Physicians warn mandatory opioid prescription training could have unintended effects
WASHINGTON (Sinclair Broadcast Group) — As deaths and medical costs associated with opioid painkiller addiction and abuse continue to rise in the U.S., the Obama administration is considering a recommendation to mandate new training for doctors who prescribe the drugs.
Following two days of hearings on improving the safety of opioid use, the Food and Drug Administration Drug Safety and Risk Management Advisory Committee agreed Wednesday to recommend that doctors be required to complete specialized training in order to be able to prescribe them.
The FDA does not have to follow the recommendations of its advisory panels, but it often does. Imposing this mandate would require congressional action.
Despite a similar expert panel recommendation in favor of mandatory training in 2012, the FDA had opted to make educational courses on safe pain prescription voluntary. As of March 2015, less than half of the 80,000 doctors the agency wanted to complete that training had done so.
Prescription opioid overdose deaths have quadrupled since 1999 as sales of the drugs have rapidly increased, according to the Centers for Disease Control and Prevention (CDC). About half of opioid overdose deaths now involve prescription drugs, including 14,000 deaths in 2014.
The prescription drugs most commonly involved in these deaths are methadone, oxycodone, and hydrocodone. The drugs have also been linked to risks of nonfatal abuse, misuse, and addiction.
The issue of opioid painkiller abuse has been thrust into the national spotlight by reports that singer Prince was suffering from addiction to pain medication prior to his death last month. The Associated Press reported that law enforcement is investigating whether he died from an overdose.
A cause of death has not been determined, but the Minneapolis Star Tribune is reporting that the opioid Percocet was found in Prince’s system during his autopsy. An attorney for a California addiction specialist has confirmed that the singer’s representatives had reached out for assistance before he died.
While many medical professionals and experts agree that opioid addiction and abuse must be addressed, some organizations that represent physicians balked at the proposal to require doctors to undergo additional training on the subject.
The American Medical Association (AMA) has opposed mandatory physician education on pain management and opioid abuse in the past, although the organization recognizes the need to improve training on the subject and is engaging with the FDA on the latest proposal. Dr. Patrice Harris, chair-elect of the AMA and chair of its Task Force to Reduce Opioid Abuse, said, “We support a voluntary approach to physician education and training, with the profession being responsible for articulating the standards and what is best for specific specialties and patient populations – rather than a one-size-fits-all response.”
“Linking mandatory training on opioids to the DEA registration process raises legitimate questions of how to best ensure the competency of physicians and other prescribers, what are possible unintended consequences for patients and their physicians, and what is the appropriate role of the federal government in this process,” Harris said in a statement.
The American Academy of Family Physicians (AAFP) has also rejected calls for additional mandatory training on painkiller prescription. The organization argues that family physicians already undergo extensive training on drug prescribing and are required to complete 150 credits of continuing medical education every three years.
The AAFP contends that further education of doctors will not address the illegal transfer of opioids from patients to others or the misuse of pain medications that are driving the epidemic. There is also concern that more training requirements will put a burden on overextended physicians or leave doctors who do not have time to take the classes unable to prescribe pain medication to patients who legitimately need them.
However, AAFP board chairman Dr. Robert Wergin emphasized that the organization does believe opioid abuse requires a response. The AAFP provides education on the subject and encourages members to participate, but he does not think it should be required.
“We certainly acknowledge and recognize the problems with opioid use… but there may be some unintended consequences with mandatory CME (Continuing Medical Education) requirements,” he said.
Wergin, a practicing physician in a rural area, said imposing training requirements that doctors may not be able to meet will create “an access problem” because there are not enough pain management centers to treat the patients whose family doctors would no longer prescribe the medication under those circumstances.
Wergin identified several steps that could be taken to address the dangers of opioid abuse, some of which he said have already proven successful in several states. One is placing restrictions on the number of pills a patient can get, and another is prescription monitoring programs that prevent patients from doctor-shopping and pharmacy-shopping.
He also recommended doctors create contracts with their pain patients to ensure that they use the medication responsibly, and he suggested drug testing to prove patients are taking the medicine, which would discourage drug diversion.
According to Wergin, it is a “mischaracterization” to suggest that family physicians currently lack the training and education to responsibly prescribe pain medication. Between medical school, residency, and existing CME courses, he feels they have access to the information they need.
Cynthia Kear, senior vice president of the California Academy of Family Physicians (CAFP), said “education is key” to addressing the opioid epidemic, but her organization also fears the unintended effects that mandatory training could have.
Kear, who participated in this week’s FDA advisory committee meetings, said there is consensus among many physicians that more needs to be done to educate doctors about pain management. The CAFP and its partner organizations attempt to make voluntary training as accessible as possible for those who want to participate.
“There has never been any documented evidence that mandatory education is any more effective in facilitating behavior change than voluntary,” said Dr. Carol Havens, a California family physician and former CAFP president who has been active in teaching other doctors about these issues.
Havens, director of Physician Education and Development for Northern California Kaiser Permanente, said the CAFP has found that doctors do want more education about the risks and benefits of prescribing pain medication. This education needs to be practical and implementable, though, and that means they need alternatives to opioids that their patients have access to and can get covered by their insurance companies.
“It’s not enough to simply say, ‘Don’t prescribe opioids,'” she said.
Kear pointed to the comprehensive, “full court press” approach that the government and the medical community took to stopping smoking, and said that coordinated effort is missing on this issue. Public service announcements and public education efforts could help fight abuse and misuse.
According to Havens, there are several other factors that present challenges for family physicians. One is that their time with each patient is often limited to a few minutes due to the demands of their busy schedules. This is why she feels it is important for insurance companies to provide sufficient reimbursement for those who undertake the necessary and time-consuming evaluation of pain patients.
“It takes time to be able to do this and to do it appropriately,” Havens said.
Doctors must contend with the threat of litigation from patients who feel they have received inadequate treatment for their pain. They also face insurance companies that sometimes tie their reimbursement to patient satisfaction.
In those cases, refusing to prescribe opioids or offering safe alternatives could lead to negative evaluations that damage their practice. Similarly, hospitals may be evaluated on ensuring that their patients do not report pain. This can all result in misplaced pressure on physicians who are making treatment decisions.
According to Kear, mandatory guidelines imposed by some states about frequency, amounts, and dosage of opioids have left physicians “feeling the rope tightening a bit.” That can drive some to not provide pain treatment at all, and patients who genuinely need that medication may not always have access to specialists, clinics, and other alternatives.
Critics of the training programs supported by the FDA have also questioned their effectiveness because it is unclear what percentage of opioid deaths are the result of inappropriately prescribed drugs rather than those that were obtained by the user illegally.
According to the Associated Press, FDA advisory panel members were unable to determine whether actions taken by the agency so far have actually reduced the threat of opioid misuse and abuse. The number of opioid prescriptions began dropping before the current rules were imposed, but overdose deaths have continued.
An expert from Public Citizen who testified before the FDA panel this week complained of the influence of “opioid industry-funded ‘education’ and promotion.” Instead, the organization called for mandatory training with minimal industry involvement
The dispute over potential training requirements for physicians underlines the complexity of the opioid abuse issue and the difficulty the FDA and the medical community must now overcome to prevent further overdose deaths.
“Everybody wants a quick fix and it does not exist,” Havens said.
Filed under: General Problems
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