When the Centers for Disease Control and Prevention (CDC) issued new opioid guidelines in 2016, I warned in the article “CDC opioid guidelines raise alarms among hospice and palliative healthcare providers” that they would result in unintended consequences for patients with serious or advanced illness. Unfortunately, those fears are now a reality.
Today, as a consequence of the CDC guidelines and associated regulatory changes, some hospice and palliative care patients are encountering barriers to accessing medications needed to relieve their pain. Although the CDC guidelines are advisory, not mandatory, they are having a chilling effect on prescribing among physicians, insurers and other government agencies.
Even when a patient can find a physician willing to prescribe opioids, some pharmacies are unwilling to stock them, especially at high doses. Patients also report being treated like substance abusers when picking up prescriptions at their local pharmacy.
In 2018, physicians across the country began reporting that payers were using the guidelines to deny opioid prescriptions, or increasing the use of prior authorizations, even for patients suffering from pain stemming from cancer treatment, end-of-life care and other conditions—placing patients at risk of inadequate pain relief.
The CDC guidelines were intended to combat the opioid epidemic that many consider a result of overprescribing of opioids. Although there is culpability among some practitioners who prescribed irresponsibly, along with patients who requested prescriptions for reasons other than pain relief, deaths from opioid overdoses continue even in the face of decreased prescribing.
In fact, the CDC has said that on average 130 Americans die every day from an overdose of opioids, although in 2017 synthetic opioids, or illicit opioids, drove most of the 47,600 opioid-related deaths—not drugs used for pain, especially for those receiving hospice or palliative care. Furthermore, recent legislation has exacerbated the situation.
Overreaction to legislation
While the CDC recently issued a clarification letter that states the agency does not want to deny clinically appropriate opioid therapy to cancer and sickle cell disease patients, at least 28 states have implemented policies to limit opioid prescribing. Neither the clarification letter nor the recent New England Journal of Medicine article by CDC panel members, however, specifically mentioned concerns about misapplication of the guidelines for patients receiving hospice or palliative care.
While the CDC guidelines along with federal and state controlled substance policies usually exempt hospice and palliative care patients, they don’t always protect them from restrictive practices by payers or pharmacies—some of which go so far as to refuse to fill or cover analgesic prescriptions.
For instance, one health insurer had denied a prescription for 28 pills and allowed only 20 to be filled. The insurer had recently changed its policy to limit opioid prescriptions for acute pain to five days, a limitation that some states also impose.
What’s more, a number of doctors have voluntarily limited the number of opioid prescriptions they write for patients, and some refuse to prescribe any opioids due to fear of being disciplined for overprescribing or because they don’t want to deal with the increasing burdens associated with mitigating risk. Others have forced patients to taper doses, even those who have been well managed for years on a stable dose, or impose strict dose limits.
Overall, health systems are prescribing fewer opioids, although there’s no evidence this has slowed the epidemic. Henry Ford Health has tracked a 40% reduction in opioid prescriptions in the past five years, but deaths from illicit drugs have not gone down. In the meantime, individuals must still deal with pain.
Earlier this year, John Mulder, M.D., director of the Trillium Institute in Grand Rapids, Michigan, and chief medical consultant for Hospice and Palliative Care at Faith Hospice, testified about such concerns and about provisions for safe post-discharge disposal of hospice medications during a congressional hearing. He stated that some states are placing limitations on the circumstances under which controlled substances can be prescribed without giving consideration to the special needs of terminally ill patients.
In a recent interview, Dr. Mulder further stated that opioid legislation has focused on a minority of patients who abuse prescriptions and gives little regard to the majority of patients for whom opioids are prescribed and used appropriately. As a result, state and federal regulators have overlooked how legislation has made it more difficult for hospice and palliative care practitioners to provide pain relief for patients with an advanced or serious illness.
Other concerns specific to hospice and palliative care:
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% 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, according to the National Hospice and Palliative Care Organization’s Facts and Figues, Hospice Care in America, 2015 edition. We currently do not have a way to identify patients as “palliative” to ensure they are excluded from regulations that allow exemption for this population.
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 guidelines include dose recommendations that are not realistic for many patients with cancer or those requiring palliative or hospice care. The guidelines recommend clinicians avoid increasing doses to ≥ 90MME [morphine milligram equivalents/day] but to achieve comfort, patients with advanced cancer or other terminal illnesses often exceed this dose. A recent nationwide study by Enclara Pharmacia of 152,000 hospice patients identified that 64.6% receive opioid doses greater than the CDC recommended 90 mg of morphine equivalents per day. With careful titration, concerns about overdose in the cancer and palliative population due to exceeding a 90MME dose are vastly overstated in the CDC guidelines.
4. In terms of eliminating drug diversion, Ohio provides a useful example. In 2014, the state passed a law requiring hospices to enhance their policies and raise the industry standard in order to prevent opiate diversion in at-home hospice settings. Hospices are taking additional steps, such as the practice of providing Standard Opioid Use Agreements, restricting days’ supply of opioids in high-risk homes and placing opioids in lock boxes in some residences to further reduce the chance of drug diversion.
5. The CDC recommends placing naloxone in the home to help prevent an overdose in those taking high doses of opioids. Currently, three states—Arizona, California and New Mexico—mandate the use of naloxone based upon either dose or days supply with no exceptions for hospice patients. However, administering naloxone to a patient at the end of life would precipitate a pain crisis and the signs of an overdose may mimic the dying process—making it exceptionally challenging for family caregivers to distinguish between the two, placing dying patients at risk to receiving naloxone when not indicated.
6. Many states require prescribers and dispensers to consult the state’s prescription drug monitoring program to review the patient’s controlled substance dispensing history before prescribing or dispensing an opioid. In Florida, there is no exemption for patients in hospice, which could lead to delays that result in unmanaged pain at the end of life.
7. 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.
A look ahead
Opioids play a key role in alleviating pain and suffering for those with advanced illness and at the end of life. For decades, hospice and palliative care providers have delivered highly skilled pain management and safely prescribed opioids, even at high doses, when clinically indicated.
The warning issued three years ago stands: State legislation and over interpretation of the CDC guidelines threaten to compromise the comfort of patients who have advanced or terminal illness. Hospice and palliative care clinicians need to take proactive steps to ensure timely access to opioids by working closely with hospice providers, other pharmacy providers, state pharmacy boards and other regulators to minimize restrictive policies and to combat opiophobia affecting patients, prescribers and payers.
While caution when prescribing opioids is appropriate, it’s important to work against the reversals in the progress made over the past two decades to effectively use opioids to treat pain in end-of-life care.
Terri Maxwell, Ph.D., APRN, is chief clinical officer at Turn-Key Health, an end-of-life population health management company.