Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians

Adi V Gundlapalli, Susan E Beekmann, Donald R Graham, Philip M Polgreen, Members of the Emerging Infections Network, Adi V Gundlapalli, Susan E Beekmann, Donald R Graham, Philip M Polgreen, Members of the Emerging Infections Network

Abstract

Background: In 2012, the US Food and Drug Administration (FDA) required drug manufacturers to give advance notice of impending drug shortages. A survey of infectious diseases (ID) physicians was undertaken to determine the impact of this requirement and to follow-up on prior perceptions of ID physicians on shortages of antimicrobial agents.

Methods: We used a web-based survey of ID physician members of the Emerging Infections Network in 2016.

Results: Of the 701 of 1597 members (44%) who responded, 70% reported the need to modify their antimicrobial choice because of a shortage in the prior 2 years. A majority (73%) reported the shortages affected patient care or outcomes by the use of broader-spectrum (75%), more costly (58%), less effective second-line (45%), or more toxic agents (37%). The most commonly reported antimicrobials in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, and cefepime. Respondents learned of shortages from hospital notification, from a colleague, contact from pharmacy after ordering the agent in short supply, or FDA or other website. The antimicrobial stewardship programs (ASPs) of a majority (83%) of respondents' institutions had developed approaches to deal with shortages. Although 71% indicated that communications were sufficient, most (87%) did not perceive any improvement in communications about shortages since the 2012 FDA requirement.

Conclusions: The persistence of antimicrobial agent shortages reported by ID physicians is disturbing as is the resulting need to use broader-spectrum or more toxic agents. The prominent role of ASPs in helping to deal with shortages, effective communication channels, and the lack of perceived improvement in FDA's communication strategy merit further consideration.

Keywords: antimicrobial agents; patient safety; shortages.

References

    1. Sparling PF. Shortages of antibiotics, antivirals, and vaccines threaten the public health. Clin Infect Dis 2001; 33:1502–3.
    1. Strausbaugh LJ, Jernigan DB, Liedtke LA et al. . National shortages of antimicrobial agents: results of 2 surveys from the Infectious Diseases Society of America Emerging Infections Network. Clin Infect Dis 2001; 33:1495–501.
    1. Shoham S, Antar AA, Auwaerter PG et al. . Antimicrobial access in the 21st century: delays and critical shortages. Ann Intern Med 2016; doi: 10.7326/M15-3076.
    1. Quadri F, Mazer-Amirshahi M, Fox ER et al. . Antibacterial drug shortages from 2001 to 2013: implications for clinical practice. Clin Infect Dis 2015; 60:1737–42.
    1. Griffith MM, Pentoney Z, Scheetz MH. Antimicrobial drug shortages: a crisis amidst the epidemic and the need for antimicrobial stewardship efforts to lessen the effects. Pharmacotherapy 2012; 32:665–7.
    1. US Food and Drug Administration (FDA). Drug Shortages. Available at: . Accessed 17 February 2018.
    1. American Society of Health-System Pharmacists. Current Shortages: Information on Drug Product Shortages and Management. Available at: . Accessed 17 February 2018.
    1. McLaughlin MM, Skoglund E, Pentoney Z, Scheetz MH. Developing a method for reporting patient harm due to antimicrobial shortages. Infect Dis Ther 2014; 3:349–55.
    1. Gundlapalli AV, Beekmann SE, Graham DR, Polgreen PM et al. . Perspectives and concerns regarding antimicrobial agent shortages among infectious disease specialists. Diagn Microbiol Infect Dis 2013; 75:256–9.
    1. Caulder CR, Mehta B, Bookstaver PB et al. . Impact of drug shortages on health system pharmacies in the Southeastern United States. Hosp Pharm 2015; 50:279–86.
    1. US Food and Drug Administration (FDA). U.S. Food & Drug Administration. Food and Drug Administration Safety and Innovation Act (FDASIA). Available at: . Accessed 25 August 2017.
    1. McLaughlin MM, Pentoney Z, Skoglund E, Scheetz MH. Projections for antiinfective drug shortages and time to actual resolution. Am J Health Syst Pharm 2014; 71:2074–8.
    1. Pillai SK, Beekmann SE, Santibanez S, Polgreen PM. The Infectious Diseases Society of America emerging infections network: bridging the gap between clinical infectious diseases and public health. Clin Infect Dis 2014; 58:991–6.
    1. World Health Organization (WHO). Antibacterial Agents in Clinical Development: An Analysis of the Antibacterial Clinical Development Pipeline, Including Tuberculosis. Geneva: World Health Organization; 2017.
    1. Peloquin CA. Shortages of antimycobacterial drugs. N Engl J Med 1992; 326:714.
    1. Centers for Disease Control and Prevention (CDC). Impact of a shortage of first-line antituberculosis medication on tuberculosis control—United States, 2012–2013. MMWR Morb Mortal Wkly Rep 2013; 62:398–400.
    1. Centers for Disease Control and Prevention (CDC). Interruptions in supplies of second-line antituberculosis drugs—United States, 2005–2012. MMWR Morb Mortal Wkly Rep 2013; 62:23–6.
    1. Scott JC, Shah N, Porco T, Flood J. Cost resulting from anti-tuberculosis drug shortages in the United States: a Hypothetical Cohort Study. PLoS One 2015; 10:e0134597.
    1. Pauwels K, Simoens S, Casteels M, Huys I. Insights into European drug shortages: a survey of hospital pharmacists. PLoS One 2015; 10:e0119322.
    1. Plüss-Suard C, Pannatier A, Ruffieux C et al. . Changes in the use of broad-spectrum antibiotics after cefepime shortage: a time series analysis. Antimicrob Agents Chemother 2012; 56:989–94.
    1. United States Government Accountability Office. Certain Factors Are Strongly Associated with This Persistent Public Health Challenge. Vol. GAO-16–595. Washington, DC: Government Accountability Office, 2016.

Source: PubMed

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