US drug manufacturers fail to regulate use of painkiller fentanyl: Suggests Report

Nearly half the patients were overprescribed the dangerous painkiller fentanyl meant to battle cancer, as per a new report released on Tuesday which throws light on how drug manufacturers and health authorities have been negligent in their surveillance.

The report findings show how the US drug manufacturers and the FDA (Food and Drug Administration) could not regulate fentanyl properly despite the safeguards adopted around 8 years ago. The findings of the report are based upon the 4,877 document pages which were gathered by the researchers at both Yale and John Hopkins University by requesting the FDA.

Though an observatory program has been launched by the FDA since the year 2011 to keep a track on such kinds of medications, the report says that the fentanyl manufacturers and FDA failed to take an action when the evidence of inappropriate prescriptions came to the fore.

The research concluded by stating that the drug makers didn’t report even one instance where a doctor prescribed fentanyl incorrectly.

The report, which appears in the Journal of the American Medical Association, comes at the time when there is an ongoing opioid crisis nationwide. Over 47,000 US residents have lost their lives due to opioids in the year 2017. And now, the over-prescription of the fentanyl is broadly being considered as one of the major reasons for the raging opioid epidemic.

The drug in question is a kind of fentanyl known as ‘Transmucosal Immediate-Release Fentanyl’ (TIRFs). It is believed that the drug is much more powerful than even morphine.

TIRFs, which can be taken in the form of buccal or sublingual tablets, sprays or lozenges, is mainly meant for the cancer patients who could not find relief from acute pain using other opioids.

However, as per the investigation conducted by the researchers, nearly half of the patients who were prescribed TIRFs shouldn’t have received the drug as they were intolerant to opioids. In fact, one of the investigated doctors didn’t even know that the painkiller was solely meant for patients who developed a tolerance for opioids. It is because of this that the drug was wrongly prescribed to serve less severe conditions such as chronic headaches or back pain.

As per a spokesperson of the FDA, the agency understands the concerns the report points at. The FDA will soon share planned measures to ensure that its observatory program works towards mitigating the risks of such medications and that these should be prescribed to only those patients who are opioid-tolerant, the spokesperson added.