Over the last several years, the United States has seen a growing rate of opioid abuse and addiction especially in patients in need of chronic pain management, bringing the issue of proper pain management to the forefront of regulatory agendas. Health-policymakers, health professionals, and regulators are working endlessly to address the need for better pain therapy and guidance surrounding the use of opioids in treatment of chronic or recurrent pain management in order to reduce drug abuse and addiction while still providing the utmost care and attention to the needs of patients suffering with chronic pain. The availability of targeted regulatory guidance, while providing practitioners with a significant database of guidelines relating to the use of opioids in their clinical practice, also subjects providers to an increased risk of scrutiny when failing to comply with the standards that have been established by relevant agencies.
Of key relevance to pain management providers has been the development of guidelines by federal agencies for the proper use of opioid medication for chronic pain management and prescription of opioids to pain patients. The Centers of Disease Control (CDC) has set forth guidelines that provide practitioners with patient-centered clinical practices to be utilized when treating chronic pain patients particularly with opioids, including conducting thorough assessments, considering all possible treatments, closely monitoring risks, and safely discontinuing opioids. Also, the FDA has recently mandated that providers prescribing, dispensing, or distributing TIRF medicines enroll in the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program in order to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines.
At the state level, several regulatory agencies have similarly taken significant steps in enacting legislation attempted at battling the “opioid epidemic.” States have adopted regulations that would, for example, establish or strengthen their prescription drug monitoring programs, require review of state databases prior to prescription of opioids, and establish education curriculum and guidance on safe prescribing, which would include certain disclosure obligations upon a physician prior to initiating opioid or narcotics-based treatments.
The growing level of attention towards regulating prescribing practices of physicians treating patients with chronic pain as well as the constantly changing legal and regulatory environment surrounding this particular area, makes it imperative for providers to conduct an analysis of their respective practices’ current processes and endeavor to improve their policies and procedures relating to the management of pain. Providers should make it a priority to ensure that their practitioners remain in compliance with standards set forth by both federal and state regulatory authorities relating to the practice of opioid prescribing.
Frier Levitt routinely advises prescribers on their legal obligations and potential exposure to liability in light of federal and state laws and regulations relating to pain management and prescribing opioids for chronic pain. We have experience with the development and implementation of comprehensive pain management compliance plans that provide a useful summary to practitioners treating chronic and recurrent pain using methods that may include the prescribing of opioid drugs. Contact us today to speak to an attorney.
