PHARMACOVIGILANCE PROFILE OF DERMATOLOGICAL ADVERSE DRUG REACTION REPORTS COLLECTED FROM A TERTIARY CARE TEACHING HOSPITAL OF BANARAS HINDU UNIVERSITY, VARANASI
Dinesh Kumar*, B. L. Pandey, Dhiraj Kishore and Ashok Kumar
ABSTRACT
Introduction: Drugs can cure, suppress or prevent a disease and are usually beneficial to humans. However, they can also produce undesirable / harmful effects, which are known as adverse drug reactions. These are important cause of morbidity, hospitalization, increased health expenditure and even death. Cutaneous adverse drug reactions are among the most frequent adverse drug reactions. Active search is essential for identification of these, as patients may tend to downplay the causal association between drug use and the subsequent cutaneous manifestation. Objective: To observe the types of drug induced dermatological drug reactions in the patients attending to out patients department of Dermatology in a tertiary care teaching hospital, Banaras Hindu University, Varanasi, and find out the incidence, causal relationship with final outcome of skin drug reactions. Patients and Methods: A prospective study involved 200 patients attending to the Dermatology Outpatient department was observed during the period of one year to find the patients with Dermatological ADRs using self-reporting method for selection of cases in the adverse drug reaction monitoring form by CDSCO, India. Causality was assessed using WHO-UMC Causality assessment Scale. Results were analysed using suitable statistical methods. Results and Discusions: Skin reactions are the most common manifestations of adverse drug reactions. The pattern of adverse drug reactions and the drugs causing them is remarkably different in our population. Knowledge of these drug eruptions, the causative drugs and the prognostic indicators is essential for clinicians for diagnosis and prevention of adverse drug reactions. It is recommended to advise patients to carry a card or an emergency identification of offending drugs in their wallets that list the drug allergies and/or intolerances.
Keywords: Pharmacovigilance, Dermatological reactions, spontaneous reactions, WHO-UMC causality assessment.
[Full Text Article]