scholarly journals A study on drug induced cutaneous adverse drug reactions at a tertiary care hospital, Mysore, India

2019 ◽  
Vol 8 (4) ◽  
pp. 777
Author(s):  
Kishore M. S. ◽  
Shashikala S. Konnur
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Tertiary Care ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Care Hospital ◽  
Drug Reactions ◽  
Drug Induced ◽  
Cross Sectional ◽  
Physician Visits

Background: Drugs, however safe and efficacious, are associated with risk of adverse reactions. Adverse Drug Reactions (ADRs) are one of the leading causes of morbidity and mortality. ADRs was rated as the fifth leading cause of death among all diseases. Consequences of ADRs range from diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of the study were to obtain information about drug induced cutaneous adverse reactions and to establish the causal relationship.Methods: Observational cross sectional study, a total of 76 patients were recruited for the study,conducted in dermatology outpatient department of K R Hospital Mysore Medical College And Research Institute Mysore for 3 months. The drug reactions were recorded in ADR form of Central Drugs Standard Control Organisation (CDSCO). Causality was assessed using Naranjo algorithm and World Health Organization- Uppsala monitoring centre (WHO-UMC) criteria.Results: 76 patients with CADRs were included in the study during the 3 months study period. Most common age group with CADRs was 20-30 years; with 55.73% of females 20.26% male and the most common suspected drug group causing CADRs was antimicrobial 35.46%. And most common lesion is maculopapular rashes. According to Naranjos scale 67.30% of CADRs were probably caused by drugs.Conclusions: variety of drugs causes CADRs. Awareness among clinicians is required for active reporting of CADRs. Patients need to be educated for the cautious use of drugs causing ADRs to prevent the same.

scholarly journals An observational study of adverse drug reactions reported in a rural tertiary care hospital

2019 ◽  
Vol 8 (11) ◽  
pp. 2367
Author(s):  
Ravi D. Mala ◽  
D. M. Ravichand ◽  
B. V. Patil ◽  
B. S. Payghan ◽  
Anurag Yadav
Keyword(s):  
Adverse Drug Reactions ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Unintended Effects ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Physician Visits ◽  
Medical College

Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.

scholarly journals Adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in south Karnataka: a prospective observational study

2019 ◽  
Vol 8 (12) ◽  
pp. 2635
Author(s):  
Sowmya M. S. ◽  
Basavanna P. L. ◽  
L. Raghavendra Gupta
Keyword(s):  
Observational Study ◽  
Adverse Drug Reactions ◽  
Cancer Chemotherapy ◽  
Prospective Observational Study ◽  
Adverse Reactions ◽  
Tertiary Care ◽  
Care Hospital ◽  
Chemotherapeutic Drugs ◽  
Drug Reactions ◽  
Active Monitoring

Background: Cancer is a multi-cellular disease which can arise from any cell type and organs. Adverse drug reactions (ADR) are undesirable consequence of cancer chemotherapeutic drugs. A great importance has to be given for their assessment, detection, monitoring, reporting and preventing these ADR for the beneficial effects of the patients. So the present study was undertaken for the purpose of detecting and quantifying those adverse reactions which is of some importance in therapeutic setting.Methods: A prospective observational study conducted in chemotherapy ward, male and female patients of any age receiving cancer chemotherapy and presenting with ADR’s in duration of 3 months.Results: 160 patients were observed. Out of 160 patients 123 presented with ADR’s. Most common ADR’s were loss of appetite (67.6), diarrhea (61.8%), vomiting (21.5%), nausea (17.7%), anemia (24.7%). Cisplatin, paclitaxel, oxaliplatin, doxorubicin, gefitinib are common drugs causing ADR’s.Conclusions: Cancer chemotherapeutic drugs are associated with various adverse reactions. This study shows the importance of active monitoring of these reactions and measures to prevent their effects early in the treatment of cancer.

scholarly journals An analysis of the pattern and profile of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective record based observational study

2018 ◽  
Vol 7 (9) ◽  
pp. 1715
Author(s):  
Abdul Aslam P. ◽  
Sangeetha Purushothaman ◽  
Jihana Shajahan
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Important Concern ◽  
Post Marketing ◽  
The Individual ◽  
Prolonged Hospital ◽  
Sectional Analysis

