Monday, May 17, 2010

A more ambitious pharmacovigilance

A year ago we mentioned in this blog the Palmarès Prescrire 2008.
Again, in the Palmarès 2009, the main categories “Pilule d'Or” and “Tableau d'honneur” were not awarded. These categories are attributed to new drugs that would constitute a breakthrough for the treatment of certain diseases, because of its efficacy or its lower incidence or severity of adverse effects.

The announcement of the results took place in Paris in January 2010 and was preceded by a panel discussion about adverse effects of drugs.Joan-Ramon Laporte, Director of the Catalan Institute of Pharmacology, participated as speaker. Prescrire has published his interesting speech.

Laporte highlights the magnitude and severity of adverse effects of drugs that are one of the leading causes of morbidity and mortality in developed countries and, therefore, the key role of Pharmacovigilance for Public Health.

This pharmacovigilance depends heavily on spontaneous reporting of adverse reactions by health professionals. But this notifications are necessary but not sufficient, because they depend on the motivation of professionals and the training, knowledge and participation in reporting systems.

The professionals would notify fundamentally the rare and new events because these ones call their attention. More proactive pharmacovigilance strategies would carry out observational studies and meta-analysis to let us know the effects of drugs usually used in the treatment of common diseases. This has happened with substances such as NSAIDS, SSRIs, neuroleptics in dementia, ezetimibe, glitazones, bisphosphonates, etc.

In regard to health professionals, Laporte also argues that the prevention of adverse effects requires a more rational prescribing, and so an independent, continuing and qualified education.

Regarding the role of health authorities we want to note the demand for new drugs that demonstrate to bring a therapeutic progress, to be more effective or safer than the reference drugs, to get their marketing.

The authorities should act with full independence and require transparency to pharmaceutical firms.

It is truly interesting to read the data and reflections of Laporte on the European Commission's proposals in pharmacovigilance that seems to be elaborated to ensure the health of the products instead of citizen´s health.

Posted by Marian López Orive
English version by Erika Céspedes

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