Cosmetovigilance in a tertiary care hospital: A prospective observational study.

Abstract

Cosmetovigilance is a term used for the activities related to the collection, evaluation, and monitoring of reporting of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. The study was conducted to assess the adverse cosmetic events from a tertiary care hospital. The patients visiting the study site was reviewed and those who met the study criteria are enrolled in the study after administration of the informed consent. Study participants were followed on regular intervals either telephonically or hospital visits in order to determine the outcome. The causality assessment of the reported event was performed using Colipa and PLM method. During the study period 22,893 patients visited the dermatology department, in which 87 subjects were enrolled in the study. The incidence of adverse cosmetic event was 0.38%. Hair care products caused more events than body care products. In 73.56% of cases, the suspected cosmetic was withdrawn and all the study population received symptomatic treatment for the adverse events. Causality assessment of Using Colipa method, categorized 49.43% events as likely and using PLM method, 64.37% events were probable. Study couldn't identify any predictors of adverse cosmetic events. Median cost associated with the management of ACRs for hair care products and body care products were 716.62 (IQR: 1011.36-470) and 557.4 (IQR: 711.63-373.8). The study suggest need for approaches such as awareness programs among the cosmetic sellers, consumers and other stakeholders on cosmetovigilance needs to be developed and implemented.