Pharmacovigilance – a long way to go…

Sweden 7-9 October – Current challenges with the pharmacovigilance regulation was discussed in detail at TOPRA annual symposium this week.

Dr Sarah Daniels, Senior Partner, TranScrip Partners offered the industry perspective, “Pharmacovigilance rules are complex and unclear with overlapping responsibilities between the parties leading to poor compliance. The complex rules for expedited ADR reporting result in the same reports, being sent in different formats, from multiple senders to multiple receivers, creating a major bureaucratic burden.”

Dr Jan Petracek, from the Pharmacovigilance and Risk Management team at the European Medicines Agency, explained “The pharmacovigilance system has known weaknesses in design and risk management can help to reduce those weaknesses, and close the gap between drug safety and patient safety.”

Risk Management is a set of pharmacovigilance activities and interventions designed to identify, characterise and prevent or minimise risks relating to medicinal products, including risk communication and the assessment of the effectiveness of risk minimisation interventions.

Dr Daniels believes that risk management’s potential impact on Public Health includes the prevention of another Vioxx , a decrease in the burden of ADRs, redirection of released resources – for industry and regulators – and an increased confidence in the pharmaceutical industry and regulators.

At the symposium Thony Björk, President of Community Pharmacists and Pharmacovigilance in the EU believes that pharmacists can act as a locus for pharmacovigilance. “Pharmacists have the appropriate level of education, are easily accessible to the population and have information that can put into evidence drug related problems.”

Dr. Vincenzo Costigiola, President, EMA (European Medical Association) offered the physician’s perspective. He concluded “Teaching pharmacovigilance has been recommended as a top priority action. Ideally this should be discussed in medical schools and teaching hospitals. To improve knowledge of drug safety, drug reactions knowledge of drug safety, drug reactions and to prevent the adverse effects of and to prevent the adverse effects of drugs. Distance learning programmes in pharmacovigilance should be linked to educational credits.”

There will be a key change to the structure of the EMEA by December with the inclusion of a single unit dealing with patient health and safety of medicines for pharmacovigilance, supervision and information.

And, looking to the future, at the meeting, Irene Sacristan Sanchez from the European Commission updated delegates on the “Pharma Package” which includes a legal proposal on Pharmacovigilance – a legal proposal to provide stronger public health protection through clarification of the rules.

Ms Sacristan Sanchez informed delegates that much progress has been achieved on the Pharmacovigilance proposal. Discussion continues on EudraVigilance: “There has been discussion on the issues of EudraVigilance, and if we were to move to this system - of a single point of collection - how do we ensure that Member States have full access to all the information they need so that they don’t lose any of the possibilities that they have today.” Much work will take place on the proposal over the autumn as the committees are working towards a plenary vote in 2010.

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