Thousands of North Carolina doctors appear to be breaking a new state law that limits opioid prescriptions for patients using the addictive drugs for the first time, according to preliminary data from the N.C. Department of Health and Human Services and the state's largest health insurer, Blue Cross and Blue Shield.
The NC STOP Act, enacted June 29 and effective Jan. 1, limits opioid prescriptions to five days for first-time patients with short-term pain, or seven days if the patient had surgery. The law, which is intended to stop patients from getting more opioids than they need, is a response to a grave public health concern that leftover narcotics could be taken recreationally or sold, feeding an opioid epidemic that claimed 12,590 lives in North Carolina between 1999 and 2016.
The data from the state health department shows that in March more than 16,000 physicians across the state prescribed opioids for over a week to at least one patient who had not had a prescription in six months. But the agency noted that additional information was needed to determine if those prescriptions actually violated the law.
The agency presented its preliminary report Tuesday to the staff of the N.C. Medical Board, the state body that licenses and disciplines the 27,000 doctors working in the state. It was the first time DHHS had provided the Board with such a list. The data comes from the state's controlled substances reporting system, a database of prescriptions doctors and pharmacists can use to see if a patient is getting opioids from multiple doctors. The challenge for DHHS and the Medical Board is that the database does not contain the medical details necessary to filter out irrelevant cases and determine if the prescription violates the STOP Act.
The Medical Board's spokeswoman noted that thousands of the prescriptions are likely legitimate, but said that the scale of the problem is challenging the organization to find alternative ways to enforce the law.
"Investigating every prescriber on the DHHS report is simply not feasible," said Jean Fisher Brinkley.
The Medical Board, which opened 2,500 investigations last year, lacks the staff and resources to investigate tens of thousands of doctors and does not expect to be ready to start warning or censuring doctors until this fall at the earliest.
"We have this big new law that changes how doctors prescribe for acute pain," Brinkley said. "It turns out it's a bear to enforce."
N.C. DHHS declined to provide The N&O with a total number of opioid prescriptions with the same parameters for January through April, which would give a more accurate picture of the difficulty officials will have enforcing the law. But it's clear that the total number of prescriptions is much bigger than that provided to the Medical Board. The DHHS list, while statewide, covers only one month and only physicians and excludes other medical professionals authorized to prescribe opioids.
The Blue Cross answer
A Blue Cross analysis of all medical practitioners in its commercial plans released Monday shows that about 4,500 doctors, dentists and other medical professionals have written prescriptions exceeding the law's limits between Jan. 1 and April 13. This data is also limited because it represents just the insurer's commercial plans, which cover 1.3 million people in North Carolina. About 9,000 Blue Cross members received the prescriptions.
"Doctors are writing them, pharmacies are filling them," said Estay Greene, Blue Cross's vice president of pharmacy programs. "If a prescription is written and you only end up using it for three days, and the doctor wrote it for 30 days, you have 27 days of opioids sitting in your medicine cabinet."
In April, Blue Cross started electronically blocking prescriptions from being filled beyond seven days. The insurer says the policy blocked more than 1,100 prescriptions and prevented between 25,000 and 30,000 opioid pills from being dispensed to patients in the first two weeks of its implementation. Based on that figure, the company estimates that 225,000 to 275,000 opioid painkillers have been over-prescribed on its commercial plans between Jan. 1 and mid-April.
Under the NC STOP Act, after the initial five- and seven-day limit, the patient can receive another prescription if the pain continues and requires medication.
Questioning the data
The data from both organizations is not precise enough to determine wrongdoing by doctors and will have to be individually assessed, according to the Medical Board.
"Large numbers of the names on that [DHHS] list we would expect to be found to have prescribed appropriately," Brinkley said. "We need a way to generate a report that filters out the appropriate prescribers."
Rep. Greg Murphy, a Republican and urologist from Pitt County who co-sponsored the opioid law, said he expected it would take some time for all doctors to understand the new law, but high numbers reported by Blue Cross don't match his personal experience in talking with doctors and the medical profession's concern about opioid abuses.
"I can't expect everyone to change their prescribing pattern overnight," Murphy said. "Those numbers look very high to me. ... It may not be what it's being portended to be."
Blue Cross spokesman Austin Vevurka said the company is confident its data is accurate.
