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Patient reporting rises after EU pharmacovigilance reforms

Safety issues detected more quickly with increased patient participation

EMA logoA new EU-wide approach to monitoring the safety of medicines has resulted in a 50% increase in direct reporting by patients, says the EMA.

A just-published report on the new pharmacovigilance legislation - which introduced new rules on the monitoring, identification and assessment of adverse events caused by pharmaceuticals - concludes that it has been successful at detecting safety issues more quickly.

The 2012 reforms gave new powers to the EMA and created a Pharmacovigilance Risk Assessment Committee (PRAC) that helped to coordinate the activities of both the centralised agency and national regulatory authorities.

As a result safety signals have been disseminated faster, "thus enabling regulators to take rapid action when needed and provide advice and warnings to users of medicines," according to the EMA, which says the new system "effectively engages patients " as it allows them to report directly to regulators. Patient and healthcare professional representatives are represented in the PRAC.

"This system effectively engages patients and healthcare professionals, who report suspected side effects, contribute to the decision-making process in case of safety concerns and add the invaluable perspective of the people most affected by diseases and their treatment," said the EMA.

In terms of numbers, the report notes that nearly 200 suspected side effects were reported between 2012 and the end of 2014, with half of these resulting in changes to product information and another quarter to other regulatory measures such as a higher level of monitoring or withdrawal from the market.

Side-effect reports related to medication errors increased from around 4,500 in 2012 to over 7,000 in 2014, a rise attributed at least in part to "increased awareness and a clearer legal basis for reporting".

The PRAC reviewed around 600 risk-management plans for centrally-authorised medicines, with national regulators across the EU handling some 20,000 plans, and there were around 200 pharmacovigilance inspections carried out each year.

At the time it was introduced the new pharmacovigilance legislation was described as the biggest change to the regulation of medicines in Europe since the EMA was set up in 1995. 

It is one of three reforms in the so-called 'pharmaceutical package' agreed by the European Commission in 2010, alongside legislation on falsified medicines and information for patients.

Article by
Phil Taylor

12th August 2016

From: Regulatory



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