Protecting Access to Treatment: Opioid Therapy for Cancer-Related Pain

Megan Bodge, PharmD BCOP
Clinical Oncology Pharmacist
WVU Medicine
Morgantown, WV

Drug overdose deaths are at an all-time high with a large number of those deaths attributable to opioids, including both pre­scription opioid pain relievers and “street” drugs such as illicit fentanyl and heroin. The Centers for Disease Control and Pre­vention (CDC) has estimated that 78 peo­ple die each day from an opioid overdose in America and that between 2000 and 2014, nearly half a million Americans perished from opioid abuse.¹ Heroin initiation and dependence has been rapidly increasing in recent years, and many users report initial use of prescription opioids for nonmedical reasons prior to heroin use.² Analysis of prescribing patterns for opioids indicate an increase in prescriptions for opioid pain medications without a reported increase in patients reporting pain, which has likely perpetuated these issues.¹

To combat the “opioid epidemic,” many federal agencies are expanding efforts to reduce opioid misuse and abuse. Efforts currently being investigated and imple­mented include expansion of educational efforts, increased availability and improved access to naloxone, expansion of resources for addiction treatment of incarcerated individuals, increased access to drug disposal sites, new evidence-based opioid and heroin treatment programs, and strengthened prescription drug monitor­ing programs (PDMPs).³ Many states are working to revise and strengthen their own laws regarding prescription opioids. Measures being implemented include limits on quantities of prescribed opioids and increased requirements regarding PDMPs, as well as and provider and patient education.³

Though this is certainly a complex topic and efforts to curb opioid abuse are largely needed, it is unclear what impact increased regulations may have on cancer patients and survivors suffering from moderate-to-severe pain. It also has been unproven that treatment of cancer-related pain with opioid medications has worsened the problem of opioid overdoses. In May 2016, the American Society of Clinical Oncology (ASCO) issued a policy state­ment putting forward several principles to balance access for appropriate patients and curbing misuse of prescription opioids.³ The full statement can be accessed at www.asco.org/advocacy-policy/policies-positions-guidance/policy-statements.

Highlighted in the statement is that cancer patients should be considered a spe­cial patient population and should likely be excluded from much of the impending legislation and regulations. Pain has been reported as one of the most feared consequences following a cancer diagnosis and may impact quality of life, physical functioning, psychological well-being, and even survival. Opioid therapy has been the gold standard for treatment of moderate-to-severe cancer-related pain, and guidelines for cancer pain manage­ment support opioid use in appropriate patients.⁴ Many barriers already exist for effective pain management in cancer patients, and more restrictions may only compound the issue. Though many regulations already have excluded patients undergoing active cancer treatment, there is ongoing concern that the needs of cancer survivors, or those not undergoing active treatment but still with active cancer, may not be fully met.

HOPA has identified pain management as an issue of importance to monitor as part of its Health Policy Agenda to ensure patients have access to essential pain medications. A policy statement issued in 2014 provides recommendations to help achieve this goal while avoiding opioid abuse and misuse.6 Pharmacists are well suited to provide comprehensive education regarding opioid regimens and assuage patient fears related to addiction and side effects. We also can serve as a resource to provide education regarding safe manipulation, storage, and disposal of medications. We can assist providers with selecting appropriate regimens for patients based on individual factors and suggest tools for assessing adherence, such as pain diaries and pill counts.⁵ All fellow pharmacists also are encouraged to stay abreast of ongoing regulatory efforts and legislation, both nationally and at the state level. Ultimately, a balance must be found to address the ongoing problem of opioid abuse and misuse while still allowing access to essential medications for patients with cancer-related pain being treated in accordance with best clinical practices.

Other principles addressed in ASCO’s policy statement³ include

• Education for providers—Risk Evaluation and Mitigation Strategies (REMS) have been in place for certain opioid medications for approximately 2 years. In May 2016, the U.S. Food and Drug Administration (FDA) panel decided to broaden REMS programs to include immediate-release opioids and require mandatory provider education. Devel­opment of education related to REMS requirements falls to the manufacturer of the medication. ASCO advocates for provider choice in materials used for education. It endorses the use of materials that are evidence based and geared toward improving outcomes related to overdoses.
• Education for patients—ASCO endorses healthcare providers as being best suited to provide education about opioid therapy for patients. Education should be clear and comprehensive regarding benefits and risks of opioid therapy, with an emphasis placed on safe storage of medi­cations. Misunderstandings regarding cancer pain can lead to suboptimal pain control, so it is essential that education for both providers and patients does occur to lead to better patient outcomes.
• Prescription limits—ASCO endorses existing exemptions for cancer patients in current regulations. It does not endorse placing limits on quantities prescribed to patients for cancer-related pain as they may limit access to needed medication. If limits are put in place, ASCO advocates for alternative means by which patients may be able to obtain additional medication, if needed.
• PDMPs—ASCO recognizes the benefits of PDMPs but also advocates for increased streamlining of the systems, ease of use, and real-time reporting. ASCO also advises caution with interpretation of data collected from PDMPs, given that some providers may have legitimate reasons to prescribe high quantities of opioids in the course of their practice, particularly in certain subspecialties.
• Patient screening and assessment before and during opioid treatment—ASCO does not endorse mandating specific requirements after initial patient screening and assessment. Specific practices should be left to the decision of the treating provider.
• Abuse-deterrent formulations—ASCO cautions that abuse-deterrent formulations may limit access for certain patients, given the high cost associated with manufacturing and obtaining these products. It recommends consideration of both abuse-deterrent and nonabuse-deterrent formula­tions for appropriate patients.
• Treatment for misuse, abuse, or addiction—ASCO offers full support of current efforts by Congress and the Adminis­tration to expand availability and coverage of medication-assisted treatment (MAT) for individuals with an opioid-related disorder.
• Prescription “Take-Back” programs—ASCO advocates for increased access to collection sites for unwanted or unused opioid medications. It also endorses changes to the Controlled Substances Act that would allow pharmacies to accept returned opioids and other controlled substances.
• Wider availability of naloxone—ASCO supports increased access to naloxone as a lifesaving medication for patients at risk of opioid overdose. It specifically comments on the need for caregiver education so caregivers can properly administer the medication and distinguish opioid overdose from symptoms of advancing disease.

References

1. Centers for Disease Control and Prevention. Increases in Drug and Opioid Overdose Deaths—United States, 2000-2014. MMWR. 2015;64:1-5.

2. Centers for Disease Control and Prevention. Demographic and Sub­stance Use Trends Among Heroin Users—United States, 2002-2013. MMWR. 2015;64(26):719-25.

3. ASCO Policy Statement on Opioid Therapy: Protecting Access to Treatment for Cancer-Related Pain. www.asco.org/sites/new-www.asco. org/files/content-files/advocacy-and-policy/documents/2016_ASCO%20 Policy%20Statement%20on%20Opioid%20Therapy.pdf. Published May 2016. Accessed June 25, 2016.

4. Glare PA, Davies PS, Finlay E, et al. Pain in Cancer Survivors. J Clin Oncol. 2014;32(16):1739-47.

5. NCCN. Adult Cancer Pain. Practice Guidelines in Oncology. 2016 Nation­al Comprehensive Cancer Network. Version 2.2016.

6. HOPA Pain Management Issue Brief. www.hoparx.org/uploads/Health_ Policy/2016/HOPA_Pain_Managment_Issue_Brief.pdf. Published August 22, 2014. Accessed June 27, 2016.13 14