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Patients’ Right To Know Their Medication Act of 2022

The Patients’ Right to Know Their Medication Act of 2022 (H.R.6519) was introduced in the House of Representatives by Representatives Jared Golden (D-ME), Buddy Carter (R-GA), Dutch Ruppersberger (D-MD), and Bruce Westerman (R-AR). 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.

Advocacy in Action

Site visits with Rep. Bryan Steil (WI), Marie Newman (IL), and Brian Fitzpatrick (PA)

The Problem

Currently, there is no 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. 6519) 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. 

Endorsers