California's controversial Death Certificate Project so far has resulted in overprescribing accusations against 46 physicians whose patients fatally overdosed in 2012 or 2013.
Cases against another 13 doctors are pending or have been referred to the state attorney general's office or local district attorneys. Out of 511 cases originally identified, 89 still await review and disciplinary actions have been taken against five.
That's the current status of what the largest physician licensing agency in the nation calls its "proactive approach" to stop opioid overdoses, said , the Medical Board of California's executive director, at a board meeting Thursday. In a program nationally unique for its scope and aggressiveness, board reviewers studied some 2,700 death certificates from 2012-2013 listing drug overdose as a cause.
But the initiative -- designed to find physicians with egregious patterns of overprescribing -- has prompted outrage from many physician groups, including the American Medical Association, and individual doctors who say their practices have been terrorized. They say the project has unfairly targeted clinicians who thought they were appropriately treating their patients' pain based on rules at the time. Besides, many of the deaths were suicides, or overdoses with street drugs or pain killers not taken as prescribed and which they couldn't prevent.
Modifications coming
At the Thursday board meeting, Kirchmeyer acknowledged their concerns and said the project can be improved. Based on physicians' objections -- some of which were aired moments earlier -- board staff "believes some methodology changes need to be made" that will "eliminate some of the concerns that have been raised."
For starters, board staff and its reviewers will now begin to examine death certificates from 2016 and 2017 for the next phase instead of reaching further back, as was previously planned, she said. That may provide a better sense of physicians' current prescribing practices.
Many physicians and leaders of organized medicine had criticized the project for its review of prescriptions from nine years earlier, saying prescribing practices were much more aggressive a decade ago -- before state and federal guidelines urging more cautious prescribing were issued in 2014 and 2016 and before the opioid epidemic's seriousness was fully appreciated.
Kirchmeyer said that instead of looking just at the physician's prescription history for each deceased patient with a death certificate, the board will expand its review to the physician's prescribing practices for other patients "at that stage, and will look for red flags for potential inappropriate prescribing patterns."
Task force review
The board also intends to address another common complaint about the project: that the current guidelines don't help doctors prescribe controlled substances for patients who "may be addicted and on high doses of opioids." She said the board intends to gather experts in a task force to recommend updates to prescribing guidelines similar to the process the board used in 2014.
Kirchmeyer said that of the 511 cases, 43 were closed because the physician had already been disciplined or their license was revoked or surrendered. Overall, Kirchmeyer boasted that 21% of the cases initially identified by board reviewers resulted in an accusation filed or an action pending, or the physician was already disciplined for overprescribing. "This shows that the physician experts doing their initial review appropriately identified those physicians with prescribing issues that violated the standard of care," she said.
"The Death Certificate Project has identified patterns of unsafe prescribing to save lives." She added that the odds of dying from an accidental overdose "are greater than dying in a motor vehicle crash."
Kirchmeyer made those remarks after numerous speakers pleaded with the board to stop the project, saying it was endangering patients because many doctors were fearfully and dangerously tapering doses abruptly or turning patients away.
MD, director of substance use research at the San Francisco Department of Public Health, and a member of the committee that developed the CDC's 2016 opioid prescribing guidelines, urged the board to stop the project.
He pointed to a CDC study that found that "patients who were discontinued from opioids were 2.5 times more likely to use street opioids than patients who were maintained on their opioids."
The project is "unintentionally harming patients," he said, because multiple providers have outright stopped prescribing controlled substances due to fears about the project, often after they or a colleague got a letter from the board saying a complaint had been filed against them.
Sometimes, more appropriate care means a "very slow and conscious taper that could take years. ... It should not be rushed by fears about one's license."
"To have prescribers stop prescribing out of fear for their licenses, and worse yet, to have them not be willing to treat opioid use disorders, which we as a medical community created ... is dangerous to patients and frankly, violates the ethical principles of medicine," Coffin said.
Patients abandoned
, MD, president of the California Society of Addiction Medicine, also urged the board to "halt the current investigative process" to address adverse outcomes when patients are abruptly cut off of their painkillers or see their prescription strengths dramatically reduced.
In a recent survey of its 600 provider members, he said, specialists "reported seeing more and more patients moving to dangerous drugs like heroin and fentanyl as a result of forced opioid tapers," 50% reported an increase in illicit opioid use as a result of opioid tapers, "and 75% rated specialty pain care in their area as worsening in access and in quality."
