USP calls for standardised labelling on medical packaging
Format, appearance, content and language should be included to address poor health literacy
To promote universal standards for prescription drug labels – and to address the problem of patient misinterpretation of medication instructions – an advisory panel formed by the US Pharmacopeial Convention (USP) has issued recommendations to bring consistency to labelling on dispensed prescription packaging.
The recommendations are focused on the patient, and were developed following a call for such standards by the Institute of Medicine (IOM).
The IOM says 90 million adults cannot fully benefit from much that the healthcare system has to offer because they have limited health literacy, which can lead to non-adherence and medication errors, which may pose significant health risks to patients. Medication misuse results in more than a million adverse drug events per year in the US.
USP formed a Health Literacy and Prescription Container Labelling Advisory Panel in 2007 to examine ways to improve the labelling of prescription drug packs. The organisation recently released the panel's recommendations, which cover format, appearance, content and language of prescription labels.
‘Patients have the right to understand health information that is necessary to safely care for themselves and their families,’ said Joanne Schwartzberg, co-chair of the USP Health Literacy and Prescription Container Labelling Advisory Panel. ‘Confusing medication labels is one area that can be improved considerably.’
The advisory panel recommendations include: simplifying language and using explicit text to describe dosage/interval instructions. For example, dosage, usage and administration instructions must clearly separate dose from interval and must provide the explicit frequency of drug administration (e.g. "Take 4 tablets each day. Take 2 tablets in the morning and 2 tablets in the evening" is better than "Take two tablets by mouth twice daily").
The panel also recommends using numeric rather than alphabetic characters for numbers; including the intended use/indication on the prescription whenever possible, stated in clear, simple language (e.g. for high blood pressure, for rash or for stomach cramps); and readability should be improved with critical information for patients appearing in an uncondensed, simple, minimum 12-point, sans serif font (e.g. Arial).
The label should be in the patient's preferred language and supplemental information on the packaging minimised and limited to evidence-based critical information.
In addition, prescribing directions to patients should be standardised and Latin abbreviations, which are often misunderstood and susceptible to variation in translation, eliminated.
These recommendations will form the basis for a new USP general chapter on prescription container labelling, which is being developed by USP's Safe Medication Use Expert Committee. This is expected to be completed within the next few months. USP then will seek input from the public, including consumer and healthcare organisations, on its content.