BACKGROUND: Data concerning the extent of off-label prescriptions for adult neurological patients are limited, and the method of assessing supporting evidence in previous studies has some limitations. OBJECTIVE: To improve the method of assessing supporting evidence, determine the status of off-label prescriptions for adult neurological patients, and evaluate the varying levels of supporting evidence. SETTING: Single, 1,264-bed, tertiary care university hospital in Beijing, China. METHOD: This was a pilot retrospective observational study for adult neurological patients during the period of March 22nd-28th, 2010. Off-label prescriptions were defined according to package inserts. The DRUGDEX system was used to evaluate supporting evidence initially; when information was not available, PubMed/CBM was searched and the grading system proposed by Oxford Centre for Evidence-Based Medicine (OCEBM) was used for categorizing supporting evidence alternatively. MAIN OUTCOME MEASURE: Types, main therapeutic classes and main neurological diseases involved, evidence and recommendation strengths of off-label prescriptions. RESULTS: A total of 418 off-label prescriptions were identified from 3,187 prescriptions for 966 patients, 193 from 759 inpatient (25.4%) and 225 from 2,428 outpatient care (9.3%). Most off-label prescriptions were related to unapproved indications. These off-label prescriptions mainly included drugs labeled for nervous system diseases, cerebrovascular diseases, anemia and ophthalmic conditions; and the medication orders were mostly for cerebrovascular diseases. A total of 155 (37.1%) were initially searched and evaluated in the DRUGDEX system; the remaining 263 (62.9%) prescriptions were found in PubMed/CBM search and evaluated by the OCEBM grading system. Sixty-six (34.2%) off-label prescriptions from inpatients and 103 (45.8%) from outpatients were categorized as Class III or Grade D recommendations. CONCLUSIONS: The improved method provided a supplementary way to study off-label uses. Off-label prescriptions for adult neurological patients mainly concerned unapproved indications, nervous system agents and cerebrovascular diseases, and many of them had inferior level of evidence.
BACKGROUND: Data concerning the extent of off-label prescriptions for adult neurological patients are limited, and the method of assessing supporting evidence in previous studies has some limitations. OBJECTIVE: To improve the method of assessing supporting evidence, determine the status of off-label prescriptions for adult neurological patients, and evaluate the varying levels of supporting evidence. SETTING: Single, 1,264-bed, tertiary care university hospital in Beijing, China. METHOD: This was a pilot retrospective observational study for adult neurological patients during the period of March 22nd-28th, 2010. Off-label prescriptions were defined according to package inserts. The DRUGDEX system was used to evaluate supporting evidence initially; when information was not available, PubMed/CBM was searched and the grading system proposed by Oxford Centre for Evidence-Based Medicine (OCEBM) was used for categorizing supporting evidence alternatively. MAIN OUTCOME MEASURE: Types, main therapeutic classes and main neurological diseases involved, evidence and recommendation strengths of off-label prescriptions. RESULTS: A total of 418 off-label prescriptions were identified from 3,187 prescriptions for 966 patients, 193 from 759 inpatient (25.4%) and 225 from 2,428 outpatient care (9.3%). Most off-label prescriptions were related to unapproved indications. These off-label prescriptions mainly included drugs labeled for nervous system diseases, cerebrovascular diseases, anemia and ophthalmic conditions; and the medication orders were mostly for cerebrovascular diseases. A total of 155 (37.1%) were initially searched and evaluated in the DRUGDEX system; the remaining 263 (62.9%) prescriptions were found in PubMed/CBM search and evaluated by the OCEBM grading system. Sixty-six (34.2%) off-label prescriptions from inpatients and 103 (45.8%) from outpatients were categorized as Class III or Grade D recommendations. CONCLUSIONS: The improved method provided a supplementary way to study off-label uses. Off-label prescriptions for adult neurological patients mainly concerned unapproved indications, nervous system agents and cerebrovascular diseases, and many of them had inferior level of evidence.
Authors: Antje Neubert; Harald Dormann; Jutta Weiss; Tobias Egger; Manfred Criegee-Rieck; Wolfgang Rascher; Kay Brune; Burkhard Hinz Journal: Drug Saf Date: 2004 Impact factor: 5.606