6:29 PM
Nov 17, 2017
 |  BioCentury  |  Regulation

Measuring regulatory outcomes

How EMA wants to use real-world data to study the health impact of safety decisions

EMA wants to increase the use of real-world evidence and digital health to better understand the impact of pharmacovigilance decisions on patient outcomes.

Pharmacovigilance decisions fall along a broad continuum, from small changes such as reducing the size of a packet of pills or adding a drug-drug interaction to a drug label, to larger decisions such as restricting an indication or withdrawing a drug from the market.

An EMA review of over 1,200 publications on studies assessing the impact of pharmacovigilance decisions found that only 25% evaluated whether a pharmacovigilance decision improved outcomes. Instead, the majority analyzed whether the decision was implemented by recording changes in drug prescriptions following a pharmacovigilance action.

In addition, very few studies analyzed whether there were any unintended consequences that resulted from pharmacovigilance actions.

At a Nov. 14 meeting co-hosted by EMA and the Drug Information Association (DIA), regulators, industry representatives and academics discussed how to improve these studies.

“We have an increasing number of potential signals and an increasing number of complex products.”

Alison Cave, EMA

“We have an increasing number of potential signals and an increasing number of complex products,” EMA’s Alison Cave said at the meeting. “There’s potential for more uncertainty, particularly around long-term safety, which is really increasing the need for an iterative, learning pharmacovigilance system.”

Cave, principle scientific administrator in EMA’s Pharmacovigilance and Epidemiology Division, said digital health technologies and real-world data contained in digitized electronic health records (EHRs)...

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