antibiotics in 2018.

Nearly 9000 potential signals of suspected adverse reactions (defined in this context as information about new or changing safety issues potentially caused by a medicine) were evaluated by EMA’s signal management team, and a similar number at member state level. About 400 (2%) of these were confirmed and went on to be prioritized and assessed by the EMA’s pharmacovilance committee (PRAC), resulting in updates to the product information in about half of the cases, and occasionally in a wider review at EU level through a so-called referral procedure.  And PRAC assessed more than 500 new or updated risk management plans each year, while national authorities assessed nearly 7,000.

Overall, “roughly half of the drug safety signals detected and managed through PRAC led directly to new and better warnings for patients in product labelling.” And there has been  “rapid action to withdraw products where the risks were considered to outweigh the benefits, to restrict the use of products to those most likely to benefit and least likely to suffer harm and the extensive work done to ensure patients and healthcare professionals receive up-to-date information about the safety profile of medicines.”

Looking ahead, the report envisages “ever-increased engagement with stakeholders, further transparency, evidence-based process improvement, and better use of real-world data and its analysis to generate real-world evidence. Additionally, earlier engagement of pharmacovigilance and real-world data support to products in development will enable optimized surveillance and risk minimization as soon as products enter the market.” And consolidation of “the strength, effectiveness and efficiency of the current system” will be brought about through “ever greater engagement with stakeholders, particularly patients and healthcare professionals”.

The record is undoubtedly impressive. Appreciation of its merits is shaded, however, buy the unavoidable reflection that as the current system is vaunting its successes, the trial of Servier over the use of Mediator continues to drag on in the French courts.





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