Treating Addiction and Winning a Battle Against Harmful Pharmacy Restrictions

Download Document

Aaron Newcomb, D.O.

ISMS Members Making it Work: Aaron Newcomb, DO
August 2020

When ISMS member Aaron Newcomb, DO, was in training, he was taught that treating chronic pain was simply a matter of reducing pain. “I was initially told that chronic pain served no purpose, and we should do anything and everything to get people out of [pain], including just escalating opioids until the patient says they don’t have pain,” says Dr. Newcomb. But by the time he was done with his residency, many healthcare professionals were expressing concern about the number of patients seeking opiates. While he realized that many patients who were prescribed opioids for chronic pain benefitted from the medications, others showed obvious signs of opioid use disorder (OUD).

This led Dr. Newcomb to explore office-based buprenorphine treatment for OUD. He has now been treating patients with medication-assisted treatment (MAT) for OUD for about nine years at Shawnee Health Care in Carbondale, a Federally Qualified Health Center (FQHC).

“There’s been a lot to learn with all the experience,” says Dr. Newcomb. “I’ve found that over the nine years of treating these patients, particularly the ones with opiate addiction, it was an area where I could be involved in relieving somebody’s suffering… I really couldn’t see the same kind of impact in other areas."

Dr. Newcomb has seen patients whose drug tests have reflected total abstinence from drug use for up to the entire nine years of his addiction medicine practice. “Somebody’s life can be completely dismantled by an addiction and come into my office, and many times I can prescribe them an effective dose [of buprenorphine] and they walk out of my office and literally start putting their lives back together that day.

This success has led Dr. Newcomb to become passionate about using MAT to treat OUD. He’s even gotten involved in advocating for other physicians to begin using MAT to treat addiction, and he frequently accepts patients from other physicians in his area because of his expertise in treating addiction and managing pain. This has led to an expansion of Shawnee Health Care’s MAT and addiction medicine program, which now includes addiction counselors and six MAT healthcare professionals in a modest organization of only twenty."

Banning the solution

But despite the success Dr. Newcomb and his colleagues have had treating OUD and addressing the opioid crisis in their community, he was in for a rude awakening as 2020 began.

“I was actually on vacation, running a soccer practice as the coach of a junior high team that my boys are on, and my nurse manager called me and said, ‘We’ve got a big problem – patients can’t fill their controlled substance prescriptions, and we don’t know why.’” Multiple patients had called and said they could not fill their prescriptions from a large pharmacy chain and that the prescriptions could not be transferred because of regulations regarding electronic transmission of controlled substance prescriptions.

Dr. Newcomb finally received a form letter later that afternoon with a vague statement from the pharmacy informing him that his prescribing practices were unacceptable, that the pharmacy wouldn’t be filling the prescriptions, and that “they were very sorry for the inconvenience.”

“There was no indication as to what controlled substance or what pattern of prescribing was the problem,” he explained. “Just that there was a pattern that they found objectionable.”

Dr. Newcomb is board certified in addiction medicine in addition to having a waiver to prescribe buprenorphine to the maximum number of patients under the Drug Addiction Treatment Act of 2000. In spite of this, the pharmacy through a simple form letter had, without warning and without specific reasons, banned him from prescribing controlled substances to patients vulnerable to opioid abuse, addiction, and overdose.

“This is causing stigmatization of the treatment [patients] receive. They’re getting the message that MAT is inappropriate because their main MAT provider for eight or nine years was rejected by a big corporation … To interrupt somebody’s treatment like that is just totally unacceptable and puts [patients] at risk.

Providing “additional information”

Dr. Newcomb immediately began working to get the ban removed in order to get back to taking care of his patients. But there was no formal process to appeal the ban, only a statement to the effect that Dr. Newcomb could provide additional information if he thought it was necessary. For Dr. Newcomb, this included multiple letters from him and his legal team at Shawnee Health Service over a period of months, detailing his prescribing practices and why they were appropriate for his patients.

