Consider the following statistics:

• From 1999 to 2016, over 200,000 people died in the U.S. from prescription opioid overdose.¹
• The prescription opioid overdose death rate was five times higher in 2016, than it was in 1999.¹
• For comparison purposes, the U.S. military death toll from the Vietnam War is estimated at 58,000.²
• In 2012, 259 million prescriptions were written for opioids.³ (As of 2016, that number had dropped to approximately 215 million prescriptions, which roughly equals 66.5 per 100 persons.⁴)
• In 2016, 2 million people had a substance use disorder involving prescription pain medications.⁴
• Four in five new heroin users started out misusing prescription pain medications, and many use heroin because prescription opioids are more expensive and harder to obtain.⁵

The United States government is referring to overdose deaths from pain medications as “a public health crisis”⁶ and “an epidemic.”⁷ In the media, physicians prescribing opioids to patients for non–cancer chronic pain have been portrayed as culprits.⁸ In response to the epidemic, in March 2016, the Centers for Disease Control and Prevention (CDC) released guidelines for primary care clinicians to “address problematic prescribing,” and “reverse the cycle of opioid pain medication misuse that contributes to the opioid overdose epidemic.”³ Although the CDC guidelines appear to put the onus on primary care clinicians to control the opioid overdose epidemic, they offer limited tools and strategies for managing patients who are already dependent on high doses of opioids for chronic pain relief. There is no perfect solution for managing these patients. However, overdose risk can be addressed with the risk management strategies and outside resources presented in this article.

CDC Guidelines Summary

The CDC guidelines are structured around 12 main recommendations that address various aspects of opioid pain management. The guidelines are controversial and, like clinical guidelines, they do not represent the standard of care and do not require conformance. However, it is likely they will be offered as support for a standard of care argument in medical malpractice lawsuits. The recommendations are summarized below:³

Considering Whether to Use Opioids for Chronic Pain Management

Recommendation 1. Prioritize nonpharmacologic and nonopioid pharmacologic pain management strategies, unless the expected benefits of opioids for both pain and function are anticipated to outweigh risks to the patient.

Recommendation 2. Establish treatment goals with patients that include realistic pain and function objectives. Ensure patients understand that opioid therapy will only continue if there is clinically meaningful improvement in pain and function that outweighs the risks.

Recommendation 3. Ensure patients understand the risks and realistic benefits of opioid therapy and the responsibilities of both patient and clinician for managing therapy.

Prescribing Opioids for Chronic Pain Management

Recommendation 4. Prescribe immediate–release opioids instead of extended–release/long–acting (ER/LA) opioids when starting opioid therapy.

Recommendation 5. Use caution when prescribing any dosage of opioids. Prescribe the lowest effective dosage when starting opioid therapy and when planning to increase dosage to ≥50 morphine milligram equivalents (MME)/day, assess the patient’s benefits versus the harms of being on the new dose. Avoid increasing dosage to ≥90 MME/day or appropriately justify a decision to do so.

Recommendation 6. When opioids are used to treat a patient in acute pain, prescribe the lowest effective dose of immediate–release opioids in no greater quantity than needed for the expected duration of pain. In most cases this will be three days or less, and rarely over seven days.

Regularly Assessing the Harms and Benefits of Opioids in Chronic Pain Management

Recommendation 7. Conduct a harm/benefit analysis with the patient within one to four weeks of starting opioid therapy or of dose escalation, and at least every three months thereafter. When benefits do not outweigh harms, optimize other therapies and taper to lower dosages or discontinue opioids.

Mitigating Overdose Risk

Recommendation 8. Regularly evaluate the patient’s overdose risk and incorporate strategies to mitigate risk in the patient’s pain management plan, for example, by offering Naloxone.

Recommendation 9. Regularly review prescription drug monitoring program (PDMP) data when starting opioids and periodically during treatment to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose.

Recommendation 10. Regularly use urine drug testing to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

Recommendation 11. Avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

Treating Opioid Use Disorder

Recommendation 12. Offer or arrange treatment for patients with opioid use disorder.