"We're seeing more and more patients are being summarily abandoned in the name of 'safety.' What is safe about leaving a doctor's office care and turning to the streets for heroin and fentanyl?" he asked.
Moreover, he said, the project's methodology appears to be judging physicians "on the knowledge that was known as long as eight years prior." Primary care doctors are no longer prescribing opioids, and their patients are being abandoned, he said.
And , MD, director of the Women's HIV Program at University of California San Francisco told the board the project has created "panic among front-line clinicians who draw patients with complex health and social conditions. Providers are scared that one of their patients will overdose for reasons totally out of their control and that they will be humiliated or worse by this board if they have prescribed opioid pain medicines for them."
This fear is justified, he said, because there's a lack of detailed guidance on how doctors can know they are in full compliance when they're treating patients who have been on opioids for chronic pain for many years.
"Out of fear to protect themselves," he said, many clinicians are coercively initiating opioid tapers or coercively changing medications to buprenorphine without "collaborative efforts with individual patients."
Many providers are "simply refusing to accept any new patient who is on chronic opioids for their chronic pain. I see the results of this in my clinic every week. Patients are increasingly presenting for care in acute withdrawal after having had their opiates rapidly tapered or stopped, or when they're unable to find a provider to accept them as a patient."
Machtinger added that the population he sees most adversely affected by the Death Certificate Project is predominantly African American, Latino, or from other minority groups.
One of the board members, MD, also weighed in, suggesting that the board take a look at how the project has affected various clinical settings, such as acute care versus federally qualified health centers.
"As we have heard, there can be an impact for some of the federally qualified health centers when ... several systems may decide not to prescribe," she said. "I think it's going to be important to review those guidelines," to address appropriate prescribing for patients who are not "opioid-naïve."
Kirchmeyer replied that she has heard many complaints that doctors are now afraid to prescribe. As she's visited many medical groups around the state to talk about new rules for reporting and checking the state's prescription database, , she said, some of the meetings have been "very adversarial."
"And usually when I bring up prescribing guidelines, I ask them, how many of you – I put up a slide -- have actually seen these guidelines. And out of rooms with sometimes 120 physicians ... we've had like six hands in the meeting room. We have to find a way to get physicians to read the information put out by the medical board," she said. "Maybe we change regulations to give out continuing medical education credits to physicians for reading the board's newsletters."
Project has fans, too
Not everyone dislikes the Death Certificate Project.
Consumer advocates urged the board to be more aggressive.
In a to the board, , executive director of Consumer Watchdog and , JD, of the Center for Public Interest Law at the University of San Diego, said they "applaud the Project's proactive approach to identifying and disciplining doctors who are contributing to the overdose crisis by overprescribing opioids and other highly addictive medications to California patients.
While the groups acknowledged that many of the overdose deaths now are not from prescription drugs but from illegally obtained opioids, it blamed negligent doctors for causing the problem. "Patients are turning to these street drugs after first getting hooked on prescription opioids obtained legally or otherwise from a doctor," the letter said.
The consumer groups said they support efforts to "redraft letters seeking access to patients' medical records so they are not about the quality of their own care."
"Investigating deaths caused by prescription drug overdoses is the most direct way to identify doctors whose excessive prescribing may otherwise fly under the radar indefinitely," it continued. "It is outrageous to suggest, as have some opponents of the program, that the Board is out of bounds for investigating the medical care provided by potentially dangerous doctors. That is the board's primary function."
Board staff previously released the names of 23 physicians in California who faced accusations of negligent prescribing that stemmed from the project. On Monday, Kirchmeyer released the names of the 23 newly accused:
, of Clovis; , of Huntington Beach; , of Concord and Zermatt, Switzerland; , of Costa Mesa; , of Los Angeles; , of Roseville; , of Walnut Creek; , of San Diego; , of Sacramento; , of San Francisco; , of San Diego; , of Martinez; , of Rohnert Park; , of Rancho Santa Fe; , of San Francisco; , of Marina del Rey; , of Lodi; , of Delano; , of Riverside; , of La Palma; , of Napa; , of Sacramento; and , of Turlock.
An accusation against MD, of San Diego, whose patient died of an apparent suicide by overdose in November 2013, was filed in February 2018 and he surrendered his license last November.
Feb. 5 update: The initial version of this story stated that 50 physicians were now accused, but Kirchmeyer subsequently clarified that four of the new accusations were additions to earlier ones.