Thaddeus Mason Pope, JD, PhD
Among other policy responses to the growing opioid epidemic, many states have enacted legislation that limits the duration or amount of opioid prescriptions issued by physicians. Although, it is clear we need strong measures to mitigate widespread overuse and misuse of opioids. These prescription-limit laws unnecessarily sweep too broadly, intruding on clinician discretion and unduly restricting the pain management of patients with cancer and cancer survivors with a legitimate medical need for opioids.
In response to this problem, several medical societies, including ASCO,1-3 and individual commentators4,5 have called on lawmakers to recalibrate the balance between reducing misuse while still enabling appropriate access. Here, we explain how prescription-limit laws adversely affect patients with cancer and cancer survivors.
Addressing the Opioid Overdose Epidemic
In October 2017, President Donald J. Trump declared the opioid crisis a “national public health emergency.”6 Similarly, the governors of several states have declared, “a state of emergency exists” regarding the need to control the overdose epidemic.7
There is ample justification for these declarations. Every day, more than 200 people in the United States die after overdosing on opioids, including prescription opioid pain relievers.8 That is 1 overdose death every 7 minutes. In addition, roughly 25% of patients misuse prescription opioids for chronic pain.9 Around 10% of these patients—an estimated 2.1 million people—develop substance-use disorders.10
Responding to the Opioid Overdose Epidemic
The legal response to the opioid epidemic has been swift, with numerous initiatives passed at both the federal and state levels. Policymakers, regulators, and litigants are taking action in all three branches of government: in the agencies, in the courts, and in the legislatures. Yet, one legal response—state legislation—merits special scrutiny, because it has had the most significant impact on the care of patients and survivors.
Over the past 2 years, every state legislature has enacted one or more statutes addressing opioid misuse and abuse. State lawmakers have taken a variety of approaches. For example, most states have adopted or strengthened electronic prescription drug monitoring programs. These programs require prescribers to check the database before prescribing an opioid, and they require pharmacies to enter information about dispensed prescriptions. Some states have established standards for continuing education and/or medical education for providers, and some states have expanded access to addiction treatment. Other states have relaxed rules for administering overdose-reversing drugs like naloxone.
Several medical societies [and] commentators have called on lawmakers to recalibrate the balance between reducing misuse while still enabling appropriate access.— Thaddeus Mason Pope, JD, PhD
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All of these new laws require the balancing of public health against legitimate access. However, an even more controversial approach is setting prescribing limits. Policymakers have modeled most of these prescription-limit laws on guidelines from the Centers for Disease Control and Prevention (CDC).11 In 2016, the CDC determined that the duration of an initial opioid prescription has a big impact on the probability of its long-term use. Accordingly, the CDC issued guidelines recommending that opioid prescriptions for acute pain should usually be for 3 days or less and rarely for more than 7 days.12
Although the CDC guidelines were voluntary, in 2017 and 2018, most states translated those guidelines into legal mandates, enacting laws that limit opioid prescriptions to a supply of 3 to 14 days. The most common limit is 7 days. Some states have also set dosage limits in terms of morphine milligram equivalents (MME). The most common limit is 90 MME per day. Like the original CDC guidelines, most of these state laws exempt patients with cancer. But there are limitations to these exemptions.
Limiting Opioid Prescriptions Adversely Affects Cancer Care
Before the latest policy responses to the opioid epidemic, patients with cancer and survivors already faced multiple barriers to accessing appropriate pain treatment.4,13,14 Some of these barriers come from clinicians who have inadequate education on pain assessment and management. Some barriers come from patients who have inadequate financial resources or a fear of addiction. Prescription-limit laws add a third type of barrier, further impeding access to appropriate pain treatment.4,13,14
Before the latest policy responses to the opioid epidemic, patients with cancer and survivors already faced multiple barriers to accessing appropriate pain treatment.— Thaddeus Mason Pope, JD, PhD
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Regulatory barriers block patients living with cancer and cancer survivors in at least four ways. First, although most prescription-limit laws exempt patients in active cancer treatment, some do not. For example, laws in Florida, Nevada, and Utah limit prescriptions but do not exempt patients with cancer.15 Second, many of the remaining laws that do exempt patients with cancer limit the exemption to patients in “active treatment.”16 That leaves cancer survivors subject to prescription limits. Third, clinicians and others may misinterpret or overinterpret prescription-limit laws, restricting their dosing even when that is not legally required. Fourth, private parties like pharmacies and managed care organizations are mirroring legislative trends by setting their own limits.17
Prescription-limit laws are well intended, [but] without clear exemptions for patients with cancer and cancer survivors, these laws sweep too broadly and unnecessarily constrain legitimate pain management.— Thaddeus Mason Pope, JD, PhD
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Prescription-limit laws are well intended and may even curb opioid misuse.18,19 Yet, without clear exemptions for patients with cancer and cancer survivors, these laws sweep too broadly and unnecessarily constrain legitimate pain management.20 Recent survey measures demonstrate that these laws already have had a substantial adverse impact on cancer patients and survivors. For example, an August 2018 report from the American Cancer Society Cancer Action Network found that nearly 50% of patients are having difficulty accessing opioids.21 Cancer survivors have fared even worse. From 2016 to 2018, their usage of opioids more than halved, decreasing from 24% to 10%.
Law and Ethics in Oncology explores the legal and ethical issues oncologists must be aware of in this era of precision medicine and changing health-care policy, both to protect patients’ rights and to safeguard against potential legal jeopardy.
