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Pharmacovigilance:
independent recommendations

A group of independent drug bulletins has published the "Berlin Declaration", a series of recommendations to highlight and especially to prevent adverse drug effects.

A working group of the International Society of Drug Bulletins (ISDB), a network of drug bulletins that are independent of the pharmaceutical industry, has produced the "Berlin Declaration on Pharmacovigilance" to reduce the risk of adverse drug effects.

The Berlin Declaration's key recommendations include:

  • Guarantee transparency: all the results of clinical and pre-clinical trials, and any new pharmacovigilance data, should be disclosed immediately.
  • Improve cooperation: the different national pharmacovigilance systems should share the information available to them.
  • Better reporting and information gathering: reporting adverse effects to the pharmacovigilance body should be actively encouraged, including feedback from patients. All health professionals should learn about pharmacovigilance early in their professional training.
  • Better information for patients and collection of feedback from them: before starting a treatment, patients should have access to full, unbiased information on the drug’s potential benefits and risks.

    All sensible recommendations, and in the interest of public health.

    (French version available at www.prescrire.org; English version available at www.isdbweb.org).

    ©Prescrire April 2005

    Source: International Society of Drug Bulletins "Déclaration de Berlin sur la pharmacovigilance" Rev Prescrire 2005 ; 25 (260) : 276-280.

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