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| Opioid Prescribing Gets Another Look as F.D.A. Revisits Mandatory Doctor Training | |
| (about 17 hours later) | |
| A pain management specialist, Dr. Nathaniel Katz, was stunned in 2012 when the Food and Drug Administration rejected a recommendation from an expert panel that had urged mandatory training for doctors who prescribed powerful painkillers like OxyContin. | A pain management specialist, Dr. Nathaniel Katz, was stunned in 2012 when the Food and Drug Administration rejected a recommendation from an expert panel that had urged mandatory training for doctors who prescribed powerful painkillers like OxyContin. |
| That panel had concluded that the training might help stem the epidemic of overdose deaths involving prescription narcotics, or opioids. At first, Dr. Katz, who had been on the panel, thought that drug makers had pressured the F.D.A. to kill the proposal. Then an agency official told him that another group had fought the recommendation: the American Medical Association, the nation’s largest doctors organization. | That panel had concluded that the training might help stem the epidemic of overdose deaths involving prescription narcotics, or opioids. At first, Dr. Katz, who had been on the panel, thought that drug makers had pressured the F.D.A. to kill the proposal. Then an agency official told him that another group had fought the recommendation: the American Medical Association, the nation’s largest doctors organization. |
| “I was shocked,” said Dr. Katz, the president of Analgesic Solutions, a company in Natick, Mass. “You go to medical school to help public health and here we have an area where you have 15,000 people a year dying.” | “I was shocked,” said Dr. Katz, the president of Analgesic Solutions, a company in Natick, Mass. “You go to medical school to help public health and here we have an area where you have 15,000 people a year dying.” |
| Now, as the White House, the Centers for Disease Control and Prevention and other federal and state agencies scramble to find solutions to the vexing opioid problem, the role of doctors is coming back to center stage. The Obama administration recently announced that it supported mandatory training for prescribers of opioids. | Now, as the White House, the Centers for Disease Control and Prevention and other federal and state agencies scramble to find solutions to the vexing opioid problem, the role of doctors is coming back to center stage. The Obama administration recently announced that it supported mandatory training for prescribers of opioids. |
| On Tuesday, a new F.D.A. panel of outside experts will meet to review once again whether such training should be required. The hearing will almost certainly touch off an intense debate inside the medical community and focus attention on medical groups like the A.M.A., which have resisted governmental mandates affecting how doctors practice for both ideological and practical reasons. The panel is expected to make its final recommendation on Wednesday. An F.D.A. spokeswoman said the agency now supported mandatory training. | On Tuesday, a new F.D.A. panel of outside experts will meet to review once again whether such training should be required. The hearing will almost certainly touch off an intense debate inside the medical community and focus attention on medical groups like the A.M.A., which have resisted governmental mandates affecting how doctors practice for both ideological and practical reasons. The panel is expected to make its final recommendation on Wednesday. An F.D.A. spokeswoman said the agency now supported mandatory training. |
| Since 2012, the F.D.A. has required drug companies that produce so-called long-acting opioids — drugs like OxyContin, fentanyl and methadone — to underwrite voluntary educational courses on the medications. In a surprise, last week many of those manufacturers came out in support of rules requiring doctors to have specific training or expertise in pain management before getting a license from the Drug Enforcement Administration to prescribe a strong opioid. | Since 2012, the F.D.A. has required drug companies that produce so-called long-acting opioids — drugs like OxyContin, fentanyl and methadone — to underwrite voluntary educational courses on the medications. In a surprise, last week many of those manufacturers came out in support of rules requiring doctors to have specific training or expertise in pain management before getting a license from the Drug Enforcement Administration to prescribe a strong opioid. |
| The approach, which would require congressional action, would ensure that prescribers got “appropriate training in pain management with opioids so their patients can continue to access treatment options,” the group said. | The approach, which would require congressional action, would ensure that prescribers got “appropriate training in pain management with opioids so their patients can continue to access treatment options,” the group said. |
| Dr. Patrice A. Harris, who is the chairwoman of the A.M.A.’s Task Force to Reduce Opioid Abuse, said the organization was committed to helping doctors better use opioids. But Dr. Harris added that the A.M.A. continued to oppose mandatory opioid training for doctors because many physicians do not prescribe the drugs. | Dr. Patrice A. Harris, who is the chairwoman of the A.M.A.’s Task Force to Reduce Opioid Abuse, said the organization was committed to helping doctors better use opioids. But Dr. Harris added that the A.M.A. continued to oppose mandatory opioid training for doctors because many physicians do not prescribe the drugs. |
| She added that the group also opposed laws that require doctors to check databases before issuing a prescription for a narcotic painkiller. Such laws, which a growing number of states have adopted, are intended to help doctors identify patients who seek prescriptions from multiple physicians and to help doctors avoid prescribing dangerous combinations of drugs. Data shows that when such programs are voluntary, many doctors do not use them. | She added that the group also opposed laws that require doctors to check databases before issuing a prescription for a narcotic painkiller. Such laws, which a growing number of states have adopted, are intended to help doctors identify patients who seek prescriptions from multiple physicians and to help doctors avoid prescribing dangerous combinations of drugs. Data shows that when such programs are voluntary, many doctors do not use them. |
| “We know these tools are a great tool in the toolbox,” said Dr. Harris, who is a psychiatrist. “But they are not a panacea.” | “We know these tools are a great tool in the toolbox,” said Dr. Harris, who is a psychiatrist. “But they are not a panacea.” |
