Adverse drug reaction monitoring in a tertiary care teaching hospital

Chawla, Shalini; Kalra, Bhupinder Singh; Dharmshaktu, Pinky; Sahni, Pooja

doi:10.4103/0976-500x.83291

Cited by 5 publications

(4 citation statements)

References 5 publications

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“…Often ADRs are seen in hospitals, yet they can also occur with outpatients and with self-medication which majority of the time goes unnoticed due to lack of knowledge among the general public and even the health care professionals. 4 To overcome this gap, Pharmacovigilance Program of India (PvPI) has started a National Pharmacovigilance Program for spontaneous reporting of ADRs in the year 2010, which is accessible to everyone. 9 The PvPI collects the ADRs from all ADR monitoring centres (AMCs) and the public in India, and conveys the substantial data to drug regulatory authorities for essential action on the drugs; it also shares the health care professionals and the public regarding the risk of ADRs, by this, it improves the patient safety and welfare.…”

Section: Discussionmentioning

confidence: 99%

“…3 Several factors like complexity of diseases, drug interactions, polypharmacy and possible negligence are associated with ADRs in hospitalized patients. 4…”

Section: Introductionmentioning

confidence: 99%

“…3 Several factors like complexity of diseases, drug interactions, polypharmacy and possible negligence are associated with ADRs in hospitalized patients. 4 The ADRs increase drug-related morbidity and mortality, enhancing the economic burden on the patients and the health care establishment, mainly in a developing country like India. 2 Health care professionals have the responsibility to report ADRs; however, due to the need for motivation, time, knowledge and attitude, several reactions are certainly not reported.…”

Section: Introductionmentioning

confidence: 99%

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A Prospective, Observational Study of the Spontaneous Reporting Patterns of Adverse Drug Reactions in a Tertiary Care Teaching Hospital

Raju¹,

Geetha²,

Kamble³

2022

Journal of Pharmacology and Pharmacotherapeutics

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Objectives: To analyse the adverse drug reactions (ADRs) reported from clinical departments of a tertiary care hospital. Materials and Methods: A prospective, observational study to analyse the reported ADRs to the pharmacovigilance unit, Department of Pharmacology, East Point College of Medical Sciences and Research Centre, between 2019 and 2021. Institutional Ethics Committee approval was taken before doing the study. The data pertaining to various parameters were recorded in the Central Drugs Standard Control Organization (CDSCO) approved ADR reporting form and were analysed with respect to each reported data using descriptive statistics and expressed as numbers and percentages using Microsoft Excel. Results: Overall, 114 ADRs were reported during the study duration, and ADRs were most commonly reported amongst females (69) and 31–45 years (27.2%) age group. Causality assessment was done using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, which showed 75 (66%) probable and 39 (34%) possible ADRs. The highest number of ADRs were reported by Medicine department (48.2%), emergency and intensive care unit (ICU) (16.6%) followed by Dermatology department (9.6%). The majority of them were due to antimicrobial agents (53.5%). The most commonly affected organ system was found to be dermatological (68.4%) followed by the body as a whole (15.7%) and gastrointestinal system (8.7%). The presentations of ADRs were diverse; itching and rashes (34 cases) were most commonly reported. Conclusion: This study gives an overall understanding of the current situation and trends in ADRs and their reporting status by health professionals in a tertiary care hospital, which would help to strengthen the pharmacovigilance activities at all levels of health care.

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Section: Discussionmentioning

confidence: 99%

“…3 Several factors like complexity of diseases, drug interactions, polypharmacy and possible negligence are associated with ADRs in hospitalized patients. 4…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A Prospective, Observational Study of the Spontaneous Reporting Patterns of Adverse Drug Reactions in a Tertiary Care Teaching Hospital

Raju¹,

Geetha²,

Kamble³

2022

Journal of Pharmacology and Pharmacotherapeutics

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“…There is a predominance of males in our study (65.3%) as compared to females (34.7%), which is comparable to other studies. [ 8 11 ] However, in some studies either females were more affected[ 12 ] or both were equally affected. [ 13 ]…”

Section: Discussionmentioning

confidence: 99%

Comparison of Sensitivities of Skin Prick and Intradermal Tests with Oral Rechallenge Test

