INTRODUCTION
Uncertainty regarding potential disciplinary action may give physicians pause when considering whether to treat a patient who may require long term or high doses of opioids. Surveys have shown that physicians fear potential disciplinary action for prescribing of controlled substances and that physicians will in some cases inadequately prescribe opioids due to fear of regulatory scrutiny.1 The prescribing of opioids for long-term pain management, particularly noncancer pain management, has been controversial, and boards have investigated and, in some cases, disciplined physicians for such prescribing. While in virtually all of these cases the disciplinary actions were successfully appealed, news of the success was not often as well publicized as news of the disciplinary actions and some physicians have remained confused about their potential liability when prescribing opioids for pain. The confusion has perhaps increased as a result of relatively recent cases wherein a physician was successfully disciplined by a state medical board for undertreatment of his patients’ pain and another was successfully sued for inadequate pain treatment.
In 1999, the Oregon Board of Medical Examiners was the first in the nation to discipline a physician for failure to prescribe adequate pain relief medication. The physician, Dr. Paul Bilder, was cited for several pain undertreatment infractions, including prescribing only Tylenol for a terminally ill cancer patient’s pain and prescribing only a fraction of the dose of morphine that another patient needed and the hospice nurse suggested. Dr. Bilder was ordered by the board to complete an educational program, a program on physician-patient communication, and undergo mental health treatment.2 Less than two years later, in June 2001, a California jury awarded $1.5 million to the surviving children of William Bergman, who sued their father’s physician, Dr. Wing Chin, for undertreating Mr. Bergman’s cancer pain before he died. Although the award was subsequently reduced by the court, it was a dramatic message to physicians. In addition, earlier this year (March 2003), the Medical Board of California filed charges against Dr. Eugene Whitney for failure to adequately treat the pain of Lester Tomlinson, an elderly man dying of lung cancer.3 Although the outcome of the case has not yet been determined, the step by the board is significant.
These cases reflect a changing attitude toward pain treatment in the United States – a recognition that patients, especially patients at the end of life, have a right to adequate pain treatment. This shift in thinking appears to have begun in the late 1980s. Prior to this time, “according to established medical opinion, the likelihood of addiction to opioids was considered too great to prescribe them to any patients but those suffering from the most serious pain.”4 This opinion was conveyed by a number of state medical boards to physicians who were disciplined for prescribing outside of these boundaries. This “sea change” came about “as evidence mounted that patients, especially cancer patients, were being undertreated for their pain, and that addiction was not a significant problem for pain patients with no prior history of substance abuse.”5 In response, physicians began to prescribe greater amounts of pain medication. In addition, professional and governmental agencies established clinical guidelines encouraging the use of opioids in the treatment of cancer pain. For example, the American Society of Law, Medicine, and Ethics (ASLME), with support from the Mayday Fund,6 addressed the issue of pain undertreatment through a variety of educational initiatives and projects. ASLME’s joint work with the Federation of State Medical Boards (Federation) resulted in issuance in May 1998 of the policy document Model Guidelines for the Use of Controlled Substances for the Treatment of Pain on the use of opioids in pain management.7
From 1989 to 2001 there was a dramatic increase in the number of new state pain policies adopted by state boards and legislatures. Many state boards adopted policies consistent with the Federation’s Model Guidelines, which endorse a balance between preventing opioid misuse and not interfering with appropriate opioid prescribing along with multidisciplinary collaboration in treating pain patients. They also include treatment standards for chronic non-malignant pain as well as standards for acute and cancer-related pain.8 In addition to these guidelines, many state legislatures passed “intractable pain statutes.” These laws “were designed to provide physicians with some assurances by reducing both the real and perceived risks of being subjected to regulatory sanctions for treating pain with controlled substances.”9 Moreover, in 2001, drug enforcement officials from the Drug Enforcement Administration (DEA) and 21 health organizations issued a joint statement that they have begun to work together “to prevent abuse of prescription pain medications while ensuring that they remain available for patients in need.”10
Yet, at the same time that these new guidelines and incentives to appropriately treat pain would seem to counteract the pressures to undertreat pain, a renewed concern about drug diversion, in light of the abuse associated with Oxycontin, took shape. Pain treatment advocates voiced concerns that this abuse would lead to reinvigorated efforts by state medical boards to examine more closely physician prescribing of pain medications and impede progress in the treatment of pain. This led the authors to initiate a study of state medical boards to determine how they are balancing the need for adequate pain treatment with concerns about drug diversion and inappropriate prescribing. This article reports on the results of that survey.
