April 03, 2018
ASA Submits Formal Communication to FDA Opioid Policy Steering Committee
On March 16, 2018 ASA submitted a formal communication to the U.S. Food and Drug Administration’s (FDA) Opioid Policy Steering Committee in response to a request for comments regarding prescribing interventions and strategies for implementation.
In the letter, ASA recommends that any policy or recommendation regarding opioid prescriptions be based on evidence-based guidelines and urges the FDA support the efforts of national professional and medical societies, such as ASA, to develop these guidelines. ASA welcomes the opportunity to work with the agency and other stakeholders to develop educational materials and guidelines on opioid prescribing, non-opioid alternatives, pain management and substance abuse prevention and treatment. A program that supports collaboration and consensus among the medical specialties and societies would increase consistency in education, as well as medical and clinical practice.
In its letter, ASA also addressed a national Prescription Drug Monitoring Program (PDMP), stating that a well-designed and implemented national PDMP could address many of the shortcoming of inconsistent state PDMPs and eventually create a uniform resource that reduces gaps in care, enables prescribers to effectively monitor patients and help prevent substance use and abuse.
The FDA specifically requested feedback from stakeholders on safe storage and disposal. ASA strongly supports the use of culturally sensitive and linguistically appropriate patient and caregiver education on safe storage and disposal of opioids and the risks of misuse, abuse and addiction associated with opioid analgesics. Effective patient education can be a powerful prevention tool and is especially important for extended or ongoing prescriptions. ASA encourages sound FDA policies around unit of use packaging, patient storage and handling of opioids, and requirements that sponsors create mechanisms by which patient could return unused pills.
ASA commends FDA for its leadership in addressing the opioid epidemic in communities across the nation. ASA will continue to monitor Congressional and Administration efforts to combat opioid abuse and supports private-public partnerships that seek to address the opioid abuse epidemic.