Impact of a Piperacillin-Tazobactam Shortage
Impact of a Piperacillin-Tazobactam Shortage
Study Objective: To evaluate the impact of a shortage of piperacillin-tazobactam in the United States in 2002 on antimicrobial prescribing and associated rates of vancomycin-resistant enterococci (VRE) and Clostridium difficile infections.
Design: Retrospective chart review.
Setting: University-affiliated medical center.
Measurements and Main Results: Microbiologic reports, patient demographics, and antimicrobial utilization were evaluated for patients admitted 6 months before the shortage (March 1-August 31, 2001) and for 6 months during the shortage (March 1-August 31, 2002). Significant increases in usage of alternative β-lactamase inhibitor combinations, cefepime, levofloxacin, vancomycin, clindamycin, and metronidazole were observed during the shortage; in contrast, a significant decrease in the use of ceftriaxone took place. No change in the rate of VRE infection was observed from before to during the piperacillin-tazobactam shortage. However, a paradoxical 47% decrease in the rate of C. difficile colitis was documented during the shortage. Subsequent multivariate analyses suggested the reduced use of ceftriaxone and increased use of levofloxacin, but not the reduced use of piperacillin-tazobactam, correlated with the decreased rate of C. difficile infections.
Conclusion: The piperacillin-tazobactam shortage was associated with significant changes in antimicrobial prescribing, which resulted in a significant reduction in the rate of C. difficile but not VRE infections.
In the United States, drug shortages including ordering inefficiencies, and U.S. Food and Drug those associated with antimicrobials have become Administration regulation and enforcement. increasingly commonplace. The American Although these causes are well described, the Society of Health-System Pharmacists Drug impact of these shortages has not been well Product Shortages Management Research Center studied. The Infectious Diseases Society of has reported an average of approximately 60 America surveyed its members regarding shortages/month. The reasons for these shortages of antimicrobial agents in their shortages are multifactorial, including hospitals and medical centers. Shortages in manufacturing factors (raw material shortage, antimicrobials were reported to affect the clinical problems with manufacturing processes), practices of most members queried. Overall, 82% inadequate planning and communication, of respondents stated that an antimicrobial economic disincentives, distribution and shortage forced them to alter treatment regimens in their primary inpatient workplace. Specific antimicrobial agents that are associated with shortages have been described, but the impact of these shortages on antimicrobial prescribing practices and other outcomes has not been well documented.
In 2002, a national shortage of piperacillin-tazobactam took place. Reduced rates of vancomycin-resistant enterococci (VRE) and Clostridium difficile-associated diarrhea (CDAD) infections have been observed with increased use of β-lactamase inhibitor combinations and a concomitant reduction in the use of third-generation cephalosporins, clindamycin, and vancomycin. Consequently, the unavailability of piperacillin-tazobactam was anticipated to be associated with an increase in the rate of VRE and CDAD infections. A significant increase in the rate of CDAD associated with the piperacillin-tazobactam shortage was reported. The authors suggested that the increase in CDAD was associated with a concomitant increase in the use of cephalosporin antibacterial agents. Other investigators similarly noted an increased rate of CDAD associated with the piperacillin-tazobactam shortage. As with the former investigation, the latter study suggested that an increased use of cefotaxime contributed to the observed increase in CDAD.
Similar to these institutions, the University of California-San Francisco (UCSF) Medical Center experienced shortages in the availability of piperacillin-tazobactam in 2002. The objectives of our study were to determine the impact of the piperacillin-tazobactam shortage on antimicrobial prescribing and on the rate of CDAD and VRE infections. Considering the previously reported reduction of VRE and CDAD infections associated with increased usage of piperacillin-tazobactam, we proposed that the shortage would be associated with an increased rate of hospital infection due to these pathogens.
Abstract and Introduction
Abstract
Study Objective: To evaluate the impact of a shortage of piperacillin-tazobactam in the United States in 2002 on antimicrobial prescribing and associated rates of vancomycin-resistant enterococci (VRE) and Clostridium difficile infections.
Design: Retrospective chart review.
Setting: University-affiliated medical center.
Measurements and Main Results: Microbiologic reports, patient demographics, and antimicrobial utilization were evaluated for patients admitted 6 months before the shortage (March 1-August 31, 2001) and for 6 months during the shortage (March 1-August 31, 2002). Significant increases in usage of alternative β-lactamase inhibitor combinations, cefepime, levofloxacin, vancomycin, clindamycin, and metronidazole were observed during the shortage; in contrast, a significant decrease in the use of ceftriaxone took place. No change in the rate of VRE infection was observed from before to during the piperacillin-tazobactam shortage. However, a paradoxical 47% decrease in the rate of C. difficile colitis was documented during the shortage. Subsequent multivariate analyses suggested the reduced use of ceftriaxone and increased use of levofloxacin, but not the reduced use of piperacillin-tazobactam, correlated with the decreased rate of C. difficile infections.
Conclusion: The piperacillin-tazobactam shortage was associated with significant changes in antimicrobial prescribing, which resulted in a significant reduction in the rate of C. difficile but not VRE infections.
Introduction
In the United States, drug shortages including ordering inefficiencies, and U.S. Food and Drug those associated with antimicrobials have become Administration regulation and enforcement. increasingly commonplace. The American Although these causes are well described, the Society of Health-System Pharmacists Drug impact of these shortages has not been well Product Shortages Management Research Center studied. The Infectious Diseases Society of has reported an average of approximately 60 America surveyed its members regarding shortages/month. The reasons for these shortages of antimicrobial agents in their shortages are multifactorial, including hospitals and medical centers. Shortages in manufacturing factors (raw material shortage, antimicrobials were reported to affect the clinical problems with manufacturing processes), practices of most members queried. Overall, 82% inadequate planning and communication, of respondents stated that an antimicrobial economic disincentives, distribution and shortage forced them to alter treatment regimens in their primary inpatient workplace. Specific antimicrobial agents that are associated with shortages have been described, but the impact of these shortages on antimicrobial prescribing practices and other outcomes has not been well documented.
In 2002, a national shortage of piperacillin-tazobactam took place. Reduced rates of vancomycin-resistant enterococci (VRE) and Clostridium difficile-associated diarrhea (CDAD) infections have been observed with increased use of β-lactamase inhibitor combinations and a concomitant reduction in the use of third-generation cephalosporins, clindamycin, and vancomycin. Consequently, the unavailability of piperacillin-tazobactam was anticipated to be associated with an increase in the rate of VRE and CDAD infections. A significant increase in the rate of CDAD associated with the piperacillin-tazobactam shortage was reported. The authors suggested that the increase in CDAD was associated with a concomitant increase in the use of cephalosporin antibacterial agents. Other investigators similarly noted an increased rate of CDAD associated with the piperacillin-tazobactam shortage. As with the former investigation, the latter study suggested that an increased use of cefotaxime contributed to the observed increase in CDAD.
Similar to these institutions, the University of California-San Francisco (UCSF) Medical Center experienced shortages in the availability of piperacillin-tazobactam in 2002. The objectives of our study were to determine the impact of the piperacillin-tazobactam shortage on antimicrobial prescribing and on the rate of CDAD and VRE infections. Considering the previously reported reduction of VRE and CDAD infections associated with increased usage of piperacillin-tazobactam, we proposed that the shortage would be associated with an increased rate of hospital infection due to these pathogens.
