Legal Considerations in the Era of an Epidemic

By Jeffrey Fitzgerald

The opioid epidemic is real, and it shows no signs of waning without significant changes in the medical field. According to a preliminary report issued by the US Centers for Disease Control and Prevention (CDC) in August 2018, more than 72,000 Americans died of drug overdoses in 2017 – an increase of almost seven percent year-over-year. The 2017 preliminary death count  represents twice the number of deaths from 2007. In fact, opioid overdose is now the leading cause of death in American adults under age 50.

These statistics make it a very scary time for physicians treating patents with chronic pain, especially when the US Drug Enforcement Agency (DEA) and US Department of Justice (DOJ) are repeatedly discussing it in the news and state attorneys general are actively cracking down on health insurance companies, prescription drug manufacturers, pharmacies and prescribers. Today, all parts of the health care industry are under immense scrutiny.

A Complex Regulatory Landscape

The latest legal requirements and guidelines cover a spectrum of opioid use. Some are legally binding, others are simply advisory. Guidance comes from a number of parties including state licensing boards, professional associations and state Medicaid agencies. The following represents some of the most broad new regulations but is by no means exhaustive.

  • The CDC has issued 12 comprehensive guidelines for opioid prescriptions. These include a preference for non-pharmacologic/non opioid treatment, careful risk analysis, development of a treatment plan, dosage limitations, ongoing patient evaluation/education and evidence-based treatment for opioid 
  • The U.S. Food and Drug Administration (FDA) has shared an ‘action plan’ with increased emphasis on regulatory oversight and policy development. Their 2016 plan includes draft guidance for development of generic abuse-deterrent opioids, expanded safety warning and labeling requirements and approval of additional opioid overdose naxalone products.
  • Established in 2014 in collaboration with a number of other medical associations, The American Medical Association created an opioid task force. Their recommendations include expanding use of prescription drug monitoring programs (PDMPs), enhancing provider education related to opioid prescribing and related issues, supporting access to treatment for opioid use disorders and reducing stigma, expanding access to naxalone through co-prescribing and encouraging safe disposal of opioids.
  • The American Academy of Pain Medicine advised precautionary prescribing that accounts for individual risk factors, patient counseling on secure storage and disposal, use of PDMPs, systematic patient follow-up, co-prescription of naloxone and use of team approaches to care.
  • The Federation of State Medical Boards published a model policy for use of opioids for chronic pain. It involves understanding pain, patient evaluation and risk stratification, documented treatment goals, informed consent and treatment agreements, initiation of opioid therapy on a trial basis, ongoing monitoring, drug testing, criteria for referral to a specialist and discontinuation practices.

The Road to Regulation 

Physicians are understandably frustrated and often confused by the relatively rapid changes in practice guidelines and recommendations for the treatment of chronic non-cancer pain and opioid prescribing. Some feel the guidelines are restricting their ability to make the best decisions for their individual patients. It may help to understand the data and rationale driving the guidelines. 

One issue is the scant evidence to support the prescribing practices that became commonplace after the establishment of the “Pain as the 5th Vital Sign” perspective in the mid- to late-1990s. A systematic review published in 2015 looked at the effectiveness and risks of long term opioid therapy for chronic pain. The review found that chronic opioid therapy resulted in side effects including nausea, constipation, somnolence, dizziness, vomiting and pruritus. The data suggests increased risk of myocardial infarction; fractures; markers of sexual dysfunction; arrhythmias; abuse; and, overdose. For some harms, higher doses were associated with increased risk.

In a 2015 abstract called The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain, the authors found higher rates of abuse and related outcomes than previously estimated. This study also suggested the higher the dose, the higher the risk. Additional clinical studies also showed that increased doses led to increases in overdose. Collectively, these efforts resulted in a move toward establishing dosing thresholds.

But dosing thresholds, like regulations, lack uniformity. Some states have guidelines, and some have rules that are, in effect, laws. Some of the guidelines come in the form of reimbursement limits for state funded programs like Medicaid. Many of the established thresholds are not absolute dose limits that can’t be crossed, but rather dose limits that once crossed, trigger some sort of precautionary behavior. Most of the guidelines indicate that they specifically pertain to chronic non-cancer pain, and are designated as directed toward primary care providers. It is important that prescribers know the specifics for their particular state. 

