Guidelines

Many states have opioid laws or regulations that limit the dose, duration, and/or quantity of opioid prescriptions.1 State laws and guidelines are also important to review prior to treatment since they may have information pertinent to local populations.2,3 For example, since marijuana use is prevalent in Oregon, clinicians should discuss this with their patients prior to prescribing opioids.4

There are no equivalent federal laws and regulations on opioid prescribing limits. However, there are a number of key national guidelines on opioid prescribing, most notably the Center for Disease Control (CDC) 2022 Clinical Practice Guideline for Prescribing Opioids for Pain.1 The Centers for Medicare and Medicaid Services (CMS) has some policies to reduce opioid over-utilization, which includes drug management programs, retrospective drug utilization reviews, and opioid safety edits at the point-of-sale.5 There are also guidelines from non-governmental organizations, which sets opioid prescribing limits for different types of procedures and pain types, for example the American Dental Association.6 Another reference for HCPs practicing in opioid treatment programs (OTPs) is the Substance Abuse and Mental Health Services Administration (SAMHSA) Federal Guidelines for Opioid Treatment Programs, a manual that covers patient assessment and treatment.7

Individual hospitals and physician groups might have their own opioid guidelines that leverage state legislation, but are more specific.8 For example, an expert panel’s best practices for opioid prescribing for common surgical procedures.8

Clinicians should stay informed on both state and federal opioid updates. For example, the Drug Enforcement Agency (DEA) Diversion Control Program issues updates related to prescribing practices. During the COVID-19 pandemic, the DEA allowed certain flexibilities in prescribing controlled substances for opioid treatment program (OTP) providers.10 Examples include take-home doses of methadone for certain patients, telehealth for buprenorphine initiation, and expanded access to treatment for certain patients.11 These flexibilities will remain in place permanently per a final rule from the Substance Abuse and Mental Health Services Administration (SAMHSA).12

In 2016, the CDC published guidelines on opioid prescribing that greatly impacted the rate of opioid prescriptions around the country.13 In 2022, CDC released updates to this guideline. Key recommendations include that opioids should be prescribed at the lowest effective dose for the duration that warrants opioid use, and that non-opioid therapy use should be maximized when possible.13

Evaluating Risks and Benefits

CDC’s Clinical Practice Guideline states that risks and benefits must be evaluated within 1-4 weeks of opioid initiation and periodically during the treatment.13 Risk mitigation strategies should be developed in the event of overdoses, and risks and benefits should be evaluated before increasing opioids, with plans for tapering and discontinuation.13 The guideline recommends that prescription drug monitoring data should be used with all patients, not just those who are thought to be at high-risk.13

The prescription drug monitoring program (PDMP) is an electronic database that tracks prescriptions of controlled substances for each state.14 Pharmacists enter data into PDMPs whenever they dispense medications. It’s an effective surveillance tool for physicians to assess patient’s medication histories before prescribing them an opioid. In fact, some states require that this occurs before a prescription of any controlled substance.15

PDMPs can also help identify at-risk patients who received or are receiving opioids from another clinician, including opioids combined with benzodiazepine.16 It can also alert clinicians of one of their patients has experienced a fatal overdose. Clinicians should check their state’s PDMP for rules around access and mandatory use laws.

CDC’s Clinical Practice Guideline has identified recommendations for clinicians using PDMPs, which can be incorporated into treatment best practices, and key considerations are as follows:1

In addition to the CDC’s Practice Guideline and PDMP databases, the FDA is also an important resource for risk/benefit information. Risks are always detailed in the Boxed Warning of a drug’s prescribing information.17 The FDA has implemented a risk evaluation and mitigation strategy (REMS) for all opioids in outpatient use.18 The Opioid Analgesic REMS Program is a training for all HCPs involved with pain management.18 Analgesic drugs outside of the classes covered by this training (eg, opioids used in inpatient settings) may require other risk mitigation strategies.18

Prescribers should continuously check for any updates from the FDA regarding opioid use.19 For example, the FDA recently released updates regarding prescribing information for immediate-release (IR) and extended release/long-acting (ER/LA) opioid.20 This includes a statement that says the risk of overdose increases as the dose increases, along with new information in the Boxed Warning section, and other updates to indications and usage.20

Opioid Agreements

Opioid agreements can be used prior to initiation of long-term opioid therapy.21 Pain agreements establish a foundation of trust and communication between the clinician and patient, and details risks and benefits of opioid therapy, as well as treatment goals.22

They are often one- or two-page documents, and the actual content of the agreement depends upon the clinician, type of practice, and the patient.21,23 Agreements might include statements that say the patient will not share or sell the opioid prescription, will only have one prescriber and one pharmacy, or keep the medication safely stored at home.24 For patients at-risk, the agreement might also say that urine drug screens may be requested at any time.25 There should be a mutual understanding that the agreement is valued and will be upheld (eg, clinician may refer the patient to a SUD specialist).25

There is potential for negative language around agreements, and using terms, such as “pain contract” or “narcotic contract” can be coercive and perpetuate stigma. Other terms that can be used are “controlled-substances agreement”, “treatment agreement”, or “opioid patient prescriber agreement”.21,26 It’s also important that the language within the agreement stays non-judgmental and non-stigmatizing, and respects the patient-provider relationship. They can be framed as agreements that outline the treatment plans with an aim to improve patient safety, health, and well-being.2

Pain agreements are not always required, while some states, such as West Virginia require informed consent and treatment agreements along with the opioid prescription.27

