Tıp Fakültesi 4. 5. ve 6. Sınıf Öğrencilerinin Farmakovijilans Hakkında Bilgi, Tutum ve Davranışları
Öz
Amaç: Farmakovijilans, advers ilaç reaksiyonları (AİR) başta olmak üzere ilaçla ilgili sorunların tespit edilmesi, yorumlanması ve önlenmesi ile ilgili bilimsel çalışmalardır. AİR bir ilaca karşı gelişen zararlı ve beklenmeyen cevap olarak tanımlanmaktadır. AİR’nın saptanması ve takibi, mortalite ve morbidite oranlarını artırması, iş gücü kaybı gibi sonuçlar nedeniyle önemlidir. Bu çalışmada tıp fakültesi 4. 5. ve 6. sınıf öğrencilerinin; farmakovijilans ve AİR konusundaki farkındalığını, bilgi ve görüşlerini belirleyerek farmakovijilans uygulamalarına ilişkin görevlerine yeterince hazırlıklı olup olmadıklarının incelenmesi amaçlanmıştır.
Yöntem ve Gereçler : Bu çalışma gözlemsel, kesitsel ve tanımlayıcı tipte 2022-2023 tarihleri arasında Sağlık Bilimleri Üniversitesi Gülhane Tıp Fakültesinde yapılmıştır. Öğrencilere, çalışma hakkında bilgi verilerek, Microsoft Forms uygulaması üzerinden anketi doldurmaları sağlanmıştır. Kullanılan anket ile tıp fakültesi öğrencilerinin demografik özellikleri, farmakovijilans ve AİR’na yönelik bilgi, tutum ve uygulamaları değerlendirilmiştir.
Bulgular: Çalışmaya katılan öğrenci sayısı 338’dir. Öğrencilerin %70’i farmakovijilansın tanımına doğru cevap vermiştir. %38’i Türkiye’de bir Farmakovijilans Merkezi’nin (TÜ- FAM) olduğunu ve %58’i Türkiye’de AİR izlenmesinden sorumlu kurumunun TÜFAM olduğunu ifade etmektedir. Öğrencilerinin %87,2’si AİR bildiriminin gerekli olduğunu düşünürken %26’sı hastanede farmakovijilans irtibat noktasının olduğunu bilmektedir. Öğrencilerin %81,6’sı AİR bildiriminin profesyonel bir yükümlülük olduğunun farkındadır. Öğrencilerin %53,5’i farmakovijilansın tıp fakültesi eğitiminde ayrıntılı olarak ele alınması gerektiğini belirtirken yalnızca %14’ü farmakovijilansın eğitimi müfredatında yeterli şekilde yer aldığını ifade etmektedir.
Sonuç: Çalışmamızda tıp fakültesi öğrencilerinin farmakovijilansa yönelik bilgi, tutum ve uygulamalarında eksiklikler olduğu gösterilmiştir. Bu eksikliklerin giderilmesi için tıp fakültesi eğitim müfredatında farmakovijilans ve AİR bildirimi ile ilgili düzenlemelerin yapılması ve ilgili hastanelerin farmakovijilans irtibat noktaları ve TÜFAM’ın bu konuda aktif rol oynamaları önemlidir.
Anahtar Kelimeler
Tıp öğrencisi Farmakovijilans İstenmeyen ilaç reaksiyon Tıp eğitimi
Destekleyen Kurum
Yok
Proje Numarası
-
Teşekkür
-
Kaynakça
- 1. T.C.S.B. Türkiye İlaç ve Tıbbi Cihaz Kurumu. Farmakovijilans. Erişim Adresi: https://www.titck.gov.tr/faaliyetalanlari/ilac/18. Erişim Tarihi: 23.07.2023
- 2. Campbell JE, Gossell-Williams M, Lee MG. A review of pharmacovigilance. West Indian Medical Journal. 2014; 63(7):771-774. doi:10.7727/wimj.2013.251
- 3. Lindquist M, Edwards IR. The WHO programme for international drug monitoring, its database, and the technical support of the uppsala monitoring center. In: Journal of Rheumatology. Vol 28. ; 2001.