The CDC provides a checklist for prescribing opioids for chronic pain at: http://stacks.cdc.gov... (accessed 6/20/2018) and a website with various fact sheets to support clinician implementation of the recommendations at: http://www.cdc.gov... (accessed 6/20/2018).

The full text of the 12 recommendations appear throughout the remainder of this article to illustrate how they can be applied as patient safety and risk management strategies.

The Importance of Morphine Milligram Equivalents (MME) Per Day

When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.³ CDC Recommendation 5

As MME increases, overdose risk increases. Compared to patients taking 1 to <20 MME/day, patients on dosages of 50 to <100 MME/day are 1.9 to 4.6 more likely to overdose and patients on ≥100 MME/day are 2.0 to 8.9 times more likely to overdose.³ Calculating MME/day is not only important for opioids prescribed personally, but also important when considering opioids being prescribed by other clinicians. Judging from the NORCAL closed claims analysis conducted for this article, keeping MME at or below 100 MME/day may be a challenge for many clinicians.

The New York City Department of Health provides a Morphine Milligram Equivalent (MME) Calculator to help health care providers calculate total daily MME based on the strength and number of tablets of various opioids prescribed to a patient. It is available at: www1.nyc.gov/... (accessed 6/20/2018).

Case One

Allegation:
The internist negligently prescribed excessive narcotic medications without proper checks and balances following the patient’s detox treatment.

In January 2010, the patient’s internist was refilling her prescription for 100 tablets of 10 mg oxycodone and 325 mg acetaminophen, 1 tablet every 4 hours as needed for diabetic peripheral neuropathy every two weeks. (MME/day = 90.) By May 2010, he had increased her prescription to 1 to 2 tablets of 10 mg oxycodone and 325 mg acetaminophen every four hours. (MME/day = 180.)  Starting in August 2010, the internist started to worry about the high MME and suspected addiction, but continued to prescribe the same amount of 10 mg oxycodone and 325 mg acetaminophen. By October 2010, the internist was refilling the patient’s prescription every week. In an attempt to reduce the patient’s need for 10 mg oxycodone and 325 mg acetaminophen, he starting prescribing diazepam and pregabalin. This continued until the patient started opioid addiction treatment in March 2011.

Following treatment, the patient was opioid free until June 2012, when she had surgery. Her surgeon prescribed hydromorphone, 4 mg every 4 hours; 75 mg fentanyl patch, 60 mg codeine, and 300 mg acetaminophen 4 times per day for post–surgical pain relief. (MME/day = 330.) Thereafter, the internist refilled the prescriptions. In September 2012, although the internist advised re–entering opioid addiction treatment, he resumed prescribing 10 mg oxycodone and 325 mg acetaminophen as before, discontinuing 60 mg codeine and 300 mg acetaminophen, and added diazepam. (MME/day = 366.) Refills for hydromorphone, fentanyl patch, 10 mg oxycodone and 325 mg acetaminophen and diazepam continued until the patient accidently overdosed in January 2013. Her cause of death was determined to be mixed prescription intoxication. Toxicology reports revealed the presence of morphine, codeine, oxycodone and diazepam in her system.

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 detox and caused the plaintiff’s wife to become addicted again.

Experts were critical of the internist for negligently acting as a pain management specialist and failing to treat the underlying causes of the patient’s pain. For example, 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 the patient to improve her compliance. Furthermore, experts believed it was below the standard of care to prescribe pain medications with no plan, screening, contract or long–term goals. Significantly, the patient had managed without opioid pain medications for over a year following opioid addiction treatment; but instead of encouraging the patient to discontinue the opioids she had received for acute pain following surgery, the internist refilled and eventually increased them. Experts believed this was inconsistent with the standard of care.

Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.³ CDC Recommendation 2.

Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.³ CDC Recommendation 3.

Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.³ CDC Recommendation 7

Addressing overdose at the source

The CDC guidelines are perhaps most useful in providing strategies to prevent future opioid dependence and addiction, and thereby reduce overdose deaths. For example, one way to decrease overdose deaths is to stop initiating opioid treatment for pain associated with nonspecific musculoskeletal disorders (e.g., back pain, headaches, fibromyalgia).³

Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.³ CDC Recommendation 1

Another strategy for decreasing opioid overdose deaths is to keep acute pain patients from becoming dependent on pain medications. For patients being treated for acute pain that is not surgical or traumatic, the guidelines urge physicians to prescribe the lowest effective dose necessary for three days or less, after which the likelihood of physical dependence significantly increases without any added benefit. Limitation of pain medications for acute pain can not only expose fewer patients to withdrawal symptoms, it can decrease the number of pills available for diversion.³

When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate–release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed. CDC Recommendation 6

Consider the following recommendations, which are primarily based on the new CDC guidelines:^2,3,9,10,11

• Create policies and procedures for prescribing opioids for chronic pain management.
• Educate patients about your policies and procedures.
• Clarify expectations for your responsibilities and the patient’s, including:
• How opioids will be prescribed (e.g., no early refills) and monitored (e.g., set appointments, urine tests and PDMP surveillance).
• What will trigger discontinuation or tapering (e.g., if treatment goals are not met).
• 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, for example, physical therapy, counseling, psychotherapy, cognitive–behavioral therapy (CBT), sleep hygiene improvement, graded exercise, mindfulness–based stress reduction techniques, spinal manipulations, meditation and yoga.
• Explicitly and realistically educate patients about the risks, benefits and alternatives of opioid therapy.
• Explain the lack of evidence to support long–term opioid therapy for chronic non–cancer pain. (The CDC refers to this lack of evidence as support for various aspects of the new guidelines.³)
• Ensure patients understand that complete, long–term pain relief is unlikely.
• Emphasize improvement in function as a primary goal.
• Ensure patients understand the risks of opioids, including addiction risk and increase in overdose risk when opioids are taken with benzodiazepines, other sedatives, alcohol, street drugs or other opioids.
• Ensure patients understand that over time, pain and function improvements can diminish and risks can increase.

• Involve patients in decision making.
• Discover what the patient’s preferences and values are and integrate those into pain management decisions.
• Be prepared with counter arguments for patients who want to limit treatment to opioid pain medication.
• Screen for prior/current substance abuse and mental health disorders (see risk management recommendations following Case Two, below, for further recommendations).
• Use a pain medication agreement whenever choosing opioid therapy for chronic pain management.
• Treat the cause of the patient’s pain.
• Work with the patient to reduce pain triggers
• Establish and track progress toward treatment goals.
• Establish functional goals (e.g., walking the dog, gardening, returning to part–time work).
• Use guideline–based screening tools.
• Assess pain and function at every visit to create a record of opioid treatment efficacy.
• Monitor patient compliance in regular follow–up assessments.
• Evaluate benefits/harms within one to four weeks of initiation or of dose escalation.
• Follow ups should be closer to one week from ER/LA initiation or dosage increase or when total daily opioid dosage is ≥50 MME/day.
• Follow up should be within three days when starting or increasing methadone.
• If there is no clinically meaningful improvement (≥30%) 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.
• Consult with pain management specialists when appropriate.
• During the referral process, discuss any opioid use disorder concerns.
• Inform the consulting pain management specialists when patients continue to seek pain medications from you after being referred.
• Appropriately document all phases of pain management and the reasoning behind dosage decisions.

When starting opioid therapy for chronic pain, clinicians should prescribe immediate–release opioids instead of extended–release/long–acting (ER/LA) opioids.³ CDC Recommendation 4

Case Two

Allegation:
The FP prescribed an excessive amount of pain medications; failed to refer the patient for addiction and psychiatric treatment and failed to discover that the patient had been obtaining pain, sleep and anxiety medications from multiple physicians.

In 2007, a 25–year–old man with bronchitis, migraines, depression, bipolar disorder and past treatment for alcohol addiction started treatment with an FP. His medications included duloxetine and quetiapine for depression, nortriptyline for stress–related migraines and zolpidem for sleep. Because he could not afford to keep going to a psychiatrist, the FP agreed to prescribe his mental health medications.  

