A STUDY ON IDENTIFICATION, MONITORING AND MANAGEMENT OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL
Author(s)
Vudugu R, Eluka vL, Konuru V, Sagar SV, Kachapuram rC
St.Peter's Institute of Pharmaceutical Sciences, Hanamkonda, India
OBJECTIVES: The main objective of the study is to identify, assess and categorize the severity and causality of adverse drug reactions (ADRs) and to analyze the management techniques to prevent them. METHODS: This is a prospective observational study done for one year at the inpatient department of a tertiary care hospital, Hanamkonda. Patients who visited the hospital with different diseases were reviewed on a daily basis and monitored for ADRs. The Patients’ data was collected from various sources and documented in a data collection form. Suspected ADRs were assessed by using WHO scale, Karch and Lasagna scale, Naranjo’s scale and severity assessment was done using Modified Hartwig and Siegel scale. RESULTS: A total of 2500 patients were reviewed, of which 120 (4.8%) patients met the study criteria of having at-least one ADR. Among 120 patients, 143 ADRs were found with a higher incidence among females 80 (56%) than males 63(44%). Among 143 ADRs, 59(41.25%) gastrointestinal reactions were more frequently reported than the others. The pattern of drugs causing these ADRs showed drugs of different classes varying from the highest being Anti-platelets- aspitin+clopidogrel {13(11%)} and Anti-cancer drugs- cisplatin {12(10%)} to the least being Penicillins’ and LMW Heparin{2(2%)}. On evaluation of the causality of ADRs, a majority of them were found to have a ‘possible ‘and ‘probable’ association with the suspected drugs. Majority of the ADRs were ‘moderate’ in severity. CONCLUSIONS: Having identified and assessed the causality and severity of these ADRs, it was found that majority of reactions were moderate, showed probable association with the drugs and found to be more in patients experiencing gastrointestinal disease condition than the others. The methods of management based on the pattern of drugs causing the ADRs are monitoring signs and symptoms, caution, contraindications, monitor serum concentrations, dosage adjustment, alternate drug, discontinuation, and limited use.
Conference/Value in Health Info
2016-09, ISPOR Asia Pacific 2016, Singapore
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PHP53
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Multiple Diseases