The Role of Pharmacovigilance in Promoting Rational Antibiotic Use in Children

Year 2025, Volume: 39 Issue: 2, 83 - 93, 30.08.2025

Ayça Pınar Nas , A Tapisiz

https://doi.org/10.54962/ankemderg.1749964

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

References

• Aagaard L, Strandell J, Melskens L, Petersen PS, Hansen EH. Global patterns of adverse drug reactions over a decade. Drug Saf. 2012;35(12):1171-82. http://doi.org/[https://doi.org/10.1007/BF03262002]
• Agbabiaka TB, Savović J, Ernst E. Methods for causality assessment of adverse drug reactions. Drug Saf. 2008;31(1):21-37
• Akici A, Kalaca S, Ugurlu MU, Oktay S. Prescribing habits of general practitioners in the treatment of childhood respiratory-tract infections. Eur J Clin Pharmacol. 2004;60(3):211-6. http://doi.org/[https://doi.org/10.1007/s00228-004-0749-9]
• Ambwani S, Mathur A. Chapter–2 Rational Drug Use. Health Adm. 2006;19(1):5-7
• Aydınkarahaliloğlu ND, Aykaç E, Atalan Ö, Demir N, Hayran M. Spontaneous reporting of adverse drug reactions by consumers in comparison with healthcare professionals in Turkey from 2014 to 2016. Pharm Med. 2018;32(5):353-64. http://doi.org/[https://doi.org/10.1007/s40290-018-0244-8]
• Edwards IR. Considerations on causality in pharmacovigilance. Int J Risk Saf Med. 2012;24(1):41-54. http://doi.org/[http://doi.org/10.3233/JRS-2012-0552]
• Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9. http://doi.org/[http://doi.org/10.1016/S0140-6736(00)02799-9]
• Farmakovijilans Derneği. Tanımlar Sözlüğü [Erişim tarihi: 24.07.2025]. Erişim adresi: http://www.farmakovijilansdernegi.org/icerik.php?id=108
• Hadi MA, Neoh CF, Zin RM, Elrggal ME, Cheema E. Pharmacovigilance: pharmacists’ perspective on spontaneous adverse drug reaction reporting. Integr Pharm Res Pract. 2017;6:91. http://doi.org/[http://doi.org/10.2147/IPRP.S105881]
• Hulscher ME, Grol RP, van der Meer JW. Antibiotic prescribing in hospitals: a social and behavioural scientific approach. Lancet Infect Dis. 2010;10(3):167-75. http://doi.org/[http://doi.org/10.1016/S1473-3099(10)70027-X]
• Khalil H, Huang C. Adverse drug reactions in primary care: a scoping review. BMC Health Serv Res. 2020;20(1):5. http://doi.org/[http://doi.org/10.1186/s12913-019-4651-7]
• Kumar AP, Bhoopathi D, Sunkara H, Chalasani SH. An Overview of Various Scales Used in Causality Assessment of Adverse Drug Reactions. Int J Pharm Pharm Sci. 2020;12(5):1-5. http://doi.org/[http://dx.doi.org/10.22159/ijpps.2020v12i5.37209.]
• Lacoste‐Roussillon C, Pouyanne P, Haramburu F, Miremont G, Bégaud B. Incidence of serious adverse drug reactions in general practice: a prospective study. Clin Pharmacol Ther. 2001;69(6):458-62. http://doi.org/[http://doi.org/10.1067/mcp.2001.116145]
• Meyboom R, Royer R. Causality classification at pharmacovigilance centres in the European Community. Pharmacoepidemiol Drug Saf. 1992;1(2):87-97. http://doi.org/[http://doi.org/10.1002/pds.2630010207]
• Mjörndal T, Boman MD, Hägg S, Bäckström M, Wiholm BE, Wahlin A, et al. Adverse drug reactions as a cause for admissions to a department of internal medicine. Pharmacoepidemiol Drug Saf. 2002;11(1):65-72. http://doi.org/[http://doi.org/10.1002/pds.667]
• Nahler G. Bayesian adverse reaction diagnostic instrument (BARDI). Dictionary of Pharmaceutical Medicine: Springer; 2009. p. 13-4. http://doi.org/[http://doi.org/10.1007/978-3-211-89836-9_109]
• Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts E, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45. http://doi.org/[http://doi.org/10.1038/clpt.1981.154]
• O’Neill J. Review on Antimicrobial Resistance Antimicrobial Resistance: tackling a crisis for the health and wealth of nations. London: Review on Antimicrobial Resistance. 2019.
• Oehme A-K, Rashed AN, Hefele B, Wong IC, Rascher W, Neubert A. Adverse drug reactions in hospitalised children in Germany are decreasing: results of a nine year cohort-based comparison. PLoS One. 2012;7(9):e44349. http://doi.org/[http://doi.org/10.1371/journal.pone.0044349]