The day before the patient died of an overdose in 2010, the FP prescribed hydrocodone–chlorpheniramine syrup. The bottle was found at his bedside. Based on what was left in the bottle, it appeared he had taken six times the recommended dosage. The cause of death was determined to be toxicity due to hydrocodone, nortriptyline, alprazolam, zolpidem and chlorpheniramine.

The patient’s family filed a wrongful death lawsuit, claiming the FP prescribed an excessive amount of pain medications; failed to refer the patient for addiction and psychiatric treatment, which he was allegedly unqualified to treat; and failed to discover that the patient had been obtaining pain, sleep and anxiety medications from multiple physicians.

Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.³ CDC Recommendation 11

The fact that the FP prescribed hydrocodone–chlorpheniramine syrup the day before the patient’s overdose made the defense of this lawsuit particularly challenging, because it appeared that the cough syrup was the major cause of the patient’s overdose. Had the FP checked the state PDMP, he most likely would have determined that the patient was getting medications from other sources. Knowing the high MME/day and high benzodiazepine daily dose probably would have prompted the FP to more carefully consider whether it was safe to regularly prescribe hydrocodone–chlorpheniramine syrup to this patient. In his defense, the FP maintained his prescribing was appropriate and the patient would not have died if he had taken his medications appropriately. However, experts believed the FP’s duty to appropriately treat the patient extended beyond simply writing out prescriptions. The patient was struggling with addiction and had additional mental health issues. According to experts, the FP had to take those comorbidities into consideration when he was prescribing opioids, and if he wasn’t qualified to treat the patient’s comorbidities, which the experts opined he was not, he should have referred the patient to specialists. In other words, the patient’s poor choices did not excuse the FP’s negligence.

Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.³ CDC Recommendation 9

When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.³ CDC Recommendation 10

When prescribing opioids to patients with mental health and/or substance abuse disorders, extra care must be taken to avoid overdose. Consider the following recommendations, which are based primarily on the CDC guidelines:^2,3,9,11

• Obtain a complete history, including review of medical records from other physicians the patient is seeing, prior to prescribing opioids.
• Use additional caution when prescribing opioids to patients with depression.
• Optimize mental health treatment.
• Refer to a behavioral health specialist when appropriate.
• Increase the frequency of follow–ups and opioid therapy benefit/harm assessments.
• Use additional caution when prescribing benzodiazepines, or when a patient on opioid therapy is receiving treatment for anxiety from another clinician.
• Consider whether benefits outweigh risks of concurrent opioid and benzodiazepine use.
• Consider consulting with a pain management specialist and/or pharmacist.
• Suggest nonpharmacological therapies (e.g., cognitive behavioral therapy) and/or anxiety medications that are not central nervous system depressants.
• If the patient is being prescribed benzodiazepines by another clinician, coordinate care to minimize the risks of overdose.
• If it is available in your state, check the PDMP at opioid therapy initiation and every three months thereafter. (Information about signing up for a PDMP can be accessed at www.namsdl.org... (accessed 6/20/2018)).
• Discuss PDMP findings with patients.
• Confirm the PDMP record is accurate.
• Ensure patients understand the overdose risks associated with high MME/day and combining medications from different sources.
• Consider tapering to a safer dosage or discontinuing opioid therapy.
• After advising the patient of your intention to do so, communicate with the other physicians prescribing medications that increase the risk of overdose and coordinate care.
• Calculate the total MME/day for the opioids you are prescribing and the opioids other physicians are prescribing pursuant to information in the PDMP.

