EVPM speeds adverse event detection in some cases, study

By Gareth Macdonald

- Last updated on GMT

Related tags Adverse drug reaction

The EMA’s EudraVigilance post-authorisation module (EVPM) speeds detection of adverse drug reactions in some cases, according to a new study published in the journal Drug Safety

The research examined if investigations of ADRs, for predefined products over a set period, would have been initiated sooner if EVPM, a predictive statistical method, rather than pharmacovigilance had been employed.

The results showed that, when applied retrospectively to ADRs reported in the period September 2003 to March 2007, EVPM detected 53.6 per cent of the events earlier than the pharmacovigilance methods used at the time.

Standard pharmacovigilance was faster for 20 per cent of the events and detected some 109 occurrences that EVPM had not by the end of the study period.

Peter Arlett, head of the European Medicines Agency’s (EMA) pharmacovigilance and risk management group told in-Pharmatechnologist the finding is significant for drugmakers supplying the European Union.

He explained that: "More than 50% of serious safety issues can be detected earlier using statistical methods in EudraVigilance and it is in everyone's interest to detect and act on safety issues as quickly as possible.

This is one of the reasons why the pharmaceutical industry has been so supportive of the establishment and maintenance of the EudraVigilance database to support pharmacovigilance in the EU.​"

Development and expansion of EudraVigilnace is a key part of the EMA’s European Risk Management Strategy (ERMS) as a means of improve the detection, assessment and communication of the risks associated with medicines.

ADR access criticism

The positive EudraVigilance finding will be welcome news for the EMA’s ADR team following criticism from the European Ombudsman P Nikiforos Diamandouros, earlier this month.

In a statement published on May 10 Diamandouros called on the EMA to reconsider its refusal to give access to ADRs after the agency refused to provide a complainant with reports related to an acne drug’s link to suicidal tendencies.

The complainant, an Irish citizen, specifically asked for reports on suspected adverse reactions to the drug, such as reactions giving rise to suicidal tendencies.

The EMA said no, arguing that EU transparency rules do not apply to adverse reaction reports.

Diamandouros disagreed, commenting: "EMA plays a crucial role in the approval and monitoring of medicines placed on the market.

"Since its work has a direct impact on the health of European citizens, it is of utmost importance for EMA to give the widest possible access to documents and also to pursue a pro-active information policy for the benefit of citizens.​"

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