EVALUATION OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE CENTER IN SOUTH INDIA-A PROSPECTIVE OBSERVATIONAL STUDY

2021 ◽  
pp. 1-3
Author(s):  
Laila KV ◽  
Fathima Habeeba TE ◽  
Mohamed Musthafa A ◽  
Jobin Louis ◽  
Madeeha Habeebulla ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Prospective Observational Study ◽  
Spontaneous Reporting ◽  
Drug Class ◽  
Care Center ◽  
Tertiary Care ◽  
Drug Reactions ◽  
Tertiary Care Centre ◽  
Males And Females ◽  
Reporting Method

Aim:To Evaluate the Adverse Drug Reactions among patients attending a tertiary care centre. Materials and Methods: Aprospective spontaneous reporting method of Adverse Drug Reaction (ADR) in hospitalised setting was conducted for a period of six months. Results: The study came across with the demography of patients, the most commonly involved classes of drugs and assessment of ADRs. The results showed that 136 adverse drug reactions were reported from a total of 11584 patients and the overall incidence of ADR calculated from patient population was 0.81%. No signicant difference was seen in overall incidence of ADRs observed in males and females. Incidence of ADRs among adults (1.15%) was signicantly higher than paediatrics and geriatrics. Antibiotics (39.71%) were the drug class most commonly associated with ADRs. Causality assessment states that majority of the reported ADRs were probable according to WHO-UMC criteria. According to the severity assessment majority of the ADRs were mild in nature. Most of the ADRs were not preventable (76.47%) according to Schumock and Thornton preventability scale. Conclusion: ADR monitoring was found to be useful to measure the effectiveness and safe use of medication.

scholarly journals STUDY TO EVALUATE SEVERE ADRS IN A TERTIARY CARE TEACHING HOSPITAL

2017 ◽  
pp. 55-58
Author(s):  
A. R. Malahat ◽  
C. Deepa Latha ◽  
Sudhakar K. ◽  
Deepika Baloju ◽  
G. Vijayalakshmi
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Prospective Observational Study ◽  
Healthcare Professionals ◽  
Tertiary Care ◽  
Care Centre ◽  
Drug Reactions ◽  
Tertiary Care Centre ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching

Objective: This study attempts to analyze the severe ADRs in a tertiary care centre and assess their seriousness, outcome, causality and severity. We emphasize on the need for reporting of ADRs by all healthcare professionals as it will reduce the burden of morbidity due to drugs and ensure better and more efficient healthcare. To analyse and evaluate the severe ADVERSE DRUG REACTIONs reported from various departments in a Tertiary care Teaching hospital.Methods: It is a prospective observational study that was carried out over a period of 6 mo (from July 2016 to December 2016) to assess the percentage of severe adverse drug reactions reported to the Pharmacovigilance cell of a tertiary care teaching hospital. The data collected included patient’s demographic details, presenting complaints, clinical diagnosis and details of the drug(s) prescribed. The data was analysed for causality (as per the WHO-UMC scale) and severity (as per Hartwig and Siegel scale).Results: Out of 64 ADRs reported, 17 were serious. The majority of serious ADRs were categorized as probable (82.35%), whilst 1(5.8%) was categorized as possible and 2(11.76%) as certain in nature. The criteria for the majority of serious ADRs were hospitalization (%) followed by intervention to prevent permanent impairment or damage (%).Conclusion: The highest percentage of severe cases was reported with Antitubercular therapy (23.5%) followed by analgesics (23%) and anti epileptic agents (17.6%).

scholarly journals A retrospective study of Adverse Drug Reactions in a tertiary care centre

2018 ◽  
Vol 7 (7) ◽  
pp. 1339
Author(s):  
V. J. Ambika Abhishake ◽  
S. Basalingappa ◽  
Arun Gopi ◽  
More Pankaj Daulat
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Unintended Effects ◽  
Age Group ◽  
Test Results ◽  
Drug Reactions ◽  
Tertiary Care Centre ◽  
Common System ◽  
Males And Females

Background: Adverse drug reactions (ADRs) are a major concern in present day clinical practice. They are inevitable consequences of drug therapy; as no pharmacotherapeutic agent is completely free from noxious and unintended effects. They are major contributors for morbidity, mortality and hospitalization of the patients increasing the economic burden on the society and uncertainty in clinical outcomes.Methods: This was a retrospective observational study, extending over 6 months (September 2016 to February 2017). A total of 290 cases were studied, excluding the geriatric age group. The data was collected using CDSCO ADR reporting form. A comparison of ADR between males and females was made; based on the organ system affected and the category of drug using “proportion test”.Results: The study showed the ADR incidence was equal in both sexes (≈50%). It was observed that majority ADRs were from gastro intestinal system (39%) followed by CNS (20%) and skin and soft tissue (14%). Constipation was found to be the most common of the reported ADRs (18%) followed by vomiting (9%) and diarrhoea (8%).Conclusions: ADRs are a major cause of morbidity worldwide. Several studies; including the present one, has shown GIT to be the most common system affected. Frequency of ADRs can be reduced by careful follow up and a robust hospital based pharmacovigilance setup.

