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According to a report released on Tuesday, the Food and Drug Administration, pharmaceutical companies and doctors have mismanaged the distribution of a potent fentanyl analgesic, thus allowing widespread prescription to ineligible patients, despite special measures designed to preserve its use.
The unusual journal of the medical journal JAMA relies on nearly 5,000 pages of documents that researchers obtained from the government through the Freedom of Information Act, rather than a more typical scientific controlled study. .
After reviewing the data, the researchers concluded that prescribers, pharmacists, pharmaceutical companies, and the FDA – all of whom had accepted special rules and surveillance for the use of the potent opioid – had left it alone. fall into the hands of thousands of inappropriate patients. Over time, the FDA and pharmaceutical companies became aware of what was happening but took no action, researchers said.
Using insurance claims data spanning five years, the researchers found that between 34.6% and 55.4% of patients should not have received the drugs.
"The purpose of this distribution system was to prevent exactly what we found," said Caleb Alexander, co-director of the Center for Drug Safety and Efficiency at the Bloomberg School of Public. Johns Hopkins University Health, and one of the leaders of the study. "It should never happen. It's an event ever. And yet, we found that this happened in 50% of the cases.
The researchers examined the distribution of pharmaceutical fentanyl in cancer patients suffering from "acute pain" despite taking opioids 24 hours a day. Fentanyl, administered in the form of lollipops, lozenges or nasal spray, marketed under several names by different companies, is about 100 times more powerful than morphine. According to the FDA, approximately 5,000 people in the United States receive such prescriptions at a time.
In a statement, an FDA spokesman said the agency "shares concerns" about how the drug is prescribed and about compliance with protective measures.
"These products are medically important for a small group of opioid-tolerant patients, but they also pose serious risks. This is why the agency has sought to ensure that the. . . The program achieves its public health goal of ensuring safe use and mitigating the risks of misuse, abuse, addiction, overdose and complications due to medication errors. "
The journal JAMA was published on the occasion of the trial of Insys Therapeutics founder John Kapoor in Boston on charges of racketeering. Prosecutors say the company has paid doctors bribes to increase the use of its Subsys product, a form of fentanyl sprayed under the tongue to relieve pain, and encouraged them to offer higher doses.
The strength of fentanyl-based pharmaceuticals and their rapid absorption through the mucous membranes of the mouth and nose pose a serious risk of overdose, abuse and dependence for those who have not already developed opioid tolerance. To protect against prescription to such patients, the FDA has created a "risk assessment and mitigation strategy" for products.
As part of this plan, pharmaceutical companies, physicians, pharmacists and the patients themselves received special instructions on the use of drugs and registered to be part of the small closed group authorized to prescribe them. deliver and take them. The pharmaceutical companies and the FDA have monitored the prescription.
But the report says that these guarantees did not work. In an assessment of claims data after four years, the drug industry told the FDA that, according to FDA standards, 12,916 of the 25,322 patients taking medications, or about 51%, had not developed opioid tolerance.
A report after 60 months found that 34.6% to 55.4% of patients were ineligible, depending on the product, reported Hopkins researchers. The FDA concluded that its primary goal, which was to keep the drug out of the reach of ineligible patients, was not achieved.
The FDA has responded to a few complaints that the rules link clinical decision makers by making the definition of opioid tolerance more precise, the report says. Doctors have the power to prescribe "noncompliant" drugs – for problems other than those stated on the drug's package. But in this case, the drugs were specifically forbidden to patients who were not already tolerant to other opioids.
Pharmaceutical companies were supposed to start doctors and others who mis-prescribed drugs. But after two years and in further analyzes, the researchers found that there was "no report" indicating that the drugs "would have been prescribed to a non-tolerant opioid." .
"The manufacturers have accepted some sort of complete oversight of the prescribers, and this has clearly failed," Alexander said in an interview. "If it worked out, prescribers would have quickly disengaged if they prescribed improperly."
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