A systematic review of antibiotic drug shortages and the strategies employed for managing these shortages.

Active pharmaceutical ingredient antibiotic shortages medicines supply chains stockouts

Journal

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
ISSN: 1469-0691
Titre abrégé: Clin Microbiol Infect
Pays: England
ID NLM: 9516420

Informations de publication

Date de publication:
26 Sep 2024
Historique:
received: 10 06 2024
revised: 15 09 2024
accepted: 23 09 2024
medline: 29 9 2024
pubmed: 29 9 2024
entrez: 28 9 2024
Statut: aheadofprint

Résumé

There is a need to examine the impact of increasingly prevalent antibiotic shortages on patient outcomes and on the emergence and spread of antimicrobial resistance (AMR). To: 1) assess patterns and causes of shortages, 2) investigate the effect of shortages on health systems and patient outcomes, and 3) identify strategies for forecasting and managing shortages. PubMed/MEDLINE, EMBASE, Scopus, and Web of Science. Studies published in English during January 2000-July 2023. Healthcare, policy and strategic teams managing and responding to shortages. Patient populations (adult and children) affected by shortages. Strategies, policies, and mitigation options for managing and responding to antibiotic drug shortages. Methodological quality of included studies was reviewed using the most appropriate tool from Joanna Briggs Institute critical appraisal tool for each study design. Data synthesis was qualitative and quantitative using descriptive statistics. The final analysis included 74 studies (61/74, 82.4% high-income countries). Shortages were most reported for piperacillin-tazobactam (21/74, 28.4%) with most of the reported antibiotics being in the WHO Watch category (27/54, 51%). Frequent cause of shortages was disruption in manufacturing including supply of active pharmaceutical ingredient and raw materials. Clinical implications of shortages included increased length of hospital stay, treatment failure after using inferior alternative agents and negative impact on antimicrobial stewardship programmes (AMS). Robust economic impact analysis of shortages is unavailable. Successfully reported mitigation strategies were driven by AMS and infectious diseases teams in hospitals. Antibiotic shortages are directly or indirectly driven by economic viability and reliance on single source ingredients. The limited data on clinical outcomes indicates mixed effect with some infections becoming more difficult to treat, though there is no robust data on the impact of shortages on AMR. The mitigation strategies to manage shortages rely heavily on AMS teams.

Sections du résumé

BACKGROUND BACKGROUND
There is a need to examine the impact of increasingly prevalent antibiotic shortages on patient outcomes and on the emergence and spread of antimicrobial resistance (AMR).
OBJECTIVES OBJECTIVE
To: 1) assess patterns and causes of shortages, 2) investigate the effect of shortages on health systems and patient outcomes, and 3) identify strategies for forecasting and managing shortages.
DATA SOURCES METHODS
PubMed/MEDLINE, EMBASE, Scopus, and Web of Science.
STUDY ELIGIBILITY CRITERIA METHODS
Studies published in English during January 2000-July 2023.
PARTICIPANTS METHODS
Healthcare, policy and strategic teams managing and responding to shortages. Patient populations (adult and children) affected by shortages.
INTERVENTIONS METHODS
Strategies, policies, and mitigation options for managing and responding to antibiotic drug shortages.
RISK OF BIAS UNASSIGNED
Methodological quality of included studies was reviewed using the most appropriate tool from Joanna Briggs Institute critical appraisal tool for each study design.
METHODS METHODS
Data synthesis was qualitative and quantitative using descriptive statistics.
RESULTS RESULTS
The final analysis included 74 studies (61/74, 82.4% high-income countries). Shortages were most reported for piperacillin-tazobactam (21/74, 28.4%) with most of the reported antibiotics being in the WHO Watch category (27/54, 51%). Frequent cause of shortages was disruption in manufacturing including supply of active pharmaceutical ingredient and raw materials. Clinical implications of shortages included increased length of hospital stay, treatment failure after using inferior alternative agents and negative impact on antimicrobial stewardship programmes (AMS). Robust economic impact analysis of shortages is unavailable. Successfully reported mitigation strategies were driven by AMS and infectious diseases teams in hospitals.
CONCLUSIONS CONCLUSIONS
Antibiotic shortages are directly or indirectly driven by economic viability and reliance on single source ingredients. The limited data on clinical outcomes indicates mixed effect with some infections becoming more difficult to treat, though there is no robust data on the impact of shortages on AMR. The mitigation strategies to manage shortages rely heavily on AMS teams.

Identifiants

pubmed: 39341418
pii: S1198-743X(24)00455-5
doi: 10.1016/j.cmi.2024.09.023
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Auteurs

Avaneesh Kumar Pandey (AK)

Clinical Pharmacology Unit, Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Jennifer Cohn (J)

The Global Antibiotic Research and Development Partnership, Geneva, Switzerland.

Vrinda Nampoothiri (V)

Department of Medical Administration, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Faridabad, Haryana, India.

Uttara Gadde (U)

University of Pennsylvania, USA.

Amrita Ghataure (A)

Health Protection Research Unit in Healthcare Associated infections and Antimicrobial Resistance, Department of Medicine, Imperial College London, UK.

Ashish Kumar Kakkar (AK)

Clinical Pharmacology Unit, Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Yogendra Kumar Gupta (Y)

Global Antibiotics Research and Development Partnership (GARDP), India; All India Institute of Medical Sciences (AIIMS), Jammu, India.

Samir Malhotra (S)

Clinical Pharmacology Unit, Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Oluchi Mbamalu (O)

Division of Infectious Diseases & HIV Medicine, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.

Marc Mendelson (M)

Division of Infectious Diseases & HIV Medicine, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.

Anne-Grete Märtson (AG)

Leiden Academic Centre for Drug Research (LACDR) Leiden University.

Sanjeev Singh (S)

Department of Medical Administration, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Faridabad, Haryana, India.

Thomas Tängdén (T)

Department of Medical Sciences, Uppsala University, Uppsala, Sweden.

Nusrat Shafiq (N)

Clinical Pharmacology Unit, Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Esmita Charani (E)

Division of Infectious Diseases & HIV Medicine, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa; Faculty of Health and Medical Sciences, University of Liverpool, Liverpool, United Kingdom. Electronic address: esmita.charani@uct.ac.za.

Classifications MeSH