This result is dramatic but not surprising. Few prescription-limit laws exempt cancer survivors. This oversight is significant, because there are over 16 million cancer survivors.22 Even though they are beyond the acute diagnosis and treatment phase and even though there is no evidence of active disease, over one-third of cancer survivors still endure severe chronic pain, especially following surgery, chemotherapy, or radiation treatment.23,24 For example, persistent pain after breast cancer treatment is especially prevalent, causing serious debilitation and morbidity.25
Opioid abuse is a public health crisis, and prescription-limit laws may be one effective mechanism to address the crisis. Yet, the undertreatment of pain is also a major public health problem.26 Therefore, lawmakers should design prescription-limit laws to curb abuse without creating barriers that prevent patients with cancer and cancer survivors from accessing needed pain treatment. ■
Dr. Pope is Director of the Health Law Institute and Professor of Law at the Mitchell Hamline School of Law in Saint Paul, Minnesota (www.thaddeuspope.com).
Editor’s Note:The Law and Ethics in Oncology column is meant to provide general information about legal topics, not legal advice. The law is complex, varying from state to state, and each factual situation is different. Readers are advised to seek advice from their own attorney.
Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO or The ASCO Post.
DISCLOSURE: Dr. Pope reported no conflicts of interest.
1. ASCO policy statement on opioid therapy: Protecting access to treatment for cancer-related pain. May 2016. Available at www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2016-ASCO-Policy-Statement-Opioid-Therapy.pdf. Accessed September 5, 2018.
2. American Society of Hematology: Statement on opioid use in patients with hematologic diseases and disorders. April 18, 2018. Available at www.hematology.org/Advocacy/Statements/8502.aspx. Accessed September 5, 2018.
3. Roubein R: Doctors bristle at push for opioid prescription limits. The Hill. April 11, 2018. Available at thehill.com/business-a-lobbying/382575-doctors-bristle-at-push-for-opioid-prescription-limits. Accessed September 5, 2018.
4. Paice JA: Cancer pain management and the opioid crisis in America: How to preserve hard-earned gains in improving the quality of cancer pain management. Cancer 124:2491-2497, 2018.
5. Access to opioids: A balance of harms. Lancet Oncol 18:1285, 2017.
6. Remarks by President Trump on combatting drug demand and the opioid crisis. October 26, 2017. Available at www.whitehouse.gov/briefings-statements/remarks-president-trump-combatting-drug-demand-opioid-crisis. Accessed September 5, 2018.
7. Baker-White A: Emergency declarations and opioid overdose prevention. Association of State and Territorial Health Officials, June 8, 2017. Available at www.astho.org/StatePublicHealth/Emergency-Declarations-and-Opioid-Overdose-Prevention/6-8-17. Accessed September 5, 2018.
8. Ahmad FB, Rossen LM, Spencer MR, et al: Provisional drug overdose death counts. National Center for Health Statistics, August 2018. Available at www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Accessed September 5, 2018.
9. Vowles KE, McEntee ML, Julnes PS, et al: Rates of opioid misuse, abuse, and addiction in chronic pain: A systematic review and data synthesis. Pain 156:569-576, 2015.
10. Substance Abuse and Mental Health Services Administration: Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health, September 2017. Available at www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.pdf. Accessed September 5, 2017.
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14. Kwon JH: Overcoming barriers in cancer pain management. J Clin Oncol 32:1727-1733, 2014.
15. National Conference of State Legislatures: Prescribing policies: States confront opioid overdose epidemic. April 5, 2018. Available at www.ncsl.org/research/health/prescribing-policies-states-confront-opioid-overdose-epidemic.aspx. Accessed September 6, 2018.
16. Washington State Health Care Authority: Opioids. Available at www.hca.wa.gov/billers-providers-partners/programs-and-services/opioids. Accessed September 6, 2018.
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18. Al Achkar MA, Grannis S, Revere D, et al: The effects of state rules on opioid prescribing in Indiana. BMC Health Serv Res 18:29, 2018.
19. Wight P: Intent on reversing its opioid epidemic, a state limits prescriptions. NPR, August 23, 2017. Available at www.npr.org/sections/health-shots/2017/08/23/543955887/intent-on-reversing-its-opioid-epidemic-a-state-limits-prescriptions. Accessed September 6, 2018.
20. Paice JA, Coyne P: Justice in America: Ethical issues in cancer pain control. J Hosp Palliat Nurs 19:508-513, 2017.
21. American Cancer Society Cancer Action Network: Achieving balance in state pain policy: A report card. August 9, 2018. Available at www.acscan.org/policy-resources/achieving-balance-state-pain-policy-report-card. Accessed September 5, 2018.
22. American Cancer Society: Cancer Treatment & Survivorship Facts & Figures 2016-2017. Available at www.cancer.org/research/cancer-facts-statistics/survivor-facts-figures.html. Accessed September 5, 2018.
23. Stallard J: Will new restrictions on opioid drugs affect people with cancer? Memorial Sloan Kettering Cancer Center, November 17, 2016. Available at www.mskcc.org/blog/will-new-restrictions-opioid-drugs-affect-people-cancer. Accessed September 5, 2018.
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25. Juhl AA, Christiansen P, Damsgaard TE: Persistent pain after breast cancer treatment: A questionnaire-based study on the prevalence, associated treatment variables, and pain type. J Breast 19:447-454, 2016.
26. Institute of Medicine Committee on Advancing Pain Research, Care, and Education: Relieving pain in America: A blueprint for transforming prevention, care, education, and research. June 2011. Available at www.nationalacademies.org/hmd/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx. Accessed September 5, 2018.