Penggunaan Off-Label Misoprostol Pada Pasien Obstetri-Ginekologi Di Rumah Sakit Swasta Kab. Banyumas
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Abstract
Penggunaan obat off-label pada pasien obstetri-ginekologi memerlukan kewaspadaan karena berisiko tinggi bagi kehamilan. Meskipun masih terjadi perdebatan, data profil penggunaannya pada praktik klinik masih kurang. Penelitian ini bertujuan untuk mengobservasi penggunaan obat off-label pada pasien obstetri dan ginekologi di rumah sakit swasta, khususnya obat Misoprostol. Penelitian ini menggunakan pendekatan deskriptif observasional terhadap data rekam medis rumah sakit. Pengambilan data penelitian secara retrospektif di RSU Bunda (RS X) periode Juli 2017 – Desember 2017 dan RS Sinar Kasih (RS Y) periode Januari 2018 – Desember 2018. Jumlah sampel ditentukan menggunakan rumus Slovin, dengan teknik sampling systematic random sampling di RS X dan total sampling di RS Y. Jumlah keseluruhan sampel adalah 220 RM di RS X 130 dan RS Y 90. Penelitian dilakukan pada rentang waktu bulan Januari 2019 – Maret 2019. Hasil dianalisis secara univariat menggunakan beberapa referensi terkait. Hasil penelitian menunjukan adanya penggunaan obat off-label misoprostol sebanyak 26,92% di RS X dan sebanyak 4% di RS Y. Obat off-label yang ditemukan adalah Misoprostol yang tergolong ke dalam kategori off-label indikasi (Missed Abortion, Abortus Incomplete, Blighted Ovum, dan Induksi persalinan pada kasus Serotinus, KPD, dan IUFD), off-label dosis (50 µg, 100 µg dan 400 µg), dan off-label rute pemberian (sublingual dan vaginal).
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References
. Radley DC, Finkelstein SN, Stafford RS. Off-label Prescribing Among Office-Based Physicians. Arch Intern Med. 2006;166(9):1021. https://doi.org/10.1001/archinte.166.9.1021
. Tabarrok AT. Assessing the FDA via the Anomaly of Off-Label Drug Prescribing. In: Assessing the FDA. The Independent Institute; 2000. p. 30.
. Eguale T, Buckeridge DL, Verma A, Winslade NE, Benedetti A, Hanley JA, et al. Association of Off-label Drug Use and Adverse Drug Events in an Adult Population. JAMA Intern Med. 2016;176(1):55. https://doi.org/10.1001/jamainternmed.2015.6058
. Setyaningrum N, Khamsani H, Mulyawati R. Obat Off-Label Pada Anak di Pelayanan Rawat Jalan Klinik Pratama Swasta Kabupaten Sleman Yogyakarta. J Sains Farm Klin. 2019;6(1):37. https://doi.org/10.25077/jsfk.6.1.37-45.2019
. Setyaningrum N, Gredynadita V, Gartina S. Penggunaan Obat Off-Label pada Anak di Apotek Kota Yogyakarta. JSainsFarKlin. 2017;4(1):30. https://doi.org/10.29208/jsfk.2017.4.1.169
. Abdulah R, Khairinisa MA, Pratiwi AA, Barliana MI, Pradipta IS, Halimah E, et al. Off-label paediatric drug use in an Indonesian community setting. J Clin Pharm Ther. 2015;40(4):409–12. https://doi.org/10.1111/jcpt.12276
. Anggriani A, Lisni I, Muttaqien W. Kajian penggunaan obat misoprostol sebagai off-label pada pelaksanaan persalinan di Klinik Utama Al-Islam Bandung. kjif. 2019;7(2):53. https://doi.org/10.26874/kjif.v7i2.161
. Voigt F, Goecke TW, Najjari L, Pecks U, Maass N, Rath W. Off-label use of misoprostol for labor induction in Germany: a national survey. European Journal of Obstetrics & Gynecology and Reproductive Biology. 2015;187:85–9. https://doi.org/10.1016/j.ejogrb.2014.11.026
. Zahran KM, Shahin AY, Abdellah MS, Elsayh KI. Sublingual versus vaginal misoprostol for induction of labor at term: A randomized prospective placebo-controlled study. Journal of Obstetrics and Gynaecology Research. 2009;35(6):1054–60. https://doi.org/10.1111/j.1447-0756.2009.01030.x
. Herring C, McManus A, Weeks A. Offlabel prescribing during pregnancy in the UK: an analysis of 18000 prescriptions in Liverpool Women’s Hospital. International Journal of Pharmacy Practice. 2010;18(4). https://doi.org/10.1211/ijpp.18.04.0007
. Tangwa GB. Ethical principles in health research and review process. Acta Tropica. 2009;112:S2–7.
