EVALUATION OF NURSING STUDENTS' ATTITUDES TOWARDS PHARMACOVIGILANCE: A DESCRIPTIVE STUDY

Abstract

Aim: Pharmacovigilance is an important public health practice that aims to maintain drug safety by monitoring and reporting adverse drug reactions. This study aims to evaluate nursing students’ attitudes toward pharmacovigilance. Methods: The sample of the study consists of 507 students studying in the nursing department of Bandırma Onyedi Eylül University in the spring semester of 2022-2023. The study was completed with 330 students who voluntarily participated by fully completing the questionnaire. The data collection tools included a descriptive information form and an attitude survey on pharmacovigilance. Descriptive statistical methods were used to analyze the data. Results: The findings indicate that the majority of students believe in the importance of pharmacovigilance in protecting public health (mean = 3.964; standard deviation = 0.892) and think that reporting would significantly contribute to the effectiveness of the national pharmacovigilance system (mean = 3.812; standard deviation = 0.892). However, students perceived the reporting process as time-consuming and increasing workload (mean = 3.37; standard deviation = 1.036). They were also concerned that reporting certain adverse drug reactions could lead to perceptions of professional incompetence and negligence (mean = 3.700; standard deviation = 1.057). While there was general agreement that pharmacovigilance processes should be the responsibility of healthcare professionals (mean = 3.794; SD = 0.995), participants demonstrated a more neutral attitude towards financial incentives (mean = 3.267; SD = 0.959). Conclusion: The results indicate that nursing students generally have a positive attitude toward pharmacovigilance, although they express certain concerns regarding the reporting process. It is recommended that undergraduate curricula include courses and topics that address students' concerns about pharmacovigilance.

Keywords

• Pharmacovigilance
• adverse drug reactions
• nursing students
• drug safety
• attitude

HEMŞİRELİK ÖĞRENCİLERİNİN FARMAKOVİJİLANSA YÖNELİK TUTUMLARININ DEĞERLENDİRİLMESİ: TANIMLAYICI BİR ÇALIŞMA

Öz

Amaç: Farmakovijilans, advers ilaç reaksiyonlarının izlenmesi ve bildirilmesi yoluyla ilaç güvenliğinin sağlanmasını hedefleyen önemli bir halk sağlığı uygulamasıdır. Bu çalışma, hemşirelik öğrencilerinin farmakovijilansa yönelik tutumlarını değerlendirmeyi amaçlamaktadır. Yöntem: Çalışmanın örneklemini Bandırma Onyedi Eylül Üniversitesi 2022-2023 bahar döneminde hemşirelik bölümünde öğrenim görmekte olan 507 öğrenci oluşturmaktadır. Çalışma anket formlarını tam doldurarak çalışmaya gönüllü katılım sağlayan 330 öğrenci ile çalışma tamamlanmıştır. Veriler tanımlayıcı bilgi formu ile farmakovijilansa yönelik tutum anketi kullanılarak toplanmıştır. Verilerin analizinde tanımlayıcı istatistikler kullanılmıştır. Bulgular: Bulgular, öğrencilerin farmakovijilansın halk sağlığının korunmasındaki önemine büyük ölçüde inandığını (ortalama = 3,964; standart sapma = 0,892) ve raporlamanın ulusal farmakovijilans sisteminin etkinliğine önemli katkı sağlayacağını düşündüklerini göstermektedir (ortalama = 3,812; standart sapma = 0,892). Ancak öğrenciler, bildirim sürecinin zaman alıcı olduğu ve iş yükünü artırabileceği görüşündedir (ortalama = 3,37; standart sapma = 1,036). Ayrıca, bazı advers ilaç reaksiyonlarının bildirilmesinin mesleki yetersizlik ve ihmalkar çalışma algısına yol açabileceğine dair endişeleri bulunmaktadır (ortalama = 3,700; standart sapma = 1,057). Farmakovijilans süreçlerinin sağlık profesyonellerinin sorumluluğunda olması gerektiği konusunda genel bir fikir birliği olduğu gözlemlenirken (ortalama = 3,794; standart sapma = 0,995), mali teşviklere yönelik tutumların daha nötr olduğu görülmüştür (ortalama = 3,267; standart sapma = 0,959). Sonuç: Sonuçlar, hemşirelik öğrencilerinin genel olarak farmakovijilansa yönelik olumlu bir tutuma sahip olduğunu ancak bildirim sürecine dair belirli kaygılar taşıdıklarını ortaya koymaktadır. Mezuniyet öncesi eğitim programlarında öğrencilerin farmakovijilansa yönelik endişelerinin giderilmesini sağlayacak ders ve konulara yer verilmesi önerilmektedir.