scholarly journals A retrospective study to evaluate the pattern of spontaneously reported antiretroviral induced adverse drug reactions in a tertiary care hospital

2018 ◽  
Vol 7 (5) ◽  
pp. 828
Author(s):  
Swati V. Patil ◽  
Sudhir R. Pawar
Keyword(s):  
Retrospective Study ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Event Monitoring ◽  
Drug Induced ◽  
Reporting Method

Background: To evaluate the adverse effect profile of spontaneously reported cases of adverse drug reactions due to antiretroviral (ART) drugs in a tertiary care teaching hospital.Methods: A descriptive retrospective study of pattern of ART induced adverse drug reactions (ADRs) spontaneously reported to the Pharmacology department at a tertiary care hospital from January 2011 to December 2016. The details of suspected ADRs including drugs involved, treatment given for ADRs, and the outcome were also documented. These ADRs were analyzed for causality (WHO scale), severity (Hartwig et al. scale), seriousness (ICH E 2A guidelines), preventability (Schumock and Thornton scale) and type based on Edwards and Aronson classification system.Results: Of the 75 cases of ART induced ADRs, reactions were slightly more common in males (52%) and had median age and duration of ART as 36 years and 109 days respectively. Drug induced anemia was the most common presentation followed by cutaneous ADR and zidovudine being the commonest offender. Severity was moderate in 85.3% and causality was probable in 16% and possible in 84% cases. The type reaction was augmented type in 41.3% and not preventable in 76%.Conclusions: Zidovudine is the commonest drug implicated in causing anemia amongst the antiretrovirals. Spontaneous reporting method for antiretroviral pharmacovigilance is insufficient. Targeted spontaneous reporting or cohort event monitoring need to be studied for antiretroviral pharmacovigilance.

scholarly journals Spectrum of adverse drug reactions and implicated drugs in a tertiary care centre: a prospective study

2018 ◽  
Vol 7 (7) ◽  
pp. 1345
Author(s):  
Kabilan K. ◽  
Sathyanarayanan V. ◽  
R. Jammuna Rani
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Type A ◽  
Drug Reactions ◽  
Male Predominance ◽  
Organ Systems ◽  
A Prospective Study

Background: Adverse Drug Reaction(ADR) is the major limitation in providing health care to patients at a global level. It affects patient’s recovery and is an important cause of mortality and morbidity in both hospitalized and ambulatory patients. ADR can occur with any class of drugs. Early detection and evaluation of ADR is essential to reduce harm to the patients. Thus, the present study was aimed to estimate the number of ADR’s reported, analyze its spectrum and the drugs attributed to it.Methods: This was a prospective study conducted in a tertiary care teaching hospital for a period of 3 months from March 2016 to May 2016 in SRM Medical College and Hospital, Potheri. Adverse drug reactions were collected by spontaneous reporting by active and passive methods. The causality assessment of the reported ADR’s was done using Naranjo causality assessment scale.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%) followed by Surgery (16%) and OG (16%) departments. Most commonly affected organ systems were skin (45%) followed by GIT (24%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). Most of the reactions were type A (68%) rather than type B (32%) and thus predictable. According to Naranjo’s causality assessment, 63% of reactions were probable, 26% were possible and 11% were definite. No reactions were unlikely. Severity assessment by Modified Hartwig and Seigel scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe and life threatening.Conclusions: The study concluded that 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. As majority of ADR is predictable (Type A), so preventable. The health system should promote the spontaneous reporting of Adverse Drug Reactions (May be done mandatory). The proper documentation and periodic reporting to regional pharmacovigilance centres to ensure drug safety.

scholarly journals STUDY TO EVALUATE USE OF IRRATIONAL FIXED DRUG COMBINATIONS

2017 ◽  
pp. 64-66
Author(s):  
Sudhakar K. ◽  
C. Deepa Latha ◽  
Deepika Baloju ◽  
A. R. Malahat ◽  
G. Vijayalakshmi
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Workers ◽  
Prospective Observational Study ◽  
Adverse Drug Reaction Reporting ◽  
Tertiary Care ◽  
Drug Combinations ◽  
Drug Reactions ◽  
Care Workers ◽  
Fixed Drug ◽  
Awareness Programs

