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    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

    Brandon K. Essig
    Brandon K. Essig is a partner at Lightfoot, Franklin & White LLC and is a member of the firm’s White Collar Criminal Defense and ...
    Jack Sharman
    Jack Sharman leads the White Collar Criminal Defense and Corporate Investigations practice at Lightfoot, Franklin and White LLC. He is ...

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