However, Blue Cross acknowledges its data does not present a complete picture. For example: The data, which comes from claims filed by pharmacies, includes acute pain patients, whose prescriptions are limited by the NC STOP Act, along with chronic pain patients, whose prescriptions don't fall under the new law. Including the chronic patients inflates the total, but Blue Cross can't filter the data without reviewing every claim.
At the same time, however, the company could be understating the problem because it excluded all newly enrolled customers from its tally, so that long-term pain patients would not automatically show up as new patients just because they're new to Blue Cross. That precaution excluded acute pain patients whose prescriptions may be out of compliance with the law.
The state data was generated using the same algorithm as Blue Cross and contains the same potential inaccuracies, Brinkley said.
State can't enforce the law
Once doctors, dentists and other health care practitioners are flagged in the database for potential violations of the law, DHHS does not have the authority to fine or otherwise discipline them. The law allows the agency only to notify the practitioners and their various licensing boards about opioid prescriptions that look suspicious.
The law also does not include criminal penalties for practitioners whose opioid prescriptions exceed the new limits. Criminal penalties are reserved for drug trafficking and drug diversion; questions of professional judgment are best left to medical licensing boards, said Laura Brewer, spokeswoman for N.C. Attorney General Josh Stein. Stein's office helped draft the legislation. Stein has said over-prescribing is the main cause of the nation's opioid crisis.
The first notices and warnings to doctors are not expected to go out from the N.C. Medical Board for months. In order to receive information from the Controlled Substances Reporting System to conduct investigations, the Medical Board has to adopt regulatory guidelines for the disclosure of confidential information, a process that needs to go through public hearings and be approved by the N.C. Rules Review Commission.
The Medical Board is discussing its options now and could vote as early as this month. If it doesn't, it won't have another opportunity until its meeting in July. Still, the board lacks the resources to double or triple its workload. One option might be to send alerts or warnings to doctors and to investigate only chronic offenders, who could be subject to harsher discipline, such as a suspended license.
Doctors in difficult position
Blake Fagan, a family physician in Asheville, said some doctors are still unaware of the new prescribing limits under the NC STOP Act. Fagan teaches courses on opioids and pain for the Mountain Area Health Education Center and has given about 30 presentations across the state on the NC STOP Act since Jan. 1.
At a February presentation to 500 podiatrists in Charlotte, at least several dozen said they had not heard about the new law, he said.
In more recent presentations, doctors say they know about the law but then ask questions — such as: How many pills can I write? What happens after seven days? — betraying their confusion about the details.
Fagan said that the law puts some surgeons in a difficult position, because they don't want their patients to get just seven days of painkillers after a mastectomy, knee replacement or gall bladder removal. Getting painkillers beyond seven days requires another consultation and a new prescription.
The law defines acute pain as pain that's expected to last less than three months. Such pain is treated by short-acting opioids like Percocet, Vicodin and Demerol.
The NC STOP Act does not apply to pharmacists who fill inappropriate prescriptions that a doctor writes in violation of the new prescription limits.
The average prescription length in Blue Cross's electronically denied cases was 19 days of opioids, said the insurer's spokesman Vevurka. When Blue Cross started blocking prescriptions in April, some customers challenged the move as an error, and Blue Cross reversed initial denials for 151 customers between April 1 and April 16, approving opioid prescriptions for longer than seven days for those customers.
Because the law doesn't define what a first-time patient is but limits controlled substances to patients after an "initial consultation," Blue Cross and DHHS defined that period as 180 days since the last opioid prescription for that patient. The law's five-day and seven-day opioid prescription limits don't apply to hospitals, nursing homes, hospices and residential care facilities.
Pharmacists say that the law's opioid prescription limits don't fit the definition of every new patient. Some undergo difficult surgeries and will experience more than seven days of pain, said Penny Shelton, executive director of the N.C. Association of Pharmacists.
People with rheumatoid arthritis and others have chronic pain symptoms that flare up infrequently enough to render the patient classified as a new prescription under the NC STOP Act, Shelton said. In those cases, the doctor can write a subsequent prescription, but it complicates life for people in extreme physical discomfort.
"Ninety-five percent are in legitimate pain and have a legitimate need for the medicine," said Jonathan Harward, pharmacy manager at Josefs Pharmacy in Raleigh.