Implementing Robust Opioid Management


May 2020 : Diversion Management - Vol. 17 No. 5 - Page #6

According to data from the National Institutes of Health, 128 Americans die each day from opioid overdoses.1 Title 21 of the Code of Federal Regulations (CFR) defines an opioid as2:

Any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.

On October 16, 2017, the US government declared the opioid epidemic a public health emergency. Although multifactorial, there are a number of key milestones thought to contribute to the opioid epidemic (see the SIDEBAR3).

The statistics resulting from the opioid epidemic in the US are staggering4:

  • More than 700,000 people died from a drug overdose between 1999 and 2017
  • The age-adjusted rate of overdose deaths increased significantly by 9.6% in 2016 (19.8 per 100,000) to 2017 (21.7 per 100,000)
  • Opioids were involved in 47,600 overdose deaths in 2017 (67.8% of all drug overdose deaths)
  • In 2017, the states with the highest rates of death due to drug overdose were West Virginia (57.8 per 100,000), Ohio (46.3 per 100,000), Pennsylvania (44.3 per 100,000), the District of Columbia (44.0 per 100,000), and Kentucky (37.2 per 100,000)1
  • In 2017, the number of overdose deaths involving opioids (including prescription opioids and illegal opioids such as heroin and illicitly manufactured fentanyl) was 6 times higher than in 1999

As a result, many states have introduced legislation to curtail inappropriate prescribing of opioids. In addition, public agencies and health systems have implemented or are considering harm reduction strategies, including increasing the availability of lifesaving medications such as naloxone, as well as providing resources for those with Opioid Use Disorder interested in recovery from addiction.

Opioid Legislation

Massachusetts passed the first legislation in 2016 limiting opioid prescriptions, including a 7-day supply limit for first-time opioid prescriptions. By the end of 2016, seven states had passed legislation limiting opioid prescriptions; by October 2018 the number of states passing opioid-prescribing related legislation was up to 33.5 The Comprehensive Addiction and Recovery Act (CARA), an attempt to address the opioid epidemic at the federal level, was also passed in 2016. Highlights of CARA are as follows6:

  • Implements a 3-day limit on initial opioid prescriptions for acute pain
  • Allows physician assistants and nurse practitioners to prescribe buprenorphine under the direction of a qualified physician
  • Allows states to waive the limit on the number of patients a physician can treat with buprenorphine, provided they follow evidence-based guidelines
  • Requires that physicians and pharmacists use their state Prescription Drug Monitoring Programs (PDMPs) upon prescribing or dispensing opioids
  • Increases civil and criminal penalties for opioid manufacturers that fail to report suspicious orders for opioids or fail to maintain effective controls against diversion of opioids
  • Creates a national standard for recovery residence to ensure quality housing for individuals in long-term recovery

Harm Reduction Strategies

Although there have been many efforts at both the state and federal level to address the opioid epidemic, individual hospitals and health care systems can also take steps to reduce harm for those with Opioid Use Disorder, including increasing the accessibility and use of naloxone.

The CDC recommends that naloxone, a lifesaving medication used to reverse the effects of an opioid overdose, be prescribed in conjunction with high dose opioid prescriptions (greater than 50 milligram equivalents of morphine). The CDC also recommends that naloxone be available in all pharmacies.7 Unfortunately, at this time, only 1 in 70 high dose opioid prescriptions are issued with a corresponding naloxone prescription, with rural counties 3 times more likely to be ranked as low dispensing locations compared to metropolitan areas.7

Classified as an opioid antagonist with a high affinity for µ-opioid receptors, naloxone was approved by the FDA in 1971 in an injectable form.8 Since that time, naloxone has been the primary recommended medication used for reversal of opioid-related overdoses,7,9,10 with its delivery methods expanding to subcutaneous, intramuscular, and intranasal spray.

When used to treat opioid overdose, it will result in withdrawal symptoms within minutes of administration and dissipate after approximately 2 hours, depending on the route of administration and the opiate that is antagonized.10 Studies have shown that it crosses the placenta and is not recommended for pregnant women unless in an emergency to save the mother’s life during an opioid overdose.10,11 It is primarily metabolized by the liver and excreted in the urine with about 70% excreted by 72 hours.10

As described in TABLE 1,12-14 there are multiple methods of delivery for naloxone. Dosage will vary based on response. See TABLE 2,15-17 for patients at high risk of opioid overdose.


