Development, implementation, and analysis of adverse drug reaction monitoring system in a rural tertiary care teaching hospital in Narketpally, Telangana

Background: Medication use has been there since time immemorial. Also, it was well known that all medications carry risk of adverse drug events. Hence regular and periodic monitoring of medications for adverse events has assumed importance. With this background pharmacovigilance has an important role to play in monitoring of adverse events to medications. Hence the present study was undertaken to analyze the pattern of adverse events reported to a tertiary care teaching hospital in Southern India (Shivamogga Institute of Medical Sciences (SIMS), Shimoga).Methods: This study is a retrospective observational study of 150 adverse drug events reported at McGann teaching hospital, SIMS, Shimoga. The adverse events reported were analyzed for their age and gender distribution, drugs causing ADRs, organ systems affected, causality, type, severity and preventability of ADRs.Results: Patients in age groups of 21-40 were most commonly affected by ADRs with a slight increase in male population affected. Cutaneous ADRs were most common and beta lactam antibiotics were most common drug group implicated in causing these ADRs. Probable/likely category most common WHO-UMC causality category, with type A ADRs being most common. Majority of ADRs were of moderate severity and nearly 86% of ADRs were of not preventable category.Conclusions: Antimicrobials were most commonly involved in causation of ADRs with cutaneous ADRs being most common. Most of ADR were not preventable category, majority of ADRs were of moderate severity and causality grading was probable/likely category.

Section: Discussionsupporting

confidence: 92%

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

Sai

2019

“…These patterns of ADRs were consistent with other studies. 17,18 According to WHO-UMC causality assessment criteria, 55% ADRs were probable with the suspected drug, 35% were possible while 10% were certain. These results were The first limitation of the study is that it is of relatively short duration.…”

Section: Discussionmentioning

confidence: 99%

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

Sen

Singh

Misra

2018

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.

“…These patterns of ADRs were consistent with other similar studies. 23,24 The causality of ADRs were assessed according to WHO-UMC causality assessment criteria and it was found that maximum ADRs were probable (94.20%), 2.89% were possible while only 1.44% belonged to both certain and unlikely category. These findings were similar to a study but different from results obtained in other studies.…”

Section: Discussionmentioning

confidence: 99%

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

Singh

Jain

Soni³

et al. 2020

Background: Adverse drug reactions (ADRs) are among the leading cause of morbidity and mortality in hospital setup. This study was conducted with the aim of understanding the pattern and occurrence of ADRs to minimize their risk and safeguard public health.Methods: This study is a retrospective analysis of pattern of ADRs reported at ADR monitoring centre (AMC) in a tertiary care hospital. A total of 207 spontaneous ADR reports collected over a period of 18 months were analysed for pattern and type of reactions, demographic profile of patients, organ system affected by ADRs, causative drugs, route of drug administration, severity of reaction, their outcome, management and causality assessment.Results: Most common age group affected by ADRs was 41-50 years with almost equal involvement of male and female gender. Cutaneous reactions involving skin like rashes and itching were most common ADRs. The most common causative drug for ADRs were antimicrobials agents like Penicillin and Cephalosporin group of antibiotics. Orally administered drugs were most commonly involved in causing ADRs. Most of the ADRs belonged to Type A category, were non-serious and moderate in severity. Most of the patients recovered from the ADRs on stopping the suspected drug. On assessing the causality, most of the ADRs were probable with the suspected drugs.Conclusions: Most of the patients recover from ADRs with appropriate and timely intervention, but it is important to understand the pattern and occurrence of ADRs for patient safety and this is possible only with an effective and robust pharmacovigilance system.