Guest Post: ‘EU pharmacovigilance changes have not addressed unsafe prescribing – experts’

APMHE-Logo This article was provided by APM Heatlh Europe from their coverage of the recent World Drug Safety Congress Europe 2013.

LONDON, Sept 12 (APM) – Experts at a conference expressed support of last year’s shake-up of Europe’s pharmacovigilance rules but warned the changes had not done enough to address the issue of unsafe prescribing by medical professionals.
In a panel discussion at the World Drug Safety Congress on Wednesday on how to ensure drug safety remains an industry priority, one expert welcomed the rules contained in the pharmacovigilance directive, which came into force in July last year.

However, another expert, while broadly welcoming the changes, said not enough was being done to ensure doctors were keeping up to date with safety changes or alerts outlined in product information.

‘Taken drug safety out of the shadows’

Dr Peter Verdru, vice president of drug safety sciences at Belgium’s UCB, said the risk-benefit approach taken by the European Medicines Agency (EMA) in the directive had won support within different departments.

He said the need for data and information for safety reports from different departments had improved collaboration between different people within his company. Verdru told the conference in London: “There was never anybody saying it was a lot of money, or this is a drain on resources. The focus on benefit and risk has taken drug safety out of the shadows,” he said at the conference, organised by Health Network Communications. 

“(Introducing) Good Pharmacovigilance Practice has cost a lot of money and the pharmacovigilance budget has increased but the benefit has been collaborative decision making,” he stressed.

No culture change in prescribing

But Amer Alghabban, director and global head of GCP quality assurance and audit management at Merck Serono, questioned whether a similar culture change had occurred in the medical profession. He told the conference in the panel debate: “There is no such thing as a safe medicine, but there are safe doctors.” He continued: “How can updating one line in the summary of product characteristics change the habits of physicians. Do they really read the safety updates?”

Dr John Solomon, head of pharmacovigilance, UK and Ireland at Sanofi, echoed Alghabban’s concerns. He said: “We need (drug safety) training within the healthcare system – among nurses, doctors and pharmacists.”

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