NOVEMBER 2019 – Best Clinical Practices and the Law
As many in the community are aware, two SouthCentral Alaskan primary care providers were arrested last month by the Drug Enforcement Administration, and are currently under trial for indictments regarding criminal practices related to the inappropriate prescription of controlled substances, primarily opioids (“narcotics”). We don’t wish to highlight their troubles here, but rather take this opportunity to discuss the very important and salient issues of the laws of the United States, professional oversight at both the regulatory and advisory levels, and what we call in the profession “standard of care.”
Opioids are dangerous substances with the potential for significant individual and public health harms, and also pose a significant national security threat. As such, federal law pertaining to the manufacture, distribution, prescription and dispensation of these drugs comprises the highest level of oversight, trumping all other considerations.
21 C.F.R.§1306.04 states that “A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” The take-home message here is that opioids are restricted by the U.S. Department of Justice, and only under certain conditions, i.e., those deemed appropriate by consensus expert opinion defining “legitimate medical purpose” and “usual practice” are prescriptions allowed. Anything falling outside of those boundaries is illegal and criminal.
The federal government for the most part has delegated the practice and governance of medicine to the individual states, and each state has a medical board that dictates essential requirements for critical matters of healthcare (with a corresponding Federation of State Medical Boards, whose perennial Model Policy on opioid prescription has shaped most states’ individual policies.) Individual state legislatures also have the authority to regulate matters pertaining to opioid prescription, and are increasingly doing so.
The determination of what defines legitimate medical purpose, and “usual practice”, and the corollary concept of standard of care is a constantly evolving dynamic based upon the recommendations of expert boards and professional societies (such as the American Society of Interventional Pain Physicians, or ASIPP). These statements are based upon careful review of the scientific and medical literature, and are frequently updated (for example, the ASIPP guidelines, which Dr. McAnally and colleague Dr. Trescot helped revise recently were just updated in 2017.)
Based upon the overwhelming evidence from laboratory and clinical investigations, as well as public health/epidemiologic data (e.g., the “opioid epidemic” which has claims more lives every year now than car wrecks) these advisory guidelines and statements are unanimous in recommending against the chronic use of opioids in non-cancer pain with rare exception, when all other modes of treatment have failed, and when the potential benefit outweighs the risks. Consideration of a trial of opioid therapy must take place under strict control including careful evaluation of a person’s symptoms and physical examination findings, along with auxiliary studies (e.g., imaging and labs) with ongoing assessment of their clinical condition, and monitoring for potential improvement, vs. potential worsening and harms. Escalation of dosing is rarely warranted if symptoms aren’t improving.
In some cases, opioid addiction/dependence is best treated by “medication-assisted treatment” (MAT) including buprenorphine (Suboxone®), methadone, or naltrexone but those treatment decisions also need to follow a careful evaluation of multiple factors, or “dimensions” as per the American Society of Addiction Medicine guidelines.
Unfortunately these two providers chose to practice well outside the guidelines, and in some cases the law, with tragic results. Again, we are not highlighting this to point the finger or pass judgment in any way, but to emphasize that this arena is fraught with complexity, confusion and danger.
A patient’s desire and request for opioids does not comprise legitimate medical purpose, no matter the circumstances behind those desires and requests. The criteria of legitimate medical purpose is only met when a careful evaluation/assessment has been performed and lower-risk or more appropriate treatments have failed.
Several of our practices locally have aligned to offer assistance to individuals and referring providers in obtaining appropriate and legitimate pain management and addiction treatment help in the wake of these events, and the Alaska Department of Health and Human Services stands by to help direct patients and other interested parties to alternate resources as well – see our Chief Medical Officer, Dr. Anne Zink’s summary at http://dhss.alaska.gov/News/Documents/press/2019/DHSS_PressRelease_HealthResponse.pdf