BMJ 2002;324:1311-1312 ( 1 June )

Primary care

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

Editorial by Banner and pp 1312, 1313

Reinhild Bücheler, specialist in internal medicine and social medicine ^a, Matthias Schwab, senior registrar in clinical pharmacology and paediatrician ^b, Klaus Mörike, lecturer in clinical pharmacology ^a, Bernhard Kalchthaler, IT engineer ^c, Hartmut Mohr, pharmacist ^c, Helmut Schröder, head of the German drug index ^d, Peter Schwoerer, head ^c, Christoph H Gleiter, professor in clinical pharmacology ^a. 

^a Division of Clinical Pharmacology, University Hospital Tübingen, D-72076 Tübingen, Germany, ^b Dr Margarete Fischer-Bosch Institut für Klinische Pharmakologie, D-70376 Stuttgart, Germany, ^c Medizinischer Dienst der Krankenversicherung Baden-Württemberg, D-77933 Lahr, Germany, ^d Wissenschaftliches Institut der AOK (Allgemeine Ortskrankenkasse), D-53177 Bonn, Germany

Correspondence to: C H Gleiter christoph.gleiter@med.uni-tuebingen.de

The first 150 words of the full text of this article appear below.

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 doctorsspecialists in paediatric, general, or internal medicinebetween 1 January and 31 March 1999 for 455 661 patients aged 0-16 years.

Table Removed (Available Only in the Full Text)

Each prescription was represented by a numerical code, describing the drug's brand name, generic name, formulation, and content per dose unit. Our database did not contain diagnoses, dosage recommendations, or individually prepared . . . [Full text of this article]

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