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12 Articles in Volume 21, Issue #2
Advanced Practice Matters with Theresa & Jeremy: MAT and the DATA Waiver Debate
Analgesics of the Future: The Potential of Vocacapsaicin Injections for Knee Pain
Authorities Update Opioid and Naloxone Prescribing Policies as Overdoses Soar
Autologous Adipose-Derived Biocellular (Stem Cell-Rich) Prolotherapy into Hoffa’s Fat Pad Improves Knee Osteoarthritis
Behavioral Medicine: How to Utilize Acceptance and Commitment Therapy in Primary Care
Case Report: How We Grew Our Pain Practice Amidst Pandemic, Opioid Crisis
Chronic Overlapping Pelvic Pain Disorders: Differential Diagnoses and Treatment
Fentanyl Transdermal Patch: Variability is Key When Prescribing
Optimizing Opioid Therapy with Pharmacogenetics
Research Insights: Advances in Shoulder Arthroplasty and Revision Surgery
Research Insights: How to Address Osteoarthritis Treatment Gaps in Women
Topical Anti-Inflammatories: Analgesic Options for Arthritis Beyond NSAIDs

Authorities Update Opioid and Naloxone Prescribing Policies as Overdoses Soar

Updated requirements and risk mitigation plans address both acute and chronic pain, pharmacy requirements, and naloxone distribution.

With the deadly COVID-19 pandemic entering its second year and so many novel issues for pain care providers to grapple with as a result, it is perhaps understandable that the urgency of the United States’ opioid overdose epidemic slipped a bit on our collective radar.

The crisis, however, is as urgent as ever, with more than 40 states reporting an increase in opioid-related deaths since the beginning of the pandemic, including a devastating 67% increase of fatal drug overdoses in Virginia after stay-at-home orders went into effect.1 This heartbreaking rise in opioid-related fatalities is despite the fact that there has been a 37% decrease in opioid prescriptions since 2014,2 and a 60% decrease in prescription opioid use from its peak in 2011.3

Thus, it is as vital as ever that the medical community continue to do its parts to take thoughtful and persistent action to prevent opioid-related deaths, thinking beyond simply reducing the number of prescriptions written. In an effort to do just that, many local, federal, and international authorities have recently updated their policies and guidance documents in a number of ways that impact both how providers of pain management care for their patients, as well as how healthcare providers may more broadly help the general public to reduce opioid overdose deaths.

See also, a commentary on why drug monitoring should not be halted during the pandemic.

The CDC issued a health advisory that states the urgent need to expand the provision and use of naloxone and overdose prevention education amidst the opioid overdose crisis. (Image: iStock)

Overdose Rescue: CDC and Local Authorities Urge Increased Naloxone Prescribing

In response to the spike in fatal overdoses, the CDC recently issued a health advisory that states the urgent need to expand the provision and use of naloxone and overdose prevention education.4 The agency recommends that public health departments and community-based organizations raise awareness about the critical need for bystanders to have naloxone on hand so it may be quickly administered during an overdose, urging HCPs to prescribe naloxone to their at-risk patients, and encouraging harm-reduction organizations to increase the provision of overdose prevention education and take-home naloxone to those likely to witness or experience an overdose (eg, caregivers and family).

Local and state authorities have acted to improve access to, and utilization of, the opioid overdose reversal medication in recent months. Last summer, New York expanded its “Good Samaritan” law to allow a slew of new types of businesses to possess and administer naloxone, including malls, beauty parlors, theaters, hotels, restaurants, bars, and retail establishments.5 This means that these businesses may now save the lives of their patrons experiencing an overdose without fear of being penalized for providing medical attention. Having experienced a record-breaking increase in opioid deaths in 2020,6 Washington, DC, is considering legislation that would expand the ranks of city employees who may carry and administer naloxone.

In accordance with the recent CDC health advisory, all HCPs should familiarize themselves with the naloxone laws in their own state, and thoughtfully consider how they may help to increase the number of naloxone carriers in their locality. Does your state allow naloxone to be carried by bartenders? Teachers? Librarians? The general public is not likely to know about their ability to save lives with naloxone, so it will be up to providers and community-based organizations to spread the word.

