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Policy Report on SB 1162: Opioid Prescribing Practices to Protect Patients and Physicians

Digital Exclusive - August 2022
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Executive Summary

Background

The current opioid overdose epidemic, which began in the 1990s with overdose deaths involving prescription opioids, has claimed the lives of hundreds of thousands of Americans. Increased acceptance and use of opioids has helped many patients manage their pain, but these medications are not without their risks, which include addiction and death. Current Arizona law imposes a rigid limitation on opioid prescriptions of doses over 90 morphine milligram equivalents (MME) per day, with certain exceptions. Senate Bill (SB) 1162 would expand the list of exemptions to include intractable pain, chronic intractable pain, and opioid prescriptions for perioperative care. The law should allow for clinicians to tailor treatment regimens to their individual patients, but some legal safeguards to protect patients are necessary and appropriate.

Review of the Evidence

The following points must be considered when considering changes to laws around opioid prescribing:

  • There is insufficient evidence that long-term opioid use is effective for chronic pain

  • Opioid use for acute pain may increase a patient’s risk of long-term use

  • Increases to a patient’s opioid dose increases their risk of overdose, including fatal overdose; and

  • Nonpharmacologic and nonopioid pharmacologic treatment may be more effective for some patients than long-term opioid use

Conclusions and Recommendations

Laws around opioid prescribed should take into account the evidence presented in this report in order to safeguard patient health. SB 1162 could be improved upon by adopting the following recommendations:

  • The provision expanding the list of exemptions from the 90 MME/day limit on opioid prescriptions to include patients experiencing chronic intractable pain should be narrowed or otherwise modified to specify conditions for which the 90 MME/day threshold may be exceeded.

  • The amendment exempting patients with chronic intractable pain once the patient has an established clinician-patient relationship and has tried doses of less than 90 MME/day without adequate improvement should be modified to stipulate that patients also try other modalities of pain management before or concurrent with increasing doses above 90 MME/day.

  • Amend the bill to include legal protections for clinicians who, in their professional judgement, choose not to exceed the 90 MME/day threshold.

 

Introduction

Prescription opioids can be used to treat moderate-to-severe pain and are often prescribed for patients after surgery or injury, or for health conditions such as cancer.1 Recent decades have seen increased acceptance and use of these medications, despite risks to patients’ health and a lack of evidence about their long-term effectiveness.(1) Prescription opioids are known to cause addiction and overdose, including fatal overdose due to the drug’s ability to stop a person’s respiratory drive.(1) In addition to these risks, opioids can cause several side effects, even when taken as directed, including tolerance (the need for higher doses to achieve the same relief), withdrawal symptoms that occur when the medication is stopped, and increased sensitivity to pain.(1)

Between 1999 and 2016, more than 630,000 people died from a drug overdose in the U.S.(2) The current epidemic of drug overdoses began in the 1990s with overdose deaths involving prescription opioids, driven heavily by increased use of the drugs to treat chronic pain.(2) In more recent years, heroin and synthetic opioids, particularly illicitly manufactured fentanyl, have contributed to continually rising overdose death rates.(2) Based on data from the 2016 National Survey on Drug Use and Health, millions of people in the U.S. reported opioid misuse or a prescription opioid use disorder in the previous year.(2) Furthermore, it is estimated that hundreds of thousands of people annually go to the ED or are hospitalized for opioid-related poisoning.(2)

In Arizona, 1,351 people died in 2019 due directly to opioids.(3) Besides directly causing the loss of human life, opioids have substantially impacted the state’s health care system due to the sheer volume of opioid-related emergency department visits and hospitalizations, which was estimated to cost over $676 million in 2019.(3)

In 2016, to address the issue of opioid-related harm, the Centers for Disease Control and Prevention (CDC) issued prescribing guidelines for primary care clinicians.(4) Among these guidelines was a recommendation to avoid or carefully justify daily doses of 90 morphine milligram equivalents (MME).(4) This equates to 90 mg of hydrocodone, 60 mg of oxycodone, or about 20 mg of methadone.(5) This guideline, in addition to the other guidelines published by the CDC, is based on emerging evidence and is intended to protect both clinicians and patients, but is explicitly voluntary, rather than prescriptive, to allow clinicians to consider the circumstances and unique needs of each of their patients.(4)

