# \[e-drug\] To: E-drug \ **URL:** \ **Category:** e-drug\ **Created:** [January 8, 2000, 10:12am UTC](https://talk.edrugplus.org/t/e-drug-to-e-drug-e-drug-usa-healthnet-org/6993 "2000-01-08T10:12:55Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![Hilbrand\_Haak1](https://avatars.discourse-cdn.com/v4/letter/h/49beb7/32.png) [@Hilbrand\_Haak1](https://talk.edrugplus.org/u/Hilbrand_Haak1)\ **Post date:** [January 8, 2000, 10:12am UTC](https://talk.edrugplus.org/t/e-drug-to-e-drug-e-drug-usa-healthnet-org/6993/1 "2000-01-08T10:12:55Z")
E-drug: Unlicensed and off label drug use in European countries --------------------------------------------- [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 \ 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 -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.