RESUMO
INTRODUCTION: This study examines the prevalence of off-label prescriptions in a large German psychiatric hospital. The influence of a 2002 decision by the Federal Social Court regarding reimbursement issues is investigated. METHODS: Two random samples ( N(1)=125; N(2)=126) of all patients treated in the years 2001-2002 and 2003-2004, respectively, were examined. All prescriptions of psychotropic drugs were evaluated and categorized as CLEARLY OFF-LABEL, PROBABLY OFF-LABEL, or ON-LABEL. Label status for each product was judged according to the information stated in the officially authorized Summary of Product Characteristics. RESULTS: In 2001-2002 20% of all prescriptions of psychotropic drugs were clearly off-label, and 19% were probably off-label. In 2003-2004 the numbers were 21% and 26%, respectively. There was a significant increase in probable and combined probable and clear off-label use. There was no significant influence of sex and patients' age on off-label prescribing, but treatment duration showed a significant positive correlation with off-label use. Drugs prescribed on discharge were significantly more often prescribed off-label than drugs prescribed during the whole duration of treatment. DISCUSSION: Prevalence of psychiatric off-label use in Germany is high. These results are in accordance with international surveys. The restrictive interpretation of the legal reimbursement provisions applied by the German Federal Social Court has not caused a decrease in off-label use. Although measures have been taken to solve the legal problems arising from off-label-use, further solutions are needed to ensure both patient and prescriber safety.
