Reducing Opioid Overdose Risk in Patients with Opioid Use Disorder

Case Two: Prescribing Opioids for Pain vs. Treating the Underlying Causes of Pain

A major concern of the consultants reviewing the following case was the physician’s apparent failure to address the patient’s poorly controlled diabetes as an element of managing the patient’s pain associated with diabetic peripheral neuropathy.

Allegation

The internist negligently prescribed excessive narcotic medications without proper checks and balances following the patient’s treatment for opioid addiction.

Case File

A patient’s internist had been prescribing oxycodone as needed for his patient’s diabetic peripheral neuropathy for many years. In March 2017 the patient checked herself into an opioid addiction rehabilitation facility. Following treatment the patient was opioid free until June 2018 when she had surgery. Her surgeon prescribed hydromorphone, fentanyl patch, and codeine/acetaminophen for post-surgical pain relief (MME/day = 230). Thereafter, the internist refilled the prescriptions until the patient accidentally overdosed in September 2018. Her cause of death was determined to be mixed prescription intoxication.

The patient’s husband filed a wrongful death lawsuit alleging the internist prescribed excessive narcotic medications without proper checks and balances to ensure that abuse was not occurring and that he negligently prescribed narcotics following OUD treatment and caused the plaintiff’s wife to become addicted again, which increased her risk of accidental overdose.

Discussion

Experts were critical of the internist for what they perceived to be a failure to properly treat the underlying causes of the patient’s pain, manage the patient’s pain, and refer the patient to a pain management specialist when it became apparent that the patient’s needs exceeded his level of expertise. There was no evidence in the patient’s record that the internist educated her about the relationship between poorly controlled diabetes and peripheral neuropathy or that he worked with her to improve her compliance.

Furthermore, experts believed it was below the standard of care to prescribe pain medications with no treatment plan, substance use disorder (SUD) screening, therapeutic agreement, long-term goals, or prescription drug monitoring program (PDMP) review. Significantly, the patient had managed without opioid pain medications for over a year following opioid addiction treatment but, instead of providing an alternative to opioids for acute pain following surgery, the internist refilled her opioid prescriptions. Experts believed this was inconsistent with the standard of care.

Risk Reduction Strategies

Reducing the risk of accidental overdose in a chronic pain patient on opioid therapy requires a multimodal approach including: assessment of the medical and the probable biopsychosocial factors causing or contributing to the patient’s pain; substance abuse and suicide risk; development of a treatment plan; utilizing alternatives to addictive medications; establishment of treatment goals; monitoring for treatment efficacy and opioid use disorder; and referral when appropriate. The patient must be engaged in a thorough informed consent process that covers the risks associated with opioid use, the expected benefits, uncertainties of the anticipated treatment plan, and the alternatives.

Ensuring that patients understand their role in the success of a pain management treatment plan is crucial. Educating family members and caregivers about the pain management process can also improve results.3 Documenting these efforts provides evidence of opioid therapy for pain management that is consistent with the standard of care in the unfortunate event of a patient overdose. Consider the following strategies:1,4,5,6,7,8

Assessments

• Obtain a complete history.
  • Request copies of prior medical records.
• Evaluate the patient’s pain using a validated tool (e.g., the McCaffrey Initial Pain Assessment Tool).
• Conduct a directed physical examination.
• Evaluate the patient’s risk factors for opioid-related harm (e.g., pregnancy, kidney disease, being 65 years of age or older, mental health conditions, substance use disorder, prior overdose).
• Evaluate for prior/current substance abuse disorder (SUD) using a validated tool. (For a list of SUD assessment tools see the ADOPT: Advancing Drug and Opioid Prevention and Treatment chart.)
  
