Identification of Off-Label Drugs for Patients with Neurological Disorders at the Psychiatric Hospital “Ghrasia” Yogyakarta

Bangunawati Rahajeng, Asih Ulandani, Astrit Ikafitriani


Off-label drug use is the prescription of drugs outside the indications approved by the authorized agency. The reasons for off-label drug use include a lack of clinical response to previous treatments, intolerance, or contraindications to drug therapy. The scientific evidence of off-label prescribing was lacking, and the risk of adverse events increased. This study aims to identify the off-label drug use for patients with neurological disorders at the Psychiatric Hospital “Grhasia” Yogyakarta. This study used a descriptive observational design with a cross-sectional method. Data collection was conducted retrospectively. Sampling was carried out by using the purposive sampling technique. The sample was patients who received a psychotropic prescription at the Psychiatric Hospital “Grhasia” Yogyakarta in January-December 2019. The data were analyzed by scrutinizing the therapeutic goals according to the diagnosis on the medical record. Prescriptions not matching the indications registered by NADFC are included in the off-label category. We used descriptive analytics for demographic data, disease diagnosis, and frequency of the off-label use of drug in neurological disorders. The research obtained a total sample of 662 patients that met the inclusion criteria, with 2,823 psychiatric drugs used. The off-label use of drug in neurological disorders at the Psychiatric Hospital “Grhasia” Yogyakarta was 884 (31%). The most frequent off-label use was lorazepam (17.53%). This study concludes that there is an off-label prescription at the Psychiatric Hospital “Grhasia” Yogyakarta. Some of the off-label use has no solid scientific evidence. These results require further research regarding the reasons for off-label prescribing and the patient's safety.


NADFC; neurological disorders; off-label; The Psychiatric Hospital “Grhasia” Yogyakarta

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Amore, M., D’Andrea, M., and Fagiolini, A. (2021). Treatment of Agitation With Lorazepam in Clinical Practice: A Systematic Review. Frontiers in Psychiatry, 12, 628965.

Aronson, J. K. (2015). Meyler’s Side Effects of Drugs—16th Edition. Elsevier Science.

Brand, S., Rahimi, A., Ahmadpanah, M., Shamsaei, F., Cheraghi, F., Sadeghi Bahmani, D., and Holsboer-Trachsler, E. (2016). Effect of adjuvant sleep hygiene psychoeducation and lorazepam on depression and sleep quality in patients with major depressive disorders: Results from a randomized three-arm intervention. Neuropsychiatric Disease and Treatment, 1507.

Brown, G. P., Stewart, L. A., Rabinowitz, T., Boudreau, H., and Wright, A. J. (2018). Approved and Off-Label Use of Prescribed Psychotropic Medications among Federal Canadian Inmates. The Canadian Journal of Psychiatry, 63(10), 683–691.

Camelia, N. (2016). Analisis Drug Related Problems Penggunaan Antipsikotik Pada Penderita Gangguan Bipolar Di Rumah Sakit Jiwa “X” Surabaya. Jurnal Ilmiah Mahasiswa Universitas Surabaya, 5(2), 15.

Darsana, I. W., and Suariyani, N. L. P. (2020). Trend Karakteristik Demografi Pasien Skizofrenia Di Rumah Sakit Jiwa Provinsi Bali (2013-2018). Archive Of Community Health, 7(1), 41.

Davies, S. J., Burhan, A. M., Kim, D., Gerretsen, P., Graff-Guerrero, A., Woo, V. L., Kumar, S., Colman, S., Pollock, B. G., Mulsant, B. H., and Rajji, T. K. (2018). Sequential drug treatment algorithm for agitation and aggression in Alzheimer’s and mixed dementia. Journal of Psychopharmacology, 32(5), 509–523.

Defrancesco, M., Marksteiner, J., Fleischhacker, W. W., and Blasko, I. (2015). Use of Benzodiazepines in Alzheimer’s Disease: A Systematic Review of Literature. International Journal of Neuropsychopharmacology, 18(10), pyv055.

Eguale, T., Buckeridge, D. L., Verma, A., Winslade, N. E., Benedetti, A., Hanley, J. A., and Tamblyn, R. (2016). Association of Off-label Drug Use and Adverse Drug Events in an Adult Population. JAMA Internal Medicine, 176(1), 55.

Ferreira, L. de A., Ibiapina, C. da C., Machado, M. G. P., and Fagundes, E. D. T. (2012). High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit. Revista Da Associação Médica Brasileira (English Edition), 58(1), 82–87.

Hariyanto, I., Putri, R. A., and Untari, E. K. (2016). Different Type of Antipsychotic Therapies on Length of Stay of Acute Schizophrenia Patients in Sungai Bangkong Regional Mental Hospital Pontianak. Indonesian Journal of Clinical Pharmacy, 5(2), 115–122.

Huang, C. L.-C., Hwang, T.-J., Chen, Y.-H., Huang, G.-H., Hsieh, M. H., Chen, H.-H., and Hwu, H.-G. (2015). Intramuscular olanzapine versus intramuscular haloperidol plus lorazepam for the treatment of acute schizophrenia with agitation: An open-label, randomized controlled trial. Journal of the Formosan Medical Association, 114(5), 438–445.

