Pharmacovigilance Study of Antidiabetic Drugs in Diabetes Mellitus Patients in Three Pharmacies in Yogyakarta

https://doi.org/10.22146/jmpf.88950

Qarriy 'Aina Urfiyya(1*), Ratu Aimeesadra Kamilabanat(2), Rahma Febita Solekhah(3)

(1) Akademi Farmasi Indonesia Yogyakarta
(2) Akademi Farmasi Indonesia Yogyakarta
(3) Akademi Farmasi Indonesia Yogyakarta
(*) Corresponding Author

Abstract


Background: Diabetes mellitus has become a global health problem. Indonesia has the third highest number of diabetes mellitus cases in the Southeast Asia region, with a prevalence of 11.3%. The high prevalence of diabetes mellitus increases the risk of Adverse Drug Reaction (ADR). Pharmacovigilance studies are important to detect possible adverse drug reaction of antidiabetic drugs.

Objective: This study aimed to describe and analyze the adverse drug reaction of using antidiabetic drugs at three pharmacies in Yogyakarta City.

Methods: This study used an analytic observational with a cross-sectional study design. Data were collected at three pharmacies in Yogyakarta City from 59 patients with diabetes mellitus who met the inclusion and exclusion criteria. The instrument used was an interview guide that refers to the Naranjo form. Data analysis included the incidence of adverse drug reaction according to patient characteristics, type of therapy, and description of antidiabetic adverse drug reaction based on causality.

Results: The results showed that antidiabetic ADRs occurred in 19 patients (32%). The incidence of ADRs was 68% in men and 32% in women. The incidence of adverse drug reaction was most prevalent at the age of 56-65 years (47%). The most common adverse drug reaction of antidiabetic metformin were flatulence, drowsiness, decreased appetite and dyspepsia, diarrhea, weight loss and nausea and vomiting.

Conclusion: This study concluded that the most common ADRs of antidiabetics was the probable and possible category (42%). The most common cause of ADRs was metformin (53%).


Keywords


Adverse Drug Reactions; Antidiabetic; Diabetes mellitus; Pharmacovigilance; Side effect



