A Randomized, Single Centered, Parallel and Open Labelled Interventional Study on Effectiveness of Clinical Pharmacists on Adverse Event Following Immunization (AEFI) in Pediatric Population.

Background: Adverse events are a major threat to any immunization programs, which have proven to be a boon for developing nations like India. Hindering factors, such as inadequate knowledge, inappropriate attitude, incorrect practices, etc., of the guardian affect the vaccination rate.

Aim: This study aims to assess the effectiveness of clinical pharmacist intervention on an adverse event following immunization in the pediatric population receiving immunization.

Methods: Pediatric subjects <5 yrs of both genders receiving immunization in a tertiary care hospital during the period of 8 months were considered. Subjects were randomized into control and interventional groups. Pharmaceutical intervention was done in interventional group in the form of patient counselling, and a patient information leaflet. Adverse event following immunization was recorded and analysed for both groups along with Knowledge, Attitude, and Practice scores of guardians' pre and post intervention through customized data collection forms. Microsoft excel and statistical software SPSS IBM version 22 was used to analyse the data.

Results: The study was conducted on a total of 88 subjects (n) in which 79 were <2 years, 1 and 8 were between 2-4 years and 4-5 years, respectively. Forty-nine subjects (55.69%) were female, while 39 were male (44.31%) with a response and completion rate of 91.66%. 97.7% of subjects received Bacillus Calmette-Guerin vaccination (majority), while 8.88% received pneumococcal special vaccine (minority). Adverse event following immunization was recorded in 31(35.22%) cases. Knowledge, Attitude and Practice scores increased by 42.17%, 52% and 12.67%, respectively in guardians after clinical pharmacist intervention.

Conclusion: This study demonstrates that educational inputs, awareness programs, and proper medical professional intervention can act as a helping factor to fight against AEFI and towards the success of an immunization program.