Peresepan Obat “Off-Label” Pada Anak Dengan Penyakit Infeksi Saluran Pernapasan Akut

Authors

  • Oki Nugraha Putra Universitas Hang Tuah, Surabaya
  • Eri Destin Anggraini Universitas Hang Tuah, Surabaya
  • Ana Khusnul Faizah Universitas Hang Tuah, Surabaya

DOI:

https://doi.org/10.31764/lf.v2i1.3729

Keywords:

off-label drugs, Acute Respiratory Tract, Infection, Prescribing, Children.

Abstract

ABSTRAK

Infeksi Saluran Pernapasan Akut (ISPA) termasuk penyakit yang banyak terjadi di Indonesia terutama pada usia anak. Pada populasi anak berisiko mendapatkan peresepan obat off-label dikarenakan terbatasanya data efikasi obat untuk anak. Penggunaan obat off-label meningkatkan risiko efek yang tidak dikehendaki. Penelitian ini bertujuan untuk mengevaluasi penggunaan obat secara off-label pada peresepan pasien ISPA anak. Penelitian ini merupakan penelitian deskriptif observasional dengan menggunakan desain cross-sectional. Pengumpulan data menggunakan peresepan obat dengan diagnosis ISPA  pada anak usia 0-18 tahun. Penelitian ini dilakukan pada bulan November 2019 sampai dengan Februari 2020. Pada` penelitian ini didapatkan 124 resep dengan diagnosis ISPA. Penggunaan obat off-label pada peresepan penyakit infeksi saluran pernapasan akut untuk pasien anak sebesar 23% dengan kategori off-label usia (15,67%), off-label dosis (5,70%), off-label rute pemberian (1,22%) dan off-label indikasi (0,40%). Jenis obat off-label paling banyak diresepkan untuk ISPA anak adalah antihistamin klorfeniramin maleat. Berdasarkan hasil penelitian yang telah dilakukan dapat disimpulkan bahwa penggunaan obat off-label pada penyakit ISPA anak cukup tinggi. Farmasis dan dokter dapat berkolaborasi untuk pemantauan penggunaan obat yang tergolong off-label. Penelitian lanjutan diperlukan untuk melihat korelasi atau faktor risiko yang berpotensi meningkatkan penggunaan off-label pada ISPA anak.

 

Kata kunci : Obat off-label; ISPA; Peresepan; Anak.


ABSTRACT

Acute respiratory tract infections (ARTI) is a disease that often occurs in Indonesia, especially in children. The population of children is high risk of receiving off-label prescription drugs. The use of off-label drugs increases the risk of undesirable effects. This study was aimed to evaluate the off-label use of drugs in prescribing with acute respiratory tract infection. This research is a descriptive observational study using a cross-sectional design. Data was collected by the prescription in children aged 0-18 years old with acute respiratory tract infection. This study was conducted from November 2019 to February 2020. In this study, 124 prescriptions were obtained with a diagnosis of ARTI. The use of off-label drugs was 23% with the off-label age category (15.67%), off-label dose (5.70%), off-label route of administration (1.22%) and off-label indication (0.40%). The type of off-label drug most commonly prescribed in children with ARTI is chlorpheniramine maleate. It can be concluded that the use of off-label drugs in children with ARTI disease is quite high. Pharmacists and clinicians should collaborate each other to monitor the use of drugs that are classified as off-label. Further research is needed to analyze   correlations or risk factors that potentially may increase off-label use in children with ARTI.


Keywords : Off-label drugs; Acute Respiratory Tract ; Infection; Prescribing; Children.

Author Biographies

Oki Nugraha Putra, Universitas Hang Tuah, Surabaya

Program Studi Farmasi

Eri Destin Anggraini, Universitas Hang Tuah, Surabaya

Program Studi Farmasi

Ana Khusnul Faizah, Universitas Hang Tuah, Surabaya

Program Studi Farmasi

References

Akbar, R., Setyaningrum, N., Estiningsih, D. (2017). Kajian Penggunaan Obat Off-Label pada Anak di Puskesmas Sleman. INPHARNMED Journal, 1(1), 21-33.

Albrecht HH., Peter VD., Eric PG. (2017). Role of guaifenesin in the management of chronic bronchitis and upper respiratory tract infections. Multidisciplinary Respiratory Medicine 12:31

Andrzejowski, P., Carroll, W. (2016). Salbutamol in paediatrics: pharmacology, prescribing and controversies Arch Dis Child Educ Pract Ed, 101:194–197.

Ballard, CD., Peterson, GM., Thompson, AJ. (2013). “Offâ€label use of medicines in paediatric inpatients at an Australian teaching hospital.†Journal of paediatrics and child health, 49(1), pp.38-42.

British National Formulary for Children. (2018). Edisi 76. British Medical Association and Royal Pharmaceutical Society of Great Britain, London.

