The Role of Pharmacovigilance in Promoting Rational Antibiotic Use in Children

Abstract

Although antibiotic use is widespread in childhood, inappropriate and unnecessary prescribing not only results in adverse drug reactions (ADRs) and therapeutic failures at the individual level but also accelerates the development of antimicrobial resistance, thereby posing a significant public health challenge. Pharmacovigilance plays a pivotal role in ensuring medication safety in pediatric populations by enabling the early detection of ADRs and preventing the emergence of antimicrobial resistance. Owing to pharmacokinetic and pharmacodynamic differences, children are at a higher risk of antibiotic-associated ADRs compared to adults. Pharmacovigilance-generated data contribute to the continuous updating of clinical guidelines, supporting rational antibiotic use, and enhancing healthcare professionals’ awareness, thereby reducing unwarranted antibiotic prescriptions. Moreover, pharmacovigilance practices facilitate the timely identification of adverse reactions, the ongoing monitoring of antibiotic safety profiles, and the characterization of resistance patterns, ultimately informing evidence-based therapeutic recommendations. In Türkiye, pharmacovigilance activities are coordinated by the Turkish Pharmacovigilance Centre; however, ADR reporting rates in pediatric populations remain suboptimal. Therefore, improving healthcare professionals’ awareness, particularly among pediatricians and family physicians, fostering routine ADR reporting, integrating regular training programs, and promoting the active incorporation of pharmacovigilance into clinical practice are essential strategies to advance rational antibiotic use in children and mitigate the growing threat of antimicrobial resistance.

Keywords

• adverse drug reactions
• antimicrobial drugs
• pharmacovigilance
• paediatric
• rational antibiotic use

ÇOCUKLARDA AKILCI ANTİBİYOTİK KULLANIMINDA FARMAKOVİJİLANSIN ÖNEMİ

Abstract

Çocukluk çağında antibiyotik kullanımı yaygın olmakla birlikte, uygunsuz ve gereksiz reçetelenmesi, sadece bireysel düzeyde advers ilaç reaksiyonları (AİR) ve tedavi başarısızlıklarına neden olmakla kalmamakta, aynı zamanda toplum genelinde antimikrobiyal direnç gelişimini hızlandırarak ciddi bir halk sağlığı sorunu oluşturmaktadır. Farmakovijilans, çocuklarda ilaç güvenliliğinin sağlanması, AİR’lerin erken saptanması ve direnç gelişiminin önlenmesinde kritik bir role sahiptir. Pediatrik popülasyonda farmakokinetik ve farmakodinamik farklılıklar nedeniyle antibiyotiklere bağlı AİR riski erişkinlere kıyasla daha yüksektir. Farmakovijilans verileri, tedavi rehberlerinin güncellenmesine katkı sağlayarak akılcı antibiyotik kullanımını desteklerken, sağlık profesyonellerinin farkındalığını artırarak gereksiz antibiyotik reçetelenmesini azaltmaktadır. Farmakovijilans uygulamaları; advers reaksiyonların erken tanımlanmasına, antibiyotiklerin güvenlilik profillerinin sürekli olarak izlenmesine, direnç paternlerinin belirlenmesine ve böylece tedavi rehberlerinin güncellenmesine katkıda bulunmaktadır. Türkiye’de farmakovijilans faaliyetleri Türkiye Farmakovijilans Merkezi (TÜFAM) tarafından yürütülmekte olup, pediatrik hasta grubunda AİR bildirimi oranları hala istenilen düzeye ulaşamamaktadır. Bu nedenle pediatristlerin, aile hekimlerinin ve yardımcı sağlık personelinin farmakovijilans konusundaki farkındalığının artırılması; raporlama alışkanlıklarının teşvik edilmesi, düzenli eğitim programlarının uygulanması ve klinik pratikte farmakovijilansın aktif olarak kullanılması, çocuklarda akılcı antibiyotik kullanımının yaygınlaştırılmasında ve antimikrobiyal direnç sorunlarının önlenmesine de önemli katkı sağlayacaktır.

Keywords

• advers ilaç reaksiyonu
• akılcı antibiyotik kullanımı
• farmakovijilans
• pediatri

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