Farmakovijilans ve Advers Etkilerin Raporlanması Üzerine Diş Hekimlerinin Görüşlerinin Araştırılması

Amaç: Bu araştırma ile farmakovijilans paydaşlarından ilaç reçete etme ve kullanma oranı fazla olan diş hekimlerinin, advers (ters) ilaç etkileri ve farmakovijilans konusundaki deneyim, bilgi düzeyi ve farkındalıklarının incelenmesi amaçlandı. Yöntemler: Kesitsel ve tanımlayıcı tipte yapılan bu çalışmada, Diyarbakır Ağız Diş Sağlığı Hastanesinde diş hekimi olarak görev yapan 100 hekime advers etkiler ve farmakovijilans ile ilgili deneyim, bilgi düzeyi ve farkındalıklarını değerlendirmek için 15 soruluk anket uygulandı. Bulgular: Diş hekimlerinin %55’i mesleki hayatlarında hiç advers ilaç reaksiyonu (ADR) ile karşılaşmadıklarını belirttiler. Yüzde 45’i meslek hayatlarında nadir olarak ADR gördüğünü bildirmiş olsa da toplam bildirim sayısı 7 olarak tespit edildi. Diş hekimlerinin %78’i bildirim yapılması gerektiğini ve bu işlemin bir mesleki sorumluluk (%86) olduğunun farkındadır. Hekimler mevcut bilgileri ile ADR’leri nasıl raporlayacakları hakkında bir fikirleri olmadığını (%81) ve diş hekimliği müfredatında farmakovijilans konusunun iyi işlenmediğini (%55) belirttiler. Bu konu ile ilgili eğitimin %86 oranında lisans düzeyinde (staj, eğitim, klinik görevlendirme) ve %58 oranında ise mezuniyet sonrası çalışma hayatında da alınması gerektiğini ifade ettiler. Sonuç: Bu çalışma, araştırmaya katılan diş hekimlerinin farmakovijilans ve ADR konusunda farkındalık ve bilgi eksiklikleri olduğunu gösterdi. Hekimler arasında advers ilaç reaksiyonu bildirimi oranının karşılaşma oranına göre çok düşük olduğu görüldü. Eğitim programına farmakovijilans konusunun dahil edilmesi ve bildirim uygulamaları için diş hekimlerine mezuniyet öncesi ve sonrası eğitim verilmesi ile halk sağlığı açısından olumlu katkı sağlanabilir.

Investigation of Dentists' Opinions on Pharmacovigilance and Reporting of Adverse Effects

Objective: In this study, it was aimed to examine the experience, knowledge, and awareness of dentists about adverse drug effects and pharmacovigilance. Methods: In this cross-sectional and descriptive study, a 15-question questionnaire was applied to 100 dentists who are working at Diyarbakir Oral and Dental Health Hospital to evaluate their knowledge, attitudes and practices about adverse effects and pharmacovigilance. Results: 55 percent of dentists stated that they had never encountered an adverse drug reaction (ADR) in their professional life. Even though 45 percent of them reported that they have rarely seen ADR in their professional life, the total number of declarations has been determined as 7.78% of dentists are aware that declaration is required and this is a professional responsibility (86%). Physicians stated that they had no idea how to report ADRs with their current knowledge (81%) and subject of pharmacovigilance was not well covered in the dental education (55%). 86% of them stated that education on this subject should be taken at undergraduate level (internship, education, clinical assignment) and 58% stated that it should be taken in their working life after graduation. Conclusion: This study showed that the dentists participating in the study had a lack of awareness and knowledge about pharmacovigilance and ADR. It was observed that the rate of ADR reporting among physicians was very low compared to the encounter rate. Inclusion of pharmacovigilance in the educational program and providing pre- and post-graduate training to dentists for declaration practices can contribute positively to public health.

