Evaluation of Suspected Adverse Drug Reactions of Oral Anti-diabetic Drugs in a Tertiary Care Hospital for Type II Diabetes Mellitus

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 COMPARISON OF CAUSALITY ASSESSMENT TOOLS FOR SUSPECTED ADVERSE DRUG REACTIONS IN HOSPITALIZED PATIENTS AT A TERTIARY CARE HOSPITAL

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2020.v13i7.38067 ◽

2020 ◽

pp. 176-181

Author(s):

PARIKH CD ◽

DESAI CK ◽

KAPADIA JD ◽

SHAH MK

Keyword(s):

Adverse Drug Reactions ◽

Causality Assessment ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Hospitalized Patients ◽

Assessment Tools ◽

Care Hospital ◽

Drug Reactions ◽

Substantial Agreement ◽

Suspected Adverse Drug Reactions

Objective: The objective of the study was to compare six causality assessment (CA) tools for suspected adverse drug reactions (ADRs) reported in hospitalized patients at a tertiary care hospital in India. Methods: Intensive ADR monitoring was performed in indoor patients of two randomly selected medicine units. A detailed case report of each suspected ADR (n=120) was provided to six independent experts for CA using either visual analog scale (VAS) or WHO-UMC scale. Investigator assessed causality using Naranjo’s scale, Koh et al. scale, the French method, and Karch and Lasagna scale. Similar causality categories from these scales were coded for correlation. Agreement among experts and that between various CA tools were analyzed using Cohen’s kappa and Fleiss kappa. Reasons for disagreements among different scales were evaluated. Results: A variation was observed in the total number of drugs suspected to cause ADR by experts and investigator. “Likely” and “Plausible” causality were suggested frequently by experts using VAS whereas “Possible” causal association was frequent according to experts using the WHO-UMC scale and also by the investigator using algorithms except Koh et al. scale. None to the slight agreement was observed among experts who used VAS (k=0.117), whereas a substantial agreement was observed among experts using the WHO-UMC scale (k=0.707). A substantial agreement was observed between Karch and Lasagna scale and the French method (k=0.740). Both scales demonstrated moderate agreement with Naranjo’s scale. Disagreement among the WHO-UMC scale, the French method, and Karch and Lasagna scale were associated with polypharmacy, serious ADRs, non-availability of laboratory data, and skin and subcutaneous tissue ADRs. Conclusion: A higher inter-rater agreement with the WHO-UMC scale suggests its utility for CA of suspected ADRs in indoor patients. The French method and Karch and Lasagna scale can be used for CA in hospitalized patients as an adjunct to Naranjo’s scale. Factors associated with disagreement should be considered at the time of reporting ADRs and evaluating causality.

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A STUDY ON INFECTIOUS DISEASE BURDEN AND ASSESSMENT OF ADVERSE DRUG REACTIONS AMONG TYPE- II DIABETES MELLITUS SUBJECTS

Journal of Biomedical and Pharmaceutical Research ◽

10.32553/jbpr.v8i3.596 ◽

2019 ◽

Vol 8 (3) ◽

Author(s):

Adarsh Mathew ◽

Bharathi DR ◽

Abubaker Siddiq ◽

Akza K Alex ◽

Tejaswini S M

Keyword(s):

Quality Of Life ◽

Diabetes Mellitus ◽

Infectious Disease ◽

Infectious Diseases ◽

Adverse Drug Reactions ◽

Type Ii Diabetes ◽

Type Ii Diabetes Mellitus ◽

Type Ii ◽

Drug Reactions

Introduction: People with diabetes are more prone to development of infections. Elevated blood sugar levels enervate the patient’s immune system and make the patient vulnerable to infections.Assessing the prescription patterns assure quality medical care by providing feedback to the prescribers. Objectives: To assess the prevalence and the prescription pattern of antibiotics in infections associated with type II diabetes mellitus along with their quality of life. To assess the Adverse Drug Reactions associated with treatment of type-II diabetes mellitus. Materials and Methods: This prospective observational study was conducted in the General Medicine Department of Basaveshwara Medical College Hospital and Research Centre, Chitradurga for a period of 10 months. Results: In this study, a total of 300 diabetic subjects were included, out of which, 192 subjects were having infectious diseases. This study reveals association between infection and diabetes with a prevalence rate of 64%. The most commonly prescribed antibiotic was found to be ceftriaxone. The quality of life of the diabetic subjects associated with infections was found to be displeasing when assessed with a validated questionnaire. Conclusion: The study shows a higher rate of prevalence of infectious disease among diabetic subjects. It is suggested to conduct more studies on this topic. Keywords: Diabetes mellitus; Infectious diseases; Adverse drug reactions; Burden of disease.

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Frequency of Dyslipidemia in Patients with Type-II Diabetes Mellitus

10.53350/pjmhs211582243 ◽

2021 ◽

Vol 15 (8) ◽

pp. 2243-2245

Author(s):

Bilal Rafique Malik ◽

Aneeqa Ilyas ◽

Rehan Anwar

Keyword(s):

Diabetes Mellitus ◽

Lipid Profile ◽

Type Ii Diabetes ◽

Tertiary Care ◽

Type Ii Diabetes Mellitus ◽

Diabetic Patients ◽

Care Hospital ◽

Type Ii ◽

Pathology Laboratory ◽

The Mean

Introduction: Dyslipidemia is one of the major risk factors for cardiovascular disease in diabetes mellitus. Early detection and treatment of dyslipidemia in type-2 diabetes mellitus can prevent risk for atherogenic cardiovascular disorder. Objective: To determine the frequency of dyslipidemia in patients with type II diabetes mellitus presenting in a tertiary care hospital for routine check-up Materials and Methods Study design: Cross sectional study Setting: Department of Medicine (South Medical Ward), Mayo Hospital, Lahore Duration: Six months i.e. 1st July 2020 to 31st December 2020. Data collection procedure: Total 220 patients fulfilling selection criteria were enrolled in the study. Then blood samples were obtained and sent to the pathology laboratory of the hospital for assessment of lipid profile. Reports were assessed and level of cholesterol and triglycerides were noted and dyslipidemia was labeled, if levels were high. All this data was recorded in proforma. Results: In this study, the mean age of patients in this study was 52.71 ± 7.46 years. There were 104 (47.3%) males and 116 (52.7%) females. There were 92 (41.8%) patients of normal BMI, 72 (32.7%) patients were overweight and 56 (25.5%) patients were obese. The mean duration of diabetes was 18.30 ± 3.92 months. Dyslipidemia was diagnosed in 97 (44.09%) patients. Conclusion: Results of this study showed high frequency of dyslipidemia among diabetic patients. Key words: Dyslipidemia, Type II, Diabetes mellitus, Lipid profile

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