August 05, 2021
ASA Provides Feedback to FDA on Applications of Morphine Milligram Equivalents
On August 3, the American Society of Anesthesiologists (ASA) submitted comments to the Food and Drug Administration (FDA) on applications of Morphine Milligram Equivalents (MMEs), communicating that it is important to fully understand the role that various analgesic modalities play in patient care. The formal comments were provided in conjunction with the FDA public workshop titled “Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.”
ASA highlighted the importance of prioritizing individualized patient care and safety during the treatment of patients with pain; it is essential that pain care is properly tailored to the individual patient and not limited by policies that set strength or dosage limits. Given that MMEs are increasingly being used to indicate abuse and/or overdose potential, ASA believes it is necessary to refine and improve the scientific basis of MME applications and recommended new areas for research.
To ensure MMEs are not used as the sole marker for limiting or tapering drug dosing in patients who have clinically justifiable reasons for using higher opioid doses, ASA recommended a comprehensive, individualized approach around opioid prescribing, as well as standardization in MME calculators. ASA noted that MMEs are a clinical tool to guide opioid therapy in acute and chronic pain patients with the goal of reducing or eliminating the practice of overprescribing. When combined with comprehensive individual patient assessments and risks vs. benefits for each patient, MMEs can assist clinicians to decide which patients need increased surveillance for opioid-related adverse outcomes.
ASA suggested that new research focus on which medical conditions opioids are most effective in treating patients. Currently, many studies do not include chronic pain patients and studies that evaluate MMEs should examine the impact on patient care and physician practice, rather than just informing prescribing thresholds or regulations, or to discipline or sanction physicians.
ASA looks forward to continuing to work with the FDA on this important issue impacting patient care.
Read the full letter here.