The PPLA advocates for legislative and regulatory change to ensure the continued use of printed pharmaceutical literature. With regular Capitol Hill day visits, the PPLA stays in close communication with the legislative branch. Additionally, we testify at public hearings and provide information to strategic partners and the public.
The PPLA platform does not oppose making labeling content for package inserts, medication guides and patient package inserts available electronically, particularly since it is already available in that format. What we do oppose is making the information available ONLY electronically and eliminating paper because:
- Electronic information is not available to everyone
- Sometimes electronic information is not available to anyone (power outages, natural or manmade disasters)
- Patients prefer information on paper, and comprehend that information better
- The law requires paper information that is manufacturer supplied and FDA approved
The PPLA is dedicated to advocating for federal policies that promote patient safety with printed literature.
Patients’ Right To Know Their Medication Act of 2019
The Patients’ Right to Know Their Medication Act of 2019 (H.R.5198) was introduced in the House of Representatives by Representatives Jared Golden (D-ME) and Buddy Carter (R-GA). This bipartisan piece of legislation addresses patient medication information (PMI) and requires:
- A one page, printed, standardized format with FDA approved content dispensed with all prescription drugs in the outpatient setting.
- Final regulations by the FDA regarding the inclusion of printed paper PMI on all prescription drugs and establish a clear and standard format of vital information (warnings, side effects, etc.).
- Timely, consistent, and accurate reviews of information as new drugs and new information become available.
Currently, there is no government mandated standard for content or format of the medication information that can be included with prescription drugs dispensed to patients. In fact, there is no requirement that this information be dispensed alongside the drugs at all.
Practically, this means that the printed information typically attached to prescription medication, known as Patient Medication Information (PMI), could be vastly different depending on which pharmacy dispensed the medication. This can lead to confusion, difficulty in adhering to medication instructions, potentially adverse drug events, and unnecessary healthcare costs.
The Pharmaceutical Printed Literature Association (PPLA) believes that we need a standardized, FDA approved, paper format PMI in order to ensure that patients can efficiently read and comprehend critical drug information, thereby preventing costly errors and increasing compliance with prescribing instructions.
How the Patients’ Right to Know Their Medication Act Will Help:
The Patients’ Right to Know Their Medication Act (H.R. 5198) amends the Federal Food, Drug, and Cosmetic Act to require standardized, FDA approved, paper format PMI to be provided with prescription drugs distributed and dispensed for outpatient use. This bill will bolster patient safety at a time when nearly half of Americans used at least one prescription drug in the past 30 days.
Specifically, the Patients’ Right to Know Their Medication Act mandates that no later than one year after passing, the FDA must issue final regulations regarding the inclusion of printed paper PMI on all prescribed drugs and that the information include clear and standardized directions, warnings, and measures patients may take, if any, to reduce side effects. Additionally, the bill would require that FDA ensure timely, consistent, and accurate reviews of information as new drugs and new information become available.
With the help of standardized printed PMI attached to prescription drugs, patients will better understand the critical information necessary to avoid preventable adverse drug events thereby saving patients and the health care system millions of dollars.
3 Ways To Get Involved
Here’s how you can help improve access to scientific information for patients, caregivers and healthcare professionals:
- Ask for information from your caregivers and your pharmacist – the more you know, the more you can be involved in healthcare for yourself and your family and friends. Ask your pharmacist for a copy of the Package Insert – they will usually have a paper copy at hand for you.
- Contact your federal representative and senators. We’ve included instructions on how to contact Congress in this website. And we have provided sample email content for you to use as is or simply as a guide to write your own. As we have learned over the years, our representatives and senators want to hear what their constituents are thinking.
- Donate to the PPLA and join us in our efforts to keep medication information on paper.