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Off label prescribing to children in primary care in Germany: retrospective cohort study

BMJ 2002; 324 doi: (Published 01 June 2002) Cite this as: BMJ 2002;324:1311
  1. Reinhild Bücheler, specialist in internal medicine and social medicinea,
  2. Matthias Schwab, senior registrar in clinical pharmacology and paediatricianb,
  3. Klaus Mörike, lecturer in clinical pharmacologya,
  4. Bernhard Kalchthaler, IT engineerc,
  5. Hartmut Mohr, pharmacistc,
  6. Helmut Schröder, head of the German drug indexd,
  7. Peter Schwoerer, headc,
  8. Christoph H Gleiter, professor in clinical pharmacology (
  1. a Division of Clinical Pharmacology, University Hospital Tübingen, D-72076 Tübingen, Germany
  2. b Dr Margarete Fischer-Bosch Institut für Klinische Pharmakologie, D-70376 Stuttgart, Germany
  3. c Medizinischer Dienst der Krankenversicherung Baden-Württemberg, D-77933 Lahr, Germany
  4. d Wissenschaftliches Institut der AOK (Allgemeine Ortskrankenkasse), D-53177 Bonn, Germany
  1. Correspondence to: C H Gleiter
  • Accepted 2 January 2002

Editorial by Banner and pp 1312, 1313

Between 35% and 90% of the drugs prescribed to hospitalised children are either not licensed for children's use or are prescribed outside the terms of their product licence (off label prescribing). 1 2 Subsequent adverse reactions are more likely than with licensed products (6.0% v 3.9%).3 We analysed the extent of prescribing off labelled products in a representative cohort of children in primary care.

Patients, methods, and results

We used the electronic database of prescriptions of Allgemeine Ortskrankenkasse, Baden-Württemberg. This health insurer covers more than four million people, 42% of the total population of the state. We retrospectively reviewed 1.74 million anonymous prescriptions written by 6886 office based doctors—specialists in paediatric, general, or internal medicine—between 1 January and 31 March 1999 for 455 661 patients aged 0-16 years.

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Most frequent off label drugs prescribed to outpatients aged 0-16 years for peroral, rectal, or nasal administration at the expense of Allgemeine …

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