While there is no current mandatory requirement that physicians take training as a precondition to prescribing long-acting and extended release opioids, an FDA statement notes that the Obama administration endorsed a mandatory training program on responsible opioid prescribing practices in April 2011 "as part of its comprehensive plan to address the epidemic of prescription drug abuse."
Such a program would be linked to a DEA registration by providers and "would require legislative changes that are being pursued by the administration," according to the FDA.
The FDA program will impact at least 20 drug manufacturers, which would be required to make educational programs available to providers based on an FDA Blueprint. Companies can meet their obligations by providing educational grants to continuing education providers, who will develop and deliver the training, according to the FDA.
The REMS also requires companies to make available FDA-approved patient education materials about the safe use of the drugs. It is expected that the first continuing education activities will begin March 1, 2013. The FDA expects the training to take about three hours, but the continuous education providers can determine the number of credit hours that will be offered at no cost.
The AAFP's Stream sees the FDA program as onerous. "This isn't a simple legislative and regulatory solution," he says.
Not all physician groups have been as upset as the AAFP about the government's educational efforts to deter opioid abuse. "Through proper education and training, opioids can be administered safely to patients and continue to be an important option in the treatment of chronic and debilitating pain that is suffered by millions of Americans," the 2,600-member American Academy of Pain Medicine said in a statement about the federal plan. The AAFP's Stream says his organization wants to battle the opioid issue on other fronts, such as advocating increased national funding to support research into "evidence-based strategies" for pain management to be included in patient-medical home programs.
Each day, Stream acknowledges there's a "fine line" that physicians must walk in the drug treatment-for-pain issue.
"We've got to treat people's pain so they aren't suffering so much they want to kill themselves, but we can't let them kill themselves with drugs, either," he says.