A PROSPECTIVE OBSERVATIONAL STUDY ASSESSMENT OF ADVERSE DRUG REACTIONS DEVELOPED WITH NEWLY PRESCRIBED DRUGS IN PATIENTS WITH CHRONIC DISEASES Authors: P. Praveen* And M. Nagulu
ABSTRACT
Objective: The objective of present research is to identify the adverse drug reactions (ADR), study the
pattern of ADRs caused by newly prescribed drugs and asses its prevalence in patients with chronic
diseases.
Methods: The study carried out in 500 bedded multispecialty Hospital at general medicine department
over a period of three years. The data was collected from patient case sheet, treatment charts, and lab
reports and by direct interviewing patients and their care takers.The collected data is analysed for
determining causative drug's relationship to ADR, for assess causality of ADR, for ADR severity
assessment and for determining preventability of an ADR. Predictability and preventability were also
assessed. Data analysed using SAS version 9.1. Chi-square and p values were calculated using Medcalc’s
calculator.
Results: Among 330 cases, 409 adverse drug reactions were identified, which shows the probability of
multiple adverse drug reactions in a single patient.Among various age groups adults (64.24%) show
higher prevalence, with male at higher risk than female.Majority of ADRs were identified by doctors or
prescribers 208(50.85%).Among 592 patients specific and symptomatic treatment was given for majority of 191 (46.69%) patients. The casuality assessment indicate that Possible and Probable are statistically
significant.Most of ADRs were gastrointestinal 106 (25.91%) reactions, central nervous 72 (17.60%)
reactions followed by cardiovascular 43(10.51%) reactions. A definite improvement was predominant in
dechalleged patients whereas recurrence of symptoms was significantly observed among rechallenged
patients with the respective suspected drug.In 409 ADRs cases majority (47.67%) weredefinitely
preventable adverse drug reactions are followed by probably preventable adverse drug reaction.
Conclusion: Adverse drug reactions are more common and preventable. Vigilance by physicians, clinical
pharmacists and other healthcare professionals in detecting, diagnosing and reporting can reduce their
impact.
Keywords: WHO ART, Chi-Square Value / P-Value, Adverse Drug Reactions, Newly Prescribed
Drugs, Chronic Diseases
Publication date: 25/09/2021 https://ijbpas.com/pdf/2021/September/MS_IJBPAS_2021_SEPT_SPCL_1045.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2021/10.9.1045