Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital

Abstract

Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in hospitals and pose great economic burden on the health care system. This study was conducted with the aim of creating awareness and developing a culture for proper communication and reporting of ADRs among health care professionals.Methods: This study is a retrospective analysis of total 60 reported ADRs from AMC at a tertiary care hospital during a period of 14 months from March 2015 to April 2016. These ADRs were analysed for the pattern and type of reactions, body systems involved, causative drugs, and severity of reaction, their outcome, management and causality assessment.Results: Patients in the age groups of 41-50 years were most commonly involved with slight male preponderance. Skin reactions like rashes and itching were the most commonly observed ADR. The most common causative drugs for ADR were antimicrobial agents; IV route was the most common route responsible. Majority of ADRs belonged to type B, were non serious and moderate in severity. Most of the patients recovered. On causality assessment scale, most of the ADRs were found to be probable with the causative drugs.Conclusions: Most of the ADRs were treatable by early and appropriate management. The major limitation was under-reporting of ADRs which can be overcome by creating awareness and enhancing the culture of ADR monitoring and reporting among health care professionals for safe use of drugs.

Analysis of adverse drug reactions in a tertiary care teaching hospital in Southern India

“…19 Causality assessment according to the WHO UMC causality assessment criteria17,18 revealed that none of the ADRs were in the definite/certain category as rechallenge with the suspected drug is not possible without the attendant risk to the life of patient, hence rechallenge is not done nowadays except under exceptional circumstances and that too with full precautions to resuscitate the patient if necessary, while probable/likely category (57.34%) was the most common causality group followed by possible (25.34%) group. These results corroborate well with other similar results published in literature by Sen et al 29 The present need of the hour is to ensure that regular sensitization of the healthcare personnel is done through conferences, seminars and CME and also by encouraging the healthcare professionals to report all the suspected ADRs in the hospital. Limitation of the present study was lack of adequate reporting by health care professionals which can be taken care of by following the above suggestions, also till now no technical associate has been provided by the PvPI to our AMC and that may be another reason for under reporting of adverse events from our AMC, inspite of these limitations all efforts are being put by the AMC personnel and concerned authorities at our AMC to ensure adequate reporting of adverse events from our Institute.…”

Pattern of adverse drug reactions reported at a tertiary care teaching hospital in northern India

“…These findings are in agreement to another similar study. 22 Patients given drugs by oral route were most commonly affected by ADRs (57%) in present study followed by I.V. route (42.51%) and I.M.…”

“…Majority of ADRs were non-serious (97.5%) and only 2.41% were serious, which is similar to another study. 22 Most of the patients recovered from the ADRs (59.90%) while 39.61% patients did not recover at all and only one case (0.48%) was fatal which led to death of the patient. In 56.52% patients, the suspected drug was stopped in 1.93% cases it was restarted again after stopping, when the symptoms of ADR subsided while in 41.54% cases the drug was not stopped at all.…”

Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India

“…Majority of cases reported attributes to nonserious as compared to serious in this study, while in India other studies published also shown homogenous studies from Venkatasubbaiah et al, Sneha et al and Singh et al observed more number of serious ADRs/AEs. 5,7,18,24,25 Considering the outcome parameter the end result of the reported cases in the indexed period are mostly recovered followed by recovering, not recovered and fortunately only one case of fatal was reported which where compared with similar to study conducted in India while studies done by Sneha et al and Hemavathy G et al reported cases with recovering outcome parameter were higher then recovered. 5,7,12,26,27 In regards to the causality assessment it is to determine the relatedness or the likelihood of the drug (s) with reaction (s) establishing the reasonable time relationship and considering the comorbid factors.…”