NONPRESCRIPTION STATUS OF RESCUE AND REVERSAL MEDICATIONS

To support the nonprescription status of medications intended for evidence-based rescue use or reversal of potentially fatal events, in delivery systems appropriate for administration by lay persons; further,

To promote practices and policies that ensure affordable and equitable access to rescue and reversal medications; further,

To support and foster standardized education and training on the role of rescue and reversal medications and their proper storage, proper administration, safe use, and appropriate follow-up care.

Rationale

As part of public health initiatives, certain medications used for rescue and reversal have moved from prescription to nonprescription status. The opioid reversal agent naloxone is the most recent approval, with naloxone nasal spray approved in March of 2023 to help combat the opioid epidemic in the United States. Rescue and reversal medications such as naloxone and epinephrine require an additional level of action from patients and caregivers because they are used to initially treat life-threatening conditions, in contrast to other nonprescription agents. These patients will often require an additional level of care to monitor for safety and potential adverse events in the event of an opioid overdose or anaphylactic reaction. Therefore, it is important that rescue and reversal medications considered for nonprescription status have evidence that supports their use.

As barriers to access are removed, patient demand for these life-saving agents will almost certainly skyrocket, aligning with the intended purpose of such initiatives. To forestall the possibility of counterproductive market shortages, efforts to support and enhance manufacturing processes should be bolstered, with the U.S. Food and Drug Administration (FDA) likely being the most effective entity for these interventions.

Similarly, pricing for rescue and reversal medications should be minimized as much as possible, including efforts to eliminate patient cost entirely. Nonprescription status often results in loss of third-party payer coverage, although there are notable exceptions to this trend (e.g., aspirin, vitamin D). The Affordable Care Act established a precedent for requiring insurer coverage of preventive drugs, and similar provisions could be made for rescue and reversal agents. Government efforts could include other related strategies, such as developing manufacturing cost subsidies, supporting tax-exempt status designations, and augmenting the wholesale distribution process and related infrastructure.

Finally, because the use of rescue and reversal medications often occurs in an emergency situation, proper storage and easy-to-understand instructions on how to use these drugs and how to escalate if a person does not respond should be encouraged by all manufacturers. These instructions should be designed, tested, and validated in a similar design to the Drug Fact Label created by the FDA, which is designed to assess whether all the components of the product with which a user would interact could be used safely and effectively as intended.