scholarly journals A study on prospective monitoring of adverse drug reactions associated with hematinics at a tertiary care teaching hospital

2021 ◽  
Vol 2 (1) ◽  
pp. 16-21
Author(s):  
P. Vinay ◽  
P. Venkata Ramana ◽  
B. Jaya Kiran ◽  
K. Meghana ◽  
N. Vineetha
Keyword(s):  
Adverse Drug Reactions ◽  
Prospective Observational Study ◽  
Adverse Reactions ◽  
Causality Assessment ◽  
Tertiary Care ◽  
General Medicine ◽  
Care Hospital ◽  
Drug Reactions ◽  
Organ Systems ◽  
Prospective Monitoring

Introduction: Adverse reactions are the documented hazards of drug treatment and they can happen with any class of drugs and several studies exposed that the incidence is increasing with blood and blood products. Objectives: The main aim of this study is to identify and analyze Adverse Drug Reactions with Hematinics in a tertiary care hospital. Methods: This prospective observational study was conducted for a period of 6 months. Results: A total of 29 ADRs were reported during the study period with a female high proportion (79.31%), more amounts of ADRs were from Obstetrics & Gynecology and General Medicine in which the mainly affected organ systems were the skin (86.20%) and the GIT (13.79%). The hematinics mostly accounted were Iron sucrose (44.82%) followed by ferric carboxy maltose (37.93%) and Iron dextran (17.24%) in which type B reactions were more compared to type A and 72.41% of them were unpredictable. The severity assessment revealed that the majority of them were moderate reactions (62.06%). Out of the reported reactions, 58.62% were definitely preventable and a causality assessment was done which showed that 68.96% of the reactions were probable, possible (20.68%) and conditional (10.34%). Most of the patients (65.51%) were treated with Antihistamines & corticosteroids, with only anti-histamines (24.13%) and no treatment (10.34%). Conclusions: The study concludes that Adverse Drug Reactions with Hematinics are increasing in recent days. Better vigilance is necessary for the implementation of safe and effective treatment with hematinics for each and individual patient.

scholarly journals ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY

2018 ◽  
Vol 10 (1) ◽  
pp. 23
Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Organ Systems ◽  
A Prospective Study

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization

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.

scholarly journals Pharmacovigilance study in geriatric patients of a tertiary care hospital

2021 ◽  
Vol 2 (2) ◽  
pp. 33-38
Author(s):  
Rajalakshmi Rukmangathen ◽  
Vasundara Devi Brahmanapalli
Keyword(s):  
Adverse Drug Reactions ◽  
Geriatric Patients ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Adverse Drug Reaction Monitoring ◽  
Medical College ◽  
Organ Systems

Introduction: The aim was to assess, categorize and analyze the adverse drug reactions among geriatric patients in a tertiary care hospital.  Methods: All adverse drug reactions of geriatric patients reported at the Adverse Drug Reaction Monitoring Center, Sri Venkateswara Medical College, Tirupati, under the Pharmacovigilance programme of India, during September 2016 and January 2018 were identified and evaluated. A retrospective analysis was carried out for ADR pattern, drug groups, organ systems implicated in suspect ADR, demographic profile, causality (as per the WHO–UMC scale), severity (Hartwig and Seigel scale), and preventability (Schumock and Thornton criteria) of a said drug. Results: A total of 120 ADRs were received among geriatric patients. Most of the ADRs occurred in male geriatrics (55.83 %) and (34.2 %) occurred in the age group of 60- 64 years. Antibiotics comprised the major group of drugs causing ADRs (18.3 %). ADRs related to gastrointestinal systems were most common with 31.7 % followed by skin disorders (15 %) and central nervous system disorders (13.3 %). As per the causality assessment scale, the majority of adverse drug reactions were found to be possible (51.7 %). Conclusions: There were 60.8 % of reactions being mild and 39.2 % were moderate reactions as per severity scale. The majority of the adverse drug reactions were non-serious (33 %) and in the serious category, 27.5 % of ADRs required intervention to prevent permanent damage.

