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A Study on Assessment, Monitoring and Documentation of Adver | 25770

International Journal of Pharmacy Teaching & Practices

ISSN - 1986-8111

Abstract

A Study on Assessment, Monitoring and Documentation of Adverse Drug Reactions

S.Yamini Padmaja, Sivanandy Palanisamy

Objectives: Main objectives of the study were to assess the pattern of adverse drug reactions, to monitor and document the reported reactions, to identify the offending drugs and severity of observed reactions and to evaluate the cost.
Method: A prospective observational spontaneous reporting study was carried out for a period of 7 months in an inpatient and outpatient department of a south Indian hospital.
Results: In a total of 103 patients, nearly 53.40 % of patients were male it indicates that the prevalence of ADRs is more in men than in women. 46.60 %, 39.08 % of ADRs were found in the age group between 41 and 60 shows that ADRs in this locality hospital is more in these age group peoples. Naranjo’s causality assessment scale shows 39.80 % (41) of ADRs were definite, 34.95 % (36) of ADRs were probable, 22.33% (23) of ADRs were possible and 2.91% (3) were unlikely. WHO probability assessment scale shows 39.80% (41) cases were certain, 34.95% (36) ADR were probable, 17.47% (18) were possible, 2.91% (3) were unlikely, and 4.85% (5) were unassessible. Severity Assessment by Modified Hartwig and Siegel Scale showed that 56.31% (58) ADRs were moderate, 38.83 % (40) ADRs were mild and 4.85% (5) ADRs were severe. No lethal effects were observed. Many of the ADRs were reported from general medicine department (33.98%), it is followed by dermatology department (14.56%) and others. Most commonly identified ADRs was maculopapular skin rashes 28 (27.18%).
Conclusion: Regular monitoring of ADRs is very essential in the day today life to avoid unnecessary exposure of patients to drugs and chemicals. All health care professional should actively participate in the regular monitoring and reporting of ADRs to maintain the good quality of patient’s life.

 
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