Part 1: Basic Framework
Over the last few years, there has been a steady increase in the number of articles in the medical press and academic journals on the opioid crisis. Some of them relate to changes in the federal response, but often state-wide, pharmacy company, and hospital system initiatives are presented. Yet, despite all this material, I was unaware that Texas passed legislation this past summer, taking effect in 2019, that requires prescribers to check the state-controlled substances database with for prescription.
In putting this editor's message together, I realized that even a basic review exceeded the space available for my bimonthly column. So, this month, I will outline the basic framework around opioid prescribing. In the May issue, I will present some of the risks around prescribing and best practices to limit those risks. By its very nature, the opioid crisis is a vexing, complex, and rapidly changing topic. I am not a lawyer. I am approaching this material from the perspective of a practicing orthopaedic surgeon with administrative responsibilities.
Yeah, yeah, we know, the opioid crisis…
Regular AAOS Now readers are already aware of the tremendous toll opioid abuse has taken on Americans. We also know that, as prescribers, we have had a role in precipitating this problem. Depending on the patient population surveyed, orthopaedic surgeons may be the third-highest prescribers of opioids. Yet, with all the media attention, it may not be clear to everyone that prescribing practices vary markedly from specialty to specialty and from state to state. Furthermore, individual actions in state capitols across the country have produced a patchwork of different laws and regulations.
Of course, to stay out of trouble with the malpractice bar, the U.S. Drug Enforcement Administration, state public safety departments, and state medical boards, orthopaedic surgeons should stay on top of initiatives within respective states. Yet, an understanding of what is happening elsewhere can be helpful for several reasons, including the following:
- surgeons frequently change jobs, requiring them to relocate to other states
- some surgeons hold multiple licenses and see patients in more than one state
- preparing for the changes already instituted in neighboring states and expanding to your state
- these rules really do improve patient health and safety and should be adopted as best practices
MED and the schedules
At the outset, it might be useful to briefly review the U.S. Food and Drug Administration's (FDA) schedule for dangerous substances. While most surgeons are aware that hydrocodone was rescheduled from III to II in 2014, many may not know that the FDA reschedules drugs and other substances annually. According to the FDA, "Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused."
You might see some substances classified as IIN. This does not stand for "narcotic," rather nonnarcotic. So, schedule IIN includes stimulants such as amphetamine. Nonstimulant and nonnarcotic drugs are also scheduled. For example, schedule II includes amobarbital, glutethimide, and pentobarbital. For our purposes as orthopaedic surgeons, however, we are concerned with opioids. Table 1 includes examples of scheduled medications commonly used by orthopaedic surgeons.
Also, critical in these discussions is an understanding of morphine equivalent dose (MED). MED is most often reported as the morphine milligram equivalency of opioid medication taken per day. Increasingly, electronic medical records systems have these calculators built in, but a number are also available online. An orthopaedic surgeon should understand the MED of any postoperative pain medication they prescribe. For example, it is useful to know that withdrawal symptoms when stopping an opioid may occur after as little as one week of use when the patient takes more than 30 mg MED per day. Thus, in these individuals, a tapering program may improve compliance and reduce relapse.
Additionally, when a new, nonopioid naïve patient comes to the office, a quick calculation of their MED may be a strong predictor of surgical outcomes and early mortality. Pain specialists argue that the equivalencies do not allow a patient to be safely and directly converted from one agent to another, as there are wide differences in patient metabolism of these agents. On the other hand, many state regulations and prescribing guidelines cleave to the MED concept.
Federal vs. state laws and their impact
Marijuana laws are not the only areas in which state laws both vary and conflict with federal law. But, unlike marijuana, no "safe harbors" have been set forth for opioid prescribing. Thus, when there is a difference, the more restrictive law should be followed.
Although we will focus on prescribing, other rules may affect physician recommendations for their patients. For example, different states offer different guidance on what constitutes "drugged driving" and use of opioids, as prescribed, is occasionally included. These driving rules are both highly variable in their scope and in the penalties conferred. The California Vehicle Code, for one, states that "It is unlawful for a person who is under the influence of any drug to drive a vehicle," but it excepts persons "participating in a narcotic treatment program." Rules vary about returning to work while on narcotics as well. The references, available online, include a document that surveys the various state laws in detail. But, even here, the language is often confusing. Does a "narcotic treatment program" include routine postoperative use or a formal methadone program?
Other important differences, often for very similar rules, are the categories of providers included and exceptions offered. In many states, opioid prescribing for cancer pain and in a hospice setting is specifically excluded. On the other hand, many add more onerous regulations to operators of pain management clinics. The percentage of patients receiving prescriptions, especially if offered over 90 days or in the form of long-acting opioids, may push an orthopaedic practice into a "pain management" designation. So, too, could the pain management physician your group hired. If your practice has hired a pain management physician, working under the same provider ID, this scenario could also change the rules for the other providers.
Another important, operational issue lies in the means of prescribing. Different states' regulations regarding oral, electronic, fax, and phone prescription of opioids and the possibility of refills and expirations for those prescriptions also widely vary. The federal rescheduling of hydrocodone has pushed some practices into all written prescriptions. However, other practices have switched to tramadol or acetaminophen with codeine products, where considerable variability remains. An excellent state-by-state overview is available from the National Alliance for Model State Drug Laws (reference below). However, the most up-to-date version I could find dated to 2016.
This marked variability in state regulations does appear to impact prescriber practices. According to AthenaHealth, which was able to report statistically reliable data from 30 states, the percentage of adults aged 18–64 with opioid prescriptions ranged from 2.4 percent in Connecticut to 9.4 percent in Oregon. It assessed the impact of various state policies on these prescription rates and, except for Oregon, states with medical marijuana laws tended to have lower opioid prescription rates. The day supply limits common in New England states were also associated with lower prescription rates. Mandating continuing medical education to pain management and opioid prescribing physicians, frequency of updates to prescription drug monitoring programs, and requiring formal substance abuse disorder assessments did not seem to have a significant impact.
As a clinician with no legal background, confused by the flurry of new laws and regulations around opioid prescribing, I was astounded by the variability in prescribing practices among countries, states, specialties, and even individual physicians within a subspecialty. I knew there would be some differences, but I was surprised by the extent of those differences and the degree to which state regulations and state medical board actions impact those practices.
In the next column, I will examine some of the real-world risks surrounding opioid prescribing and some best practices to limit those risks.
Eeric Truumees, MD, is the editor-in-chief of AAOS Now and an orthopaedic spine surgeon in Austin, Texas, where he is also professor of orthopaedics at the Dell Medical School, University of Texas.
Editor's note: This article is part one of a two-part series. The final installment will appear in the May issue of AAOS Now.