Since the mid-2000s, medication and illicit drug abuse in the United Sates has steadily increased, creating what has now been termed an “opioid epidemic.” In response, Congress and the Bush and Obama Administrations have launched intervention and regulatory proposals to help turn the troubling trend around. Moreover, many state and local agencies have implemented new laws and oversight programs directed at opioid prescribing. ASCO supports the efforts to stem opioid abuse, but the Society is concerned that well-intentioned regulations could inadvertently create an atmosphere that inhibits access to vitally needed opioid pain treatment for cancer patients and cancer survivors.

ASCO Policy Statement on Opioid Therapy

In May 2016, ASCO released a policy statement on opioid therapy,¹ which, among other things, emphasized the unique pain management needs of patients with cancer, especially those with advanced disease. The escalation of opioid abuse is a complex societal issue; however, when policymakers and the media use the term “opioid epidemic,” it oversimplifies the issue and could lead to a one-size-fits-all solution, which makes it difficult for prescribing physicians to treat pain in their patients with cancer and cancer survivors.

In its policy statement, ASCO points out that there is mass unavailability of opioids on a global scale, leaving millions of cancer patients, especially in the developing world, suffering needlessly. While the United States is the largest consumer of opioids worldwide, undertreated cancer pain remains a challenging issue within our cancer community. According to ASCO, “Large-scale proposals currently being considered in the U.S. could likely exacerbate this problem and have adverse consequences on patients in need of medically indicated treatments.”

It is important to note that, regulatory restrictions aside, numerous circumstantial barriers can impede opioid access for cancer patients. The ASCO policy statement makes this point clear by highlighting barriers encountered by oncology providers in the community, such as partial filling of opioid prescriptions by pharmacies lacking a full supply, which requires the patient to obtain a new prescription for the remaining supply; refusals by pharmacies to honor 3-day emergency supplies allowed in state regulations; and several insurance and reimbursement limitations.

While judicious prescribing is important, prescription limits imposed in statutes or regulations are not the answer.

— Marilyn Heine, MD, FACP

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Marilyn Heine, MD, FACP, of Regional Hematology Oncology Associates in Langhorne, Pennsylvania, recently spoke with The ASCO Post about this issue, commenting, “Policymakers who seek to tackle the opioid epidemic should focus primarily on the main drivers of opioid use disorder—social and environmental factors and mental illness—as well as treatment for opioid use disorder. While judicious prescribing is important, patients with cancer and cancer survivors should not be subjected to arbitrary prescription limits. In 2013 and 2014, the National Survey on Drug Use and Health found that only 22.1% of people who misused prescription painkillers got them from a doctor.”

Federal Initiatives

The White House Office of National Drug Control Policy (ONDCP) coordinates numerous agencies to address opioid abuse, such as the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Drug Enforcement Agency (DEA). The FDA has a special department on controlled substances called the Center for Drug Evaluation and Research, which has oversight of abuse liability and risk-management requirements during the review and postmarketing process. In February 2016, the FDA announced an opioid action plan focused on prescribing guidelines and approval standards for abuse-deterrent formulations. The agency also rescheduled hydrocodone from Schedule III to the more restrictive Schedule II. Moreover, it expanded safety labels on all immediate-release opioids. 

Asked to comment on the stepped-up regulations, Dr. Heine said, “It has been documented that cancer patients, especially older individuals and minorities, fear the stigma of needing to take an opioid. With heightened attention to the opioid issue, there appears to be greater resistance among cancer patients to accept an opioid prescription to treat their pain, as they are concerned this may cause them to develop opioid use disorder. In fact, a poster proposed by Pennsylvania officials promoted this idea by equating an opioid prescription with a path to heroin use; such a piece would have had a further chilling effect on cancer patients using much-needed medication, and fortunately, this item appears not to have advanced in production.”

In March 2016, the CDC released extensive guidelines on the prescription of opioids for patients with chronic pain unrelated to active cancer treatment who are not receiving palliative or end-of-life care. However, the ASCO policy statement noted that these recommendations might not be clear to some patients, in that some experience pain as a result of effective cancer treatment. Moreover, palliative care may be initiated at the time of diagnosis, and there is no standard definition of end-of-life care. 

The CDC guidance stresses the need for improved communication between providers and patients about the risks and benefits of opioid use, to reduce the risks of abuse, dependence, overdose, and death. However, it also contains concerning statements such as: “Benefits of high-dose opioids for chronic pain are not established.… At the same time, risks for serious harms related to opioid therapy increase at higher opioid dosage.” These statements do not coincide with best practices in cancer pain control, especially in late-stage cancer, which is another example of why cancer patients are a unique population in the pain-control spectrum. 

