Opioid Prescribing and Physician Autonomy: A Quality of Care Perspective – free full-text /PMC6384205/ – Feb 2019
As one article published in American Family Physician in 2000 stated: “Despite recent advances in the understanding of pain management, patients continue to suffer needlessly, primarily because of improper management and inadequate pain medication”
This article evaluates the effectiveness of recent legislative mandates and restrictions on opioid prescribing and proposes alternative frameworks for combatting and preventing harms caused by the misuse of prescribed opioids.
Although the majority of opioid prescribing regulation has taken place at the state level, federal law also imposes restrictions.
Drug Enforcement Administration regulations restrict the use of methadone for addiction therapy and create strict administrative requirements for physicians treating addiction with buprenorphine, a partial opioid agonist also used in the treatment of addiction
Additionally, state-level guidelines relating to opioid prescribing have been introduced in many states and are often unusually detailed relative to guidelines applicable to other drugs.
Although these guidelines may not always have the force of law, they affect physician decision-making and convey the message that opioids should be considered to be in a separate class from other controlled drugs.
Another mechanism of enforcement is the professional discipline system. The practice of medicine in each state is regulated by a board of medicine or similar governing body, which promulgates guidance and rules for physicians licensed in the state and handles enforcement matters, sometimes in conjunction with criminal prosecutors
Board for Professional Medical Conduct, which oversees OPMC, is made up of a combination of physician and lay members. OPMC has the authority to impose sanctions on licensed physicians up to and including a permanent surrender of the physician’s medical license
Professional discipline systems are not the only safeguard against improper prescribing behavior. Other ways in which physicians are held accountable are through the peer review and quality assurance systems.
Both peer review and quality assurance are forms of review that, although mandated through certain legal frameworks (such as Medicare Conditions of Participation), are conducted internally within a health care institution or group practice rather than through an external body
Peer review, in which physicians’ quality of work is evaluated by other health care providers, is required by the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations [JCAHO]). Through this process, physicians are typically subject to retrospective review of patient records by a peer review committee made up of other physicians
Peer review committees, made up of fellow physicians and other providers, evaluate quality of care on a case-by-case basis and report their findings as to whether the standard of care has been met in particular cases, and then determine the systemic causes of medical errors and identify process improvements
Quality assurance and quality improvement plans may include specific measures relating to opioid prescribing when that prescribing has been identified as a quality of care issue
Researchers have attempted to evaluate the impact of federal and state-level legal interventions relating to opioid prescribing on a variety of health-related outcomes, including overdose deaths, emergency department visits, and quantity of opioid prescriptions.
No, they have not. No research has been conducted on patient outcomes, which are the real goal of medical care, not how many milligrams of opioid medications were prescribed.
A number of studies have concluded that states with PDMPs have not experienced statistically significant differences in the rates of opioid consumption, prescription, or overdose mortality. The literature suggests that PDMPs have led to no discernable or measurable impact on the amount of opioids distributed per capita.
Notably, significant reductions in patients that fall in high-risk opioid use categories, such as Medicare beneficiaries, have not been consistently observed
Furthermore, associations have not been established between PDMP prescribing requirements and opioid prescribing decisions, and PDMPs have had no effect on the rates of opioid-related visits to emergency departments
studies have found that PDMPs have actually increased the rates of opioid consumption and mortality, as well as rates of use of other illicit drugs.
One study determined that PDMPs dramatically increased the shipment of opioids, a counterintuitive finding.
Studies of other interventions have produced similarly varied results. Perhaps because these other interventions are less commonly adopted than PDMPs, the body of research on them is less conclusive and less voluminous
Studies exploring the effects of prescribing guidelines and limits on prescriptions, for example, have found largely positive results, although these studies often focus on reductions in the amount of drug prescribed, rather than more direct metrics of harm.
No studies look at patient outcomes, only milligrams prescribed and population opioid harms, including illicit with prescribed opioids. These studies aren’t separating pain patients from recreational drug users, making their subjects a mish-mash of different groups, not all of which are medical patients.
Multiple studies have found that prescribing limits had no meaningful effect on health outcomes.
Studies evaluating the effects of mandated warnings and required training have also found mixed results.
In another study, a group practice that implemented mandatory training saw decreases in opioid prescribing for chronic pain treatment, but did not see reductions in overall opioid prescribing.
Throughout modern medical history, the trust and discretion afforded to physicians have been pillars of the physician-patient relationship.
All of the legal interventions discussed above limit physician autonomy and interfere with professional judgment and discretion, thereby restricting this discretion and narrowing a physician’s range of options for treating patients.
In the case of laws and regulations specifically restricting how, when, and under what circumstances all physicians may prescribe opioids to all patients, physician decision-making for the best interest of the patient may be impeded.
Apparent solutions of general applicability may result in individual cases of suboptimal medical care.
