What USP <797> and New Hampshire Senate Bill 581 Means for Infusion Providers
On November 17, 2017, infusion providers across the state of New Hampshire received a letter from the state’s board of pharmacy indicating that any care setting preparing intravenous (IV) and injectable medications in its office would have to comply with the same requirements, known as the United States Pharmacopeia (USP) Chapter <797>, as pharmacies and other large health care facilities. Offices that continued to prepare IV medications would have to do so in ISO 5 conditions, which would require the purchase of expensive equipment, such as sterile glove boxes, and comply with complex gowning techniques pharmacists use in sterile pharmacy clean rooms.
According to the letter, any provider found out of compliance with USP <797> after January 1, 2018, would have to cease preparing IV medications or be subject to significant fines.
With only 45 days to comply, many office-based infusion providers were worried, not only for the future of their practice, but also for the inevitable interruption in their patients’ care.
The New Hampshire Board of Pharmacy’s intention to extend compounding regulations from pharmacies to physician offices allegedly was due to concerns that there could be a risk to patient health and safety, if the medications were not compounded in compliance with their rules.
Currently, infusion providers are preparing and administering medications in accordance with the US Food and Drug Administration’s (FDA’s) approved product labeling. The FDA is recognized as having federal authority not only over medications’ preparation and administration, but also their approval. At this time, nonpharmacy care settings, such as physician offices, are required to prepare and administer injectable medications in accordance with FDA-approved product labeling. As such, medications are prepared as a continuous, uninterrupted process, and administered immediately following preparation.
New Hampshire’s statutory definition of compounding was interpreted in a way that includes the reconstitution of biologics and other IV/injectable medications, so the state’s board of pharmacy was executing their statutory mandate to enforce standards relating to the compounding of sterile products to ensure that patient health and safety was not compromised.
Impact on Quality and Cost of Care
The more imminent threat to patient safety is not related to the preparation of the medications, but the delay in their administration if offices are no longer able to treat patients. With only 45 days remaining to comply with USP <797>, many infusion office providers proactively began to refer patients in their care to larger health care facilities. Not only was this an administrative encumbrance, but many larger facilities were unable to provide the same appointment availability to patients whose health and well-being depended on consistent and timely treatments.
If a critical health care delivery channel, such as in-office infusion facilities, are deterred or precluded from providing IV treatments, patients who seek treatment at hospital-based sites of care could incur twice the per capita costs per treatment.1
New Hampshire Senate Bill 581
Soon after receiving the letter, concerned infusion providers contacted the National Infusion Center Association (NICA), a 501(c)(3) nonprofit advocacy organization established to help patients who rely on access to in-office infusion therapy, to articulate their concerns to the New Hampshire Board of Pharmacy. Convinced that applying USP <797> to nonpharmacy care settings would restrict patient access to care, NICA joined the fight to find an alternative solution.
Learn more about NICA’s advocacy efforts
The evident threat to patients’ access to quality care catalyzed a meeting between the New Hampshire Board of Pharmacy and concerned stakeholders, including health care providers, patients, nonprofits, and coalition members. Although this resulted in the delay of the implementation of USP <797>, the state’s board of pharmacy was adamant about the eventual enforcement of USP <797> standards across all IV medication delivery channels.
The New Hampshire Senate Bill 581 (NH SB 581) was introduced in the state’s Senate in January 2018. It amends the definition of compounding to preclude the preparation of a single dose of a nonhazardous, commercially available drug or licensed biologic for administration to an individual patient prepared in accordance with the manufacturer’s approved labeling.
NH SB 581 passed in the New Hampshire Senate, and passed in the House of Representatives in May with an amendment stipulating that administration must occur within two hours of preparation. On June 12, the bill was signed into law by state governor Chris Sununu.
New Hampshire’s intention to develop and enforce standards that promote patient safety is both commendable and necessary. The implementation of rigorous medication preparation standards is essential in preventing contamination, mitigating error, and ensuring a consistent formula. It is important that policymakers and health care providers continue to work together to understand regulation standards, as well as the evolving health care delivery channels that protect patients’ access to safe, affordable care.
National Infusion Center Association (NICA) is a nonprofit organization founded to improve patient access to in-office infusion. Since its inception in 2010, NICA has worked to support infusion patients and their office-based care settings through advocacy, education and resource development. As the only organization dedicated to preserving patient access to provider-administered parenteral medications in more economical and accessible alternatives to hospital sites of care, NICA strives to: connect infusion providers and patients with the resources they need; collaborate with stakeholders to develop all-win solutions; and advocate on behalf of this historically underrepresented patient group.
1. Magellan Rx Management. Medical Pharmacy Trend Report. https://www1.magellanrx.com/media/604882/2016mrxtrendreport_final.pdf. Published 2016. Accessed May 15, 2018.