Review: Penggunaan Obat Off-label pada Anak-Anak

FEBBY VALENTINE PURWADI, Rano K. Sinuraya

Abstrak


Hingga saat ini pengujian klinis pada populasi pediatrik masih terbilang sedikit dibandingkan dengan pengujian klinis pada populasi dewasa. Hal ini berdampak pada ketersediaan informasi mengenai efikasi dan keamanan obat untuk populasi pediatrik. Alhasil, dokter dengan terpaksa harus mengambil keputusan untuk memberikan obat secara off-label. Penggunaan obat off-label dapat meningkatkan insiden terjadinya Medication error dan Adverse drug reaction (ADR), sehingga penggunaannya memunculkan kekhawatiran sebagaimana risiko tersebut dapat terjadi. Review ini bertujuan untuk memberikan gambaran mengenai pengguanaan obat off-label dan keamanan penggunaan obat off-label pada populasi pediatrik.


Teks Lengkap:

PDF

Referensi


Tefera, Y.G., Gebresillassie, B.M., Mekuria, A.B., Abebe, T.B., Erku, D.A., Seid, N. and Beshir, H.B. 2017. “Off‐label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia.” Pharmacology research & perspectives, 5(2).

Wittich, C.M., Burkle, C.M. and Lanier, W.L. 2012. “Ten common questions (and their answers) about off-label drug use.” In Mayo Clinic Proceedings (Vol. 87, No. 10, pp. 982-990). Elsevier.

Neville, K.A., Frattarelli, D.A., Galinkin, J.L., Green, T.P., Johnson, T.D., Paul, I.M. and Van Den Anker, J.N. 2014. “Off-label use of drugs in children.” Pediatrics, 133(3), pp.563-567.

Czarniak, P., Bint, L., Favié, L., Parsons, R., Hughes, J. and Sunderland, B. 2015. “Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital.” PloS one, 10(3), p.e0120630.

Kimland, E. and Odlind, V. 2012. “Off‐label drug use in pediatric patients.” Clinical Pharmacology & Therapeutics, 91(5), pp.796-801.

Bavdekar, S.B. 2013. “Pediatric clinical trials.” Perspectives in clinical research, 4(1), p.89.

Knopf, H., Wolf, I.K., Sarganas, G., Zhuang, W., Rascher, W. and Neubert, A. 2013. “Off-label medicine use in children and adolescents: results of a population-based study in Germany.” BMC public health, 13(1), p.631.

Ballard, C.D., Peterson, G.M., Thompson, A.J. and Beggs, S.A. 2013. “Off‐label use of medicines in paediatric inpatients at an Australian teaching hospital.” Journal of paediatrics and child health, 49(1), pp.38-42.

Ruíz-Antorán, B., Piñeiro, R., Avendaño, C., Román, E., Cilleruelo, M.L., Gutiérrez-Junquera, C., Centeno, G. and Cilleruelo, M.J. 2013. “Drug utilization and off-label drug use in Spanish pediatric gastroenterology outpatients.” Journal of pediatric gastroenterology and nutrition, 56(2), pp.173-177.

Saiyed, M.M., Lalwani, T. and Rana, D. 2014. “Off-label medicine use in pediatric inpatients: a prospective observational study at a tertiary care hospital in India.” International journal of pediatrics, 2014.

Corny, J., Bailey, B., Lebel, D. and Bussières, J.F. 2016. “Unlicensed and off-label drug use in paediatrics in a mother-child tertiary care hospital.” Paediatrics & child health, 21(2), pp.83-87.

Carnovale, C., Conti, V., Perrone, V., Antoniazzi, S., Pozzi, M., Merlino, L., Venegoni, M., Clementi, E. and Radice, S. 2013. “Paediatric drug use with focus on off-label prescriptions in Lombardy and implications for therapeutic approaches.” European journal of pediatrics, 172(12), pp.1679-1685.

Langerová, P., Vrtal, J. and Urbánek, K. 2014. “Incidence of unlicensed and off-label prescription in children.” Italian journal of pediatrics, 40(1), p.12.

Ribeiro, M., Jorge, A. and Macedo, A.F. 2013. “Off-label drug prescribing in a Portuguese paediatric emergency unit.” International journal of clinical pharmacy, 35(1), pp.30-36.

