Patient Medication Information: Printed and/1 or Electronic? Full Study, Dr. Ruth S. Day, Duke University
Enhanced PMI -1 Page Overview, Dr. Ruth S. Day, Duke University
American Association of Retired Persons (AARP)
AARP publications on drugs, side effects, nutritionals and other health-related topics
Americans For Safe Medicine
Cody Miller Initiative for Safer Prescriptions
Daily Med – How to Access the Official Package Insert
The Food and Drug Administration makes the official labeling content available on its website, entitled for this purpose “Daily Med”. In many cases, there will be multiple inserts. Sometimes the differences are minor (different manufacturers). At other times there may be substantive differences. Some drugs come in different forms (capsules, gels, extended release, etc.).
Food and Drug Administration (FDA):
GAO Study on “Electronic Drug Labeling”
The Government Accountability Office, as Congress requested,
published a report on Electronic Drug Labeling on July 8, 2013; follow the link
to find an abstract of the report as well as a PDF of the final report.
Informed Medical Decisions Foundation (recently merged with Healthwise)
Institute for Healthcare Improvement
Institute of Medicine – To err is human
The Institute of Medicine is part of the National Science Foundation.
In 1999, it published a study entitled, “To Err is Human,” quantifying that preventable medical errors caused more deaths annually in the U.S. than AIDS, breast cancer, or motor vehicle accidents.
Abstract of the study and ordering information:
In April 2014, the NCPA sent a letter to the Office of Management and Budget (OMB) and the Food and Drug Administration (FDA) to suspend plans to issue the pending proposed regulation "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products"
Save The Michaels
Awareness of Prescription Drug Addiction
Studies to measure the quality of Consumer Medication Information (CMI).
In 2001 and 2008, the FDA chartered studies to measure the quality of Consumer Medication Information (CMI). The studies were conducted by pharmacy schools at the University of Wisconsin and the University of Florida, respectively. The URL for the Wisconsin study is an abstract; the URL for the University of Florida provides the text of the final report. Findings were similar in both.
University of Wisconsin School of Pharmacy, 2001 report on state of CMI:
The results were detailed in:
Svarstad, BL, Bultman, DC, Mount, JK, Tabak, ER. Evaluation of Written Prescription Information in Community Pharmacies: A Study in Eight States J Am Pharm Assoc. 2003: 43:383-393.
University of Florida Pharmacy School November, 2008 report on state of CMI:
International Study on Consumer Medication Information (CMI).
Unique for a developed economy, the United States does not require government-approved, manufacturer-supplied leaflets as Consumer Medication Information (CMI).
Comparative studies show that leaflets in Australia, the United Kingdom and the United States received a mean overall score of 90%, 81% and 68% respectively. U.S. leaflets delivered 50% or less adherence for contraindication and precaution information. Results of the comparative study were published.
Raynor, D.K. Theo; Svarstad, Bonnie; Knapp, Peter; Asiani, Parisa; Rogers, M. Brooke; Koo, Michelle; Krass, Ines; and Silcock, Johnathan: “Consumer medication information in the United States, Europe, and Australia: A comparative evaluation” Journal of the American Pharmaceutical Association. An abstract can be found at:http://www.ncbi.nlm.nih.gov/pubmed/18032134