Pattern of adverse drug reactions in a regional pharmacovigilance center of a tertiary care teaching hospital

Seenivasan, P; Anandan, S.; Pradhan, Vivek; Rajanandh, Muhasaparur Ganesan; Adikrishnan, S

doi:10.1007/s40267-017-0474-y

Cited by 3 publications

(4 citation statements)

References 17 publications

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“…A 25.2% prevalence rate of anemia and thrombocytopenia was reported in our setting, i.e., significantly lower, compared with 31.5% and 48.1% stated in other studies [15]. Moreover, a 9% nausea and vomiting was reported, i.e., significantly lower, compared with 31.5% and 48.1% were reported in two other studies [7,17]. The lower incidence of these adverse reactions is accounted for the anti-emetic drugs, like granisetron and the administration of pantoprazole, dexamethasone, and aprepitant (Tables 1 and 2).…”

Section: Discussioncontrasting

confidence: 66%

“…In this study, Naranjo and the WHO scales were used for causality assessment. The most common ADRs detected in cancer patients receiving anticancer agents include the following: alopecia, nausea, vomiting, burning sensation, tingling, fatigue, anorexia, anemia, thrombocytopenia, leucopenia, ulceration, fever, and bone marrow suppression [7,11,12]. The common anti-cancer drug which manifests ADRs are rituximab, imatinib, bortezomib, thalidomide, methotrexate, 5-fluorouracil, cisplatin, paclitaxel, adriamycin, leucovorin, oxaliplatin, and etoposide [13][14][15].…”

Section: Prescription Event Monitoringmentioning

confidence: 99%

“…[2][3][4]. Worldwide, ADRs accounted for 10% of hospital admissions [5] and 6% of hospitalized patients encountered ADRs [6,7]. The most commonly used method for post-marketing surveillance is ADR monitoring.…”

Section: Introductionmentioning

confidence: 99%

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Adverse Drug Reaction Monitoring of Anticancer Drugs in Hematology Department

Roohi

Najari

2021

IJMTFM

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Background: Cancer is among the leading causes of mortality in India. Studies have reported antineoplastic agents as the common class of drugs causing Adverse Drug Reactions (ADRs). The present study aimed to conduct active surveillance of ADRs of anticancer drugs in the hematology department. Methods: A prospective observational study was conducted in 136 patients with cancer and the incidence and frequency of ADRs were assessed. The study was conducted in 6 months in a multispecialty hospital. Results: Among 136 cancer patients, All was more prevalent (39.70%); CLL, Non- Hodgkin’s Lymphoma were less prevalent (0.73%). ADRs were more prevalent in the Pediatrics department, i.e., 18.53% of ADRs were observed in patients aged <10 years. ADRs in male patients constituted 54.39%, whereas it was 45.60% in female patients. Cytarabine caused the highest number of ADRs (34.48%). The most prevalent ADR was anemia (25.60%). Conclusion: Multiple ADRs were detected in cancer patients. We found that hematological ADRs were more prevalent. Most of the ADRs were possible reactions according to Naranjo and the World Health Organization (WHO) scales.

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Section: Discussioncontrasting

confidence: 66%

Section: Prescription Event Monitoringmentioning

confidence: 99%

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Adverse Drug Reaction Monitoring of Anticancer Drugs in Hematology Department

Roohi

Najari

2021

IJMTFM

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“…The Pharmacovigilance center of the SRIHER is recognized by the Pharmacovigilance Program of India (PvPI) and officially designated an ADR monitoring center under the PvPI network from January 2014. 8…”

Section: Study Sitementioning

confidence: 99%

Surveillance of adverse drug reactions and drug–drug interactions with pediatric oncology patients in a south Indian tertiary care hospital

Joseph

Scott

Rajanandh

2019

J Oncol Pharm Pract

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Objective The present study was conducted to evaluate the pattern of occurrence of adverse drug reactions and drug–drug interaction in a pediatric oncology unit of a tertiary care hospital. Methods A prospective, observational study was conducted in the Department of Pediatric Oncology, Sri Ramachandra Medical College and Hospital, India. Patients were monitored actively for the occurrences of any adverse drug reaction during the study period. Patient's demographic details, clinical, and treatment data were collected for drug–drug interaction analysis. The detected adverse drug reaction was assessed for causality, severity, and preventability. Drug–drug interaction identified was rated based on their level of urgency and the nature of actions necessary to respond to an interaction. Results Of 176 patients, 118 were detected for the occurrence of various adverse drug reaction. The majority of the cases were suffering with acute lymphocytic leukemia (67.9%). Vincristine was noted for a maximum number of adverse drug reaction in cytotoxic drugs. Rash is the most frequently occurred reaction. Assessment of causality showed that the majority of cases are “probable” (60.16%). In evaluating the severity of adverse drug reactions, 57.6% reactions were moderately severe and 74.5% of the reactions were preventable. Upon assessing the drug–drug interaction, 38.13% of the prescription needs to be monitored and 10 drug–drug interactions were under the risk category of “X.” The majority of the adverse drug reaction was moderately severe in nature and those were preventable. Conclusion Since pediatrics are vulnerable population, they must have a thorough surveillance system for adverse drug reaction and drug–drug interaction; thereby, a positive impact on the medication-use system and improved patient care can be achieved.

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Pattern, severity, and outcome of adverse drug reactions in a tertiary care hospital: an evidence from a cross-sectional study

Chhabra

Jangra

Rashid³

et al. 2021

Journal of Basic and Clinical Physiology and Pharmacology

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Objectives Study aim to describe the spontaneous reporting of the adverse drug reactions (ADRs) among the patients admitted to medicine department of a tertiary care hospital. Methods A prospective observational study was conducted over a period of four months at the medicine department. On the daily basis, all the patients aged >18 years admitted to the internal medicine department were followed and analyzed for occurrence of ADRs. Naranjo scale was used to determine causal relationship between the ADRs and suspected drugs. The nature of ADRs and its severity was assessed using the Hartwig scale. Results A total of 4,530 patients were screened for the ADRs, out of which 90 ADRs were developed in the 89 patients. The overall incidence of ADRs was found to be 1.96% in the studied population. The most common ADRs encountered during the study period were type A (augmented). The least number of ADRs were observed in the age group of 31–40 years. Furthermore, the more significant number of male patients suffered from a severe type of ADRs as compared to females. Sixteen ADRs were of the mucocutaneous type of reaction followed by dizziness in 12 cases. The higher number of patients recovering from the ADRs was in the age group 41–60 years. The outcomes of ADRs were not found to be statistically significant with gender and age groups. Conclusions There is a strong need to extend the monitoring and reporting of the ADRs to ensure the patient safety. However, the overall incidence of ADRs appeared to be less in our study, highlighting the need for strengthening reporting system of ADRs. The results indicate that elderly patients are at significant risk of developing ADRs.

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Pattern of adverse drug reactions in a regional pharmacovigilance center of a tertiary care teaching hospital

Cited by 3 publications

References 17 publications

Adverse Drug Reaction Monitoring of Anticancer Drugs in Hematology Department

Adverse Drug Reaction Monitoring of Anticancer Drugs in Hematology Department

Surveillance of adverse drug reactions and drug–drug interactions with pediatric oncology patients in a south Indian tertiary care hospital

Pattern, severity, and outcome of adverse drug reactions in a tertiary care hospital: an evidence from a cross-sectional study

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