Maltz, L.A., Klugman, D., Spaeder, M.C. and Wessel, D.L. 2013. “Off-label drug use in a single-center pediatric cardiac intensive care unit.” World Journal for Pediatric and Congenital Heart Surgery, 4(3), pp.262-266.

Lee, J.L., Redzuan, A.M. and Shah, N.M. 2013. “Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in Malaysia.” International journal of clinical pharmacy, 35(6), pp.1025-1029.

Ventola, C.L. 2015. “The antibiotic resistance crisis: part 2: management strategies and new agents.” Pharmacy and Therapeutics, 40(5), p.344.

Bryce, A., Hay, A.D., Lane, I.F., Thornton, H.V., Wootton, M. and Costelloe, C. 2016. “Global prevalence of antibiotic resistance in paediatric urinary tract infections caused by Escherichia coli and association with routine use of antibiotics in primary care: systematic review and meta-analysis.” bmj, 352, p.i939.

Yang, W.C., Chan, O.W., Wu, T.L., Chen, C.L., Su, L.H. and Chiu, C.H. 2016. “Development of ceftriaxone resistance in Salmonella enterica serotype Oranienburg during therapy for bacteremia.” Journal of Microbiology, Immunology and Infection, 49(1), pp.41-45.

Dharmapalan, D., Shet, A., Yewale, V. and Sharland, M. 2017. “High Reported Rates of Antimicrobial Resistance in Indian Neonatal and Pediatric Blood Stream Infections.” Journal of the Pediatric Infectious Diseases Society, 6(3), pp.e62-e68.

Woo, Y., Kim, H.E., Chung, S. and Park, B.J. 2015. “Pediatric Medication error Reports in Korea Adverse Event Reporting System Database, 1989-2012: Comparing with Adult Reports.” Journal of Korean medical science, 30(4), pp.371-377.

Ewig, C.L., Cheung, H.M., Kam, K.H., Wong, H.L. and Knoderer, C.A. 2017. “Occurrence of Potential Adverse Drug Events from Prescribing Errors in a Pediatric Intensive and High Dependency Unit in Hong Kong: An Observational Study.” Pediatric Drugs, 19(4), pp.347-355.

Neubert, A., Dormann, H., Weiss, J., Egger, T., Criegee-Rieck, M., Rascher, W., Brune, K. and Hinz, B. 2004. “The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients.” Drug safety, 27(13), pp.1059-1067.

Saiyed, M.M., Lalwani, T. and Rana, D. 2015. “Is off-label use a risk factor for adverse drug reactions in pediatric patients? A prospective study in an Indian tertiary care hospital.” International Journal of Risk & Safety in Medicine, 27(1), pp.45-53.

Bellis, J.R., Kirkham, J.J., Thiesen, S., Conroy, E.J., Bracken, L.E., Mannix, H.L., Bird, K.A., Duncan, J.C., Peak, M., Turner, M.A. and Smyth, R.L. 2013. “Adverse drug reactions and off-label and unlicensed medicines in children: a nested case? Control study of inpatients in a pediatric hospital.” BMC medicine, 11(1), p.238.

Bellis, J.R., Kirkham, J.J., Nunn, A.J. and Pirmohamed, M. 2014. “Adverse drug reactions and off‐label and unlicensed medicines in children: a prospective cohort study of unplanned admissions to a paediatric hospital.” British journal of clinical pharmacology, 77(3), pp.545-553.

Horen, B., Montastruc, J.L. and Lapeyre-Mestre, M. 2002. “Adverse drug reactions and off-label drug use in paediatric outpatients.” British journal of clinical pharmacology, 54(6), p.665.




DOI: https://doi.org/10.24198/jf.v16i1.16843

DOI (PDF): https://doi.org/10.24198/jf.v16i1.16843.g8459

Refbacks

  • Saat ini tidak ada refbacks.




Sitasi manajer:   

 

 

Jurnal ini diindeks dalam:

 

 

View My Stats 

ISSN: 1693-1424

e-ISSN: 2716-3075

 

Farmaka by Universitas Padjadjaran is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

Copyright © 2013 Jurnal Farmaka - All Right Reserved