scholarly journals Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India

2019 ◽  
Vol 8 (11) ◽  
pp. 2541
Author(s):  
E. Bhuvaneshwari ◽  
T. Chakradhar ◽  
M. Sravani
Keyword(s):  
Causality Assessment ◽  
Tertiary Care ◽  
Age Groups ◽  
Individual Case ◽  
Medical College ◽  
Monitoring Centre ◽  
Ich Guidelines ◽  
Study Results ◽  
And Gender ◽  
Pharmacogenomic Studies

Background: Drugs are double edged weapons, they are used in treatment of the patients but in return can harm as well. The safety of drug prescribing has become a need of the hour topic in medicine. Safety monitoring of patients via Pharmacovigilance tool has become an integral part of pharmacotherapy. This study has been undertaken to analyze the various individual case safety reports including the Special situation cases of medicational error and over dose and to promote the reporting of adverse drug reactions (ADRs) among the healthcare professionals (HCPs).Methods: A retrospective non-interventional observational study was done for indexed period of six months at AMC-PvPI under Osmania Medical College and General Hospital. The reported individual case safety reports (ICSRs) are evaluated on basis of demographics of age and gender, seriousness criteria, outcome parameters and causality assessment of suspected drug (s) and suspected ADR/AE (s) as per the ICH guidelines and WHO causality assessment scale.Results: A total of 177 ICSRs are reported out of that 137 were ADRs, 36-medication error cases and 4-cases of over dose. The incidence of ADRs in females are high compared with males was identical. The occurrence of ADRs in adult patients (61%) was significantly higher than other age groups. Of total ADRs, most of them were with analgesics (26%) and highly reported system organ classification was CNS. Overall, 79% patients were recovered from ADRs.Conclusions: The results depicted an insight to the HCPs on the importance of monitoring and reporting of ICSRs. Our study results emphasized need to roll out a pharmacovigilance practice tool to ensure the safe use of drugs for better Pharmacotherapy and development of pharmacogenomic studies.

scholarly journals Causality assessment and pattern of adverse drug reactions in a tertiary care hospital

2018 ◽  
Vol 7 (2) ◽  
pp. 210
Author(s):  
Dinesh K. Badyal ◽  
Bimal Kanish ◽  
Gaurav Gulrez
Keyword(s):  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Study Results ◽  
Set Up ◽  
Definition Of ◽  
Almost All

Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management. Hence, this study was planned to evaluate causality and pattern of ADRs in a tertiary care hospital.Methods: The present study was undertaken in a tertiary care teaching hospital. A total of 200 ADRs reports collected in the ADR monitoring centre were analysed. The WHO definition of an ADR was adopted as well as WHO scale for causality assessment was used. Evaluation of the data was done for various parameters which included drug groups causing ADRs, body systems affected in ADRs, reporters and seriousness of reactions.Results: Overall occurrence of ADRs was slightly more in males (58%). Skin (72%) was the most commonly affected organ system. Antimicrobials (47%) were the drug group most commonly involved in ADRs. The causative drug was withdrawn for the management of the ADR in the majority (86%) of the patients. Upon causality assessment, majority of the ADRs were rated as probable (83.5%). Almost all of the reports were contributed by clinicians (99%).Conclusions: The causality assessment and pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.

scholarly journals Adverse drug reaction prevalence pattern among drugs and its correlation with causality assessment in ADR monitoring centre in Kerala over 6 months

2018 ◽  
Vol 8 (1) ◽  
pp. 47
Author(s):  
Sunil Nettath
Keyword(s):  
Anticancer Agents ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Tertiary Care Centre ◽  
Medical College ◽  
Monitoring Centre ◽  
The Past ◽  
Different Types ◽  
Retrospective Data Collection ◽  
Pattern Distribution

Background: Prevalence of adverse drug reactions had been studied extensively in the past to find out the drug pattern distribution of ADR. In this study, authors tried to find out the prevalence pattern and its correlation with the WHO causality assessment over the 6 months.Methods: This study was done in Govt Medical College Palakkad Kerala as an observational study. Without revealing the identity of the patients as is done in ADR reporting in pharmacovigilance program, a retrospective data collection was done by collecting different types of ADR reported in this hospital for the previous six months. Only data of inpatients was collected and tabulated for different group of drugs. Then using the WHO scale of causality assessment, the ADR individually was classified to probable, possible, or certain and tabulated.Results: In this study, the prevalence pattern of drugs causing ADR was evaluated over six months in a tertiary care centre. Out of the 45 cases reported, major ADR were for antibiotics (55.5%) and anticancer agents (18.2%) and the least reported ADR were for vaccines and supplements (2.2%). In causality assessment WHO scale only one case was certain (2.2%). Here the majority Causality assessment was found to be probable (44.45%) and possible (51.2%).Conclusions: From this study it is concluded that the antibiotics has the major ADR pattern. It’s also known that the probable and possible causalities are more common when ADR are reported.