References

  1. Dowell D, et al. CDC Clinical Practice Guideline for Prescribing Opioids for Pain United States, 2022. MMWR Recomm Rep. 2022;71:1-95.
  2. Sedney CL, et al. Assessing the impact of a restrictive opioid prescribing law in West Virginia. Subst Abuse Treat Prev Policy. 2021;16:14.
  3. Sullivan KJ, et al. Impact of statewide statute limiting days’ supply to opioid-naive patients. Am J Prev Med. 2024;66:112-118.
  4. Oregon Health Authority: Public Health Division. Oregon chronic opioid prescribing guidelines. 2017-2018. https://www.oregon.gov/obnm/Documents/Chronic-Opioid-Prescribing-Guidelines.pdf
  5. Centers for Medicare & Medicaid Services (CMS). Medicare Part D Opioid Safety Edit Reminders and Recommendations and Frequently Asked Questions (FAQs). December 19. 2022. https://www.cms.gov/files/document/cy-2023-opioid-safety-edit-reminders-and-recommendations.pdf
  6. Carrasco-Labra A, et al. Evidence-based clinical practice guideline for the pharmacologic management of acute dental pain in adolescents, adults, and older adults: A report from the American Dental Association Science and Research Institute, the University of Pittsburgh, and the University of Pennsylvania. J Am Dent Assoc. 2024;155:102-117.e9.
  7. Substance Abuse and Mental Health Services Administration (SAMHSA). Federal Guidelines for Opioid Treatment Programs. HHS Publication No. (SMA) PEP15-FEDGUIDEOTP. 1/2015. https://store.samhsa.gov/sites/default/files/guidelines-opioid-treatment-pep15-fedguideotp.pdf
  8. Overton HN, et al. Opioid-prescribing guidelines for common surgical procedures: An expert panel consensus. J Am Coll Surg. 2018;227:411-418.
  9. Berube J. Opioid Prescribing Guidelines. https://www.massgeneral.org/assets/mgh/pdf/opioid-task-force/opiodprescribingguidelines.pdf
  10. Drug Enforcement Administration (DEA). DEA, SAMHSA Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications for Six Months While Considering Comments from the Public. Published May 9, 2023. https://www.dea.gov/press-releases/2023/05/09/dea-samhsa-extend-covid-19-telemedicine-flexibilities-prescribing
  11. US Code of Federal Regulations. Medications for the Treatment of Opioid Use Disorder: A Rule by the Health and Human Services Department. February 2, 2024. https://www.federalregister.gov/documents/2024/02/02/2024-01693/medications-for-the-treatment-of-opioid-use-disorder
  12. American Medical Association. New rules enable telemedicine treatment for opioid-use disorder. Published March 12, 2024. https://www.ama-assn.org/delivering-care/overdose-epidemic/new-rules-enable-telemedicine-treatment-opioid-use-disorder
  13. Gangal A, et al. The 2022 CDC opioid prescription guideline update: Relevant recommendations and future considerations. JAAD Int. 2023;13:48-49.
  14. Centers for Disease Control and Prevention (CDC). Prescription Drug Monitoring Programs (PDMPs): Overdose Prevention. Published 5/7/2024. https://www.cdc.gov/overdose-prevention/php/interventions/prescription-drug-monitoring-programs.html
  15. Strickler GK, et al. Effects of mandatory prescription drug monitoring program (PDMP) use laws on prescriber registration and use and on risky prescribing. Drug Alcohol Depend. 2019;199:1-9.
  16. Centers for Disease Control and Prevention (CDC). Leveraging Prescription Drug Monitoring Program (PDMP) Data in Overdose Prevention and Response. Published March 2021. https://www.cdc.gov/overdose-prevention/media/pdfs/pubs/Leveraging-PDMPs-508.pdf
  17. Delong C, Preuss CV. Box warning. StatPearls. Last updated June 17, 2023. https://www.ncbi.nlm.nih.gov/books/NBK538521/
  18. US Food and Drug Administration (FDA). Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry. Last updated June 2019. https://www.fda.gov/media/128150/download
  19. US Food and Drug Administration. FDA MedWatch. Last updated August 16, 2024. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
  20. US Food and Drug Administration (FDA). FDA Updates Prescribing Information to Provide Additional Guidance for Safe Use. Last updated April 13, 2023. https://www.fda.gov/safety/medical-product-safety-information/all-opioid-pain-medicines-drug-safety-communication-fda-updates-prescribing-information-provide
  21. US Food and Drug Administration (FDA). FDA Opioid Agreement. August 9, 2024. https://www.fda.gov/files/drugs/published/Opioid-Patient-Prescriber-Agreement-(PPA).pdf
  22. Pergolizzi JV, et al. A multicentre evaluation of an opioid patient-provider agreement. Postgrad Med J. 2017;93:613-617.
  23. Cheatle MD, Savage SR. Informed consent in opioid therapy: A potential obligation and opportunity. J Pain Symptom Manage. 2012;44:105-116.
  24. Pacheco S, et al. Adherence to opioid patient prescriber agreements at a safety net hospital. Cancers (Basel). 2023;15:2943.
  25. McDonald JV. What do you do, when a patient violates a pain agreement? Published 6/10/2015. https://health.ri.gov/publications/guidelines/provider/PatientViolatesPainAgreement.pdf
  26. Tobin DG, Keough Forte K, Johnson McGee S. Breaking the pain contract: A better controlled-substance agreement for patients on chronic opioid therapy. Cleve Clin J Med. 2016;83:827-835.
  27. Dydyk AM, et al. West Virginia opioid prescribing for chronic pain while avoiding drug diversion. StatPearls. Last updated June 12, 2023. https://www.ncbi.nlm.nih.gov/books/NBK563323/

All URLs accessed August 15, 2024.

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