Cancer Patients And Opiate Laws: Who Does It Apply To?

Cancer patients often require opioids to manage pain. While opioids are highly addictive and regulated, most states have exempted cancer-related pain from prescription opioid limitations. However, the specific phrasing of these exemptions varies from state to state, and some states do not provide exemptions for cancer patients at all. This raises the question: do opiate laws apply to cancer patients, and if so, how do these laws affect successful pain management for this vulnerable group?

Cancer patients' exemption from opioid prescription laws

In recent years, the opioid crisis has led to a wave of new laws and guidelines that limit the duration and amount of opioid prescriptions issued by physicians. While these measures are necessary to curb opioid overuse and misuse, they have also inadvertently restricted the pain management of patients with cancer and cancer survivors.

CDC Guidelines and State Laws

In 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines recommending conservative opioid prescribing practices, including limiting opioid doses and quantities. While the CDC guidelines specifically exempted patients with cancer, there is evidence that this exemption has not been consistently applied in state-level legislation.

A 2021 study reviewed state-level opioid prescribing laws and their exemptions for patients with cancer-related pain. The study found that out of 36 states with formal legislation limiting opioid prescriptions, 32 (89%) explicitly exempted patients with cancer-related pain. However, the exemptions were broadly applied, with few states providing specific guidance for cancer-related pain prescribing.

Impact on Cancer Patients

The laws limiting opioid prescriptions have created undue barriers for patients with cancer and cancer survivors. These restrictions have made it more difficult for cancer patients to access appropriate pain treatment, as they often limit the duration of prescriptions and the dosage of opioids.

A 2020 study found that oncologists and other doctors have been prescribing fewer opioid drugs to older patients, with a decline in the national opioid prescribing rate for Medicare beneficiaries of approximately 21% among oncologists and 23% among all other doctors from 2013 to 2017. This trend may be due to the measures taken to contain the opioid epidemic, such as making opioids harder to obtain.

Need for Clear Exemptions

It is important to strike a balance between reducing opioid misuse and enabling appropriate access for patients with a legitimate medical need. Clear exemptions for cancer patients and survivors are necessary to ensure they have access to the pain management they require. Without these exemptions, prescription-limit laws can sweep too broadly and constrain legitimate pain management.

Future Directions

Additional resources and guidance are needed to clarify the intersection of opioid-related legislation and clinical pain management for cancer patients. This includes revising state laws to emphasize patient-centered pain management and providing targeted education for clinicians about the scope and intention of prescription opioid laws, including relevant exemptions for patients with cancer.

CDC guidelines and cancer-related pain

In 2016, the Centers for Disease Control and Prevention (CDC) issued a guideline for prescribing opioids that emphasised the potential risks of prescription opioids and encouraged conservative opioid prescribing practices. This included recommendations such as prescribing opioids only after other analgesics have been tried, limiting opioid doses and quantities, and avoiding co-prescribing other sedating medications. While this guideline was intended to curb the overuse of opioids, it had unintended consequences for patients with legitimate needs for opioid-based pain care, including cancer patients and survivors.

Recognising these unintended consequences, in 2022, the CDC issued a clarification to its 2016 guideline, noting that it was not meant to restrict access to appropriate pain treatment for people living with chronic pain from certain serious conditions like cancer. The CDC's clarifying letter stated that the guideline was not intended to deny any patients with chronic pain access to opioid therapy as an option for pain management. This clarification was welcomed by patient advocacy groups, who had been working to highlight the adverse impact of the 2016 guideline on cancer patients and survivors, who often have unique therapeutic goals and ethical considerations when it comes to pain management.

Despite this clarification, data suggests that cancer patients and survivors continue to experience greater difficulty in accessing the pain medication they need. Surveys indicate that nearly half of cancer patients (48%) and more than half of those with other serious illnesses (56%) reported that their doctors indicated treatment options for their pain were limited by laws, guidelines, or insurance coverage. This may be due in part to the variable scope of practice laws and prescribing restrictions, as well as the fear of potential legal consequences and regulatory oversight, which can inhibit patient access to opioid pain management.

To address these challenges, most states have enacted specific opioid dosage and/or duration limitations while also providing broad exemptions for cancer-related pain from prescribing limitations. However, the specific phrasing and application of these cancer exemptions vary widely from state to state. While 32 states (89%) explicitly exempted patients with cancer-related pain from opioid prescribing limitations, Michigan, Nevada, Vermont, and Utah did not. These exemptions are generally applied broadly to "cancer patients", "pain associated with a cancer diagnosis", or "pain being treated as part of cancer care". However, few states provide specific guidance for cancer-related pain prescribing, and even fewer specify the phases of the cancer continuum for exemption. This lack of clarity and consistency in state-level legislation can lead to confusion and potentially impact patient access to necessary pain management options.

State-specific opioid prescription laws

Colorado

In Colorado, the revised Guidelines for Prescribing and Dispensing Opioids were adopted by six prescribing and dispensing boards in March 2019. The law limits the number of opioid pills a healthcare provider can prescribe and affects a range of medical professionals. It mandates that a patient's initial prescription of an opioid should not exceed a seven-day supply if they have not received an opioid prescription in the previous 12 months. However, this limit does not apply to patients with chronic pain, cancer-related pain, or those undergoing palliative or hospice care. After the first prescription, healthcare providers are required to check the Prescription Drug Monitoring Program database before prescribing additional opioids.

