PHARMACOVIGILANCE AND PHARMACOECONOMIC EVALUATION OF EMERGING DRUG DELIVERY SYSTEMS
Abstract
Pharmacovigilance and pharmacoeconomic evaluation of emerging drug delivery systems was conducted as a quantitative comparative assessment of safety, clinical, and economic outcomes in relation to conventional drug formulations. A total of 240 adult patient records were analyzed, including 120 patients treated with emerging drug delivery systems and 120 patients treated with conventional formulations. Data were collected from medical records, prescription charts, pharmacy records, adverse drug reaction reports, laboratory findings, and billing documents. Pharmacovigilance outcomes included adverse drug reaction incidence, severity, seriousness, and predictors, while
pharmacoeconomic outcomes included total treatment cost, adverse reaction management cost, hospitalization, adherence, treatment response, cost-effectiveness ratio, and incremental cost-effectiveness ratio. Adverse drug reactions were significantly lower among patients receiving emerging drug delivery systems than among those receiving conventional formulations (18.3% vs. 31.7%; p = 0.017). Emerging systems also showed better treatment response (80.0% vs. 68.3%; p = 0.039), higher adherence (84.2% vs. 71.7%; p = 0.020), and shorter hospital stay (3.8 ± 1.6 vs. 5.2 ± 2.1 days; p < 0.001). The mean total treatment cost was higher for emerging systems (₹42,850 ± ₹11,620) than conventional formulations (₹31,470 ± ₹9,840; p < 0.001), with an ICER of ₹97,264.96 per additional successful response. Emerging drug delivery systems showed improved safety and clinical effectiveness but required higher economic investment.
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