bmjqs-2012-001704

Medication-related adverse events are a major cause of disability and death,1 and one of the most common reasons that patients attend hospital emergency departments.2 Much of this harm is pre-ventable, either because a less hazardous treatment is available, the medicine is not really needed, or it is inappropriate for this specific patient. Many initiatives exist to improve medi-cine use. Schiff et al3 call for a more judi-cious and precautionary approach to prescribing, with a focus on long-term as well as short-term health. To judge a medicine’s net benefit to a patient, pre-scribers need comprehensive, accurate information on potential harmful as well as beneficial effects. Given the import-ance of medicines in treatment, informa-tion on harm is surprisingly inconsistent and elusive. Approved product information describes adverse events experienced by patients in premarket studies as well as new safety signals once a drug is marketed. In their article, ‘Speaking the same language? International variations in the safety infor-mation accompanying top-selling prescrip-tion drugs’, Kesselheim et al4 describe differences in numbers and types of adverse events in product information for the same 20 top-selling medicines in the US, UK, Canada and Australia. There is no reason to suspect tha