  • If it is available in your state, check the PDMP website. (See the Federation of State Medical Board’s Prescription Drug Monitoring Programs: State-by-State Overview for a state-by-state list of PDMP websites.)
    • Be aware of any state requirements for initially checking the PDMP and monitoring frequency thereafter.
    • When opioids or benzodiazepines are being prescribed by multiple sources, discuss PDMP findings with the patient.
  • With the patient’s consent, conduct urine drug screening.
  • Corroborate self-reports of substance use with medical records.
• Assess the patient for behavioral health disorders. (See the case study “Optimizing Opioid Therapy for Patients with Behavioral Health Disorders” for additional risk reduction strategies.)
• Document the use of pain, behavioral health, and SUD assessment tools and their results.

Treatment Planning

• Establish a treatment plan and goals.
• Establish expectations for pain relief.
• Involve patients in decision-making.
  • Discover the patient’s preferences and values and integrate them into the treatment plan.
• Treat the cause of the patient’s pain.
  • Work with the patient to reduce pain triggers.
• Prioritize alternatives to opioid therapy.
  • When appropriate (prior to considering opioid pain medications) prescribe a trial of non-opioid medications and non-pharmaceutical therapies that have been shown to decrease chronic pain (e.g., physical therapy, counseling, psychotherapy, cognitive-behavioral therapy [CBT], sleep hygiene improvement, graded exercise, mindfulness-based stress reduction techniques, spinal manipulations, meditation, and yoga).
  • Be prepared with counter arguments for patients who want to limit treatment to opioid therapy; for example, “I know this pain is causing you to suffer and I want to help with that. I need to do that in a way that is safe and prescribing abc is not safe. I’d like to recommend we try xyz.”
• Use the lowest possible MME/day in addition to alternative pain management strategies.
• Use additional caution when prescribing opioids to patients with depression or SUD.
• Initiate opioid therapy only if the potential benefits outweigh the risks.
  • Approach opioid therapy as a trial. Explain this plan to the patient and document it in the medical record.
  • Have a plan for evaluating effectiveness.
  • Have a plan to discontinue opioids if there is no clinically meaningful improvement in pain and function or if risks exceed benefits.
  • Set appropriate limits with therapeutic agreements and stick to them.
    • Refer to a pain management specialist if limits are exceeded.
  • If the PDMP indicates (or the patient reveals) that other physicians are prescribing medications that increase the risk of overdose, coordinate care with the other physicians.
    • Consider whether benefits outweigh risks of concurrent opioid therapy when combined with medications prescribed by other physicians, particularly benzodiazepines.
    • Calculate the total MME/day for the opioids you plan to prescribe and the opioids other physicians are prescribing.
      • If necessary, take measures to maintain total MME/day at safe levels.
    • Whenever more than one physician is prescribing opioids, delineate who will prescribe which medications.
    • Document the reasoning behind the selection of one therapy over another (including when treatment regimens are altered), both pharmacologic and non-pharmacologic.
    • Regularly revisit the treatment plan.
      • Adjust the treatment plan as the patient’s needs change.
    • Appreciate the importance of documenting your clinical decision-making process. Such documentation helps demonstrate that you are orchestrating patient care and taking a comprehensive approach rather than acquiescing to patient demands for certain medications.

Patient Education, Informed Consent, and Therapeutic Agreements

• Explicitly and realistically educate patients about the risks, benefits, and alternatives associated with opioid therapy initially, periodically during opioid therapy, and when therapy or the risk/benefits analysis changes. Set realistic expectations.
  • Engage the patient in an informed consent process that includes education about:
    • The risks of opioid therapy, including addiction, overdose, constipation, sedation, and hormonal changes
    • The overdose risks of combining opioids with benzodiazepines, other sedatives, alcohol, street drugs, or other opioids
    • The overdose risks associated with a high MME/day
    • The potential for tolerance and dependence
    • The potential for withdrawal symptoms if therapy is abruptly discontinued but also how the opioid therapy can be safely discontinued
    • Directions for informing other health professionals about the opioid therapy plan
    • How opioids will be prescribed (e.g., no early refills) and monitored (e.g., set appointments, urine tests, and PDMP surveillance)
    • The consequences associated with violating the therapeutic agreement, failing drug testing, obtaining opioids from multiple physicians, or otherwise circumventing treatment plans
    • The lack of evidence to support long-term opioid therapy for chronic non-cancer pain
    • The possibility that over time pain and function improvements that initially result from opioid therapy will diminish and risks can increase
    • The low probability of complete long-term pain relief
  • Emphasize improvement in function as a primary goal.
  • Document the informed consent process.
  • Facilitate the informed consent process with an informed consent form.
    • Give the patient a copy and maintain the original in the record.
  • Enter into a therapeutic agreement and monitor adherence.
    • Give the patient a copy and maintain the original in the record.