The study, conducted in late 2001 and the first half of 2002, just after the high visibility given to the abuse of Oxycontin in the press, sought information regarding trends in the number and nature of complaints received by boards for inappropriate prescribing of opioids (i.e., “overprescribing” or “underprescribing”), how boards evaluate such complaints, and under what circumstances boards would discipline physicians falling into one of those categories. The focus of the survey was board experience during the past five years (1997–2001). The survey was directed (by name) to the state board medical director, or individual with a comparable title.11 Of the fifty states and the District of Columbia, 38 state medical boards participated (a 74.5 percent response rate).
SURVEY OF STATE MEDICAL BOARDS – RESULTS
Opioid Overprescribing: Complaints
Respondents were asked to estimate the number of complaints12 their board had received in 2001 related to opioid overprescribing (i.e., “physicians who allegedly prescribed opioids unnecessarily, in too high a dose, or for too long a duration”).13 Twenty-five individuals were able to give such an estimate. According to those estimates, the average number of complaints in 2001 was 3.1 per 1,000 doctors in the state (SD = 2.8, range = 0 to 13.8).14 The most common sources of these complaints were pharmacies, government regulatory agencies such as the DEA, and family members of patients.
When respondents were asked their impression of whether complaints against physicians for opioid over-prescribing had increased, decreased, or stayed the same over the past five years, 17 respondents (45 percent) thought complaints had stayed the same, 14 (37 percent) thought they had increased, and four (10.5 percent) thought they had decreased (three did not know). (See Figure 1.)
Perceived Trends in Complaints, Investigations and Disciplinary Actions for Overprescribing Opioids from 1997–2001
DRUG DIVERSION AND ABUSE TRENDS: OXYCONTIN
Respondents were asked whether the problem of drug diversion and abuse in their state, in general, had improved, become worse, or stayed the same during the last five years. Eighteen (47 percent) thought it had become worse, 11 (29 percent) thought it had stayed the same, and five (13 percent) thought it had improved. (Four had no real impression.) Some commented that the drug diversion/abuse problem was not necessarily worse, but their board was doing more (“taking a little sterner approach than before 1996” or “pursuing it more diligently”). Fifteen of the 18 (83 percent) who thought drug diversion and abuse in their state had become worse, thought that the abuse and diversion of Oxycontin had contributed to that trend, while the remaining three thought it had not. Some thought the abuse of Oxycontin had made the public more aware of diversion issues, but had not increased their complaints or investigations. Others made reference to Oxycontin being “the drug of the month” (“20 years ago it was Dilaudid, then Percocet, once upon a time it was Demerol”). One respondent commented, “we don’t have issues with physicians abusing Oxycontin…our problem has been with patients selling or diverting the Oxycontin and physicians not tuning in to that.” A few respondents, however, described serious problems in their state with overdose deaths from Oxycontin, or of people in their state breaking into pharmacies and holding pharmacists up at gunpoint, specifically requesting Oxycontin.
INVESTIGATIONS FOR OVERPRESCRIBING
When asked whether their board had changed its approach to the investigation of physicians for opioid-prescribing in response to Oxycontin abuse and diversion, 29 (76 percent) said no and five (13 percent) said yes (four had no opinion). Those who had not changed their approach commented that they conducted the “same thorough investigation” of all valid complaints. Others felt their investigative approach had not changed but their attention to the issue had increased. One respondent identified drug diversion as a priority of the board, which was working more with law enforcement to “stay on top of what’s going on.”
A number of respondents admitted that finding the balance between identifying physicians who overprescribe opioids and those who are appropriately treating chronic pain is not always easy. As one respondent stated, “[We’re] still working on trying to figure out the appropriate balance between pain management and overprescribing. We’re still looking at research to find that balance.”
When asked whether board investigations of physicians’ opioid-prescribing practices had increased, decreased, or stayed the same over the past five years (1997–2001), 17 respondents (45 percent) said the number of investigations had stayed the same, 15 (39.5 percent) said they had increased, and three (8 percent) said they had decreased (three did not know). (See Figure 1.) Respondents were asked why they thought the number of investigations had increased or decreased. Regarding increased numbers of investigations, a commonly cited reason was increased public awareness, “patients and families are more aware,” and “people are more inclined to speak up than they have been in the past.” Some mentioned law enforcement actions (“there have been more cases where there have been convictions [of physicians] on drug trafficking and selling [opioid] prescriptions for money”). Regarding decreased investigations, one respondent cited economic factors that limited the resources the board could direct toward investigations. Changes in the board’s attitude toward opioid prescribing was mentioned as a reason for both increased and decreased investigations over the past five years. One respondent shared his impression that “the board is taking these cases more seriously than in the past…[by] cracking down on doctors who are overprescribing, and wanting us to find information to back that up.” Others pointed to their board’s changed attitude toward the treatment of chronic pain resulting in fewer full investigations.
