Feds Urge Doctors to Co-Prescribe Naloxone    

By Pat Anson, PNN Editor

Pain patients taking relatively modest doses of opioid medication should be co-prescribed naloxone, according to a recommendation released this week by the U.S. Department of Health and Human Services.

Naloxone is an overdose recovery drug administered by injection or nasal spray that rapidly reverses the effects of an opioid overdose. It has been credited with saving thousands of lives, although recently there has been controversy over a company exploiting demand for the drug by raising the cost of its naloxone injector over 600 percent.

“Given the scope of the opioid crisis, it’s critically important that healthcare providers and patients discuss the risks of opioids and how naloxone should be used in the event of an overdose,” said Adm. Brett Giroir, MD, assistant secretary for health and senior advisor for opioid policy at HHS.

“Co-prescribing naloxone when a patient is considered to be at high risk of an overdose, is an essential element of our national effort to reduce overdose deaths and should be practiced widely.”

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But the “guidance” released by HHS could involve millions of patients who are not necessarily at high risk and have been taking opioids safely for years.  It urges doctors to “strongly consider” prescribing naloxone to patients under these circumstances:

  • Patients prescribed opioids at a dose of 50 morphine milligram equivalents (MME) or more per day

  • Have respiratory conditions or obstructive sleep apnea (regardless of opioid dose)

  • Have been prescribed benzodiazepines (regardless of opioid dose)

  • Have a mental health or non-opioid substance use disorder such as excessive alcohol use

  • Are receiving treatment for opioid use disorder

  • Have a history of illegal drug use or prescription opioid misuse

The HHS guidance was issued days after an FDA advisory committee voted 12 to 11 in favor of adding language to opioid warning labels recommending that naloxone be co-prescribed.  Some panel members objected to the labeling because of the additional cost involved and because it does not address deaths caused by illicit opioids, which account for the vast majority of opioid overdoses.

The guidance notes that most health insurance plans, including Medicare and Medicaid, will cover at least one form of naloxone. For patients without insurance, the guidance suggests contacting a state or local program that may supply naloxone for free or at low cost.

Naloxone costs only pennies to make and syringes containing generic versions of the drug typically cost about $15 each. But formulated and branded versions that have a more sophisticated delivery system are much pricier. According to Health Care Bluebook, a package of two nasal sprays of naloxone sold under the brand name Narcan will cost about $135.  Evzio, a kit that contains two auto-injectors of naloxone, retails for about $3,700.   

A recent U.S. Senate report found that Kaleo, a privately-owned drug maker, jacked up the price of Evzio by over 600% to “capitalize on the opportunity” of a “well established public health crisis.” As a result, the report estimates the U.S. government paid over $142 million in excess costs to Kaleo for prescriptions covered by Medicare.  

The new HHS guidance mirrors that of the 2016 CDC opioid guideline, which encourages physicians to consider prescribing naloxone to pain patients on “higher opioid dosages” of 50 MME or more.

“I’m personally against it, because I don’t think most patients who require opioids for pain management are at risk of overdose,” said Andrea Anderson, Executive Director, Alliance for the Treatment of Intractable Pain (ATIP).  “I also don’t think naloxone helps unless you’re with other people, which makes more sense for those who are using illicit opioids rather than those who rely on opioids for routine pain relief. 

“I don’t think the government should require patients to buy medications for which they do not have a proven need. This sounds like another one of those good ideas in theory but poor in practice.”

New Federal Task Force to Address Opioid Prescribing

By Pat Anson, Editor

The federal government is forming another advisory panel to study and develop "best practices" for treating acute and chronic pain. And for the first time, the feds are seeking nominations from the public for members to serve on the panel, who would represent pain patients and pain management experts.

The Pain Management Best Practices Inter-Agency Task Force was authorized by the Comprehensive Addiction and Recovery Act of 2016 – also known as the CARA Act – a landmark bill signed into law last year to address the nation's addiction and overdose crisis.

While much of CARA is focused on preventing and treating opioid addiction, the law also calls for the Department of Health and Human Services (HHS) to form a task force to recommend solutions to “gaps or inconsistencies” in pain management policies among federal agencies.

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Currently, the Centers for Disease Control and Prevention, Food and Drug Administration, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, and the Department of Defense all have different regulations and guidelines for opioid medication.

“This Task Force represents a critical piece of HHS’s five-point strategy to defeat the opioid epidemic, which includes advancing the practice of pain management,” HHS Secretary Tom Price said in a news release.

“Top experts in pain management, research, addiction and recovery can help us reassess how we handle the serious problem of pain in America.”

The task force could have as many as 30 members representing a broad spectrum of interests in pain management, according to a notice being published in the Federal Register:

The members of the Task Force shall include currently licensed and practicing physicians, dentists, and non-physician prescribers; currently licensed and practicing pharmacists and pharmacies; experts in the fields of pain research and addiction research, including adolescent and young adult addiction; experts on the health of, and prescription opioid use disorders in, members of the Armed Forces and veterans; and experts in the field of minority health.

The Members of the Task Force shall also include… representatives of pain management professional organizations; the mental health treatment community; the addiction treatment community, including individuals in recovery from substance use disorder; pain advocacy groups, including patients; veteran service organizations; groups with expertise on overdose reversal, including first responders; State medical boards; and hospitals.

Members will also be appointed to represent Veterans Affairs, Department of Defense, Office of National Drug Control Policy, and “relevant HHS agencies.” The latter most likely includes the FDA and CDC. The Drug Enforcement Administration, an agency in the Department of Justice, will apparently not have a representative on the task force.

Pain patients and pain management experts have been poorly represented – and in some cases excluded – from previous federal advisory panels that addressed opioid prescribing and addiction. Some panel meetings were also closed to the public.

President Trump’s opioid commission, for example, includes three governors, a former congressman, and a Harvard professor who has been a longtime critic of opioid prescribing. No patients, pain management experts or practicing physicians were appointed, and the commission only heard testimony from addiction treatment advocates during its one public meeting.

That was better than the CDC, which held no public hearings while preparing the initial draft of its opioid prescribing guideline in 2015. As PNN has reported, the “Core Expert Group” and various stakeholders that advised the CDC were dominated by special interest groups and addiction treatment specialists, including five board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Only after a public outcry and threats of a lawsuit did the agency delay the release of the guideline, seek public comment and form a new advisory panel.

Are you interested in becoming a member of the new task force on pain management or know someone who might?

Information on how to nominate individuals – including self-nominations -- can be found by clicking here. Applications are due by Wednesday, September 27. All nominations must be submitted via email to the attention of Vanila Singh, MD, Chief Medical Officer at PainTaskforce@hhs.gov.

Members of the task force who are not government employees will receive per diem pay and reimbursement for travel expenses. All task force meetings will be open to the public.