While the CDC’s opioid prescribing guidelines are not binding, Arizona state law is. Section 32-3248.01 of the Arizona Revised Statues prohibits health professionals from issuing “a new prescription to be filled or dispensed for a patient outside of a health care institution for a schedule II controlled substance that is an opioid that exceeds ninety morphine milligram equivalents per day.”(6) Exceptions to this rule include the continuation of a prior prescription issued within the previous 60 days, an opioid with a maximum total daily dose in the labeling as approved by the FDA, and prescriptions issued following surgical procedures and that are limited to 14 days or less.(6) Additional exceptions are made for patients who:

  • Have an active cancer diagnosis

  • Have a traumatic injury, not including a surgical procedure

  • Are receiving hospice care

  • Are receiving end-of-life care

  • Are receiving palliative care

  • Are receiving skilled nursing facility care

  • Are receiving treatment for burns

  • Are receiving medication-assisted treatment for a substance abuse disorder; or

  • Are hospitalized.(6)

Furthermore, prescribers may exceed the 90 MME/day limit if they feel it is necessary and receive approval from a consulting physician who is board-certified in pain medicine, or a referral service designated by the Department of Health Services.(6)

Senate Bill 1162 (SB 1162), if passed, would expand the list of exemptions from the 90 MME/day limit to include patients experiencing intractable or chronic intractable pain or receiving opioid treatment for perioperative surgical pain.(7) This bill would address what many physicians deem to be an inappropriate constraint on their ability to tailor their medical care to their individual patients.(8) However, cautious prescribing practices protect both physicians and patients, and SB 1662, as written, raises concerns about opioid prescribing in Arizona.

Review of the Evidence

Lack of Evidence for Long-Term Effectiveness of Opioids for Chronic Pain

SB 1162 defines “chronic intractable pain” as pain that is both: 1) Excruciating, constant, incurable and of such severity that it dominates virtually every conscious moment; and 2) Produces mental and physical debilitation.(7)

Unfortunately, opioids are not known to be an effective therapy for such pain. A CDC systematic review found no study evaluating the effectiveness of long-term opioid therapy.(4) Thus, there is insufficient evidence that opioids are effective for chronic pain in terms of pain relief, function, or quality of life.

Opioid Use for Acute Pain May Increase Patients’ Risk of Long-Term Use

“Intractable pain,” which may be included in the category of acute pain, is defined by SB 1162 as a “pain that persists beyond the usual course of an acute disease or healing of an injury or surgery or that results from a chronic disease or conditions causing continuous or intermittent pain over a period of months or years.”(7)

The previously mentioned CDC review found multiple studies showing that opioid therapy prescribed for acute pain was associated with greater likelihood of long-term use.(4) One of the included studies evaluated opioid-naïve patients (i.e., patients who have not used opioids consistently in the past) who had undergone low-risk surgeries. Those who used opioids within seven days of surgery were more likely to be using opioids one year later.(9) These results highlight the risk for opioid dependence, even when opioids are used as directed. To this point, another study of over 32,000 patients followed for up to 13 years from their first opioid prescription found that one of every 550 died from an opioid-related overdose, and that one in every 32 patients who escalated to over 200 MME/day died from an opioid-related overdose.(10) Therefore, clinicians should exercise caution and discuss the risks and benefits of opioid therapy with their patients whenever they are considered writing a new opioid prescription.

Higher Risk of Overdose with Higher Prescribed Doses

The CDC 90 MME/day guideline arose from a review of multiple studies that found opioid-related overdose risk to be dose dependent, meaning higher prescribed doses are associated with higher overdose risk. The risk of overdose among patients prescribed 50-100 MME/day for chronic non-cancer pain increased by a factor of 1.9-4.(6) compared to that of patients prescribed dosages of 1-20 MME/day.(4) Dosages of 100 MME/day or higher increased the risk of overdose by a factor of 2.0-8.9.(4) One of the studies included in the CDC review was conducted on a national sample of Veterans Health Administration patients with chronic pain. It found that the mean dose among patients who died from opioid overdose was 98 MME/day, compared to 48 MME/day among those that did not experience fatal overdose.(11) Therefore, based on the available evidence, the CDC’s dosing guideline is quite reasonable, although even the CDC itself has acknowledged concerns from the American Medical Association that its guidelines have been misconstrued to enacted rigid limitations into law.(8)