| Doctors say measures like checking prescription databases take up more time in days already filled with bureaucratic duties, and many express ideological concerns about government’s reach into medicine. And experts say many doctors believe that their practices and their patients are not responsible for the opioid problem. | Doctors say measures like checking prescription databases take up more time in days already filled with bureaucratic duties, and many express ideological concerns about government’s reach into medicine. And experts say many doctors believe that their practices and their patients are not responsible for the opioid problem. |
| Timothy Condon, a former official at the National Institute on Drug Abuse, said he encountered that attitude in 2010 when several federal agencies approached the A.M.A. and medical groups representing specialists to seek their support for mandatory physician training. | Timothy Condon, a former official at the National Institute on Drug Abuse, said he encountered that attitude in 2010 when several federal agencies approached the A.M.A. and medical groups representing specialists to seek their support for mandatory physician training. |
| “The take-home message was, who are you as feds to tell us how to practice medicine, you already regulate us so much,” said Mr. Condon, who is now a research professor at the University of New Mexico in Albuquerque. | “The take-home message was, who are you as feds to tell us how to practice medicine, you already regulate us so much,” said Mr. Condon, who is now a research professor at the University of New Mexico in Albuquerque. |
| He added that when he countered that the scale of the prescriptions that doctors were writing for opioids was central to the overdose problem, the response from the medical group was “silence.” | He added that when he countered that the scale of the prescriptions that doctors were writing for opioids was central to the overdose problem, the response from the medical group was “silence.” |
| Mandatory training before prescribing the drugs is not the only area where government officials and medical experts are cautiously circling each other. | Mandatory training before prescribing the drugs is not the only area where government officials and medical experts are cautiously circling each other. |
| The Obama administration has asked American medical schools to incorporate new recommendations from the Centers for Disease Control and Prevention about how to treat pain into their curriculums. Along with urging physicians to try nondrug approaches first, the guidelines suggest that opioids be used sparingly. | The Obama administration has asked American medical schools to incorporate new recommendations from the Centers for Disease Control and Prevention about how to treat pain into their curriculums. Along with urging physicians to try nondrug approaches first, the guidelines suggest that opioids be used sparingly. |
| So far, however, only about one-quarter of the 145 teaching institutions that belong to a major organization, the Association of American Medical Colleges, have agreed to incorporate the C.D.C. guidelines into their programs. | So far, however, only about one-quarter of the 145 teaching institutions that belong to a major organization, the Association of American Medical Colleges, have agreed to incorporate the C.D.C. guidelines into their programs. |
| Dr. Darrell G. Kirch, the organization’s president, said his group and medical schools were actively working to reduce inappropriate opioid use. But he added that many institutions preferred to develop teaching guidelines based on their own expertise. | Dr. Darrell G. Kirch, the organization’s president, said his group and medical schools were actively working to reduce inappropriate opioid use. But he added that many institutions preferred to develop teaching guidelines based on their own expertise. |
| In addition, Dr. Kirch said that medical school leaders feared that committing to one federal guideline could lead to a situation where lawmakers imposed agendas on physicians that are not in the interest of patient care. | |
| Last week, the F.D.A. released data showing the impact of a voluntary approach to educating doctors. The figures showed that only about half of the 80,000 doctors who the agency had hoped would receive training by March 2015 had completed it. | |
| While the agency said the results “make it difficult to draw conclusions regarding the success” of the program, it also raised concerns that requiring training could make it harder for patients to get needed drugs. The F.D.A. will also ask the panel to review whether doctors who prescribe so-called short-acting narcotics like Percocet or Vicodin should have access to training. | While the agency said the results “make it difficult to draw conclusions regarding the success” of the program, it also raised concerns that requiring training could make it harder for patients to get needed drugs. The F.D.A. will also ask the panel to review whether doctors who prescribe so-called short-acting narcotics like Percocet or Vicodin should have access to training. |
| The medical community is not monolithic in its views. Recently, for example, the Massachusetts Medical Society supported legislation in that state imposing a limit on an initial opioid prescription to a seven-day supply. Some doctors and dentists give patients 60 or 90 high-strength painkillers, enough for a month, giving rise to potential misuse of the drugs or opening a door to addiction. | The medical community is not monolithic in its views. Recently, for example, the Massachusetts Medical Society supported legislation in that state imposing a limit on an initial opioid prescription to a seven-day supply. Some doctors and dentists give patients 60 or 90 high-strength painkillers, enough for a month, giving rise to potential misuse of the drugs or opening a door to addiction. |
| Dr. Katz, the pain expert in Massachusetts, said he understood the resistance of physicians to mandates, including the fear that malpractice lawyers will seek to wield them as weapons. But he has been urging regulators for about 15 years to require doctors to undergo mandatory training. | Dr. Katz, the pain expert in Massachusetts, said he understood the resistance of physicians to mandates, including the fear that malpractice lawyers will seek to wield them as weapons. But he has been urging regulators for about 15 years to require doctors to undergo mandatory training. |
| “There is incredible rationalizing that exists,” he said. “There is a problem, and patients and doctors are a part of it. But doctors think it is not me and it is not my patients.” | “There is incredible rationalizing that exists,” he said. “There is a problem, and patients and doctors are a part of it. But doctors think it is not me and it is not my patients.” |