A new study suggests that the FDA and manufacturers did not act when evidence emerged that potentially lethal fentanyl products were being inappropriately prescribed to patients.
A new study suggests that the FDA and manufacturers did not take action when evidence emerged that potentially lethal fentanyl products were being inappropriately prescribed to patients.
Researchers at the Johns Hopkins Bloomberg School of Public Health were interested in how the FDA and opioid makers managed the safety of a class of opioids that are highly dangerous if misused or prescribed to inappropriate patients.
The study, published February 19 in the Journal of the American Medical Association, was based on a review of 4,877 pages of FDA reports and other documents obtained through the Freedom of Information Act (FOIA) from years 2012 to 2017; these materials, which were part of an FDA monitoring program, are not routinely made available to researchers or the general public.
Even as evidence surfaced that as many as half of patients taking the powerful opioids known as TIRFs (transmucosal immediate-release fentanyl) should never have been prescribed them, the FDA and fentanyl makers did not review prescribing records of even one physician to consider disqualifying them from the program, which would have prevented them from prescribing the products.
“FDA did not intervene to reduce risky prescribing of fentanyl products, even when given evidence suggesting that half of prescriptions were being written to inappropriate patients,” says study co-author James Heyward, MPH, an analyst with the Johns Hopkins Center for Drug Safety and Effectiveness. “These findings are concerning given that just one dose can be fatal for patients receiving these products who are not already opioid-tolerant.”
In late 2011, the FDA began a Risk Evaluation and Mitigation Strategy (REMS) program that required all doctors, pharmacists, and patients to certify their understanding of the risks and proper use of these drugs in order to prescribe, dispense, or take a TIRF product. The program consisted of a “closed distribution system,” the most stringent type of REMS that the FDA uses. TIRF makers were also required to submit annual reports to the FDA demonstrating their compliance with the REMS requirements.
Knowledge surveys of prescribers, pharmacists, and patients found that the vast majority were aware of appropriate prescribing practices, but a significant minority believed these products could be used by patients who were not already on round-the-clock opioids, according to Heyward.
The safety program had protocols for dis-enrolling prescribers who wrote inappropriate prescriptions, but in five years not a single prescriber was dis-enrolled, according to Heyward.
“This is one of the most restrictive safety programs that FDA and manufacturers employ, yet it was not effective in preventing dangerous prescribing,” he says.
“Five years after the initiation of the program, the FDA and manufacturers were unable to determine if the program was effectively meeting its goals,” he says.
What can health execs do?
“Inappropriate prescribing of opioids is a driver of the opioid epidemic and can lead to adverse outcomes include addiction, overdose, and death among patients receiving those drugs,” Heyward says. “Adverse outcomes from inappropriate opioid prescribing and resultant burdens on the healthcare system, and the community at large, should concern all stakeholders.
Healthcare executive must remain vigilant about appropriate opioid prescribing, “and both the FDA and manufacturers missed important opportunities with respect to these potentially fatal prescription products,” Heyward says. “Healthcare systems have a role to play in ensuring that patient safety is protected.”