Becker's ASC Review

41 Executive Briefing Sponsored by: I n an effort to provide high-quality, cost-effective care, ASCs rely on outsourced human drug compounding to accommodate specific patient orders. Most centers don't possess the appropriate staffing or access to the most advanced technology for safe in-house compounding and search elsewhere for the service. Compounded human drugs are combined, mixed or altered ingredients creating a medication for a specific patient's needs. A licensed pharmacist or licensed physician compounds the drugs; in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist is allowed to compound drugs. Outsourcing facilities can be used to fill the gap between traditional pharmacy compounding and industrial manufacturing when compounded products are needed for patient care at healthcare facilities. For years, few federal regulations bound compounding facilities to deliver high-quality products. In 2013, Congress passed the Compounding Quality Act as part of the Drug Quality and Security Act, which armed the FDA with more oversight of compounding pharmacies and created section 503B to define outsourcing facilities. The FDA defines outsourcing facilities as those compounding drugs via provider requests without patient-specific prescriptions. Outsourcing facilities are also required to compound drugs in compliance with the FDA's Current Good Manufacturing Practice regulations. The law establishes the annual registration requirement for outsourcing facilities and biannual reporting of the products they have compounded during the past six months. While the FDA has made strides in boosting patient safety among compounders, it falls upon providers to determine whether their outsourcing facility is practicing high-quality processes. The question keeping ASC administrators up at night: How can you ensure your compounding pharmacy will deliver superior results? Leiters knows how challenging the process can be to research and audit outsourcing facilities. The company strives to bring "health to outsourcing" by focusing on three key pillars: people, place and product. "[Quality] starts with a different perspective — prioritizing what matters most, putting the patient at the center of everything we do and defining a source for greater accountability," says Paul Yamamoto, RPh, corporate pharmacist and general manager at one of Leiters' San Jose locations. "Before you know it, the need for greater quality becomes the opportunity to make the world a healthier place to live." He suggests ASCs ask outsourcing facilities 17 questions covering key compliance issues, quality control and best- practice validation. Compliance To select a quality compounding facility, keep your finger on the pulse of compounding outsourcing regulations and how suppliers are performing within these guidelines. "The risks associated with using a facility that is not bound to cGMP are too high and can compromise patient safety," warns Mr. Yamamoto. ASCs can use local compounding pharmacies, but they often comply with the less-stringent standards of the United States Pharmacopeia <797> Chapter, which can put their products at risk. "As has been seen recently, 503A compounding pharmacies can lack the resources and expertise to consistently provide safe, quality medications. Unfortunately, this has led to instances where patients are harmed," Mr. Yamamoto says. Six key compliance questions to ask a potential outsourcing partner are: 1. How do you qualify your suppliers/vendors? 2. How do you appropriately procure and test materials? 3. How do you ensure you have the appropriate environmental controls to produce sterile products? 4. How do you ensure use of an accredited outside vendor to certify the compounding space and hoods, including adequate airflow studies under dynamic conditions (e.g. in-sight smoke study)? 5. How do you monitor disinfectant efficacy and ensure that you have appropriate cleaning supplies that are sterile and adhere to appropriate contact times? 6. How do you monitor for nonviable particles and viable microorganisms? "I would encourage facilities looking to enter into the outsourcing space to really do due diligence in assessing any potential 503B facility before purchasing products from them," says William Churchill, MS, RPh, former chief pharmacy officer at Boston-based Brigham and Women's Hospital. "This is a hugely important decision and requires thoughtful assessment of any potential vendor." Mr. Yamamoto agrees, noting many facilities lack the "tools, expertise and leadership to correctly follow Current Good Manufacturing Practices." Medication production leaves no Is your 503B outsourcing facility up to par? 17 vital questions for ASCs

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