Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Study of cutaneous adverse drug reactions in a tertiary care hospital

2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Mohammed Yunus Khan, Prudhwi, Alekhya, Arun Jyothi, Srinivas and Swetha Rani

Posters: Pharmaceut Reg Affairs

Abstract :

ADR?S are negative consequences of drug therapy and can be a major setback in clinical practice. Cutaneous adverse drug reactions (CADR?S) are the commonest manifestations of ADRs. Effective monitoring of CADRs forms an integral part of ADR monitoring programmes as well as pharmacovigilance. The present study was taken to augment existing limited data regarding CADRs. All cases suspected of having a CADR during the period of one and half year were evaluated by a prospective study. The causal relationship with the offending drug was established as per WHO-UMC causal assessment scale. Only certain, probable and possible cases were considered for the study and the data was subjected to descriptive and statistical analysis. This study shows that a wide range of CADR?S from mild to moderate to severe like SJS/TEN are possible. Antimicrobials and Analgesics/NSAID?S were found to be most common causative drug category. According to Hartwig severity scale most of the reactions were of moderate type. According to WHO-UMC criteria most of the reactions were probable followed by possible. Based on Schumock Thornton criteria majority of CADR?S were not preventable. Similar studies conducted over longer period are necessary to validate the findings. Adverse drug reaction monitoring should be a ongoing and continuous process because newer and newer drug molecules are being introduced in the market and monitoring of adverse effect of new drug molecules particularly serious adverse effects is the need of the hour. Physicians and other health care professionals should be made aware of and trained in rational drug use and drug monitoring process.

Biography :

Mohammed Yunus Khan is pursuing his postgraduation (MD, Pharmacology) in Kakatiya Medical College, Warangal.

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