A RETROSPECTIVE STUDY: THE OFF-LABEL USE OF ANTICONVULSANTS AT A PRIVATE HOSPITAL IN INDONESIA
Keywords:Anticonvulsants, Off-label, Private hospitals, Evidence-based medicine, Safe-prescribing
Objective: Anticonvulsant is one class of drugs often used off-label. This study was conducted to investigate the prevalence and the indication of the off-label use of anticonvulsants in a private hospital in Java, Indonesia.
Methods: This was an observational study with a retrospective data collection in a private hospital in Java. Data were obtained on the prescription of anticonvulsants. Indications of the use of anticonvulsants were obtained from the medical records of patients who were prescribed anticonvulsants. The off-label use of anticonvulsants was defined a prescribing of medication outside the indication approved by The National Agency of Drug and Food Control Indonesia (NA-DFC). The use off-label of anticonvulsants was calculated by descriptive analysis and presented as a percentage.
Results: It showed that in one year there were 5,310 for 1,316 patients: of this 462 patients (35.11%) were for an off-label use. The anticonvulsants used off-label were oxcarbazepine 67.27% (37/55), carbamazepine 46.15% (54/117), pregabalin45.45% (60/132), phenytoin37.62% (225/598), valproate 25.34% (37/109), and gabapentin 18.28% (49/219). The highest off-label use of anticonvulsants was found in neurological and psychiatric disorders 67.32% (n=311), and on 97.19% of them were not supported by strong clinical evidence.
Conclusion: The off-label use of anticonvulsants occurred in one-third of patients receiving prescriptions of anticonvulsants, even though for most of them there was a lack of evidence. More attention must be paid to the efficacy and risk of side effects of the drug used.
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