By Taylor Knopf

Amidst the opioid crisis, calls have been pouring in to the North Carolina Medical Board from chronic pain patients who say their doctors have stopped prescribing their pain medication.

Some patients say their doctors cite opioid prescribing guidelines created by the Centers for Disease Control and Prevention in 2016, which sets daily dosage limits and recommendations for tapering patients to those limits.

Other patients call and say their doctors handed them a copy of North Carolina’s STOP Act, a 2017 law that limits the number of opioids for acute pain, such as a broken ankle or a wisdom tooth extraction.

And then there are some providers who say they fear that the medical board will sanction them if they prescribe opioids.

The North Carolina Medical Board surveyed its medical licensees to see how they have responded to the opioid crisis. Of the 2,661 survey respondents, 58 percent said that their practices had been affected by the opioid crisis. Of that number, 43 percent — or 663 people — indicated that they had ceased opioid prescribing altogether.

The medical board’s message back to them: “We are pro-appropriate care, not anti-opioids.”

“Treat with opioids when it’s appropriate,” said the board’s spokesperson Jean Brinkley.

“Prescribers should be thoughtful, and carefully documenting treatment and reasons,” she said. “If it’s appropriate, make sure the record is clear. That’s the board’s expectation.”

Culture of fear

The N.C. Medical Board has a professional outreach program and board staff spoke about once a week last year to professional audiences. The number one topic: appropriate opioid prescribing.

“Anecdotally, we’ve had people look the speaker in the eye and say, ‘That’s fine, but we don’t believe you,’” Brinkley said. “The fear factor is real.”

There is so much scrutiny of opioid prescribing because thousands of Americans are dying from drug overdoses — largely from heroin and fentanyl — each year. And according to the National Institute on Drug Abuse, 80 percent of Americans using heroin reported misusing prescription opioids before turning to heroin. However, there has been a sharp increase in the last decade of people who initiated their opioid abuse with heroin and not prescription drugs.

Those statistics and the fear of scrutiny by the Drug Enforcement Administration or an investigation from the state medical board makes physicians hesitant to prescribe opioids.

In 2016, the North Carolina Medical Board launched its Safe Opioid Prescribing Initiative, which included investigations into licensees who manage many patients on high daily doses of opioids and licensees who have had two or more patients die from opioid overdoses in one year’s time. The initiative also included training for physicians around the state on the STOP Act and better prescribing practices.

Since then, the board opened 111 cases, which accounts for 0.2 percent of all active licenses. The large majority of those cases stemmed from patient deaths. In the end, more than 60 percent of the investigations closed with no action against the prescriber.

In a letter to licensees, former medical board president Eleanor Greene empathized with physicians who feel like they are in a tight spot with opioid prescribing.

“There is no simple answer to this question. I can only say that treatment decisions must be guided by clinical judgment individualized for each patient, not by a desire to avoid Board scrutiny or regulatory action,” Greene wrote.

“Sometimes clinical judgment may lead to a course of treatment that diverges from specific recommendations contained in the CDC Guideline, but is the best option for the patient,” she noted.

The board adopted the CDC’s opioids prescribing guidelines. But Brinkley said the message around them has always been that they are “not regulations and they don’t set the standard of care in all contexts.”

“It’s hard for me to envision what more we could do to get that message out,” Brinkley said. Nonetheless, she said that “we regularly get calls from patients that they can’t get care for pain.”

CDC guidelines and ‘insufficient evidence’

The definition of chronic pain varies. The CDC defines it as “pain that typically lasts more than three months or past the time of normal tissue healing. Chronic pain can be the result of an underlying medical disease or condition, injury, medical treatment, inflammation, or an unknown cause.”

The CDC says that about 11 percent of American adults report feeling pain on a daily basis and that between 9 and 11 million U.S. adults were prescribed long-term opioid medication in 2005.

The Institute of Medicine states that pain is a public health issue that affects more than 100 million Americans.

The CDC guidelines made 12 recommendations for treating patients with chronic pain ranging from when to initiate opioids to follow-up care.

The guidelines rate evidence to support recommendations on a scale of 1 to 4.

“This hierarchy reflects the degree of confidence in the effect of a clinical action on health outcomes,” according to the CDC document.

Type 1 evidence means there was overwhelming support from randomized clinical trials and studies. Type 4 means there is “little confidence” and the evidence is “considered to be insufficient,” according to the CDC.

Surprisingly, the majority of evidence backing the CDC’s 12 prescribing guideline for chronic pain patients is Type 4, the lowest and most insufficient.

 

 

 

 

 

 

 

“Although there was widespread agreement on some of the recommendations, there was disagreement on others,” wrote CDC staff. “Experts did not vote on the recommendations or seek to come to a consensus. Decisions about recommendations to be included in the guideline, and their rationale, were made by CDC.”

The CDC sent copies of the drafted guidelines to these experts to review. However, they were not asked to review the final guidelines before publication.

A few doctors push back

“They say repeatedly that all the scientific evidence is of low quality. Well, the problem is, there’s no category lower than that. Low quality means no quality,” said Thomas Kline, a Raleigh chronic disease physician, who’s an outspoken critic of the CDC’s opioid guidelines.

“I became concerned that the CDC was going to come to my office and sit there, tell me how to prescribe,” he said.

Kline argues that it’s not the CDC’s place to tell physicians how to prescribe medications. He believes that it’s the role of the Food and Drug Administration (FDA).

And Kline’s gained quite a following in the pain community for his stances. He took a countercultural approach to the drug overdose epidemic in his News & Observer opinion column last year called, “The myth that prescriptions caused the opioid crisis.”

His Twitter account has grown from about 400 followers to more than 26,000. And his pinned tweet is a running list of people that he claims have taken their own lives due to forced tapering of pain medication.

He believes the maximum dosage limits set by the CDC are arbitrary, but that “people love even numbers and glommed onto them.”

Steven Prakken, a psychiatrist and pain physician with Duke Health, agrees that the prescribing limits are just arbitrary numbers.

“People are going to drive for that number, regardless of function, regardless of outcome, regardless of patient harm,” he said.

Prakken said that the CDC relied on very conservative voices in researching its guidelines, gathered them very quickly, and didn’t respond well to outside feedback.

He said he believes the CDC hand-picked the experts they wanted in order to get a “particular flavor of opinion” and that “was not appropriate.”

Meanwhile, the FDA has taken a much more careful approach to chronic pain, holding a lengthy public meeting, listening to chronic pain patients, and soliciting public opinion.

Who will treat pain?

Prakken says he’s feeling the effects from other physicians who have stopped treating pain patients.

“Doctors are saying, ‘It’s against the law. I can’t write. I’m going to get in trouble for writing,’” Prakken said. “And I get those referrals every day.”

As doctors “flee the pain space,” he said that patients still need care but often have nowhere to go. And they can become desperate.

The waitlist to get into Duke Health’s pain center to see Prakken is more than six months long.

Kline has re-focused his practice to take solely, what he calls, “pain refugees.”

These are people with chronic pain who have been turned away by at least 10 providers or pain clinics and who have become desperate — even suicidal — because of it.

Tomorrow: Pain patients push back.

Clarification: The initial version of this story stated that “more than a thousand” North Carolina doctors said they had stopped prescribing opioids. During the reporting of this story, a representative of the NC Medical Board confirmed in an email exchange that as many as 1,144 licensees had stopped prescribing opioids as a result of the opioid crisis. After publication, the Medical Board notified NC Health News that they had given an incorrect number of licensees who had changed prescribing patterns. The actual number is 663.