Ten years ago at the launch of this survey, USP <797> was just 3 years old and controversy was swirling around its enforcement with concerns over the cost and complications of implementation. A decade later, there has been a flurry of additional regulatory activity, including <797> updates, the FDA’s Drug Quality and Security Act (DQSA), and USP <800>, along with increased state board of pharmacy oversight. Likewise, we have experienced the horrors of the deadly fungal meningitis outbreak from the contaminated steroid injections sold by NECC. It is safe to say pharmacy practice has changed significantly over this past decade and change is expected to be a constant moving forward.
The State of Pharmacy Compounding survey quantifies that change and includes projections of future practice. The survey queries pharmacy directors on a broad range of compounding practices, from inspection experiences to technology adoptions and outsourcing choices, among other topics. Survey responses are solicited via email, and this year a total of 361 responses were received, yielding a confidence interval of 4.99 (95% +/– 4.99) based on the total population of pharmacy directors nationwide. We purposely survey a random sampling of pharmacy directors, not just readers of PP&P, to ensure the data herein reflects trends across the entirety of health-system practices. Therefore, we are quite pleased to learn that more than three-quarters of pharmacy directors rely on PP&P as a resource for compounding information.
The depth and breadth of regulatory inspections can be exacting, and this is particularly true when the inspector is a pharmacist. BUD remains a strong point of interest for inspectors who are not only reviewing pharmacy department BUD policies but also querying technicians on their actual practices and understanding of the policy. Other areas of focus for inspectors this year were staff competencies, air pressure monitoring, garbing, and references for formulations.
The highest performing hospital pharmacies are in states with a board of pharmacy that requires compliance with USP <797>. Facilities under such purview are more likely to be familiar with their state board requirements, have an environmental monitoring plan in place, and document cleaning processes. All of this underscores the concept that we respect what is inspected.
FDA oversight under DQSA has led to significant scrutiny of 503B facilities; nonetheless, this should not result in any less stringent oversight by pharmacy. It remains imperative for pharmacy to develop detailed vendor selection guidelines and be involved in the contracting process with their outsourced compounding vendors. Likewise, pharmacy should remain abreast of any regulatory actions taken against their vendors and review the vendor’s response. As such, it is concerning that 45% of pharmacy directors utilizing outsourcing are unaware as to whether the FDA has inspected their vendor in the past 5 years, and 60% do not know if their vendor has been recently inspected by the board of pharmacy.
The importance of familiarity with state board expectations is underscored by the fact that some state boards expect facilities to exceed the minimum requirements of <797> and instead attain recommended best practices. In these cases, the boards have established more frequent environmental monitoring requirements and detailed documentation expectations, for example. The board of pharmacy can serve as an ally in the effort to implement compliant compounding practices, and as a resource for best practices. At the very least, pharmacy must engage with the state board to ascertain their requirements.
The utilization of technology in the cleanroom is key to assisting pharmacy in achieving compounding safety: IV workflow systems bring the safety and security of bar coding and gravimetrics to the production process, closed system drug-transfer devices (CSTDs) lower the risk for employees handling HDs, and ready-to-use products deliver workflow efficiency while reducing contamination risk. Many of the products available to augment pharmacy’s effort in the cleanroom are advancing and adding new offerings. While it can be daunting to remain aware of these evolving options, the good news is that many of the supportive products and technologies offered for the cleanroom are highly rated by their users, meaning there is an abundance of excellent options available. The top-rated equipment classes in this year’s survey are:
- Cleaning Products
- Ready-to-Use IVs
- Environmental Monitoring Equipment
Due to aging infrastructure and looming USP <800> requirements, cleanroom construction is projected to be the area with the most significant investments over the next few years. In fact, 65% of facilities with older compounding complexes are planning a renovation over the next few years. These renovations will need to address segregated unpacking and storage areas, proper external ventilation, and sufficient primary engineering controls, among myriad other issues.
A commitment to compliant compounding practices requires continuous efforts at improving compounding expertise and ongoing vigilance to ensure patient safety. We often hear the lament that pharmacy is now being tasked to do more with less. Of course this is true, but the expectation is not new. The nature of any evolutionary process is to change, and hopefully that change is for the better. Just as we expect senior staff to be more productive now than when they first joined the department, we should also expect (and endeavor to ensure) that compounding practices continually evolve to become safer and more efficient. With almost no facilities projecting decreases in their compounding volume in the near future, the adoption of processes and technology that increase efficiency will be key to managing the cleanroom of the future.
Ten years on, some lessons are clear. Without a strong commitment to compliance, complete success is difficult to achieve. Now is the time to leverage pharmacy’s regulatory requirements to ensure sufficient financial support for your compliance efforts. Consider utilizing wipe analysis results to underscore your case to administration. Ultimately, delivering safety for patients and staff requires an organizational-wide effort.
Deanne Halvorsen is the editorial director of Ridgewood Medical Media, publisher of Pharmacy Purchasing & Products and MedicalLab Management. She can be reached at email@example.com.
As we do every year, we invite you to take advantage of our Compounding Slide Kit. Pharmacy Purchasing & Products is happy to provide much of the data you find on the following pages as PowerPoint slides. You are welcome to use this data in your own presentations; we hope it serves as a valuable support as you make the case for additional investments at your facility. And you are certainly welcome to incorporate the data into presentations you may make externally to educate your colleagues on compounding opportunities they may be considering. Simply access the slides on our website (www.pppmag.com/slides).
Perform an Assessment of Risk to Comply with USP <800>
Drive Compliance with the 340B Program
Managing Oral Chemotherapy
Comparison of USP <800> Gap Analysis Tools
March 2017 : IV Safety
Insourcing IV Compounding with Robotics
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