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In the September issue of Prescrire International - Management of serious adverse drug reactions: proposals from a victims' organisation

 FREE DOWNLOAD  The position statement on drug-related risks from the French victims' organisation Amalyste provides valuable food for thought, both for healthcare professionals and for drug regulatory agencies, and has the potential to improve practice.
Full text available for free download.

Summary

  • Amalyste is a French patient-advocacy group for victims of two very serious adverse drug reactions: Lyell and Stevens-Johnson syndromes. The aims of this organisation are to represent the interests of patients who have experienced these syndromes; to better inform the public about these syndromes; to provide analyses of drug-related risks; and to demand collective compensation for victims of serious adverse drug reactions.
     
  • Amalyste's position statement on drug-related risks (1), translated in the September issue of Prescrire International, provides valuable food for thought, both for healthcare professionals and for drug regulatory agencies, and has the potential to improve practice.   
     
  • The group concludes that drug therapy currently resembles a gigantic game of Russian roulette. The “risk-benefit ratio” – the concept on which the current system is based – creates a situation in which society and drug companies reap most of the benefit while leaving a handful of victims to shoulder the risks.
     
  • How can this situation be remedied? Regulatory authorities must create a level playing field in which the community fully assumes its responsibility for the consequences of marketing a high-risk drug. This implies acknowledgement of the existence of the risk; an obligation to provide the means necessary to reduce drug-related illness (means compatible with the importance of the public health implications); an obligation to conduct research on adverse reactions to high-risk drugs; and proper management of the consequences when harmful effects occur, including financial compensation. 

Reference:
1- Amalyste “La gestion du risque médicamenteux grave”. www.amalyste.fr accessed 8 February 2012: 7 pages.    

Full text available for free download.

 ©Prescrire 1 September 2012

"Management of serious adverse drug reactions: proposals from a victims' organisation. Challenging the "risk-benefit ratio"" Prescrire Int 2012; 21 (130): 220-223. (Pdf, free)

 
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For more information:

An example to us all
A patient group raises
awareness about Lyell
and Stevens-Johnson
syndromes
Prescrire Int 2012;
21 (130) 200.
Pdf, free