Abstract

CUTANEOUS ADVERSE DRUG REACTION-A PHARMACOVIGILANCE STUDY

*Dr. Pranjal Pal, Dr. Cybelda Alicia Chadichal, Dr. Carol Fernandes and Dr. Balakeshawa Ramaiah

ABSTRACT

Under the program PvPI, ADRs are being recognized and voluntarily reported by the healthcare professional of AMC. Reporting of an ADR directly helps in drug monitoring and will guide the Pharmaceutical companies and regulatory authorities for better use of drugs.this study is a prospective interventional study carried out in tertiary care hospital and data on cutaneous ADRs was collected from regular ward rounds in a redesigned data collection form. Primary outcome of this study was assessment of causality, severity and preventability of cutaneous ADRs and reporting of these ADRs to PvPI. This study included 60 cases over a period of 6 months and according to Naranjo’s scale the cutaneous ADRs were Definite (45%), Possible (30%) and Probable (25%), by WHO scale cutaneous ADRs were Probable (73.3%), Possible (23.3%) and Certain (1.6%), by Karch and Lasagna’s scale cutaneous ADR were Probable (38.3%), Possible (36.3%), and Definite (25%). By the Hartwig severity scale were Moderate (79.9%), Mild (18%) and Severe (1.6%). Schumok and Thornton preventability scale tells that most cutaneous ADRs were Probably preventable (41.6%) followed by Definitely preventable (58.3%). After assessment all the cutaneous ADRs were reported to the PvPI In every health care institution monitoring and reporting of ADRs should be encouraged to improve quality of patient care.

Keywords: Pharmacovigilance Programme of India (PvPI), Cutaneous Adverse drug reaction (CADR), ADR Monitoring Center (AMC), causality assessment.