The data from pediatric populations also highlights the fact that health care providers may be inadvertently contributing to the opioid epidemic by providing overly generous prescriptions to patients who are not themselves abusing – but rather, are making these medications accessible to others. According to a MetLife Foundation study, more than one-third of U.S. teens abusing opioids got them from their own medicine cabinets. Half received them from friends – who in turn likely obtained them from their own family medicine cabinet. This has fueled the more recent wave of guidelines that limit quantities or durations of acute opioid prescriptions, and wider adoption of these kinds of rules and guidelines will surely come to pass. 

Lastly, there have been findings that about half of overdose deaths involved both opioids and benzodiazepines. This combination nearly quadruples the risk for overdose death and helps explain both the CDC’s precaution that this combination should be avoided and the FDA’s August 2016 black-box warning with the same precaution. 

Overcoming the Obstacles: Organizational Practices to Support Compliance and Minimize Risk

Health care facilities and organizations are now faced with the challenge of managing pain while curbing the prescription drug overdose epidemic. With the importance that institutions (and clinicians themselves) place on patient satisfaction, clinicians are truly between a rock and a hard place. After all, one of the hardest jobs a physician faces is convincing a patient that what they think they want is not what is best for them. But there are best practices that organizations can follow to help alleviate some of the tension when prescribing an opioid makes the most sense.

  • Clear protocols. The regulatory guidelines really are a protection for prescribers hoping to stay off the radar of regulatory bodies like the licensure board and the DEA. It is important to foster an environment where clinical guidelines are seen and used as practice safeguards – not practice constraints – and that they are not used punitively. Well-established, clearly communicated protocols can help minimize the burden on the prescriber while mitigating legal risk for the organization and the individual.
  • Consistent monitoring. Because there is a known correlation between the duration of patient visits and prescription rates, creating time-saving efficiencies can help reduce the number of opioid prescriptions. While every patient is different, the framework of expectations for monitoring patients on chronic opioid therapy is fairly predictable – or can be made that way. Monitoring consistency and accessibility allows clinicians to maximize their efficiency. 
  • Current technology. Investment in appropriate technology can help make the process of managing patients on chronic opioids more seamless and efficient and less time consuming. Electronic medical records systems can help automate physicians’ documentation of their initial and periodic patient evaluations, treatment plans and risk mitigation strategies. Users can receive a cue to include clinical rationale; verify depression, anxiety and addiction screening; document patient agreement with periodic updating; schedule PDMP checks; track results of urine drug testing; schedule follow up reminders; and, prompt the user to prescribe and document guidance for noxalone to be taken with the opioid.
  • Patient education. An established framework to deliver and document information lowers the legal risk of prescribing opioids. Patient education can be very time consuming and is often shortchanged in a fast-paced environment. Systemwide efforts to create an effective, comprehensive education program for patients – that ideally can be partially provided by staff –is helpful. Patients should systematically be educated about expectations, risks, benefits, alternatives, safe use, storage and disposal. 
  • Regulatory awareness.  Managing patients on chronic opioid therapy is constantly influenced by new research and data that lead to new standards and guidelines. Prepare your clinicians for changes and updates. Organizations should have an established committee or individual tasked with staying apprised of new data, information, guidelines, and standards facilitating dispersion of new information and continuing education of prescribers.

If the only tool available to providers (or the only tool affordable for patients) are opioids, that is what will be used.  Health care facilities and organizations can also ensure that clinicians have access to other practical ways to address chronic pain, and paths forward for patients who are identified as having a substance use disorder.

Finally, while regulations can frustrate prescribers, there is new evidence that following guidelines leads to meaningful outcomes. A review of the impact of guidelines in Washington State guidelines showed that they appear to have resulted in a significant decrease in the prescribing of opioids – and in opioid-related deaths.  Changing rules without well-articulated benefits can seem meaningless, but communicating the legal, medical and organizational benefits may help ease the sting of compliance. After all, clinicians want the best outcome for their patients; when they see good rationale behind regulations, most are willing participants.

Attorney Jeffrey Fitzgerald is a shareholder in the health care practice at Am Law firm Polsinelli.

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