Implications of the Newly Proposed Regulations for Handling Hazardous Drugs

This is the first in a series of articles addressing compliance with current and proposed regulations concerning the handling of hazardous drugs. Managing the compounding and handling of hazardous drugs has always been complicated, but it is one of the cornerstones of the care we provide in oncology practices. These drugs are critical in the battle against cancer. New rules governing the administration of hazardous drugs, such as those used in chemotherapy, are being written in the pharmacy arena. These rules affect every oncology practice, regardless of its size or corporate structure—private or hospital-owned. The goal of this series is to provide information primarily on the nonreimbursed compliance efforts of one private medical oncology practice. Although a significant focus here is on the US Pharmacopeial Convention (USP)’s “General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings” (USP 800), it should be noted that the Occupational Safety & Health Administration (OSHA) also has regulations covering hazardous drugs.¹ Furthermore, the Oncology Nursing Society (ONS), the American Society of Clinical Oncology, and the Hematology/Oncology Pharmacy Association have recently issued a joint position statement on this, titled “Ensuring Health Care Worker Safety When Handling Hazardous Drugs.”²

The USP 800 Will Impact All Oncology Practices

The USP is a nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines worldwide. The USP’s drug standards are considered enforceable in the United States. The group has recently proposed the USP 800, a new chapter that addresses the handling of hazardous drugs in healthcare settings. It will impact all oncology providers who store, prepare, compound, or administer oncology drugs. This chapter is still in the development phase: commentary and feedback were sought and received, and the final regulations may be promulgated by the summer of 2016. Why is this important to private practices? On many levels, the USP 800 regulation will likely change aspects of the operations, marketing, contracting, and financial structure of oncology drug delivery in the near future. The USP 800 is being written to identify the safe handling of hazardous drugs for the protection of staff and patients. It is also intended to apply to all healthcare settings. Once the USP 800 regulation is finalized, it is expected to be applicable to all relevant entities—not only hospitals or compounding pharmacies—and will subject all organizations to enforcement. Practices that are not compliant with the USP 800 standards could face a loss of market share, adverse publicity, or enforcement expense and other obligations.

Practical Implications

How can pharmacy regulation affect us? How will a regulation that is mostly enforced by state pharmacy boards 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 the USP 800 standards do not apply to it, this may not stand as a valid argument in the following situations:

• Legislative action. The local state legislature may take action related to the standards set forth in USP 800 and make them law with enforceable deadlines
• The court of public opinion. The 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, the USP 800 regulation would be national in scope and would apply to all healthcare providers, regardless of type or size—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), the Joint Commission, and individual state pharmacy boards. Pharmacy regulations differ across states, which is why physicians are able to dispense drugs in most but not in all states.

What Does the USP 800 Cover?

The new USP chapter was created to identify requirements for the receipt, storage, mixing, preparing, compounding, dispensing, and administration of hazardous drugs to protect the patient, healthcare personnel, and the environment. The details of the USP 800 can be found on the USP’s website. The standards outlined in the USP 800 apply to all personnel who compound hazardous drug preparations and to all physical places where hazardous drugs are prepared—pharmacies, hospitals, and other healthcare institutions, as well as patient treatment clinics, physicians’ practice facilities, and veterinarians’ offices. The previous chapter, “General Chapter 797 Pharmaceutical Compounding—Sterile Preparations,” included an allowance for facilities that prepare a “low volume” of hazardous drugs, but the USP 800 is expected to remove that allowance in its final regulations.

USP 800 Identifies Best Practices

The USP 800 identifies 10 sources of best practices for handling hazardous drugs, stating that where conflicts exist, the most stringent requirements prevail. These sources include publications and regulations from OSHA, the National Institute for Occupational Safety and Health, the American Society of Health-System Pharmacists, and ONS. Many of these regulations have been previously applied more often to hospitals and pharmacy settings than to private practice settings. The USP 800 is now bringing every requirement to bear on all healthcare facilities, including private practices.

Other Recent Regulations to Consider and Review

The Drug Quality and Security Act was signed into law on November 27, 2013. It involves 2 primary sections: one addresses compounding quality and the other addresses drug supply chain security. The purpose of this act was to better manage and control drug compounding, especially in outsourced settings; to improve communications between the FDA and state regulators for better management of drug-related crises; to preserve and protect the practice of traditional pharmacy compounding in community pharmacies; and to create a process for the registration of outsourcing facilities (ie, entities engaged in the compounding of sterile drugs). A related effect of these regulations on private practices involves the policies of practices that allow the white bagging or brown bagging of drugs. White bagging is when the payer or its agent (a pharmacy of its choosing) sends the drug to the medical practice outside of the contracted chain of custody; brown bagging occurs when patients bring their drug with them for practices to store and/or administer. Aspects of the USP 800 or the Drug Quality and Security Act may affect medical practices, depending on state regulations, the structure of the entity, and engagement with licensed pharmacists.³

What Should a Medical Practice Do?

It is fairly certain that the USP 800 will be adopted, so it is important to read the proposed chapter carefully and to approach the material in a planned way. There have already been several excellent presentations and articles on this topic, and continuing education is important. Oncology practices should review and discuss this information internally through their exposure control or safety committees, and they should keep their physicians informed. Many practices can expect that a sizable expense will be involved making workflow and physical plant changes to ensure compliance with the USP 800 regulation. Subsequent articles in Oncology Practice Management will outline the process, deliberations, substantive issues, and cost elements that our medical practice experienced in our ongoing quest to become compliant with these regulations.

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