These types of general restrictions conflict with the more traditional legal mechanisms for ensuring that physicians engage in proper prescribing behavior for all medications, including opioids—namely, peer review and quality improvement activities carried out by health care institutions and physician group practices, and the medical profession’s state-level self-regulation through state medical boards.
Professional disciplinary bodies are composed of medical professionals and administrators with the knowledge and experience to determine whether individual opioid prescribing behavior fails to adhere to evolving medical standards.
State medical boards and peer review committees have longstanding experience in investigating and enforcing behavior that could constitute a deviation from acceptable standards of medical practice, including in complicated areas in which the opinion of the medical community has evolved rapidly, as with opioid prescribing over the past two decades
Peer review and quality improvement systems are already powerful tools to ensure quality of patient care and address individual instances of inappropriate provider behavior relating to the prescription of opioids
Peer review systems have been occasionally criticized for being ineffective or arbitrary, but studies show measurable improvement associated with implementing and maintaining these systems, including with regard to opioid prescribing.
In the history of the regulation of medical practice, even in the midst of public health crises, it is unusual that a broad area of practice is pre-empted by legislative or regulatory measures. Specifically, the sort of interference with physician autonomy that these opioid-related legal interventions represent has been used in relation to only a small number of other areas of medical practice.
With these few exceptions, physicians have not experienced areas of practice in which they must consider legal requirements (and the normative message conveyed by such requirements) in rendering their best medical judgment.
Some prominent physicians have publicly opposed specific restrictions on physician judgment in opioid prescribing for pain management, citing their own clinical experience and the scholarship on the topic.
These concerns—over limiting autonomy and the ability of providers to treat patients in the method they deem most clinically appropriate—must be considered here, as the sum of the evidence described in the scientific literature does not yet point toward any of the detailed regulatory schemes adopted to date as being particularly effective as means of reducing opioid-related harms
As described above, the individual studies that have looked at specific opioid-related initiatives reveal that the most common types of interventions adopted by states have been of limited, or unproven, efficacy.
Additionally, even if the above-described studies had each observed statistically significant results in their primary endpoints, they focused predominantly on endpoints that are limited or misleading in their public health significance, such as the number of individuals receiving prescriptions or the total amount of opioids prescribed.
These types of metrics provide a limited view of the overarching public health considerations involved in the opioid crisis
Of the many people who use prescription opioids, 4 to 6% go on to use heroin. Additionally, there is strong evidence showing that much of the opioid-related harm in recent years has resulted from illicit fentanyl (much of which now comes from outside the USA rather than diversion of domestic supply) and heroin rather than prescription opioids
Simply reducing the volume of opioids prescribed may address the risks of diversion, but does not necessarily capture whether a legal intervention has the desired ultimate effect on public health.
Whether intended or unintended, many of these legal interventions have had the effect of reducing access to opioids, not only for the illicit purposes lawmakers are concerned about but also for legitimate uses in the treatment of pain.
Any regulation that has the effect of reducing the amount of opioids in the system is likely to make it more difficult, and in some cases impossible, for a patient in chronic pain to get the medication he or she needs, creating a parallel “crisis” for some whose pain goes untreated or partially treated.
One writer, discussing her personal experience with barriers to access, reported that an alarming number of individuals she knew personally who suffered from pain and were unable to obtain the drugs they needed had committed suicide.
It is a genuine and pressing quality of care issue not only that patients may have inappropriate access to medically unnecessary prescription opioids, but it is also a quality of care issue that other patients do not have access to medically necessary and clinically appropriate opioid drugs, whether for the treatment of acute or chronic pain or of addiction.
Legislators undoubtedly have had the best intentions in drafting laws designed to stem the rising tide of opioid-related addiction and death. However, in many cases, these laws miss the mark.
In addition to their questionable efficacy, many regulations may be impeding physicians’ ability to properly treat their patients’ pain and address addiction.
Research should focus on whether these legislative restrictions have had positive correlations with reduction in opioid-associated harms, but also on whether these restrictions may have had adverse effects on clinically appropriate care. Both are important questions, but the latter appears to have been studied much less carefully.
Also, the traditional and longstanding self-regulating physician discipline system can be used more aggressively and more effectively to detect, punish, and prevent inappropriate opioid prescribing.
The professional disciplinary and peer review systems have the advantage of examining physician prescribing behavior in individual patient cases, with the appropriateness of those practices calibrated to individual cases and allowing for exceptional patient needs.
That sort of calibration and allowance of exceptional cases is not possible in the more specific legal regulations adopted by state legislatures, or even by federal authorities, as in the case of specific restrictions on use of buprenorphine
Poor physician practices in the prescribing of opioids should not be defended, and should be prevented, and aggressively so. The questions are whether the current legislative focus on decreeing “one size fits all” standards for all physicians in this area is effective, and whether a more robust approach using peer review and professional disciplinary processes can be more effective, while simultaneously more protective of the independence of physician decision making in the interests of individual patients.