Printed Literature 101
Medication information comes in different formats for different purposes.
Here are definitions of the main terms used in this site to help you understand why keeping medication information on paper is critical to patient health and safety.
Package Inserts
The package insert (PI) is an FDA regulated document included in the package of a medication that has technical guidance and information about the drug and its use. It is designed for medical professions.
Patient Medication Information
The patient medication information (PMI) is an unregulated document designed for consumers containing salient pieces of information – including drug uses, warnings, and side effects, and directions.
Medication Guides
Medication guides are FDA-approved patient information that must be distributed to patients with every prescription for certain high-risk drugs including NSAIDs (non-steroidal anti-inflammatory drugs) and anti-depressants. It has a standard format and is designed for consumers.
Commonly Asked Questions
Why is medication information so important?
Medication information is critical for patients, caregivers, and health care providers to understand prescription drug dosage, administration, side effects, adverse reactions, and interactions with other drugs. This confidence helps ensure patient health and safety and achieve higher compliance.
Why medication information on paper?
The 1938 United States Federal Food, Drug, and Cosmetic Act requires that written, printed, or graphic matter bearing directions for use and warnings be upon the immediate container of any article. In addition, research shows that patients prefer and better comprehend medication information on paper.
What about information in electronic form?
We support the availability of medication information in electronic form as a complement to information on paper. However, we strongly oppose efforts to make electronic media the ONLY source of medication information . Not everyone has access to electronic information, and the information itself may not be available for any number of reasons, not the least of which are power outages from natural or man-made causes. As well, several recent studies, including those by the U.S. Department of Commerce, indicate that up to 33% of Americans do not utilize electronic media under any circumstances.