Background: Adverse drug reactions (ADRs) are an important concern in modern therapeutics. Due to limitations in identifying ADRs during research phase, organized post marketing studies are essential. However, there are only few recent studies on this subject available in India. Hence this study was done in a tertiary care hospital in South Kerala to evaluate the profile and causality of ADRs.Methods: The details of patients who developed ADRs during the period from October 2016 to November 2017 were collected. Data collection was done using the suspected drug reactions monitoring form by CDSCO used under PvPI and a retrospective observational cross-sectional analysis was done. The profile and causality of ADRs were evaluated.Results: The total number of ADR events reported was 300. 179 ADRs were hypersensitivity reactions (Aronson Type B) and the remaining 121 reactions were Type A reactions. The individual drug class causing majority of the ADRs was antibiotics (36%). Commonest significant dose related ADR was bleeding (7%) caused by combined use of antiplatelets and anticoagulants. The organ system most affected as per SOC classification was skin and appendages (56%). Causality assessment revealed that majority (76%) belonged to “probable” category, whereas 23.6% were of “possible” type.Conclusions: The development of ADRs can significantly affect treatment course – interruption of drug therapy, use of additional drugs and prolonged hospital stay. Employing monitors dedicated to ADR detection and education of prescribers to closely monitor patients can help manage ADRs effectively.

scholarly journals Knowledge, attitude and practice towards adverse drug reactions reporting in post graduate students of a tertiary care hospital

2019 ◽  
Vol 8 (6) ◽  
pp. 1320
Author(s):  
Aparna S. Chincholkar ◽  
Alisha Naik
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Microsoft Excel ◽  
Cross Sectional ◽  
Adr Reporting ◽  
Microsoft Office ◽  
Knowledge Attitude And Practice

Background: Adverse Drug Reactions (ADRs) are a major cause of morbidity and mortality. Under reporting of ADRs by health care professionals is a very common problem worldwide. So, the present study was planned to assess the knowledge, attitude and practices of postgraduate (PG) students towards ADR reporting and suggest possible ways for improvement.Methods: It was a cross sectional questionnaire-based study conducted among 44 PG students using a questionnaire with questions on knowledge (21), attitude (13) and practices (15) of ADR reporting. The questionnaire was analyzed question wise and the percentage was calculated using Microsoft Excel spreadsheet in Microsoft Office 2010 software.Results: Most of them were aware of the term pharmacovigilance (PV) (95.45%). 54.55% agreed to be trained on how to report an ADR. 88.63% knew about the existence of pharmacovigilance committee in the institute.93% of participants knew that Central Drug Standard Control Organization (CDSCO) is responsible for monitoring of ADRs. 56.82% were aware about VIGIBASE an online software to report ADR. 81.82% of participants had agreed to witness ADRs in patients but only 38.64% reported them. The main reason behind it was non – availability of ADR forms. 42.55% opine that mobile based app would be the most preferred method to send ADR information to an ADR reporting center.Conclusions: There exists a huge gap between ADR experienced and ADR reported by PG students. Participants agreed upon necessity of reporting ADR and periodic briefing about PV.

scholarly journals Evaluation of adverse drug reactions of anti-tubercular drugs in the treatment of tuberculosis in tertiary care hospital

2020 ◽  
Vol 9 (9) ◽  
pp. 1430
Author(s):  
Krishnakanth K. ◽  
Jagadeesh A. ◽  
Swetha T. D.
Keyword(s):  
Adverse Drug Reaction ◽  
Adverse Drug Reactions ◽  
Adverse Drug Events ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Medicine Department ◽  
Study Results

Background: Adverse drug reactions are very common among patients on anti-tubercular treatment. Hence, the current study was done to evaluate the adverse drug reaction (ADR) profile in patients receiving anti-tubercular treatment (ATT).Methods: A 6 months prospective, cross-sectional observational study was performed in collaboration with Pulmonology Medicine department. WHO-UMC scale and Naranjo scale was used to evaluate the ADRs.Results: Ninety-two patients receiving ATT presented with 113 adverse drug events (ADE). Males were more affected than females. DOTS category-1 regimen was mostly responsible for ADE. Addition of drugs for the management of ADR events was done.Conclusions: The study results show more ADRs related to ATT demanding increased collaboration between NTEP 2020 and Pharmacovigilance Programme of India to enhance drug safety in this field.