scholarly journals A Prospective Study on Adverse Drug Reactions in Inpatients of General Medicine Department in a Tertiary Care Hospital- A clinical Pharmacist-led Study

2021 ◽  
pp. 111-122
Author(s):  
Shereen Hassan ◽  
U. Ujwal Kumar ◽  
Venessa Mascarenhas ◽  
G. Suresh ◽  
K. C. Bharath Raj ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Data Gathering ◽  
Drug Effects ◽  
General Medicine ◽  
Care Hospital ◽  
Age Group ◽  
Drug Reactions ◽  
Medicine Department

The present study was carried out to determine the incidence of Adverse Drug Reactions (ADRs) in general medicine department and to assess and analyze the causality, severity, and preventability of ADRs. A prospective observational study was conducted in the general medicine department for six months. All patients receiving drug therapy are considered and are selected based on the inclusion criteria. Patient demographic details like age, gender, diagnosis, past medical history, concomitant medications, etc., are recorded from the patient data gathering form. The causality assessment is accomplished using Naranjo and WHO scales. The severity is carried out using the Modified Hartwig and Siegel scale. The preventability evaluation is accomplished using the Modified Schmock and Thornton scale. The study included 385 patients were between the age group of 18 years and, out of which 34 patients developed adverse drug effects including female and male. Patients between the age group of 40-50 years (18.1%) developed a high incidence of ADRs. The causality was assessed using Naranjo’s causality assessment scale, 44.1% reactions were probable; 29.4% reactions were certain, 23.5% reactions were possible and 2.9 % reactions were conditional. When the reactions were assessed most of them were assessed 55.1% were moderate and 61.8% were probably preventable. Appropriate observation of the drug effect is essential to ensure the safety of the patient. This also will have the advantage of reducing the incidence of the ADRs, thus deplete the complications and helps to improve the quality of life of the patients.

scholarly journals A retrospective study of adverse drug reactions in a tertiary care center

2020 ◽  
Vol 9 (4) ◽  
pp. 611
Author(s):  
Ankitha L. ◽  
Ramesh H.
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Causality Assessment ◽  
Care Center ◽  
Tertiary Care ◽  
General Medicine ◽  
Accurate Estimate ◽  
Care Hospital ◽  
Drug Reactions

Background: Adverse drug reactions (ADRs) are a major concern in clinical practice. Reporting of ADRs either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the prevalence, severity and preventability of ADRs. Present study was conducted to evaluate the prevalence of adverse drug reactions in a tertiary care hospital in Hubballi, Karnataka, India.Methods: This was a retrospective observational study, extending over 6 months (May 2019 to October 2019). A total of 124 cases comprising patients of either sex and age group ranging from 1month to 72 years were studied. The data was collected using CDSCO ADR reporting form. “Naranjo’s Assessment Scale” was used for causality assessment and severity assessment was done in accordance with “Hartwig and Siegel scale”.Results: The study showed majority of ADRs were from General Medicine department and affected skin and appendages (59%). Skin rashes 44 (31.7%) were found to be the most commonly reported ADRs most of them were with antimicrobials 67 (54%).  After causality assessment 83 (66.9%) of the cases were classified as probable and 41 (33.1%) were classified as possible. Majority of serious ADRs were not preventable in our study.Conclusions: ADRs are a major cause of morbidity worldwide. Frequency of ADRs can be reduced by careful follow up and a robust hospital-based pharmacovigilance setup. Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended.

scholarly journals Adverse drug reactions in hospitalized patients in a tertiary care teaching hospital: analysis of the reported cases