British National Formulary for Children. (2019). Edisi 78. British Medical Association and Royal Pharmaceutical Society of Great Britain, London.

British Thoracic Society. (2014). British Guideline on The Management of asthma, A national clinical guideline, London, UK.

Church, MK., Church DS. (2013). Pharmacology of antihistamines. Indian J Dermatol, 58(3):219-224.

Czarniak, P., Bint, L., Favié, L. (2015). Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital. PloS one, 10(3), p.e0120630.

de Martino M., Chiarugi A. (2015). Recent Advances in Pediatric Use of Oral Paracetamol in Fever and Pain Management. Pain Ther, 4(2):149–168.

Depkes RI. (2005). Pharmaceutical Care untuk Penyakit Infeksi Saluran Pernafasan Direktorat Bina Farmasi Komunitas dan Klinik. Jakarta: Dirjen Bina Kefarmasian dan Alat Kesehatan.

Kemenkes RI. (2011). Buku Bagan Manajemen Terpadu Balita Sakit (MTBS). Jakarta: Kementerian Kesehatan Republik Indonesia

Kemenkes RI. (2013). Riset Kesehatan Dasar. Riskesdas 2013, Badan Penelitian dan pengembangan Kesehatan Kementrian Kesehatan RI, Jakarta.

Kemenkes RI. (2018). Riset Kesehatan Dasar. Riskesdas 2018, Badan Penelitian dan pengembangan Kesehatan Kementrian Kesehatan RI, Jakarta.

Depkes. 2009. Profil Kesehatan Indonesia 2008. http://www.depkes.go.id. unduhan pada tanggal 19 september 2020.

Ferdiansyah, HN., Nazir Hz HM., Theodorus. (2010). Hubungan kadar Seng dan Vitamin A dengan kejadian ISPA dan Diare. Sari pediatri, 12(4): 241-246

Fitzsimons, R., Van Der Poel, A., Thornhill, W. (2015). Antihistamine use in children. Arch Dis Child Educ Pract Ed, 100(3);122-131

Furey, K., Wilkins, K. (2016). Prescribing “Off-Labelâ€: What Should a Physician Disclose?. AMA Journal of Ethics, 18(6): 587-593

Global Initiative for Asthma (GINA). (2014). Pocket Guide for Asthma Management and Prevension in Children. Diakses tanggal 10 Desember 2020

Kimland, E., Odlind, V. (2012). “Off-label drug use in pediatric patients. Clin Pharmacol Ther, 91(5);796-801.

Lazzerini M, Wanzira H. (2016). Oral zinc for treating diarrhoea in children. Cochrane Database Syst Rev, 12(2): CD005436

Malone, M., Kennedy, TM. (2017). Review: Side Effects of Some Commonly Used Allergy Medications (Decongestants, Anti-Leukotriene Agents, Antihistamines, Steroids, and Zinc) and Their Safety in Pregnanc. Int J Aller Medications, 3(1)

Matera, MG., Rogliani, P., Zanasi A. (2017). Bronchodilator therapy for chronic cough. Pulm Pharmaco Ther, 47; 88-92.

Purwadi, FV., Rano, KS. (2018). Review: Penggunaan Obat Off-Label Pada Anak-Anak. Farmaka, 16(1); 54-59

Rajesh, SM., Singhal, V. (2013). Clinical Effectiveness of Co-trimoxazole vs. Amoxicillin in the Treatment of Non-Severe Pneumonia in Children in India: A Randomized Controlled Trial. Int J Prev Med, 4(10): 1162–1168

Rerksuppaphol, S., Lakkana R. (2019). A randomized controlled trial of zink supplementation in the treatment of acute respiratory tract infection in Thai children. Pediatr Rep, 11(2):7954

Richter P, dalam Wexler P. (2014). Guaifenesin. Encyclopedia of Toxicology, Edisi ketiga. Academic Press

Saigal, P., Damian, H. (2020). Does zinc improve symptoms of viral upper respiratory tract infection?. Evidence-Based Practice, 23;37-39

Science, M., Johnstone J., Loeb M. (2012). Zinc for the treatment of the common cold: a systematic review and meta-analysis of randomized controlled trials. Canadian Medical Association Journal, 184(10);551-561

Setyaningrum, N., Viara, G., Suci G. (2017). Penggunaan Off-Label pada Anak di Apotek Kota Yogyakarta. Jurnal Sains Farmasi & Klinik, 4(2), 30-35.

Tefera, YG., Gebresillassie, BM., Mekuria, AB. (2017). Offâ€label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia. Pharmacology research & perspectives,5(2).

Craig S, Tusynski M, Armstrong D. (2016) It is time to stop prescribing oral salbutamol. Aust Fam Physician, 45(4); 245-247

Witch CM, Burkle CM, Lanier WL. (2012). The common question (and their answer) about off-label drug use, Mayo Clinic Proceedings.

Downloads

Published

2021-01-25

Issue

Section

Articles