- 4. Ithnin M, Rani MDM, Latif ZA, et al. Mobile app design, development, and publication for adverse drug reaction assessments of causality, severity, and preventability. JMIR Mhealth Uhealth. 2017;5(5): e78. doi:10.2196/mhealth.6261
- 5. Ergün Y, Ergün TB, Toker E, Ünal E, Akben M. Knowledge attitude and practice of Turkish health professionals towards pharmacovigilance in a university hospital. Int Health. 2019;11(3):177-184. doi:10.1093/inthealth/ihy073
- 6. Ozcan G, Aykac E, Kasap Y, Nemutlu NT, Sen E, Aydinkarahaliloglu ND. Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation. Drugs Real World Outcomes. 2016;3(1):33-43. doi:10.1007/s40801-015-0054-1
- 7. Bhagavathula ASK, Elnour AA, Jamshed SQ, Shehab A. Health professionals’ knowledge, attitudes and practices about Pharmacovigilance in India: A systematic review and meta-analysis. PLoS One. 2016;11(3):e0152221. doi:10.1371/journal.pone.0152221
- 8. Tiftik N, Duman İ, Ün İ. Bir Üniversite Hastanesinde Görev Yapan Hemşirelerin Farmakovijilans Hakkında Bilgi, Tutum ve Uygulamalarının Değerlendirmesi. Mersin Üniversitesi Tıp Fakültesi Lokman Hekim Tıp Tarihi ve Folklorik Tıp Dergisi. 2019;9(3):285-293. doi:10.31020/mutftd.581540
- 9. Emerce E. Seçilmiş Üç Eczacılık Fakültesinin 3. 4. ve 5. Sınıf Öğrencilerinin Farmakovijilans Konusundaki Farkındalık Durumu Bilgi ve Görüşlerinin İncelenmesi. Yüksek Lisans Tezi. Hacettepe Üniversitesi Sağlık Bilimleri Enstitüsü Halk Sağlığı Ana Bilim Dalı, Ankara, 2019.
- 10. Reumerman M, Tichelaar J, Richir MC, van Agtmael MA. Medical students as adverse drug event managers, learning about side effects while improving their reporting in clinical practice. Naunyn Schmiedebergs Arch Pharmacol. 2021;394(7):1467-1476. doi:10.1007/s00210-021-02060-y
- 11. Katyal J, Arora E, Gupta YK. Impact of increased focus on pharmacovigilance on knowledge and attitude towards adverse drug reaction reporting among medical students in India. Int J Risk Saf Med. 2020;31(1):15-24. doi: 10.3233/JRS-195012.
- 12. Alwhaibi M, Alhindi G, Alshamrani M, Essa M Bin, A. Al Aloola N, Alhawassi TM. Pharmacovigilance in healthcare education: Students’ knowledge, attitude and perception: A cross-sectional study in Saudi Arabia. BMC Med Educ. 2020;20(1):210. doi:10.1186/s12909-020-02116-2
- 13. Thangaraju P, Venkatesan S, Tamilselvan T, Sivashanmugam E, Showkath Ali M. Evaluation of awareness about pharmacovigilance and adverse drug reaction monitoring among medical professionals attending Central Leprosy Institute. Mustansiriya Med J. 2018;17(2):63-68. doi:10.4103/mj.mj_20_18
- 14. Meher B, Joshua N, Asha B, Mukherji D. A questionnaire based study to assess knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India. Perspect Clin Res. 2015; 6(4):217-221. doi:10.4103/2229-3485.167102
- 15. Rauniyar GP, Pandey DR, Rauniyar N, et al. Awareness of Adverse Drug Reactions and its Reporting among Third-year Undergraduate Medical Students. J Nepal Health Res Counc. 2022;19(4):762-766. doi:10.33314/jnhrc.v19i04.3714
- 16. Abubakar A, Chedi B, Mohammed K, Haque M. Perception of Nigerian medical students on adverse drug reaction reporting. J Adv Pharm Technol Res. 2015;6(4):154-158. doi:10.4103/2231-4040.165021
- 17. Abubakar AR, Simbak N Bin, Haque M. A systematic review of knowledge, attitude and practice on adverse drug reactions and pharmacovigilance among doctors. J Appl Pharm Sci. 2014;4(11):117-127. doi:10.7324/JAPS.2014.40121
- 18. Umair Khan M, Ahmad A, Ejaz A, et al. Comparison of the knowledge, attitudes, and perception of barriers regarding adverse drug reaction reporting between pharmacy and medical students in Pakistan. J Educ Eval Health Prof. 2015;12:28. doi:10.3352/jeehp.2015.12.28
- 19. Ismail SB, Rahman NIA, Anantrao NH, Dali WPEW, Umar BU, Haque M. Awareness of pharmacovigilance among future house officers; a study among first batch of final year medical students of UniSZA, Malaysia. International Journal of Pharmaceutical Research. 2015;7(2):96-101.
