Issue link: https://beckershealthcare.uberflip.com/i/827052
23 Executive Briefing Sponsored by: Outsourcing Sterile Compounding Can Help ASCs Maximize Value-based Care By Laura Dyrda I ncreasing competition and decreasing reimbursement for services provided are driving healthcare organizations to seek innovative value-based, patient-safety focused solutions. Hos- pitals and Ambulatory Surgery Centers (ASCs) are examining their processes to eliminate inefficiencies and take advantage of savings opportunities. One opportunity that hospitals and ASCs should evaluate as a strategic decision for advancing patient safety and operational efficiency is outsourced sterile compounding. Outsourcing the preparation of compounded sterile preparations (CSPs) provides safeguards and may augment compliance and quality initiatives within the ASC. Healthcare organizations that perform sterile drug compounding in-house have recently been facing new, heightened quality and patient safety requirements and intensive regulatory oversight to assure compliance with the standards. Until late 2013, sterile compounding had largely been governed by the standards set forth in the United States Pharma- copoeia (USP) at Chapter <797> (2004) which had been incor- porated into many state pharmacy practice laws and regulations. Chapter <797> established risk classifications based on the vary- ing degrees of complexity in sterile compounding scenarios, pro- viding incremental controls for higher risk preparations. Though compliance with its requirements was considered es- sential to the safe compounding of sterile pharmaceuticals, it was essentially impossible for USP <797> to provide safe- guards for every conceivable drug compounding scenario. Moreover, its effectiveness depended upon strict adherence by practitioners, measured through rigorous pharmacy inspec- tions by state regulatory agencies. "Although an ostensibly promising regulatory regime at its inception, it was not long un- til a number of adverse events and deadly sequelae stemming from poor compounding practices gave rise to intense public outcry and demand for change in the regulatory framework for compounding," said Andrew Harrison, Vice President of Legal & Compliance at PharMEDium Services, LLC. In fact, the order and magnitude of the injuries to patients caused by compounders in 2011 and 2012 alone was unprece- dented. That period witnessed the emergence of such malefac- tor compounders as the New England Compounding Center where, according to the Centers for Disease Control, the firm's products led to the injury of hundreds of people and over sixty deaths across twenty states. "The aftermath of the NECC trage- dy highlighted a major public health crisis and garnered the at- tention of mainstream media – [NECC] exploited a fragmented regulatory system for personal gain, jeopardizing the unassum- ing public," said Harrison. With the media attention and public outcry over the NECC situation, lawmakers acted quickly, re- sponding with sweeping congressional reforms for the sterile pharmaceutical compounding industry. DQSA and the new Outsourcing Facility sector The federal Drug Quality and Security Act (DQSA) was en- acted on November 27, 2013, with Title I of DQSA containing the Compounding Quality Act. Together, these acts amended certain requirements in the federal Food, Drug & Cosmetic Act applicable to traditional compounding pharmacies, namely the requirement that the pharmacy compound pursuant to a pre- scription. The Act also created a new, voluntary class of com- pounding facilities under Section 503B, known as Outsourcing Facilities, which could provide custom compounded sterile preparations without receipt of a prescription (provided certain critical criteria, including compliance with good manufacturing practices (cGMP) for finished pharmaceuticals, were met). Under the law, Outsourcing Facilities must register with and be inspected by the FDA against stringent regulatory standards for the production of finished pharmaceuticals. The heightened re- quirements, coupled with federal regulatory oversight, provide a higher degree of quality assurance for healthcare organizations and ASCs. Practitioners have been informed by the FDA that they should rely on registered 503B outsourcing facilities to supply routine, ready-to-use preparations and also individual or unique preparations, to ensure all are prepared with the same quality standards. "Substantial compliance with cGMP requirements is a defining obstacle for those entities considering registering as Outsourcing Facilities. The FDA is looking to regulate 503B en- tities as sterile drug manufacturers. Transitioning from the USP <797> compliance standards to that of drug manufacturing regulations sets a very high bar. Compounding facility inspection results from 2013 forward provide evidence of the difficulty of moving from Chapter <797> standards to cGMP," said Harrison. During 2013 and 2014, FDA issued at least 350 reports citing egregious and repeated instances of non-compliance and urged compounders to issue voluntary recalls due to inadequate safe- guards to assure the sterility of their preparations. In Novem- ber 2016, the Government Accountability Office reported 72 recalls associated with the inspection of 503A and other drug compounders that are not outsourcing facilities due to insani- tary conditions and sterility assurance concerns. In other cases, the FDA alerted healthcare professionals of its concerns about certain compounding operations, referred select compounders to their resident state regulatory agencies for further action, and obtained administrative warrants to inspect facilities. With the FDA descending on the compounding industry with new authority and intensive inspections on both 503A and 503B compounders, investigators documented certain insanitary conditions that were so significant that the Agency ultimately issued draft guidance for industry to define what the FDA views as objectionable practices and conditions. This guidance was issued amid a flurry of other compounding industry related FDA guidance documents between 2014 and 2016. Without question, the regulatory responsibilities of compounders have undergone a major paradigm shift – one intended to ensure adherence to strict safety standards and controls.