Antimicrobial Access in the 21st Century: Delays and Critical Shortages
Authors: Shmuel Shoham, Annukka A.R. Antar, Paul G. Auwaerter, Christine M. Durand, Mark S. Sulkowski, Deborah J. Cotton
Journal: Annals of Internal Medicine (2016)

Ideas and Opinions5 July 2016Antimicrobial Access in the 21st Century: Delays and Critical ShortagesShmuel Shoham, MD, Annukka A.R. Antar, MD, PhD, Paul G. Auwaerter, MD, MBA, Christine M. Durand, MD, Mark S. Sulkowski, MD, and Deborah J. Cotton, MD, MPHShmuel Shoham, MDFrom Johns Hopkins University School of Medicine, Baltimore, Maryland, and Boston University School of Medicine, Boston, Massachusetts.Search for more papers by this author, Annukka A.R. Antar, MD, PhDFrom Johns Hopkins University School of Medicine, Baltimore, Maryland, and Boston University School of Medicine, Boston, Massachusetts.Search for more papers by this author, Paul G. Auwaerter, MD, MBAFrom Johns Hopkins University School of Medicine, Baltimore, Maryland, and Boston University School of Medicine, Boston, Massachusetts.Search for more papers by this author, Christine M. Durand, MDFrom Johns Hopkins University School of Medicine, Baltimore, Maryland, and Boston University School of Medicine, Boston, Massachusetts.Search for more papers by this author, Mark S. Sulkowski, MDFrom Johns Hopkins University School of Medicine, Baltimore, Maryland, and Boston University School of Medicine, Boston, Massachusetts.Search for more papers by this author, and Deborah J. Cotton, MD, MPHFrom Johns Hopkins University School of Medicine, Baltimore, Maryland, and Boston University School of Medicine, Boston, Massachusetts.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-3076 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail A young woman with a bone marrow transplant and relapsed leukemia is placed on a regimen of the antibiotic imipenem–cilastatin due to a shortage of meropenem, the preferred drug. She has a seizure, a known complication that is more common with imipenem–cilastatin. An elderly kidney transplant recipient has an interruption in maintenance pyrimethamine therapy for central nervous system toxoplasmosis because of a substantial increase in the cost of the drug. Her encephalopathy recurs. These cases point to failures in the antimicrobial supply chain. Transplant patients frequently develop infections and often require treatment with several anti-infectives. Such immunosuppressed patients are the ...References1. U.S. Government Accountability Office. Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability. Report to Congressional Addressees no. GAO-14-194. Washington, DC: U.S. Government Accountability Office; 2014. Google Scholar2. Quadri F, Mazer-Amirshahi M, Fox ER, Hawley KL, Pines JM, Zocchi MS, et al. Antibacterial drug shortages from 2001 to 2013: implications for clinical practice. Clin Infect Dis. 2015;60:1737-42. [PMID: 25908680] doi:10.1093/cid/civ201 CrossrefMedlineGoogle Scholar3. Meropenem injection. American Society of Health-System Pharmacists. 2016. Accessed at www.ashp.org/menu/DrugShortages/CurrentShortages/bulletin.aspx?id=969 on 29 January 2016. Google Scholar4. U.S. Food and Drug Administration. Strategic Plan for Preventing and Mitigating Drug Shortages. Silver Spring, MD: U.S. Food and Drug Administration; 2013. Google Scholar5. Calderwood SB, Adimora A; Infectious Diseases Society of America; HIV Medicine Association. Letter to Turing Pharmaceuticals (Tom Evegan and Kevin Bernier) on Pyrimethamine. 8 September 2015. Accessed at www.hivma.org/uploadedFiles/HIVMA/HomePageContent/PyrimethamineLetterFINAL.pdf on 29 January 2016. Google Scholar6. Rockoff JD. Nonprofit reacquires rights to tuberculosis drug after hefty price hike. The Wall Street Journal. 21 September 2015. Google Scholar7. Alpern JD, Stauffer WM, Kesselheim AS. High-cost generic drugs—implications for patients and policymakers. N Engl J Med. 2014;371:1859-62. [PMID: 25390739] doi:10.1056/NEJMp1408376 CrossrefMedlineGoogle Scholar8. An Open Appeal to Turing Pharmaceuticals. HIV Medicine Association. 22 October 2015. Accessed at www.hivma.org/uploadedFiles/HIVMA/HomePageContent/Turing_Open_Letter.pdf on 29 January 2016. Google Scholar9. American Society of Health-System Pharmacists. 2014 Drug Shortages Summit. Bethesda, MD: American Society of Health-System Pharmacists; 2014. Google Scholar10. Why Are Some Generic Drugs Skyrocketing in Price?, 113th Cong, 2nd Sess (2014) (testimony of Aaron S. Kesselheim, MD). Google Scholar Author, Article, and Disclosure InformationAffiliations: From Johns Hopkins University School of Medicine, Baltimore, Maryland, and Boston University School of Medicine, Boston, Massachusetts.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-3076.Corresponding Author: Shmuel Shoham, MD, Division of Infectious Diseases, Johns Hopkins University School of Medicine, 1830 East Monument Street, Room 447, Baltimore, MD 21205; e-mail, [email protected]edu.Current Author Addresses: Dr. Shoham: Division of Infectious Diseases, Johns Hopkins University School of Medicine, 1830 East Monument Street, Room 447, Baltimore, MD 21205.Dr. Antar: Division of Infectious Diseases, Johns Hopkins University School of Medicine, 1830 East Monument Street, Room 450-B, Baltimore, MD 21205.Dr. Auwaerter: The Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases, Johns Hopkins Medicine, 725 North Wolfe Street, PTCB - Room 231, Baltimore, MD 21287.Dr. Durand: Division of Infectious Diseases, Johns Hopkins University School of Medicine, 1830 East Monument Street, Room 450-D, Baltimore, MD 21205.Dr. Sulkowski: Division of Infectious Diseases, Johns Hopkins University School of Medicine, 1830 East Monument Street, Room 445, Baltimore, MD 21205.Dr. Cotton: Boston University School of Medicine, One Boston Medical Center Place, Dowling 3 North, 3118, Boston, MA 02118. Author Contributions: Conception and design: S. Shoham, A.A.R. Antar.Analysis and interpretation of the data: S. Shoham.Drafting of the article: S. Shoham, A.A.R. Antar, P.G. Auwaerter, C.M. Durand, M.S. Sulkowski.Critical revision of the article for important intellectual content: S. Shoham, A.A.R. Antar, P.G. Auwaerter, M.S. Sulkowski, D.J. Cotton.Final approval of the article: S. Shoham, A.A.R. Antar, P.G. Auwaerter, C.M. Durand, M.S. Sulkowski, D.J. Cotton.Administrative, technical, or logistic support: S. Shoham.Collection and assembly of data: A.A.R. Antar.This article was published at www.annals.org on 22 March 2016. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byCritical National Shortage of Cefazolin in Japan: Management StrategiesAntimicrobial Resistance and Social Inequalities in Health: Considerations of JusticeAntimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians 5 July 2016Volume 165, Issue 1Page: 53-54KeywordsAntimicrobialsDisclosureDrug administrationDrug pricesDrugsFood and Drug AdministrationInfectious diseasesMotivationPyrimethamineToxoplasmosis ePublished: 22 March 2016 Issue Published: 5 July 2016 Copyright & PermissionsCopyright © 2016 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...