- 20. Opadeyi AO, Fourrier-Réglat A, Isah AO. Educational intervention to improve the knowledge, attitude and practice of healthcare professionals regarding pharmacovigilance in South-South Nigeria. Ther Adv Drug Saf. 2019;10:2042098618816279. doi:10.1177/2042098618816279
- 21. Schutte T, Tichelaar J, Reumerman MO, et al. Pharmacovigilance Skills, Knowledge and Attitudes in our Future Doctors – A Nationwide Study in the Netherlands. Basic Clin Pharmacol Toxicol. 2017;120(5):475-481. doi:10.1111/bcpt.12712
- 22. Van Eekeren R, Rolfes L, Koster AS, et al. What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects. Drug Saf. 2018;41(11):1003-1011. doi:10.1007/s40264-018-0681-z
Knowledge, Attitudes, and Behaviors About Pharmacovigilance of Medical Faculty 4th, 5th, and 6th Grade Students
Öz
Purpose: Pharmacovigilance is characterized as scientific studies related to the detection, interpretation, and prevention of drug-related problems, especially adverse drug reactions (ADRs). ADR is defined as a harmful and unintended response to a drug. Detection and monitoring of ADR is important due to consequences such as increased mortality and morbidity rates and loss of workforce. In this study, we aimed to determine whether the 4th, 5th, and 6th year medical faculty students are sufficiently prepared for their duties regarding pharmacovigilance practices by determining their awareness, knowledge, and opinions about pharmacovigilance and ADR.
Method: This observational, cross-sectional, and descriptive study was conducted between 2022-2023 at Gülhane Faculty of Medicine, University of Health Sciences. Students were informed about the study and were asked to fill out the survey via Microsoft Forms application. The demographic characteristics of medical faculty students, their knowledge, attitudes, and practices toward pharmacovigilance and ADR were evaluated.
Results: 338 students participated in the study. While 70% of the students answered correctly to the definition of pharmacovigilance, 38% stated that there is a Pharmacovigilance Center (Turkish Pharmacovigilance Center-TÜFAM) in Turkey and 58% stated that the institution responsible for monitoring ADRs in Turkey is TÜFAM. While 87.2% of the students think that ADR notification is necessary, 26% know that there is a pharmacovigilance contact point in the hospital. 81.6% of the students are aware that reporting ADR is a professional obligation. While 53.5% of the students stated that pharmacovigilance should be discussed in detail in medical school education, only 14% stated that pharmacovigilance was adequately included in the curriculum.
Conclusion: Our study showed that medical faculty students have deficiencies in their knowledge, attitudes, and practices toward pharmacovigilance. To resolve these deficiencies, it is important that regulations regarding pharmacovigilance and ADR notification be made in the medical faculty education curriculum and that the pharmacovigilance contact points of the relevant hospitals and TÜFAM must play an active role in this regard.
Anahtar Kelimeler
Medical student Pharmacovigilance Adverse drug reaction Medical education
Proje Numarası
-
Kaynakça
- 1. T.C.S.B. Türkiye İlaç ve Tıbbi Cihaz Kurumu. Farmakovijilans. Erişim Adresi: https://www.titck.gov.tr/faaliyetalanlari/ilac/18. Erişim Tarihi: 23.07.2023
- 2. Campbell JE, Gossell-Williams M, Lee MG. A review of pharmacovigilance. West Indian Medical Journal. 2014; 63(7):771-774. doi:10.7727/wimj.2013.251
- 3. Lindquist M, Edwards IR. The WHO programme for international drug monitoring, its database, and the technical support of the uppsala monitoring center. In: Journal of Rheumatology. Vol 28. ; 2001.
- 4. Ithnin M, Rani MDM, Latif ZA, et al. Mobile app design, development, and publication for adverse drug reaction assessments of causality, severity, and preventability. JMIR Mhealth Uhealth. 2017;5(5): e78. doi:10.2196/mhealth.6261
- 5. Ergün Y, Ergün TB, Toker E, Ünal E, Akben M. Knowledge attitude and practice of Turkish health professionals towards pharmacovigilance in a university hospital. Int Health. 2019;11(3):177-184. doi:10.1093/inthealth/ihy073
- 6. Ozcan G, Aykac E, Kasap Y, Nemutlu NT, Sen E, Aydinkarahaliloglu ND. Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation. Drugs Real World Outcomes. 2016;3(1):33-43. doi:10.1007/s40801-015-0054-1
- 7. Bhagavathula ASK, Elnour AA, Jamshed SQ, Shehab A. Health professionals’ knowledge, attitudes and practices about Pharmacovigilance in India: A systematic review and meta-analysis. PLoS One. 2016;11(3):e0152221. doi:10.1371/journal.pone.0152221
- 8. Tiftik N, Duman İ, Ün İ. Bir Üniversite Hastanesinde Görev Yapan Hemşirelerin Farmakovijilans Hakkında Bilgi, Tutum ve Uygulamalarının Değerlendirmesi. Mersin Üniversitesi Tıp Fakültesi Lokman Hekim Tıp Tarihi ve Folklorik Tıp Dergisi. 2019;9(3):285-293. doi:10.31020/mutftd.581540
- 9. Emerce E. Seçilmiş Üç Eczacılık Fakültesinin 3. 4. ve 5. Sınıf Öğrencilerinin Farmakovijilans Konusundaki Farkındalık Durumu Bilgi ve Görüşlerinin İncelenmesi. Yüksek Lisans Tezi. Hacettepe Üniversitesi Sağlık Bilimleri Enstitüsü Halk Sağlığı Ana Bilim Dalı, Ankara, 2019.
