Yatan Hastalarda Raporlanan Advers İlaç Reaksiyonlarının Değerlendirilmesi

Year 2023, Volume: 10 Issue: 2, 452 - 468, 31.08.2023

Yasemin Aslan

https://doi.org/10.21020/husbfd.1146973

Abstract

Amaç: Bu çalışmada, bir üniversite hastanesinde bildirimi yapılan advers ilaç reaksiyonlarının değerlendirilmesi amaçlanmıştır.
Gereç ve Yöntem: Çalışma tanımlayıcı tipte kesitsel bir araştırmadır. Veriler, 01.01.2018-31.12.2021 tarihleri arasında hastanenin Eczane Müdürlüğü kayıtlarında arşivlenen 95 adet “Türkiye Farmakovijilans Merkezi Advers Reaksiyon Bildirim Formu” kullanılarak retrospektif olarak incelenmiştir. Microsoft Excel programına aktarılan verilerin analizinde PivotTable raporlarından ve tanımlayıcı istatistiklerden yararlanılmıştır. Advers reaksiyona neden olduğundan şüphelenilen ilaçların sınıflandırılmasında “Dünya Sağlık Örgütü Anatomik Terapötik Kimyasal Sınıflandırma Sistemi” kullanılmıştır.
Bulgular: Çalışmada, bildirimi yapılan advers reaksiyonların %40,9’unun dermatolojik belirtiler ve %18,8’inin solunum sıkıntısı olduğu saptanmıştır. Advers reaksiyon gelişen hastaların %41,1’inin akut lenfoblastik lösemi, %10,5’inin üst solunum yolu enfeksiyonu tanısı aldığı görülmüştür. Hastaların %82,1’inde ciddi olmayan advers etkilerin geliştiği ve advers reaksiyon gelişen hastaların %86,3’ünün iyileştiği tespit edilmiştir. Advers etkiye neden olduğu düşünülen ilaçların %51,6’sının sistemik antienfektifler ve %27,4’ünün antineoplastik ve immünomodülatör ajanlar grubuna dahil olduğu saptanmıştır.
Sonuç: Çalışma sonucunda advers reaksiyona en fazla neden olan ilaç gruplarının sistemik antienfektifler ile antineoplastik ve immünomodülatör ajanlar olduğu ve en sık görülen advers reaksiyonların dermatolojik belirtiler olduğu saptanmıştır. Advers ilaç reaksiyonu gelişmesi açısından yüksek riskli grupta yer alan hasta ve ilaçların tanınması, advers reaksiyonlar konusunda çalışanlara eğitim verilmesi ve advers reaksiyon nedenlerinin tespit edilmesi için ileri düzey çalışmalar yapılması önerilmektedir.

Keywords

Advers ilaç reaksiyonu, üniversite hastanesi, yatan hastalar

Supporting Institution

Çalışmayı destekleyen herhangi bir kurum bulunmamaktadır.

Evaluation of Adverse Drug Reactions Reported in Inpatients

Abstract

Objectives: In this study, it was aimed to determine the adverse drug reactions reported in a university hospital.
Materials and Methods: The study is a descriptive cross-sectional study. Data were analyzed retrospectively using 95 “Turkish Pharmacovigilance Center Adverse Reaction Notification Forms” archived in the hospital's Pharmacy Department records between January 01,2018 and December 31,2021. Microsoft Excel PivotTable reports and descriptive statistics were used in the analysis of the data. “The World Health Organization Anatomical Therapeutic Chemical Classification System” was used to classify drugs suspected to cause adverse reactions.
Results: In the study, 40.9% of the reported adverse reactions were dermatological symptoms and 18.8% were respiratory distress. It was observed that 41.1% of the patients who developed adverse reactions were diagnosed with acute lymphoblastic leukemia and 10.5% were diagnosed with upper respiratory tract infection. It was determined that 82.1% of the patients developed non-serious adverse reactions and 86.3% of the patients who developed adverse reactions recovered. It was determined that 51.6% of the drugs thought to cause adverse reactions were included in the group of systemic anti-infectives and 27.4% in the group of antineoplastic and immunomodulatory agents.
Conclusion: As a result of the study, it was determined that the drug groups that caused the most adverse reactions were systemic antiinfectives, antineoplastics, and immunomodulatory agents, and the most common adverse reactions were dermatological symptoms. It is recommended to identify patients and drugs in the high-risk group for adverse drug reactions, training to employees about adverse reactions, and to carry out advanced studies on the causes of adverse reactions.

