IAI SPECIAL EDITION: Adverse drug reaction of antiepileptic monotherapy on epileptic paediatric patients in Dr Sardjito Hospital, Yogyakarta, Indonesia

Authors

  • Woro Harjaningsih Universitas Gadjah Mada, Yogyakarta, Indonesia https://orcid.org/0000-0002-2084-2876
  • Emma Rahmania Universitas Gadjah Mada, Yogyakarta, Indonesia
  • Sheila Nabila Firdha Universitas Gadjah Mada, Yogyakarta, Indonesia

DOI:

https://doi.org/10.46542/pe.2022.222.242247

Keywords:

Cognitive function, Effectivity, Epilepsy, Monotherapy, Paediatric

Abstract

Introduction: Epilepsy is a neurological disease with the highest prevalence in paediatrics. Using anti-epileptic drug as monotherapy is the first-line therapy for paediatrics based on risk-benefit ratio consideration in the patients effectiveness and adverse drug reaction of anti-epileptic monotherapy drug for the cognitive function in paediatric patients.   

Objectives: The aim of the study is to assess effectivity and adverse drug reaction of anti-epileptic monotherapy drug for the cognitive function in

paediatric patients.   

Methods: This was a cross sectional study. This study used patients from the Dr. Sardjito hospital’s outpatient paediatric unit’s Neurology division from May to July 2013 and May to June 2019 to select the subjects. Patient questionnaires and medical records provided the data that was used. Effectiveness was assessed by seizure severity with Hague Seizure Severity Scale (HASSS) questionnaire  and seizure frequency, while adverse drug reactions in cognitive function were assessed by the PESQ (Pediatric Epilepsy Side Effect Questionnaire) instrument.   

Results: In total, 29 patients received monotherapy, with 26 patients (89.66%) receiving valproate,  two (6.89%) receiving phenytoin, and one (3.45%) receiving phenobarbital. A total 89.66% of patients did not have severe seizures, but 6.90% had moderate seizures. The cognitive function of epileptic patients with co-morbidities receiving valproate monotherapy had moderate (27.59%) and severe (20.69%) side effects. The adverse drug reaction experienced in epileptic patients without co-morbidities using valproate was with the cognitive function, with 6.89% of patients experiencing severe effects, 13.79% moderate and 20.69% mild effects.    

Conclusion: While anti-epileptic monotherapy can control seizures in children, the commonly prescribed valproate can impair cognitive function, especially in those with co-morbidities.

Author Biographies

Woro Harjaningsih, Universitas Gadjah Mada, Yogyakarta, Indonesia

Faculty of Pharmacy

Emma Rahmania, Universitas Gadjah Mada, Yogyakarta, Indonesia

Faculty of Pharmacy

Sheila Nabila Firdha, Universitas Gadjah Mada, Yogyakarta, Indonesia

Faculty of Pharmacy

References

Aldenkamp, A.P., & Bodde, N. (2005). Behaviour, cognition and epilepsy. Acta neurologica Scandinavica, 182, 19–25. https://doi.org/10.1111/j.1600-0404.2005.00523.x

Allain, H., Schück, S., Nachit-Ouinekh, F., Plouin, P., Brunon, A., Boulliat, J., Mercier, F., Slama, A., Baulac, M., El Hasnaoui, A. (2006). Improvement in quality of life after initiation of lamotrigine therapy in patients with epilepsy in a naturalistic treatment setting. Seizure, 16, 173-184. https://doi.org/10.1016/j.seizure.2006.11.009

Bayu, P.P., Agung, T. & Dwi, S. (2019). Cognitive function in children with epilepsy. Journal of Nepal Paediatric Society, 38 (2), 74 – 79. https://doi.org/10.3126/jnps.v38i2.19386

Brunbech, L. & Sabers, A. (2012). Effect of antiepileptic drugs on cognitive function in individuals with epilepsy: a comparative review of newer versus older agents. Drugs, 62, 593-604. https://doi.org/10.2165/00003495-200262040- 00004

