The epidemic of accidental deaths due to overdosing on opioid medicines has been well-documented. The perils of chronic pain management are the subject of Patrick’s patient safety newsletter this month. One way authorities are dealing with the problem is via a database of controlled drug use, so that practitioners and pharmacists can see if patients are “doctor-shopping” to get more meds than are safe.
One doctor who got into trouble has gone to court over this database monitoring, claiming that his state’s medical board violated his patient’s privacy rights when investigators ran the doctor’s name through the database.
As explained in a story by KaiserHealthNews.org (KHN), the case against Dr. Alwin Lewis started with a patient’s complaint about his dietary advice. By the time it reached the California Supreme Court, the issue was much graver: Should regulators have unrestricted access to the state database detailing doctors’ prescribing practices?
Lewis’ patient had complained to the Medical Board of California about his “five-bite” diet program, which consisted of no breakfast, then just five bites of any food for lunch and dinner. That complaint didn’t much interest the medical board, but when they searched the database, investigators noticed other possible problems about how Lewis was prescribing medications to other patients.
In 2013, the medical board found that Lewis had kept poor records and had briefly overprescribed medications to two patients. It placed him on three years’ administrative probation.
Lewis charged that the board had gone fishing for a case against him, and used the privacy issue as his legal argument. His attorney said regulators should have to get a court order or a signed patient release to look through the database, just as they are required to do for a patient’s medical records.
Lewis lost in lower court, and took the case to the state Supreme Court. It has agreed to hear the case sometime this year.
Access to prescription databases by law enforcement officials has been challenged in other states, KHN reported, but the California case is thought to be among the first to challenge medical boards’ unrestricted access.
Although the decision would have an effect only in California, the case is of national interest. The American Medical Association (AMA) joined the California Medical Association in filing briefs supporting Lewis.
In California, the prescription drug database is maintained by the state’s Department of Justice. Based on weekly reports from pharmacies that have filled prescriptions for high-risk drugs including powerful painkillers, it compiles information including names of physicians and patients. By law, the justice department must provide reports to certain civil and criminal investigators, including the medical board.
The state Prescription Drug Monitoring Programs (PDMP) were established to ferret out “doctor shopping” by addicts and drug dealers looking to fill pain prescriptions from multiple providers. Although it’s a federal initiative, each state runs its own program, licensing medical boards and law enforcement to spot and address reckless prescribing by doctors.
Some civil liberties advocates, including the American Civil Liberties Union, (ACLU) are troubled by the sweeping nature of a PDMP’s power. They say that law enforcement should have to meet a “probable cause” standard before getting such records, just as cops must have probable cause before they may search your car when they stop you for a traffic infraction.
One ACLU attorney who has brought such cases, agreed with Lewis’ attorney that even medical licensing officials should have to meet some legal standard before getting such records, because it’s about not only the doctor, but the patient.
According to KHN, states generally don’t make it difficult for medical licensing boards seeking information as part of their duties. Some industry observers say that a decision in Lewis’ favor could encourage states to erect new barriers against licensing boards learning about medical providers who prescribe dangerous and addictive medications.
But as Lewis says, the original complaint against him wasn’t about drug prescriptions, it was about dietary advice. But the board still ran his name through its huge database of patient names and medications.
Although the AMA supports maintaining drug prescription databases, in a statement, its chairman-elect said, “allowing unfettered access by those outside of the health-care system to use information in [the databases] violates essential legal and ethical standards of patient privacy.”
The California medical board, supported by lower court rulings, says waiting long enough to get a court order could imperil patient safety, and claims that the situation is not analogous to protecting private medical records.
Unlike medical records, said an appeals court, prescriptions for controlled substances “are subject to regular scrutiny by law enforcement and regulatory agencies.” So patients have a “diminished expectation of privacy” about their information in the databases.
“If the privacy issue were litigated before accessing [the database], the prescribing physician under investigation could stall the release of these records, which would prevent the state from exercising its police power to protect the public health.”
Privacy concerns have been voiced since the PDMPs first got significant federal grant money about a decade ago to deal with prescription drug abuse. Some people think there’s a middle ground between protecting privacy and protecting patients, such as shielding certain identifying information from investigators before they get court orders for the reports.
“Too much is at stake to weaken the programs,” KHN said in summarizing the opinion of Thomas Clark, a researcher at PDMP Center for Excellence at Brandeis University. He said they were valuable tools in finding wrongdoing among patients, doctors and pharmacies.
“Any one of them could be doing something potentially risky,” he said.