References

  1. Kementrian kesehatan republik indonesia (Kemenkes RI). Tetap Produktif, Cegah Dan Atasi Diabetes Mellitus. pusat data dan informasi kementrian kesehatan RI.2020
  2. Kementrian Kesehatan Republik Indonesia (Kemenkes RI). Hasil Riset Kesehatan Dasar Tahun 2018. Kementrian Kesehatan RI. 2018;53(9):1689-1699
  3. Jansson SPO. A Longitudinal Study of Diabetes Mellitus : With Special Reference to Incidence and Prevalence, and to Determinants of Macrovascular Complications and Mortality. Acta Universitatis Upsaliensis; 2014.
  4. Pavlov R, Topličan I, Vrcić Keglević M. Ten-Year Trends in the Morbidity of Diabetes Mellitus and Antidiabetic Drug Utilization in Croatia: A Study Based on Routinely Collected Data. Int J Family Med. 2016;2016:1-9. doi:10.1155/2016/9837496
  5. Aditya. M., Muhammad, H.A., Feliadewi, R. Reaksi Obat Yang Tidak Dikehendaki (ROTD) Pada Pasien Rawat Jalan Penyakit Ginjal Kronis Tahap Akhir Di Komunitas Pasien Cuci Darah Indonesia Cabang Jawa Timur : Metode Cross Sectional. BIMFI.2021
  6. Kementrian Kesehatan Republik Indonesia (kemenkes). Modul Penggunaan Obat Rasional Dalam Praktek. Kementerian Kesehatan Republik Indonesia. 201;3–4
  7. U.S.Food and Drug Administration (FDA). Preventable Adverse Drug Reactions: A Focus on Drug Interactions. 2018. https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions . Diakses 18 Juni 2024
  8. Desiani E, Anindhita MA, Rusli Effendi M. Evaluasi Farmakovigilans Obat Antidiabetes Oral Pada Pasien Rawat Jalan Diabetes Mellitus Tipe Ii Di Rsud Bendan Kota Pekalongan. Cendekia Journal of Pharmacy. 2020. http://cjp.jurnal.stikescendekiautamakudus.ac.id
  9. Joddy Sutama Putra R, Achmad A, Rachma Pramestutie H. Kejadian Efek Samping Potensial Terapi Obat Anti Diabetes Pada Pasien Diabetes Melitus Berdasarkan Algoritme Naranjo. Pharmaceutical Journal of Indonesia. 2017;2(2):45-50. doi:10.21776/ub.pji.2017.002.02.3
  10. Yosmar R, Putri Inanta N, Yelly D, Sari O. Studi Prospektif Adverse Drug Reactions (ADRS) Obat Hipoglikemik Oral Terhadap Pasien Diabetes Mellitus Tipe 2 di Suatu Rumah Sakit, Padang (A Prospective Study On Adverse Drug Reactions (Adrs) Of Oral Hypoglycemic Agents Among Type 2 Diabetes Patients in A Hospital, Padang). 2018;5(3):169-175. http://jsfk.ffarmasi.unand.ac.id
  11. Malhotra NK, Dash S. Marketing Research: An Applied Orientation. 7th edition. Pearson Education; 2016.
  12. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-245. doi:10.1038/clpt.1981.154
  13. BPOM. Modul farmakovigilans untuk tenaga kesehatan proyek 'ensuring drug and food safety. BPOM Japan International coorporation agency.2020.
  14. Rahayu S, Jayakarta PKP DKI Jakarta Stik. Hubungan Usia, Jenis Kelamin Dan Indeks Massa Tubuh Dengan Kadar Gula Darah Puasa Pada Pasien Diabetes Melitus Tipe 2 Di Klinik Pratama Rawat Jalan Proklamasi, Depok, Jawa Barat.; Jurnal Kesehatan Kusuma Husada. 2020.
  15. Davies EA, O’Mahony MS. Adverse drug reactions in special populations - The elderly. Br J Clin Pharmacol. 2015;80(4):796-807. doi:10.1111/bcp.12596
  16. Maher RL, Hanlon J, Hajjar ER. Clinical consequences of polypharmacy in elderly. Expert Opin Drug Saf. 2014;13(1):57-65. doi:10.1517/14740338.2013.827660
  17. Riwu M, Subarnas A, Lestari K. The Correlation of Age Factor, Administration, and Metformin Dose Against Risk of Side Effect on Type 2 Diabetes Mellitus. Indonesian Journal of Clinical Pharmacy. 2015;4(3):151-161. doi:10.15416/ijcp.2015.4.3.151
  18. Adiputra R. Efek Samping Penggunaan Obat Anti Diabetes Jangka Panjang: Sebuah Meta Analisis. Jurnal Kesehatan Tambusai. 4(3).2023
  19. Isnani, M., Muliyani. Pengaruh Karakteristik Pasien Dengan Terjadinya Adverse Drug Reaction (ADR) Pada Pasien Diabetes Melitus Tipe 2 Rawat Inap. Jurnal Mandala Pharmacon Indonesia. 2018;4. www.jurnal-pharmaconmw.com/jmpi
  20. Endokrinologi Indonesia. Pedoman Pengelolaan Dan Pencegahan Diabetes Melitus Tipe P. Pedoman Pengelolaan Dan Pencegahan Diabetes Melitus Tipe 2 Dewasa Di Indonesia-2021.2020.Penerbit PB. PERKENI.
  21. Muthukumar A, Sundaraganapathy R, Mohan S. A Pharmacovigilance Study Of Antidiabetic Drugs In Hypertensive Patients In A Territory Hospital In Coimbatore Zone. Der Pharmacia Lettre. 2017. http://scholarsresearchlibrary.com/archive.html]