Keywords

Adverse drug reaction, university hospital, inpatients

References

• A Aagaard, L., Strandell, J., Melskens, L., Petersen, P. S. G., & Holme Hansen, E. (2012). Global patterns of adverse drug reactions over a decade. Drug Safety, 35(12), 1171-1182. https://doi.org/10.2165/11631940-000000000-00000
• Alan, S., Ozturk, M., Gokyildiz, S., Avcibay, B., & Karataş, Y. (2013). An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey. Indian Journal of Pharmacology, 45(6), 616-618. https://doi.org/10.4103/0253-7613.121375
• Aykan, D. A., Nazik, H., & Ergün, Y. (2019). Advers ilaç reaksiyonları spontan bildirimlerinin değerlendirilmesi: Klinik farmakoloji deneyimimiz. Kocaeli Medical Journal, 8(2), 230-239.
• Baniasadi, S., Fahimi, F., & Shalviri, G. (2008). Developing an adverse drug reaction reporting system at a teaching hospital. Basic and Clinical Pharmacology and Toxicology, 102(4), 408-411. https://doi.org/10.1111/j.1742-7843.2008.00217.x
• Berga Culleré, C., Gorgas Torner, M. Q., Altimiras Ruiz, J., Tuset Creus, M., Besalduch Martín, M., Capdevila Sunyer, M., Torres Gubert, M., Casajoana Cortinas, M. T., Baró Sabaté, E., Fernández Solà, J. R., Moron i
• Besolí, A., Òdena Estradé, E., Serrais Benavente, J., Vitales Farrero, M. T., & Codina Jané, C. (2009). Detecting adverse drug events during the hospital stay. Farmacia Hospitalaria, 33(6), 312-323. https://doi.org/10.1016/S1130-6343(09)72974-5
• Bushra, R., Baloch, S. A., Jabeen, A., Bano, N., & Aslam, N. (2015). Adverse drug reactions: Factors and role of pharmacist in their prevention. Journal of Ayub Medical College Abbottabad, 27(3), 702-706.
• Campbell, J. E., Gossell-Williams, M., & Lee, M. G. (2014). A review of pharmacovigilance. West Indian Medical Journal, 63(7), 771-774. https://doi.org/10.7727/wimj.2013.251
• Desai, C.K., Lyar, G., Panchal, J., Shah, S., & Dikshit, R. K. (2011). An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspectives in Clinical Research, 2(4), 130-136. doi: 10.4103/2229-3485.86883.
• Ding, W. Y., Lee, C. K., & Choon, S. E. (2010). Cutaneous adverse drug reactions seen in a tertiary hospital in Johor, Malaysia. International Journal of Dermatology, 49(7), 834-841. https://doi.org/10.1111/j.1365-4632.2010.04481.x
• Dubrall, D., Just, K. S., Schmid, M., Stingl, J. C., & Sachs, B. (2020). Adverse drug reactions in older adults: A retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices. BMC Pharmacology and Toxicology, 21(1), 1-20. https://doi.org/10.1186/s40360-020-0392-9
• Ersulo, T. A., Yizengaw, M. A., & Tesfaye, B. T. (2022). Incidence of adverse drug events in patients hospitalized in the medical wards of a teaching referral hospital in Ethiopia: a prospective observational study. BMC Pharmacol Toxicol, 23, 30. https://doi.org/10.1186/s40360-022-00570-w
• Fisun, V., Seval, Ç., & Birol, V. (2014). Sık karşılaşılan ilaç uygulama hataları ve ilaç güvenliği. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi, 5(4), 271-275.
• Formica, D., Sultana, J., Cutroneo, P. M., Lucchesi, S., Angelica, R., & Crisafulli, S. (2018). The economic burden of preventable adverse drug reactions : A systematic review of observational studies. In Expert Opinion on Drug Safety, 0(0). Taylor & Francis. https://doi.org/10.1080/14740338.2018.1491547
