Patient Medication Information: Your Input Can Help Keep It Simple
Research suggests that about 50 percent of Americans find it difficult to read health information.
Consumers who cannot find the information they need, or who do not understand the information
because it is presented in a convoluted manner, are less likely to use it to prevent unnecessary
medical errors. We know that consumers are receiving information – sometimes too much information.
Not only are consumers receiving pages of medication information, the information they receive is
uncoordinated and sometimes conflicting. Some documents are written by the drug manufacturer, and
others are written by pharmacies or another third party. Some medication information documents are
FDA-approved and others are not.
The real question is – could medication information be presented in such a way that it would be
more useful for consumers? The answer is a resounding “yes.” One study found that just 75 percent
of consumer medication information met the minimum criteria for usefulness. That number might be
impressive as a field goal percentage in the NBA, but for consumers it represents an unmet need for
high quality medication information.
The U.S. Food and Drug Administration (FDA) has spent the past several years working with
stakeholders to determine the most effective methods for conveying medication information. One
overarching principle that has emerged from FDA’s engagement with the health care community is the
need for a single, standardized document to replace the numerous existing documents. This document
is identified as Patient Medication Information (PMI). PMI was intended to create an easier way for
consumers to access and understand their medication information. By presenting the most salient
pieces of information – including drug uses, warnings, side effects, and directions – on a single
page that is easy to navigate, PMI can be a useful tool for enhancing treatments and preventing
avoidable medication errors or side effects. PMI holds promise both for consumers and the broader
health care system. For consumers, PMI could contribute to better outcomes and an overall
improvement in patient experience. For health systems, PMI’s positive impact on medication
adherence could improve performance on quality measures, such as hospital readmissions, that could
lead to shared savings or other rewards.
Through a cooperative agreement, the Engelberg Center for Health Care Reform at the Brookings
Institution has worked in collaboration with FDA over the past few years to convene a series of
workshops focused on identifying best PMI practices – for example, how to make PMI both more usable
and accessible. Workshop participants identified several guiding principles for improving the
content, format, and distribution of PMI.
PMI Guiding Principles
• PMI content should be consumer-friendly. Expert stakeholders identified a lack of
consumer-friendly information as one of the most important barriers to effectively communicating
critical medication information. To fix this problem, the language used in PMI will need to be
simplified, patient-centric, and understandable across the entire spectrum of health literacy
levels. The types of information that should be included in PMI must be essential for taking a
medication properly. Extraneous information, such as a discussion of previous treatments a consumer
must have previously tried and failed before receiving the new prescription, may be more confusing
• The best PMI formats are simple and easy to navigate. Consumers don’t want to be given a
technical-looking instruction manual when they pick up their prescriptions. Participants at the
workshops generally agreed that it would be ideal to keep PMI to a single page. They also agreed
that actionable headers that help consumers locate the information they are looking for are
preferable to the question and answer format (e.g., “Uses” and “Directions” are more effective than
“What does the drug treat?” and “How do I use the drug?”). There was consensus on the point that
consumers will ultimately decide the best format.
• Access to PMI will be bolstered by multiple channels of distribution. Paper is still the primary
source of medication information, and is preferred by certain demographics. However, technology is
revolutionizing the way consumers receive information. This is generally good for society, but it
introduces some challenges, including the fact that consumers now have more access to information
of questionable quality. One method for ensuring access to consistent and high quality PMI would
be to have a central repository for all PMI documents. This approach could support distribution of
both printed and electronic PMI. Access to PMI could be further enhanced by making it available on
smartphones and via email.
On July 1, the Center will convene a Public Meeting that will provide an opportunity for the health
care community to discuss the issues mentioned above. Researchers will give an update on progress
made since the previous meetings and share the lessons they learned from recent studies. Diverse
stakeholders – including patient advocacy groups, providers, pharmacies, and drug manufacturers –
will provide their perspectives on the future of PMI and assess their role in making high quality
PMI a reality.
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.