Advers Reaksiyonların Bildirilmesinde Sosyal Medyanın Kullanımına Dair Halkın ve Farmakovijilans Çalışanlarının Bakış Açılarını Değerlendiren Karma Yöntemli Çalışma

Öz

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.

Anahtar Kelimeler

• Farmakovijilans
• sosyal medya
• hasta bildirimi
• sağlık iletişimi
• istenmeyen ilaç reaksiyonları
• etik hususlar

Destekleyen Kurum

Destekleyici kuruluş yoktur.

Etik Beyan

Çalışmanın tüm bölümlerinin araştırma protokolleri TOBB ETÜ Etik Kurulu tarafından onaylanmıştır (Onay Numarası: KAEK-118/146-116 ve KAEK-118/147-117). Gönüllüler hem anket bölümünde hem odak grup görüşmesinde çalışma hakkında bilgilendirilmiş, takiben onay verenlerin çalışmaya katılmaları mümkün olmuştur.

A MIXED-METHOD STUDY ON PERSPECTIVES OF PUBLIC AND PHARMACOVIGILANCE PROFESSIONALS ON THE USE OF SOCIAL MEDIA FOR ADVERSE DRUG REACTION REPORTING

Öz

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.

Anahtar Kelimeler

• Pharmacovigilance
• social media
• patient reporting
• health communication
• adverse drug reactions
• ethical considerations

Destekleyen Kurum

No financial support received during the conduct of this research.

Etik Beyan

The research protocols for all parts of the study were approved by the TOBB ETU Ethics Committee (Approval Number: KAEK-118/146-116 and KAEK-118/147-117). Volunteers were informed about the study before the survey and focus group interviews, and those who gave their consent were then able to participate in the study.

Teşekkür

Anket bağlantısının dağıtımında kronik hastalık hasta derneklerinin katkıları için teşekkür ederiz.

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