. BPOM RI. Misoprostol [Internet]. PIONAS. 2019 [cited 2019 Aug 15]. Available from: https://pionas.pom.go.id/monografi/misoprostol
. FDA. Misoprostol (marketed as Cytotec) Information [Internet]. U.S. Food and Drug Administration. 2015. Available from: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/misoprostol-marketed-cytotec-information
. Legro RS. Introduction: On-label and off-label drug use in reproductive medicine. Fertility and Sterility. 2015;103(3):581–2. https://doi.org/10.1016/j.fertnstert.2015.01.028
. Wibowo A. Metodologi penelitian praktis bidang kesehatan. Jakarta: Rajawali Pers; 2014. 1–298 p.
. Staffs of Lexi-Comp. Drug Information Handbook. 27th ed. LexiComp; 2018.
. BPOM RI. Informatorium Obat Nasional Indonesia (Cetakan tahun 2017). Jakarta: Sagung Seto; 2014.
. Macones GA. Management of Labor and Delivery. 2nd ed. John Wiley & Sons, Ltd; 2016.
. WHO. Clinical Practice Handbook for Safe Abortion [Internet]. Switzerland: WHO Press; 2014. Available from: https://apps.who.int/iris/bitstream/10665/97415/1/9789241548717_eng.pdf?ua=
. Riwidikdo H. Statistik Kesehatan Belajar Mudah Tehnik Analisis Data Dalam Penelitian Kesehatan. Yogyakarta: Mitra Cendekia Press; 2015.
. Mubarak WI. Promosi Kesehatan untuk Kebidanan. Jakarta: Salemba Medika; 2013.
. Xiaoli L, Weiyuan Z. Effect of maternal age on pregnancy: a retrospective cohort study. Chinese Medical Journal. 2014;12(127):6.
. Prihandini SR, Pujiastuti W, Hastuti TP. Usia Reproduksi Tidak Sehat Dan Jarak Kehamilan Yang Terlalu Dekat Meningkatkan Kejadian Abortus Di Rumah Sakit Tentara Dokter Soedjono Magelang. JURNAL KEBIDANAN. 2016;(9):12.
. Anonim. Profil RSU Bunda Purwokerto [Internet]. RSU Bunda Purwokerto. 2019 [cited 2019 Jan 1]. Available from: https://rsubundapurwokerto.co.id/profil/
. Drina M. Peptic ulcer disease and non-steroidal anti-inflammatory drugs. Aust Prescr. 2017;40(3):91–3. https://doi.org/10.18773/austprescr.2017.037
. Acharya T, Devkota R, Bhattarai B, Acharya R. Outcome of misoprostol and oxytocin in induction of labour. SAGE Open Medicine. 2017;5:205031211770080. https://doi.org/10.1177/2050312117700809
. Pourali L, Saghafi N, Eslami Hasan Abadi S, Tara F, Vatanchi AM, Motamedi E. Induction of labour in term premature rupture of membranes; oxytocin versus sublingual misoprostol; a randomised clinical trial. Journal of Obstetrics and Gynaecology. 2018;38(2):167–71. https://doi.org/10.1080/01443615.2017.1329284
. Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: Pharmacokinetic profiles, effects on the uterus and side-effects. International Journal of Gynecology & Obstetrics. 2007;99:S160–7. https://doi.org/10.1016/j.ijgo.2007.09.004
. Bakker R, Pierce S, Myers D. The role of prostaglandins E1 and E2, dinoprostone, and misoprostol in cervical ripening and the induction of labor: a mechanistic approach. Arch Gynecol Obstet. 2017;296(2):167–79. https://doi.org/10.1007/s00404-017-4418-5
. Weaver E, Soong B, Anantharm H, Aziz R, Becker J, Bolton E, et al. Guideline: Perineal care. Statewide Maternity and Neonatal Clinical Network (Queensland); 2018.