State pain guidelines, statutes, regulations, or policies were mentioned as providing guidance for when to proceed with a full investigation of a physician for overprescribing. All but six of the boards responding to the survey currently have some form of guideline (n = 16), statute (n = 15), regulation (n = 12), or policy (n = 9) related to pain management.15 For many boards, if a complaint was made against a physician who was found not to be in compliance with the board’s pain rules/guidelines, this would trigger a full investigation of that physician.
Some respondents commented that the volume or amount of opioids prescribed by a physician might trigger an investigation — for example, if there were “large numbers of patients receiving large numbers of opioids from the same individual who was seeing patients from a large geographic region, that would trigger an investigation.” Also, “if there were extremely large dosages [prescribed], that would make [the board] question if the patient could safely consume that much.” However, if there was evidence that backed up the need for the amount of opioid prescribed, most boards would not investigate further (e.g., “if we determined that they were providing therapeutic interventions, then we would close the investigation”).
In the absence of a board pain management policy or guideline, decisions about investigating or disciplining a physician were often based on deviations from the recognized standard of care. For example, a respondent from a state that had contemplated but not yet adopted pain management guidelines stated:
[An investigation is triggered by] the deviation from an accepted norm — if someone is prescribing differently from their peers in a specific specialty. As an example, the pain management people will write 10 times the amount of opioids as others. We wouldn’t waste time with that person. But if a physician’s billing as an internist and prescribing the same as a pain management person, we’re going to go find out why. And if the pain management person is prescribing way above others, we’d check that out too.
Several references were made to using judgment in each case:
You have to apply judgment; this is not an area that lends itself to cookbook approaches. You have to react to good intelligence, for example, a reliable source like a pharmacy or another health care provider — their threshold to report to the board is high. We review DEA reports for excess purchases monitored, but pure volume doesn’t necessarily indicate a problem. You have to tell whether it’s below standard of care, not just volume.
In addition to the volume of opioids prescribed, the credibility of the complaint source, and documented compliance with the pain management standard of care and/or board policies or guidelines, state regulations and statutes, boards look at the egregiousness of the physician’s conduct — one instance of highly egregious conduct may be sufficient to warrant a full investigation and subsequent discipline, whereas with milder forms of physician misconduct, a board may look at the number of complaints and evaluate patterns of inappropriate prescribing or practice. The uniqueness of each case was emphasized by many respondents.
DISCIPLINE FOR OVERPRESCRIBING
When asked whether respondents thought the number of physicians in their state who had been disciplined for overprescribing opioids had increased, decreased, or stayed the same during the past five years, 15 (39.5 percent) thought the number had stayed the same, 14 (37 percent) thought it had increased, and six (16 percent) thought it had decreased (three had no real impression). (See Figure 1.) Reasons given for increased numbers included: 1) an increase in numbers across the board, i.e., more complaints, more investigations; 2) increased awareness about the issue of drug diversion; 3) an increased level of sophistication among drug diverters/abusers; and 4) increased scrutiny by the medical board. Reasons given for a decrease in numbers of disciplinary actions taken against physicians during the past five years for overprescribing opioids involved the redefinition of “overprescribing.” Respondents explained: “The board’s attitude has changed; now we have pain management guidelines and have an established way of determining if a physician is deviating from those guidelines. We’re more aware of the need for adequate pain management and how that should be documented. Because the quantity of opioids thought to be appropriate has increased tremendously, those who used to be disciplined now are not considered in violation. The upper limit has been raised, and we’re okaying quantities now [that are] four to six times greater than before.”
Respondents were asked what factors would determine whether their board would discipline a physician for overprescribing opioids. Several respondents commented that each case has a unique combination and presentation of facts, making it difficult to identify specific infractions that would automatically lead to a physician being disciplined — use of individual judgment was necessary. Comments included: “The board doesn’t have any policies or procedures on this. We would look at it on a case by case basis;” and “We look for records, tests, documentation, etc., and [the board] make[s] a decision about discipline. Our practices are very subjective.” There was generally less subjectivity and inconsistency involved in criminal diversion cases (“[The board is] pretty consistent, we usually get a drug profile, get records, get DEA or police to investigate that, make a criminal arrest or investigate and get an emergency suspension for 90 days....”).