Naloxone Guidance and Legislation

The World Health Organization offers guidance for organizations that provide harm reduction services, including naloxone programs. For example, suggested core services include ensuring naloxone is accessible to people who are more likely to witness an opioid overdose.18 Since this guidance was released in 2010, there has been a rapid expansion of naloxone distribution programs integrated within the community, increasing accessibility to naloxone and reducing opioid overdose-related deaths. Moreover, naloxone distribution programs are considered safe and cost effective.19,20

These initiatives also led to a guide produced by the Harm Reduction Coalition that provides a framework of factors to consider when implementing a naloxone distribution program. Suggestions include20:

  • Know the state rules and laws
  • Maintain awareness of other available harm reduction resources that can be utilized
  • Obtain education on how to assemble and distribute naloxone kits
  • Follow recommended training when responding to an opioid overdose

In addition, an Opioid Overdose Prevention Toolkit,9 released by the Substance Abuse and Mental Health Services Administration (SAMHSA), expands on use of naloxone in the community. This resource provides guidance on:

  • Naloxone prescribing information for prescribers and first responders
  • Information for patients and their caregivers on preventing and recognizing an opioid overdose
  • Resources to consider after recovery from an opioid overdose

As of 2018, all 50 states and the District of Columbia have passed some type of legislation to make naloxone more accessible to the layperson,21 which has contributed to a decrease in opioid overdose-related deaths.11,13 It should be noted that there are variances in the state laws regarding who can prescribe the medication, prescriber immunity, good Samaritan laws, dispensing to a third-party individual, and whether naloxone is considered a prescription product.22,23 It is important for community groups or pharmacies that stock and dispense naloxone to know their state laws and regulations and track dispensing and administration to better advocate for increased accessibility and funding of such programs.24

Resources for Recovery

Awareness of resources available to people who are addicted to opioids and would like to quit is critical. Between 2003 and 2016, as the heroin and synthetic opioid phases of the opioid epidemic increased, there was also a 39% increase in opioid treatment programs across the US, as well as a sharp increase in medication-assisted treatment for Opioid Use Disorder.25 Increased funding recently announced by SAMHSA26 focuses on medication-assisted therapies and peer-to-peer support to further enhance recovery. Increased press coverage and online resources help make finding a treatment center more accessible. Additional resources include a 24-hour hotline for identifying a treatment center, an online treatment center locator by zip code, resources detailing how to access care if insured or uninsured, and five recommended signs to look for when identifying a quality treatment program.27,28

These resources should be readily available at sites distributing naloxone, combining the principles of harm reduction with education on recovery options.29

Conclusion

Although Opioid Use Disorder is a serious, life-threatening condition, resources are available from multiple sources for individuals seeking recovery. The increased availability of naloxone and other risk reduction strategies are effective tools to help manage the opioid epidemic. Health systems should strongly consider employing these strategies to curtail the epidemic and to ensure that their patients have access to the resources they require.


