Action from FDA results in some hospice drug shortages
Manufacturers working to update documentation
Hospice medical directors still are finding shortages of certain opioid medications three months after the Food and Drug Administration (FDA) notified manufacturers of certain types of opioid medications that they would no longer be able to manufacture the drugs. Although the manufacturers are addressing the issues raised by the FDA, hospices still are scrambling to find alternative pain medications for some patients.
The most critical drug on the list was 20 mg/ml morphine sulfate oral solution, which is required for hospice patients who cannot swallow pills. In a surprise move on March 31, the FDA amended its action to exclude the oral solution from the list of unapproved drugs until at least one manufacturer completes the documentation and receives approval to manufacture the drug. At that point, other manufacturers have 180 days to complete submission of their documents. The other drugs, which included immediate-release tablets containing morphine sulfate, hydromorphone, and oxycodone, still were included in the action that required manufacturers to meet certain requirements to gain approval for the drugs.
The drugs on the list were not FDA-approved, primarily because some of the data that the FDA now requires are missing on drugs that have been used in hospice before the FDA was charged with their oversight, says Porter Storey, MD, executive vice president of the American Academy of Hospice and Palliative Medicine. "Manufacturers are in the process of meeting the documentation requests, and the FDA assured health care providers that they will move quickly to approve the drugs and manufacturers that meet their requirements," he says. Until then, hospice clinicians will have to continue to find alternative medications during the shortages, Storey adds.
The biggest concern of the hospice industry was the FDA's move to restrict the supply of drugs without talking with health care representatives, says Phyllis Grauer, PharmD, CGP, RPh, clinical consultant at Palliative Care Consulting Group, a Dublin, OH-based division of HospiScript Services. "As health care professionals, we don't want tainted products on the market, but if it is a matter of crossing all the T's and dotting the I's on documentation, the FDA should evaluate the effect of shortages that an action such as this will have on patients," she says. "If we had known that this action was being considered, we could have mobilized to recommend time frames that would not have created shortages."
Although physicians are able to try alternative medications, it is not always easy to switch pain medications, points out Storey. "There is a reason that there are so many pain medications on the market," he says. "Every patient reacts differently to the medications. For example, one patient might experience nausea with morphine but not oxycodone, and another patient experiences nausea with oxycodone and not morphine."
Once a physician and patient find a medication that can be tolerated with few side effects, there is usually no change to the medication unless it becomes ineffective, Storey says. "Many patients are reluctant to use opioids anyway; so switching between medications is not easy once they've become accustomed to one," he adds.
Another concern of hospice medical directors and palliative care specialists is the additional cost represented by some of the alternative medications or dosages, says Storey. "In hospice, most of the drugs we use are old, proven drugs that are inexpensive, but effective," he says. "When we face shortages, we often find ourselves forced to buy more expensive, potentially less effective medications."
Grauer says, "We did experience some shortages of oxycodone and morphine solutions initially, but as more companies meet the FDA requirements, the drugs are more available." Hospice and palliative care physicians have switched to other strengths, dosages, or drugs to meet the needs of their patients, she says. "If a patient cannot tolerate another pain medication, or if another drug doesn't work well for the patient, pharmacists can compound medications if they are not available commercially," Grauer says.
Compounding medications might meet the patients' needs, but there are risks, she points out. "There are no quality checks on the medication when a pharmacist compounds the medication," Grauer says. "I believe that compounding should be used only when there is no other solution to managing the patient's pain."
While manufacturers and hospices are working through the current issues, the most critical challenge facing hospices and palliative care providers is still to come, points out Grauer. "The FDA has been charged with examining drugs most commonly associated with abuse and creating a process to limit access to the drugs," she says. The program, Risk Evaluation and Mitigation Strategies (REMS), potentially will limit the number of prescribing doctors, which also can affect access for hospice patients, Grauer reports.
"Because many of the drugs that fall into this category are used in hospice, we hope that they can address the abuse of these drugs without affecting their availability to patients who need them," Grauer says.
Hospice medical directors still are finding shortages of certain opioid medications three months after the Food and Drug Administration (FDA) notified manufacturers of certain types of opioid medications that they would no longer be able to manufacture the drugs.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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