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 PATTERN OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL: A CROSS-SECTIONAL STUDY

2017 ◽  
Vol 10 (3) ◽  
pp. 170 ◽  
Author(s):  
Sangeetha Raja ◽  
Jamuna Rani R ◽  
Kala P
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching

ABSTRACTObjective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining InstitutionalEthics Committee approval.Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRswere due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo’sprobability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig’s criteria forseverity assessment.Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.

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 Dermatological adverse drug reactions in tertiary care hospital: an analysis of causality and severity

2018 ◽  
Vol 7 (8) ◽  
pp. 1620
Author(s):  
Kalpana R. Bharani ◽  
Nitibhushansingh R. Chandel ◽  
Chhaya A. Goyal
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Age Distribution ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Age Group ◽  
Drug Reactions ◽  
Morphological Pattern ◽  
Cross Sectional ◽  
Moderate Severity

Background: Dermatological adverse drug reactions (ADRs) are easily detected by patients and that precludes further usage of drugs. So, decided to study the pattern, causative drugs, severity of adverse drug reactions and their causality in tertiary care hospital.Methods: It was prospective non inventional cross sectional study. Patients attending OPD or admitted to IPD of all age group and both gender with suspected dermatological ADRs following drug intake were included and the ADRS were recorded on CDSCO’s Pharmacovigilance form. Collected data was analyzed for assessment of causality using WHO-UMC scale, for severity by using Modified Hartwig and Siegel. Morphological pattern, drug groups, gender and age distribution was analyzed.Results: 231 dermatological ADRs were recorded and analyzed. Maximum cases were found in 21-30 years age group (74 cases). Dermatological ADRs were found in 143 females and in 88 males. Three major classes of drugs found responsible for causing dermatological ADRs were -oral Antimicrobials-41 (17.75%) and Injectable Antimicrobials-40 (17.32%), NSAID's-40 (17.32%.) and Topical Betnovate-36 (15.58%.). Regarding the type, 95 cases were of maculopapular rashes (41.12%), steroid damaged face in 42 (18.18%) andacute urticaria in 20 (8.65%). In terms of Severity assessment, authors found 23 cases (9.95%) as Mild, 176 cases (76.19%) of moderate severity and 32 cases (13.85%) of Severe category. In terms of causality assessment: 3 cases as Certain, 68 cases as Probable and 160 cases as Possible.Conclusions: From this study, it was found maximum Dermatological ADRs of moderate severity and few cases of causality category as “Certain”.

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

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.

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

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.

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.

SOCIODEMOGRAPHIC AND ANTHROPOMETRIC PROFILE OF DIABETIC PATIENTS ATTENDING IN A DIABETIC CLINIC IN A TERTIARY MEDICAL COLLEGE AND HOSPITAL, WEST BENGAL

2021 ◽  
pp. 12-15
Author(s):  
Smarajit Banik ◽  
Sandip Saha ◽  
Sudipan Mitra ◽  
Ujjwal Pattanayak ◽  
Rajib Sikder ◽  
...  
Keyword(s):  
West Bengal ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Diabetic Patients ◽  
Care Hospital ◽  
Diabetes Clinic ◽  
Cross Sectional ◽  
Medical College ◽  
Study Participants

Background: Diabetes mellitus is one of the important causes of morbidity and mortality. With a rise in non communicable diseases in India, diabetes has become a modern epidemic showing a rising trend in West Bengal also. A large number of diabetes patients come to the diabetes clinic of our tertiary care hospital in North Bengal Medical College and Hospital, Darjeeling, West Bengal. The large proportion of patients presenting with this condition prompted us to study the Sociodemographic and Anthropometric Prole of such patients. Methods: This was a descriptive hospital based cross sectional study involving a total of 344 diabetic patients enrolled in the diabetes clinic of a tertiary care teaching hospital from December 2019 to February 2020. A self-administered questionnaire was used to collect data and was analyzed in Microsoft excel sheet and using SPSS 20.0 software. Results: Among the 344 study participants, we found that 220 (63.95%) were males and 124 (36.05%) were females. Diabetes was more common among those aged 51-60 years 108 (31.40%). Family history was present among 188 (54.65%) of the diabetic patients. Almost 160 (46.51%) patients have diabetes 1.1 – 5 years. Hypertension was present among 216 (62.79%) patients. Almost 218 (63.37%) of the patients were overweight and 84 (24.42%) were obese. Conclusions: The diabetic patients presenting to this tertiary care hospital belong lower socioeconomic strata and having limited education in their age group. There is high proportion of obesity and hypertension among them.

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