Assessment of Causality, Preventability and Severity of Cutaneous Adverse Drug Reactions: A Prospective Observational Study

Abstract

Background: All drug regulatory authorities have to ensure the safety, efficacy and quality of all the marketed products. Quality and efficacy can be determined by the data from preclinical and clinical trials. In clinical trials at the pre-marketing stage, it is challenging to identify rare Adverse reactions (ADR) and delayed side effects or effects due to long-term exposure because of lack of follow-up. In this case, pharmacovigilance comes into picture where it plays a significant role in marketed drugs safety profile establishment. Aim: This study helps in safety profile establishment for drugs. Methodology: It was conducted by the Department of pharmacy practice at drug information Centre in collaboration with Department of pharmacology at private multi-specialty Hospital. ADR reporting forms of the Central Drug Standard Control Organization has been used for collecting the data, and this form includes patient demographic details like clinical history, co-morbid conditions like Diabetes mellitus, Hypertension, Asthma, history of any drug allergies etc. were collected. The chance of preventability modified Schumock and Thornton criteria was found to be very less, and it was evident that most of them were not. By using Hartwig et al., scale, the severity of ADRs were of moderate severity. The reason behind this moderate severity was a history of allergy and multiple drug therapy. Result: It was observed that preventability 86% were not preventable whereas 14% were preventable as per Schumock and Thornton scale. In these cases of definitely preventable cases were due to history of reaction upon administration of the same drug. It is advised that in such cases usage of drug alert card is preferred. Conclusion: The major risk factor for the development of ACDR includes self-medication, patients’ lack of awareness regarding the dose and frequency of administration, polypharmacy. This can be avoided by prescribing the required drugs only and by educating     the patients regarding the drugs.