Hostname: page-component-586b7cd67f-2plfb Total loading time: 0 Render date: 2024-11-28T23:31:20.948Z Has data issue: false hasContentIssue false

Legal implications of antibiotic stewardship programs

Published online by Cambridge University Press:  13 May 2020

George Maliha
Affiliation:
Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
Mary Ellen Nepps
Affiliation:
University of Pennsylvania, Office of the General Counsel, Philadelphia, Pennsylvania
Pranita D Tamma
Affiliation:
Johns Hopkins University School of Medicine, Baltimore, Maryland
Elizabeth Dodds Ashley
Affiliation:
Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina
Julia E Szymczak
Affiliation:
Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania
Emma Kolesar
Affiliation:
University of Pennsylvania Law School, Philadelphia, Pennsylvania
Keith W Hamilton*
Affiliation:
Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
*
Author for correspondence: Keith W. Hamilton, E-mail: [email protected]

Abstract

Infectious diseases professional societies, public health agencies, and healthcare regulatory agencies call for antibiotic stewardship programs (ASP) in many healthcare settings. However, medical legal implications of these programs remain largely uncharted territory. Although there is no legal precedent addressing issues of liability and standards of care on this subject, anticipating how the courts may assess questions of medical liability with respect to the various components of ASPs is important to define best practices in ASP operations, not only to manage the potential risk but also to improve patient care. This article seeks to address some of the common processes and interventions involved in antibiotic stewardship and the potential professional liability implications of these activities.

Type
SHEA White Paper
Copyright
© 2020 by The Society for Healthcare Epidemiology of America. All rights reserved.

