California's Death Certificate Project, in which physicians were investigated and sometimes punished after patients fatally overdosed, may have resulted in a terrible unintended consequence: More, not fewer, overdose deaths around the state.
New data culled from 2019 death certificates from the state's 58 counties add up to 2,666 overdose fatalities, versus 2,694 reported during 2012 and 2013, the first and only two years examined so far under the project. That's a 98% increase over the annual average for those earlier years.
"It represents almost a doubling of the death reports, so that obviously is a serious cause for concern," William Prasifka, who became the Medical Board of California's executive director in June. He said he plans to remodel the program. Additionally, the board investigations will now skip ahead five years and focus just on overdose deaths in 2019.
Prasifka presented the 2019 data and the program changes during the board's quarterly meeting Friday.
He said that while the board's analysts have not yet dug into the 2019 cases in detail, "there are some indications that there is a high percentage of the deaths which are related to street drugs," not drugs prescribed by physicians.
Now, board members are becoming introspective, with some wondering whether the overdose death rate was higher in 2019 in part because of the Death Certificate Project, which launched in 2015.
Doctors shamed
Many prominent physicians saw themselves publicly shamed as careless overprescribers over the past several years, prompting their colleagues to get so scared they abruptly refused to prescribe opioids again, even for long-standing patients.
That resulted in many, many patients who had depended on their doctors suddenly having to find non-medical sources, especially since pain management specialists -- already in scarce supply -- were getting slammed.
One of those introspective Medical Board of California members is Richard Thorp, MD, an internist in rural Butte County in northern California. He called the new data "eye-opening."
"It's increasingly difficult to find, as it has for the last several years, physicians willing to prescribe opiates," he said. "Just saying there's a reality for people who were denied medication [to] look for other sources, and some of those sources are extremely unsafe, of course."
Many patients were taken off their opioid narcotics abruptly, Thorp continued. They "become desperate and then many of them actually do go to the street to look for other sources of opioids rather than a more controlled way of getting medications," he said.
Thorp acknowledged that times have changed. Doctors mistakenly used to prescribe whatever pain medication a patient seemed to need. "That's clearly the wrong approach. And now we have this very restrictive policy where doctors are afraid to write pain medications because of the Death Certificate Project," Thorp said.
He noted that of the doctors earmarked for investigation, maybe 1% "were actually malignantly prescribing medications in a way that was unethical."
As part of the prior investigative process, the board sent surviving family members a letter requesting that they tell the deceased patient's physician to release his or her medical records to the state. The language in the letter implied that the board had concerns that the treating clinician used poor judgment.
A Witch Hunt
The Death Certificate Project outraged many physicians in pain management as well as those in primary care, some of whom labeled it nothing more than "a witch hunt" that required hours of their time and expensive attorneys' fees, fractured the doctor-patient relationship, and would hurt rather than help efforts to improve patient safety.
Besides, they argued, they were just trying to relieve their patients' pain as they were taught, that pain was to be considered "the fifth vital sign."
Speaking before the board, Yvonne Choong, MPP, a vice president of the California Medical Association, said letters the board sent to physicians were "highly stressful and disruptive" to their practices, leading to "fear and mistrust" of the board's disciplinary process.
She urged the board to work with independent experts in drug addiction to review how it picks out physicians whose prescribing is inconsistent with standard of care -- in particular, to identify risk factors that more accurately identify problematic prescribers.
The board also is looking at whether the yield from the Death Certificate Project was worth it. Out of those 2,694 overdoses identified from 2012 and 2013, the agency initiated 520 cases against 471 physicians out of the state's 145,000.
Some 75 accusations were filed against 66 physicians, 21 physicians received public letters of reprimand, and 20 physicians were placed on probation. Eleven physicians surrendered their licenses, including several whose accusations and lists of overprescribed medications took up nearly 70 pages.
Fourteen cases were closed because the doctor was deceased, and five of the physicians had already had their licenses revoked prior to the project.
Several consumer representatives urged the board to move ahead with the effort to punish doctors who overprescribe, but lamented that the board will skip investigations of deaths occurring from 2014 through 2018.
That leaves a five-year gap, "when overdoses will be overlooked, leaving a number of dead patients and grieving families without accountability," said Marian Hollingsworth. Consumer advocate Eric Andrist urged the board not to listen to Choong or the CMA. "Their concern is only for the poor little doctors who might get snagged for their wrongdoing, not for the huge patient safety protection that the Death Certificate Project provides to consumers in this state."
Renamed 'Prescription Review Program'
In a memo to the board, Prasifka wrote that all of the 520 cases "involve a great deal of work including obtaining records and then having those records reviewed to determine if possible violations occurred." He added, "just because a patient death occurred it does not automatically mean that a violation occurred. Some deaths were due to street drugs."
Board president Denise Pines reminded the board "that the original impetus or thought process" behind the Death Certificate Project "was that we would be looking for those physicians who were behaving badly across the state."
Perhaps, she said, the board should "modify or transform this program some way so that it's not just a disciplinary or enforcement program, but one where we can do some education of our constituent physicians, but also the public as well."
Thus, the project is getting a new name, the Prescription Review Program, or PRP, which is less inflammatory and "more positive" than the Death Certificate Project, and which, Prasifka said, "better captures the ethos and objectives of the program."
Prasifka said the agency has "learned from experience" and as the PRP gets going, will alter some of its processes, making sure that it conducts a "more robust" screening of cases before launching an official investigation.
In that way it can track what kinds of drugs the physician routinely prescribed, in what strengths, how frequently, for what reasons, and in what combinations with other drugs.
Now, the PRP will look to "the entire prescription profile of the physician" using the state's CURES database, which will address some of the concerns about how the board ran the project in the past.
Prasifka told MedPage Today that while the 2019 death certificates include many deaths related to street drugs, the board will henceforth investigate only those deaths linked to prescriptions written by physicians.
In the past, several physicians under investigation told MedPage Today that the triggering death occurred in a patient who died of suicide, drugs obtained from a different physician, or street drugs, but they had prescribed drugs for that patient months or years previously. That, they said, was grossly unfair.