. Zaidan A, Al-Juffairi ZA. The Effectiveness of Misoprostol in Causing a Complete Miscarriage in a Blighted Ovum Pregnancy. Bahrain Medical Bulletin. 2019;41(2):4.
. Petersen SG, Perkins AR, Gibbons KS, Bertolone JI, Mahomed K. The medical management of missed miscarriage: outcomes from a prospective, singleâ€centre, Australian cohort. Medical Journal of Australia. 2013;199(5):341–6. https://doi.org/10.5694/mja12.11813
. Gurung G, Rana A, Baral J. Use of Misoprostol in the Management of Early Pregnancy Loss. Nepal j obstet gynaecol. 2014;7(2):9–13. https://doi.org/10.3126/njog.v7i2.11133
. Sotiriadis A, Makrydimas G, Papatheodorou S, Ioannidis JPA. Expectant, Medical, or Surgical Management of First-Trimester Miscarriage: A Meta-Analysis: Obstetrics & Gynecology. 2005;105(5, Part 1):1104–13. https://doi.org/10.1097/01.AOG.0000158857.44046.a4
. Blum J, Bynum J, Dabash R, Diop A, Durocher J. Misoprostol for Treatment of Incomplete Abortion: An Introductory Guidebook. USA: Gynuity Health Projects; 2010.
. Abediasl Z, Sheikh M, Pooransari P, Farahani Z, Kalani F. Vaginal misoprostol versus intravenous oxytocin for the management of second-trimester pregnancies with intrauterine fetal death: A randomized clinical trial: Misoprostol vs oxytocin in IUFD. J Obstet Gynaecol Res. 2016;42(3):246–51. https://doi.org/10.1111/jog.12910
. Harandi R, Karamali M, Moein A. Induction of labor with titrated oral misoprostol solution versus oxytocin in term pregnancy: randomized controlled trial. Revista Brasileira de Ginecologia e ObstetrÃcia. 2013;35(2). https://doi.org/10.1590/S0100-72032013000200004
. Cunningham FG, Leveno KJ, Bloom S, Spong C, Dashe JS. William Obstetrics. 24th ed. Mc Graw Hill Education; 2014.
. Gómez Ponce de León R, Wing D, Fiala C. Misoprostol for intrauterine fetal death. International Journal of Gynecology & Obstetrics. 2007;99:S190–3. https://doi.org/10.1016/j.ijgo.2007.09.010
. Tharihalli C, Bhat S. Study of vaginal misoprostol for labour induction in intra uterine fetal demise. Int J Reprod Contracept Obstet Gynecol. 2017;6(2):479. https://doi.org/10.18203/2320-1770.ijrcog20170366
. Shrestha SD, Singh A, Rc L, Pradhan B, Shah W, Shrestha R. Misoprostol for Termination of Second Trimester Pregnancy. J Patan Acad Health Sci. 2015;1(1):16–9. https://doi.org/10.3126/jpahs.v1i1.13010
. Nautiyal D, Mukherjee K, Perhar I, Banerjee N. Comparative Study of Misoprostol in First and Second Trimester Abortions by Oral, Sublingual, and Vaginal Routes. J Obstet Gynecol India. 2015;65(4):246–50. https://doi.org/10.1007/s13224-014-0587-3