Antimicrobial stewardship efforts to manage a pentamidine shortage

The number of drug shortages quadrupled from 2004, with 58 shortages, to 267 in 2011.1 Eighty percent of the 127 studied shortages in 2010–11 involved sterile injections, and the leading causes for the reported sterile injection shortages included problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and shortages in active pharmaceutical ingredients (10%).2 Sterile injectables have unique manufacturing and market features that make shortages of such products more likely to occur and harder to prevent. There are few manufacturers of generic injectable products, with the top three manufacturers of generic injectables holding 71% of the market by volume.2 When quality-control issues (e.g., lack of sterility) are identified, they are usually not easy to fix and, because multiple injectable products may be produced in one facility, quality-control issues can affect multiple products. Alternative production is difficult to arrange, since dedicated manufacturing lines are often required. Once a production line has been halted and the drug distributor’s stock has been exhausted, a drug shortage is created, affecting both suppliers and hospitals.1