E-drug: Unlicensed and off label drug use in European countries
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[The below abstract is from an article in the most recent BMJ. It not
only points to drug regulatory problems, but also to serious drug
prescribing problems in Europe. I believe that it puts into perspective
the drug regulatory and use problems of developing countries, that are
more frequently discussed on this list. I would be interested to know
whether the authors plan interventions. Published as fair use. Hilbrand
Haak, E-drug co-moderator]
BMJ 2000;320:79-82 ( 8 January 2000)
Survey of unlicensed and off label drug use in paediatric wards in
European countries
S. Conroy, I. Choonara, A. Mohn, H. Arnell, A. Rane, C. Knoeppel, H.
Seyberth, C. Pandolfini, M.P. Raffaelli, F. M. Bonati, G. `t Jong, M. de
Hoog, J. van den Anker,
Correspondence: I Choonara <Imti.choonara@nottingham.ac.uk>
Objective: To determine the extent of use of unlicensed and off label
drugs in children in hospital in five European countries.
Design: Prospective study of drugs administered to children in general
paediatric medical wards over four weeks.
Setting: Children's wards in five hospitals (one each in the United
Kingdom, Sweden, Germany, Italy, and the Netherlands).
Subjects: Children aged 4 days to 16 years admitted to general
paediatric medical wards.
Main outcome measure: Proportion of drugs that were used in an
unlicensed or off label manner.
Results: 2262 drug prescriptions were administered to 624 children in
the five hospitals. Almost half of all drug prescriptions (1036;
46%) were either unlicensed or off label. Of these 1036, 872
were off label and 164 were unlicensed. Over half of the
patients (421; 67%) received an unlicensed or off label drug
prescription.
Conclusions: Use of off label or unlicensed drugs to treat children is
widespread. This problem is likely to affect children throughout
Europe and requires European action.
Key messages
- Many drugs are not tested in children, which means that they are
not specifically licensed for use in children
- Licensed drugs are often prescribed outside the terms of the
product license (off label) in relation to age, indication, dose of
frequency, route of administration, or formulation
- Over two thirds (67%) of 624 children admitted to wards in five
European hospitals received drugs prescribed in an unlicensed or
off label manner
- 39% of the 2262 drug prescriptions given to children were off
label
- The problem of off label and unlicensed drug prescribing in children
is a European problem that requires European action
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