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 Knowledge, attitude and practice toward adverse drug reaction reporting among practicing clinicians at a tertiary care hospital

2017 ◽  
Vol 6 (4) ◽  
pp. 845
Author(s):  
Toshan L. Todar ◽  
Manju Agrawal ◽  
Rajesh Hishikar ◽  
Anuja Jha ◽  
Basant Maheshwari ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Tertiary Care ◽  
Reaction Monitoring ◽  
Adverse Drug Reaction Monitoring ◽  
Medical College ◽  
Monitoring Centre ◽  
Adr Reporting ◽  
Attitude And Practice ◽  
Knowledge Attitude And Practice

Background: Pharmacovigilance has evolved as an important tool for dealing with Adverse Drug Reactions (ADRs) both in pre-marketing and post-marketing scenario. Underreporting of ADRs at our Adverse drug reaction Monitoring Centre (AMC) led us to conduct this study to assess Knowledge, Attitude and Practice (KAP) of the practicing clinicians at our tertiary care Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur, Chhattisgarh, India, towards ADRs reporting.Methods: This was a cross-sectional study using pretested questionnaires consisting of 29 questions related to KAP of the practicing clinicians at Pt. J.N.M. Medical College associated Dr. B.R.A.M.  Hospital, Raipur towards ADRs reporting. The percentage of responders for each question was calculated. All statistical analysis was performed in Microsoft Office Excel 2007.Results: Out of 135 questionnaires distributed only 100 were considered for analysis, so the overall response rate was 74.07%. We calculated the result from the 100 responders. Overall 77% responders were aware of existence of ADR monitoring system in India, while only 40% were aware of its existence at their hospital. Only 8% responders had reported ADRs to the National Pharmacovigilance Centre and 10% to the Adverse drug reaction Monitoring Centre (AMC) at their hospital. Lack of knowledge about where, how and whom to report ADRs, lack of time, inability to decide what to report (known or unknown ADRs) and unavailability of ADR reporting form were the important factors discouraging them reporting ADRs.Conclusions: Creating awareness regarding ADR reporting through CMEs among practicing clinicians and early sensitization at medical undergraduate level for medical students may improve the current ADR reporting rate.  

scholarly journals A study on the demographic features of cancer patients done in a tertiary care centre in South India

2020 ◽  
Vol 11 (SPL2) ◽  
pp. 194-200
Author(s):  
Mathupriya S G ◽  
Ganthimathy Sekhar ◽  
Porchelvan S
Keyword(s):  
Cancer Patients ◽  
Statistical Significance ◽  
Tertiary Care ◽  
Age Groups ◽  
Care Centre ◽  
Tertiary Care Centre ◽  
Cancer Breast ◽  
And Gender ◽  
Screening And Prevention ◽  
One Year

Cancer is a major cause of increased morbidity and mortality in today’s world. Several studies have shown that its incidence is governed by the gender and age of a person. The site and histological subtype of cancer vary between different age groups and sex. Knowledge of the demography of cancer in affected individuals will help in planning screening and prevention strategies. The present study was done to analyse the site of different cancers among various age groups and gender in patients coming to a tertiary care centre. Data of cancer patients was retrospectively analysed in terms of age, sex, site, and histopathological subtypes. The histopathological reports of all cases of cancer recorded at the histopathology laboratory of the tertiary care centre during a one year period- November 2017 to October 2018 were perused and the findings were recorded. Analysis of the data was done using SPSS version 17 to obtain the statistical significance. There were a total of 330 cases of cancer recorded during the study period. Out of these, 143 were male and 187 were female. Age group between 51 and 60 years had the maximum number of cases of cancer. Breast cancer in female and stomach cancer and oropharyngeal cancer in male were found to be more common. Among the histological subtypes, adenocarcinoma was found to be the most commonest across all ages and in both sexes.

