HHS Releases Final Version of National Pain Strategy

FDA Issues Draft Guidance on Abuse-deterrent Opioids, Adds Safety Warnings to Packaging

March 30, 2016 02:40 pm Chris Crawford
[Black male with painful expression on his face]

On March 18, the Office of the Assistant Secretary for Health at HHS released its National Pain Strategy (NPS),(iprcc.nih.gov) outlining the federal government’s first coordinated plan for reducing the burden of chronic pain in the United States.

Coordinated by the Interagency Pain Research Coordinating Committee, the NPS is a comprehensive, population health-oriented plan based on a 2011 report from the Institute of Medicine that offered recommendations "to increase the recognition of pain as a significant public health problem in the United States."

Chronic pain affects millions of Americans and incurs significant economic costs to our society, said HHS Acting Assistant Secretary for Health Karen DeSalvo, M.D., M.P.H., M.Sc., in a news release.(www.hhs.gov) "This report identifies the key steps we can take to improve how we prevent, assess and treat pain in this country," she said.

The final NPS report makes recommendations for improving overall pain care in America in six key areas: population research; prevention and care; disparities; service delivery and payment; professional education and training; and public education and communication.

Story highlights
  • On March 18, the Office of the Assistant Secretary for Health at HHS released its National Pain Strategy, outlining the federal government's first coordinated plan for reducing the burden of chronic pain in the United States.
  • On March 24, the FDA issued a draft guidance to support the development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.
  • Also last week, the FDA announced it would require new safety warnings for prescription opioid medications.

The strategy looks to:

  • develop methods and metrics to monitor and improve the prevention and management of pain,
  • support the development of a system of patient-centered integrated pain management practices based on a biopsychosocial model of care that enables physicians and patients to access the full spectrum of pain treatment options,
  • reduce barriers to pain care and improve the quality of pain care for vulnerable, stigmatized and underserved populations and
  • increase public awareness of pain, increase patient knowledge of treatment options and risks and help to develop a better-informed health care workforce with regard to pain management.

The NPS provides opportunities to reduce the need for and over-reliance on prescription opioid medications, including to:

  • improve physician education on pain management practices and team-based care in which multiple treatment options are offered -- moving away from an opioid-centric treatment paradigm;
  • improve patient self-management strategies as well as patient access to quality, multidisciplinary care that does not depend solely on prescription medications, especially for vulnerable populations;
  • encourage the evaluation of risks and benefits of current pain treatment regimens;
  • provide patients with educational tools to encourage safer use of prescription opioids and
  • conduct research to identify how best to provide the appropriate pain treatments to individual patients based on their unique medical conditions and preferences.

The plan is for these efforts to bolster how HHS best equips physicians with the tools and information they need to make informed patient-centered treatment decisions that include safer and appropriate prescribing of opioids.

Family Physician Expert's Take

Robert Rich, M.D., past chair of the AAFP Commission on Health of the Public and Science and the AAFP's representative on the AMA Task Force to Reduce Opioid Abuse, told AAFP News that the NPS appears to be well written and covers most aspects of a comprehensive pain strategy.

"Where the recently published CDC guideline(www.cdc.gov) focuses on what a (physician) should not do in prescribing medications for pain management, the NPS outlines the essential elements of a comprehensive nationwide strategy," he said.

Rich said the policy correctly outlines the disparities that exist nationwide in access to comprehensive pain services for many population groups. This includes access to behavioral health services, as well as access to complementary and alternative pain treatments, which would lessen the dependence on opioid pain relievers. The NPS also includes a discussion of the need for governmental and private insurers to provide coverage for these services.

Next, he said the policy describes an emphasis on team-based care, particularly in the primary care setting, as well as a need for more evidence-based research into pain management guidelines and strategies and the need to improve the dissemination of those best strategies.

"This is very much in keeping with our own AAFP opioid (position),"(15 page PDF) Rich said.

The NPS also describes the need for improved professional education regarding pain management -- from medical school through residency to postgraduate levels -- including the desired attributes of such education, Rich said.

In addition, he said, the policy correctly identifies the need for national educational campaigns highlighting the importance of such concepts as increased patient self-management of pain, safer use of medications for pain control including opioids, and addressing the many myths, misconceptions and stigmatization surrounding chronic pain and pain control.

"In general, the policy summarizes the current state of pain management, develops one-, three- and five-year strategies and utilizes the expertise of and recommendations from the many national stakeholders with an interest in pain in developing those strategies," Rich said. "I would recommend that the AAFP support the NPS."

The AAFP is reviewing the final version of the NPS and will decide whether or not to support it.

FDA Draft Guidance on Abuse-deterrent Opioids

On March 24, the FDA issued a draft guidance(www.fda.gov) in an effort to support the development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.

"For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care," said FDA Commissioner Robert Califf, M.D., in a news release.(www.fda.gov) "We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy."

To encourage additional input from outside experts and the public, the FDA also will hold a public meeting later this year to discuss the draft guidance on generic ADF products and a broad range of issues related to the use of abuse-deterrent technology as one tool to reduce prescription opioid abuse. The agency will then take this feedback into consideration when developing the final guidance on this topic.

The FDA encourages feedback from all stakeholders during the 60-day comment period(www.federalregister.gov) on this draft guidance, which runs through May 24.

FDA Safety Warnings for Opioid Medications

Just two days before issuing the draft guidance on ADF opioids, the FDA announced(www.fda.gov) it would require new safety warnings to be added to prescription opioid medications.

These new class-wide safety labeling changes require boxed warnings about the serious risks of misuse, abuse, addiction, overdose and death to be included for immediate-release (IR) opioid pain medications.

Updated dosing information also provides clearer instructions on patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient, according to a news release.(www.fda.gov)

In addition, the FDA now requires the boxed warning on IR opioid analgesics to include a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated using protocols developed by neonatology experts.

Finally, the agency is requiring updated labeling for all opioids (both extended-release/long-acting and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in serotonin syndrome. Updated labeling also will include information about opioid effects on the endocrine system, including adrenal insufficiency and androgen deficiency.

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