  22. Dey I, Mohanty S, Prasad A, Patnayak C, Palit R. A study on adverse drug reactions of oral anti-diabetic agents in patients with type II diabetes mellitus in Hi-Tech Medical College and Hospital, Bhubneswar, Odisha, India. Int J Basic Clin Pharmacol. 2019;8(5):837. doi:10.18203/2319-2003.ijbcp20191566
  23. Malik M, Habib A, Ahmad R, Khanna S. Comparison of the Efficacy and Safety of Various Oral Antidiabetic Drug Regimens Used for Type-2 Diabetes Mellitus-in a Tertiary Care Hospital in South Delhi International Journal of Toxicological and Pharmacological Research. International Journal of Toxicological and Pharmacological Research Original Research Article. 2023;13(3):155-166. www.ijtpr.com
  24. Roy K, Divya S, Nadig P, Prakash B. Monitoring And Analysis Of Adverse Drug Reactions In A Private Tertiary Care Teaching Hospital. 2015;8. http://apps.who.int/medicinedocs/en/d/Jh3009e/.
  25. Pizzimenti V, Ientile V, Fava G, Giudice I, Bonfiglo C, Alecci U. Adverse Reactions with Antidiabetic Drugs: Results from a Prospective Cohort Study in Sicily. Asian J Pharm Clin Res.8(2):335-7. 2015 www.tcpdf.org
  26. Bucşa C., Farcaş, A., Cazacu, I., Leucuta D., Achimas-Cadariu, A., Mogosan, C., Bojita, M. How many potential drug-drug interactions cause adverse drug reactions in hospitalized patients? Eur J Intern Med. 2012;24. doi:10.1016/j.ejim.2012.09.011
  27. Nur Fahmi K, Urfiyya A. Gambaran Penggunaan Insulin Pada Pasien Diabetes Melitus Tipe 2 Rawat Jalan Di Rsi Hidayatullah Yogyakarta An Overview Insulin Used In Outpatient With Diabetes Mellitus Type 2 At Hidayatullah Islamic Yogyakarta Hospital. Jurnal Inovasi Farmasi Indonesia. 2022;4(1).
  28. Barrouq D. Development of Hypoglycemia Associated with Therapeutic Dose of Metformin: a Case Report. International Journal of Medical Reviews and Case Reports. 2020;(0):1. doi:10.5455/ijmrcr.hypoglycemia-metformin
  29. American Diabetes Association. Standard medical care in diabetes 2018. The journal of clinical and applied research and education. 2018;41(January). doi:10.2337/dc18-Sint01
  30. Deb T, Chakrabarty A, Ghosh A. Adverse drug reactions in Type 2 diabetes mellitus patients on oral antidiabetic drugs in a diabetes outpatient department of a tertiary care teaching hospital in the Eastern India. Int J Med Sci Public Health. 2017;6(3):1. doi:10.5455/ijmsph.2017.0423203102016
  31. Nabrdalik K, Skonieczna-Żydecka K, Irlik K, Krzysztof & Hendel, Mirela & Kwiendacz, Hanna & Loniewski, Igor & Januszkiewicz, Kornelia & Gumprecht, Janusz & Lip, Gregory. Gastrointestinal adverse events of metformin treatment in patients with type 2 diabetes mellitus: A systematic review, meta-analysis and meta-regression of randomized controlled trials. Front Endocrinol (Lausanne). 2022;13. doi:10.3389/fendo.2022.975912
  32. Subramaniam K, Joseph MP, Babu LA. A Common Drug Causing a Common Side Effect at an Uncommon Time: Metformin-Induced Chronic Diarrhea and Weight Loss after Years of Treatment. Clinical Diabetes. 2021;39(2):237-240. doi:10.2337/cd20-0101
  33. Malin SK, Kashyap SR. Effects of metformin on weight loss: potential mechanisms. Curr Opin Endocrinol Diabetes Obes. 2014;21(5):323-329. doi:10.1097/MED.0000000000000095
  34. Aberg JA, LC, AL, GM and LLL. Drug Information Handbook . 17th ed. American PharmacistAssociation.; 2014.
  35. Sheehan MT. Current Therapeutic Options in Type 2 Diabetes Mellitus: A Practical Approach. Vol 1.; 2003. www.mfldclin.edu/clinmedres
  36. Donnor T, Sarkar S. insulin- Pharmacology, Therapeutic Regimens and Principles of Intensive Insulin Therapy. https://www.ncbi.nlm.nih.gov/books/NBK278938/.
  37. Mahirsyah WT, Andayani TM, Ika PS. Hubungan Antara Ketepatan Penggunaan Obat Pada Pasien Usia Lanjut Terhadap Efek Samping Dan Lama Perawatan Di Bangsal Rawat Inap RSUP Dr Kariadi Semarang. Universitas Gadjah Mada; 2016.



DOI: https://doi.org/10.22146/jmpf.88950

Article Metrics

Abstract views : 12

Refbacks

  • There are currently no refbacks.


Copyright (c) 2025 JURNAL MANAJEMEN DAN PELAYANAN FARMASI (Journal of Management and Pharmacy Practice)

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

©Jurnal Manajemen dan Pelayanan Farmasi
Faculty of Pharmacy
Universitas Gadjah Mada
Creative Commons License
View My Stats