FDA Eyes Mandatory Opioid Training for Prescribers
Friday, July 14, 2017
By Elaine Goodman
National U.S. Food and Drug Administration Commissioner Scott Gottlieb wants to expand training available to doctors on opioid prescribing — and is even considering mandatory opioid education for prescribers.
Gottlieb discussed (http://www.fda.gov/NewsEvents/Speeches/ucm566189.htm) the issue on Monday during an FDA meeting on abuse-deterrent opioids.
“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,” Gottlieb said.
FDA currently provides opioid education for prescribers through the Risk Evaluation and Mitigation Strategy — steps that opioid manufacturers must take to offset the risks of the drugs. Drug companies have teamed up on the REMS for extended-release and long-acting opioids, in which the drug makers “strongly encourage” doctors to complete a continuing education program on opioid prescribing. The drug companies provide funding for the training programs, which are then available at little or no cost to the prescribers.
For example, on July 28, a REMS-compliant opioid training will be offered by the California Academy of Family Physicians at the Hyatt Regency San Francisco. In New York, a session will be held at the Saratoga Hilton in Saratoga Springs on Oct. 21. A complete schedule is available here (http://search.er-la-opioidrems.com/Guest/GuestPageExternal.aspx) .
Although the training is funded by opioid manufacturers, the FDA has said that the content is “objective and independent.”
Gottlieb said he wants to extend the Risk Evaluation and Mitigation Strategy requirements for extended-release opioids to manufacturers of immediate-release opioids.
“The new training will be aimed at making sure providers who write prescriptions for the IR opioids are doing so for properly indicated patients, and under appropriate clinical circumstances,” Gottlieb said.
The prescriber training will also be beefed up to include more information on management of acute and chronic pain, alternatives to drugs for treating pain, and opioid and non-opioid drugs as pain treatment. That’s in addition to information on safe opioid use, addiction medicine basics and opioid use disorders.
The training will be available not just to physicians, but also to others such as nurses and pharmacists.
“FDA believes that all health care providers involved in the management of pain should be educated about the safe use of opioids,” Gottlieb said.
If Gottlieb decides to impose opioid training requirements on doctors, he wouldn’t be the first government official to do so.
Some states that have recently adopted supply limits for initial opioid prescriptions for acute pain have also approved training requirements. In New Jersey, Senate Bill 3 (http://www.njleg.state.nj.us/2016/Bills/S0500/3_R1.PDF) , signed into law in February, mandates opioid education for prescribers in addition to placing a five-day cap on initial opioid prescriptions.
And in Louisiana, Senate Bill 55 (http://www.legis.la.gov/legis/BillInfo.aspx?s=17RS&b=SB55) , by Sen. Fred Mills Jr., R-St. Martin Parish, will require continuing education for physicians on controlled substance prescribing and addiction treatment. The bill was signed into law last month.
Some say a multi-pronged approach is needed to promote safe opioid use.
“Successfully addressing safe opioid use while ensuring access to these medications for patients in pain requires a comprehensive approach that includ(es) patients, physicians and pharmacies,” Jennifer Luddy, director of corporate communications at Express Scripts, said in commenting on an article (http://www.washingtonpost.com/news/to-your-health/wp/2017/07/10/fda-chief-to-impose-tougher-doctor-training-rules-on-opioid-manufacturers/?utm_term=.41b93dced908) in the Washington Post on the FDA’s potential education requirement.
Luddy pointed to Express Scripts’ program called Advanced Opioid Management, which sends messages to opioid-writing physicians to inform them of potential duplicate therapy, drug interactions, use of multiple prescribers or pharmacies, or when their patient is approaching a morphine equivalent dose threshold.
Since FDA rolled out the prescriber training programs in March 2013, the agency’s thinking may have evolved regarding extended- versus immediate-release opioids.
“As the opioid epidemic has evolved in recent years, extended-release and long-acting opioids have clearly emerged as products with the highest potential for harm, misuse and abuse,” the agency said in a March 2013 letter (http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm330614.htm) to prescribers. “These products contain large amounts of opioids in a single dosage form, sometimes in sufficient quantity to be lethal, especially in children, and they are a prime target of drug abusers.”
Gottlieb on Monday noted that about 90% of opioid prescriptions are for immediate-release formulations, and the nation is “simply awash” in the products.
“Immediate-release opioid products may serve as the gateway for patients and non-patients who may continue to use or misuse these products, which could lead to a lot of new addiction,” Gottlieb said. “And we all need to work to advance policies that rationalize the prescribing and dispensing of these products.”