References

  1. Opioid Overdose Crisis. National Institute on Drug Abuse. https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis. Updated February 2020.
  2. Code of Federal Regulations Title 21. US Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=862.3650. Updated April 1, 2019.
  3. Jones M, Viswanath O, Peck J, Kaye A, Gill J, Simopoulos T. A Brief History of the Opioid Epidemic and Strategies for Pain Medicine. Pain Ther. 2018;7(1):13-21.
  4. Opioid Overdose: Understanding the Epidemic. Centers for Disease Control and Prevention. https://www.cdc.gov/drugoverdose/epidemic/index.html. Updated March 19. 2020.
  5. Prescribing Policies: States Confront Opioid Overdose Epidemic. National Conference of State Legislatures. http://www.ncsl.org/research/health/prescribing-policies-states-confront-opioid-overdose-epidemic.aspx. Published June 20, 2019.
  6. The CARA 2.0 Act of 2018. State of West Virginia. https://www.capito.senate.gov/imo/media/doc/CARA%202.0%20Act%20One-Pager.pdf
  7. Vital Signs: Life-Saving Naloxone from Pharmacies. Center for Disease Control and Prevention. https://www.cdc.gov/vitalsigns/naloxone/index.html. Updated August 6, 2019.
  8. Joint Briefing Note on Behalf of Adapt Pharma, Kaleo and Insys Therapeutics Naloxone Co-Prescribing November 2018. US FDA. https://www.fda.gov/media/121181/download. December 17, 2018.
  9. Opioid Overdose Prevention Toolkit. Substance Abuse and Mental Health Services Administration. https://store.samhsa.gov/product/Opioid-Overdose-Prevention-Toolkit/SMA18-4742. Published June 2018.
  10. Naloxone Hydrochloride Injection [package insert]. Cherry Hill, NJ: West-Ward Pharmaceuticals Group; 1971.
  11. ASAM Board of Directors. National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. Maryland: American Society of Addiction Medicine; 2015. https://www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-national-practice-guideline-supplement.pdf?sfvrsn=24. Published June 1, 2015.
  12. Highlights of Prescribing Information: Narcan Nasal Spray. US FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf. Updated November 2015.
  13. Highlights of Prescribing Information: Evzio. US FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf. Updated October 2016.
  14. Jiang T. Clinical and Regulatory Overview of Naloxone Products Intended for Use in the Community. US FDA. https://www.fda.gov/media/121189/download. December 17, 2018.
  15. Medication and Counseling Treatment: Naloxone. Substance Abuse and Mental Health Services Administration. https://www.samhsa.gov/medication-assisted-treatment/treatment/naloxone. Updated September 27, 2019.
  16. Naloxone: The Opioid Reversal Drug that Saves Lives. U.S. Department of Health and Human Services. https://www.hhs.gov/opioids/sites/default/files/2018-12/naloxone-coprescribing-guidance.pdf
  17. Power in a Bottle. Open Society Foundations. https://www.opensocietyfoundations.org/voices/power-bottle.
  18. International Standards for the Treatment of Drug Use Disorders. United Nations Office on Drugs and Crime. https://www.who.int/substance_abuse/activities/msb_treatment_standards.pdf?ua=1&ua=1. Published March 2017.
  19. Naumann RB, Durrance CP, Ranapurwala SI, et al. Impact of a community-based naloxone distribution program on opioid overdose death rates. Drug Alcohol Depend. November 1, 2019;204:107536. doi: 10.1016/j.drugalcdep.2019.06.038.
  20. Wheeler E, Jones, TS, Gilbert M, Davidson P. Opioid Overdose Prevention Programs Providing Naloxone to Laypersons – United States, 2014. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6423a2.htm Published June 19, 2015.
  21. Naloxone Overdose Prevention Laws. Prescription Drug Abuse Policy System. http://www.pdaps.org/datasets/laws-regulating-administration-of-naloxone-1501695139. Updated July 1, 2017.
  22. Is naloxone accessible? National Institute on Drug Abuse. https://www.drugabuse.gov/publications/medications-to-treat-opioid-addiction/naloxone-accessible. Updated June 2018.
  23. Case Studies. Naloxone Info.org. www.naloxoneinfo.org/case-studies/standing-orders.
  24. Advocacy. Naloxone Info.org. http://naloxoneinfo.org/advocacy/document-your-work.
  25. Alderks C. Trends in the Use of Methadone, Buprenoprhine, and Extended-Release Naltrexone at Substance Abuse Treatment Facilities: 2003-2015 (Update). The CBHSQ Report. https://www.samhsa.gov/data/sites/default/files/report_3192/ShortReport-3192.pdf. Published August 22, 2017.
  26. State Opioid Response Grants by State. U.S. Department of Health and Human Services. https://www.hhs.gov/about/news/2019/09/04/state-opioid-response-grants-by-state.html. Published September 4, 2019.
  27. Behavioral Health Treatment Services Locator. Substance Abuse and Mental Health Services Administration. https://findtreatment.samhsa.gov/
  28. Finding Quality Treatment for Substance Use Disorders. Substance Abuse and Mental Health Services Administration. https://store.samhsa.gov/system/files/pep18-treatment-loc.pdf
  29. Principle of Harm Reduction. Harm Reduction Coalition. https://harmreduction.org/about-us/principles-of-harm-reduction/

Sheetal Patel-House, PharmD, is the system clinical manager for the Controlled Substances Assessment (CSA) program at University of North Carolina (UNC) Health.

Ashley L. Pappas, PharmD, MHA, is the director for UNC Health’s Medication Management and Optimization team, including the CSA program, and the Pharmacy Analytics and Outcomes team.

 


 

SIDEBAR

Events Contributing to the Opioid Epidemic3

In 1986, the World Health Organization (WHO) addressed the undertreatment of postoperative and cancer pain with their Cancer Pain Monograph. This resulted in rapid improvement in the treatment of cancer pain in many countries, as well as a number of publications in the 1990s that focused on the undertreatment of pain. In 1995, the American Pain Society launched their influential Pain as the Fifth Vital Sign campaign with the intent to encourage consistent assessment and treatment of pain symptoms. Subsequently, in 2000, The Joint Commission published standards for pain management requiring health care providers to ask every patient to rate their pain on a scale of 1 to 10.

The Federation of State Medical Boards and the DEA also issued statements promising less regulatory scrutiny over opioid prescribers, thereby lowering physician reluctance to prescribe more liberal amounts of opioids. Certain pharmaceutical companies also started to focus on the use of opioids as a compassionate treatment option, often using paid physician consultants to emphasize the safety and benefits of opioid use.

From 1997 to 2002, oxycontin prescriptions increased from 670,000 to 6.2 million and overall opioid consumption steadily increased throughout the 2000s; this time period is considered the first wave of the opioid epidemic. The second wave began in 2010, with rapid increases in overdose deaths involving heroin. The third wave began in 2013, with significant increases in overdose deaths involving synthetic opioids—particularly those involving illicitly manufactured fentanyl.

 

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