Unlicensed and off-label antibiotic use in a paediatric city hospital in Russia

Abstract number: R2358

Ratchina S., Belokhvostova A., Konovalova L., Zharkova L.

Objectives: To determine the proportion of unlicensed and off-label antibiotic prescriptions in hospitalised paediatric patients.

Methods: All antibiotic prescriptions to children admitted to neonatology unit and three medical units for toddlers, school-age children and teenagers were prospectively recorded from 1st of January to 30th of June 2006. Categories of unlicensed use included: 1. unlicensed medicines imported from foreign countries; 2. adult preparations that is not suitable for children; 3. modifications to licensed drugs formulation; 4. use of chemicals as drugs; 5. medicines prepared or modified by hospital pharmacy. Prescriptions were considered off-label in the following cases: 1. use for indication not described in the licence; 2. use when product is contraindicated; 3. administration outside the age range; 4. use of wrong dose, frequency or alternative routs of administration. Package inserts and National Drug Register edited in 2004 were used as reference sources.

Results: Four hundred sixty nine patients aged from five days to 18 years (55.3% female, median age 8.9 years) were included in the study. A total of 469 antibiotic prescriptions were written for the patients. Antibiotics were prescribed to 51% of children in neonatology unit, to 34%, 41% and 56% of toddlers, school-age children and teenagers, respectively. In 93% of cases antibiotics were written by attending paediatrician, followed by doctor on call (3.2%) and clinical pharmacologist (3.2%). There were no cases of unlicensed antibiotic use recorded. The incidence of off-label prescriptions was the highest in neonatology wards (49%) and decreased with age (28%, 10% and 11% in toddlers, school-age children and teenagers, respectively). Off-label use due to unproved indication was registered in 38% of cases; it was related to dose and frequency of administration, age limitations in 36% and 26% of prescriptions, respectively.

Conclusion: The practice of off-label antibiotic use was quite common in hospitalised children in Russia especially in neonatal wards. These findings underline the importance of research on antibiotic use in paediatric population as well as additional efforts to improve the quality of their prescribing within the licence.

Session Details

Date: 19/04/2008
Time: 00:00-00:00
Session name: 18th European Congress of Clinical Microbiology and Infectious Diseases
Location: Barcelona, Spain
Presentation type:
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