Lupin 2023

Coalition formed to safeguard access to OTC pain relievers

Print Friendly, PDF & Email

WASHINGTON — A group of drug- and health-related companies and organizations have formed the Protecting Access to Pain Relief Coalition (PAPR), which seeks to preserve Americans’ access to and choice of safe, effective pain relief best-suited for their condition.

Pain relief aisle_acetaminophen_Rite AidAnnounced Wednesday, the PAPR Coalition includes stakeholder groups advocating for pain relief, including public health organizations, medical professionals, consumers living with pain and concerned citizens. The coalition aims to work with the Food and Drug Administration, Congress, health care providers and others to ensure consumers have access to pain relief, including products with acetaminophen.

PAPR also advocates for education of consumers and health care professionals about the appropriate use of prescription and over-the-counter medicines.

Members of the coalition include the Alliance for Aging Research, American Association of Colleges of Pharmacy, American Association of Kidney Patients, American College of Preventive Medicine, American Pharmacist Association, McNeil Consumer Healthcare, National Council on Patient Information and Education, Society for Women’s Health Research, The Gerontological Society of America and the U.S. Pain Foundation.

“For the more than 100 million Americans living with persistent pain, such as pain caused by disease or other health issues, protecting access to safe and effective pain relief is a top priority,” Paul Conway, president of the American Association of Kidney Patients and chair of the PAPR Coalition steering committee, said in a statement. “While protecting access to pain relief is important to all Americans, it is particularly important to the 53% who depend on acetaminophen, because their age and/or health conditions put them at increased risk of adverse events from alternative forms of pain relief.”

The PAPR Coalition noted that the FDA is mulling regulatory changes that could restrict access to OTC doses of acetaminophen over 325 mg (with a maximum single dose of 650 mg). If implemented, such a policy could cause consumers to switch to other pain medicines to achieve the equivalent relief, the group explained. And because not all pain medicines are appropriate for millions of Americans with pain, switching could lead to an increase in adverse events, higher health care utilization costs, and other unintended public health and economic consequences, according to the coalition.

“The Protecting Access to Pain Relief Coalition has come together at a critical time, when Americans are being encouraged to take an active role in their own health care. This coalition helps to ensure that access to the pain relief these patients currently rely upon — and in many cases the only pain relief they can take based on their health conditions — remain available as over-the-counter options,” added Conway, who previously served as chief of staff of the U.S. Department of Labor and deputy secretary of health and human resources for Virginia.

Consmer and health care provider education is key to promoting a better understanding the safe and proper use of acetaminophen, the PAPR Coalition pointed out. According to a recent survey conducted by the Alliance for Aging Research, Americans favor education about the safe use of acetaminophen and disagree with restricting access to those same OTC medicines as the alternative.

“Older adults in the U.S. experience pain on a regular basis, and many of these seniors rely on OTC pain relievers that contain acetaminophen to manage their pain and maintain their quality of life,” stated Cynthia Bens, vice president of public policy for the Alliance for Aging Research and vice president of the PAPR Coalition steering committee. “A survey commissioned by the Alliance for Aging Research revealed that only 16% of Americans believe that it is a good idea for the FDA to implement policies that would limit access to OTC pain medicines containing acetaminophen.”

When used as directed, acetaminophen has one of the most favorable safety profiles among OTC pain relievers, according to the coalition. The safety and efficacy of various doses of acetaminophen — including 500 mg, 650 mg and 1,000 mg — have been well-established in clinical trials and clinical use, the group said, adding that the availability of a full range of OTC doses of acetaminophen is important to help consumers manage their pain.


Comments are closed.