1. Samson, Kurt

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SAN DIEGO-Inpatient treatment of cancer patients for pain and pain-related issues has increased significantly as a result of the ongoing shortage of parenteral and IV opioid medications, according to a new study of individuals seen by palliative care personnel at MD Anderson Cancer Center in Houston.

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Data presented at the 2018 Palliative and Supportive Care in Oncology Symposium sponsored by ASCO suggest that efforts to curb the national epidemic of opioid abuse has led to a marked decrease in oncologists prescribing parenteral opioid medications, and an increase in cancer patients seeking pain and pain-related help at hospitals (Abstract 201).


The investigators found that use of parenteral opioids (IV breakthrough and patient-controlled analgesia) before the shortage were 35 percent and 47 percent by the oncology and palliative care teams, respectively, and fell to 18 percent and 29 percent in the month after the shortage was announced by federal officials. As a result, significantly fewer patients achieved pain improvement at the first follow-up on day one.


"Parenteral opioid such as morphine, hydromorphone, methadone, and fentanyl are essential drugs and should be available to treat acute cancer pain," said Ali Haider, MD, Assistant Professor in the Department of Palliative, Rehabilitation, & Integrative Medicine, MD Anderson Cancer Center.


He noted that multivariate analysis showed that, before the shortage, patients had an 89 percent higher chance of achieving pain control on their first day of follow-up.


"Certain clinical measures such as the use of non-opioid analgesic-cannabinoids, gabapentin, and ketamine-and use of less common parenteral opioids-nalbuphine and buprenorphine-might be used to treat cancer pain during the time of shortages. However, their effectiveness is limited due to lack of evidence in cancer pain, complex opioid rotations, and risk of toxicity," Haider told Oncology Times.


He also predicted that drug shortages, especially of sterile injectable products, will likely persist.


"Hospital and health care administrators must be able to provide timely, safe, and effective countermeasures to avoid patient suffering. Hopefully knowledge from this study will help health care providers and hospital facilities to create timely, safe, and effective countermeasures."


Moreover, he stated that policymakers should address the underlying issues behind the opioid shortage, such as delays and reductions in the production quotas of schedules I and II drugs set by the Drug Enforcement Agency (DEA) and shortages of sterile injectable products from drug manufacturers.


In a joint statement issued last August, the U.S. Department of Justice and the DEA called for reducing the quantity of controlled substances permitted to be manufactured in 2019. The agencies also proposed decreasing the 2019 Aggregate Production Quotas for six of the most frequently misused opioids by an average of 10 percent.


Methodology, Other Findings

The investigators compared electronic health records for 386 consecutive inpatient palliative care consultations during the month preceding and the month after the February 2018 opioid shortage announcement.


Eligible patients were 18 years of age or older, were taking opioids at the time of consultation, and had a minimum of at least two consecutive visits with the palliative care team. The researchers also adjusted for patient demographics, cancer type, opioid type, route, and dose.


They reported patients seeing members of the cancer center's palliative care team used fewer parenteral opioids and more use of non-parenteral opioids by referring oncologists, and significantly fewer patients achieved better pain control after the shortage (62% compared to 75%). However, at second follow-up, the proportion of pain improvement was similar in both groups.


Non-parenteral routes included intramuscular, subcutaneous, and IV, and included extended-release, transdermal, and oral breakthrough opioids. Parenteral routes included patient-controlled analgesia and IV breakthrough opioid medications. The following shows the changes reported:


Changes in opioid delivery routes by the oncology team


* Non-parenteral: 65 percent before shortage; 82 percent after shortage


* Parenteral: 35 percent before shortage; 18 percent after shortage



Changes in opioid delivery routes by the palliative care team


* Non-parenteral: 53 percent before shortage; 71 percent after shortage


* Parenteral: 47 percent before shortage; 29 percent after shortage




According to Joseph Rotella, MD, Chief Medical Officer for the American Academy of Hospice and Palliative Medicine, said the opioid shortage is likely to continue unless patients and their oncologists speak out.


"We might expect to see a similar impact on prescribing behavior and initial pain control as long as the parenteral opioid shortage persists, or if it occurs again in the future," he told Oncology Times.


Rotella noted that other routes of administration of opioids may not be as effective as the parenteral route for achieving initial pain control in some hospitalized cancer patients, so he feels it is critical to address and prevent current and future shortages.


"Drug shortages persist on a national level for a host of parenteral and oral medications, not just opioids," he stressed. "Physicians and patients should make their voices heard by regulators and policy makers. We need to secure the supply chain for all vital medications, and that must include full access to injectable opioids for treating severe pain."


Kurt Samson is a contributing writer.


FDA Resources to Address the Opioid Shortage

FDA Drug Shortages Task Force


This group has been charged with delving more deeply into the reasons why some shortages remain a persistent challenge. The new task force is to look for holistic solutions to addressing the underlying causes for these shortages.


Parenteral Opioid Shortage Guidance Document


This fact sheet summarizes the status of the current acute shortage of small-volume parenteral solutions and provides an outline of potential actions for organizations to consider in managing the shortage.


Injectable Opioid Shortage Guidance Document


This fact sheet provides an outline of potential actions for organizations to consider in managing the acute shortages of injectable hydromorphone, morphine, and fentanyl.


Injectable Opioid Survey Report


This survey measured the impact of injectable opioid shortage and update on small-volume parenteral solution supplies.