3 Ways to Help Mitigate Criminal Risk when Prescribing Opioids

Opioids play an important role for patients with both acute and chronic pain.  But the epidemic of opioid overdoses continues to worsen, despite restrictive measures by the Drug Enforcement Administration, and physicians are being held partly responsible.  So, for a physician who prescribes opioids for pain management, prescribing safely is the goal.  In this blog, we'll lay out 3 ways proper documentation can help to mitigate criminal risk when prescribing opioids. 


Introduction

According to the CDC, more than 115 people die each day in the United States after an opioid overdose. With increased awareness of this deadly epidemic comes additional scrutiny on doctors prescribing opioids to their patients.

 https://www.cdc.gov/drugoverdose/images/data/OpioidDeathsByTypeUS.PNG

https://www.cdc.gov/drugoverdose/images/data/OpioidDeathsByTypeUS.PNG

While some of this intervention is needed and plays a positive role in removing “pill mill” practices and concurrently decreasing the overdose rate, there are a large number of well-meaning physicians who are doing a lot of things right but are missing the proper documentation in their charts. In a July 2017 article, CNN described some of the ways prescribers are mitigating risk.

Doctors have been coming up with ways to avoid being put under the microscope themselves: by documenting their appointments meticulously, by following guidelines and by checking statewide prescription drug databases before taking out their pens.
— https://www.cnn.com/2017/07/31/health/opioid-doctors-responsible-overdose/index.html

While matters of civil and criminal liability are not always simple and straightforward, there are some steps a physician can take when documenting, to help mitigate the likelihood of being prosecuted for a criminal act.

1.  Document MME Tapering to Help Mitigate Criminal Risk When Prescribing Opioids

A guideline may sound like a suggestion, but when an adverse event occurs (and they will) they will be used to help substantiate the medical standard of care and legitimate medical purpose. The CDC says that prescribers should “avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.” 

We work with physicians every day that have patients on higher than 89 MME doses and live in fear of what might happen in the event of an investigation. The simple reality is that for too long, doctors were taught that there was no ceiling to the dose of opioid that could be prescribed. Now, the pendulum has swung the other way and doctors have to cut doses rapidly or put patients at risk and face criminal and civil repercussions. 

In Between a Rock and a Hard Place: Can Physicians Prescribe Opioids to Treat Pain Adequately While Avoiding Legal Sanction? Kelly K. DIneen and James M. DuBois articulate this history.

The inadequate treatment of pain was the subject of significant clinical and policy efforts in the 1990s; among those efforts were the increased use of opioids for acute pain and the use of long-term opioid therapy for patients with chronic pain.
— https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494184/

When it comes to criminal charges, criminal intent must be proven. A good rule of thumb is that if a prosecutor, judge or jury must guess at what your motives were, they will likely get it wrong. If you have patients on doses higher than 89 MME and you are attempting to taper to a safer dose, document it. Keep it simple, something like “tapering opioid below 90 MME” will suffice, just make sure that you document your progress each time the dose is reduced.

2.  Document Benzodiazepine Tapering to Help Mitigate Criminal Risk when Prescribing Opioids

In August of 2016, the FDA issued its strongest warning against the concomitant use of opioids and benzodiazepines.

A U.S. Food and Drug Administration (FDA) review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths… Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate.
— HTTPS://WWW.FDA.GOV/DRUGS/DRUGSAFETY/UCM518473.HTM

According to the National Institute of Drug Abuse, nearly one third of opioid-related overdose deaths involved benzodiazepines.

More than 30 percent of overdoses involving opioids also involve benzodiazepines…
— HTTPS://WWW.DRUGABUSE.GOV/DRUGS-ABUSE/OPIOIDS/BENZODIAZEPINES-OPIOIDS

This presents a significant danger for many physicians as currently many chronic opioid therapy patients are also being prescribed benzodiazepines.

An overview of recent case law shows us that benzodiazepines are often being treated as contraindicated with opioids. As a result, many doctors are requiring their patient to choose either opioid therapy or benzodiazepines, not both.

Unfortunately, the process of tapering a patient off of benzodiazepines is lengthy and can result in more severe side effects.

If you are currently tapering patients off of a benzodiazepine, simple documentation may help provide evidence of your intent. Similar to your documentation of tapering an opioid, “tapering and discontinuing benzodiazepine” is sufficient. As before, document your progress with each reduction.

3.  Document Benefits and Risks to Help Mitigate Criminal Risk when Prescribing Opioids

After you have determined that an opioid is indicated and have done your due diligence to actively verify the patient’s level of suitability for opioids, your attention should shift to weighing both the risks and benefits of opioids each time you decide to continue therapy. In most of the disease states primary care physicians treat, benefit is measurable and easily determined and documented. Pain however, is not as straightforward. If a patient’s pain level is severe during an initial exam, there is a very good chance that it will be severe when the patient returns for a refill (I will discuss the psychology of this phenomenon in another blog). This may not seem like an issue to a physician who is thinking about whether opioids are “still indicated” or not, but remember, it’s not indication the doctor should be concerned with. At this point in the treatment, prescribers should be determining whether or not the therapy is benefitting the patient.

If a patient has repeated severe pain scores, and the opioid is refilled, there is a likelihood that others may deem the therapy “not beneficial” and, therefore, not being prescribed for a legitimate medical purpose. When treating chronic pain patients with opioids, it is important to assess which activities of daily living are hindered by the pain and set treatment goals based on those ADL’s.

Treatment goals such as, “Allow Mr. Phillips to perform moderate exercise 3 days a week for 30 minutes at a time” should be measured against each time the prescription is refilled. If the risk to benefit ratio begins to show risk higher than benefit, doctors should consider tapering and discontinuing the opioid.


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John Bowman is the CEO of Sure Med Compliance, a medical organization with a mission to end the opioid epidemic through the reeducation of healthcare providers and standardization of internal prescribing protocols. Their proprietary software, the Care Continuity Program, has revolutionized the pain management industry by allowing for patients to be remotely screened for risk factors prior to prescribing and providing a legal report that helps mitigate a physician’s civil and criminal risk. John Bowman is not a licensed attorney and does not practice law. This blog should not be used as a substitute for professional legal advice.

For more information on Sure Med Compliance and product features such accredited CME courses, software licensing, EMR integration and chart auditing, email us at inquiry@suremedcompliance.comFollow us on Twitter LinkedIn Facebook.