Drug Compounding: New Rule a Game Changer for Oncology Practices
Managing the compounding and handling of hazardous drugs has always been complicated, but it is the cornerstone of the care we provide. These drugs offer hope to patients battling cancer. Many oncology practices would be surprised to hear, though, that new rules governing the administration of hazardous drugs like chemotherapy are being written in the pharmacy arena. They affect every oncology practice, regardless of size or corporate structure (private or hospital owned).
The US Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines worldwide. USP’s drug standards are considered enforceable in the United States. The group is proposing General Chapter <800> (USP 800), a new chapter that addresses the handling of hazardous drugs in healthcare settings. It intends to affect all oncology providers who store, prepare, compound, or administer oncology drugs. This chapter is still in proposal form; commentary and feedback are being accepted this year until July 31.
Why is it important to oncology practices? On many levels, this new regulation may change the operations, marketing, contracting, and financial structure of oncology delivery in the immediate future. USP 800 is written to identify safe handling of hazardous drugs for the protection of staff and patients. It is also written to apply to all healthcare settings. Once USP 800 is finalized, it is out there for potential enforcement. Practices that are not compliant with USP 800 standards could face a loss of market share, adverse publicity, or enforcement obligations.
How can pharmacy regulation affect a medical practice? One might ask how a regulation mostly enforced by state boards of pharmacy might affect a medical practice operating under different oversight and regulation. If a practice has registered within a state as a registered pharmacy, then that pharmacy is subject to pharmacy board regulations. Even if a practice were to take the position that these USP 800 standards do not apply to its practice, there are situations where it might not stand as a valid argument.
- Legislative action: The local state legislature might take action related to the standards set forth in USP 800 and make them law with enforceable deadlines
- The court of public opinion: It is stated clearly in USP 800, “There is no acceptable level of personnel exposure to HDs [hazardous drugs].”1 USP 800 standards have been written to protect staff and patients. It would be difficult to argue that they should not be followed in any setting
- Enforceability: USP chapters numbered below 1000 are considered enforceable, and those with higher numbers are considered guidelines. If implemented, USP 800 would be national in scope and apply to healthcare providers of all shapes and sizes (private or hospital-based, pharmacy or physician)
- Enforcement: This varies because the USP does not have its own enforcement body, so most enforcement is accomplished by the US Food and Drug Administration (FDA), Joint Commission, and individual state boards of pharmacy. Pharmacy regulations differ across states, which is why physicians are able to dispense in most states, but not all.
What does USP 800 cover? The chapter was created to identify requirements for receipt, storage, mixing, preparing, compounding, dispensing, and administration of HDs to protect the patient, healthcare personnel, and environment. Details of USP 800 can be found on the USP website.1 Standards outlined in USP 800 apply to all personnel who compound HD preparations and all places where HDs are prepared (eg, pharmacies, hospitals, and other healthcare institutions, patient treatment clinics, physicians’ practice facilities, and veterinarians’ offices). The prior chapter, USP 797, titled Pharmaceutical Compounding–Sterile Preparations, included an allowance for facilities that prepared a “low volume” of HDs, but USP 800 removes that allowance.
It is not just about USP 800; other standards now apply to medical practices, not just hospitals. USP 800 identifies 10 sources of best practices for handling HDs, stating that where conflicts exist, the most stringent requirements prevail. These sources include publications and regulations from the Occupational Safety and Health Administration, the National Institute for Occupational Safety and Health, the American Society of Health-System Pharmacists, and the Oncology Nursing Society. Many of these regulations have previously been applied to hospital or pharmacy settings and not so much to private practice settings. USP 800 is now bringing all of these requirements to bear on all healthcare facilities, including private practices.
Other recent regulations you should consider and review. The Drug Quality and Security Act (DQSA) was signed into law on November 27, 2013. There are 2 primary sections, one addresses compounding quality, and the other addresses drug supply chain security. The purpose of the act was to better manage and control drug compounding (especially in outsourced settings), improve communications between the FDA and state regulators (for better managing of drug-related crises), preserve and protect the practice of traditional pharmacy compounding in community pharmacies, and create a process for the registration of “outsourcing facilities” (entities engaged in the compounding of sterile drugs). Aspects of DQSA may affect medical practices depending upon state regulations, structure of entity, and engagement with licensed pharmacists. The text of DQSA is available online.2
What should oncology practices do? It seems fairly certain that USP 800 will be adopted, so it is important for oncology practices to read the proposed chapter carefully and provide comments via the appropriate channels by the July 31, 2014, deadline. The proposed chapter is posted online3; click on the link labeled “<800> Hazardous Drugs—Handling in Healthcare Settings” to reach the proposal, presented with numbered lines. Comments may be addressed to CompoundingSL@usp.org, and are more likely to be addressed if accurate line numbers are referenced with the comments.
1. US Pharmacopeial Convention. <800> Hazardous Drugs—Handling in Healthcare Settings. www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf. Accessed June 5, 2014.
2. GOVTRACK. H.R. 3204: Drug Quality and Security Act. www.govtrack.us/congress/bills/113/hr3204#overview. Accessed June 9, 2014.
3. US Pharmacopeial Convention. General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. www.usp.org/usp-nf/notices/compounding- notice. Accessed June 5, 2014.