A missed opportunity to strengthen patient safety: not seeing the forest from the trees
18 July 2012
The “end the national reporting of adverse drug reactions” is described as a progress (1). A cautious approach is warranted.
Eudravigilance is a centralised ‘mega-database’ where suspected adverse drug reactions (ADRs) are coded using ICH terminology (MedRA dictionary). In practice, spontaneous reports can be stripped of clinical significance, resulting in data being minimised or misinterpreted (2).
The submission of suspected ADRs directly to Eudravigilance will bypass local expert teams who are close to the population in language and lifestyle, preventing them from obtaining further information from ADR reporters , hindering accurate data analysis and interpretation (3).
Evidence of data withholding by pharmaceutical companies is vast (3,4). And yet, pharmaceutical companies will be left to their own devices when it comes to safety signal detection. Health authorities will have but a limited role; that of evaluating data previously interpreted by companies, which is likely to bias decision-making (3).
The new Pharmacovigilance Risk Assessment Committee’s hands are tied: their role is restricted to making recommendations . With the looming end of publicly-funded pharmacovigilance in sight, a fee for service system is enacted jeopardizing the financial and intellectual independence of EU pharmacovigilance (3).
1- Watson R “New EU drug safety committee ends national reporting of drug reactions” BMJ 2012 ; 345:e4690.
2- Prescrire Editorial Staff “Patient reporting improves pharmacovigilance" Prescrire International 2008 ; 17 (98) : 241-242.
3- ISDB & MIEF “Pharmacovigilance in Europe: the European Commission’s proposals endanger the population" Joint analysis ; October 2009.
4- Psaty B et Kronmal R “Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment : a case study based on documents from rofecoxib litigation” JAMA 2008 ; 299 (15) : 1813-1817.
Competing interests: None declared
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