• Shakir SA, Layton D. Causal association in pharmacovigilance and pharmacoepidemiology. Drug Saf. 2002;25(6):467-71. http://doi.org/[http://doi.org/10.2165/00002018-200225060-00012]
• Slama TG, Amin A, Brunton SA, File Jr TM, Milkovich G, Rodvold KA, et al. A clinician’s guide to the appropriate and accurate use of antibiotics: the Council for Appropriate and Rational Antibiotic Therapy (CARAT) criteria. Am J Med. 2005;118(S7A):1S-6S. https://doi.org/10.1016/j.amjmed.2005.05.007.
• Stausberg J. International prevalence of adverse drug events in hospitals: an analysis of routine data from England, Germany, and the USA. BMC Health Serv Res. 2014;14(1):125. http://doi.org/[http://doi.org/10.1186/1472-6963-14-125]
• Sturkenboom MC, Verhamme KM, Nicolosi A, Murray ML, Neubert A, Caudri D, et al. Drug use in children: cohort study in three European countries. BMJ. 2008;337:a2245. http://doi.org/[http://doi.org/10.1136/bmj.a2245]
• 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(5):556-62. http://doi.org/[http://doi.org/10.1007/s11096-008-9209-4]
• Turner WM. The Food and Drug Administration algorithm: special workshop—regulatory. Drug Inf J. 1984;18(3-4):259-66. http://doi.org/[http://doi.org/10.1177/009286158401800311]
• Türk Eczacılar Birliği Eczacılık Akademisi. Farmakovijilansın Önemi. Ankara: Türk Eczacılar Birliği Eczacılık Akademisi; 2007.
• Türkiye İlaç ve Tıbbi Cihaz Kurumu. Advers ilaç reaksiyonları hakkında genel bilgiler [Erişim tarihi: 24.07.2025]. Erişim adresi: https://www.titck.gov.tr/faaliyetalanlari/ilac/18
• Türkiye İlaç ve Tıbbi Cihaz Kurumu. İlaçların Güvenliliği Hakkında Yönetmelik Resmi Gazete No: 28973 2014 [Erişim tarihi: 24.07.2025]. Erişim adresi: https://www.resmigazete.gov.tr/eskiler/2014/04/20140415-6.htm
• Türkiye İlaç ve Tıbbi Cihaz Kurumu. İyi Farmakovijilans Uygulamaları (İFU) Kılavuzu Modül I – Advers ilaç reaksiyonlarının yönetimi ve bildirimi 2014 [Erişim tarihi: 24.07.2025]. Erişim adresi: https://www.titck.gov.tr/Dosyalar/Ilac/Farmakovijilans/%C4%B0FU%20Mod%C3%BCl%20I.pdf
• Uppsala Monitoring Centre. What is UMC? [Erişim tarihi: 20.07.2025]. Erişim adresi: https://www.who-umc.org/about-us/who-we-are/
• Uppsala Monitoring Centre. WHO causality assessment [Erişim tarihi: 20.07.2025]. Erişim adresi: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf
• Versporten A, Sharland M, Bielicki J, Drapier N, Vankerckhoven V, Goossens H. The antibiotic resistance and prescribing in European Children project: a neonatal and pediatric antimicrobial web-based point prevalence survey in 73 hospitals worldwide. Pediatr Infect Dis J. 2013;32(6):e242-53. http://doi.org/[http://doi.org/10.1097/INF.0b013e318286c612]
• World Health Organization. Members of the WHO Programme for International Drug Monitoring [Erişim tarihi: 10.07.2025]. Erişim adresi: https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/who-programme-members/
• World Health Organization. Rational use; a major global problem Geneva: WHO; [Erişim tarihi: 24.07.2025]. Erişim adresi: https://www.who.int/teams/health-product-policy-and-standards/medicines-selection-ip-and-affordability/medicines-policy/rational-use
• World Health Organization. Conference of experts on the rational use of drugs;1985 Nov 25-29. Nairobi, Kenya: WHO; 1985.
• World Health Organization. International monitoring of adverse reactions to drugs adverse reaction terminology. Uppsala: WHO Collaborating Centre for International Drug Monitoring; 1989.
• World Health Organization. The importance of pharmacovigilance: safety monitoring of medicinal products. . Geneva: WHO; 2002.
• World Health Organization. Antimicrobial resistance: a threat to global health security. rational use of medicines by prescribers and patients. Geneva: WHO; 2005.
• World Health Organization. The pursuit of responsible use of medicines: Sharing and learning from country experiences. Geneva: WHO; 2012.