• Giardina, C., Cutroneo, P. M., Mocciaro, E., Russo, G. T., Mandraffino, G., Basile, G., Rapisarda, F., Ferrara, R., Spina, E., & Arcoraci, V. (2018). Adverse drug reactions in hospitalized patients: results of the FORWARD (Facilitation of Reporting in Hospital Ward) study. Frontiers in Pharmacology, 9, 350. doi: 10.3389/fphar.2018.00350
• Hakkarainen, K. M., Hedna, K., Petzold, M., & Ha, S. (2012). Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions. PLoS One, 7(3), e33236. https://doi.org/10.1371/journal.pone.0033236
• Herdeiro, M. T., Figueiras, A., Pol, J., & Gestal-otero, J. J. (2005). Physicians’ attitudes and adverse drug reaction reporting a case-control study in Portugal. Drug Safety, 28(9), 825-833. doi: 10.2165/00002018-200528090-00007.
• Kubat, H. (2018). Hekimlerin akılcı ilaç kullanımı ve farmakovijilansa yönelik bilgi ve tutumları. Çukurova Medical Journal, 43(2), 286-294. https://doi.org/10.17826/cumj.341469
• Lazarou, J., Pomeranz, B. H., & Corey, P. N. (1998). Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 279(15), 1200-1205. doi:10.1001/jama.279.15.1200
• Marques, J., Ribeiro-Vaz, I., Pereira, A. C., & Polõnia, J. (2014). A survey of spontaneous reporting of adverse drug reactions in 10 years of activity in a pharmacovigilance centre in Portugal. International Journal of Pharmacy Practice, 22(4), 275-282. https://doi.org/10.1111/ijpp.12078
• Marzano, A. V., Borghi, A., & Cugno, M. (2016). Adverse drug reactions and organ damage: The skin. European Journal of Internal Medicine, 28, 17-24. https://doi.org/10.1016/j.ejim.2015.11.017
• McKenna, J. K., & Leiferman, K. M. (2004). Dermatologic drug reactions. Immunology and Allergy Clinics of North America, 24(3), 399-423. https://10.1080/10.1016/j.iac.2004.03.007
• Miller, A. (2014). Application of Excel©RPivot tables and PivotCharts for efficient library data analysis and illustration. Journal of Library Administration, 54, 169-186. https://10.1080/01930826.2014.915162
• Montastruc, J. L., Lafaurie, M., de Canecaude, C., Durrieu, G., Sommet, A., Montastruc, F., & Bagheri, H. (2021). Fatal adverse drug reactions: A worldwide perspective in the World Health Organization pharmacovigilance database. British Journal of Clinical Pharmacology, 87(11), 4334-4340. https://doi.org/10.1111/bcp.14851
• Oğan, D., & Dikmen, M. (2020). İlaç kullanımı ile oluşan cilt reaksiyonları. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, 9(2): 186-194.
• Ozcan, G., Aykac, E., Kasap, Y., & Nemutlu, N. T. (2016). Adverse drug reaction reporting pattern in Turkey : Analysis of the National Database in the context of the first pharmacovigilance legislation. Drugs - Real World Outcomes, 3(1), 33-43. https://doi.org/10.1007/s40801-015-0054-1
• Pirmohamed, M., Ostrov, D. A., & Park, B. K. (2015). New genetic findings lead the way to a better understanding of fundamental mechanisms of drug hypersensitivity. Journal of Allergy and Clinical Immunology, 136(2), 236-344. https://doi.org/10.1016/j.jaci.2015.06.022
• Poudel, D. R. (2017). Burden of hospitalizations related to adverse drug events in the USA : A retrospective analysis from large inpatient database. Pharmacoepidemiol Drug Safety, 26(6), 635-641. https://doi.org/10.1002/pds.4184
