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Some 800,000 Californians now on high-dose opioids are at risk of harm if their physicians taper them off their pain medications too quickly, as some may be doing in fear of disciplinary action. The number of patients who use illicit drugs could double, and rates of suicidal ideation or self-harm may quadruple.

Those are some of the potential "unintended consequences" stemming from the Medical Board of California's highly controversial Death Certificate Project, according to Kelly Pfeifer, MD, director of high-value care for the influential . She detailed numerous concerns and recommendations for change in a earlier this month. The board released the letter on Thursday in response to a request. (Pfeifer and the medical board both declined to comment further.)

The project, intended to curtail opioid-related deaths, began years ago as the board obtained death certificates for patients who fatally overdosed in 2012 and 2013. The effort has enabled board staff to link the names of those deceased patients with the names of the physicians who wrote prescriptions for them for controlled substances up to three years earlier.

After reviewing the physician's prescribing history, the board sent pegged to a complaint to hundreds of physicians suspected of overprescribing. The letters seek the deceased patient's medical records and physician's explanation, and threaten a subpoena and heavy fines if the physician fails.

Thus far the board has filed formal accusations against 23 physicians alleging a pattern of negligent overprescribing, among other things. They face being publicly reprimanded, or could lose some or all of their license to practice, depending on decisions from an administrative law judge.

But rather than curtailing opioid overprescribing, Pfeifer's letter said the project may be hurting patients. "On the surface, it may seem harmless to send out 500 letters to identify 23 physicians with violations," wrote Pfeifer, who also directs the foundation's $5-million opioid safety initiative. "However, there is a growing concern that the letters are causing harm," because after they receive such a letter or know someone who has, physicians are "changing their prescribing practice to the detriment of patient care."

Pfeifer's letter, on CHCF letterhead, is noteworthy because the foundation plays an important role in California healthcare and is not a physician advocacy group. It has about $800 million in assets and funds programs on improving access and value of healthcare for underserved groups -- with a specific focus on reducing harm from opioid prescription drugs. Last year it spent about $40 million on grants, direct charitable activities, and program support. CHCF was founded 21 years ago with community benefit funds stemming from Blue Cross of California's conversion from non-profit to for profit.

Pfeifer said she has concerns the project "could exacerbate the shortage of providers" willing to treat patients with pain. "Many clinicians have mentioned to me their growing fear that their license could be at risk by continuing to care for complex patients on high opioid doses."

She gave examples of how physicians' practices have already been affected after receiving letters from the medical board. One has stopped prescribing; another lost patients after becoming fearful and abruptly tapering doses for several of them; and two addiction specialists said they had patients who switched to heroin after being "kicked off" high-dose prescription opioids without being offered alternatives.

Numerous physicians, including pain management specialists, organized medicine groups including the American Medical Association have expressed horror at the project, saying the letters and investigatory process they bring has "terrorized" physicians and is essentially a "witch hunt" against physicians who are just trying to alleviate patients' pain, as they were taught.

Changes needed, foundation says

Pfeifer recommended the following approach in identifying physicians whose prescribing may be endangering patients:

• Instead of looking at death certificates first, the board should start by sampling clinicians in the top one percentile of opioid and benzodiazepine prescriptions, obtained through the state's (Controlled Substance Utilization Review and Evaluation System) database. Those are the "physicians at the most risk of doing harm," Pfeifer said, citing a published in the Journal of Primary Prevention. That study concluded that within this one percentile, 32% to 77% had written a prescription within 30 days of a patient's overdose death.
• Rather than focusing on opioid-repeated deaths that occurred six years ago or more, limit investigations to deaths after 2017, because most physicians have now changed their prescribing practices to align with safer guidelines.
• Decrease turnaround time between notification and resolution of each case. Pfeifer noted that the current lag is more than 500 days or more, and some clinicians have waited for a resolution on their letters for more than 16 months. "Long investigation times could harm patients," she wrote.

Pfeifer also pointed to the lack of clarity in state or federal guidelines on how physicians should manage patients who are already on high-dose opioids. Her letter recommended against involuntary opioid tapering, and all tapering "should be halted if the patient shows signs of medical or psychiatric instability."

"While the 800,000 Californians on high-dose opioids and the almost 700,000 Californians on opioids and benzodiazepines are clearly at risk of harm if they stay on these regimens, they are also at risk if tapered off altogether," she wrote.

"A physician could be practicing safe medicine by simultaneously prescribing high-dose opioids and benzodiazepines if the patient has been taking these medications for years." But if the patient fatally overdoses and comes under review of the Death Certificate project, "the regimen is very likely to be judged by an expert as unsafe. This, despite that fact that the prescriber would have been following CDC guidance to avoid involuntary tapers," Pfeifer wrote.

Pfeifer has asked state health officials to analyze data to see if involuntary tapering is leading to hospitalizations and deaths, but such a review will take up to a year.

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