Anahtar Kelimeler

• Farmakovijilans
• advers ilaç reaksiyonları
• hemşirelik öğrencileri
• ilaç güvenliği
• tutum

Kaynakça

1. 1. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9. https://doi.org/10.1016/S0140-6736(00)02799-9.
2. 2. Coleman JJ, Pontefract SK. Adverse drug reactions. Clin Med (Lond). 2016;16(5):481-5. https://doi.org/10.7861/clinmedicine.16-5-481.
3. 3. Kommu S, Carter C, Whitfield P. Adverse drug reactions. In: StatPearls. StatPearls Publishing, Treasure Island (FL) 2024. Available at: https://www.ncbi.nlm.nih.gov/books/NBK599521/ Accessed on July 4, 2025.
4. 4. Bajwa SF, Mohammed RH. Type II Hypersensitivity Reaction. In: StatPearls. StatPearls Publishing, Treasure Island (FL) 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK563264/#:~:text=Type%20II%20hypersensitivity%20reaction%20refers,loss%2C%20or%20damage%20to%20tissues Accessed on July 4, 2025.
5. 5. Usman N, Annamaraju P. Type III Hypersensitivity Reaction. In: StatPearls. StatPearls Publishing, Treasure Island (FL) 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK559122/#:~:text=In%20type%20III%20hypersensitivity%20reactions,trigger%20the%20classical%20complement%20pathway Accessed on July 4, 2025.
6. 6. Marwa K, Kondamudi NP. Type IV Hypersensitivity Reaction. In: StatPearls. StatPearls Publishing, Treasure Island (FL) 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK562228/#:~:text=Type%20IV%20hypersensitivity%2C%20or%20delayed,can%20take%20weeks%20to%20manifest Accessed on July 4, 2025.
7. 7. FDA. Adverse event reporting system (FEARS) public dashboard. U.S. Food and Drug Administration; 2025. Available at: https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis Accessed on July 6, 2025.
8. 8. Türkiye İlaç ve Tıbbi Cihaz Kurumu. 2024 yılı idare faaliyet raporu. Erişim adresi: http://www.sp.gov.tr/upload/xSPRapor/files/VCaxM+titck_2024_fr.pdf. Erişim tarihi: 10.08.2025.

