An evaluation of adverse drug reactions monitoring at a pharmacovigilance unit under pharmacovigilance program of India in a tertiary care hospital of Haryana

Kharb, Preeti; Mittal, Neelam; Gupta, Mahesh

doi:10.18203/2319-2003.ijbcp20150039

Cited by 14 publications

(14 citation statements)

References 17 publications

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“…The age group affected most commonly with ADRs were in the age range of 41-50 years (21.25%), as found in other studies also. 17,18 The age group most commonly involved also depends on the type of disease for which the patients are visiting particular hospital setup. As there are diseases which affect a particular age group and so the ADRs caused by such treatments will also affect only that particular age group of patients.…”

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

Int J Basic Clin Pharmacol

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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.

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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

Int J Basic Clin Pharmacol

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“…Several methods can be suggested to improve ADR reporting. [14,15] These include creating awareness about ADR monitoring among health care professionals and consumers, through appropriate educational interventions [e.g. seminars, CMEs, make ADR reporting forms easily available and simplifying the process of ADR reporting.…”

Section: Discussionmentioning

confidence: 99%

Assessment of Knowledge, Awareness and Practices among Healthcare Professionals about Pharmacovigilance and Adverse Drug Reactions Reporting in Dharmapuri and Krishnagiri Districts of Tamilnadu, India

Damodar¹,

Joseph²,

Cheaten³

et al. 2018

JPPCM

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“…It was observed that the percentage of cutaneous ADRs among the total number of ADRs received at AMCs varied among different studies. [18][19][20] (16) Ciprofloxacin (13) Levofloxacin (2) Norfloxacin (1) Pruritus (9) Maculopapular rash (3) Urticaria (2) DRESS * (1) Fixed Drug Eruption (1) 2…”

Section: Discussionmentioning

confidence: 99%

“…This findings were in consistent with studies that reported that the overall occurrence of ADRs in any system organ class were higher in this age group. 19,21 With regard to gender preponderance of occurrence of cutaneous ADRs, the available literature suggests that there is mixed response. The present study showed ADRs to be slightly higher prevalent in female (51.29%) and this association was also observed in other studies.…”

Section: Discussionmentioning

confidence: 99%

Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

Konda

Pilla

Surekha

et al. 2018

Int J Basic Clin Pharmacol

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Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs.Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability.Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication.Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients.

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An evaluation of adverse drug reactions monitoring at a pharmacovigilance unit under pharmacovigilance program of India in a tertiary care hospital of Haryana

Cited by 14 publications

References 17 publications

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

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

Assessment of Knowledge, Awareness and Practices among Healthcare Professionals about Pharmacovigilance and Adverse Drug Reactions Reporting in Dharmapuri and Krishnagiri Districts of Tamilnadu, India

Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

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