For many respondents, violation of a medical standard of care was enough to warrant disciplining a physician for opioid overprescribing (“there’s no need for a pattern or more than one case. One act or omission failing to meet the guidelines or standard of care is enough if the facts are corroborated.”). Others commented: “...we’d discipline based on failure to meet generally acceptable standards of practice, usually it’s based on poor record keeping, [rather than] ‘overprescribing opioids,’” “...it’s based on adherence to medical standards of practice, and proof of that in documentation.”
Respondents mentioned various things they looked for when investigating physicians for overprescribing opioids, including poor maintenance of patient records/poor documentation, “upcoding third party billing from a routine to a sick visit when [the visit is] under five minutes...significant findings of another disease entity not being followed, like hypertension or hyperlipidemia...” “red flags in the [patient] record like lost meds…if we see a lot of that stuff we start to think the doc doesn’t know what he’s doing. Especially whether the doctor refers out or not [to a pain specialist].”16
Boards that had adopted pain guidelines referred to them in making judgments about a particular physician’s actions. One respondent stated: “We look to [our pain rules] to give us guidance as to whether there’s a violation. We tend to act in formal disciplinary action with doctors who have shown egregious conduct or established a poor pattern of practice.” Another commented, “We refer to our pain guidelines. It’s not based just on dose but quantity. We realize that people are in pain and need medication for that, but there comes a point where it’s not physically possible to consume so many opioids in such a short period of time.”
The most common form of sanction imposed in overprescribing cases was mandatory education/retraining. Other sanctions included (listed in order of frequency mentioned) license suspension, license revocation, probation, restricting opioid-prescribing, monitoring of prescribing practices, mentoring and supervision, reprimand/censure, and a fine.
OPIOID UNDERPRESCRIBING
Complaints
Nineteen respondents (50 percent) were aware of complaints to their board against physicians for undertreatment or inadequate treatment of pain in 2001. Based on the 33 respondents who were able to estimate the number of complaints, the average per 1,000 doctors in the state was .46 (SD = 1.1, range = 0 to 5.9).17 The major source of such complaints was patients, followed by family members. A few respondents did not perceive undertreatment of pain to warrant a serious response by the board. (“Normally those were dismissed or no action was taken because the board doesn’t perceive that circumstance as a real high threshold of some kind of negligence or incompetence”). Others demonstrated a commitment to the issue, despite the absence of complaints (“...as a cancer survivor I’m sensitive to the issue, but I don’t see complaints from cancer patients saying the doctor didn’t treat my pain carefully.”).
Twenty-five respondents (69 percent) thought there had been no change in the number of complaints the board had received in the past five years regarding inadequate treatment of pain. Six respondents thought there had been more complaints, and two thought less (three had no opinion). Those who thought the number of complaints had increased attributed it to increased public awareness (“...my husband recently had surgery and they were constantly asking him about pain — having him score his pain every time you turned around.”).
The most common form of sanction imposed in overprescribing cases was mandatory education/retraining. Other sanctions included (listed in order of frequency mentioned) license suspension, license revocation, probation, restricting opioid-prescribing, monitoring of prescribing practices, mentoring and supervision, reprimand/censure, and a fine.
INVESTIGATIONS AND DISCIPLINE FOR UNDERPRESCRIBING
Complaints
Respondents were asked to estimate the number of investigations their board had ever conducted related to pain undertreatment. Nineteen respondents thought their board had never investigated a physician for undertreating a patient’s pain, and 16 thought their board had (three did not know). Of the latter 16, 11 were able to estimate the number of investigations their board had ever conducted related to undertreatment of pain. Of those, the average number of investigations per board was 1.7 (SD = 3.4, range = 0 to 13).
A number of boards appeared disinclined to consider a standard of care violation alone as a basis of disciplinary action in cases of pain undertreatment (“the Board tends not to discipline based on standard of care but on [gross] negligence”). One respondent voiced frustration with this general tendency of the board:
My problem here is we see standard of care [violation] cases all the time but we don’t discipline on [violation of] standard of care. For some reason our reviewer…says ‘well, it’s not the best medical care, but it doesn’t rise to the level of gross negligence.’ I wonder, what constitutes gross negligence?…I don’t think we do a good job at all on standard of care. I’d like to think so, but we don’t.
Some thought that the physician’s intent would be relevant (“was he trying to avoid DEA scrutiny rather than intentionally make people suffer?”), implying that lack of physician knowledge of pain management provided adequate grounds to evade board sanctions for pain undertreatment (“You would almost have to show criminal cruelty. [Giving Tylenol for cancer pain, knowing it doesn’t alleviate the pain] could show that”). However, a few thought their boards would discipline if they could prove that the standard of care was violated (“yes, standard of care would be disciplined, depending on the facts;” “we do discipline standard of care issues; it’s hard to prove sometimes, but we do.”).