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1. Kumar A. Pharmacovigilance: Importance, concepts, and processes. Am J Health Syst Pharm 2012; 74: 606- 12.
2. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. The Lancet 2000; 356: 1255-9.
3. Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systemic review of prospective observationalstudies. The annals of pharmacotherapy 2008; 42: 1017-25.
4. Kulkarni MD, Baig MS, Chandaliya KC, et al. Knowledge, attitude and practice of pharmacovigilance among prescribers of government medical college and hospital, Aurangabad (Maharashtra). Int J Pharm Ther 2013; 3:10-8.
5. Caduff-Janosa P. Lost in regulation. Pharmacovigilance. Springer 2017; 9-19.
6. World Health Organization. Pharmacovigilance (cited 2019); Available from: https://www.who.int/medicines/areas/quality_safet y/safety_efficacy/pharmvigi/en/.
7. The Uppsala Monitoring Center. The story of UMC and the WHO Programme 2018 (cited 02 Şubat 2018). Available from: https://www.who-umc.org/globalpharmacovigilance/ who-programme/the-story-ofumc- and-the-who-programme/.
8. TUFAM activities, Available from: https://www.titck.gov.tr/faaliyetalanlari/ilac/18 (Access date: 1 Sep 2021).
9. World Health Organization. Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre. World Health Organization and the Uppsala Monitoring Centre, Available online: www who-umc org/graphics/4807 pdf. 2000.
10. Ozcan G, Aykac E, Kasap Y, et al. 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: 33-43.
11. Alan S, Öztürk M, Gökyıldız S, et al. An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey. Indian J Pharmacol 2013; 45: 616- 8.
12. Vural F, Çiftçi S, Vural B. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital. NortClin Istanbul 2014; 1: 147-52.
13. Smith RG, Burtner AP. Oral side-effects of the most frequently prescribed drugs. Spec Care Dentist 1994; 14: 96–102. DOI: 10.1111/ j.1754- 4505.1994.tb01112.x.
14. Karataş Y, Khan Z, Ozagil EZ, et al. Knowledge, attitude and practices about pharmacovigilance. J Health Sci Med 2020; 3: 367-71.
15. Palaian S, Ibrahim MI, Mishra P. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharmcy practice 2011; 9: 228-35.
16. Arjun TN, Sudhir H, Gouraha A, et al. Assessment of knowledge, attitude and practice related to pharmacovigilance among the healthcare professionals in a teaching hospital in central India: An questionnaire study. World J Pharm Sci 2015; 4: 785- 99.
17. Lee KK, Chan TY, Raymond K, et al. Pharmacists' attitudes toward adverse drug reaction reporting in Hong Kong. Ann Pharmacother 1994; 28: 1400-3.
18. Bishen KA, Anil B, Madhusudan A, et al. A study on knowledge, attitude and practices of private dental practioners regarding pharmacovigilance and adverse drug reaction reporting in Jodhpur City, India. European Journal of Biomedical 2018, 5: 652-7.
19. Talattof Z, Azad A. An evaluation of knowledge, attitude and practice of adverse drug reaction reporting in dental practice. Pak J Nutr 2015; 14: 712– 5. DOI: 10.3923/pjn.2015.712.715.
20. Shalini S, Mohan S. Knowledge and attitude towards pharmacovigilance and adverse drug reaction reporting among dental students in a private university, Malaysia. J Young Pharm 2015; 7: 118–25. DOI: 10.5530/jyp.2015.2.10.
21. Khan SA, Goyal C, Tonpay SD. A study of knowledge, attitudes, and practice of dental doctors about adverse drug reaction reporting in a teaching hospital in India. Perspect Clin Res 2015; 6: 144–9. DOI:10.4103/2229- 3485.159938.
22. Campbell JE, Gossell-Williams M, Lee MG. A Review of Pharmacovigilance. West Indian Med J 2014; 63: 771.
23. Ergün Y, Ergün TB, Toker E, et al. Knowledge attitude and practice of Turkish health professionals towards pharmacovigilance in a university hospital. International Health 2019; 11: 177-84.
24. Ozcan G , A ykac E , K asap Y , e t al. A dverse d rug reaction reporting pattern in Turkey: Analysis of the national database in the context of the first pharmacovigilance legislation. Drugs-real world outcomes 2016; 3: 33–43.
25. Toklu HZ, Uysal MK. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci 2008; 30: 556–62.
26. Toklu HZ, Soyalan M, Gultekin O, et al. The knowledge and attitude of the healthcare professionals towards pharmacovigilance and adverse drug reaction reporting in northern Cyprus. J Pharmacovigilance 2016; 4: 1–7.
27. Kulkarni MD, Baig MS, Chandaliya KC, et al. Knowledge, attitude and practice of pharmacovigilance among prescribers of Government medical college and hospital, Aurangabad (Maharashtra). Int J Pharm Ther 2013; 3: 10-8.