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A Research Study on Impact of Pharmacovigilance Implications over OTC Drug Safety Surveilliance in Optimization of Rational Drug Usage

Mekkanti Manasa Rekha, Sambhu Charan Pusti, Rinku Mathappan


The Presentresearch study involves in application of Pharmacovigilance implications over OTC drug safety surveillance in optimization of rational drug usageand was conducted in bhuvaneswari medicals and tripuraswari medicals, R.T. Nagar, Bangalore, Karnataka, India over a minimum period 4 months from 16th April 2020 to 16th august 2021with an estimated sample size was 250–300 for the present study.The data was collected by using different scales and methods were implemented to monitor the OTC drug safety surveillance. A total of 220 patients were enrolled in the study out of which the males are 135 and females are 85 in which 182 (82.727%) patients were literates and 38 (17.272%) patients were illiterates, 38 patients were alcoholic and 49 patients were having behavior of smoking and 35 patients were having both alcoholic+smokingbehaviour, total 80 Adverse drug reactions were screened during study period. In which month wise screening of adverse drug reactions includes 24(30%) ADR’s were screened in April month, 18(22.5%) ADR’s were screened in May month, 20 (25%)ADR’s were screened in June month, 10 (12.5%) ADR’s were screened in July month, 8 (10%) ADR’s were screened in August month, Majority 48(60%) of the pediatrics who experienced ADRs were recovered and 32(40) were continuing with ADRs with 0 percent fatality, the reported ADRs were categorized using Hart wig's severity scale, maximum reported ADRs 32 (40%), 30 (37.5%) were mild in nature where as remaining 18(22.5%) ADRs were moderate in nature, Causality assessment of ADRs was carried out using WHO probability scale and Naranjo algorithm. As per WHO probability scale, majority of ADRs 20(25%) were ‘Possible’ followed by ‘Conditional’ 15 (18.75%), ‘Probable’ 14 (17.5%) and 12 (15%) ADRs were ‘Unlikely’. As per Naranjo algorithm, majority of ADRs 20(25%) were ‘Possible’ and 14(17.5%) ADRs were ‘Probable’, P value was calculated by using Graph pad prism software. P value was 0.001 which states the present study is highly significant. The Conclusions drawn from the above study clearly indicated there is a need of strict pharamacovigilance practices to be done for monitoring the OTC drug safety surveillance in India.


OTC drug safety surveillance, optimization of rational drug usage, Graph pad prism software, Naranjo algorithm,adverse drug reaction,etc.

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