FDA says physicians will have to receive training to prescribe opioid painkillers

FDA says physicians will have to receive training to prescribe opioid painkillers


The Food and Drug Administration proposed on Monday new guidelines to fight the growing opioid epidemic that’s hitting the U.S., and pledged to make it its priority.

 FDA Commissioner Scott Gottlieb announced plans to require manufacturers of immediate-release painkillers to provide thorough education for physicians and health care professionals who prescribe these drugs.
Image Credit: Shutterstock
Image Credit: Shutterstock

The announcements were part of the opening statement of a two-day FDA meeting on painkiller abuse. Painkiller prescriptions account for 90 percent of the opioids prescribed in the United States, and some of the compounds include dangerous opioids like hydrocodone or combinations such as oxycodone with acetaminophen.

FDA will require training to prescribe extended-release opioid painkillers

Gottlieb noted that, for the time being, only makers of extended-release painkillers, which account for the remaining 10 percent of prescriptions, are required to provide training.

“America is simply awash in immediate-release opioid products,” said Gottlieb.

He noted that the new training requirements would aim at making sure that prescriptions are for patients who actually need them and under appropriate clinical circumstances.

The FDA will also survey doctors to ensure the term “abuse deterrent” isn’t giving a false sense of security that these drugs are less likely to lead to addiction than pills without that designation. Gottlieb noted that while abuse-deterrent versions of painkillers are manufactured to be harder to crush, snort or inject, the FDA doesn’t want to convey a perception that these versions are less prone to fueling addiction because they’re not.

Although the FDA does not require doctors to undergo the training currently, Gottlieb said he wants to pursue that possibility.

“Based on the feedback we’ve received from two public meetings over the past year, we’re actively exploring the question of whether, in the future, there should be mandatory provider education, and how we’d operationalize such a condition,” he said.

The commissioner that most people who become addicted to opioid painkillers will eventually move on to look higher dose formulations of these compounds or they’ll seek illicit street drugs that are “increasingly the low-cost alternatives.”

Endo International Plc halted sales of its addictive painkiller Opana ER

The agency has been taking measures against pharmaceutical companies, too, as the opioid epidemic continues to claim lives around the country. Last week, Endo International Plc complied with FDA’s request to halt U.S. sales of its powerful opioid painkiller Opana ER.

The FDA had said the abuse-deterrent version of the painkiller was linked to an outbreak of HIV and hepatitis C after users would inject it for a more potent high and share used needles. That marked the first time the FDA asked for the removal of an opioid from the market because of a public health consequence of abuse.

A court filing against Endo and Purdue Pharma, another pharmaceutical manufacturer, were also added last week to a lawsuit from 2014 by two counties in California. The lawsuits were filed as an effort to make the drug companies pay for the cost of addressing the opioid crisis.

Gottlieb also noted the agency would examine whether it should take action to reduce the number of 30-day prescriptions that are issued for pain related conditions that don’t need a whole month’s supply, such as dental procedures.

5 Responses

  1. this the prohibition of our times,,,,,and if we don’t stop it,,,no-one will,,,maryw

  2. Their outcome will be worse than the CDC guidelines. They’re seeking to eliminate an entire population of all addicted and all with chronic intractable pain who take opiates or opioids. They need to learn how ALL should be treated humanely, respectfully & with dignity to the best of our knowledgeable PHYSICIANS. Not by one w/o a medical decree. We sent our letters before 6/16/17 & did it matter? NOPE!! 9 addiction groups spoke & NOT one who treats or has intractable pain. CDC, FDA, DEA, VA, PROP, ALL government agencies & all individuals responsible need to be held accountable ASAP. They’re all stepping outside the law & need to have their asses sued. Google “Find form 95A on department of justice” & DO it as many times as needed.

  3. The FDA said they’d read ALL comments up until 11:59pm 7/10 before a final decision is made on Dr’s getting more training. Why is Zyhodo still on market? It has NO abuse deterrent, but Opana ER does. Makes you wonder who’s lining the pockets of Gottlieb? If you share needles to inject anything you’ll get HIV or Hep C. Indiana ABUSED Opana ER to get high same as did Tenn., but they got a disease specific to oxymorphone all in the name of getting HIGH. When will All Lives Matter of Addicts & Intractable Pain Patient’s? IMO they don’t care about either just ask ALL on Trump’s Commission for Addiction and Opioid Crisis? Do they care or have a pre-.determined outcome protecting addiction? Follow the $ & see what they’ve in common?

    • Sherry,,this is exactly what they did here,in wisco,,,That V.A.. Tomah,,V.A.,,,,their was 1 opiate in a 35 year old man,,,,his parents,,,called him their baby,,,well,,1 opiate,,the weakest 1,,tramadol,,600 NANOGRAMS,,was in his system when he died in a psychward,,,they never checked on him for 4 f-hours,,,he died of cardiac arrest,,,laid there for 4 hours,,they thought he was alseep,,,,,by the time they realized,,,shift change,,,at 4,,,too late,,never KNEW how,, in the psych-ward how to do cpr,,,any how,,,THEY BLAMED THE WHOLE THING ON OPAITES,,,THE NEWSPAPERS PUBLISHED EVERYWHERE ,,”CANDY LAND FOR OPIATES,”,,CENSORRED ANY COMMENTS FOR THE TRUTH,,’DISABLED VET ONLINE PAPER WAS THE WORSE PROPGANDA MACHINE,,EVERY OTHER DAY,.,,,DEMON OPIATES,,,,, point being it had NOTHING TO DO W/OPIATES,,,NOTHING,,,BUT THE MEDIA,,WAS WONDERFUL AT PUBLISHING PROPAGANDA,,,JUST LIKE YOUR HIV BULLSHIT IN iNDIANA,,BLAMIMNG MEDICINE,OPIATES,,,, for stupid decisions,,,MARYW

  4. This is more of a curiosity question than a comment. Don’t pain management doctors already have special training? Or, is this more in regards to acute pain scripts? Why would someone get a prescription for an extended release medication for something like dental treatment?
    Is the fear that the rules will be misunderstood, much like the CDC guidelines?

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