PPLA - The Pharmaceutical Literature Association; We're fighting to keep medication information on paper - for patient health and safety

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.

PIs

The “Package Insert (PI)” is the FDA-mandated and approved information on paper that accompanies most prescription containers. It’s also referred to in legislation as the “Labeling Content.” It is designed for healthcare providers and involved caregivers and patients.

Medication Guides

This is FDA-approved patient information in a standard format that must be distributed to patients with every prescription for certain high-risk drugs. In recent years, classes that have been required to supply MedGuides include NSAIDs (non-steroidal anti-inflammatory drugs) and anti-depressants. It is designed for consumers.

To see an example of a Medication Guide:

Go to http://dailymed.nlm.nih.gov/dailymed/about.cfm
Search Boniva® (Copyright R unnecessary for search)
Click on the “tab” labeled “Medication Guide”

PPIs

Similar in content and format to Medication Guides, Patient Package Inserts (PPIs) can be required for drugs that are marketed directly to consumers through advertising. It is designed for consumers.

To see an example of a Patient Package Insert:

Go to http://dailymed.nlm.nih.gov/dailymed/about.cfm
Search Viagra® (Copyright R unnecessary for search)
Click on the “tab” labeled “Patient Package Insert”

CMI

Consumer Medication Information (CMI) is the generic term for the information provided to consumers by pharmacies, pharmaceutical companies, and the worldwide web.

Both MedGuides and PPIs, because they are geared to consumers, as opposed to healthcare professionals, fall under the category of “CMI.”

Two other categories that also fall under this designation are information supplied by pharmacies and information available on the Internet.

Pharmacy Supplied CMI and its drawbacks

  • Information printed at the pharmacy delivers unregulated content. Even when the information does come from a central, usually commercial, database, pharmacies can and do change this information.
  • Pharmacy practices are regulated by Boards of Pharmacy on a state-by-state basis, not by the FDA.
  • A consumer filling the same prescription for the same drug at five different pharmacies will almost certainly receive five different pieces of CMI. The poor quality of this information is well documented and covered elsewhere on this website.

Internet CMI

The Internet houses vast amounts of both information and misinformation. Search engine results do NOT direct the user to Daily Med, where official versions of the PI and PPI can be found. Daily Med is a website operated by the U.S. National Library of Medicine to publish up-to-date and accurate drug labels to health care providers and the general public. The contents of Daily Med is provided and updated daily by the FDA.