Those whose state medical boards had pain management guidelines or end-of-life legislation used those guidelines, policies, or legislation to benchmark the physician’s actions. One respondent stated, “our state has pain rules that were made by the board that the physician is expected to follow, and if it was verified that the physician didn’t follow them...that physician would most likely be disciplined.” Another commented:
A doctor would have to show a pattern of practice of undertreatment, and following our pain guidelines, if the patient’s pain was 10 out of 10 and [he’s] giving Tylenol or ibuprofen, that’s really ridiculous. Our consultants are in pain management and they believe in treating for pain. [But] it’s hard to gauge since we’ve never [disciplined for undertreatment of pain] before. There are 18 different personalities on our board, and it’s hard to say how they’d go.
Several respondents thought that, depending on the facts of the case, a physician would likely be educated about pain management before sterner sanctions were invoked. One respondent stated, “they probably wouldn’t suspend a doctor’s license, they would probably want re-education.”
BALANCING THE NEED FOR APPROPRIATE TREATMENT WITH PREVENTING ABUSE AND DIVERSION
A few respondents thought that physicians might be hesitant to prescribe opioids to terminally ill patients out of fears of hastening the patient’s death. One respondent said that the allegations made to the board relating to undertreatment of pain typically involved “a fundamental value system” in which physicians “have very strong feelings about not wanting to hasten a patient’s death.” In such cases, the board “trie[s] to assure physicians that it’s within accepted practice to palliate at the end of life and this is not seen as euthanasia or physician-assisted suicide, but often physicians really struggle with that issue.” Most respondents, however, felt that pain management at the end of life had seen the most improvements as far as boards being better able to distinguish adequate opioid-prescribing from overprescribing, as is evident in the following comment:
The board’s in a tough spot. As soon as it goes after someone for overprescribing, the first reaction is “that’s chilling treatment for pain.” They duck for cover under that. But those cases are apples and oranges. Those who are diverting opioids take cash only, they deal with patients who have a criminal history, they don’t keep records. For example, there’s no comparison to treating a dying cancer patient. Complete apples and oranges. It’s not like someone in hospice, dealing with a patient who needs pain medications. Our board has a position statement on end of life that covers all this.
Some respondents commented on the difficulty in reconciling the changing attitudes and practice standards in pain management of recent years with the ongoing problem of drug abuse and diversion. One stated, “it’s a real challenge, finding that balance between under- and over-treating pain.” For some respondents, their job was easier when there was a clearly established upper limit for prescribing opioids, as the following comments demonstrate:
[There’s been a] tremendous change in the management of chronic pain and the attitude that there doesn’t seem to be any upper limit on opioids. The attitude now is “whatever works.” I have problems with that because I’m faced with figuring out whether opioids are being diverted or not, and I have suspicions that a lot of patients are conning a lot of doctors into giving them meds and don’t get questioned because of this “whatever works” attitude. We will have to figure out how to counter that…We used to sanction based on the PDR limit (like 40 mg a day for Oxycodone), but now that’s almost never the basis of our sanctions. Patients are on 700 to 800 mg of Oxycodone a day.
The numbers we’re seeing, the doses are kind of unreal at times. You have a physician who’s not educated in pain management, and this might sound bad, but there is this rhetoric about serving chronic pain patients, so physicians tend to do it. Some have good hearts and don’t know how to do it well, some don’t have the heart but see it as a way to have a practice, but they’re not following good medical practice in prescribing, they’re just prescribing. They don’t have consults, they don’t document about what’s going on, sometimes it’s not even based on good pharmacology, just “oh this is good.” Under-prescribing is still an issue, but there’s also the issue of people being so overprescribed — we had one woman who was a school bus driver and she couldn’t even move [because she was so drowsy from the pain medication].
Another commented:
It’s the standard of care to take care of people’s pain just like it’s the standard of care not to be duped. That shows how colosally difficult the board’s job is here. When do you cross over from appropriately treating pain to hurting patients? I think people get into trouble with this because it’s easy money for doctors. I think the brass ring is a pain center connected with an academic center, where they’re well trained, well-managed, look at all problems, not just pain. Patients who are marginal and might be abusers are put on contracts and they have ways to keep them from participating in diversional activity...I’m always impressed with these pain centers to the point where they make it undesirable for drug-seeking individuals to [use their services].
