FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids

The American Pharmacists Association (APhA) appreciates the opportunity to provide input on the Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids (hereinafter "Draft Blueprint"). APhA, founded in 1852 as the American Pharmaceutical Association, represents 64,000 pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in improving medication use and advancing patient care. APhA members provide care in all practice settings, including community pharmacies, hospitals, long-term care facilities, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and the uniformed services. APhA has served as a strong advocate for legislative, regulatory, and private sector efforts to address our Nation's substance use disorder epidemic, however, it is important to balance those efforts with the legitimate needs of the millions of patients living with pain. APhA is committed to working with the Food & Drug Administration (FDA), and other federal agencies, Congress, state agencies and officials, health professionals and stakeholders to identify ways to maximize the role of the pharmacists in curbing opioid misuse and providing treatment options. Education is an important component of a multipronged approach in addressing use and misuse of opioid medications. APhA is generally supportive of the Draft Blueprint and its broad focus on pain management and substance use disorder treatment. We believe solutions to this epidemic will require the unified and coordinated efforts of many diverse stakeholders, including health care professionals, patients and caregivers, community-based organizations, and federal, state, and local governments. Pharmacists are often an underutilized health care resource despite their medication expertise and accessibility. Pharmacists today graduate with a Doctorate of Pharmacy (PharmD) degree, which requires six to eight years to complete, and have more medication-related training than any other health care professional. While many view pharmacists strictly in a dispensing role with regard to opioids, APhA notes pharmacists may also prescribe opioids in certain states and have a role in substance misuse treatment as well. APhA encourages FDA to include and support in its policies the role of the pharmacist in treating patients in pain. APhA offers the following recommendations to further this goal and enhance the impact of a final blueprint. See, attached comments. Thank you for the opportunity to provide comments on the Draft Blueprint. APhA is committed to working collaboratively to reduce substance use disorders and improve the safe use of opioids. We appreciate FDA's work on this important issue and encourage the Agency to use APhA as resource.