Monitor

• Reevaluate and document the patient’s level of pain, function, and response to treatment at each visit with a validated tool (e.g., Pain Assessment and Documentation Tool).
  • Track progress toward functional goals (e.g., walking the dog, gardening, returning to part-time work).
  • Consider integrating various assessment instruments into the electronic health record system.
  • Consider having the patient keep a pain diary.
    • Examples of pain diaries can be found online. These include the American Chronic Pain Association Pain Log and the WebMD Pain Control Chart. Mobile applications for pain management are also widely available to assist patients in keeping a diary of their symptoms.
  • Include the name of the drug, dose, and frequency with which the patient has been taking the medication.
• Monitor patient compliance with the treatment plan through regular follow-up assessments.
• Monitor the patient’s tolerance and dependence.
• If there is no clinically meaningful improvement in pain and function as compared to the start of treatment or in response to a dose change, or if adverse effects are significant, taper and discontinue opioids and use other approaches to pain management.
• Have a system in place to recognize and respond to indicators of substance abuse or diversion.
  • Regularly check the PDMP pursuant to state law requirements.
  • Ensure refills are not routinely renewed by office protocol or staff.
  • Perform urine toxicology screening to determine whether patients are taking the medications you have prescribed or taking medications that you have not prescribed.
  • Note the frequency with which the patient requests refills.
    • Understand the basis for patient requests for increased doses of opioids (e.g., increased pain, analgesic tolerance, or some other effect such as sedation or reduced anxiety).
  • Follow standardized procedures in response to indications that the patient is taking medications you have not prescribed or is requesting increased dosage of opioids for apparent non-analgesic effects.
  • Document support for the conclusion of suspected SUD or diversion, outcomes of discussion with the patient, suggestions for further treatment, etc.
  • Notify law enforcement and other authorities (e.g., Drug Enforcement Administration) if evidence of drug diversion or fraud arises.
• Document the monitoring process and responses to findings.

Consult/Refer

• Consult with pain management, behavioral health, or substance abuse specialists when appropriate.
• Use a matter-of-fact and unapologetic tone when presenting the need for referral to the patient.
  • Appropriately explain to the patient your reason for the referral to a particular specialist.
  • If the patient refuses a necessary referral, reiterate clinical rationale for making the referral, present and discuss the potential risks of refusal, and use a refusal-of-treatment form.
• Help the patient make appointments with specialists and explore telehealth options with specialists if access will be problematic for the patient.
• Follow up on referrals.
• Determine among yourself and consultants who will coordinate care.
  • Ensure that the patient knows which clinician is coordinating care.
• Document the various aspects of the referral process and efforts to ensure continuity of care, including:
  • Rationale for referral decisions
  • Efforts to refer the patient and the patient’s response to those efforts
  • Difficulties engaging a consultant
  • Communication with consultants

It’s important to note that proposing risk reduction strategies for pain management comes with the acknowledgement that some primary care practices may face limited referral options, insurance coverage for various pain management modalities, and clinician time to manage cases. It is important to realize, however, that lack of resources, insurance, options, etc. are not valid defenses to medical negligence. Primary care physicians cannot abdicate responsibility to address a patient’s complaints of pain – keeping in mind that addressing pain does not mean curing pain. Expectation management is important for all pain management patients, but crucial for legacy patients (patients who have been on long-term opioid therapy) in practices with limited resources. If a particular patient’s pain management is outside a physician’s scope, or resources cannot be accessed, the physician has to communicate that clearly and compassionately. A physician can state the needed care is “past my area of expertise and I need help managing your condition in the safest way possible.”