Several respondents confirmed the difficulty boards had distinguishing valid chronic pain from drug-seeking behavior. One stated, “with the advent of new end-of-life legislation…physicians…feel freer to go ahead and prescribe the pain medications that are needed. This helps a lot. Regarding chronic pain, physicians are much more cautious about that.” Another acknowledged:
It’s easy if the patient is terminal. It’s not so easy with intractable pain. Is this a drug-seeking patient or a patient with valid intractable pain? That’s a difficult call for physicians and a difficult call for us. Maybe with time there will be more sophisticated diagnostic tools available to make it easier.
DISCUSSION
Study results indicate significant variation among the states regarding experience with and reaction to complaints about inappropriate pain treatment. While more than half of respondents (55 percent) reported that opioid overprescribing complaints had decreased or stayed the same, over a third of respondents perceived that opioid overprescribing complaints had increased in their jurisdiction over the past five years. This appeared tied to a perception that drug diversion, in general, had been increasing. A significant number of respondents believed that drug diversion on the whole was worse in their state than it was five years ago, although some attributed this to more diligent efforts to seek out such diversion. Of the 18 respondents who thought drug diversion had worsened in their state, 15 thought that Oxycontin had significantly contributed to this problem. On the other hand, of 33 respondents who had an opinion on this issue, 14 (42 percent) did not think Oxycontin was a problem in their state. This is likely due to the variation in abuse patterns of Oxycontin across the nation. A large majority of respondents stated that their board had not changed its investigative approach in light of Oxycontin concerns, but the overall tone of their comments regarding drug diversion indicated that, in general, their boards had taken more active steps to address this problem.
In regard to decisions to investigate physicians for overprescribing, it appears that a number of boards are attempting to find the appropriate balance between identifying physicians who overprescribe and those who are appropriately treating patients with chronic pain. A number referred to the fact that their board had developed a policy or guidelines for chronic pain prescribing which was a significant aid to them in deciding whether to investigate or discipline a physician. The number of boards that have adopted pain management guidelines, regulations, or policies has, in fact, increased over the last four years, with boards specifically addressing the issue of chronic non-malignant (or “intractable”) pain. In 2001, the University of Wisconsin Pain & Policy Studies Group documented a total of 82 state pain policies in the form of statutes, regulations, guidelines, or policy statements. In addition, the Group found that 12 states had adopted the Federation’s Model Guidelines in full, and nine in part.18
Respondents’ comments indicate that boards are focusing on making their pain policies known to physicians so that physicians are aware of what is required of them to avoid scrutiny by the board. A number of boards emphasize what should be present in the patient’s chart to avoid suspicion by the board that the physician is overprescribing (e.g., patient assessment, pain diagnosis, plan of care, evaluation, follow-up, specialist referral, etc.). On the other hand, if a physician is accused of overprescribing and lacks proper documentation of his or her practices, a board is much more likely to investigate and potentially discipline the physician.
An encouraging result for pain management advocates was that boards appear to be moving away from volume or quantity of opioids as a primary basis for investigating physicians for overprescribing opioids. Some respondents referred to volume as a trigger but not conclusive evidence for a decision to investigate. Many respondents indicated that these were very fact-specific cases that had to be evaluated individually; that all facts, including the diagnosis of the patient, the documentation of the prescriptions ordered and consistency with established guidelines, had to be considered. Despite this positive trend away from using volume as a determinative factor in moving forward to investigate or discipline, a few respondent comments were troublesome in that they implied a continued reliance on volume and, in at least one case, a lack of knowledge regarding issues of dosage and volume. Thus, misunderstandings may still exist about opioid volume and quantity upper limits (i.e., that the latter exists independently of case-specific facts, which is generally not the case).
In response to the question regarding factors that the board would consider in deciding whether to discipline in a case involving overprescribing of opioids, most respondents stated that it was a matter of judgment, that it was very fact specific, and often subjective. However, for those that had established pain management policies or guidelines, these appeared key in determining whether to discipline. Significant variation from the policies, in some cases, could be a basis for discipline. Boards varied regarding whether they would require a pattern or more than one instance of overprescribing before disciplining. Poor documentation and record keeping were also consistently cited as a key factor in disciplining physicians in these cases.
More than half of respondents (56 percent) thought the number of board disciplinary actions relating to opioid prescribing practices had either stayed the same or decreased over the past five years. Reasons respondents who observed a decrease gave were encouraging for advocates of better pain management. These board representatives stated that they thought their board’s attitude toward opioid prescribing had changed over the past five years, that their pain management guidelines helped them, in a number of cases, determine that the prescribing practices of the doctor under investigation were reasonable where prior to the adoption of the guidelines they might have disciplined the physician.