Alabama

In Alabama, the Medicaid Agency implemented a policy limiting short-acting prescription opioids for patients without an opioid claim history in the past 180 days. The policy sets a maximum supply of seven days for adults and five days for children, with a 50 morphine milligram equivalent (MME) limit per day. The Alabama Medical Association (AMA) has also implemented a policy to decrease the daily cumulative MME limit gradually.

Alaska

Alaska was one of the first states to address the opioid crisis by implementing strict opioid prescription laws. Governor Bill Walker signed House Bill 159 into law in July 2017, limiting the first fill prescription of opioids to a seven-day supply. Prescriptions can exceed this limit if a doctor provides a valid reason, including logistical barriers or the need to manage chronic pain. The legislation also mandates opioid prescription training for medical professionals.

Arizona

Arizona has taken a comprehensive approach to combat the opioid epidemic. In October 2016, Governor Doug Ducey signed an executive order limiting opioid prescriptions for adults insured under Medicaid or the state's employee insurance plan to a seven-day supply. In January 2018, Governor Ducey signed the Arizona Opioid Epidemic Act, which further limited the first fill prescription for adults to five days, invested $10 million in treatment access improvements, expanded access to Naloxone, and mandated continuing medical education for opioid prescribers.

Maine

Maine has also taken a proactive approach to addressing the opioid crisis. State laws limit opioid prescriptions to 100 morphine milligram equivalents (MME) per day and impose a 30-day supply restriction for patients under treatment for chronic pain. Additionally, within a seven-day period, patients under treatment for acute pain cannot be prescribed more than a seven-day supply, unless the opioid is labeled by the FDA for a longer duration. Exceptions are made for patients with cancer-related pain, palliative care, end-of-life care, and medication-assisted treatment for substance use disorder.

Challenges in drafting opioid legislation

The opioid crisis has led to a wave of legislation and policy interventions at both the state and federal levels in the US. However, drafting opioid legislation is challenging due to the heterogeneous nature of the patient population, the complex nature of pain, and the need to balance effective pain management with the risk of opioid misuse and abuse. Here are some of the key challenges in drafting opioid legislation:

• Addressing the diverse needs of patients: Patients with cancer-related pain have diverse needs, including those at various stages of the cancer continuum and with different sources and types of pain. Drafting legislation that is nuanced and clinically relevant to this diverse patient population is challenging.
• Ensuring patient-centered approaches to pain management: Current attempts to regulate opioid prescribing at the state level may unintentionally undermine patient-centered approaches to pain management. It is important to ensure that legislation does not create barriers to accessing opioids for legitimate medical purposes, such as cancer pain management.
• Balancing pain management and opioid misuse: There is a delicate balance between ensuring access to opioids for pain management and preventing opioid misuse and abuse. Legislation must address both aspects effectively to avoid unintended consequences, such as restricting access to needed pain medication or contributing to the opioid epidemic.
• Inconsistent state laws: State laws regulating opioid prescribing vary widely across the US, with some states providing broad exemptions for cancer-related pain and others having more restrictive policies. This inconsistency can create confusion and challenges for patients and healthcare providers, especially when patients cross state lines for treatment.
• Physician resistance and technical challenges: Implementing prescription drug monitoring programs (PDMPs) has been a key component of opioid legislation. However, there is often resistance from physicians who view PDMPs as burdensome and time-consuming. Additionally, technical challenges, such as slow systems and integration issues with electronic medical records, can hinder the effective use of PDMPs.
• Funding for naloxone kits: Naloxone is a medication used to reverse opioid overdoses. While many states have expanded access to naloxone, funding for naloxone kits has been a challenge. Appropriating funds to purchase naloxone kits and ensuring sustainable funding sources are ongoing issues.
• Shifting nature of the opioid epidemic: As efforts to curb opioid prescriptions have intensified, there has been a shift towards the use of illicit opioids, such as heroin and fentanyl. Legislation and policy must adapt to this evolving nature of the opioid epidemic to effectively address the crisis.
• Lack of coordinated efforts: A lack of coordination among stakeholders and a disjointed legislative process can hinder the successful passage and implementation of opioid policies. It is important to engage all relevant stakeholders, including healthcare providers, law enforcement, and community organizations, to ensure a comprehensive and cohesive approach.
• Limited research and data: There is a need for more research to evaluate the impact and potential unintended consequences of increased legislation and regulation related to opioids. Additionally, standardized electronic health data methods are required to assess the use, effectiveness, and costs of pain treatments and services.
• Addressing acute and end-of-life pain: While much of the focus has been on chronic pain, there is also a need to address acute pain and pain at the end of life in opioid legislation. This includes developing guidelines and best practices for managing pain in these specific contexts.

Impact of opioid laws on cancer patient care

Opioid laws do apply to cancer patients, however, there are some exceptions. Opioids are the treatment of choice for moderate to severe cancer pain at the end of life. However, studies have shown that Black and Hispanic patients with cancer who are nearing the end of life are less likely than White patients to get needed opioid medications to control their pain. This is due to a number of factors, including physician bias, barriers to accessing opioid medications, and policies intended to prevent opioid misuse.

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