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FEATURE


proceeding,” she says. “I get the phar- macy’s licensing information, liability insurance coverage and all other doc- umentation. We work with our con- sulting pharmacist to make sure we address everything.”


Johnson also requests copies of licenses for the pharmacists working in the compounding pharmacy.


Other Important Steps O’Neal says ASCs would be wise to research the compounding pharmacy’s track record, including checking with their state’s board of pharmacy and the FDA. Updates concerning non-compli- ance with FDA rules are reported in a user-friendly list (www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/PharmacyCompounding/ ucm339771.htm) for quick reference. “That is all public record,” he says.


“If you find a report, make sure to read it carefully and do not jump to conclusions. A compounding phar- macy might receive a letter from the FDA about problems found during an inspection which concern manag- ing paperwork correctly, for example. An FDA letter does not necessarily indicate a patient safety risk. If there was a systematic failure that could have jeopardized patient safety, then I would consider that a red flag and potentially not use that compounding pharmacy until it has, at least, satis- fied the FDA’s requirements.” Before her ASCs proceeded with purchasing the intravitreal injection they requested, Johnson carefully researched the performance of the pharmacy and the drug. “We checked how many cases had been performed with this drug across the country and reviewed data on outcomes. I called other ASCs that had purchased the drug through the pharmacy and spoke with their administrators. I asked about their experience with the pharmacy, if they had any issues with the drug and other questions I considered important


I would not rely on my experience with any specific compounding pharmacy. Go through due diligence at the current time to make sure the pharmacy has maintained its accreditation and its sterility standards are still up to par.”


— Sharon Johnson, RN, CASC Ambulatory Surgical Centers of America


before making a purchase, such as the drug’s delivery and packaging.” Make sure to run your intention to


work with a compounding pharmacy by your governing body, Johnson advises. “My advice,” he adds, “would be to present the surgeon’s request for a compounded drug, and all available information on the drug and the com- pounding pharmacy, to the governing body to determine if members have any concerns. They are, ultimately, the decision makers for the ASC.”


Plan for the Unexpected ASCs should also establish a process that spells out what their ASC should do if there is ever a question about the sterility or stability of a product,


O’Neal says. “If I am looking at a vial of an injectable provided by a com- pounding pharmacy and it has partic- ulate matter in it or something else that makes me question whether to use it, there needs to be a very clear and fast process to be able to vet that drug with the compounding pharmacy.” He also advises ASCs to establish a process concerning recalls. “If the com- pounding pharmacy recalls a product, there should be a process in place for the pharmacy to immediately notify the ASC of the recall rather than the ASC learning about the recall through the FDA. You do not want to wait a few weeks for the FDA to issue a voluntary recall when you could be administering the drug during that time period.” Have an urgent question for your compounding pharmacy? “Call the pharmacy and always ask to speak with the pharmacist in charge,” O’Neal advises.


Avoid Complacency Even though her ASC never experi- enced any problems with its two com- pounding pharmacies, Faucette allo- cates time every year to repeat the research process. “I make sure all of the documentation I gathered previ- ously is still valid and the pharmacies continue to meet our expectations.” Johnson also advises repeating the process every time you are con- sidering a new drug from a com- pounding pharmacy. “I would not rely on my experi- ence with any specific compounding pharmacy,” she says. “Go through due diligence at the current time to make sure the pharmacy has maintained its accreditation and its sterility standards are still up to par. I would not blan- ket everything with a positive answer just because we had used a pharmacy before. Things can change, and we need to make sure our patients are still going to get the high-quality drug they deserve.”


ASC FOCUS JUNE/JULY 2017 |www.ascfocus.org 15


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