The number of estimated complaints boards received for underprescribing were significantly fewer than those received for overprescribing (in 2001, an average of .46 versus 3.13 complaints, respectively, per 1,000 doctors in the state). In addition, a significant majority saw no change in the number of complaints received for underprescribing during the past five years. While some respondents thought the problem of pain undertreatment was real and merely underreported, others did not seem to view undertreating pain (particularly chronic, non-malignant pain) as a significant problem.
In regard to disciplinary action for undertreating, many boards appear disinclined to discipline simply for violation of standard of care, which is how many respondents depicted cases of underprescribing pain medication. They would be more likely to suggest rather than mandate education to physicians in such cases. This appeared somewhat at odds with responses given to questions about disciplining for overprescribing, where respondents appeared more likely to say they would discipline for violation of standard of care, even without a pattern of poor practice. Thus, there seems to be a lack of parity in application of standard of care and patient harm as bases for discipline in cases of undertreatment vs. overtreatment. Overprescribing is more often seen as a clear violation of standard of care and a clear threat to patient harm, while many respondents, or their boards, do not view pain undertreatment, particularly for chronic pain, in the same way. They appear to apply a higher threshold of harm for undertreating pain. A number of respondents, however, did provide examples of cases they thought could be construed as gross negligence or egregious behavior regarding pain undertreatment and said that such cases might lead to disciplinary action.
This type of attitude may contribute to a shortage of physicians who are able and willing to treat patients who have chronic pain. While advocacy for pain management on the part of many state boards may ease physicians’ fears about being disciplined for opioid overprescribing, many physicians may decide that their safest (or “least burdensome”) course is to refer patients with chronic pain to a pain specialist. With the number of patients suffering from chronic pain greatly outnumbering the number of qualified pain specialists, the results do not add up in favor of those with chronic pain.
CONCLUSION
We cautiously conclude from our survey results that medical board attitudes and practices toward physician prescribing of opioids have changed for the better during the past several years. Respondents’ references to the need for “balance” between ensuring appropriate treatment of pain and disciplining physicians who are inappropriately prescribing opioids are illustrative of this movement. Moreover, the abandonment of opioid quantity as a marker of questionable practice and replacement by an emphasis on individual assessment of whether the physician has appropriately evaluated the patient, prescribed consistent with board guidelines, and appropriately documented his or her prescribing, further indicates progress in board recognition of the need for adequate pain treatment.
At the same time, some board attitudes and practices remain problematic — in particular, a continued tolerance of undertreatment. While many boards are becoming more proactive in educating physicians about pain management issues, the focus is on what physicians who choose to prescribe opioids for pain must do to avoid board scrutiny. There appears to be a discrepancy in the weight given to violation of standard of care, patient harm, and gross negligence for overprescribing issues as compared to pain undertreatment issues. Specifically, boards seem to have a higher threshold for patient harm in cases involving pain undertreatment — particularly for chronic, non-malignant pain. To this extent, physicians may be getting mixed messages from boards: on the one hand, that effectively managing their patients’ pain is the expected standard of care, and on the other, that the board is more concerned about opioid overprescribing than pain undertreatment. Perhaps this is unavoidable given the realities of opioid diversion practices. Reformers may simply have to accept that management of chronic pain inevitably carries with it more entanglement with licensing and law enforcement authorities than management of cancer pain, given the higher risks of diversion.
ACKNOWLEDGEMENTS
Funding for this study was provided by the Mayday Foundation. Parts of this article were taken from “Achieving the Right Balance in Oversight of Physician Opioid Prescribing for Pain: The Role of State Medical Boards,” published in the Volume 31, Number 1, 2003, issue of The Journal of Law, Medicine & Ethics.
References
- 1.↵Several physician surveys have provided evidence of the chilling effect of sanctions against physicians for opioid prescribing. In 1990, physician members of the Eastern Cooperative Oncology Group were surveyed and 18% of 897 responding oncologists rated excessive regulation of analgesics as one of the top four barriers to adequate cancer pain management. See J.H. Von Roenn et al., “Physician Attitudes and Practice in Cancer Pain Management. A Survey from the Eastern Cooperative Oncology Group,” Annals of Internal Medicine, 119 (1993): 121–126. In a 1991 survey of members of the American Pain Society, 40% of surveyed physician members said concerns about regulatory scrutiny rather than medical reasons led them to avoid prescribing opioids for chronic non-cancer pain patients. D.C. Turk et al., “Physicians’ Attitudes and Practices Regarding the Long-Term Prescribing of Opioids for Non-Cancer Pain,” Pain, 59 (1994): 201–08. In a survey of Wisconsin physicians conducted in the same year, over half reported decreasing the dose, quantity, or number of refills, or switching to a lower scheduled medication, due to fear of regulatory scrutiny. D.E. Weissman et al., “Wisconsin Physicians’ Knowledge and Attitudes About Opioid Analgesic Regulations,” Wisconsin Medical Journal, 90 (1991): 671–75. And, in a 1993 California survey, 69% of physician respondents felt that doctors were more conservative in their use of opioids in pain management because of fear of disciplinary action and a third felt that their own patients may be suffering from untreated pain. See Turk et al.