When cancer pain treatment—especially in the metastatic setting—is inadvertently included in broad-based government initiatives to address the opioid epidemic, the results can have an inhibiting effect on patient care. As noted by Dr. Heine, “The increased scrutiny of opioid prescribing likely contributes to the decrease in opioid prescriptions. Physician colleagues report prescribing smaller quantities, and some have curtailed prescribing. Factors include media coverage of the issue, patients’ fear of taking an opioid, and physicians’ concern with the need to adhere to diverse practice guidelines or prescription drug monitoring program queries promoted by state and federal legislators and regulators. The statutory and regulatory requirements do not always acknowledge the need to exempt cancer-related pain.”

Further, the ASCO policy statement makes clear that the approximately 12 million cancer survivors in the United States constitute a unique heterogeneous population whose pain management needs are varied and complex, including chemotherapy-induced peripheral neuropathy, lymphedema, postsurgical pain syndromes such as phantom limb pain, graft-vs-host disease after transplant, or post–radiation therapy syndromes. To that end, ASCO has developed guidelines on pain management in cancer survivors.² 

Comprehensive Addiction and Recovery Act

In recent years, more than a dozen bills in Congress have been related to opioid abuse, most of which have focused on expanding prevention and education efforts, promoting evidence-based intervention programs, and strengthening prescription drug monitoring programs. On July 16, 2016, President Obama signed one such bill into law, the Comprehensive Addiction and Recovery Act (CARA). The bipartisan legislation authorizes evidence-based prevention, treatment, and recovery programs and law enforcement initiatives to prevent overdose deaths and improper prescriptions. 

The bulk of the bill centers on evidence-based treatment and counseling services as well as diversion programs for people involved in the use of illicit opioids. CARA also has a provision that, for the first time, permits nurse practitioners and physician assistants to prescribe buprenorphine for medication-assisted therapy for opioid use disorder. Moreover, the bill increases the number of patients a practitioner can treat with buprenorphine from 100 to 275.

With CARA enacted, opioid-related legislation is not currently “in play” in Congress, and it remains to be seen whether the new Congress will do more on this issue. In a forward-thinking effort to prevent opioid-overdose deaths, the FDA with the support of the Substance Abuse and Mental Health Services Administration (SAMHSA), is inviting entrepreneurs from the tech sector to create a mobile phone app that connect opioid-overdose incidents to nearby carriers of naloxone, the antidote for opioid overdose.

State and Local Governments

States across the country have wide authority to control prescription drug policies and have implemented a range of prescription drug monitoring programs. Many states are in the process of strengthening their own opioid prescribing laws. For instance, in March 2016, Massachusetts enacted a law that might serve as a model for other states, becoming the first in the country to limit opioid prescriptions to a 7-day supply for a first-time prescription. The Massachusetts law also requires physicians and pharmacists to check the state’s prescription monitoring program before prescribing any Schedule II or III opioid. 

Cancer patients are at risk of being inappropriately undertreated if policies pass across the states without exemptions…. Opioid abuse is such a problem, but regulation without careful consideration of our most vulnerable patient populations is likely to harm them.

— Debra Patt, MD, MPH, MBA

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In a recent interview with The ASCO Post, Debra Patt, MD, MPH, MBA, Vice President, Texas Oncology, said, “Cancer patients are at risk of being inappropriately undertreated if policies pass across the states without exemptions. It is a tricky issue, as opioid abuse is such a problem, but regulation without careful consideration of our most vulnerable patient populations is likely to harm them.”

Dr. Patt testified on prescription monitoring program exemptions for cancer patients at the Sunset Commission in Texas. She said, “Failing to exempt vulnerable patients from these [prescription monitoring program] policies will increase suffering among the most vulnerable Texans. As abuse and diversion are rare among these populations of patients, exemption would be low risk to the policies’ effectiveness.” 

Dr. Patt and her colleagues also presented guidance from the American Medical Association (AMA), CDC, and ASCO, recommending that cancer and hospice patients should be exempted from such policies and providing examples from other states’ experiences with similar policies. 

Many states are enacting policies that vary widely in their scope and structure. At the most extreme end of the spectrum, a legislative initiative in Kentucky declared a state of emergency, ending with this warning: 

Whereas the epidemic of prescription drug abuse represents a clear and present danger to the lives, safety, and health of all Kentuckians, and no just cause exists for delay, an emergency is declared to exist, and this Act takes effect upon its passage and approval by the Governor or upon its otherwise becoming a law.

