washingtonpost.com: FDA, drug companies, doctors mishandled use of powerful fentanyl painkiller

2/20/2019

 


Researchers concluded that prescribers, pharmacists, drug companies and the FDA — all of whom had agreed to special rules and monitoring for use of fentanyl — had allowed it to fall into the hands of thousands of inappropriate patients. (Jacquelyn Martin/AP)

 

 

The Food and Drug Administration, drug companies and doctors mishandled distribution of a powerful fentanyl painkiller, allowing widespread prescribing to ineligible patients despite special measures designed to safeguard its use, according to a report released Tuesday.

The unusual paper in the medical journal JAMA relies on nearly 5,000 pages of documents that researchers obtained from the government via the Freedom of Information Act, rather than a more typical controlled scientific study.

After reviewing the data, the researchers concluded that prescribers, pharmacists, drug companies and the FDA — all of whom had agreed to special rules and monitoring for use of the powerful opioid — had allowed it to fall into the hands of thousands of inappropriate patients. Over time, the FDA and drug companies became aware this was happening but took no action, the researchers found.

Using five years of insurance claims data, the researchers found that between 34.6 percent and 55.4 percent of patients shouldn’t have received the drugs.

“The whole purpose of this distribution system was to prevent exactly what we found,” said Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins University Bloomberg School of Public Health, and one of the leaders of the study. “It should never happen. It’s a never event. And yet we found it was happening in 50 percent” of the cases.

The researchers looked at the distribution of pharmaceutical fentanyl for cancer patients experiencing “breakthrough pain” despite receiving opioids round the clock. The fentanyl, administered via lollipops, lozenges or nasal spray, marketed under several names by different companies, is about 100 times as powerful as morphine. According to the FDA, about 5,000 people in the United States receive such prescriptions at any one time.

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