Fear of disciplinary action
SB 273 was enacted during a time when physician arrests and convictions had been increasing for years and were becoming more prevalent and more publicized. Figure 2 details some of the many investigations and disciplinary actions against physicians in the time period leading up to the enactment of SB 273, along with other societal events pertaining to opioid prescribing. Physicians under investigation had their practice interrupted, including having records confiscated and offices closed, which other physicians often became aware of anecdotally through community contacts, patients, or other providers. Often such investigations and charge filings were publicized on a local or state level, broadening the sphere of impact of the actions -these included lay news media publications, board of medicine announcements of disciplinary action, etc. Physicians were portrayed as criminals in the lay media, as in these quotes from a U.S. Attorney: “Home-grown drug dealers hidden behind the veil of a doctor’s lab coat, a medical degree, and a prescription pad, are every bit as bad as the heroin dealers that flood into WV”  and WV Assistant Attorney General: “To the doctors, pharmacists, and other medical professionals engaged in this egregious criminal behavior across Appalachia and our country, the data in our possession allows us to see you and see you clearly, no matter where you are… and if you behave like a drug dealer, we will find you and ensure that the American justice system treats you like the drug dealer you are” . Determination of guilt could be years after the initial investigation, and importantly, some physicians were never charged nor found guilty after having their practice interrupted with lengthy investigations.
Importantly, news coverage of such disciplinary actions against physicians included some legal and allowable practices in primary care as evidence of guilt: operating a cash-based practice, not accepting insurance, charges of “$240 for an initial appointment and at least $160 for each subsequent appointment”, not requiring referrals, receiving patient calls on a personal cell phone, and not having special training in pain management to prescribe opioids .
Participants referenced multiple instances of known physicians, either in their own community or people they heard about through media or news stories, who suffered disciplinary action for opioid prescribing. Some prescribers against whom disciplinary action was taken were acknowledged to be practicing inappropriately. However, disciplinary action against these outlying prescribers resulted in fear amongst other prescribers and affected their prescribing habits, overpowering other considerations in decisions regarding prescribing. This fear was expressed by multiple participants and consequences included licensure revocation or criminal penalties related to opioid prescribing which the prescriber feared would be seen as excessive or inappropriate, even if they deemed it medically necessary. Licensing boards, the Drug Enforcement Administration, and local law enforcement were seen as enforcers. As one participant noted:
“…the fear of having your license taken away or the fear of imprisonment, or you've been burned by the DEA as someone who has been negligent, that will take over.” (GP, female, 15 years of practice)
These enforcers were alerted by pharmacists or the Board of Medicine that a prescribers’ practices were concerning, creating a conflicted environment between the two groups as prescribers felt like they were being policed by dispensers in their community and their medical judgement was being questioned.
“[M]ost of us noticed that whenever all of the pill mills got shut down prior to the law, it was because pharmacists were reporting the doctors who were writing too many prescriptions to the DEA and then the DEA would come and destroy you.” (GP, male, 11 years of practice)
These prescribers detailed that some providers caught up in disciplinary action were viewed as “good doctors” or were practicing within what they perceived to be accepted norms of patient care. In some cases, the physicians were never charged with any crimes but could not recover after their practice had been shut down, records confiscated, or had poor publicity in the media. This resulted in a reluctance to prescribe opioids even if pain medication was perceived to be needed by patients. Another participant noted that even being “outside of the norm” of opioid prescribing was seen as high risk for disciplinary action:
“[It] really started to scare a lot … of providers into feeling that it wasn't worth the risk to continue to prescribe for fear of being labeled as an over prescriber or being outside of the norm or, you know, the potential liability that goes along with it.“ (GP, male, 14 years of practice)
These actions created an atmosphere of fear amongst prescribers which, according to one prescriber, preceded restrictive prescribing laws in WV and rendered these subsequent actions unnecessary.
“They were coming in and busting a lot of docs and then making it so… that we didn't need that law to be afraid.” (GP, female, 11 years of practice)
Importantly, this temporal association (reactionary fear of prescribing opioid medications to patients based upon disciplinary action before SB 273) correlates to our previously published quantitative findings of opioid prescribing trends in WV, which documented consistent declines in opioid prescribing that preceded the implementation of the 2018 law .
2. Opioid legislation exacerbated prescriber fear
In addition to disciplinary actions against prescribers, numerous other instructions, guidelines, and regulations impacted the prescribing of opioid medication leading up to the enactment of SB 273 (Figure 2). The CDC created prescribing guidelines for opioid medication in March 2016 , and the WV Board of Medicine also created opioid guidelines in 2017 , both with the focus of curtailing inappropriate prescribing. The state of WV also created an “Opioid Response plan” in January 2018  to handle what was perceived as inappropriate prescribing of opioids. As a result, nearly all participants noted that prescribing of opioids, both their own habits and what they observed in their community and amongst their partners, evolved towards moderation over time as knowledge of opioid-related harms increased. This is supported by our earlier work assessing opioid prescribing practices in the 64 weeks before and after SB 273 was implemented, demonstrating a decreasing trend throughout the entire period before the law . Furthermore, our assessment of key requirements of SB 273, such as duration of opioid prescriptions, demonstrated no change in relation to SB 273 – however, over the duration of our study, the days’ supply of medication decreased from 13.9 days to 7.9 and 7.3 days prior to law signing and enactment respectively, making current clinical practice at the time of law signing and enactment already in line with the 7 day prescribing limit of new opioid prescriptions for SB 273 .
