Off-Label Drug Use in Acute Respiration Infection Patient at Pangandaran Hospital, Pangandaran District, West Java - Indonesia
Abstract
Acute respiratory infections (ARIs) are infectious diseases of the upper or lower respiratory tract that cause a spectrum of illnesses from mild to severe infections. ARI is one of the leading causes of death in children in developing countries. The high incidence of ARI in children results in the use of off-label drugs. Off-label medicine is the use of drugs outside the provisions of the license relating to dose, age, route of administration, contraindications. This study aims to determine the use of off-label drugs in children with a diagnosis of ARI at Pandega Pangandaran Hospital, Pangandaran District, West Java - Indonesia. This study was an observational study with a cross sectional design and data collection was done retrospectively using Chi-square data analysis with a significance level of 0.05. Of the 84 patients who fit the inclusion criteria, there was an off-label drug use of 16.01% with the categories of off-label age (11.16%), off-label dose (4.37%), and off-label indication (0.48%) while in the category of route of administration and contraindications no off-label drug use was found. The most common type of off-label drug used was cetirizine antihistamine. Based on the results, pharmacist’s supervision related to the risk of drug use is strongly recommended.
Keywords
Full Text:
PDFReferences
Pengobatan Infeksi Saluran Pernapasan Akut Berat [Internet]. 2020 [cited 2022 Oct 30]. Available from: https://www.who.int/
Lazamidarmi D, Sitorus RJ, Listiono H. Faktor-Faktor yang Berhubungan dengan Kejadian ISPA pada Balita. Jurnal Ilmiah Universitas Batanghari Jambi. 2021 Feb 8;21(1):299.
Badan Penelitian dan Pengembangan Kesehatan. Laporan Nasional Riskesdas 2018. Kementerian Kesehatan Republik Indonesia
Tefera YG, Gebresillassie BM, Mekuria AB, Abebe TB, Erku DA, Seid N, Beshir HB. Off-label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia. Pharmacology Research & Perspective, 2017, 5(2), e00304.
Anggraini D, Putra ON, Faizah AK. Peresepan Obat “Off-label” Pada Anak Dengan Penyakit Infeksi Saluran Pernapasan Akut. Jurnal Ilmu Kefarmasian. 2021;2(1).
O’Hara K. Paediatric pharmacokinetics and drug doses. Australian Prescriber. 2016;39(6):208–10.
Setyaningrum N, Gredynadita V, Gartina S. Penggunaan Obat Off-Label pada Anak di Apotek Kota Yogyakarta. Jurnal Sains Farmasi & Klinis. 2017 Dec 15;4(1):30.
Tuloli TS, Rasdianah N, Datau M. Gambaran Penggunaan Obat Off-Label Pada Pasien Pediatrik Rawat Inap Di Rumah Sakit. Indonesian Journal of Pharmaceutical Education. 2022 Jul 29;2(2):130–42.
Lazzerini M, Wanzira H. Oral zinc for treating diarrhoea in children. Vol. 2016, Cochrane Database of Systematic Reviews. John Wiley and Sons Ltd
Syafitri N, Faisal M, Indriyanti N. Kajian Penggunaan Obat Off-Label Pada Penyakit ISPA Pasien Pediatri di RSUD Majene. Proceeding of Mulawarman Pharmaceuticals Conferences. 2021 Dec 31;14:96–105.
Lin J, Zhou X, Wang C, Liu C, Cai S, Huang M. Symbicort® Maintenance and Reliever Therapy (SMART) and the evolution of asthma management within the GINA guidelines. Vol. 12, Expert Review of Respiratory Medicine. Taylor and Francis Ltd.; 2018. p. 191–202.
Tukayo BLA, Sunderland B, Parsons R, Czarniak P. High prevalence of off-label and unlicensed paediatric prescribing in a hospital in Indonesia during the period Aug.—Oct. 2014. Vol. 15, PLoS ONE. Public Library of Science; 2020.
Vervloet M, Puigmarti CM, Damen N, Marchange S, Langedijk J, Lisman J, et al. Study on off-Label Use of Medicinal Products in European Union, European Union. 2017.
Katy Sutcliffe, Gillian Stokes, Alison O’Mara, Jenny Caird, Kate Hinds, Mukdarut Bangpan, et al. Paediatric medication error : a systematic review of the extent and nature of the problem in the UK and international interventions to address it. Social Science Research Unit, UCL Institute of Education. 2014. 1–164 p.
Knopf H, Wolf IK, Sarganas G, Zhuang W, Rascher W, Neubert A. Off-label medicine use in children and adolescents: Results of a population-based study in Germany. BMC Public Health. 2013;13(1).
Rerksuppaphol S, Lakkana R. A randomized controlled trial of zinc supplementation in the treatment of acute respiratory tract infection in Thai children. Pediatric Reports 2019;11(7954).
Paediatric Formulary Committee. British National Formulary for Children 2019-2020. 2019; Available from: https://nhathuocngocanh.com/
Rusz CM, Ősz BE, Jîtcă G, Miklos A, Bătrînu MG, Imre S. Off-label medication: From a simple concept to complex practical aspects. Vol. 18, International Journal of Environmental Research and Public Health. MDPI; 2021.
Aagaard L, Kristensen K. Off-label and unlicensed prescribing in Europe: implications for patients’ informed consent and liability. Vol. 40, International Journal of Clinical Pharmacy. Springer Netherlands; 2018. p. 509–12.
Jaroszyński J, Mela A, Furtak-Niczyporuk M, Poniatowski ŁA, Dąbrowski J, Czajka-Bełz A, et al. Off-label use of medicinal products ñ legal rules and practices. Acta Poloniae Pharmaceutica - Drug Research. 2019;76(4):621–8.
DOI: https://doi.org/10.15416/pcpr.v8i3.48103
Refbacks
- There are currently no refbacks.







