Unlicensed and off-label use of medicines at a neonatology clinic in Italy
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Many drugs used for children are not licensed or are used off-label. An increased risk of medication errors and unexpected adverse drug reactions (ADR) associated with off-label and unlicensed drug prescription has been reported. This risk increases in the newborn, who are more likely to be predisposed to an ADR due to their physiological immaturity. The objective of this study was to describe the use of unlicensed or off-label drugs in a Neonatal Intensive Care Unit (NICU).
All drugs prescribed to newborn admitted to the Neonatology Unit of Bari University Hospital, from July 1st to August 31st in 2004 were recorded.
Main outcome measures
All the drugs prescribed were analysed with regard to their license status, then the licensed drugs were compared to the indications, dose, route of administration, duration of treatment, contraindications and warnings specified in the summary of product characteristics of the marketing authorization.
Data were collected on 176 prescriptions for 61 different drugs given to 34 newborns. Drugs were licensed in 88% and unlicensed in 12% of cases. About the licensed drugs, in 37.5% medicines were used following the terms of the marketing authorization, in 22.7% of cases medicines were used in an off-label manner as they contained no information for paediatric use in the marketing authorization and in 27.8% of cases medicines were licensed for paediatric use, but they were used off-label with regard to age, dose, route of administration and duration of treatment.
Despite European and American initiatives aiming to promote greater awareness and research in the paediatric population, these data demonstrate that there is still a high percentage of unlicensed or off-label drugs use in neonatology, underlining the need to stimulate scientific data collection by means of experimental studies or outcome research.
KeywordsDrug use Intensive care unit Italy Neonatology Off-label prescribing Unlicensed medicines
The authors would like to thank Babett Pragnell for the support in the translation, Angela Mautone and Michele Lattarulo, the Chief of the Department of Biomedicine of Evolutive Age and the Chief of the Service of Pharmacy, respectively.
- 1.Legislative Decree n. 178 of 1991.Google Scholar
- 3.Law n. 94 of 08 April 1998.Google Scholar
- 14.US Food and Drug Administration. Class labeling for intranasal and orally inhaled corticosteroid containing drug products regarding the potential for growth suppression in children. Division of Pulmonary Drug Product. Rockville, MD: US Food and Drug Administration; November 9,1998. Talk Paper. Available at://www.fda.gov/cder/news/cs_label.htm.Google Scholar
- 15.ICH Topic E11: Clinical investigation of medicinal products in the paediatric population. European Agency for the Evaluation of Medicinal products, 2001.Google Scholar
- 16.Regulations requiring manufactures to assess the safety and effectiveness of new drugs and biological products in paediatric patients: final rule. Federal register 1998:66631–73.Google Scholar
- 17.10th Congress of the United States of America. Best pharmaceuticals for children Act, S.1789 109.Google Scholar
- 18.European Agency for the evaluation of Medicinal Products. Note for guidance on clinical investigation of medical products in children. London: European Agency for the Evaluation of Medicinal products, 1997.Google Scholar
- 19.CINECA—Society interuniversity. Progetto ARNO–Paediatrics, Report 2004. Bologna, Italy: Centauro s.r.l.;2005. ISBN 88-85980-46-5.Google Scholar
- 20.Official Gazette no. 227 29th of September 2005. AIFA: The independent research of drugs financed by AIFA.Google Scholar
- 21.Improving children’s medicines: EU reaches final agreement. IP/06/715; June 01 2006.Google Scholar