Eduardo Bruera, MD
In response to the opioid-overdose epidemic, several measures have been put in place, such as the reclassification of hydrocodone as a Schedule II opioid and new requirements for physician review of prescription drug–monitoring program databases in most states. Moreover, the Surgeon General and the Centers for Disease Control and Prevention have issued strict guidelines for opioid prescribing. Although most guidelines exempt patients with cancer, there has been a marked decrease in the use of morphine and, more alarming, a shortage of parenteral opioids for cancer pain treatment.
To shed light on this critical issue, The ASCO Post recently spoke with palliative care specialist Eduardo Bruera, MD, Chair of the Department of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, about these concerns and how they may impact patients with cancer as well as the oncologists who manage their pain.
Reclassification of Hydrocodone
What effect did the reclassification of hydrocodone to Schedule II have on cancer pain management?
The reclassification was probably a reasonable approach, and the reason I say that is because hydrocodone is more potent
There has been an increased use of oral and transdermal pain medications, trying to avoid the use of intravenous opioids.— Eduardo Bruera, MD
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than previously thought. It is an old opioid, so there have not been any studies done to determine its equivalence to other opioids. However, our team here at MD Anderson, led by Akhila S. -Reddy, MD, PhD, clearly found that hydrocodone is about 1.5 times more potent than morphine. Therefore, it is a drug that should be treated with the same level of caution as all other powerful opioids.
Additional Burdens for Oncologists
The median daily equivalent opioid dose of morphine prescribed by cancer specialists before referral to palliative care decreased from 78 mg/d to 40 mg/d. What does that say about our current awareness of treating cancer pain?
I think this reflects the increased pressure felt by oncologists who are trying to prescribe opioids for their patients with cancer. There are multiple barriers that were not present before the opioid-overdose crisis in America, including the increased requirements from insurers to provide additional prescribing information, which burdens oncologists who are already overtaxed with administrative work. The need to screen patients for nonmedical risk factors in opioid use by constantly checking the prescription drug-monitoring program to see whether a patient also received medications from other sources is also a time-consuming barrier, as is the occasional need to order a urinary drug-screening test.
When you add up all of the newer requirements, it has made treating pain in patients with cancer much more onerous than before the onset of the opioid crisis. In reaction, some oncologists may try to continue using Schedule IV opioids or keeping their patients on nonopioid analgesics longer, which can cause stressful issues in pain management. And some oncologists are referring their patients to a supportive care specialist as soon as a pain-management issue arises, which is one way to cope with the burden imposed by the new regulations and environment.
However, the challenge with this quick hand-off strategy is that there are simply not enough supportive and palliative care specialists around the country to handle the influx of patients in pain. There were not enough prior to this crisis, and this only exacerbates the shortfall. There are no easy remedies to this issue, which is why we need to work together as a community to make sure that our patients with cancer have adequate pain control.
Closer Look at Parenteral Opioid Shortage
What are the root causes of the shortage in parenteral opioids for patients with cancer?
There are several conjoining factors that have caused the shortage in parenteral opioids. On the one hand, there has been a mandate by the Drug Enforcement Agency to reduce the production of opioids by 20%, and this has been compounded by manufacturing problems in both the drug-producing companies as well as with the suppliers. This problem has been developing over many months, and it is projected to worsen.
What measures can cancer institutions and hospitals take to address this shortage?
The shortage we are facing at MD Anderson centers on the three main parenteral opioids: morphine, fentanyl, and hydromorphone. And a similar shortage was reported from cancer centers and hospitals around the country. It has forced us
Just as the nation has a strategic oil reserve to maintain a supply if needed, health-care networks need to have a strategic opioid reserve, to mitigate a crisis like we are currently involved in.— Eduardo Bruera, MD
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to change the way we manage our patients with cancer. For instance, there has been an increased use of oral and transdermal pain medications, trying to avoid the use of intravenous opioids.
There has also been a shift toward some of the less common opioids such as nalbuphine and buprenorphine. However, there is little evidence that these agents have sufficient efficacy, plus they require a complex rotation schedule; and there are some toxicity issues as well. When oncologists find out the drug they are familiar with is not available, it increases the risk of medication errors and puts added stress on them as well as their patients. When a drug needs to be switched, physicians must access patients’ record, calculate the new opioid drug ratio and adjustments for the alternative drug, notify the patients, and write the order. It is a time-consuming and stressful process. More important, the three parenteral opioids that are in shortage produce the best analgesic effects for patients with cancer who are in severe pain.
Is there anything further you would like to add on this vital issue?
Unfortunately, the serious societal issue of the opioid-overdose epidemic has inadvertently affected the attitude and supply of much-needed parenteral pain medications for our patients with cancer. Not only is there a shortage of the three major parenterally prescribed opioids, but also now methadone has been added to the list.
With few regulatory changes, we’ve noted that pharmacies could prepare parenteral opioids from powder, as they do in some hospitals across Canada. It costs less than purchasing opioids from drug companies, and the efficacy is equal. Moreover, many of the leaders in universities and the federal funding agencies have failed to support the academic structures that are dedicated to relieving pain and suffering.
We have also lagged in research efforts to come up with better nonpharmacologic therapies to replace opioids. Just as the nation has a strategic oil reserve to maintain a supply if needed, health-care networks need to have a strategic opioid reserve, to mitigate a crisis like we are currently involved in. We must make it a clinical priority to secure the availability of parenteral opioids for our patients with cancer who are in pain. ■
DISCLOSURE: Dr. Bruera has received research funding from Helsinn Healthcare.