CDC opioid guidelines raise alarms among hospice and palliative healthcare providers

The Centers for Disease Control and Prevention (CDC) have issued the CDC Guideline for Prescribing Opioids for Chronic Pain to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary care settings, strongly advising against opioids for the routine management of chronic pain.

These recommendations are aimed at decreasing the routine use of opioids in chronic pain management, with the exception of patients receiving active cancer treatment, or palliative care and end-of-life care. While they are similar to previous guidelines, the two key exceptions include lower dose limitations and, for acute pain not related to major surgery or trauma, opioids should be prescribed for only three days.1

The CDC guidelines are advisory, not mandatory, but nonetheless they are likely to influence physicians, insurers and other government agencies. These guidelines address the rising public health problem of inappropriate opioid use and its consequences, and are designed specifically to improve the prescribing of opioids by primary care and other physicians, especially because state-by-state policies about pain management and opioid prescribing have been inconsistent.2

Nevertheless, while cancer, palliative and end-of-life patients are exempt, if widely adopted, the CDC Guidelines could have a negative impact on this patient population. For many years, hospice and palliative care providers have provided highly skilled pain management, and safely prescribed opioids, even at high doses, when clinically indicated. Opioids play a key role in alleviating pain and suffering for those with advanced illness and at the end of life.

Among the groups opposing the new guidelines is the American Cancer Society's Cancer Action Network, which has asked the CDC to withdraw the guidelines, stating that they were based on "limited" and "low quality" evidence. Other organizations that have expressed concern about the guidelines include the American Medical Association, the American Academy of Pain Management, the Oncology Nursing Society, the Interstitial Cystitis Association and the U.S. Pain Foundation.3

The Challenges
Overall, the CDC's policies, combined with all of the recent negative messaging about opioids, are likely to have a chilling impact on pain management efforts, even for those groups of patients for whom the guidelines were not intended, leading to the under-treatment of disabling pain in those with serious or advanced illness. The guidelines also pose a risk of further limiting access to opioids at local pharmacies. Access is already limited in many urban and rural areas because, for safety and other reasons, pharmacies are unwilling to stock narcotics, especially at high doses.

Here's a look at other concerns:
1) Determining when patients are "palliative" and "end of life" can be challenging and is often not well defined. Admitting patients to hospice during their dying days is a well known problem, with half of patients enrolled in hospice for 14 days or less and over 35 percent die or are discharged during the first week. Waiting to exempt patients from the CDC guidelines until they meet a "palliative" standard can result in needless suffering, especially when initiating or titrating opioids earlier in the disease process would have been appropriate.4

2) Physicians are under increasing scrutiny for prescribing opioids and may be especially concerned about prescribing at doses higher than the guidelines recommend -- which are low for many patients with cancer and those at the end of life. Even some palliative care physicians, whose primary practice is focused on the provision of expert pain and symptom management, are being investigated by state boards for their opioid prescribing practices.

3) The new guidelines will require clinicians to work more diligently to ensure that years of teaching patients and families that opioids are safe and effective at the end of life are not undone. On a daily basis, hospice clinicians are encountering patients and family members who are afraid to use opioids to manage their symptoms. Hospice and palliative care providers need to reassure patients and families that the benefits of opioid use to manage symptoms outweigh the potential risks, including sharing evidence showing that relieving pain actually helps to prolong survival.

4) The guidelines include dose recommendations that are not realistic for many patients with cancer or requiring palliative care. In fact, to achieve comfort, patients with advanced cancer or other illness often must exceed the recommended CDC dose. With careful titration, concerns about overdose in the cancer and palliative population are vastly overstated in the CDC guidelines.

5) In terms of eliminating drug diversion, the HB 366 Hospice Opioid Diversion bill, signed into law in 2014, targets this risk by enhancing existing hospice program policies and raising the industry standard in order to prevent opiate diversion in at-home hospice settings. Hospices are taking additional steps such as the use of Standard Agreements and lock boxes to further reduce the chance of drug diversion.

