FDA to Hold Workshop on Mandatory Prescriber Education for Opioids
The U.S. Food and Drug Administration (FDA) announced on September 8 that it would be conducting a two-day public workshop, "Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis," to allow stakeholders to provide input on aspects of the current opioid crisis that could be mitigated measurably by requiring mandatory prescriber education as part of a REMS. The public workshop will be held on October 13 and 14.
At the workshop, FDA will explore the value of a single source for education on the appropriate use of opioids, risks of opioid abuse and misuse, and treatment of opioid use disorder to address multiple needs and reduce the burden on prescribers.
FDA noted that the number of opioid analgesic prescriptions dispensed per capita in the U.S. has steadily declined from a peak of 81 prescriptions per 100 residents in 2012 to 47 prescriptions per 100 residents in 2020. However, as of 2020, prescription opioids were involved in more than 16,000 fatal overdoses per year, higher than the number seen at the peak of opioid analgesic dispensing in 2012.
Impact on General Dentistry: AGD appreciates FDA's efforts to address the opioid crisis and believes it is incumbent upon the profession of dentistry and all dental associations to support and further the education of dentists, dental staff members, and the public to recognize the indicators of propensity and likelihood of opioid addiction, and to understand, consider, and utilize alternative pain management strategies. However, AGD also believes that assessments of the causation of opioid addiction based solely on the number of prescriptions written result in overestimating the dental profession's effect on opioid addiction. AGD plans to engage with the FDA as they explore the topic of prescriber education for opioids to ensure that dentists are not overly burdened as they deliver care to their patients.
At the workshop, FDA will explore the value of a single source for education on the appropriate use of opioids, risks of opioid abuse and misuse, and treatment of opioid use disorder to address multiple needs and reduce the burden on prescribers.
FDA noted that the number of opioid analgesic prescriptions dispensed per capita in the U.S. has steadily declined from a peak of 81 prescriptions per 100 residents in 2012 to 47 prescriptions per 100 residents in 2020. However, as of 2020, prescription opioids were involved in more than 16,000 fatal overdoses per year, higher than the number seen at the peak of opioid analgesic dispensing in 2012.
Impact on General Dentistry: AGD appreciates FDA's efforts to address the opioid crisis and believes it is incumbent upon the profession of dentistry and all dental associations to support and further the education of dentists, dental staff members, and the public to recognize the indicators of propensity and likelihood of opioid addiction, and to understand, consider, and utilize alternative pain management strategies. However, AGD also believes that assessments of the causation of opioid addiction based solely on the number of prescriptions written result in overestimating the dental profession's effect on opioid addiction. AGD plans to engage with the FDA as they explore the topic of prescriber education for opioids to ensure that dentists are not overly burdened as they deliver care to their patients.