- 10. Reumerman M, Tichelaar J, Richir MC, van Agtmael MA. Medical students as adverse drug event managers, learning about side effects while improving their reporting in clinical practice. Naunyn Schmiedebergs Arch Pharmacol. 2021;394(7):1467-1476. doi:10.1007/s00210-021-02060-y
- 11. Katyal J, Arora E, Gupta YK. Impact of increased focus on pharmacovigilance on knowledge and attitude towards adverse drug reaction reporting among medical students in India. Int J Risk Saf Med. 2020;31(1):15-24. doi: 10.3233/JRS-195012.
- 12. Alwhaibi M, Alhindi G, Alshamrani M, Essa M Bin, A. Al Aloola N, Alhawassi TM. Pharmacovigilance in healthcare education: Students’ knowledge, attitude and perception: A cross-sectional study in Saudi Arabia. BMC Med Educ. 2020;20(1):210. doi:10.1186/s12909-020-02116-2
- 13. Thangaraju P, Venkatesan S, Tamilselvan T, Sivashanmugam E, Showkath Ali M. Evaluation of awareness about pharmacovigilance and adverse drug reaction monitoring among medical professionals attending Central Leprosy Institute. Mustansiriya Med J. 2018;17(2):63-68. doi:10.4103/mj.mj_20_18
- 14. Meher B, Joshua N, Asha B, Mukherji D. A questionnaire based study to assess knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India. Perspect Clin Res. 2015; 6(4):217-221. doi:10.4103/2229-3485.167102
- 15. Rauniyar GP, Pandey DR, Rauniyar N, et al. Awareness of Adverse Drug Reactions and its Reporting among Third-year Undergraduate Medical Students. J Nepal Health Res Counc. 2022;19(4):762-766. doi:10.33314/jnhrc.v19i04.3714
- 16. Abubakar A, Chedi B, Mohammed K, Haque M. Perception of Nigerian medical students on adverse drug reaction reporting. J Adv Pharm Technol Res. 2015;6(4):154-158. doi:10.4103/2231-4040.165021
- 17. Abubakar AR, Simbak N Bin, Haque M. A systematic review of knowledge, attitude and practice on adverse drug reactions and pharmacovigilance among doctors. J Appl Pharm Sci. 2014;4(11):117-127. doi:10.7324/JAPS.2014.40121
- 18. Umair Khan M, Ahmad A, Ejaz A, et al. Comparison of the knowledge, attitudes, and perception of barriers regarding adverse drug reaction reporting between pharmacy and medical students in Pakistan. J Educ Eval Health Prof. 2015;12:28. doi:10.3352/jeehp.2015.12.28
- 19. Ismail SB, Rahman NIA, Anantrao NH, Dali WPEW, Umar BU, Haque M. Awareness of pharmacovigilance among future house officers; a study among first batch of final year medical students of UniSZA, Malaysia. International Journal of Pharmaceutical Research. 2015;7(2):96-101.
- 20. Opadeyi AO, Fourrier-Réglat A, Isah AO. Educational intervention to improve the knowledge, attitude and practice of healthcare professionals regarding pharmacovigilance in South-South Nigeria. Ther Adv Drug Saf. 2019;10:2042098618816279. doi:10.1177/2042098618816279
- 21. Schutte T, Tichelaar J, Reumerman MO, et al. Pharmacovigilance Skills, Knowledge and Attitudes in our Future Doctors – A Nationwide Study in the Netherlands. Basic Clin Pharmacol Toxicol. 2017;120(5):475-481. doi:10.1111/bcpt.12712
- 22. Van Eekeren R, Rolfes L, Koster AS, et al. What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects. Drug Saf. 2018;41(11):1003-1011. doi:10.1007/s40264-018-0681-z
Ayrıntılar
| Birincil Dil | Türkçe |
|---|---|
| Konular | Sağlık Hizmetleri ve Sistemleri (Diğer) |
| Bölüm | Makaleler |
| Yazarlar | |
| Proje Numarası | - |
| Erken Görünüm Tarihi | 15 Mart 2024 |
| Yayımlanma Tarihi | 31 Mart 2024 |
| Gönderilme Tarihi | 23 Ağustos 2023 |
| Yayımlandığı Sayı | Yıl 2024 Cilt: 14 Sayı: 1 |
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