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COVER STORY


Managing Drug Shortages


As FDA requirements changed, manufacturing costs escalated, production decreased and needs increased. BY SAHELY MUKERJI


D


rug shortages continue to be a challenge for ASCs as they impact


providers with little or no warning and potentially threaten patient safety, says Norman Tomaka, clinical consultant pharmacist in Melbourne, Florida. “When faced with a drug shortage, the ultimate goal is to avoid the situ- ation in which a provider at the ASC is told that the drug of choice is not available due to a shortage,” he says. “ASC management must have a pro- active strategy that fosters safety and economic security.”


Reasons and History “The spiraling drug costs that we expe- rience in our practices are the result of several possible realities,” says Shel- don S. Sones, president of Sheldon S. Sones and Associates, a pharmacy and accreditation consulting firm based in Newington, Connecticut. “Diminished


12 ASC FOCUS JANUARY 2017


availability of raw materials, unantici- pated demand, regulatory enforcement and possible market manipulation, all could be theorized as resulting in short- ages as well as the natural progression thereafter of costs, following basic sup- ply/demand and market fluctuations.” Natural disasters, voluntary recalls


and inventory manipulation could be other reasons behind a drug shortage, Tomaka adds. The shortage crisis that started in 2009, at the lowest point of the reces- sion, is a result of two factors that con- verged, Tomaka says: “1) a shortage stemming from manufacturers trying to streamline their products to have less wastage and 2) the US Food and Drug Administration (FDA) enforcing the new Drug Supply Chain Integrity requirements around 2000–03.” The FDA introduced the integrity requirements to stop counterfeiting,


diversion, cargo theft and importation of unapproved or otherwise substan- dard drugs. To ensure quality, he says, the FDA standardized the Current Good Manufacturing Practice (CGMPs) reg- ulation for human pharmaceuticals in 2000. “By 2003, this requirement went into play and when the recession hit, this converged with the shortage that resulted from manufacturers trying to streamline their products [see factor 1 in the preceding paragraph] and cre- ated a massive shortage that lasted 10 years with the last five being particu- larly inflammatory, especially for sterile injectables,” Tomaka says. According to the FDA web site, in 2010, there were 178 drug shortages reported to FDA, 132 of which involved sterile injectable drugs. In 2011, there were 251 drug shortages reported, 183 of which involved sterile injectable drugs. In 2012, there were 117 new drug shortages, 84 of which involved sterile injectable drugs and in 2013, there were 44 new drug shortages, 35 of which involved sterile injectable


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