PATTERN OF SUSPECTED ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL – A CROSS-SECTIONAL STUDY

2021 ◽  
pp. 51-53
Author(s):  
LIMA KORUTHARA MOHANAN ◽  
DHANYA THIROOKARAN HARICHANDRAN ◽  
SANALKUMAR KB
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Antineoplastic Drugs ◽  
Care Hospital ◽  
Sectional Study ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Suspected Adverse Drug Reactions

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.

scholarly journals ANALYSIS OF THE ADVERSE DRUG REACTIONS COLLECTED THROUGH ACTIVE SURVEILLANCE IN THE PHARMACOVIGILANCE UNIT OF A TERTIARY CARE HOSPITAL

2018 ◽  
Vol 11 (8) ◽  
pp. 383
Author(s):  
Anand M Ingale ◽  
Pratibha Nadig ◽  
Ananya Chakraborty
Keyword(s):  
Active Surveillance ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Organ System ◽  
Research Centre ◽  
Care Hospital ◽  
Drug Reactions ◽  
Comorbid Conditions ◽  
Medical Sciences ◽  
Cross Sectional

Objectives: The objectives of the study were to analyze the various adverse drug reactions (ADRs) collected in the Pharmacovigilance Unit of Vydehi Institute of Medical Sciences and Research Centre with respect to their causality, severity, and preventability and also to identify the various risk factors, concomitant medications, and comorbid conditions with the occurrence of these events.Methods: A prospective, non-interventional, observational, and cross-sectional study was carried out in the various clinical departments of Vydehi Institute of Medical Sciences and Research Centre from June 2014 to May 2015. The Classes of drugs, Organ system involved, Comorbid conditions associated and Concomitant drugs involved in causing ADRs were looked into. The assessment for causality and severity was determined by Naranjo and Modified Hartwig and Siegel scales, respectively. The data were compiled and subjected to descriptive statistical analysis.Results: A total of 433 patients developing ADR reports were analyzed during our study period. Of these, 53.59% were females. 75% of them were of adult age group. Antimicrobials and chemotherapy group showed the maximum ADRs. The skin and appendages (27.6%) were the most affected organ system followed by the gastrointestinal system (22.8%). Comorbid conditions were found in 76 (20.1%) reports; of which diabetes (28.9%) and hypertension (26.3%) were maximum. 74 were serious reports. Maximum reports were probable and of mild severity.Conclusion: Through active surveillance of the ADRs helps in early detection and prevention of all the possible adverse events associated with the usage of drugs and thereby provides a better health-care treatment to the patients. 

scholarly journals A PROSPECTIVE STUDY OF ADVERSE DRUG REACTIONS DUE TO PLATINUM ANALOGS - CHEMOTHERAPY IN A TERTIARY CARE HOSPITAL

2018 ◽  
Vol 11 (6) ◽  
pp. 215
Author(s):  
Sumit Kumar ◽  
Badruddeen Badruddeen ◽  
Singh S P ◽  
Mohammad Irfan Khan
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
World Health ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical College ◽  
Health Organization ◽  
A Prospective Study ◽  
Platinum Analogs

Objective: The objective of this study was to analyze the types of adverse drug reactions (ADRs) associated with platinum analogs (cisplatin, carboplatin and oxaliplatin) used for cancer chemotherapy in a tertiary care hospital and determine their causal relationship with the offending drug.Methods: This prospective, observational, non-interventional study was conducted in a tertiary care hospital at GSVM Medical College Kanpur, India, for 4 months. Patients of all age and either sex were included in the study. ADRs were reported by the physicians of oncology department of the hospital and ADRs were assessed for different parameters -causality, outcome, and seriousness of ADR as per the World Health Organization (WHO), type of ADRs as per expanded Rawlins and Thompson’s classification, predictability using council for international organization of medical sciences guidelines and severity using modified Hartwig’s scale. Descriptive statistics were used for data analysis.Results: A total of 140 ADRs were reported from platinum analogs following treatment of different types of cancer in hospital. The burden of ADRs in each patient was 2.41. Most of the ADRs were observed in the age group of 40–60 years. Vomiting (27 ADRs) was commonly reported reaction. Among platinum analogs, cisplatin leads to 82 ADRs (58.57%) followed by carboplatin with 53 ADRs (37.86%) and least with oxaliplatin 5 ADRs (3.57%). Most of the ADRs on causality assessment were possible (104, 74.29%) and probable (36, 25.71%) in nature. Type -A ADRs account for 4/5th of the total reported ADRs, followed by Type-B and C. Severity of 90.71% ADRs was found to be mild followed by moderate, with no case of severe and serious nature. Nearly, most of the ADRs were of predictable type (97.14%).Conclusion: The potential of platinum analogs to cause ADRs is high; thus, the need of effective ADRs monitoring is highly emphasized.

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