The awareness among paediatricians of off-label prescribing in children: a survey of Italian hospitals.
OBJECTIVE
To investigate paediatricians' perception and awareness of off-label (OL) and unlicensed drug usage in clinical practice.


METHODS
We conducted a questionnaire-based, observational study involving 28 departments/specialty units of four tertiary paediatrics Italian hospitals. The questionnaire was sent to a designated paediatrician in each department/specialty 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.


RESULTS
A total of 95 drugs were identified. The most common perceived reasons detected for OL use were age and formulation. Corticosteroids, ACE-inhibitors, beta-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".


CONCLUSIONS
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.
Marchetti
Federico
F
Department of Paediatrics, Institute of Child Health, IRCCS Burlo Garofolo and University of Trieste, Via dell'Istria 65/1, 34100 Trieste, Italy. fedemarche@tin.it
Bua
Jenny
J
Ventura
Alessandro
A
Notarangelo
Luigi D
LD
Di Maio
Salvatore
S
Migliore
Giuseppina
G
Bonati
Maurizio
M
D001291:Attitude of Health Personnel; D002648:Child; D002983:Clinical Competence; D017277:Drug Approval; D004348:Drug Labeling; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D004363:Drug Utilization / Q000706:statistics & numerical data; D006776:Hospitals, Pediatric / Q000706:statistics & numerical data*; D006801:Humans; D007558:Italy; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires
D004364:Pharmaceutical Preparations