Outsourcing the preparation of IV solutions can provide important economic and patient care benefits for smaller hospitals with limited pharmacy staffs and compounding facilities that don’t meet U.S. Pharmacopeial Convention (USP) Chapter <797> or <800> standards. But even larger hospitals and health systems often find value in employing a third-party vendor to fill some of their compounding needs.

At Brigham and Women’s Hospital (BWH) in Boston, for example, William W. Churchill, MS, RPh, the chief pharmacy officer, said BWH’s primary goal in using an outsourcer was to maximize cleanroom productivity and use staff as efficiently as possible. BWH compounds about 1 million doses a year, he said. “We don’t need to tie up our staff and hood space with items that are probably smaller in volume but way more labor-intensive, such as TPNs [total parenteral nutrition].”

TPN also is a major outsource category for Yale-New Haven Health System, in Connecticut, according to Lorraine Lee, MHA, BS Pharm, executive director of pharmacy services. Ms. Lee cited an additional reason for outsourcing some products—the longer stability that may be available for some high-demand sterile solutions.

Stuart Hinchen, the co-founder and CEO of QuVa Pharma Inc., the Sugar Land, Texas–based provider of compounded sterile products, told Pharmacy Practice News that it was a “misconception” that outsourcing is suited only for smaller hospitals. The reality, he noted, is that larger hospitals and health systems also can benefit. That is particularly the case for facilities that want to continue compounding more than the minimal number of anticipatory doses that the FDA allows for specific departments (e.g., the emergency room), because such facilities will have to comply with the agency’s current good manufacturing practice (CGMP) regulations, under Section 503B of the Federal Food, Drug, and Cosmetic Act. That’s a challenging and costly path to take, Mr. Hinchen said. “A hospital shouldn’t have to worry about meeting CGMP requirements,” he said. “It takes the focus off what it really should do, which is all about patient care.”

An FDA-registered outsourcing facility, on the other hand, can offer hospitals “an enormous degree of comfort from a risk perspective,” he said. “It’s a controlled environment monitored by the FDA. All products are tested prior to release.”

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