• Rademaker, M. (2001). Do women have more adverse drug reactions? American Journal of Clinical Dermatology, 2(6), 349-35. https://doi.org/10.2165/00128071-200102060-00001
• Rational Drug Use and Pharmacovigilance Department (JFDA). (2014). Guidelines for detecting & reporting adverse drug reactions. Individual Case Safety Reports For Healthcare Professionals. Version 01.
• Rosli, R., Ming, L. C., Abd Aziz, N., & Manan, M. M. (2016) A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients. PLoS ONE, 11(6), e0155385. doi:10.1371/journal.pone.0155385.
• Sendekie, A. K., Netere, A. K., Tesfaye, S, Dagnew, E. M., & Belachew, E. A. (2023). Incidence and patterns of adverse drug reactions among adult patients hospitalized in the University of Gondar comprehensive specialized hospital: A prospective observational follow-up study. PLoS One, 18(2), e0282096. doi: 10.1371/journal.pone.0282096
• Stricker, B. C., & Psaty, B. M. (2004). Detection, verification, and quantification of adverse drug reactions. British Medical Journal, 329(7456), 44-47. https://doi.org/10.1136/bmj.329.7456.44 Sultana, J., Cutroneo, P., & Trifirò, G. (2013). Clinical and economic burden of adverse drug reactions. Journal of Pharmacology & Pharmacotherapeutics, 4(1), 73-77. https://doi.org/10.4103/0976-500X.120957
• T.C.Sağlık Bakanlığı Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK). (2022). Farmakavijilans. https://www.titck.gov.tr/faaliyetalanlari/ilac/18 adresinden 19.07.2022 tarihinde erişildi.
• T.C.Sağlık Bakanlığı Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK). (2014). İyi farmakovijilans uygulamaları kılavuzu. https://titck.gov.tr/storage/announcement/887fa82316364.pdf adresinden 19.07.2022 tarihinde erişildi.
• Uzuntarla, Y., Cihangiroğlu, N. (2017). Hemşirelerin akılcı ilaç kullanımı ile kişilik özellikleri arasındaki ilişkinin analizi. TAF Preventive Medicine Bulletin, 15(1), 1-8. https://doi.org/10.5455/pmb.1-1428420168
• Vural, F. (2015). The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital. Northern Clinics of Istanbul, 1(3), 147-152. https://doi.org/10.14744/nci.2014.41636
• WHO. (2002). Safety of medicines : A guide to detecting and reporting adverse drug reactions: Why health professionals need to take action. World Health Organization. https://apps.who.int/iris/handle/10665/67378.
• WHO. (2021). Collaborating centre for drug statistics methodology, guidelines for ATC classification and DDD assignment 2022. Oslo, Norway: WHO Drug Information.
• Wolfe, D., Yazdi, F., Kanji, S., Burry, L., Id, A. B., Butler, C., Esmaeilisaraji, L., Hamel, C., Hersi, M., Skidmore, B., Id, D. M., & Id, B. H. (2018). Incidence, causes, and consequences of preventable adverse drug reactions occurring in inpatients : A systematic review of systematic reviews. PLoS One, 13(10), e0205426. doi: 10.1371/journal.pone.0205426
• Zopf, Y., Rabe, C., Neubert, A., Gaßmann, K. G., Rascher, W., Hahn, E. G., Brune, K., & Dormann, H. (2008). Women encounter ADRs more often than do men. European Journal of Clinical Pharmacology, 64(10), 999-1004. https://doi.org/10.1007/s00228-008-0494-6
• Zucker, I., & Prendergast, B.J. (2020). Sex differences in pharmacokinetics predict adverse drug reactions in women. Biology of Sex Differences, 11, 32. https://doi.org/10.1186/s13293-020-00308-5