9. 9. Yadesa TM, Kitutu FE, Deyno S, Ogwang PE, Tamukong R, Alele PE. Prevalence, characteristics and predicting risk factors of adverse drug reactions among hospitalized older adults: A systematic review and meta-analysis. SAGE Open Med. 2021;9:20503121211039099. https://doi.org/10.1177/20503121211039099
10. 10. Khan Z, Karataş Y, Kıroğlu O. Evaluation of adverse drug reactions in paediatric patients: a retrospective study in Turkish hospital. Front Pharmacol. 2021;12:786182. https://doi.org/10.3389/fphar.2021.786182.
11. 11. Khan Z, Öz E, Kıroğlu O, Karataş Y. Analysis of adverse drug reactions in hospitalized patients reported to pharmacovigilance center in a teaching hospital. Cukurova Medical Journal. 2020;45(2):556-61. https://doi.org/10.17826/cumj.671198.
12. 12. Laatikainen O, Miettunen J, Sneck S, Lehtiniemi H, Tenhunen O, Turpeinen M. The prevalence of medication-related adverse events in inpatients-a systematic review and meta-analysis. Eur J Clin Pharmacol. 2017;73(12):1539-49. https://doi.org/10.1007/s00228-017-2330-3.
13. 13. Aslan Y. Yatan hastalarda raporlanan advers ilaç reaksiyonlarının değerlendirilmesi. Hacettepe Univ Fac Health Sci J. 2023;10(2):452-68. https://doi.org/10.21020/husbfd.1146973
14. 14. Alan S, Ozturk M, Gokyildiz S, Avcibay B, Karataş Y. An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey. Indian J Pharmacol. 2013;45(6):616-8. https://doi.org/10.4103/0253-7613.121375
15. 15. Jennings ELM, Murphy KD, Gallagher P, O'Mahony D. In-hospital adverse drug reactions in older adults; prevalence, presentation and associated drugs-a systematic review and meta-analysis. Age Ageing. 2020;49(6):948-58. https://doi.org/10.1093/ageing/afaa188
16. 16. Patel TK, Patel PB, Bhalla HL, Dwivedi P, Bajpai V, Kishore S. Impact of suspected adverse drug reactions on mortality and length of hospital stay in the hospitalised patients: a meta-analysis. Eur J Clin Pharmacol. 2023;79(1):99-116. https://doi.org/10.1007/s00228-022-03419-7
17. 17. Wolfe D, Yazdi F, Kanji S, Burry L, Butler C, Esmaeilisaraji L, Hamel C, Hersi M, Skidmore B, Moher D, Hutton B. Incidence, causes, and consequences of preventable adverse drug reactions occurring in inpatients: a systematic review of systematic reviews. PLoS One. 2018;13(10):e0205426. https://doi.org/10.1371/journal.pone.0205426
18. 18. Laroche ML, Tarbouriech N, Jai T, Valnet-Rabier MB, Nerich V. Economic burden of hospital admissions for adverse drug reactions in France: the IATROSTAT-ECO study. Br J Clin Pharmacol. 2025;91(2):439-50. https://doi.org/10.1111/bcp.16266
19. 19. Formica D, Sultana J, Cutroneo PM, Lucchesi S, Angelica R, Crisafulli S, Ingrasciotta Y, Salvo F, Spina E, Trifirò G. The economic burden of preventable adverse drug reactions: a systematic review of observational studies. Expert Opin Drug Saf. 2018;17(7):681-95. https://doi.org/10.1080/14740338.2018.1491547
20. 20. Iwasaki H, Sakuma M, Ida H, Morimoto T. The burden of preventable adverse drug events on hospital stay and healthcare costs in Japanese pediatric inpatients: the JADE study. Clin Med Insights Pediatr. 2021;15:1179556521995833. https://doi.org/10.1177/1179556521995833
21. 21. Durand M, Castelli C, Roux-Marson C, Kinowski JM, Leguelinel-Blache G. Evaluating the costs of adverse drug events in hospitalized patients: a systematic review. Health Econ Rev. 2024;14(1):11. https://doi.org/10.1186/s13561-024-00481-y
22. 22. Campbell JE, Gossell-Williams M, Lee MG. A review of pharmacovigilance. West Indian Med J. 2014;63(7):771-4. https://doi.org/10.7727/wimj.2013.251
23. 23. Patil D, Shivamurthy RM, Geetha S, Patil UN. Evaluation of awareness of knowledge, attitude and practices of nursing students on monitoring and reporting of adverse drug reactions in a tertiary care hospital. World J Pharm Res. 2015;4(5):1361-71. https://doi.org/10.51131/IJPCCR/v2i4.6
24. 24. Gafoor A, Mutha AS, Sahai J, Sankpal JT. Knowledge, attitude and practice study on pharmacovigilance among nursing students and staff before and after a training session at a tertiary care hospital in India. Int J Basic Clin Pharmacol. 2025;14(4):492-8. https://doi.org/10.18203/2319-2003.ijbcp20251832
25. 25. Gosavi PA, Kalikar MV, Mahakalkar SM, Pawar SP, Bansod S, Nama P. Impact of educational intervention on knowledge, attitude & practice about pharmacovigilance in nursing students in a tertiary care teaching hospital in India: a cross-sectional study. J Pharm Res Int. 2024;36(6):67-76. https://doi.org/10.9734/jpri/2024/v36i67523
26. 26. Tadvi NA, Alromaih AA, Aldahash AA, Almuhesseny AA, Alotaibi SH, Alduhayshi IS, Alrukimi AS, Sami W. Knowledge, attitude and practice of pharmacovigilance in healthcare professionals and medical students in Majmaah, Saudi Arabia care centre. Health Sci. 2018;7(4):101-17.
27. 27. Maqsood S, Afzal M, Abdullahi KO, Gilani SA. Knowledge and attitude of nursing students towards pharmacovigilance and adverse drug reactions. Merit Res J Med Med Sci. 2022;10(2):31-6. https://doi.org/10.5281/zenodo.6275144
28. 28. Raikar SR, Sneha S, Sreeraj G, Janarthanan R. Awareness and knowledge of adverse drug reactions and pharmacovigilance among medical and nursing students and staff in a tertiary care hospital. Cureus. 2024;16(9):e69981. https://doi.org/10.7759/cureus.69981
29. 29. Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK). Farmakovijilans. T.C. Sağlık Bakanlığı; 2025. Erişim adresi: https://www.titck.gov.tr/faaliyetalanlari/ilac/18. Erişim tarihi: 06 Haziran 2025.
30. 30. Vural F, Ciftci S, Vural B. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital. North Clin Istanb. 2014;1(3):147-52. https://doi.org/10.14744/nci.2014.41636
31. 31. Sayılan H, Gürkan S, Turan K, Duran MK, Akpınar G. Hemşirelik lisans öğrencilerinin farmakoloji eğitimine yönelik görüşlerinin değerlendirilmesi. Journal of 5N1Quality. 2023;1(2):57-65.
32. 32. Gürbüz S, Şahin F. Sosyal bilimlerde araştırma yöntemleri, 3. Baskı, Seçkin Yayıncılık, Ankara 2018.
33. 33. Živanović D, Mijatović Jovin V, Javorac J, Kvrgić S, Rašković A, Stojkov S, Kašiković Lečić S, Savić N, Kralj M, Milenković A. Measuring pharmacovigilance knowledge and attitudes among healthcare sciences students: development and validation of a universal questionnaire. Eur Rev Med Pharmacol Sci. 2022;26(4):1196-214. https://doi.org/10.26355/eurrev_202202_28112
34. 34. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000;25:3186-91.
35. 35. Polit DF, Beck CT. The content validity index: Are you sure you know what’s being reported? critique and recommendations. Res Nurs Health. 2006;29:489-97. https://doi.org/10.1002/nur.20147
36. 36. Tiftik RN, Duman İ, Ün İ. Bir üniversite hastanesinde görev yapan hemşirelerin farmakovijilans hakkında bilgi, tutum ve uygulamalarının değerlendirilmesi. Lokman Hekim Derg. 2019;9(3):285-93. https://doi.org/10.31020/mutftd.581540
37. 37. Sivadasan S, Sellappan M. A study on the awareness and attitude towards pharmacovigilance and adverse drug reaction reporting among nursing students in a private university, Malaysia. Int J Curr Pharm Res. 2015;7(1):84-9.