Painkiller Overdose Problems May Lead to New FDA Training Requirements
In an effort to address the rising number of overdose deaths attributed to the narcotic painkiller epidemic in the U.S., federal health regulators may require doctors to take a specialized training course before they are allowed to prescribe the powerful and addictive medications.
Opioid painkiller prescriber training is currently voluntary among doctors. However, regulators say only half the number of doctors anticipated have taken the voluntary training program.
Because of the low participation in the voluntary training, a panel of FDA advisors will meet this week to review a risk management plan put into place by the agency in 2012, which was designed to reduce the misuse and abuse of opioid painkillers.
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According to the FDA, only 37,500 doctors had completed the voluntary training programs by March 2015. The agency initially set a goal of 80,000 doctors.
Research published in 2013 found that opioid painkiller prescription use doubled since 2000, despite no increase in the use of non-narcotic painkillers during the same time period. They also warn that the nation’s narcotic painkiller abuse problem is worsening.
Part of the 2012 risk management program set into place by the FDA included voluntary training for doctors on how to safely prescribe opioid painkillers, new prescribing guidelines enacted by the CDC for primary care doctors to help improve opioid safety, and drug label changes for long-acting opioid painkillers to discourage abuse.
The panel of experts who advised the FDA when the safety measures were considered previously said a voluntary program is not enough to reduce abuse and recommended mandatory physician training.
The drug industry has pushed back against the recommendation, arguing that certification will be too burdensome for doctors. At the time, the FDA said the program was designed to address inappropriate use of narcotic painkillers, not deliberate abuse. So a voluntary program was put into place with the rest of the risk plan in July 2012.
The final plan called on doctors to offer patients pamphlets about the risks of opioid painkillers and drugmakers would fund optional physician training. Surveys conducted by drug manufacturers concluded 40% of prescribers were unaware of the anti-abuse programs offered.
Opioid Abuse Rampant
FDA officials say it is difficult to draw conclusions about the success of the risk management program, but are considering the recommendations of the advisory panel. While the FDA is not required to follow the panel’s recommendation, the agency often does.
The increasing narcotic painkiller drug epidemic led the FDA to issue draft guidance in 2013 to fight the opioid overdose epidemic. The guidance recommendations called for the industry to create new abuse-deterrent drug formulations.
The FDA will present the findings to the advisory panel over a two-day meeting beginning Tuesday, focusing on what changes need to be made to the risk management program.
Narcotic painkiller overdoses have increased over the last ten years. A study published in 2015, concluded opioid overdose deaths increased significantly, despite the decrease in narcotic painkiller abuse for non-prescription reasons.
Since 2000, the rate of drug overdose deaths increased 137 percent, for overdoses involving painkillers like Vicodin and OxyContin. Drug overdose deaths reached nearly 50,000 in 2015, 1.5 times the number of people killed in vehicle collisions every year.
The FDA says it supports having doctors take a training course before renewing their prescribing registration with the Drug Enforcement Administration. Only those registered with the DEA can prescribe opioids. However, enacting this requirement would require action by Congress since it imposes burdens on the healthcare system.
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