Objective: To identify fixed drug combinations causing the adverse drug reactions both rational and irrational.Methods: A prospective observational study was carried out over a period of 6 mo (between June 2016 to December 2016) to evaluate adverse drug reactions related to fixed drug combinations in a tertiary care teaching hospital using suspected adverse drug reaction reporting form.Results: A total number of 64 adverse drug reactions were reported during this period. Of the total adverse drug reactions reported, 27 (42%) were due to fixed drug combinations. 6 (28.5%) were serious and 21(71.5%) were non-serious. Causality was certain in 4 (14.8%) cases and probably in remaining 23 (85.2%) cases. 19(70%) irrational fixed drug combinations were reported.Conclusion: The above results show that irrational fixed drug combinations contribute major extent to adverse drug reactions. Hence, awareness programs should be conducted for all the health care workers to improve the rationality of prescription and to decrease adverse drug reactions.

scholarly journals Pattern of adverse drug reactions due to antibiotics in a tertiary care hospital

2017 ◽  
Vol 6 (8) ◽  
pp. 2027
Author(s):  
Suchitra D. Akalu ◽  
Niveditha G. Belavadi
Keyword(s):  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Tertiary Care ◽  
Length Of Hospital Stay ◽  
Antibiotic Use ◽  
Care Hospital ◽  
Glycopeptide Antibiotics ◽  
Drug Reactions ◽  
Beta Lactam ◽  
Antibiotic Drug

Background: Adverse reactions are known to occur with all classes of drugs and the incidence of adverse drug reactions (ADRs) due to antibiotics has increased with rise in infectious diseases contributing significantly to the increased health care costs.Methods: This retrospective observational study analysed the ADRs due to antibiotics that were reported by spontaneous reporting to ADR monitoring centre (AMC), functioning from Department of Pharmacology, ESIC-MC and PGIMSR. The total study period was 48 months from January 2013 to December 2016. During this period, all the ADRs due to antibiotics reported to the AMC were included in the study. This study analysed the retrospective data to find out the pattern of adverse drug reactions due to antibiotic drug class. Causality, severity and preventability were assessed using standard scales.Results: During the study period, a total of 228 ADRs due to antibiotic use were reported among 179 patients. Gender-wise distribution showed that males were slightly more affected than females by the ADRs due to antibiotics [93(52%) Vs. 86 (48%)]. Out of the total 179 antibiotics administered to the patients, beta-lactam antibiotics dominated followed by nitroimidazoles, quinolones and glycopeptide antibiotics in causing ADRs. Rashes and itching were most common ADRs followed by breathlessness and hypotensive episodes. Causality was assessed by Naranjo algorithm scale and causality was definite in 16 (7%), probable in 87 (38%) and possible in 125 (55%). Severity of the ADRs was assessed by Hartwig and Siegel scale and it was found that most of the ADRs 198 (87%) were of mild severity and 30 (13%) were of moderate severity and none of them were severe or lethal. Preventability was assessed by Schumock and Thornton scale and it was found that only 24 (11%) were preventable, 74 (32%) were probably preventable and 130 (57%) were not preventable.Conclusions: The study concluded that ADRs due to antibiotics are common and few of them resulted in increased healthcare cost due to the need for some interventions and increased length of hospital stay. The health system should promote the spontaneous reporting of ADRs due to antibiotics, proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety.

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 Collection and analysis of adverse drug reactions of antiretroviral therapy in a tertiary care hospital in central India

2018 ◽  
Vol 7 (7) ◽  
pp. 1326
Author(s):  
Sandeep Kumar Adwal ◽  
B. L. Bamboria ◽  
Ashutosh Chourishi ◽  
Aditya Bamboria
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Prospective Observational Study ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Central India ◽  
Treatment Interruption ◽  
Care Hospital ◽  
Drug Reactions ◽  
The Common

Background: The main objective of study is to monitor and analyze the adverse drug reactions (ADRs) of ART and to assess causality and severity of the ADRs detected.Methods: It is a prospective observational study conducted in the ART centre of a tertiary care teaching hospital in central India. The data collected were recorded on standard ADR reporting forms. Causality was assessed by Naranjo’s algorithm. Severity of ADR’s was assessed by modified Hartwig and Seigel scale. Modified Shumock and Thorton criteria used for preventability assessment.Results: In twelve months duration 351 patients on ART were observed for ADRs. Total 166 ADRs detected in 96 patients. Incidence of ADRs was slightly more in female. The common systems involved were gastrointestinal 42.77% followed by nervous system 18.07%, musculoskeletal 15.06% skin/mucous membrane 07.83%, metabolic and nutritional 04.82%, red blood cell disorders 01.20 %, endocrinal 00.60 % and others 09.64%. The causality assessment as per Naranjo’s scale showed that out of 166 ADRs, 28.92% were probable and 71.08% were possible. Severity assessment by modified Hartwig and Siegel scale showed that 83.34% ADRs were mild and 15.66% were moderate. 46.39 % ADRs were probably preventable.Conclusions: Considering the magnitude of ADR related problems, there is a need for greater awareness among health care professionals, to detect and report them. These ADRs if recognized in time and managed properly can prevent treatment interruption.

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