6) The CDC recommends placing naloxone in the home to help prevent an overdose in those taking high doses of opioids. Administering naloxone to a patient at the end of life, however, would precipitate a pain crisis.

Drug monitoring programs are important to combat "doctor shopping" among opioid abusers, but requiring hospices to enter information into drug-monitoring databases would be burdensome and not beneficial because even patients with substance abuse disorders deserve good pain management at the end of life.

Although perhaps unintended, the CDC guidelines threaten to compromise the comfort of end-of-life patients. Hospice clinicians need to take proactive steps to ensure timely access to opioids by working closely with hospice pharmacy providers and to combat the resurgence of opiophobia affecting patients and prescribers through education.

Go-forward Recommendations
One of the first places to begin process improvement is the transition from paper-based prescription systems to E-prescribing. E-prescribing mitigates fraud, prevents controlled substance misuse and diversion upstream, and improves access to opioids for individuals with advanced illness and at the end-of-life. E-prescribing also offers a way to institute system checks -- from the nurse to the doctor to fulfillment and then to the patient. Additionally, two-way authentication ensures that the correct provider is authorizing the controlled-substance prescription, and there is no chance of diversion.

Furthermore, E-prescribing helps to reduce greater potential for errors and delays, while increasing provider and patient satisfaction. The pharmacies used must be certified to accept controlled-substance prescriptions, and the EHR or third-party vendor that handles processing electronic prescriptions must also be certified for controlled substances.5

The next recommendation is to partner with a specialized hospice pharmacy or PBM that can also improve access to medications that are urgently needed by patients. This is particularly important because specialized pharmacy organizations take proactive steps to ensure that they have adequate stock of opioids and other commonly used hospice medications. Additionally, some hospice pharmacies contract with thousands of retail and institutional pharmacies to ensure that they also stock medications commonly needed at the end of life, including opioids.

Also, look specifically for a hospice-dedicated pharmacy/PBM that is certified by SureScripts to receive and dispense all medications – including scheduled narcotics – directly from a mail order fulfillment center. Ideally, this resource should provide interface options, including automatic fulfillment, with many of the largest national EMR providers.

Hospice pharmacies, national palliative and hospice organizations and clinicians should collaborate to develop strategies for educating patients and families about the appropriate use of opioids in hospice, and assess for concerns about addiction, tolerance and accidental overdose. Media attention to the appropriate use of opioids in these patient populations to help counter-balance the negative messaging is also needed.

Going forward, it is essential that under-treatment of pain in cancer and end-of-life patients becomes a larger part of the current conversation about opioids. Hopefully, this issue will spark a national health policy debate specifically to ensure that cancer and end-of-life patients maintain much-needed access to pain management. In fact, efforts should be made to go beyond the CDC guideline exemptions for these patients and establish regulatory protection against unnecessary restrictions to opioids.

Terri Maxwell, Ph.D., APRN, Vice President of Clinical Education at Enclara Pharmacia, oversees and contributes to the development of resources to assist hospice partners in providing evidence-based symptom management and palliative care to their patients.

1 Foreman, Judy; Analysis: Controversy Over CDC’s Proposed Opioid Prescribing Guidelines; Common Health; January 9, 2016; http://commonhealth.wbur.org/2016/01/analysis-controversy-over-cdcs-proposed-opioid-prescribing-guidelines; accessed March 31, 2016.
2 AAPainManage.org; State by State Laws, Regulations and Guidelines for Pain Management; Jan. 14, 2016; http://blog.aapainmanage.org/state-state-laws-regulations-guidelines-pain-management/; accessed March 30, 2016.
3 Foreman, 2016.
4 NHPCO Facts and Figures, Hospice Care in America 2015 Edition
5 MPR; E-Prescribing for Opioids Offers Opportunity to Combat Misuse, Diversion; Sept. 11, 2015; http://www.empr.com/painweek-2015/eprescribing-opioids-preventing-misuse-diversion/article/438145/; accessed May 10, 2016.

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