Issue link: https://beckershealthcare.uberflip.com/i/956253
42 Executive Briefing room for error, and providers must ensure they are purchasing quality and safe products for patients. Quality control In a competitive landscape, some compounders are looking to cut costs, which can lower quality if organizations aren't careful. Although it is tempting to choose an outsourcing facility with lower prices, ASCs should be aware of the risks associated with poor-quality compounding processes. If quality is overlooked in an outsourcing facility, ASCs may receive contaminated products with sterility, potency and endotoxin issues. "Cost is important, but it should be measured as but one factor in deciding on your outsourcer," says Mr. Yamamoto. With the following eight key questions, you can determine whether the compounding facility maintains a quality assurance program: 1. What are your compounding processes, and do you use all sterile supplies? 2. What studies or processes do you have that illustrate your practices around preventing cross contamination? 3. If you produce beta lactams, how do you conform to the requirements to do so? 4. If equipment is used, how do you qualify it to perform those activities? 5. How do you ensure you have adequate aseptic training and how do you conduct employee qualifications, such as passing at least three successful, successive media fill simulations designed to verify the adequacy of their technique and behavior? 6. What is your process to ensure your products have full validation studies, container closure integrity studies and shipping studies? 7. What is your process to visually inspect each unit with the proper training and qualified equipment? 8. What is your process to keep products quarantined until release? How do you submit samples? Is it based on USP <71> standards and is the analytical lab using validated methods? The outsourcing compounder should have a strong grasp of the FDA regulations to achieve optimal quality control. The FDA's "Outsourcing Facilities" website offers a variety of online resources for customers selecting a compounder, including information regarding facilities' inspection outcomes. Local Boards of Pharmacy also provide an online record of the facility's status as well as any disciplinary actions. Best practices |Still a relatively new industry, the 503B landscape is continuously evolving to ensure best practices for patient safety. There are best practices every reliable facility adheres to, and ASCs that conduct a rigorous audit reinforce the demand for safe medications. Here are three key questions to determine whether compounding facilities follow industry best practices: 1. Does the quality department have the authority to release and reject products, and what is the process? 2. How does the quality department collect and review all the appropriate data before a product is released or rejected? (Be sure the outsourcer is doing a review of the raw data collected by the lab for chemistry and microbiology.) Do you review both the environmental and personnel data associated with the compounding of the product? Have you ever released a batch that was outside of your specifications and if yes, why? 3. How often do you report adverse events and recalls? Do you report them all? What is your customer notification process? Brigham and Women's initially built an in-house compounding program, but then decided to outsource. Mr. Churchill worked with several colleagues to research compounding facilities, investigating via the state Boards of Pharmacy and department of public health. His team identified regulatory actions or sanctions against facilities and leveraged a customized survey tool to analyze the facility's compliance and quality systems. Their audit included: • Licensure reviews • Records review from external audits • Compounding records • Training records • Equipment certification and validation records "Only after satisfactorily passing all of these areas would the 503B facility be eligible for potential contracting and partnership with our institution." Mr. Churchill says. Visit www.leiters.com to learn more and schedule a visit at the company's new facility in Englewood, CO. n Leiters is a FDA-registered 503B outsourcing provider of high quality ophthalmology and hospital- based services. We are committed to providing healthcare professionals and their patients with high quality medications. Our team of experts in sterile pharmaceutical manufacturing, repackaging, and compounding provide a sophisticated understanding of what it takes to elevate quality and consistency of supply in outsourcing. We combine our team of experts, our robust processes and our state of the art manufacturing facilities to ensure the highest quality products and services. We believe the most important consumer of our products are patients, and patients have trusted Leiters with their health for nearly a century. For more on how we are elevating the standards in pharmaceutical outsourcing please visit www.leiters.com