Risk management lessons from an opioid trial

The use of opioid medications to treat pain is at a watershed moment in the United States.

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Over the past three decades, opioids have become a standard and effective component of pain management for many practitioners. They are effectively and safely prescribed in every conceivable clinical environment-primary care facilities, hospitals, pain management clinics and even dentist offices. They are prescribed to treat chronic and intractable pain, such as advanced stage cancer pain or severe burns, but they are also prescribed to treat soft tissue injuries and even prophylactically for post-operative situations where the practitioner knows that the recovery typically, but not always, involves pain. 

However, the medical community in the United States, and indeed society as a whole, is also now facing the reality that the side effects of opioid medications can be devastating. When misused and abused, opioids can have the same ill effects on society as any other illicit drug-addiction, crime, overdose, massive public health costs and death. In other words, society is now grappling with the dual realities of opioid medication: 1 – its use as an effective pain management tool is proven and here to stay; and 2 – its dangers and risks are also proven and must be contained. 

Medical practitioners who prescribe opioid medications as part of their treatment of patients in pain are caught in the middle of this struggle. Unfortunately for them, one of the primary ways society has chosen to address the dangers and risks of opioids is through legal action-both civil and criminal-against the healthcare practitioners who prescribe them to their patients. Therefore, physicians and other practitioners who prescribe controlled substances are participating in what is perhaps the most high-risk practice of medicine today. 

The Regulatory Framework

As a threshold matter, it is important to point out that the distribution of opioid medications is a violation of federal law. The only exceptions are for manufacturers/distributers and physicians, nurses and other practitioners who are licensed by the Drug Enforcement Administration (DEA) and their state medical boards to prescribe opioids.

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Opioid prescriptions are lawful when they are valid in form (i.e. signed, dated and issued properly) and they are provided to a patient for “a legitimate medical purpose” and “in the usual course of professional practice.” These last two terms are nebulous and poorly defined, but understanding what they mean is critical for any licensed prescriber, because the failure to adhere to the concepts of “legitimate medical purpose” and “usual course” can result in devastating legal consequences, including substantial monetary penalties or even jail time.

Next: Managing key risks

The DEA has specifically refused to define the concepts of “legitimate medical purpose” and “usual course.” The same is true for guidance published by entities such as the Centers for Disease Control and the Federation of State Medical Boards. As a result, it is difficult for a prescribing practitioner consulting such regulations and guidance to know what types of prescribing activity and treatment can result in civil or even criminal liability. 

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In addition, most of the regulations promulgated by the DEA and state boards are designed to be administrative in nature and address technical requirements for an opioid prescription. As with many other such requirements, practitioners rightfully view them as guidelines to inform their day-to-day practice, but not absolute rules to be adhered to strictly. 

However, courts often allow the DEA, prosecutors and other regulators to use technical violations of administrative regulations, and even imperfect electronic medical records, to serve as the basis of civil and criminal liability for practitioners. For this reason, the best compliance policy for a practitioner prescribing opioid pain medications is to make every effort to strictly adhere to all federal, state and discipline-specific rules that govern the prescribing of opioid medications.

Similarly, practitioners should endeavor to make their records for opioid patients as precise as possible, documenting in as much detail as possible the basis for each and every opioid prescription they write. 

Managing Key Risks

Again, the greatest risk posed by the various regulations and guidance governing opioid prescriptions is that they do little to define the risk at all, because they provide no bright line rules. For example, they place no limit on the number of pills a practitioner can prescribe a given patient at a given time, nor do they limit the amount of time for which a patient can be given a particular prescription. In fact, the DEA’s manual on the subject of opioid prescriptions describes the task of providing prescriber’s definitive guidance as “impossible.” 

How then should a practitioner manage the risks associated with prescribing opioids? How can a practitioner be sure that his or her prescribing practices will not be perceived by regulators as illegal?

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The answers to these questions are neither easy nor definitive, but the criminal prosecutions and civil lawsuits brought against practitioners for their prescribing practices do provide some guidance. Below is a list of the prescribing activity or factors that most often lead to prescriber liability. For each factor, I provide a short description of the risk presented and some advice of ways to manage those risks.

Next: Common factors of prescriber liability

Common Factors of Prescriber Liability  

·      Prescription volume – The DEA perceives large volumes of prescriptions as a primary indicator that a prescriber is dispensing opioids without medical necessity, or at least beyond what is medically required. Practitioners should manage this risk by limiting the dosage and pill quantity of each prescription to the lowest amount possible to address the patient’s condition. Although the DEA authorizes longer prescription intervals, a practitioner who limits dosage and pill quantity to a 30-day supply is less likely to draw scrutiny.

·      Physical examinations – The regulations and medical literature state that a physical examination of the patient should be done prior to the dispensing of opioid medication. However, the literature does not define what such an examination should consist of, how thorough it should be nor how often it should be done. Practitioners can manage this risk by insisting on a multi-step physical examination at the initial visit of an opioid patient and should insist that the examination be repeated at various intervals during the course of treatment. The most important practice, however, is to make sure that all physical examinations are recorded in the patient’s medical record in exhaustive detail. 

·      Screening for Diversion – Prescription drug “diversion” is any distribution of a prescription opioid that takes place other than through a lawful prescription issued during the course of a practitioner-patient relationship. The most common diversion screening tools are prescription monitoring program (PMP) databases and patient urine drug screens (UDS). Many states require practitioners to consult PMP as part of their opioid prescribing practice, and the DEA perceives the failure to do so as a sign of illegal prescribing. The same is true for patient UDS. Although not required, the most conservative approach is for a practitioner to run a PMP report on each opioid patient for each visit. Similarly, the practitioner should obtain a UDS at a patient’s first visit and then at reasonable intervals during the course of treatment. Again, the most critical factor in utilizing these tools is to make sure that their results are thoroughly documented in the patient’s file each and every time they are performed.

·      Addressing Signs of Diversion – The patient factors that indicate diversion are myriad and too in-depth to address here. However, the point for practitioners is that they must address with their patients any sign of diversion that they observe in their patients.Whether the indicator is a PMP report that evidences doctor shopping, a UDS that is negative for the prescribed opioid (or positive for an illicit drug) or a patient’s mere suspicious behavior, a practitioner must do two things: First, address the issue with the patient, and second, document that the issue was addressed. Practitioners should also have a clear and consistent process for escalating signs of diversion and be prepared to terminate treatment of a patient who demonstrates obvious signs of diversion or a pattern of less obvious but problematic behaviors. 

Conclusion

Opioid medications are an important but dangerous treatment option for medical practitioners who treat patients in pain. Such practitioners are subject to an increasingly aggressive enforcement environment with potentially dire consequences. The risks are compounded by the fact that the controlling federal and state regulations do not clearly define what is unlawful.

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Therefore, the best practice is to conduct opioid prescribing activity conservatively, document all treatment thoroughly and continuously self-educate to avoid the ever-evolving enforcement trends that lead to criminal and civil liability.