kırıkkale üni tıp derg The Journal of Kırıkkale University Faculty of Medicine 2148-9645 Kırıkkale Üniversitesi 10.24938/kutfd.1757469 Health Care Administration Health Services and Systems (Other) Sağlık Kurumları Yönetimi Sağlık Hizmetleri ve Sistemleri (Diğer) Advers Reaksiyonların Bildirilmesinde Sosyal Medyanın Kullanımına Dair Halkın ve Farmakovijilans Çalışanlarının Bakış Açılarını Değerlendiren Karma Yöntemli Çalışma A MIXED-METHOD STUDY ON PERSPECTIVES OF PUBLIC AND PHARMACOVIGILANCE PROFESSIONALS ON THE USE OF SOCIAL MEDIA FOR ADVERSE DRUG REACTION REPORTING https://orcid.org/0000-0001-6982-9026 Güner Müberra Devrim Department of Medical Pharmacology, Faculty of Medicine, Kırıkkale University, KIRIKKALE, TÜRKİYE https://orcid.org/0000-0001-6592-2960 Ekmekci Perihan Elif Department of History of Medicine and Ethics, Faculty of Medicine, TOBB University of Economics and Technology, ANKARA, TÜRKİYE. https://orcid.org/0009-0004-0655-9718 Akgök Bengü Faculty of Medicine, TOBB University of Economics and Technology, ANKARA, TÜRKİYE. https://orcid.org/0009-0006-9104-5766 Özsipahi Ayça Faculty of Medicine, TOBB University of Economics and Technology, ANKARA, TÜRKİYE. https://orcid.org/0009-0009-4314-8420 Demir Gizemnur Faculty of Medicine, Gazi University, ANKARA, TÜRKİYE. 04 27 2026 28 1 25 35 08 05 2025 12 15 2025 Copyright © 1999, Kırıkkale Üniversitesi Tıp Fakültesi Dergisi 1999 Kırıkkale Üniversitesi Tıp Fakültesi Dergisi

Amaç: Nadir advers ilaç reaksiyonları (ADR'ler) klinik çalışmalarda sıklıkla tespit edilemediğinden, pazarlama sonrası izlem (post-marketing gözetim) büyük önem taşımaktadır. Yerleşik farmakovijilans (FV) sistemlerine rağmen ADR bildirimi yetersiz kalmaktadır. Sosyal medya (SM), ADR bildirimini artırmak için potansiyel bir araç olarak öne çıkarken, entegrasyonu etik ve pratik endişeleri de beraberinde getirmektedir. Gereç ve Yöntemler: Bu karma yöntemli çalışma, hastaların, bakım verenlerin ve farmakovijilans profesyonellerinin (FVP’ler) ADR bildirimi ve FV faaliyetlerinde SM'nin kullanımı konusundaki bilgi, tutum ve etik bakış açılarını değerlendirmiştir. Bulgular: 707 katılımcıdan yalnızca %3,68’i ulusal FV sistemleri hakkında tam bilgiye sahipti ve çoğu daha önce hiç ADR bildirmemişti. Bildirimde bulunmamanın başlıca nedenleri arasında bildirim sürecine dair belirsizlik, geri bildirim eksikliği ve sürecin karmaşık algılanması yer aldı. SM tercih edilen bir bildirim kanalı olmasa da, katılımcılar SM’nin hem destek hem de yanlış bilgi kaynağı olabilecek ikili doğasını kabul ettiler. Odak grup görüşmeleri bu bulguları pekiştirmiş ve veri gizliliği, bilgilendirilmiş onam ve içerik doğrulama gibi etik güvencelerin önemini vurgulamıştır. Sadece 51 FVP çalışmaya katılmıştı ve çoğu sınırlı ADR bildirimi deneyimine sahipti. Tüm tereddütlere rağmen, her iki grup da uygun şekilde tasarlanmış ve denetlenen SM araçlarının farkındalık yaratma, iletişimi kolaylaştırma ve veri toplamayı geliştirme yoluyla FV’ye katkı sağlayabileceğini kabul etmiştir. Sonuç: SM, ADR izleme, iletişim ve halk eğitimi açısından giderek daha fazla gerçek dünya verisi kaynağı olarak kabul edilmektedir. Yanlış bilgi, gizlilik endişeleri ve bildirim kalitesi gibi zorluklara rağmen, katılımcılar SM’nin FV çalışmalarını güçlendireceğini ön görmektedir. FV sistemlerine ilişkin farkındalığın düşük olması ve bildirimlerin yetersizliği, daha geniş kapsamlı halk eğitimi ihtiyacına işaret etmektedir. SM'nin FV faaliyetlerinde etkili kullanımı dikkatli bir tasarım, etik denetim ve paydaşların aktif katılımını gerektirmektedir.

