Breaking News on Global Pharmaceutical Technology & Manufacturing

USP proposes standardising labels to reduce drug misuse

By Nick Taylor, 11-May-2010

Related topics: Regulations, Drug Delivery

A US Pharmacopeial Convention (USP) advisory panel has issued recommendations intended to improve drug compliance and minimise misuse by standardising prescription medication labels.

Inability to properly understand medication guidelines and supplemental instructions is a problem, according to the Institute of Medicine, leading to 90m adults in the US having limited health literacy. This can lead to drug misuse and consequently the USP is seeking to improve matters.

A USP advisory panel believes improvements would be best achieved by having manufacturers adopt universal standards for prescription labels. This would ensure labels “provide reliable, simple and concise information”, added Joanne Schwartzberg, co-chair of the panel.

If the suggestion is adopted each label would have certain characteristics. For instance, the USP has proposed that all critical information is printed in a minimum 12-point, sans serif font, punctuated like a normal sentence in English, to improve readability.

This critical information, which is needed to ensure safe and effective use, should be the only information on the prescription container. Organising information in this “patient-centred manner” is intended to reflect how most people seek out and follow medication instructions.

In addition to standardising visual presentation of information the USP believes it is important to simplify the language used. Sentences should be clear, concise and standardised, while avoiding the use of medical jargon and ambiguous directions.

Patient understanding should also be supported by explicitly explaining dosage and interval instructions. For example, the USP believes “Take 4 tablets each day. Take 2 tablets in the morning and 2 tablets in the evening” is clearer than “Take two tablets by mouth twice daily”.

Furthermore, the USP recommends providing labelling in the patient’s preferred language whenever possible. Translations should be produced using a high-quality translation process.

These recommendations will form the basis for consideration of a new USP general chapter. After completing the proposed chapter the USP will seek input from the public, including consumer and health care organisations.