The Rules for Opioid Prescribing in 2018

Surgeons must know the risks and mitigate them by implementing best practices
In the March issue of AAOS Now, frustrated by my own ignorance of the web of conflicting laws and regulations around opioid prescribing, I offered a framework to better understand our roles as orthopaedic surgeons. With this column, I’d like to explore the “real-world” risks of ill-considered prescribing and some best practices to mitigate those risks.

A wide range of legal risks
We are aware of the high-profile cases in which doctors were arrested for their opioid prescribing practices. Most, like the 2015 murder conviction of Lisa Tseng, MD, are typically described in the lay media as “pill mill” situations and do not seem relevant to the orthopaedic surgeons managing acute postinjury or postsurgery pain.

In fact, most doctors feel the opposite pressure, which is to give in to their patients’ demands for pain medications. This pressure can arise from empathy, a desire to avoid lower satisfaction scores, or even the loss of a referral source (as when the patient calls his or her primary doctor and complains), or some combination of the three scenarios. The case of Todd Graham, MD, of South Bend Orthopaedics, has not drifted far from our minds. He was shot to death in the practice’s parking lot after he refused to write the murderer’s wife, a new patient for whom he’d never prescribed anything, an opioid script.

I did a quick search to see how many doctors have been sued for prescribing or failing to prescribe opioids. I was not able to locate any statistical overview, rather a series of cases, whose illustrative value is probably limited. For example, in June 2016, a jury awarded St. Louis City Parks employee Brian Koon $17.6 million in his lawsuit against St. Louis University and his primary care physician. After four years of escalating doses, by 2012, he was taking 40 pills with a morphine equivalent of more than 1,500 mg per day.

The best review of legal risks I found was published by AAOS fellow David Sohn, MD, JD, and his colleagues, Justin A. Julian and Kristin A. Toy. Their report cited a number of novel ways physicians have been held liable for both over- and under-prescribing opioids. They reported that, in 2001, the Joint Commission of Accreditation of Hospitals Organization codified the American Pain Society’s concept that pain control is a “basic right” of patients in its 2001 Pain Management Standards. This effort led to the “Pain as the Fifth Vital Sign” campaign and a sharp increase in opioid utilization thereafter.

Their search uncovered both civil court awards and state board disciplinary actions for under-prescribing. Traditional standards for medical negligence have been difficult to apply to under-prescribing allegations. As a result, novel approaches, such as citing the physician under elder abuse statutes, have been utilized.

Of course, Sohn and coauthors also cited multiple examples of successful and failed lawsuits involving over-prescription. Aside from the more common civil and criminal charges filed when patients overdose, they reported that “the West Virginia Supreme Court ruled that patients who become addicted are able to sue pharmacies and doctors for addiction-related damages even when the plaintiffs themselves were using the medications in a criminal way.” They warn physicians about third-party liability, noting the 2007 Massachusetts case in which a pedestrian struck by a 75-year-old man with metastatic lung cancer sued the man’s doctor. On appeal, the court found that physicians “do have a duty of reasonable care to everyone foreseeably put at risk by the medications prescribed.”

Best practices
One thing is clear—continuing to do things the same way we always have will not work. The only way for orthopaedic surgeons to safely chart these ever-changing waters lies in a set of formally reviewed and frequently updated best practices. Many recommendations are available at the Academy website and in this article’s online reference section. At AAOS Now, we welcome reader response: other ideas, how recommendations have/have not worked, etc.

The first step, in my opinion, is to meet with your colleagues and office staff to understand current practices and readiness to unify your approach. In my practice, simply setting expectations has been extremely powerful. Clearly stating your practice’s opioid prescribing policy on its website, appointment packet, and signs in the office help set the tone. In our experience, patients primarily seeking a specific medication (rather than seeking a solution to a problem, which might include medications) simply turn to other practices.

After setting expectations, the next most useful step is standardized scripting around pain medication requests. Every office staffer who interacts with patients in person or on the phone should be trained in steering these interactions in a positive, nonjudgmental direction. A variety of these scripts are available online, though I found the Stanford Center for Continuing Medical Education’s YouTube videos particularly realistic.

Optimally, a provider agreement should include standardized dispensing patterns for common conditions across the entire group. Even when this level of agreement cannot be reached, make sure you understand your state’s regulations. Incorporate those rules into the practice’s overall opioid policies. For example, Ohio requires that new opioid prescriptions for adults be limited to 14 days duration and not exceed 30 mg morphine equivalent dose (MED). For persisting pain requiring refills, formal re-evaluation, incorporating standardized pain assessment tools, and a state medication database check are required at two and six weeks.

Other common, practice-wide rules include:

do not prescribe opioids after hours do not prescribe opioids to patients not physically seen
wean patients on long-acting opioids prior to elective interventions
carefully address and document need for refills
use intake forms and an evaluation process that screen for a history of drug abuse, addiction, or comorbid psychiatric conditions

While long-acting opioids are commonly found in postoperative pain management protocols, orthopaedic surgeons must be very careful about their incorporation. Ideally, pain specialists should be involved when developing these protocols. Not only are these medications associated with higher mortality rates, some come with black box warnings about acute, postprocedural pain.

A standard approach to pain management consultation might be considered for any patient on long-acting opioids or above a given MED threshold. The trigger, or warning threshold, commonly utilized when considering referral to a pain management specialist has decreased over time. For example, many states used to target daily doses above 120 mg MED, but many have now reduced the daily doses to 90 mg MED. Interestingly, the Centers for Disease Control and Prevention recommends offering a naloxone prescription to anyone getting more than 50 mg MED or when other risk factors are present.

For reference, a patient taking one to two oxycodone tablets every four to six hours could be ingesting as much as 180 mg MED per day.

When calculating these risks, consider multimodal pain management, but be careful when combining multiple central nervous system depressants. The combination of benzodiazepines and opioids should be avoided, when possible.

Given the physician’s theoretical liability for third-party harms, processes that limit excessive intake and diversion should be considered. For patients coming from long distances and likely to need refills, giving several scripts with “do not fill until” notices may be recommended. These notices are not recognized in every state. But, when possible, they reduce large pill counts that could attract theft or diversion. Other monitoring programs are more commonly found in pain clinics but may be required in your state, including urine drug screens and pill count documentation.

Pill counts are a nuisance but can be very helpful to ensure that directions were understood and the patient was compliant. Typically, the patient brings all pills in the original container. If the count is too low for the expected, prescribed dosage, the physician needs to consider decreasing drug efficacy or nonmedical use (e.g., to “get high” or self-medicate mental health issues) or drug diversion on the patient’s part.

One strongly recommended practice is to clearly describe the medication’s side effects, especially addiction and sedation. Document this discussion and offer hard copy companion materials. Ideally, these materials could include the usual recommendations for duration of use of medications, a program for tapering, disposal options for unused pills, and nonopioid alternatives suitable in the given clinical environment. It is important the patient understand that “some pain is ok and expected.”

Prescribing opioid pain medications is a common, and typically justified, practice for most orthopaedic surgeons. Yet, we are all aware of the risks these medications pose to our patients and the community at large. The web of conflicting laws and regulations around opioid prescribing means that some of those risks extend to the prescribers themselves. With this series, I offered a framework to better understand our roles as orthopaedic surgeons prescribing these medications and explored the real-world risks of ill-considered prescribing. I learned about some best practices to mitigate those risks and hope AAOS Now readers will share their experience and wisdom with us as well.
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 the final installment of a two-part series. The first article appeared in the March issue of AAOS Now.

References

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AAOS Now

The Rules for Opioid Prescribing in 2018

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