2018 ◽  
Vol 7 (7) ◽  
pp. 1377
Author(s):  
Althab Begum M. ◽  
Satyajit Mohapatra ◽  
R. Jamuna Rani
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Spontaneous Reporting ◽  
Causality Assessment ◽  
Tertiary Care ◽  
General Medicine ◽  
Drug Reactions ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching ◽  
Organ Systems

Background: Adverse Drug Reactions (ADR’s) contributes to the burden of drug-related morbidity and mortality. ADRs are seen frequently in hospitals due to a variety of factors like complexity of diseases, drug interactions, polypharmacy, and possible negligence. The purpose of the study was to identify and assess ADR in various departments of a tertiary care teaching hospital.Methods: A prospective spontaneous reporting was carried out in a tertiary care teaching hospital during a period of four months from November 2016 to February 2017. All suspected spontaneous ADRs were assessed and the information was collected and analyzed by the pharmacologists for causality assessment using the Naranjo’s causality assessment scale.Results: A total of 30 ADRs were reported with female preponderance (70%). Majority of ADRs were from General Medicine and Oncology departments. The most affected organ systems were skin (80%) followed by the gastrointestinal system (13.3%). The most frequent drugs causing ADRs were antibiotics (56.3%) in which type B reactions were more compared to type A and followed by anticancer drugs (10%). The severity assessment showed that most of them were mild reactions (76.6%). Causality assessment revealed that 90% of the reactions were probable, 10% were possible and no reactions were unlikely.Conclusions: The study accomplished that ADRs are widespread and a few of them raised the healthcare expenditure due to increased hospital stay. The reporting of the ADRs to regional Pharmacovigilance centers should be encouraged to ensure drug safety.

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 To monitor the adverse drug reactions and safety of medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital

2014 ◽  
Vol 2 (03) ◽  
pp. 112-119
Author(s):  
Kavita Dhar ◽  
Shalu Chauhan ◽  
Jyotsna Sharma ◽  
Preeti Gaur ◽  
V. S. Chopra ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Vascular System ◽  
Tertiary Care Hospital ◽  
Safety Issue ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Obstetrics And Gynaecology ◽  
Organ Systems

Adverse drug reactions are the recognized hazards of drug therapy and they can occur with any class of drugs. Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. Adverse Drug Reactions result in increased healthcare cost due to the need of some interventions and increased hospital stay. The study was undertaken to monitor the adverse drug reactions to medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital, to establish ten most commonly prescribed medicines in this unit that gave maximum adverse drug reactions and to determine the list of commonly affected organ systems and assess their causality. In this Retrospective, non-interventional study a total of 63 adverse drug reaction reports were collected from 249 patients. The most common medicine that caused maximum ADRs was Oxytocin 10 (15.87%). Other frequently used drugs were Amikacin, Methylergometrine, Mifepristone+Misoprostol,Levonorgestrel+Ethinylestradiol, Cefotaxim+sulbactam, Cefixime+Ofloxacin, Mifepristone alone,Clomifene citrate, Tramadol. The most commonly affected organ system was cardio-vascular system 12 (19.04%).The assessment by Naranjo’s scale showed that out of 63 ADRs, 41 (65.07%) ADRs were probably related to drugs, 21 (33.33%) ADRs were possibly related to drugs and 1 (1.58%) ADR was doubtful. WHO causality assessment scale revealed that out of 63 ADRs, 51(80.95%) ADRs were probable or likely, 12(19.04%) ADRs were possible. It was observed that safe medicines were prescribed in obstetrics and gynaecology department as per FDA category A with no banned drugs .However, there is a need to sensitize the doctors to prescribe rationally and emphasize this aspect in under and post graduate medical teaching as well. The health system needs to promote spontaneous reporting of Adverse Drug Reactions from all health care professionals and the public at large in a well structured programme to build synergies for monitoring ADR in the country. Also proper documentation and periodic reporting to regional pharmacovigilance centres should be encouraged to arrive at meaningful conclusion on safety issue of medicines and thereby reduce considerably social and economic consequences of ADRs.

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