• With the patient’s consent, conduct urine drug screening initially and thereafter as appropriate.
• Follow standardized procedures in response to screening results indicating a patient is taking medications that you have not prescribed.
• Assess the patient for opioid use disorder.
• Ask patients about their drug and alcohol use.
• Research indicates that asking, “How many times in the past year have you used an illegal drug or used a prescription medication for nonmedical reasons?” is 100% sensitive and 73.5% specific for detecting drug use disorders in a primary healthcare setting.¹⁰
• If the patient has an opioid use disorder, offer to or refer the patient for treatment.
• Utilize measures to decrease overdose risk.
• Use the lowest possible MME/day in addition to alternative pain management strategies.
• Prescribe immediate release opioids instead of ER/LA opioids.
• When indicated, discuss naloxone use for overdose reversal.
• Enter into a pain medication agreement and monitor adherence. (NORCAL pain contract sample form)

Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid–related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present.³ CDC Recommendation 8

Clinicians should offer or arrange evidence–based treatment (usually medication–assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder. ³ CDC Recommendation 12

New Patients on High–Dose Opioid Therapy for Chronic Pain

The most conservative addiction and overdose prevention policies and procedures can’t protect a primary care clinician from inheriting a patient who iås taking high doses of opioids for chronic pain. In many cases, because of the patient’s limited resources and/or the limited number of specialists in the community, primary care clinicians are expected to satisfy the patient’s needs for specialty care, including pain management, mental health and physical therapy. Although there is no perfect solution for clinicians faced with these challenging patients, the following recommendations can decrease the risk of overdose and increase the chance that patients can be transitioned to safer pain management:³

• Review the benefits and risks of continued high–dosage opioid therapy with the patient.
• Determine whether the patient is achieving any pain or function improvement on current doses.
• Offer to collaborate with the patient to taper medications to safer dosages or discontinue opioids.
• Do not rush the tapering schedule. Patients who have been taking opioids for many years may require very slow tapers with occasional pauses.
• Identify and treat anxiety, depression and opioid use disorder that may arise during tapering/discontinuing.
• Consult with mental health and/or addiction specialists.
• Maximize nonpharmacologic and nonopioid pharmacologic treatments as appropriate.
• Consult with a pain management specialist.
• Have an opioid pain medication discontinuation plan in place that utilizes pain management policies and protocols for patients attempting tapering and/or discontinuing long–term opioid therapy.
• Consider using a medication termination agreement (e.g., see Appendix 1 at: painmedicine.oxfordjournals.org... (accessed 6/20/2018).

Resources for Counselling and Managing Inherited Patients on High Doses of Opioids

Although limited, there are resources for counselling and managing inherited chronic pain patients who are taking high doses of opioid pain medications, including:

• Boston University’s online opioid prescribing course.
• Materials addressing high–dose opioids in an inherited patient can be accessed at: www.opioidprescribing.com... (accessed 6/20/2018).
• Gourlay DL, Heit HA. Universal Precautions Revisited: Managing the Inherited Pain Patient. Pain Medicine 2009 Jul; 10 (suppl 2): S115–S123. Available at: painmedicine.oxfordjournals.org (accessed 6/20/2018).

Resources for Tapering and Discontinuing Opioid Pain Medications

Opioid tapering and discontinuation should be individualized. The following resources may provide some guidance in constructing tapering/discontinuation policies and procedures for long–term opioid users:

U.S. Department of Veterans Affairs Opioid Taper Decision Tool
Available at: www.pbm.va.gov/... (accessed 6/20/2018).

Washington State Taper Plan
Available at: www.hca.wa.gov... (accessed 6/20/2018).

Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non–Cancer Pain
Appendix B–12: Opioid Tapering
Available at: nationalpaincentre.mcmaster.ca... (accessed 6/20/2018).

Clinicians are responsible for the safety of the patients for whom they prescribe opioid pain medications. The CDC guidelines provide materials clinicians can use to build or supplement chronic pain prescribing policies and procedures that can mitigate the risk of overdose and thereby reduce malpractice liability risk. This is a good time to take a careful look at pain medication prescribing practices and see how they compare to the new CDC guidelines. If you are currently prescribing opioids for chronic non–cancer pain, you are in an excellent position to educate patients about the questionable efficacy of long–term opioid therapy,³ its significant risks and its viable alternatives. Using the strategies provided in this article should help you address chronic pain in a manner that is appropriate, compassionate and defensible.