Anti-infectives-induced adverse drug reactions in hospitalized patients

Gholami, Kheirollah; Parsa, S.; Shalviri, Gloria; Sharifzadeh, Mohammad; Assasi, Nazila

doi:10.1002/pds.1099

Cited by 50 publications

(78 citation statements)

References 10 publications

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“…A study by Gholami et al shows similar result in which most of the adverse drug reaction are of moderate severity. 15 A study by Tak D K also supported this result. 16 …”

Section: Discussionmentioning

confidence: 61%

“…Gholami et al also supported the same findings that the probable reaction was the more. 15 The reported ADRs were classified into different levels like mild, moderate or severe based on the Modified Hartwig and Siegel scale. The severity assessment of ADRs showed that 48% reactions were moderate and 52% were of the 'mild' nature as per the Hartwig et al scale.…”

Section: Discussionmentioning

confidence: 99%

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A study of adverse drug reactions among pulmonary tuberculosis patients treated under dots in a tertiary care hospital

Bai

Ravikumar

Salma

2017

Int J Basic Clin Pharmacol

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Background: DOTS under RNTCP is the current treatment available for Pulmonary Tuberculosis. This treatment exhibit a greater level of efficacy with a small degree of toxicity. The present study aims to determine demography of patients with pulmonary tuberculosis and to study the ADRs caused by anti tubercular drugs and to assess the causality and severity of the reported ADRs.Methods: We studied cases of Pulmonary Tuberculosis diagnosed and treated under category I DOTS at Department of Pulmonary Medicine for the period of one year (during 2015). Adverse effects observed during treatment course were recorded in standard ‘Adverse Drug Event Reporting Form’. ADRs were also assessed for their causality and severity by using WHO-UMC criteria and Hartwig’s scale.Results: Pulmonary cases accounted for 67.6% of total TB cases. Among 434 cases of pulmonary tuberculosis 33 (7.6%) patients were defaulters; among them 3(9.5%) cases were defaulters due to ADRs. In our study 96 patients developed 123 ADRs of various types and most of the ADRs noted within first 2 weeks of initiation of treatment. Gastritis was the most common ADRs (28/22.7%) followed by anorexia (26/21.1%).Conclusions: In our study 22.1% of patients developed ADRs. ADRs recorded in our study were categorised under ‘probable’ and ‘possible’ causes and severity assessment showed 48% are moderate and 52% are ‘mild’ in nature. Still ADRs accounted for 9% default rate. Hence implementations of good patient care oriented programs are needed for early diagnosis and to reduce default rate and drug resistance.

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“…A study by Gholami et al shows similar result in which most of the adverse drug reaction are of moderate severity. 15 A study by Tak D K also supported this result. 16 …”

Section: Discussionmentioning

confidence: 61%

Section: Discussionmentioning

confidence: 99%

A study of adverse drug reactions among pulmonary tuberculosis patients treated under dots in a tertiary care hospital

Bai

Ravikumar

Salma

2017

Int J Basic Clin Pharmacol

View full text Add to dashboard Cite

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“…Anti-TB drugs could cause significant adverse effects both in magnitude and severity 6 . Results of our study reveal that 84% of patients developed one or more ADR's and a total of 118 ADR's occurred in our study.…”

Section: Discussionmentioning

confidence: 99%

“…This is in concordance with the study done by Kheirollah et al and Abideen et al in which maximum number of ADR's were seen within lag period of 1-15 days. 6,15 Causality assessment revealed that most of ADR's were in probable category and severity assessment revealed that most of ADR's belong to level 4 (Moderate severity).…”

Section: Discussionmentioning

confidence: 99%

“…ATT exhibits greater level of efficacy but with a significant degree of toxicity, especially during 1 st and 2 nd month of the start of therapy. 6,7 The need of the hour is pharmacovigilance study of anti-tubercular therapy so that early diagnosis and management of ADR's can be done actively, which will further improve patient adherence and treatment outcomes.…”

Section: Introductionmentioning

confidence: 99%

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Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis

Agarwal¹,

Goel²,

Rai³

et al. 2017

Int J Basic Clin Pharmacol

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Background: Study was done to determine incidence of ADR’s in sputum positive, pulmonary TB patients, on DOTS category I and to determine the effect of ADR’s on sputum conversion.Methods: Open, prospective, observational, non-comparative study conducted in the Department of Pharmacology in collaboration with Department of Tuberculosis and Chest Diseases, Government Medical College, Amritsar for the duration of 18 months (March 2015 to September 2016). One hundred sputum positive patients of pulmonary tuberculosis on DOTS category I, of either sex, in age group of 14 years to 65 years, were recruited and followed up during intensive phase of therapy at end of 1st and 2nd month. Causality and Severity assessment were done by using WHO-UMC causality scale and Hartwig’s severity scale respectively.Results: Out of 100 patients 84 (84%) developed one or more ADR’s and a total of 118 ADR’s occurred in our study. The most common ADR was GI upset 45(38.13%), followed by hepatitis 42 (35.59%), rash 12 (10.16%), CNS 8 (6.77%), arthritic symptoms 5 (4.23%), visual disturbance 2 (1.69%), bleeding problems 2 (1.69%), hyperuricemia 1 (0.84%) and peripheral neuropathy 1 (0.84%). Causality assessment revealed that most of ADR’s(60) were in probable category and severity assessment revealed that most of ADR’s(55) belonged to level 4 (Moderate severity). Most of the ADR’s occurred within 30 days of the start of treatment (84.74%).Conclusions: With such a high incidence of ADR’s there is a need of incorporating pharmacovigilance programme into this vital health programme for more comprehensive monitoring of tuberculosis patients on DOTS for timely prevention, detection, and management of ADR’s. This will decrease non-adherence and dropouts, and thus result in better treatment outcomes.

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Current awareness: Pharmacoepidemiology and drug safety

2005

Pharmacoepidem. Drug Safe.

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of pharmacoepidemiology and drug safety. Each bibliography is divided into 20 sections: 1 Books, Reviews & Symposia; 2 General; 3 Anti‐infective Agents; 4 Cardiovascular System Agents; 5 CNS Depressive Agents; 6 Non‐steroidal Anti‐inflammatory Agents; 7 CNS Agents; 8 Anti‐neoplastic Agents; 9 Haematological Agents; 10 Neuroregulator‐Blocking Agents; 11 Dermatological Agents; 12 Immunosuppressive Agents; 13 Autonomic Agents; 14 Respiratory System Agents; 15 Neuromuscular Agents; 16 Reproductive System Agents; 17 Gastrointestinal System Agents; 18 Anti‐inflammatory Agents ‐ Steroidal; 19 Teratogens/fetal exposure; 20 Others. Within each section, articles are listed in alphabetical order with respect to author. If, in the preceding period, no publications are located relevant to any one of these headings, that section will be omitted.

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Anti-infectives-induced adverse drug reactions in hospitalized patients

Abstract: The rate of ADRs induced by anti-infective agents in this study was 8.2%. This is higher than a standard (5%) which has been reported in other studies. This study also shows that some of the classes of anti-infective agents like anti-fungals need more attention.

Cited by 50 publications

References 10 publications

A study of adverse drug reactions among pulmonary tuberculosis patients treated under dots in a tertiary care hospital

A study of adverse drug reactions among pulmonary tuberculosis patients treated under dots in a tertiary care hospital

Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis

Current awareness: Pharmacoepidemiology and drug safety

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