Nonpharmacologic and Nonopioid Pharmacologic Treatment May Be More Effective for Some Patients

Nonpharmacologic therapies and nonopioid pharmacologic therapies have shown potential in managing chronic pain. Nonpharmacologic therapies like cognitive behavioral therapy, which trains patients in behavioral techniques and helps them modify situational factors and cognitive process that exacerbate pain, and exercise therapy have been demonstrated to benefit some patients through reduced pain and improved physical function.(4) Nonopioid medications, like acetaminophen, NSAIDs, and some anticonvulsants and antidepressants have also been shown to benefit patients.(4) Furthermore, multimodal approaches that combine these therapies can more effectively reduce pain and improve function that single modalities.(4) Clinicians should therefore consider other modalities if opioid therapy is not achieving the patient’s goals or the patient is required increasing doses.

Conclusions

 

Opioids are well known to carry significant, even life-threatening risks. Therefore, good prescribing practices are essential to prevent additional Arizonans from becoming dependent on or suffering other adverse consequences from prescription opioids, as well as to reduce the financial burden on our health care system. Available evidence shows that increasing opioid doses increases the risk of overdose, and that opioid use for acute pain may lead to long-term use and dependence. Also, there is insufficient evidence to suggest that long-term opioid use is effective for chronic pain. Moreover, other nonpharmacologic and nonopioid pharmacological treatment may be more beneficial than opioid therapy to some chronic pain patients.

Given the damage done by opioids to so many lives, clearly written, evidence-based limitations and exemptions, written into law, are certainly appropriate and protect both clinicians and patients. However, certain rigid limitations under current law may be inconsistent with what the CDC intended in its published prescribing guidelines. SB 1162 should take this into account, while also safeguarding patients from the known harms of prescription opioids.

 

Recommendations

1) The provision expanding the list of exemptions from the 90 MME/day limit on opioid prescriptions to include patients experiences chronic intractable pain should be narrowed or modified to specify medical conditions for which the 90 MME/day threshold may be exceeded​.

The term “chronic intractable pain,” despite the criteria stated in the bill, is somewhat vague and may be interpreted in an inappropriately broad manner. Given the potential harms of higher doses of opioids, in addition to the lack of evidence supporting their use for chronic pain, this exemption should be narrow, especially since many other situations in which a patient may be experiencing chronic pain are already exempt. The provision may be amended to exempt specific medical conditions. For example, patients with sickle cell disease often experience severe chronic pain, for which high doses of opioids are necessary to reduce pain and improve quality of life. Patients experiencing chronic pain due to sickle cell disease, or other conditions specified in the bill, would reasonably be exempted from the 90 MME/day limit. (In their opioid prescribing guidelines, the CDC specifically mentions sickle cell disease and defers to recommendations from the Nation Heart, Lung, and Blood Institute, which provide for tailored pain regimens to meet the patient’s needs.(12) Narrower, well-defined, exemptions would protect people, for whom opioid therapy may not be appropriate, from being prescribed dangerous doses of opioids. It may additionally prevent clinicians from inadvertently exposing their patients to the risks of opioids that would not be outweighed by the benefits.

2) Modify the amendment exempting patients with chronic intractable pain once the patient has an established health professional-patient relationship and has tried doses of less than 90 MME/day that have been ineffective at addressing the patient’s pain.

This amendment could be improved upon to protect patients from the risks of increasing doses of opioids. As noted in the review of evidence, there is a lack of studies demonstrating the effectiveness of opioid therapy for chronic pain patients in reducing pain, improving physical functioning, or improving quality of life. It has also been shown that higher doses of opioid are associated with a higher risk of overdose and death. Thus, the author of this report feels it is insufficient to stipulate only that a chronic pain patient first try doses of less than 90 MME/day without adequate pain relief. There is evidence that other nonpharmacological or nonopioid pharmacological treatments may be beneficial to some patients. Patients may be unfamiliar with these modalities, and clinicians should consider them before increasing opioid doses to potentially unsafe levels. This amendment could thus be modified to stipulate that patients try other modalities of pain management before or concurrent with increasing doses above 90 MME/day.

