The US Pharmacopoeia (USP) has announced a new "universal" standard for the content and appearance of prescription container labels, a response to what it says is a surge of medicate misuse resulting in part from non-standard and confusing labeling formats.
"Wide variability in prescription container labels exists today across individual prescriptions, pharmacies, retail chains and states," USP explained. The new standard, it said, will provide guidance based on research reflecting how patients, "Seek out and understand medication instructions."
A lack of standards is a "root cause" for mix-ups, errors and non-adherence, said Joanna Schwartzberg, a member of USP's Expert Committee on Nomenclature, Safety and Labeling. These factors are further exacerbated by elderly patients, an increasingly diverse population and patients on an increasing number of medications.
According to some estimates, nearly half of all patients misunderstand at least one instruction printed on their medicines. Rates were markedly higher for patients with lesser levels of reading proficiency-a group of Americans estimated to number 77 million.
The labeling changes are set to be implemented at the pharmacy and retail level-not by manufacturers or sponsors of medications-but could markedly affect adverse event reporting if they are successful in increasing rates of instructional compliance.
The standard requires instructions to be written in plain language and in clear, readable text using high contrast lettering using familiar fonts. Instructions for use should be explicit and open to as little ambiguity as possible. For instance, USP said the instructions should call for patients to, "Take two tablets in the morning and two tablets in the evening" instead of, "Take two tablets twice daily."
USP also recommended the medication include a simple label indicating the medicine's use-"for high blood pressure" instead of "for hypertension"-but also conceded off-label regulations established by the US Food and Drug Administration (FDA) might limit the use of such labels for any unapproved uses.
"Patients' best-and often only-source of information regarding the medications they have been prescribed is on the prescription container label," Schwartzberg said. Those patients rarely consult the drug facts label or FDA-approved labeling, and instead rely on their pharmacist-provided labeling.
The standard, developed with the assistance of the US Institute of Medicine, may be adopted on a state-by-state basis and determined by their respective state boards of pharmacy, USP explained.