Appropriate documentation of efforts to accomplish pain management in a manner consistent with the standard of care is a crucial aspect of liability risk management in difficult circumstances. At a minimum, medical record documentation should include efforts to coordinate care and refer to specialists, the results of those efforts, and patient response to those efforts, as well as conversations with patients about waiting periods for specialty care referral and what can and cannot be done in the meantime.

Resources

The following is a sample of the many guidelines and tools available online that address opioid prescribing for chronic pain management.

Guidelines

U.S. Department of Health and Human Services 2019 Pain Management Best Practices Inter-Agency Task Force Report.

American Society of Interventional Pain Physicians. 2017 Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

United States Department of Veterans Affairs and the Department of Defense “Use of Opioids in the Management of Chronic Pain (2022)”

Tools

Safe Opioid Prescribing. U.S. Department of Health and Human Services. 2019.

• A collection of resources including links to continuing medical education, guidelines, and screening tools that aims to “promote the responsible and effective use of these medications in the treatment of pain”

Checklist for Prescribing Opioids for Chronic Pain. Centers for Disease Control and Prevention. 2020.

• A one-page checklist designed for primary care providers considering long-term opioid therapy for adults with chronic pain

Managing Chronic Pain in Adults with or in Recovery from Substance Use Disorders: “Appendix B. Assessment Tools and Resources.” United States Substance Abuse and Mental Health Services Administration. 2012.

• A collection of tools and resources including links to assessment tools for pain; substance abuse disorder; emotional distress, anxiety, pain-related fear, and depression; and coping

Training

SCOPE of Pain. Boston University School of Medicine. 2019.

• A series of continuing medical and continuing nursing education activities designed to help participants “safely and competently use opioids, if appropriate, to manage your patients with chronic pain”

Pathways to Safer Opioid Use. U.S. Department of Health and Human Services. 2017.

• Interactive online training that “promotes the appropriate, safe, and effective use of opioids to manage chronic pain” that is based on the opioid-related recommendations in the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan)

References

1. National Quality Forum. Opioids and Opioid Use Disorder: An Environmental Scan of Quality Measures Final Report. September 12, 2019.

2. Stephanie Slat, Jennifer Thomas, et al. “Coronavirus Disease 2019 and Opioid Use — A Pandemic Within an Epidemic.” JAMA Health Forum. 2020;1(5):e200628. DOI: 10.1001/jamahealthforum.2020.0628.

3. U.S. Department of Health and Human Services. Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations. 2019.

4. Deborah Dowell, MD; Tamara M. Haegerich, et al. “CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016.” Morbidity and Mortality Weekly Report, Recommendations and Reports. 2016;65(No. RR-1):1–49. DOI: 10.15585/mmwr.rr6501e1.

5. National Institute on Drug Abuse (NIDA). “Improving Opioid Prescribing.” Policy Brief. March 30, 2017.

6. Fa-ngam Charoenpol, Nuj Tontisirin, et al. “Pain Experiences and Intrapersonal Change Among Patients with Chronic Non-Cancer Pain After Using a Pain Diary: A Mixed-Methods Study.” Journal of Pain Research. 2019;12:477-487. DOI: 10.2147/JPR.S186105.

7. Substance Abuse and Mental Health Services Administration. “TIP 54: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders.” U.S. Department of Health and Human Services. Treatment Improvement Protocol (TIP) Series. Publication ID: SMA13-4671. 2012.

8. Federation of State Medical Boards. Guidelines for the Chronic Use of Opioid Analgesics. 2017.