Cross-sectional study regarding pattern of adverse drug reactions in a tertiary care hospital, Kakinada, India

Objective: The objective of the study was to study the pattern of suspected adverse drug reactions (ADRs) in a tertiary care hospital. Methods: This is a cross-sectional study conducted in the Department of Pharmacology of a Tertiary Care Teaching Hospital, Kerala. As part of pharmacovigilance activities, the ADRs were collected in Central Drug Standard Control Organization Suspected ADR reporting form from various departments during a period of 3 months and recorded in Pharmacovigilance register maintained by the pharmacology department. As part of our study, we collected the details such as patient’s initials, age, gender, reporting department of hospital, description of the ADR, duration of the reaction, name of suspected ADRs, and outcome from the Pharmacovigilance register. Descriptive statistics will be used for data analysis by statistical package for the social science for windows 16. Results: Two hundred and twenty-two ADR from 141 patients obtained during a period of 3 months. The maximum ADR reports were in age group more than 50 years of age. The skin and appendages were most affected followed by gastrointestinal tract. Antineoplastic drugs accounted for 59.7% of drug class suspected for ADRs followed by use of more than one drug (14.1%). Among antineoplastic drugs, cyclophosphamide and carboplatin accounted for majority causes of ADR. The antibiotics accounted for 12.7% of all drugs. Among the antibiotics penicillin and cephalosporins caused most of the ADRs. Conclusion: The maximum number of ADR reported in our study was with the use of antineoplastic drugs and most common ADR reported was alopecia.

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A cross-sectional study of surveillance of adverse drug reactions in inpatient departments of a tertiary care hospital

Journal of Basic and Clinical Physiology and Pharmacology ◽

10.1515/jbcpp-2012-0077 ◽

2014 ◽

Vol 25 (1) ◽

Author(s):

Ambili Remesh ◽

Aswathy Balan ◽

Angela Gnanadurai

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Cross Sectional Study ◽

Care Hospital ◽

Sectional Study ◽

Drug Reactions ◽

Cross Sectional

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Analysis of adverse drug reactions encountered in a tertiary care hospital: a cross sectional study

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20182100 ◽

2018 ◽

Vol 7 (6) ◽

pp. 1164

Author(s):

Syed Hussain F. ◽

Sathyanarayanan V. ◽

Jamuna Rani R.

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Cross Sectional Study ◽

Assessment Scale ◽

Care Hospital ◽

Sectional Study ◽

Drug Reactions ◽

Cross Sectional ◽

Organ Systems

Background: Adverse drug reactions are due to hazards of drug therapy and can occur with any class of drugs. The aim of this study was to evaluate and record adverse drug reactions reported from various departments of a tertiary care hospital.Methods: A Cross Sectional study conducted in a tertiary care hospital for a period of 4 months from March to June 2017 after Institutional Ethics Committee approval. ADRs reports collected and analyzed for causality, severity and preventability by international standardized scales.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%). Most commonly affected organ systems were skin (45%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). According to Naranjo’s causality assessment scale 74% of reactions were probable, 26% were possible, Modified Hartwig and Seigel severity assessment scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe, Modified Schumock and Thorton Preventability assessment scale which revealed 61% ADRs were not preventable, 32% were probably preventable,7% were definitively preventable.Conclusions: Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. The health system should promote the spontaneous reporting of ADR’s. The proper documentation and periodic reporting to Pharmacovigilance Centres is required to ensure drug safety.

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ADVERSE DRUG REACTIONS IN PEDIATRIC PATIENTS IN A TERTIARY CARE HOSPITAL IN KOLLAM

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2021.v14i4.40453 ◽

2021 ◽

pp. 113-115

Author(s):

REEJA R ◽

BEENA JS ◽

AJITHKRISHNAN AS ◽

BINDULATHA NAIR R

Keyword(s):

Adverse Drug Reactions ◽

Pediatric Patients ◽

Tertiary Care ◽

Cross Sectional Study ◽

Care Hospital ◽

Sectional Study ◽

Drug Reactions ◽

Local Data ◽

Cross Sectional ◽

Dosing Regimens

Objective: Adverse drug reactions have not been as thoroughly studied in children as they have in adults. Extrapolation of efficacy, dosing regimens, and ADRs from adult data are inappropriate owing to developmental changes in physiology and drug handling. There is a lack of local data regarding the potential risk of ADRs in pediatric patients. Objective of this study is to identify the adverse drug reaction (ADR) profile in pediatric patients. Methods: In this cross-sectional study, 450 children attending the pediatric inpatient and outpatient department were selected, and the CDSCO reporting form for suspected ADR reporting forms was collected from those who had any adverse events by the consulting pediatrician. Later, this form was analyzed for the details for ADRs and assessed for causality, severity, and preventability using Naranjo’s algorithm, Hartwig and Siegel scale, and modified Schumock and Thornton scale of adverse drug reactions. Results: The cross-sectional study revealed a prevalence of 12.89%. Antibiotics caused more ADRs than any other group of drugs. Dermatological ADRs were the most common. Most ADRs were not preventable and were of moderate severity. The causality assessment showed that most ADRs were possible category. Conclusion: The ADRs are often unrecognized. We need more strict monitoring for early detection, treatment, and more importantly prevention of these events in the future. For that, more awareness programs, CMEs and teamwork are extremely important among the caregivers.

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