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Medication safety: opening up the black box
  1. Barbara Mintzes
  1. Correspondence to Dr Barbara Mintzes, School of Population and Public Health, University of British Columbia, #307, 2176 Health Sciences Mall, Vancouver, British Columbia, Canada 604 822 7130; Barbara.mintzes{at}

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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 preventable, 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 medicine use. Schiff et al3 call for a more judicious 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, prescribers need comprehensive, accurate information on potential harmful as well as beneficial effects. Given the importance of medicines in treatment, information 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 information accompanying top-selling prescription 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 that Americans, Australians, Canadians or the English differ in vulnerability to harm from medicines. As well as numbers of events, individual adverse events—including life-threatening harm—were inconsistently listed. The size of patient safety populations on which assessments were based ranged widely, from a median of 3563 in Australia to 7819 in the UK.4 This was product information for the same medicines, produced by the same manufacturers, and obtained at the same time.

Regulatory warnings of serious risks also differed: the US Food and Drug Administration …

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