Pharmacy Rules Hospital Leaders Must Know in 2016

By Kenneth Maxik MBA, MBB, FACHE

Since the 2010 signing of the Affordable Care Act, the healthcare industry has buzzed with news of increased regulation, and the effect expanded oversight may have on health organizations and practitioners. As they navigate regulatory waters, hospital leaders should be sure they have the following new pharmacy rules on their sonar, as they will have a direct impact on patient safety – and, in many cases, business’s bottom lines – in 2016.

USP <797> and USP <800>

In 2015, the U.S. Pharmacopeial Convention (USP) – which sets FDA enforceable drug standards in the U.S. – proposed changes to USP <797> (Pharmaceutical Compounding – Sterile Preparations)* and introduced USP <800> (Hazardous Drugs – Handling in Healthcare). While the brunt of implementation responsibility may fall to hospital pharmacy departments, executives with budget oversight should know these new rules may require increased time and resources for employee training, and in some cases, updates to HVACs, refrigeration systems, and/or facility designs.

As of January 2016, USP <797> is closed for comment. If finalized in its current form, hospitals – many of which, in a time of constrained resources, have lacked the funds or the volume to adopt best practices for compounding sterile preparations – may face barriers on their road to compliance. As an example, while these measures may certainly improve patient safety and minimize the risk of contamination, the requirement that more products be mixed in the central pharmacy will require an increase in time and cost associated with staff competency and environmental testing.

In February 2016, USP approved a new chapter, <800>, defining practice and quality standards for handling hazardous drugs to improve patient safety, worker safety, and environmental protection. USP <800> applies to everyone who is involved in the receipt, storage, mixing, preparing, compounding, dispensing, and administration of hazardous drugs – including, but not limited to, pharmacists, nurses, and physicians – necessitating training across the organization to promote compliance. While hospitals won’t be held accountable for the new rules until July 2018, they should work with staff now to determine what facility or equipment upgrades may be required to correctly store and prepare hazardous medications for both sterile and non-sterile compounding. Organizations should begin the implementation process for those items that would aid in reducing exposure to hazardous drugs “to as low a limit as reasonably achievable.”

*In October 2015, CMS incorporated USP <797> into its conditions for participation in Medicare and Medicaid programs, which may lead to more stringent review by CMS and regulatory bodies related to compliance with the chapter.

Drug Supply Chain Security Act

In 2013, President Obama signed into law the Drug Supply Chain Security Act, which offers a uniform national standard to reduce the risk of suspect products entering the pharmaceutical supply chain. As part of the first stage of implementation, hospitals are now responsible for a system to monitor medications received and distributed through the health system. This system must track whether, as required by the act, products arrive with the “3Ts” (transaction history, transaction information, and transaction statement), which pharmacies are required to retain for six years from the date of transaction. The challenges presented by this requirement – while significant – are nothing compared to those associated with the coming requirement that pharmacies store identifiers, serial numbers, and lot numbers for each individual drug product by 2023. Hospitals should act now to get ahead of such changes, as they may necessitate a significant investment in data and automation systems.

Environmental Protection Agency Subpart P (Pharmaceutical Waste)

In December 2015, the Environmental Protection Agency (EPA) closed the comment period for a proposed subpart P under its Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities rule. If, as expected, the proposal is finalized in 2016, hospitals will need to educate staff on key changes, including a ban on sewer (i.e. drain or toilet) disposal of hazardous waste pharmaceuticals – currently, a common practice – for most healthcare facilities and reverse distributors.

 As the healthcare landscape continues to evolve, hospitals must stay up to date with regulatory and government standards. Healthcare leaders should work directly with Pharmacy and other departments to proactively address updates that may help promote patient safety and minimize the risk of non-compliance.

Kenneth Maxik –  director of patient safety and compliance for CompleteRx – has more than 20 years of pharmacy operations and management experience. Leveraging a deep understanding of the changing healthcare landscape, Ken works closely with hospitals and health systems across the country to help their organizations stay ahead of current and imminent regulatory standards.     

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