Safety Profile of Mass Administration of Albendazole Among School Children (6-19 Years): A Prospective Active Surveillance Study
Authors: Sheoran Babita , Deb Tirthankar , Misra Saurav , Tuteja Mayur , Vohra Abhimanyu , Beniwal Ritu 
Published: August 2024

Background:
Infections with Soil-transmitted Helminths (STHs) impact about 24% of
the global population. A disproportionate number of individuals, particularly those from low socioeconomic
backgrounds, live in emerging nations. In India, between the ages of one and fourteen,
almost 220 million children are susceptible to intestinal worm infestations caused by parasites. The
National Deworming Day (NDD) initiative was started by the Indian government in February 2015
as a part of the National Health Mission to address this problem. Though the adverse effects of albendazole
in routine therapy are known, the mass administration of the medicine in children as part
of a public health program has not been adequately studied.

Objective:
This study aimed to determine the occurrence, type, and severity of adverse drug reactions
resulting from mass administration of albendazole in school children aged 6-19 years in a district
of northern India.

Methods:
Twenty specified clusters were randomly chosen from a total of 94 clusters in the state to
participate in this prospective, descriptive, observational study that was carried out in Karnal, Haryana.
Both a passive approach and an active adverse drug reaction reporting system were used in
the study. The six-step process known as Deb’s Active Surveillance & Assisted Reporting System
was employed in our study. Adverse drug reactions were recorded using the suspected Adverse
Drug Reaction (ADR) reporting form of the Pharmacovigilance Programme of India (PvPI).

Results:
Twenty clusters with a combined total of 94 schools and 12,751 students were observed
during the study. In this study, there were more female participants (N = 8,060; 63.21%) than male
participants (N = 4,691; 36.78%). A total of 29 ADRs were reported. All reported ADRs were mild
in nature. It was discovered that there were 1.37 incidences for every 1000 individuals. As illustrated
in Fig. (1), the most frequently reported Adverse Drug Reactions (ADRs) were vomiting (N
= 10), nausea (N = 4), abdominal pain (N = 2), and headache (N = 1). The majority of ADRs were
categorized as probable (N=18; 62.06%), followed by possible (N=11; 37.93%).

result:
Twenty clusters with a combined total of 94 schools and 12,751 students were observed during the study. In this study, there were more female participants (N = 8,060; 63.21%) than male participants (N = 4,691; 36.78%). A total of 29 ADRs were reported. All reported ADRs were mild in nature. It was discovered that there were 1.37 incidences for every 1000 individuals. As illustrated in figure 1, the most frequently reported adverse drug reactions (ADRs) were vomiting (N = 10), nausea (N = 4), abdominal pain (N = 2), and headache (N = 1). The majority of ADRs were categorized as probable (N=18; 62.06%), followed by possible (N=11; 37.93%).

Conclusion:
An active surveillance system alongside voluntary passive reporting during the mass
administration of medicines can help evaluate the safety profile of the medicinal products. The occurrence
of ADRs following mass administration of albendazole in school children was found to be
only 1.37 incidences for every 1000 recipients, being mild in nature, with vomiting being the most
common.