SB 273, while implemented to address opioid over-prescribing, was viewed as exacerbating the fear already being experienced by prescribers, and for which prescribers had already changed their practice. As a result, many participants felt that the law had minimal impact because most prescribers had already curtailed opioid prescribing. However, participants noted that this law prompted further, more extreme changes in practice amongst physicians who otherwise felt they were practicing appropriately, such as cessation of all opioid prescribing. The prevailing view of participants was that all of the outlying or “irresponsible” prescribers had already been dealt with prior to SB 273. The law led many prescribers to further curtail opioid prescriptions, and in some cases, refuse to prescribe any controlled substance including medications like gabapentin (Schedule 5).
“[SB 273] ended up affecting mostly the responsible prescribers of opioids. The people who were already doing due diligence ended up being the ones who were concerned about the law because all the irresponsible prescribers I think were already getting obliterated.” (GP, male, 11 years of practice)
A “chilling effect” instigated by fear of disciplinary action and exacerbated by SB 273 created a dearth of prescribers willing to provide opioid prescriptions within entire communities as it was considered to be increasingly risk-laden. This occurred even as the need for opioid medication was recognized within the prescriber community. The enormity of the need was recognized by prescribers even as they did not feel capable of meeting it themselves:
“Almost all prescribers in WV cut it back, a few that still do it, really do so at great risk to themselves. I think the law that occurred in 2018, really, if anything shifted us to a place where there's not enough opioid prescribing for many painful conditions that aren't treatable with other means.” (GP, male, 11 years of practice)
The change was noted among prescribers across practice types and locations and included patients with cancer-related pain or those which were taking opioids prior to the January 1, 2018, both populations which were specifically excluded by the law.
“There was a dramatic reduction in the number of physicians in the area who were writing anything controlled. It didn't matter if it was a schedule 2 or a schedule 5. They just said, "No, I'm not going to do this. I'm not putting my license on the line." (GP, female, 10 years of practice)
3. Care shifts and treatment gaps resulted from disciplinary actions and legislation
The fear created by disciplinary actions against other prescribers and exacerbated by SB 273 led to refusal by some prescribers to continue prescribing opioid medications; this created care shifts and treatment gaps, particularly for chronic pain patients. This, again, is supported by our prior quantitative findings . While first time opioid prescriptions and days’ supply, which were the specific focus of SB 273, did not change in relation to the law, overall prescription numbers decreased, demonstrating a differential impact on continuing opioid medications. Participants described these care shifts and treatment gaps as negatively affecting patient care, as patients could not access continued opioid medication for their chronic conditions. Prescribers detailed a chaotic in-flooding of patients left with no prescriber for their opioid medications after disciplinary action against some physicians or prescribing cessation as a result of the law, and this care shifted to remaining physicians in the community. These patients either shifted to other primary care physicians, specialty pain physicians, or were in effect forcibly tapered.
“Every time a physician is raided or arrested, we get several hundred referrals of those patients who are, either appropriately, or inappropriately on opioids that we have to sort out.” (Specialist, male, over 30 years of practice)
Treatment gaps in chronic opioid management represented de facto patient abandonment amongst prescribers who stopped prescribing due to fear of disciplinary action in light of the new legislation. Some general practice physicians refused to treat chronic pain completely. Often these patients were in effect forcibly tapered or transferred to outlying specialty pain clinics in faraway locations. Participants describe patients attempting to change physicians after their own physician refused to continue writing chronic opioids with only a week’s worth of medications or enough medication to get them to the date of the specialist clinic visit. Specialists noted an increase in patient referrals requesting to take over long-term opioid management for their chronic pain after their primary care physicians refused upon passage of SB 273. Primary care participants noted that these patients were a stretch on already tenuous rural clinic capacity due to the number of patients and the level of management required.
“When these prescribers were shut down by the, either Board of Medicine or the DEA, we had to pick up the pieces as other local physicians-- well, we would get an influx of patients from these doctors each time” (GP, male, 30 years of practice)
4. Conversion to illicit substances
The perception of many prescriber participants was that patients who were left without opioids, either from provider refusal due to fear of disciplinary action and restrictive opioid legislation, or from disciplinary action against the provider causing abrupt lack of care, transitioned to illicit substances such as heroin. One participant related direct experience with patients as they later presented in a clinical capacity asking for help with their substance use disorder, and another physician related that he obtained his X-waiver purely to meet the patient need of those whom had been forcibly tapered off of chronic opioid medication.
“[T]hey show up at my door a year later, using heroin for a year… saying, ‘I need help.’ And I said, ‘Well, what happened?’ ‘Well, I was getting a legitimate prescription, and then they stopped…’ And it's definitely, honestly, it's a lot more now than what it was before this legislation.” (GP, male, 14 years of practice)
Participants noted that these patients often directly related this transition to changes in the availability of prescribed opioids for chronic pain. The participants felt that these care gaps and unintended consequences were created by disciplinary actions taken against physicians without considering the impact on the patients receiving chronic opioid medication.
“That was a big problem and a big oversight on behalf of law enforcement and the physician community… We didn't have a good plan when we got these doctors down. We didn't- we didn't go in and find all these patients and… pick up the pieces from these patients. So that we could appropriately taper them and in a way that managed … their withdrawal symptoms and their dependency without them turning to the illicit market. And I think that's a big source of a lot of our problems.” (GP, male, 30 years of practice)
Participants recognized that these unintended effects were understudied, but have had potentially significant effects on communities in WV.