Simplifying drug labels

The Institute of Medicine, which made headlines some years ago when it estimated that medical mistakes kill as many as 98,000 patients a year, followed up more recently with a report on the major cause – medication errors.

The Institute believes that one way to prevent such errors is through computerised prescribing systems; another is to present drug labels in clear English. The Institute wants hospitals to computerise their prescribing systems by next year and to start using them by 2010. It also wants the drug industry and the FDA to avoid the confusion created by look-alike and sound-alike drug names – and to simplify labels and packages.

In a study published in the Annals of Internal Medicine, Terry C. Davis and colleagues asked patients at three primary care clinics to demonstrate their understanding of five common drug labels. Almost half of the patients misunderstood at least one of the five labels.

For example, the requirement that ‘medication should be taken with plenty of water’ raises the question about what exactly ‘plenty’ means. The exhortation to ‘avoid prolonged exposure or excessive exposure to direct and/or artificial sunlight while taking this medication’ was understood by fewer than 40% of patients with an 8th or 9th grade education in the Davis study, and by a mere 4% of those with a 6th grade level.

Patients also confused tablespoons with teaspoons and were less likely to understand multiple instructions such as ‘take one tablet by mouth twice daily for seven days.’

It is surely in the best interests of both the patient and the pharmaceutical industry that drug labels be worded in language that can be understood by anyone. Clear, simple, unambiguous, helpful … and, above all, not hazardous to health.