[Controversies with the "off label" use of medications in the paediatrics--research on the selected paediatricians].
The "off label" use of medications is not such a rare practice necessary in the treatment of patients in a situation, where there is no medication available which could be used in compliance with registered indications. The aim of the study was to estimate the prevalence of "off label" drug use in pediatrics as well as examining the common views and general knowledge of pediatricians on the matter.


METHODS
we distributed 176 questionnaires composed of 11 questions and received anonymous answers from 103 pediatricians.


RESULTS
70.9% of respondents had come across the term "off label", 38.2% had never consciously used "off label" drugs, and 4.9% could not determine. The most common reason for administering "off label" drugs was in the use of: 1. antipyretic therapy (33.9%), 2. symptomatic respiratory tract infection treatment (29%), 3. antibiotic therapy based on the antibiogram (25.8%). The main consideration in administering the drug were: health needs (47%) and whether it was for the good of a patient (25%). The most important arguments for using "off label" drugs are: the personal conviction of its higher efficiency (47,3%), if its use is life-saving (28%), the results of laboratory or microbiological tests (26.9%) and less adverse reactions (24.7%). 75.5% of respondents check the drug registered indications, 93% is aware of the responsibility, 14% think that the responsibility also rests on the producer of drugs or the supervisor.


CONCLUSIONS
The use of "off label" drugs is common and an inevitable phenomenon in pediatrics, therefore it is necessary to spread knowledge on medical law among pediatricians.
Kuchar
Ernest
E
Katedra i Klinika Pediatrii i Chorób, Infekcyjnych Akademii Medycznej we Wrocławiu. infped@zak.am.wroc.pl
Szenborn
Leszek
L
Rorat
Marta
M
Jurek
Tomasz
T
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002648:Child; D005334:Fever / Q000188:drug therapy; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010372:Pediatrics / Q000706:statistics & numerical data*; D011044:Poland; D011159:Population Surveillance; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D012141:Respiratory Tract Infections / Q000188:drug therapy; D012941:Social Responsibility; D011795:Surveys and Questionnaires
D000900:Anti-Bacterial Agents