The authors declare that they have no competing interests.
Authors PL and JV recorded the following characteristics for each patient: age, sex, and the number of prescriptions. In addition, the incidence of unlicensed and off-label prescription of drugs was recorded and the drugs most commonly prescribed were identified. Author PL as well created all tables and drafted the manuscript. Author KU revised the results and the manuscript. All authors read and approved the final manuscript.
Many common drugs have not been licensed for use in children.
This study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Pediatrics during a period of six months. A total of 8,559 prescriptions for 4,282 children were processed.
Off-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respectively. Unlicensed prescriptions were significantly more common in boys (1.5%) than in girls (1.0%) (p = 0.037). There was no significant difference between off-label prescriptions in boys (9.0%) and in girls (9.1%) (p = 0.89). The prescription of unlicensed drugs was significantly more frequent in school age children (p < 0.0001). The most commonly prescribed unlicensed drugs were angiotensin-converting enzyme inhibitors; among off-label drugs, antihistamines and bronchodilators.
This study shows that the incidence of unlicensed and off-label drug prescriptions in our patients is not as high as in other studies.
Strnadová V: O čem se diskutuje v oblasti klinických studií. Klin Farmakol Farm. 2007, 21 (3–4): 119-121.
European Medicines Agency: The European paediatric initiative: History of the Paediatric Regulation. 2007, London: EMEA, Doc. Ref: EMEA/17967/04 Rev 1
Grantham JJ, Nair V, Winklhoffer F: Cystic diseases of the kidney. Brenner & Rector’s The Kidney. Vol. 2. Edited by: Brenner BM. 2000, Philadelphia: WB Saunders Company, 1699-1730. 6
Del Cuvillo A, Sastre J, Montoro J, Jáuregui I, Ferrer M, Dávila I: Use of antihistamines in pediatrics. J Investig Allergol Clin Immunol. 2007, 17 (Suppl 2): 28-40. PubMed
- Incidence of unlicensed and off-label prescription in children
- BioMed Central
Neu im Fachgebiet Pädiatrie
Meistgelesene Bücher aus dem Fachgebiet
Mail Icon II