Singh

Bohara

Rai

2021

Indian Journal of Dermatology

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Background: Identification of culprit drug causing adverse cutaneous drug reactions may not be possible clinically due to the intake of more than one drug. Aim: To compare the sensitivity of skin tests with gold standard oral rechallenge test to detect adverse cutaneous drug reactions. Materials and Methods: This is a prospective interventional hospital-based study of patients with adverse cutaneous drug reactions attending the outpatient department of dermatology and venereology at a tertiary care center over a 12-month period. Skin prick tests, intradermal tests, and oral rechallenge tests were performed in these patients and their sensitivities were compared. The data of quantitative nature is presented in mean and standard deviation, and categorical variables are presented in number and percentage. The sensitivity of skin tests is compared with the gold standard oral rechallenge test. Results: A total of 49 patients with adverse cutaneous drug reactions were evaluated. Clinical spectrum of adverse cutaneous drug reactions ranged from mild to severe, with fixed drug eruption being the commonest (55.1%) followed by maculopapular exanthem (32.7%). The highest incidence was with fluoroquinolones (43.8%) followed by nonsteroidal anti-inflammatory drugs. Fluoroquinolones were the major cause of fixed drug eruption followed by nonsteroidal anti-inflammatory drugs. The sensitivity of skin prick test and intradermal tests were 49% and 73%, respectively and the difference was highly significant ( P < 0.001). The difference in sensitivity in skin prick test versus oral rechallenge test and intradermal test versus oral rechallenge test was also highly significant ( P < 0.001). Limitations: Small sample size was a major limitation. Histopathological examinations and human leukocyte antigen associations could not be done. Conclusion: Predominant causative drugs were fluoroquinolones followed by nonsteroidal anti-inflammatory drugs. Sensitivities of skin prick test and intradermal test were quite good and these skin tests should be performed before oral rechallenge test in cases of adverse cutaneous drug reactions.

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Incidence and Severity of Adverse Drug Reactions in Medical Intensive Care Unit

Shaikh,

Raut,

Jambhale

et al. 2024

CDS

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Background: Adverse drug reactions (ADRs) curtail patients’ quality of life by virtue of increasing therapeutic complexity and rising multimorbidity. In India, the frequency of ADRs for individual drugs and their economic burdens are rarely evaluated. This study aimed at identifying the incidence and severity of ADRs leading to hospitalization (ADRA) and occurring during a hospital stay (ADRH). Objective: The objective of this study is to study the incidence and severity of ADRs in the ICU and their impact on the duration of hospitalization, along with the cost incurred to treat ADRs in the ICU. Method: Demographic, clinical, and pharmacological data on patients admitted to the ICU were collected, analyzed and evaluated for ADRs. According to the setting analyzed, a descriptive analysis of the reactions, suspected medicines, and associated factors was undertaken. Result: A total of 208 patients were admitted to the ICU during the study period, of which ADRA contributed 9.1% of the incidence rate and 8.1% of ADRH in 36 patients. Males had a higher incidence of ADRs than females. Patients who had ADRs had a substantially longer length of stay than those who did not. Electrolyte disturbance was the most commonly found ADR. According to the Hartwig scale and WHO-causality scale, 88.9% were moderate, and 97.2% were possible ADRs, respectively. Conclusion: In this study, a similar incidence rate of ADRA and ADRH was observed. The average cost for treating ADRA was higher than that for treating ADRH. As a result, identifying and preventing these reactions is critical, as they cause the patient greater suffering.

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Adverse drug reaction monitoring in a tertiary care teaching hospital

Cited by 5 publications

References 5 publications

A Prospective, Observational Study of the Spontaneous Reporting Patterns of Adverse Drug Reactions in a Tertiary Care Teaching Hospital

A Prospective, Observational Study of the Spontaneous Reporting Patterns of Adverse Drug Reactions in a Tertiary Care Teaching Hospital

Comparison of Sensitivities of Skin Prick and Intradermal Tests with Oral Rechallenge Test

Incidence and Severity of Adverse Drug Reactions in Medical Intensive Care Unit

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