The FDA has just issued new opioid standards and a stark warning about a potentially addictive herbal pain relief drug known as Kratom. Both will affect the practice of treating musculoskeletal pain. They are:
1. New Standards for Approving New Opioids
On June 20, FDA issued a draft of guidance for opioid manufacturers on how it will assess new applications for approval of opioid analgesic drugs.
Titled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework–Guidance for Industry,” it describes how the agency plans to change the ways in which it will apply the existing benefit-risk assessment framework for proposed new opioid treatments.
Most of the guidance is aimed only at new standards for manufacturers when they submit applications for new opioid formulations. However, one small detail, buried toward the bottom of the document, goes to how opioids are handled by caregivers.
Currently, FDA already requires that drug manufacturers write Risk Evaluation and Management Strategies (REMs) for classes of opioids (with a few exceptions), and that they provide unrestricted grants to providers of continuing medical education (CME) on how to abide by these REMs.
Under the proposal, FDA says it might require manufacturers to add product-specific REMs or parts of REMs and additional CME on these product-specific REMs.
“For example, an opioid analgesic drug that must be restricted to use in a monitored inpatient setting may need additional risk mitigation strategies to ensure the drug product does not leave the hospital,” the proposal says. “In short, the applicant for an opioid analgesic drug should include any proposed REMS that the applicant considers necessary to ensure a drug’s benefits outweigh its risks.”
The implication for physicians, nurses, and pharmacists is that FDA is aiming to require stricter, product-specific handling procedures for individual new opioid formulations and will demand additional CME for them. Exactly what such restrictions and training might entail seems to be something FDA wants manufacturers to decide on a product-by-product basis.
To gather information related to this proposals, FDA has scheduled a public hearing on September 17, 2019, “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction” at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503 B/C), Silver Spring, MD 20993-0002.
2. Warning to Public on Kratom Implies Stronger Vigilance by Pain Med Prescribers
A nationwide, adverse phenomenon the FDA has cited in its previously announced plans to write situation-specific guidance for prescribing opioids is that some patients who have been denied legal opioid …….