- 2.↵GoodmanE., “Patients in pain need compassion,” The Boston Globe, Friday, September 10, 1999, available at www.reporternews.com/1999/opinion/pain0910.html, accessed 10/31/02.
- 3.↵In the Matter of the Accusation Against: Eugene B. Whitney, M.D., Case No. 12 2002 133376.
- 4.↵HoffmannD.E., “Undertreating pain in women: A risky practice,” Journal of Gender Specific Medicine, 5 ( 2002): 10– 15.
- 5.↵Id. at 12
- 6.↵The Mayday Fund was established in 1992 with funds from the estate of the late Shirley Steinman Katzenbach. It is dedicated to the reduction of the physical and psychological effects of pain. www.painandhealth.org/mayday/mayday-home.html.
- 7.↵FSMB’s Model Guidelines for the Use of Controlled Substances for the Treatment of Pain were adopted on May 2, 1998. They recommend evaluation of the pain patient by the physician, formulation of a treatment plan, securing informed consent for treatment, performing periodic review of therapy and outcomes, obtaining appropriate consultations or referrals for patients when necessary (e.g., patients with substance abuse history), keeping accurate and complete medical records, and maintaining compliance with controlled substance laws and regulations. See S.H. Johnson, “Introduction: Legal and regulatory issues in pain management.” Journal of Law, Medicine & Ethics, 26 (1998): 265–66.
- 8.↵Annual Review of State Pain Policies (2001), Pain & Policy Studies Group, www.medsch.wisc.edu/painpolicy/publicat/01annrev/.
- 9.↵Hoffmann, supra note 4., citing Martino, “In search of a new ethic for treating patients with chronic pain: What can medical boards do?,” Journal of Law, Medicine & Ethics, 26 (1998): 332–49 at 263.
- 10.↵“Promoting Pain Relief and Preventing Abuse of Pain Medications: A Critical Balancing Act,” A Joint Statement from 21 Health Organizations and the Drug Enforcement Administration, issued on October 21, 2001. See www.medsch.wisc.edu/painpolicy/dea01.htm.
- 11.↵In some cases, that individual identified someone else who could better answer the survey questions.
- 12.↵Twenty-two of the 38 respondents accepted complaints in the form of phone, e-mail, or anonymous complaints, although anonymous complaints were investigated in rare circumstances (i.e., regarding serious complaints when sufficient information was provided to investigate further). Some states had a formal process that first considered allegations which were transformed into complaints after a formal process in which preliminary evidence was collected.
- 13.↵This could include complaints against physicians related to prescribing opioids for pain patients they were treating, prescribing for themselves, or trading opioids for money or sex.
- 14.↵The actual range of values was 0 to 250. To correct for the outlier values of 100 and 250, these values were “windsorized” to the next highest values of 57 and 58, respectively. Those numbers were then divided by the number of physicians per state (http://www.education-world.com/a_lesson/TM/WS_census_states.shtml data) and multiplied by 1000.
- 15.↵Information current as of February 2002, available at www.medsch.wisc.edu/painpolicy/matrix.htm.
- 16.↵The respondent conveyed that referral to a pain management specialist would be expected for primary care physicians treating patients with complex chronic pain.
- 17.↵Eighteen (18) thought their boards had not received any such complaints — their pain undertreatment complaint estimate was entered as zero. Of the 19 who thought their boards had received such complaints, 15 were able to give a 2001 estimate — if a range was given, the median of the range was entered. The actual range of values was 0 to 25. To correct for the outlier value of 25, that value was “windsorized” to the next highest value of 13. Raw values were then divided by the number of physicians per state (http://www.education-world.com/a_lesson/TM/WS_census_states.shtml data) and multiplied by 1000.
- 18.↵“2001 Annual Review of State Pain Policies: A Question of Balance (2002).” Pain & Policy Studies Group, University of Wisconsin, www.medsch.wisc.edu/painpolicy/.
