US FDA Seeks Patient Data Sheets For All New Scripts

The US Food and Drug Administration has proposed that patients receive clear and simple information sheets about every medicine with all new prescriptions. Under the proposal, pharmacists would voluntarily offer patients new, comprehensive and clear information on all the 3,300 or so medicines currently available.

Secretary of Health and Human Services Donna Shalala said the scheme would require pharmacists to provide written information to 75% of patients receiving new prescriptions by the year 2000, and this should reach 95% 10 years after such a regulation went into effect. Should the quotas not be met, the brochure would become mandatory; to ensure the requirements are met, the FDA will conduct surveys asking whether patients are getting the inserts and if they are clear and complete. At present, only Texas requires written patient instructions with every prescription.

The Medication Guides would be developed under agency guidelines. A prototype two-page insert for an antibiotic, offered by the FDA as an example, included a box containing the most important information, followed by simple questions and answers about who should take the drug, how to take it, possible side effects and storage.