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Barlam, TF, Cosgrove, SE, Abbo, LM, et al. Implementing an antibiotic stewardship program: guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis 2016;62:e51e77.Google Scholar
Black’s Law Dictionary, 11th ed. Eagen, MN: Thompson/West; 2019.Google Scholar
Lee, JD, Lindahl, BA. Modern Tort Law: Liability and Litigation, 2nd ed. Eagan, MN: West; 2018.Google Scholar
Speiser, SM, Krause, CF, Gans, AW. American Law of Torts. Rochester, NY: Lawyers Co-operative; 2019.Google Scholar
Hansen-Turton, T, Ware, J, McClellan, F. Nurse practitioners in primary care. Temple L Rev 2010;82:12351261.Google Scholar
Warren v. Dinter, 926 N.W.2d 370 (Minn. 2019).Google Scholar
Rigelhaupt, JL. What constitutes physician-patient relationship for malpractice purposes. ALR.4th 2019;17:132.Google Scholar
Reform of Requirements for Long-Term Care Facilities. Federal Register: the Daily Journal of the United States Government. A Rule by the Centers for Medicare and Medicaid Service on 10/04/2016. The Federal Register website. https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities. Accessed January 13, 2020.Google Scholar
Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care. Federal Register: the Daily Journal of the United States Government. A Rule by the Centers for Medicare and Medicaid Service on 09/30/2019. The Federal Register website. https://www.federalregister.gov/documents/2019/09/30/2019-20736/medicare-and-medicaid-programs-regulatory-provisions-to-promote-program-efficiency-transparency-and. Accessed January 13, 2020.Google Scholar
Antimicrobial Stewardship Standard. Joint Commission Perspectives 2016;36:14.Google Scholar
Antimicrobial Stewardship in Ambulatory Health Care. R3 Report (23). The Joint Commission website. https://www.jointcommission.org/en/standards/r3-report/r3-report-issue-23-antimicrobial-stewardship-in-ambulatory-health-care/. Accessed January 13, 2020.Google Scholar
National Childhood Vaccine Injury Act of 1986. 42 U.S.C. §§ 300aa-1 to 300aa-34.Google Scholar
Charles v. S. Baptist Hosp. of Fla., Inc., 209 So.3d 1199 (Fla. 2017).Google Scholar
Tibbs v. Bunnell, 448 S.W.3d 796 (Ky. 2014).Google Scholar
Simmons v. Sonyika, 394 F.3d 1335 (11th Cir. 2004).Google Scholar
Van Beek, JL. The future for pharmacists: does physician-pharmacist collaborative practice mean collaborative liability. J Legal Med 2015;36:442458.CrossRefGoogle ScholarPubMed
Albert, E. The case for pharmacists as legal health care providers. Ind Health L Rev 2012;9:187214.Google Scholar
United States v. Willner, 795 F.3d 1297 (11th Cir. 2015).Google Scholar
Collip v. Ratts ex rel. Ratts, 49 N.E.3d 607 (Ind. Ct. App. 2015).Google Scholar
Antimicrobial stewardship requirements for hospitals. Standard MM.09.01.01. January 2017. The Joint Commission website. https://www.jointcommission.org/assets/1/6/AdHoc_HAP_ABX_R3_20160822.pdf. Accessed May 12, 2019.Google Scholar
Wibberley, LEA. Telemedicine in Illinois: untangling the complex legal threads. J Marshall L Rev 2017;50:885.Google Scholar
Kepler, T, McGinty, CL. Telemedicine: how to assess your risks and develop a program that works. AHLA Seminar Papers: Hospitals & Health Systems Law Institute. 2009. CD-ROM.Google Scholar
Levine v. Rosen, 616 A2d 623 (Pa. 1992).CrossRefGoogle Scholar
Mello, MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. U Pa L Rev 2001;149:645.CrossRefGoogle Scholar
Grosso, S. What is reasonable and what can be proved as reasonable: reflections on the role of evidence-based medicine and clinical practice guidelines in medical negligence claims. Ann Health L 2018;27:74.Google Scholar
Conn v. United States, 880 F. Supp. 2d 741 (S.D. Miss. 2012).Google Scholar
Jones v. Chidester, 610 A.2d 964 (Pa. 1992).10.1093/ml/73.4.610CrossRefGoogle Scholar
Core elements of hospital antibiotic stewardship programs. Centers for Disease Control and Prevention website. https://www.cdc.gov/antibiotic-use/healthcare/implementation/core-elements.html. Accessed April 11, 2019.Google Scholar
Bratzler, DW, Dellinger, EP, Olsen, KM, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm 2013;70:195283.10.2146/ajhp120568CrossRefGoogle ScholarPubMed
Freifeld, AG, Bow, EJ, Sepkowitz, KH, et al. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis 2011;52:e56e93.CrossRefGoogle ScholarPubMed
Joyce v. Boulevard Physical Therapy & Rehabilitation Ctr., P.C., 694 A.2d 648 (Pa. Super. Ct. 1997).Google Scholar
Durbin, WA, Lapidas, B, Goldman, DA. Improved antibiotic usage following introduction of a novel prescription system. JAMA 1981;246:17961800.CrossRefGoogle ScholarPubMed
Woodward, RS, Medoff, G, Smith, MD, Gray, JL. Antibiotic cost savings from formulary restrictions and physician monitoring in a medical-school–affiliated hospital. Am J Med 1987;83:817823.CrossRefGoogle Scholar
Singer, MV, Haft, R, Barlam, T, et al. Vancomycin control measures at a tertiary-care hospital: impact of interventions on volume and patterns of use. Infect Control Hosp Epidemiol 1998;19:248253.CrossRefGoogle Scholar
Evans, ME, Millheim, ET, Rapp, RP. Vancomycin use in a university medical center: effect of a vancomycin continuation form. Infect Control Hosp Epidemiol 1999;20:417–20.CrossRefGoogle Scholar
Dreschsler, CT. Liability of physician for lack of diligence in attending patient. ALR 2019;57:379.Google Scholar
Purver, JM. Malpractice: attending physician’s liability for injury caused by equipment furnished by hospital. ALR 2019;35:1068.Google Scholar
Leahy, MCM. Liability for staph and other hospital-acquired infections. Am Jur Proof Facts 2019;106:1.Google Scholar
Thompson v. Nason, 527 Pa. 330, 591 A.2d 703 (1991).Google Scholar
LaRosa, LA, Fishman, NO, Landis, JR, et al. Effect of communication errors during calls to an antimicrobial stewardship program. Infect Control Hosp Epidemiol 2007;28:13741381.Google Scholar
Pegalis, SE. American Law of Medical Malpractice, 3rd ed. Eagen, MN: Thompson/West; 2018.Google Scholar
Penofsky, DJ. Diagnostic radiology malpractice litigation. Am Jur Trials 2019;75:55.Google Scholar
Handelman, EJ. Misdiagnosis of or failure to detect cancer. Am Jur Proof Facts 2019;120:443.Google Scholar
Miller, CJ. Patient’s failure to reveal medical history to physician as contributory negligence or assumption of risk in defense of malpractice action. ALR 2019; ALR 4th; 33:790.Google Scholar
Ey, RM. Cause of action against health care practitioner for negligent failure to refer or consult. Causes Action 2019;20:333.Google Scholar
Supplementary material: File

Maliha et al. supplementary material

Maliha et al. supplementary material

Download Maliha et al. supplementary material(File)
File 47.9 KB