On July 1, 2018, United States Pharmacopeia’s (USP) general chapter <800> will become enforceable. For those who are unfamiliar, the rule “provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients, and environments.” While the rule was published more than a year ago, many facilities to which it applies – including labs that handle hazardous drugs – are behind the ball when it comes to compliance. These organizations should strongly consider prioritizing the following steps to put them on track toward timely compliance with these federally recognized standards.
- Maintain a list of hazardous drugs. The first and most logical step for any organization on the road to USP <800> compliance is to understand how USP defines hazardous drugs, and maintain a list of drugs in its facility to which that definition applies. Per USP, a “hazardous drug” is any identified as such by the National Institute for Occupational Safety and Health (NIOSH) on the basis of carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity. It’s critical to closely review this list, and not rely on existing assumptions of what constitutes a hazardous drug, as some inclusions may be surprising (e.g., drugs that only become hazardous once manipulated into other forms).
- Conduct a risk assessment. After creating a list of hazardous drugs, the next step is to determine employee exposure to each of these drugs via a risk assessment. This assessment should include an overview of how each drug is used and by whom, what their potential exposure is, what the consequence of such exposure would be, containment strategies to minimize this risk, and contingency plans for how to best address exposure if it were to occur. Through this process, organizations can understand how broadly USP <800> applies to them, and prioritize compliance actions. For example, facilities that use antineoplastic agents (that only require counting or packaging), non-antineoplastics, or reproductive only hazards may find only portions of USP <800> apply to them; however, facilities that manipulate any hazardous drugs, such as by crushing tablets or opening capsules to make a suspension, must follow all the containment and work practice strategies defined in the chapter. Finally, facilities that don’t conduct an assessment of risk, no matter which hazardous drugs they use, must follow the full set of guidelines.
- Budget for construction requirements. Organizations may realize that USP <800> compliance will require significant time and resources, but many underestimate how much capital investment may also be necessary. In fact, while required changes, such as HVAC improvements for proper air handling or adjustments to the facility’s footprint to comply with storage guidelines, could cost anywhere from $50,000-500,000, very few organizations have taken steps to implement these changes – a critical issue when you consider financial outlays of this size would typically need to be accounted for in an organization’s annual capital improvement plan. As soon as possible, leadership must budget for necessary construction. In extreme cases, organizations may even need to relocate to a new space if their current facility can’t be successfully altered for compliance.
- Designate a USP <800> champion. USP <800> is a complex guideline, and in many cases, requires a designated employee who’s well versed in the rule to help keep his or her facility compliant on an ongoing basis. Some organizations may find it helpful to hire an objective third party to conduct an initial gap analysis, write appropriate operating procedures, and then “train the trainer” who will be responsible for communicating the new guidelines to employees. The primary objective of USP <800> is to protect employees, and once capital improvements are made and new procedures are rolled out, employees play the most critical role in keeping themselves safe. A peer advocate can help relay the rule’s importance, and serve as a resource for any questions or concerns.
While USP <800> compliance may be daunting for some organizations, it’s an important measure to promote worker safety and environmental protection. By prioritizing the steps above, organizations may find developing a tailored action plan to be more manageable, and in some cases, their compliance “to do list” to be shorter than they’d imagined. In any case, the most important step any organization can take is simple: just get started.
Kenneth Maxik is director of patient safety and compliance for CompleteRx. He has more than 20 years of pharmacy operations and management experience and works closely with health organizations across the country to help them stay ahead of current and imminent regulatory standards.
Filed Under: Drug Discovery