Antibacterial Drug Shortages From 2001 to 2013: Implications for Clinical Practice

Quadri, Farha; Mazer‐Amirshahi, Maryann; Fox, Erin R.; Hawley, Kristy L.; Pines, Jesse M.; Zocchi, Mark S.; May, Larissa

doi:10.1093/cid/civ201

Cited by 67 publications

(43 citation statements)

References 13 publications

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“…The impact of drug shortages is critical to antibiotic prescribing since 15% of all drug shortages are attributed to anti‐infective agents (Quadri et al . ). The FDA's approval of new antimicrobial drugs spurs hope for the future.…”

Section: Resultsmentioning

confidence: 97%

Combating antibiotic resistance, mitigating future threats and ongoing initiatives

Velez

Sloand

2016

Journal of Clinical Nursing

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Section: Resultsmentioning

confidence: 97%

Combating antibiotic resistance, mitigating future threats and ongoing initiatives

Velez

Sloand

2016

Journal of Clinical Nursing

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“…Since bacteria possess or can quickly develop resistance mechanisms to antibiotics [4, 5] it is likely that the useful lifespan of any new antimicrobial will be relatively short-lived. There have also been supply shortages of licensed antimicrobial agents [32]. Thus, there is an urgent need for alternative therapeutic approaches to the treatment of serious GNB infections.…”

Section: Discussionmentioning

confidence: 99%

Phase 1 testing of detoxified LPS/group B meningococcal outer membrane protein vaccine with and without synthetic CPG 7909 adjuvant for the prevention and treatment of sepsis

Cross¹,

Greenberg²,

Billington³

et al. 2015

Vaccine

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Background Gram-negative bacteria (GNB) are a leading cause of nosocomial infection and sepsis. Increasing multi-antibiotic resistance has left clinicians with fewer therapeutic options. Antibodies to GNB lipopolysaccharide (LPS, or endotoxin) have reduced morbidity and mortality as a result of infection and are not subject to the resistance mechanisms deployed by bacteria against antibiotics. In this phase 1 study, we administered a vaccine that elicits antibodies against a highly conserved portion of LPS with and without a CpG oligodeoxynucleotide (ODN) TLR9 agonist as adjuvant. Methods A vaccine composed of the detoxified LPS (dLPS) from E. coli O111:B4 (J5 mutant) non-covalently complexed to group B meningococcal outer membrane protein (OMP). Twenty healthy adult subjects received three doses at 0, 29 and 59 days of antigen (10 μg dLPS) with or without CPG 7909 (250 or 500 μg). Subjects were evaluated for local and systemic adverse effects and laboratory findings. Anti-J5 LPS IgG and IgM antibody levels were measured by electrochemiluminesence. Due to premature study termination, not all subjects received all three doses. Results All vaccine formulations were well-tolerated with no local or systemic events of greater than moderate severity. The vaccine alone group achieved a ≥4-fold “responder” response in IgG and IgM antibody in only one of 6 subjects. In contrast, the vaccine plus CPG 7909 groups appeared to have earlier and more sustained (to 180 days) responses, greater mean-fold increases, and a higher proportion of “responders” achieving ≥4-fold increases over baseline. Conclusions Although the study was halted before all enrolled subjects received all three doses, the J5dLPS/OMP vaccine, with or without CpG adjuvant, was safe and well-tolerated. The inclusion of CpG increased the number of subjects with a ≥4-fold antibody response, evident even after the second of three planned doses. A vaccine comprising J5dLPS/OMP antigen with CpG adjuvant merits further investigation.

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“…Insufficient sedation may result in patient discomfort and unplanned selfextubation of mechanically ventilated patients, which is harmful to patients and places staff at risk of disease transmission. Supervising Editor: Mark B. Mycyk, MD Multifocal pneumonia and sepsis will require treatment with antibiotics and vasopressors, which have also already been affected by drug shortages [2,3]. Although chloroquine and hydroxychloroquine recently received emergency use authorization from the Strategic National Stockpile by the Food and Drug Administration for COVID-19 treatment, there are already reported shortages of these medications.…”

Section: Covid-19 Drug Shortagesmentioning

confidence: 99%

“…In recent years, shortages of drugs and basic medical supplies-including saline solutions and sterile water-have affected all medical specialties [1][2][3][4][5]. Historically, prescription drug shortages primarily impact generic injectable products and are commonly caused by quality problems at production sites [1][2][3][4][5][6].…”

Section: Introductionmentioning

confidence: 99%

ACMT Position Statement: Medication Shortages During Coronavirus Disease Pandemic

et al. 2020

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Prescription drug shortages are a major public health problem, and the coronavirus disease 2019 (COVID-19) pandemic has the potential to further precipitate critical shortages of essential medications. These shortages may compromise quality of care and pose a threat to patient safety at a time when the healthcare system is overwhelmed by critically ill patients. The American College of Medical Toxicology (ACMT) calls upon stakeholders to implement measures to ensure patient safety and access to medications in the setting of this unprecedented global pandemic.

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Antibacterial Drug Shortages From 2001 to 2013: Implications for Clinical Practice

Abstract: There were a substantial number of drug shortages from 2001 to 2013, with a dramatic rise in shortages since 2007. Shortages of agents used to treat multidrug-resistant infections are of concern due to continued transmission and limited treatment options.

Cited by 67 publications

References 13 publications

Combating antibiotic resistance, mitigating future threats and ongoing initiatives

Combating antibiotic resistance, mitigating future threats and ongoing initiatives

Phase 1 testing of detoxified LPS/group B meningococcal outer membrane protein vaccine with and without synthetic CPG 7909 adjuvant for the prevention and treatment of sepsis

ACMT Position Statement: Medication Shortages During Coronavirus Disease Pandemic

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