The following quote is attributed to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research
“The opioid crisis continues to evolve and there are still relevant concerns with overprescribing, especially among vulnerable populations.
Although many public and personal entities have independently implemented their own education schemes and other interventions to encourage safe and effective prescribing practices for opioid analgesics, there’s no consistent education that each one prescribers are required to require about the safe use of opioid medicines. Therefore, these programs likely differ with reference to content, focus and duration.
The FDA recognizes that there could also be new opportunities to enhance prescriber education through the Opioid Analgesic Risk Evaluation and Mitigation Strategy and make sure that the education is being delivered during a way that minimizes the burden on the health care delivery system.
The upcoming public workshop is that the beginning of a crucial series of discussions with a broad group of stakeholders because the agency explores the worth of mandatory opioid prescriber education on the acceptable use of opioids, the risks of opioid abuse and misuse and therefore the treatment of opioid use disorder to deal with multiple needs and reduce the burden on prescribers.
Opioid addiction and abuse remain a significant public health crisis and addressing it’s among the FDA’s highest priorities. we’ll still explore new approaches that allow us to confront the crisis head-on.”
The FDA is reconsidering the necessity for mandatory opioid prescriber education through the Opioid Analgesic (OA) Risk Evaluation and Mitigation Strategy (REMS).
The agency announced a two-day public workshop “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) during a n Evolving Opioid Crisis” to offer stakeholders a chance to supply input on aspects of the present opioid crisis that would be mitigated in a measurable way by requiring mandatory prescriber education as a part of a REMS.
Among the various topics which will be discussed, the FDA will explore the worth of one source for education on the acceptable use of opioids, risks of opioid abuse and misuse and treatment of opioid use disorder to deal with multiple needs and reduce the burden on prescribers.
The number of dispensed prescriptions for opioid analgesics has been steadily declining from a peak of 84 prescriptions per 100 residents in 2012 to 43 prescriptions per 100 residents in 2020.
A wide sort of interventions intended to scale back inappropriate or unnecessary prescribing, including prescriber education initiatives.
Despite this decrease in dispensing, opioid overdoses and opioid-involved deaths are above ever, with opioids often seen together with other substances like cocaine, methamphetamine and benzodiazepines.
This rise has been driven primarily by a surge in overdose deaths initially involving heroin then illicitly manufactured fentanyl and fentanyl analogues. Although these overdose deaths largely involve illicit substances, many users of illicit opioids are initially exposed to opioids through nonmedical use of prescription opioids. Moreover, as of 2020, prescription opioids were involved in additional than 16,000 fatal overdoses per annum , above the amount seen at the height of opioid analgesic dispensing in 2012.
The workshop is being convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between the FDA and Duke-Margolis. A second public workshop is being planned to solicit input on additional issues related to a move to mandatory prescriber education under a REMS, like operational and technical issues associated with such a system and what should be included in potential mandatory prescriber education.
Source link: https://www.fda.gov/