Does the use of new cephalosporins follow the authorised, financed and approved indications? A study of their use in routine clinical practice in a tertiary hospital. 2022

Andrés Pintado-Álvarez, and Lucia Yunquera-Romero, and Ignacio Márquez-Gómez, and Rocío Asensi-Díez
Hospital Pharmacy, Hospital Regional Universitario de Malaga, Malaga, Andalucía, Spain.

To evaluate the appropriateness of ceftazidime-avibactam (C-A), ceftolozane-tazobactam (C-T) and ceftaroline prescriptions according to European Medicines Agency (EMA)/Spanish Agency of Medicines and Medical Devices (AEMPS) approved indications, financed indications in the Spanish health system and hospital Infection Commission (IC) recommendations in a tertiary hospital. Observational, descriptive and retrospective study of inpatients aged ≥18 years, who were prescribed the above-mentioned antimicrobials during the period January-December 2020. Variables obtained were demographic (sex and age), pharmacological (antibiotic, use - empiric or targeted, indication) and microbiological (sensitivity testing and antibiotic tested) data. A total of 79 patients were included. C-A (n=40): 67.5% of patients were male, with a mean age of 61 (range 22-87) years. Empiric treatment was applied in 30% of the cases (n=12). De-escalation in 33.33% of individuals. Sensitivity testing was done in 92.86% of patients, including C-A in 57.69% of them. C-T (n=19): 89.47% of patients were male, with a mean age of 65 (range 18-82) years. An empiric approach was followed in 5.26% of subjects; de-escalation was performed in all cases due to culture with multidrug-resistant (MDR) Pseudomonas aeruginosa. Sensitivity testing was carried out in 100% of patients, including C-T in 26.32% of them. Ceftaroline (n=20): 70% of patients were male, with a mean age of 55.5 (range 23-79) years. Empiric treatment was applied to 30% of cases. In 50% of these subjects de-escalation was done. Sensitivity testing was done in 92.85% of them, but in none with ceftaroline. Regarding the percentage of appropriateness: approved EMA/AEMPS indications: C-A: 100%; C-T: 84.21%; ceftaroline: 75%; financed indications in the Spanish health system: C-A: 85%; C-T: 100%; ceftaroline: 15%; IC: C-A: 60%; C-T: 57.9%; ceftaroline: 15%. Our results highlight the importance of stewardship programmes in the decision-making process and in the follow-up of patients with infections caused by MDR microorganisms.

UI MeSH Term Description Entries
D008297 Male Males
D008826 Microbial Sensitivity Tests Any tests that demonstrate the relative efficacy of different chemotherapeutic agents against specific microorganisms (i.e., bacteria, fungi, viruses). Bacterial Sensitivity Tests,Drug Sensitivity Assay, Microbial,Minimum Inhibitory Concentration,Antibacterial Susceptibility Breakpoint Determination,Antibiogram,Antimicrobial Susceptibility Breakpoint Determination,Bacterial Sensitivity Test,Breakpoint Determination, Antibacterial Susceptibility,Breakpoint Determination, Antimicrobial Susceptibility,Fungal Drug Sensitivity Tests,Fungus Drug Sensitivity Tests,Sensitivity Test, Bacterial,Sensitivity Tests, Bacterial,Test, Bacterial Sensitivity,Tests, Bacterial Sensitivity,Viral Drug Sensitivity Tests,Virus Drug Sensitivity Tests,Antibiograms,Concentration, Minimum Inhibitory,Concentrations, Minimum Inhibitory,Inhibitory Concentration, Minimum,Inhibitory Concentrations, Minimum,Microbial Sensitivity Test,Minimum Inhibitory Concentrations,Sensitivity Test, Microbial,Sensitivity Tests, Microbial,Test, Microbial Sensitivity,Tests, Microbial Sensitivity
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011550 Pseudomonas aeruginosa A species of gram-negative, aerobic, rod-shaped bacteria commonly isolated from clinical specimens (wound, burn, and urinary tract infections). It is also found widely distributed in soil and water. P. aeruginosa is a major agent of nosocomial infection. Bacillus aeruginosus,Bacillus pyocyaneus,Bacterium aeruginosum,Bacterium pyocyaneum,Micrococcus pyocyaneus,Pseudomonas polycolor,Pseudomonas pyocyanea
D002511 Cephalosporins A group of broad-spectrum antibiotics first isolated from the Mediterranean fungus ACREMONIUM. They contain the beta-lactam moiety thia-azabicyclo-octenecarboxylic acid also called 7-aminocephalosporanic acid. Antibiotics, Cephalosporin,Cephalosporanic Acid,Cephalosporin,Cephalosporin Antibiotic,Cephalosporanic Acids,Acid, Cephalosporanic,Acids, Cephalosporanic,Antibiotic, Cephalosporin,Cephalosporin Antibiotics
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D000369 Aged, 80 and over Persons 80 years of age and older. Oldest Old

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