The awareness among paediatricians of off-label prescribing in children: a survey of Italian hospitals
- 170 Downloads
To investigate paediatricians’ perception and awareness of off-label (OL) and unlicensed drug usage in clinical practice.
We conducted a questionnaire-based, observational study involving 28 departments/speciality units of four tertiary paediatrics Italian hospitals. The questionnaire was sent to a designated paediatrician in each department/speciality unit with the request that they summarise their awareness of OL prescriptions after a group discussion with all paediatricians working in the same department/unit.
A total of 95 drugs were identified. The most common perceived reasons detected for OL use were age and formulation. Corticosteroids, ACE-inhibitors, β-blockers and calcium-antagonists were most frequently indicated as OL for formulation, while ACE-inhibitors, new generation anti-epilepsy drugs, immunosuppressants, ketorolac and propofol as OL for age. Adrenaline, midazolam and ACE-inhibitors were indicated as unlicensed for route of administration. We found a high concordance between the OL drugs identified by physicians and those reported in the “Italian Summary Product Characteristics”.
Italian paediatricians perceived different drugs as unlicensed/OL from those identified by existing prescriptions studies. These perceived drugs may represent a priority in tackling the problem of OL usage in the hospital practice. The review of the Italian Summary Product Characteristics of some of the drugs identified, together with the monitoring of permanent clinical practice and with new clinical research, may be a step forward to reduce OL use in children.
KeywordsOff-label drugs Children Hospital-based survey
- 11.Repertorio Farmaceutico Italiano, REFI (2006) Masson, Elsevier Company, MilanGoogle Scholar
- 13.Richard DA, Nousia-Arvanitakis S, Sollich V, Hampel BJ, Sommerauer B, Schaad UB (1997) Oral ciprofloxacin vs. intravenous ceftazidime plus tobramycin in pediatric cystic fibrosis patients: comparison of antipseudomonas efficacy and assessment of safety with ultrasonography and magnetic resonance imaging. Cystic Fibrosis Study Group. Pediatr Infect Dis J 16(6):572–578PubMedCrossRefGoogle Scholar
- 24.McIntyre J, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, Martland T, Berry K, Collier J, Smith S, Choonara I (2005) Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet 366(9481):205–210PubMedCrossRefGoogle Scholar
- 26.European Medicines Agency (2004) Medicines for children: The European Paediatric Initiative. Oct 26, http://www.emea.eu.int/htms/human/peg/pegfaq.htm. Cited 14 Oct 2005