Root causes of the problems in the pharmacy compounding arena range from the absence of training in pharmacy schools to commercial pressures that prompt established pharmaceutical firms to leave the market and force hospitals to rely on less qualified providers to fill their immediate patient needs, Merck Engineering BioSterile Validation Director Chris Smalley commented at the April PDA annual meeting held in San Antonio, Texas.
Smalley’s insightful analysis of the current high-profile issues in the compounding arena was informed by both his extensive pharma experience as well as by the first two decades of his career, which was spent in the U.S. military as a licensed pharmacist performing hospital compounding.
As a hospital pharmacist, Smalley prepared IVs and total parenteral nutritional (TPN) packages. He explained that his training in pharmacy school in the 1970’s included laboratory courses that taught various types of compounding and evaluated the student’s ability to perform them.
“I couldn’t pass compounding lab until I could make capsules,” Smalley commented. “We made suppositories. We made powder…. And we made sterile products,” including hand-filling ampules with syringes. “I learned about aseptic technique.”
Over the intervening three decades, the pharmacy school curriculum has shifted towards clinical pharmacy – focused on drug/patient issues – and hands-on pharmacy compounding is no longer usually taught, Smalley pointed out.
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