Regulators Propose Remedy for Medication Misuse

The nonprofit group that sets quality standards for U.S. drugs has a new prescription for reducing medication misuse in the U.S. — presenting pharmaceutical information to consumers in plain, simple English.

“Inadequate understanding of prescription directions for use and auxiliary information on dispensed containers is widespread,” the U.S. Pharmacopeial Convention, or USP, said in proposing new standards for prescription container labeling. “Studies have found that 46 percent of patients misunderstood one or more dosage instructions and 56 percent misunderstood one or more auxiliary warnings.”

“Lack of universal standards for labeling on dispensed prescription containers is a root cause for patient misunderstanding, nonadherence, and medication errors,” it adds.

The USP’s remedy for these ills includes:

  • Prominently displaying information that is critical for safe and effective use of the medicine. “Place at the top of the label the patient’s name, drug name and strength, and explicit clear directions for use in simple language.”
  • Using only common terms and sentences on labels. “Do not use unfamiliar words (including Latin terms) or unclarified medical jargon.”
  • Giving explicit instructions on medication use — for example, write, ‘‘Take 2 tablets in the morning and 2 tablets in the evening’’ rather than ‘‘Take two tablets twice daily.”
  • Including the purpose of the medication on the label if it’s OK with the patient. “Current evidence supports inclusion of purpose-for-use language in clear, simple terms (“for high blood pressure” rather than “for hypertension.”)

The deadline for comments on the proposals, which could be adopted by state pharmacy boards or other regulators, is March 31.

Related Post:
Flawed Medicine Dosing Instructions Can Puzzle Parents and Harm Children, Study Finds

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