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Documents reveal FDA efforts to limit fentanyl prescriptions are failing miserably 

Doctors are over-prescribing powerful fentanyl opioid painkillers – and the FDA’s program to oversee the drugs is letting too much slip through the cracks, a new study suggests. 

Transmucosal immediate-release fentanyl (TIRF) drugs are potent drugs approved only to treat the most severe ‘break through’ pain for cancer patients. 

Fentanyl is often sold or made as an illicit drug as well and, because it is up to 50 times more potent than heroin, and is now believed to be driving the overdose epidemic in the US. 

In 2012, the US Food and Drug Administration created a program to oversee and monitor TIRF prescriptions to ensure they didn’t fall into the wrong hands, leading to addictions and overdoses – but punted the ‘administration’ to a drug company. 

A newly completed report by Johns Hopkins University found that the FDA and its partner in the program, McKesson, are failing to stop doctors from prescribing TIRFs to patients that have no need for them. 

Potent fentayl painkillers like Subsys are being prescribed to patients that haven’t tried weaker painkillers half the time, but the FDA is failing to stop doctors from giving out the potentially deadly drug, a new Johns Hopkins report found 

In decades past, heroin was the drug of destruction, known for its lethal potency and crippling withdrawals that made it hard to give up. 

In the 1960s, an estimated 80 percent of people treated for opioid addiction had started with heroin.  

Now the tables have turned. 

Opioid addiction started at a physician’s prescription pad for 80 percent of people end up using heroin. 

As fentanyl has become the driving force of opioid overdoses in the US, public health watchdogs are watching the drug – in prescription and street forms – more closely. 

Fentanyl is used primarily to reduce pain during surgery or for people who are already tolerant to other more moderate opioids. 

TIRFs are particularly dangerous because they are intended to act very quickly and relief intense pain – called breakthrough pain – from cancer that comes on suddenly and in spite of their regular regimens of painkillers. 

The ‘risk evaluations and mitigation strategy’ (REMS) was introduced in 2012 to make sure the drugs’ ‘benefits outweigh the risks,’  FDA Commissioner Dr Scott Gottlieb said in a later statement. 

REMS involved measures to educate prescribers on the proper uses of TIRFs and their dangers and, perhaps most importantly, a monitoring system that is supposed to flag doctors who prescribe it inappropriately and take away their permissions to prescribe the drug if they did so repeatedly. 

The FDA collaborated with manufacturers and McKesson, a drug company conglomerate assigned to be administrator of the REMS program.  

Johns Hopkins University researchers reviewed nearly 5,000 pages of FDA reports on  a subset of TIRF prescriptions written between 2012 (when the oversight program was introduced) to 2017. 

Rather than falling after the monitoring program was introduced, prescriptions for off-label uses of the drug – like chronic pain or headaches – had increased.  

By 2016, over half of all TIRF prescriptions were written for patients that were opioid naive – meaning they’d never tried weaker opioid painkillsers like OxyContin. 

‘Even though these products account for only a small proportion of all opioid sales, this is a really serious issue, because the adverse outcome we’re talking about here is death, not heart burn,’ says study author and co-director of Johns Hopkins’s Center for Drug Safety and Effectiveness, Dr Caleb Alexander.

‘Drugs are prescribed off label all the time, but this is no ta typical drug, and not a typical use. This should be a “never” event.’ 

Most worrying of all, by the time the program had been operating for three years, over half of those who were prescribed TIRFs were opioid naive. 

‘That’s a huge deal’ says Dr Alexander. 

And over the entire study period, despite the clear evidence that TIRFs are being prescribed dangerously – and more often than not – not a single doctor was so much as flagged, let alone disenrolled from prescribing the drugs. 

‘We are left with this jarring conclusion … and it’s hard to understand what went wrong,’ says Dr Alexander. 

‘But if the system were functioning as intended, these instances of unsafe prescribing would never have occurred.’  







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