SAFE MEDICATION SOURCING, STORAGE, PREPARATION, AND ADMINISTRATION IN ALL SITES OF CARE

To advocate that all sites of care be required to meet the same regulatory standards for medication sourcing, storage, preparation, and administration to ensure safety and quality.

Rationale

Payers have implemented strategies that fragment providers’ comprehensive care management of the patient. These strategies include but are not limited to site-of-care (SOC) optimization, which shifts care away from hospitals, and payer-directed drug distribution models (ASHP policy 2309, Payer-Directed Drug Distribution Models), which undermine hospitals’ patient safety protections and jeopardize patient care. The payers’ overarching goal is cost containment, while maintaining access to the prescribed therapy. Cost containment efforts have shifted beyond the traditional pharmacy point-of-sale management intended for self-administered medications under the pharmacy benefit, such as formulary tiering, prior authorization requirements, drug exclusions, and step therapy implementation. Payer strategies targeting provider-administered medications under the medical benefit present risks to patient care and safety. Patients are increasingly being required to receive care at lower-cost nonhospital SOCs, rather than at traditional venues, such as hospital outpatient infusion centers. Alternative or nonhospital SOCs include nonhospital-affiliated outpatient infusion centers, physicians’ offices, ambulatory infusion centers, or patients’ homes. Payer-imposed SOC restrictions and policies jeopardize the continuity of care for the patient by introducing incongruent providers and systems (ASHP policy 2031, Continuity of Care in Insurance Payer Networks). These same policies also create additional logistical challenges for the patient to navigate and can impede timely access to care for patients who require additional special assistance or services, such as access to emergency staff in the event of an adverse reaction. Further, the level of infrastructure required to adequately address regulatory and accreditation requirements focused on quality and safety (e.g., United States Pharmacopeia General Chapters <797> and <800>, Drug Supply Chain Security Act, state board of pharmacy regulations, and the standards of accreditors such as The Joint Commission and Det Norske Veritas Healthcare) varies across SOCs, with hospitals carrying the greatest administrative burden and costs. As a result, health systems should collaborate with pharmacy leadership when exploring ways to optimize medication access and appropriate utilization in nonhospital SOCs.