“Our letters were seven, eight, nine pages long with ten to twenty citations in the literature that noted how that type of policy [imposed by the pharmacy] was specifically warned against by the Centers for Disease Control and Prevention (CDC), how the U.S. Department of Health and Human Services (HHS) had put out warnings about abruptly stopping opioids … we talked about how the CDC guidelines were meant to address decreased prescribing of opioids going forward, but that doesn’t mean that we simply turn our backs on and abandon patients that are on opioids now.”

His letters also discussed the way broad corporate pharmacy policies treat all patients the same, while only a physician who knows each patient well can treat that individual patient according to his or her unique needs. Dr. Newcomb emphasizes that “You can’t do this to an entire population of patients; not every patient is the same, and they need to be treated individually or you’ll cause serious patient harm.”

Further citations backed Dr. Newcomb’s MAT prescribing practices. But his letters were met only with more questions – never any acknowledgement of the content of the letters Dr. Newcomb and his team sent, or of the extensive research they had done, or of the guidance they had cited.

One question from the pharmacy was why Dr. Newcomb was using buprenorphine that doesn’t include naloxone. The dual formulation of buprenorphine and naloxone is often sold as Suboxone, and may have decreased value as a street drug because of the inclusion of naloxone.1 However, there may be tolerability issues, complications with pregnant patients, and cost barriers. According to Dr. Newcomb, this line of questioning once again illustrates why patients need to be considered on an individual basis rather than according to overly-broad policies from corporate pharmacies: “Initially, when we were treating patients with buprenorphine instead of the dual agent, it was a matter of life and death. Suboxone wasn’t generic, and it was $14 to $19 per dose and patients need two doses for it to be effective. The plain buprenorphine was $3 per dose. When I later tried to switch many of these patients that were being successfully treated to Suboxone, there were tolerability problems and these patients’ drug test were perfect. So there was literally no clinical reason to force them onto this other medication.

Organized medicine advocates for physicians and their patients

Lacking clear answers from the pharmacy, Dr. Newcomb searched the internet to try to find out more information about his situation. He found that he was far from alone in having problems with broad, seemingly arbitrary corporate pharmacy prescribing policies. The American Academy of Addiction Medicine, the American Medical Association (AMA), the Illinois Academy of Family Physicians (in which Dr. Newcomb has been involved with an opioid safety group for years), and the Illinois State Medical Society (ISMS) had all been battling this problem.

A Zoom meeting was set-up between Dr. Newcomb and decision makers with the pharmacy. Even during this meeting, which was three to four months after the ban, Dr. Newcomb was faced with many complicated clinical questions about patients being treated with MAT, but was never once asked about prescribing opioids for chronic pain despite this being the ostensible focus of efforts to reduce opioid prescribing.

“I just couldn’t give up. I just felt very, very passionately that this was wrong, that it was harming my patients, so I didn’t let it go,” says Dr. Newcomb. “Honestly, I’m not sure what did it, but they finally did lift the ban. Maybe they were just sick of trying to deal with me. But something helped us prevail. Even after they lifted the ban, they never indicated why, just that they had received more information and that after reviewing that, they lifted the ban.” The process had taken over five months.

Dr. Newcomb credits the support and coordination from ISMS and other medical professional membership organizations with getting his ban reversed, since it was through these groups that he found a contact within the department of the corporate pharmacy that was about to put a “human touch” on Dr. Newcomb’s predicament. “I got support all around the board. I got affirmed for my practice and I got direct support coordinating my response.”

Opioids trends in Illinois

Illinois Department of Public Health Opioid Dashboard 

• 2,098 fatal overdoses (as of May 8, 2020)
• 14,592 non-fatal overdoses (as of May 8, 2020)

• Fatal overdose rate has increased by 87% since 2015, non-fatal overdose rate has increased by 97%
• At the same time that the overdose rate has increased, the number of opioid prescriptions fell by over 2.7 million prescriptions (36%) from 2015 to 2018

Illinois Prescription Monitoring Program (PMP) monthly statistics

• As of July, 2020 there are 72,087 registered PMP users, as an increase of more than 44,000 users and 160% since 2015.
• PMP inquiries have increased by nearly 7 million since July of 2015, largely driven by PMPnow, which connects directly to EHR systems.