Milena M McLaughlin1, Zachary Pentoney1, Erik Skoglund1, Marc H Scheetz2. 1. Milena M. McLaughlin, Pharm.D., is Assistant Professor, Department of Pharmacy Practice, Midwestern University Chicago College of Pharmacy, Downers Grove, IL, and Infectious Diseases Pharmacist, Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL. Zachary Pentoney, Pharm.D., is Postgraduate Year 1 Pharmacy Resident, Northwestern Memorial Hospital; at the time of writing, he was a Pharm.D. student, Midwestern University Chicago College of Pharmacy. Erik Skoglund, B.S., is a Pharm.D. student, Midwestern University Chicago College of Pharmacy. Marc H. Scheetz, Pharm.D., M.Sc., is Associate Professor, Department of Pharmacy Practice, Midwestern University Chicago College of Pharmacy, and Infectious Diseases Pharmacist, Department of Pharmacy, Northwestern Memorial Hospital. 2. Milena M. McLaughlin, Pharm.D., is Assistant Professor, Department of Pharmacy Practice, Midwestern University Chicago College of Pharmacy, Downers Grove, IL, and Infectious Diseases Pharmacist, Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL. Zachary Pentoney, Pharm.D., is Postgraduate Year 1 Pharmacy Resident, Northwestern Memorial Hospital; at the time of writing, he was a Pharm.D. student, Midwestern University Chicago College of Pharmacy. Erik Skoglund, B.S., is a Pharm.D. student, Midwestern University Chicago College of Pharmacy. Marc H. Scheetz, Pharm.D., M.Sc., is Associate Professor, Department of Pharmacy Practice, Midwestern University Chicago College of Pharmacy, and Infectious Diseases Pharmacist, Department of Pharmacy, Northwestern Memorial Hospital. mscheetz@nmh.org.
Abstract
PURPOSE: The results of a national study of projected versus actual times to resolution of temporary U.S. shortages of antiinfective drugs are presented. METHODS: Descriptive data on antiinfective drug shortages, including differences between manufacturer-estimated and actual times to shortage resolution, were collected over a one-year period via regular monitoring of the websites of ASHP and the Food and Drug Administration. Inventory data from one large hospital in the Midwest were collected in order to characterize realized shortages (i.e., those for which mitigation was required). RESULTS: During the study period, there were 47 transient shortages of antiinfective medications involving 381 unique products or formulations, of which 40% (n = 19) were emergent shortages. Generic-only and brand-only medications accounted for 53% (n = 25) and 21% (n = 10) of the evaluated shortages, respectively; the median shortage duration was 40 days (interquartile range [IQR], 22-91 days). The reasons for shortages most frequently cited by manufacturers were product or formulation discontinuation (21%), increased demand (12%), and raw material shortfalls (8%). Some shortages were resolved sooner than originally projected, but overall, actual shortage durations exceeded manufacturer-projected durations by a median of 17 days (IQR, 0-52.5 days). Ten realized shortages occurred at the hospital study site, compelling the antimicrobial stewardship team to recommend alternative therapies or restrict the use of drugs in short supply. CONCLUSION: The actual durations of evaluated antiinfective drug shortages during the study period were longer than the manufacturer-projected durations by a median of 17 days.
PURPOSE: The results of a national study of projected versus actual times to resolution of temporary U.S. shortages of antiinfective drugs are presented. METHODS: Descriptive data on antiinfective drug shortages, including differences between manufacturer-estimated and actual times to shortage resolution, were collected over a one-year period via regular monitoring of the websites of ASHP and the Food and Drug Administration. Inventory data from one large hospital in the Midwest were collected in order to characterize realized shortages (i.e., those for which mitigation was required). RESULTS: During the study period, there were 47 transient shortages of antiinfective medications involving 381 unique products or formulations, of which 40% (n = 19) were emergent shortages. Generic-only and brand-only medications accounted for 53% (n = 25) and 21% (n = 10) of the evaluated shortages, respectively; the median shortage duration was 40 days (interquartile range [IQR], 22-91 days). The reasons for shortages most frequently cited by manufacturers were product or formulation discontinuation (21%), increased demand (12%), and raw material shortfalls (8%). Some shortages were resolved sooner than originally projected, but overall, actual shortage durations exceeded manufacturer-projected durations by a median of 17 days (IQR, 0-52.5 days). Ten realized shortages occurred at the hospital study site, compelling the antimicrobial stewardship team to recommend alternative therapies or restrict the use of drugs in short supply. CONCLUSION: The actual durations of evaluated antiinfective drug shortages during the study period were longer than the manufacturer-projected durations by a median of 17 days.