Objective: Rare adverse drug reactions (ADRs) often go undetected in clinical trials, making post-marketing surveillance essential. Despite established pharmacovigilance (PV) systems, underreporting of ADRs persists. Social media (SM) has emerged as a potential tool for enhancing ADR reporting, though its integration raises ethical and practical concerns. Material and Methods: This mixed-methods study assessed the knowledge, attitudes, and ethical perspectives of patients, caregivers, and PV professionals (PVPs) regarding ADR reporting and the use of SM in PV activities. Results: Among 707 respondents, only 3.68% had full knowledge of national PV systems, and most had never reported an ADR. Barriers included uncertainty about the reporting process, lack of feedback, and perceived complexity. While SM was not a preferred reporting channel, respondents recognized its dual potential as both a source of support and misinformation. Focus group discussions reinforced these findings and highlighted the importance of ethical safeguards, including data privacy, informed consent, and content validation. Only 51 PVPs responded; most had limited ADR-reporting experience. Despite hesitations, both groups acknowledged that, with proper design and oversight, SM could support PV by raising awareness, facilitating communication, and enhancing data collection. Conclusion: SM is increasingly recognized as a potential source of real-world data for ADR monitoring, communication, and public education. Despite challenges such as misinformation, privacy concerns, and reporting quality, participants acknowledged the value of SM in enhancing PV efforts. Limited awareness of PV systems and underreporting highlight the need for broader public education. SM’s effective use in PV activities requires careful design, ethical oversight, and proactive stakeholder engagement.

 Pharmacovigilance social media patient reporting health communication adverse drug reactions ethical considerations Farmakovijilans sosyal medya hasta bildirimi sağlık iletişimi istenmeyen ilaç reaksiyonları etik hususlar No financial support received during the conduct of this research. Onakpoya IJ. Rare adverse events in clinical trials: Understanding the rule of three. BMJ Evid Based Med. 2018;23(1):6. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA. 1998;279(15):1200-1205. White TJ, Arakelian A, Rho JP. Counting the costs of drug-related adverse events. Pharmacoeconomics. 1999;15(5):445-458. Rodríguez-Monguió R, Otero MJ, Rovira J. Assessing the economic impact of adverse drug effects. Pharmacoeconomics. 2003;21(9):623-650. Freitas GRM, Tramontina MY, Balbinotto G, Hughes DA, Heineck I. Economic impact of emergency visits due to drug-related morbidity on a Brazilian Hospital. Value Health Reg Issues. 2017;14:1-8. Uppsala Monitoring Centre. VigiBase: WHO’s global database signalling harm and pointing to safer use. Access date: 11 December 2025. https://who-umc.org/vigibase/vigibase-who-s-global-database. Aagaard L, Strandell J, Melskens L, Petersen PS, Hansen EH. Global patterns of adverse drug reactions over a decade: Analyses of spontaneous reports to VigiBase™. Drug Saf. 2012;35(12):1171-1182. Ozcan G, Aykac E, Kasap Y, Nemutlu NT, Sen E, Aydinkarahaliloglu ND. Adverse drug reaction reporting pattern in Türkiye: Analysis of the national database in the context of the first pharmacovigilance legislation. Drugs Real World Outcomes. 2016;3(1):33-43. Güner MD, Ekmekci PE. Healthcare professionals' pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. J Drug Assess. 2019;8(1):13-20. Türkiye İlaç ve Tıbbi Cihaz Kurumu. Türkiye Farmakovijilans Merkezi internet sayfası (Turkish Medicines and Medical Devices Agency Turkish Pharmacovigilance Center). Access date: 11 December 2025. https://www.titck.gov.tr/faaliyetalanlari/ilac/18. Türkiye İlaç ve Tıbbi Cihaz Kurumu. İlaçların Güvenliliği Hakkında Yönetmelik Resmi Gazete No: 289732014 (Türkiye Pharmaceuticals and Medical Devices Agency, Legislation on Drug Safety Official Gazette) No: 289732014. Access date: 11 December 2025. http://www.resmigazete.gov.tr/eskiler/2014/04/20140415-6.htm van Hunsel F, Härmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: An 11-country survey. Drug Saf. 2012;35(1):45-60. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: A review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148-156. Fortnum H, Lee AJ, Rupnik B, Avery A; Yellow Card Study Collaboration. Survey to assess public awareness of patient reporting of adverse drug reactions in Great Britain. J Clin Pharm Ther. 2012;37(2):161-165. Robertson J, Newby DA. Low awareness of adverse drug reaction reporting systems: A consumer survey. Med J Aust. 2013;199(10):684-686. Härmark L, van Hunsel F, Grundmark B. ADR reporting by the general public: lessons learnt from the Dutch and Swedish systems. Drug Saf. 2015;38(4):337-347. Bulcock A, Hassan L, Giles S, et al. Public perspectives of using social media data to improve adverse drug reaction reporting: A mixed-methods study. Drug Saf. 2021;44(5):553-564. Avery AJ, Anderson C, Bond CM, et al. Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': Literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):1-4. Sabblah GT, Darko DM, Mogtari H, Härmark L, van Puijenbroek E. Patients' perspectives on adverse drug reaction reporting in a developing country: A case study from Ghana. Drug Saf. 2017;40(10):911-921. Sales I, Aljadhey H, Albogami Y, Mahmoud MA. Public awareness and perception toward adverse drug reactions reporting in Riyadh, Saudi Arabia. Saudi Pharm J. 2017;25(6):868-872. Inácio P, Cavaco A, Airaksinen M. The value of patient reporting to the pharmacovigilance system: A systematic review. Br J Clin Pharmacol. 2017;83(2):227-246. van Hunsel F, Passier A, van Grootheest AC. Comparing patients’ and healthcare professionals’ ADR reports after media attention: The example of the Netherlands. Br J Clin Pharmacol. 2009;68(6):965-970. Cook S, Conrad C, Fowlkes AL, Mohebbi MH. Assessing Google flu trends performance in the United States during the 2009 influenza virus A (H1N1) pandemic. PLoS One. 2011;6(8):e23610. World Health Organization (WHO). Unmasking safety signals during a pandemic: Virtual meeting - technical meeting report; 2021 Access date: 11 December 2025. https://cdn.who.int/media/docs/default-source/medicines/pharmacovigilance/unmasking-safety-signals-in-an-infodemic_technical-report.pdf Powell GE, Seifert HA, Reblin T, et al. Social media listening for routine post-marketing safety surveillance. Drug Saf. 2016;39(5):443-454. Jarernsiripornkul N, Patsuree A, Krska J. Public confidence in ADR identification and their views on ADR reporting: Mixed methods study. Eur J Clin Pharmacol. 2017;73(2):223-231. Maclennan K, Brounéus F, Parkin L. Public knowledge and desire for knowledge about drug safety issues: A survey of the general public in New Zealand. Pharm Med. 2016;30(6):339-348. Al Dweik R, Stacey D, Kohen D, Yaya S. Factors affecting patient reporting of adverse drug reactions: A systematic review. Br J Clin Pharmacol. 2017;83(4):875-883. van Stekelenborg J, Ellenius J, Maskell S, et al. Recommendations for the use of social media in pharmacovigilance: Lessons from IMI WEB-RADR. Drug Saf. 2019;42(12):1393-1407. Karapetiantz P, Audeh B, Redjdal A, Tiffet T, Bousquet C, Jaulent MC. Monitoring adverse drug events in web forums: Evaluation of a pipeline and use case study. J Med Internet Res. 2024;26:e46176. Oyebode O, Orji R. Identifying adverse drug reactions from patient reviews on social media using natural language processing. Health Inform J. 2023;29(1):14604582221136712. Wessel D, Pogrebnyakov N. Using social media as a source of real-world data for pharmaceutical drug development and regulatory decision making. Drug Saf. 2024;47(5):495-511. Aygun O, Cerim S. The relationship between general health behaviors and general health literacy levels in the Turkish population. Health Promot Int. 2021;36(5):1275-1289. Sloane R, Osanlou O, Lewis D, Bollegala D, Maskell S, Pirmohamed M. Social media and pharmacovigilance: A review of the opportunities and challenges. Br J Clin Pharmacol. 2015;80(4):910-920. Ghalavand H, Nabiolahi A. Exploring online health information quality criteria on social media: A mixed method approach. BMC Health Serv Res. 2024;24(1):1311. Banovac M, Candore G, Slattery J, et al. Patient reporting in the EU: Analysis of EudraVigilance data. Drug Saf. 2017;40(7):629-645. Almeida D, Umuhire D, Gonzalez-Quevedo R, et al. Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU. Front Med (Lausanne). 2024;11:1408636. Bousquet C, Dahamna B, Guillemin-Lanne S, et al. The Adverse Drug Reactions from Patient Reports in Social Media Project: Five major challenges to overcome to operationalize analysis and efficiently support pharmacovigilance process. JMIR Res Protoc. 2017;6(9):e179. Naik P, Umrath T, van Stekelenborg J, et al. Regulatory definitions and good pharmacovigilance practices in social media: Challenges and recommendations. Ther Innov Regul Sci. 2015;49(6):840-851. Tricco AC, Zarin W, Lillie E, et al. Utility of social media and crowd-intelligence data for pharmacovigilance: A scoping review. BMC Med Inform Decis Mak. 2018;18(1):38.