Hung, Y.-Y., and Huang, T.-L. (2006). Lorazepam and Diazepam Rapidly Relieve Catatonic Features in Major Depression. Clinical Neuropharmacology, 29(3), 144–147.

Le Jeunne, C., Billon, N., Dandon, A., participants of round table N° 3 of Giens XXVIII:, Berdaï, D., Adgibi, Y., Bergmann, J.-F., Bordet, R., Carpentier, A., Cohn, E., Courcier, S., Girault, D., Goni, S., Jolliet, P., Liard, F., Prot-Labarthe, S., Simon, T., Vernotte, C., and Westerloppe, J. (2013). Off-label Prescriptions: How to Identify Them, Frame Them, Announce Them and Monitor Them in Practice? Thérapie, 68(4), 233–239.

Leslie, D. L., and Rosenheck, R. (2012). Off-Label Use of Antipsychotic Medications in Medicaid. The American Journal Of Managed Care, 18(3), 9.

Lin, C.-C., and Huang, T.-L. (2013). Lorazepam–diazepam protocol for catatonia in schizophrenia: A 21-case analysis. Comprehensive Psychiatry, 54(8), 1210–1214.

Lucca, J., Vamsi, A., Kurian, S., and Ebi, S. (2019). A prospective observational study on psychotropic drug use in non psychiatric wards. Indian Journal of Psychiatry, 61(5), 503.

McDonagh, M. S., Dana, T., Selph, S., Devine, E. B., Cantor, A., Bougatsos, C., Blazina, I., Grusing, S., Fu, R., Kopelovich, S. L., Monroe-DeVita, M., and Haupt, D. W. (2017). Treatments for Schizophrenia in Adults: A Systematic Review. US : Agency for Healthcare Research and Quality.

Nielsen, J., Kane, J. M., and Correll, C. U. (2012). Real-world effectiveness of clozapine in patients with bipolar disorder: Results from a 2-year mirror-image study: Clozapine for bipolar disorder. Bipolar Disorders, 14(8), 863–869.

Pemerintah Pusat. (2009). Undang-undang Republik Indonesia nomor 36 tahun 2009 tentang Kesehatan. Lembaran Negara Republik Indonesia Nomor, 144.

Picchioni, M. M., & Murray, R. M. (2007). Schizophrenia. BMJ, 335(7610), 91–95.

PIO Nas. (2021). Monografi Klozapin. Available from: [Accessed 28nd April, 2021]

Rahajeng, B., Ikawati, Z., Andayani, T. M., and Dwiprahasto, I. (2018). A Retrospective Study: The Off-Label Use Of Anticonvulsants At A Private Hospital In Indonesia. International Journal of Pharmacy and Pharmaceutical Sciences, 10(5), 119.

Menteri Kesehatan RI. (2015). Keputusan Menteri Kesehatan Republik Indonesia Nomor HK.02.02/MENKES/73/2015.

Rusli. (2018). Bahan Ajar Farmasi Klinik. Jakarta: Kementrian Kesehatan Republik Indonesia.

Santarsieri, D., and Schwartz, T. (2015). Antidepressant efficacy and side-effect burden: A quick guide for clinicians. Drugs in Context, 4, 1–12.

Semiun, Y. (2006). Kesehatan mental (Vol. 3). Yogyakarta: Kanisius.

Shekelle, P., Maglione, M., Bagley, S., Suttorp, M., Mojica, W. A., Carter, J., Rolon, C., Hilton, L., Zhou, A., Chen, S., Glassman, P., and Newberry, S. (2007). Comparative Effectiveness Review. Agency for Healthcare Research and Quality U.S. Department of Health and Human Services, 6, 375.

Sienaert, P., Lambrichts, L., Dols, A., and De Fruyt, J. (2013). Evidence-based treatment strategies for treatment-resistant bipolar depression: A systematic review: Treatment-resistant bipolar depression. Bipolar Disorders, 15(1), 61–69.

Thaler, K. J., Morgan, L. C., Van Noord, M., Gaynes, B. N., Hansen, R. A., Lux, L. J., Krebs, E. E., Lohr, K. N., and Gartlehner, G. (2012). Comparative Effectiveness Of Second-Generation Antidepressants For Accompanying Anxiety, Insomnia, And Pain In Depressed Patients: A Systematic Review: Antidepressant Effects for Accompanying Symptoms. Depression and Anxiety, 29(6), 495–505.

Wittich, C. M., Burkle, C. M., and Lanier, W. L. (2012). Ten Common Questions (and Their Answers) About Off-label Drug Use. Mayo Clinic Proceedings, 87(10), 982–990.

Yulianty, M. D., Cahaya, N., & Srikartika, V. M. (2017). Studi Penggunaan Antipsikotik dan Efek Samping pada Pasien Skizofrenia di Rumah Sakit Jiwa Sambang Lihum Kalimantan Selatan. Jurnal Sains Farmasi & Klinis, 3(2), 153.


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