FDA Publishes Final Opioids Blueprint
With input from AMTA and other stakeholders in the fight for safer pain relief options, the final draft of the U.S. Food and Drug Administration’s (FDA’s) blueprint includes a recommendation of complementary therapies as defined by NIH/NCCIH.
The FDA has determined that a REMS (Risk Evaluation and Mitigation Strategy) is necessary for all opioids intended for outpatient use to ensure that the benefits of these drugs continue to outweigh the risks. The Opioids Analgesic REMS, approved on September 18, 2018, is one strategy among multiple national and state efforts to reduce the risk of abuse, misuse, addiction, overdose, and deaths due to prescription opioids.
The REMS program requires that health care providers receive training on pain management, and should be knowledgeable about the range of non-pharmacologic treatment options available. These options (found to be effective alone or as part of a comprehensive pain management plan), include: complementary therapies, psychological, physical rehabilitative, surgical approaches and approved/cleared medical devices for pain.
AMTA has been in conversations with legislators, insurance companies, and collaborators in the healthcare profession to discuss the current science behind massage therapy and its role in an integrative approach to care. It has become widely accepted in major hospitals and in daily medical practice. A wealth of research has shown the impact of massage therapy as a complement to other non-pharmacological and pharmacological approaches to pain management and relief.