The Food and Drug Administration, drug companies and doctors all mishandled the distribution of the powerful painkiller fentanyl, allowing ineligible patients to receive prescriptions despite special measures designed to safeguard its use, according to a report released Tuesday.
That paper was based on over 5,000 pages of government documents obtained via the Freedom of Information Act, The Washington Post reported. Researchers were able to conclude from those files that prescribers, pharmacists, drug companies and the FDA — all of whom had agreed to special rules and monitoring for use of the powerful and dangerously addictive opioid — had allowed it to fall into the hands of thousands of inappropriate patients.
Using five years of insurance claims data, the study found that between roughly 35% and 55% of patients shouldn’t have received the drugs.
The researchers also discovered that the FDA and drug companies became aware of this problem over time and did nothing about it.
“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%” of the cases.
The specific type of fentanyl in question is typically prescribed to cancer patients experiencing “breakthrough pain” despite receiving opioids round the clock, the Post explained. It’s administered via lollipops, lozenges or nasal spray and is about 100 times more powerful as morphine.
According to the FDA, about 5,000 people in the United States receive such prescriptions at any one time.
Thanks for reading InsideHook. Sign up for our daily newsletter and be in the know.