3) Amend the bill to include legal protections for clinicians who choose not to exceed the 90 MME/day threshold.

Some clinicians may feel uncomfortable prescribing opioid doses higher than 90 MME/day given the risk of dependence, overdose, and death, as well as the unclear risk-benefit ratio in many cases. The language of the bill, therefore, should not be construed to mean that clinicians should exceed the 90 MME/day for chronic pain patients. Clinicians who, based on their professional judgement, choose not to exceed the 90 MME/day limit for patients whom they feel do not meet one or more of the criteria for exemption, should not be at risk of facing litigation for what some people may deem inadequate pain management. Therefore, legal protections for clinicians written into the bill should be considered.

To address the opioid epidemic within Arizona, it is vital that laws around prescribing serve to safeguard public health. Adopting the above recommendations can help ensure that SB 1162 accomplishes its intended goal of meeting patients’ pain management needs, while ensuring that patient safety is not compromised.

References:

1. Centers for Disease Control and Prevention. Prescription Opioids. Centers for Disease Control and Prevention. March 31, 2022, 2022. Updated August 29, 2017. Accessed March 31, 2022, 2022. https://www.cdc.gov/opioids/basics/prescribed.html

2. Centers for Disease Control and Prevention. 2018 Annual Surveillance Report of Drug-Related Risks and Outcomes — United States. 2018. August 31, 2018. Accessed March 31, 2022. https://www.cdc.gov/drugoverdose/pdf/pubs/2018-cdc-drug-surveillance-report.pdf

3. Arizona Department of Health Services. 2019 Opioid Death & Hospitalizations Report. Accessed March 21, 2022. https://www.azdhs.gov/documents/prevention/health-systems-development/epidamic/2019-opioid-death-hospitalizations.pdf

4. D. Dowell, T. M. Haegerich, R. Chou. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. Mar 18 2016;65(1):1-49. doi:10.15585/mmwr.rr6501e1

5. Centers for Disease Control and Preventions. Calculating Total Daily Dose of Opioids For Safer Dosage. https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf

6. A.R.S. Section 32-3248.01, Arizona Revised Statues. Accessed March 31, 2022. https://www.azleg.gov/viewdocument/?docName=https://www.azleg.gov/ars/32/03248-01.htm

7. An Act Amending Section 32-3248.01, Arizona Revised Statutes; Related to Controlled Substances, S.B. 1162, 55th Legislature of the State of Arizona, 2nd Regular Session session (Barto N 2022). Accessed March 31, 2022. https://www.azleg.gov/legtext/55leg/2R/bills/SB1162H.pdf

8. A.M.A. Pain Care Task Force. Addressing Obstacles to Evidence-Informed Pain Care. AMA J Ethics. Aug 1 2020;22(1):E709-717. doi:10.1001/amajethics.2020.709

9. A. Alam, T. Gomes, H. Zheng, M. M. Mamdani, D. N. Juurlink, C. M. Bell. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. Mar 12 2012;172(5):425-30. doi:10.1001/archinternmed.2011.1827

10. A. S. Bohnert, M. Valenstein, M. J. Bair, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. Apr 6 2011;305(13):1315-21. doi:10.1001/jama.2011.370

11. A. S. Bohnert, J. E. Logan, D. Ganoczy, D. Dowell. A Detailed Exploration Into the Association of Prescribed Opioid Dosage and Overdose Deaths Among Patients With Chronic Pain. Med Care. May 2016;54(5):435-41. doi:10.1097/MLR.0000000000000505

12. Lung NIH National Heart, and Blood Institue. Evidence-Based Management of Sickle Cell Disease: Expert Panel Report, 2014. 2014. Accessed March 31, 2022. https://www.nhlbi.nih.gov/sites/default/files/media/docs/sickle-cell-disease-report%20020816_0.pdf