See also, Should naloxone be made available in schools? An April 2021 regulatory update regarding HHS buprenorphine prescribing guidelines.


Opioid REMS Program: FDA Updates Requirements for Prescribers and Pharmacies  

The FDA has taken steps to ensure that the benefits of opioid drugs continue to outweigh the risks, aiming to improve the Risk Evaluation and Mitigation Strategy (REMS) programs for transmucosal immediate-release fentanyl (TIRF) and opioid analgesic (OA) products.

According to the FDA, TIRFs are particularly powerful opioid medications and may only be used to safely manage breakthrough pain in adults with cancer who are opioid tolerant based on concurrent regular use of another opioid medication.7 Therefore, to ensure the safety of patients, FDA has strengthened their REMS program by:

  • requiring that prescribers document a patient’s opioid tolerance with each prescription of a TIRF medicine for outpatient use;
  • implementing new requirements for inpatient and outpatient pharmacies; and
  • creating a new patient registry to monitor for accidental exposure, misuse, abuse, addiction, and overdose.

The FDA is also considering making changes to the OA REMS program, having held a public workshop in December 2020 on the program’s effect to date on prescribing behaviors and patient outcomes.8 Following the workshop, public written comments were collected through February 2021. It is likely that, after the agency has considered all public comments and related data, updates to the OA REMS program will be forthcoming.


AHRQ Launches Report, Ongoing Review of New Treatments for Pain

The Agency for Healthcare Research and Quality (AHRQ) – the federal agency responsible for producing evidence to make healthcare safer, higher quality, more accessible, equitable, and affordable – has been taking a close look at a variety of treatments for acute and chronic pain.

In the last days of 2020, AHRQ released Treatments for Acute Pain: A Systematic Review, a report that should interest all HCPS, from pain management specialists to primary care and advanced practice providers.9 After analyzing 183 RCTs, the committee determined that opioid therapy was associated with decreased or similar effectiveness as an NSAID for some acute pain conditions but carried an increased risk of short-term adverse events. Further, while evidence on nonpharmacological therapies was limited, heat therapy, spinal manipulation, massage, acupuncture, acupressure, a cervical collar, and exercise were all deemed effective for specific acute pain conditions.

The full evidence summary may be of particular interest to clinicians wanting to learn more about the evidence associated with specific treatments.

The agency is also investigating interventional treatments for acute and chronic pain,10 integrated pain management programs,11 and is running a living systematic review on cannabis and other plant-based treatments for chronic pain.12 The timeframe for the public to submit relevant evidence has ended for the projects related to interventional treatments and integrated programs, and final reports will likely be released in the coming months. The living systematic review will assess the effectiveness and harms of plant-based treatments for chronic pain conditions using methods to identify and synthesize recently published literature on an ongoing basis, so there is no anticipated endpoint for that project.

WHO Issues Guidelines on the Management of Chronic Pain in Children

The World Health Organization (WHO) has issued Guidelines on the Management of Chronic Pain in Children, providing recommended physical, psychological, and pharmacological interventions for pain relief in children aged 0 to 19 years.13 The new guidelines are intended to support WHO members  (including the US) as they develop and implement national and local policies, regulations, pain management protocols, and best practices for pain relief, as well as highlight the importance of opioid stewardship so that states may best address the related worldwide concerns.

The recommendations from WHO include three areas of treatment: physical therapy, psychological therapy, and pharmacological management, which may include the use of morphine for end-of-life-care or when chronic pain is associated with life-limiting conditions. Further, the guidelines take a similar approach to the US’s Pain Management Best Practices Inter-Agency Task Force Report (recently discussed by PPM and Dr. Vanila Singh),14 stating that children with chronic pain must be cared for from a biopsychosocial perspective, as opposed to treating pain as a purely biomedical problem.

Although the WHO guidelines are intended to aid policymakers at the state and federal levels, providers would certainly benefit from familiarizing themselves with the guideline’s section on best practices for the clinical management of chronic pain and the related recommendations, while researchers will be interested in the portion related to research gaps related to specific populations and interventions.

More on the WHO update in our Q&A with steering committee member Bernadette Daelmans, MD.

Last updated on: April 28, 2021
Continue Reading:
The Biden Administration Plan for Treating Opioid Use Disorder in the US: Is There One?
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