Carpay, J.A. & Arts, W.F. (1996). Outcome assessment in epilepsy: available rating scales for adults and methodological issues pertaining to the development of scales for childhood epilepsy. Epilepsy Research, 24(3), 127-136. https://doi.org/10.1016/0920-1211(96)00013-7

Carpay, J.A. Vermuelen, J., Stroink, H., Brouwer, O.F., Peters, A.C., Aldenkamp, A.P., van Donselaar, C.A., & Arts, W.F. (2005). Seizure severity in children with epilepsy: a parent-completed scale compared with clinical data. Epilepsia, 38(3), 346–352. https://doi.org/10.1111/j.1528-1157.1997.tb01127.x

Cherry, K. (2019). The Basics of Cognition and Mental Processes, Available at: https://www.verywellmind.com/what-is-cognition-2794982

Eddy, C.M. Rickards, H.E., & Cavanna, A.E.. (2011). The cognitive impact of antiepileptic drugs. Therapeutic Advances in Neurology Disorders, 4(6), 385-407. https://doi.org/10.1177/1756285611417920

EMA (European Medice Agency). (2001). ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Topic E11: Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99). Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-1.pdf

Malerba, A. Ciampa, C., De Fazio, S., Fattore, C., Frassine, B., La Neve, A., Pellacani, S., Specchio, L.M., Tiberti, A., Tinuper, P., & Perucca, E. (2010). Patterns of prescription of antiepileptic drugs in patients with refractory epilepsy at tertiary referral centres in Italy. Epilepsy research, 91(2-3), 273-282. https://doi.org/10.1016/j.eplepsyres.2010.08.002

National Institute for Health and Care Excellence (NICE). (2012). Epilepsies: the diagnosis and management. NICE Clinical guideline 137, United Kingdom. Available at: https://www.nice.org.uk/guidance/cg137

Pinzon, R. (2006). Karakteristik Epidemiologi Onset Anakanak: Telaah Pustaka Terkini. Dexa Medica Jurnal Kedokteran dan Farmasi, 19(3), 131-133

Putra B.P. (2015). Hubungan Fungsi Kognitif Dengan Epilepsi Pada Anak, Thesis, Fakultas Kedokteran Universitas Gadjah Mada, Yogyakarta

Sabaz, M. Cairns, D.R., Lawson, J.A., Bleasel, A.F., & Bye, A.M. (2001). The health-related quality of life of children with refractory epilepsy: a comparison of those with and without intellectual disability. Epilepsia, 42(5), 621-628. https://doi.org/10.1046/j.1528-1157.2001.25200.x

Veenendaal, T.M., IJff, D.M., Aldenkamp, A.P., Lazeron, R., Hofman, P., de Louw, A., Backes, W.H., & Jansen, J. (2017). Chronic antiepileptic drug use and functional network efficiency: A functional magnetic resonance imaging study. World Journal of Radiology, 9(6):287-294. https://doi.org/10.4329/wjr.v9.i6.287

Virag, L., Murgas, M., & Kuzelova, M. (2012). Pharmacotherapeutic adherence and quality of life in paediatric outpatients with epilepsy. Supplementum, 6, 76- 83. https://doi.org/10.2478/v10219-012-0009-5

Wells, B.G. (2019). Neurologic Disorder: Epilepsy. In Dipiro, J.T., (Eds.). Handbook of Pharmacotherapy: A Pathophysiology Approach, 7th Edition, 927-951, McGrawHill, America

World Health Organization. (2018). Epilepsy. Available at: https://www.who.int/news-room/fact-sheets/detail/epilepsy

Downloads

Published

31-03-2022

How to Cite

Harjaningsih, W. ., Rahmania, E. ., & Firdha, S. N. . (2022). IAI SPECIAL EDITION: Adverse drug reaction of antiepileptic monotherapy on epileptic paediatric patients in Dr Sardjito Hospital, Yogyakarta, Indonesia. Pharmacy Education, 22(2), p. 242–247. https://doi.org/10.46542/pe.2022.222.242247

Issue

Section

Special Edition