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Written Prescription Drug Information - Guidelines 1
In December 1996, the “Action Plan for the Provision of Useful Prescription Medicine Information” was presented to the Secretary of Health and Human Services. The plan, commonly known as the “Keystone Plan,” described certain criteria for written prescription medicine information.
The purpose of these guidelines - comprising format, content, and accessibility of prescription drug leaflets - is to help ensure that leaflets are useful. In this context, “useful” means that recipients receive, understand, and are motivated to apply written information about their medicines to achieve maximum benefit and minimize harm. Dispensers, prescribers, health care providers who counsel patients about their medicines, and the patients themselves are intended to be the primary beneficiaries for these guidelines.
Criteria: Written prescription medicine information should be based on the following criteria:
Scientifically accurate, Unbiased in content and tone, Sufficiently specific and comprehensive, Presented in an understandable and legible format that is readily comprehensible to consumers, Timely and up-to-date, and Useful.
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