New challenge coming from FDA
New challenge coming from FDA
Certification required to prescribe some meds
Although hospices and drug manufacturers are finding solutions and alternatives to pain medications to address the current drug shortage, the more critical challenge is the Food and Drug Administration's (FDA) close look at drugs that are typically considered drugs of abuse, says Phyllis Grauer, PharmD, CGP, RPh, clinical consultant at Palliative Care Consulting Group, a Dublin, OH-based division of HospiScript Services.
The FDA's Risk, Evaluation, and Mitigation Strategies (REMS) that are being considered for opioid drugs, especially long-acting products including methadone, might have long-lasting effects on hospice and palliative care, she says.
Long-acting drugs such as methadone, oxycodone, and fentanyl are staples of pain management in hospice, but the FDA is evaluating ways to limit their availability to control the risk of abuse, explains Grauer. These drugs were selected for scrutiny because they do result in higher rates of mortality for people who abuse them, she says.
FDA recommendations include creation of a registry of physicians and pharmacists who can prescribe or distribute the medications, says Grauer. "Physicians would need to attend classes to obtain the certification and meet requirements to maintain certification," she says. "I believe that doctors who don't prescribe these medications or who rarely prescribe the medications won't go through the certification process. Hospice medical directors and physicians who frequently care for patients at the end of life will pursue certification."
Hospices are concerned that this certification will take away from reliance on community physicians to continue caring for their patients even while they are in hospice care, says Grauer. "Many internal medicine specialists or family practitioners will not pursue the certification because they know the hospice has a physician who can prescribe the drugs," she says. "Even though hospices are required to have a medical director according to Conditions of Participation, the reduction in numbers of community physicians who can prescribe certain pain medications will greatly increase the medical director's responsibility and involvement with all patients."
The comment period on the FDA recommendations ended June 30; at press time, hospice and palliative care specialists were watching for a decision, says Porter Storey, MD, executive vice president of the American Academy of Hospice and Palliative Medicine in Glenview, IL. He adds, "The American Academy of Hospice and Palliative Medicine will offer training to physicians as soon as it is defined and becomes available."
Although hospices and drug manufacturers are finding solutions and alternatives to pain medications to address the current drug shortage, the more critical challenge is the Food and Drug Administration's (FDA) close look at drugs that are typically considered drugs of abuse, says Phyllis Grauer, PharmD, CGP, RPh, clinical consultant at Palliative Care Consulting Group, a Dublin, OH-based division of HospiScript Services.Subscribe Now for Access
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