AMA Adopts ASCO Resolution

In November 2016, the AMA overwhelmingly voted to adopt the ASCO-led Resolution 918: Ensuring Cancer Patient Access to Pain Medication.³ ASCO’s delegates at the AMA House of Delegates meeting included Edward P. Balaban, DO, FACP, FASCO, and Thomas A. Marsland, MD, FASCO. They discussed a wide range of issues and policies of concern to ASCO, foremost the Society’s efforts to ensure that access to cancer pain treatment is not impeded by government initiatives directed at opioid abuse. In short, the resolution states that the AMA will advocate against arbitrary prescription limits that restrict access to medically necessary pain treatment for cancer patients.

Equally important, the resolution enlists the AMA to work with the CDC to provide flexibility in the interpretation of the CDC’s opioid prescribing guidelines. The resolution makes clear that the CDC guidelines were intended to target primary care physicians, although their interpretation has changed the clinical pain management environment by influencing state legislation and payer policies. ASCO provided expert testimony that highlighted the unintended consequences of the CDC guidelines. 

Referencing her home state, Dr. Heine said, “Pennsylvania enacted a requirement for physicians to query the [prescription drug monitoring program] prior to every prescription of an opioid or benzodiazepine for all patients, including those with cancer. This requirement necessitates that clinical staff take time away from patient care in order to check the database.”

She continued, “As the nation’s supply of opioids is anticipated to decrease, it is essential that patients who have pain receive comprehensive and compassionate care. While this should include options for the range of evidence-based, nonopioid and nonpharmacologic treatments, cancer patients should have the safeguard of assured access to opioid pain medication when this is indicated.”

Striving for Balance

While ASCO supports all efforts to reduce the misuse of opioids, the Society’s primary goal is to ensure that cancer patients across the country have unfettered access to the pain management that their oncologists and palliative care specialists prescribe. 

In the larger picture of this difficult social crisis, the ASCO policy statement points out that more than 75% of recreational opioid users receive the drugs from nonmedical sources; “a small percentage only of patients with emergency department visits for opioid overdose actually have a pain diagnosis. Most overdose deaths involve polysubstance abuse.”

ASCO stresses to policymakers and the mainstream media that cancer is a complex disease that presents unique pain-management needs. Legislation that makes overly rigid demands on patient screening creates burdensome prescription monitoring programs, calls for mandatory education, and links prescribing rights to compulsory activities could erect barriers to appropriate access to pain medications. To that end, ASCO stands ready to work with policymakers to achieve a reasonable balance of public health and opioid access for patients in the oncology community. ■

Disclosure: Drs. Heine and Patt reported no potential conflicts of interest.

References

1. ASCO Policy Statement on Opioid Therapy: Protecting Access to Treatment for Cancer-Related Pain. Available at http://www.asco.org/advocacy-policy/policies-positions-guidance/policy-statements. Accessed January 31, 2017.

2. Paice JA, Portenoy R, Lacchetti C, et al: Management of chronic pain in survivors of adult cancers: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 27:3325-3345, 2016.

3. ASCO-led resolution on opioid therapy adopted by the AMA House of Delegates. ASCO in Action, November 15, 2016. Available at http://www.asco.org/advocacy-policy/asco-in-action/ama-hod-opioid-resolution. Accessed January 31, 2017.

ASCO Principles for Opioid Access 

• Patients with cancer are a special population that should be largely exempt from restrictive regulations intended to restrict access or limit doses.
• Providers should have a choice of sources and materials for education in opioid prescribing.
• Patients with cancer and survivors of cancer should not be subject to arbitrary prescription limits that artificially limit access to medically necessary treatment.
• Patient education on the correct medical use of opioids is best provided by a health-care professional with the addition of supplementary materials as appropriate.
• Individual state prescription drug monitoring programs should be accessible through a single portal or interoperable in a way that is seamless to the end user.
• After initial screening and assessment of patients with cancer, the timing and form of subsequent assessments should be left to the judgment of the treating physicians.
• ASCO supports efforts to develop abuse-deterrent formulations as one approach to mitigating abuse but notes that most prescription drug abuse and overdose occur via the oral route.

Adapted from ASCO Policy Statement on Opioid Therapy: Protecting Access to Treatment for Cancer-Related Pain.¹