Pharmacovigilance and incidence of adverse drug reactions in hospitalized pediatric patients: a mini systematic review

Abstract

Background Pharmacovigilance is an identifying and responding process against an adverse drug reaction (ADRs) problem encountered in the drug administration. ADRs are among the common reasons for morbidity and fatality in pediatrics throughout the globe. Main body A systemic review of the previous 10 years (2010–2019) published studies were taken into consideration to describe observational studies on ADRs and to determine the incidence and characteristics of ADRs in pediatrics. Electronic relevant literature was searched in PMC, PubMed, Google Scholar, and OvidSP databases using MESH heading and text words. The titles, text, and abstracts were checked for patients below 18 years of age, nature of ADRs, observational studies (prospective or retrospective), and maximum information was recorded to count their frequency. The studies which discussed specific or particular drug exposures were not selected in this review. Of the 36,689 titles retrieved, 27 studies were selected for full-text review. Ten observational studies were added in the final review. Observational studies on pediatric were carried out in seven distinct nations. The predominant study design within observational methodological studies was prospective (n = 5, 50%). The overall average occurrence of ADRs incidence was 9.52%. ADRs reporting in male patients (54.6%) were more than females (45.4%). The severe types of ADRs were reported in four studies. Anti-microbials were the most common class of drugs related to ADRs. Conclusion This systematic review reveals that ADRs in pediatrics are serious public health problems. Periodic drug surveillance studies are mandatory for the safe and appropriate usage of medicines in pediatrics.

Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital

“…), patients and caregivers are the primary source of voluntary ADRs reporting (Ergün et al, 2019;Khan et al, 2020b;Haines et al, 2020). Underreporting of ADRs continues to be a widespread issue (Ergün et al, 2019;Güner and Ekmekci, 2019;Khan et al, 2020a). According to a recent report, Turkey submitted only 89 ADR reports per million population to the World Health Organization (WHO) Vigiflow database in 2020 (Turkey Pharmaceuticals and Medical Devices Agency TPMDA, 2020).…”

“…Drug safety is an important part of health care and understanding ADRs is crucial for avoiding harmful effects ( Dittrich et al, 2020 ). The safety of drugs in paediatric patients is a serious public health problem ( Rosli et al, 2017 ; Khan et al, 2020a ). ADRs in paediatric patients have been shown to cause not only hospital admissions or lengthy hospitalization, but also chronic disability or even death ( Le et al, 2006 ).…”

“…The medication mistakes in paediatric patients were found to be three times higher than in adults, mostly due to considerable variation in body mass, which necessitates individual dose measurements depending on patient age, weight, or body surface as well as the clinical situation ( Khan et al, 2020a ). The development of renal functions and enzyme systems, pharmacokinetic and pharmacodynamic parameters in paediatric patients also alter throughout time ( Rosli et al, 2017 ).…”

“…A previous study revealed that ADRs affects around one out of every ten children in the hospital, with 12% of them were serious ( Clavenna and Bonati, 2009 ). According to systematic reviews, the overall average incidence of ADRs in paediatric patients was 9.52–9.53% ( Impicciatore et al, 2001 ; Khan et al, 2020a ). ADRs also imposed a higher financial cost on patients.…”

Evaluation of Performance of IHI Global Trigger Tool in Identification of Adverse Drug Events: A Prospective Observational Study

“…The advancements in the drug discovery process have enabled surprising benefits for the patients; concomitantly, there was a substantial rise in the incidence of adverse drug reactions (ADRs) or adverse drug events (ADEs) [1]. ADRs are the critical cause of hospitalization, morbidity, and fatality [2].…”