Outsourced Compounding
Outsourced compounding vendors are intrinsic to the provision
of CSPs within the hospital and typically garner solid user satisfaction rankings. Nonetheless, there is the potential for significant change in this marketplace as many users are open to switching vendors. It is notable that while 90% of hospital pharmacies review the contracts for their vendors, a much smaller number conduct onsite visits and remain up-to-date as to the inspection activities at their vendors. This lack of awareness could leave facilities unprepared to respond should negative findings occur.
While the overall vendor satisfaction rate is an impressive 97%, just 24% deem their vendors to be excellent, underscoring the challenges involved in addressing shortages and managing recalls.
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For the vast majority of facilities of all sizes, the pharmacy department is involved in reviewing the contracts for outsourced compounding facilities.
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Just under 6 out of every 10 facilities are sourcing at least some of their OR syringes and pitocin/oxytocin IVs from outsourced vendors. TPNs, epidurals, PCAs, and products on shortage are also commonly sourced from compounding vendors.
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While pharmacy review of outsourcing contracts is the norm, fewer than 4 out of 10 pharmacy directors have ever conducted an onsite visit to their outsourced compounding vendors.
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Despite the FDA and state boards’ rigorous inspection schedules of outsourced compounding vendors, many hospital pharmacies do not know if their vendor has undergone an inspection within the past 5 years.
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Given the frequency at which the FDA issues Form 483s following an inspection, it is concerning that more than a third of facilities do not know if their vendor has received such a regulatory action. Nevertheless, it is notable that the vast majority of hospital pharmacies following their vendor’s response to 483s are satisfied with the corrective actions taken.
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While most hospital pharmacies expect to continue their current outsourcing relationships, a significant 47% are open to considering or actively planning to switch vendors.
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The vast majority of hospital pharmacies plan to maintain or increase their outsourcing volume over the next few years; decreases in outsourcing will be rare.
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