scholarly journals Status of Vitamin D among Patients Visiting a Tertiary Care Centre in Rupandehi, Nepal

2021 ◽  
Vol 9 (4) ◽  
pp. 256-260
Author(s):  
Tirtha Narayan Shah ◽  
Amar Kumar Sinha ◽  
Krishna Kumar Jha ◽  
Ram Jiban Prasad
Keyword(s):  
Vitamin D ◽  
Tertiary Care ◽  
Age Groups ◽  
Serum Vitamin ◽  
Hypovitaminosis D ◽  
Target Population ◽  
Tertiary Care Centre ◽  
Medical College ◽  
Serum Vitamin D ◽  
High Level

Serum vitamin D is one of the fat-soluble vitamin which has the role in maintenance of calcium and phosphorus levels  and ultimately proper bone health and various physiological processes.  Although many studies prevail hypovitaminosis D, we focused to find out the pattern of  elevated or decreased  serum vitamin D level as its deficiency and surplus have adverse effects to our health.. For this, a retrospective study was done from the records present in a hospital laboratory of Devdaha Medical College and Research Institute (DMCRI), Rupandehi, Nepal from January 2018 to December 2020 where 201 participants with 70.1% male and 29.9% female with different age groups were present. From total participants, 14.9% had deficient, 42.8% had insufficient, 35.3% had sufficient and 7%  had high level of serum vitamin D. Male had 2.9% deficient and 14,9% insufficient vitamin D whereas female had 11.9% deficient, 27.8% insufficient and 7.0% surplus vitamin D. The greater prevalence of hypovitaminosis D in the females than the males could be overcome by the necessary strategies in the form of further studies and judicious supplementation vitamin D in the target population by monitoring the level of serum vitamin D. Int. J. Appl. Sci. Biotechnol. Vol 9(4): 256-260.

scholarly journals Utilization of drug in patients admitted with abnormal uterine bleeding in a tertiary care teaching hospital

2020 ◽  
Vol 9 (8) ◽  
pp. 1258
Author(s):  
Dhivya Govindasamy ◽  
Padmavathi Karunakaran ◽  
Rajalakshmi Ramesh ◽  
Kamalavarshini Paramasivamsasanger ◽  
Rajalakshmi Ponnusamy
Keyword(s):  
Ferrous Sulfate ◽  
Tamil Nadu ◽  
Tertiary Care ◽  
Age Groups ◽  
Abnormal Uterine Bleeding ◽  
Uterine Bleeding ◽  
Defined Daily Dose ◽  
Care Teaching ◽  
Medical College ◽  
Daily Dose

Background: The objective of the study was assessing utilization of drug in patients admitted with Abnormal Uterine Bleeding in a tertiary care teaching hospital.Methods: The observational study was conducted at Department of Obstetrics and Gynecology, Rajah Muthiah Medical College and Hospital, Annamalai University, Annamalai Nagar, Tamil Nadu, from the period of July 2019 to September 2019. A total 30 gynecology patients were included.Results: A total 30 patients most of the patients were between the age groups of 36-45 years 66.6%. The most common clinical condition AUB and co-morbidities condition were 19 (63.3%). The majority of patient were prescribed with ferrous sulfate 27 (90%). The defined daily dose (DDD) per patient for norethisterone 36 followed by ferrous sulfate 23.11. The average number of drugs per prescription 10.8, percentage of drug prescribed in generic name 69.56% and number of drugs prescribed from NLEM-2015 86.95%, number of drugs prescribed from EDL-2019 were 69.56% and percentage of prescription with antibiotic 80%, percentage of prescription with injection 70%.Conclusions: This study has shown the utilization of drugs prescribed in AUB patient. The most commonly prescribed drug was ferrous sulfate and most prescribed antifibrinolytic drug was tranexamic acid for treating AUB.

scholarly journals Epidemiology, types and clinical features of cases of ocular injuries attending a tertiary care teaching hospital of Eastern India

2018 ◽  
Vol 5 (3) ◽  
pp. 1072
Author(s):  
Asok Kumar Naskar ◽  
Suman Adhikari ◽  
Sabyasachi Bandopadhyay ◽  
Kanchan Kumar Mondal ◽  
Asim Chakravorty ◽  
...  
Keyword(s):  
Clinical Features ◽  
Ocular Trauma ◽  
Tertiary Care ◽  
Age Groups ◽  
Ocular Motility ◽  
Early Management ◽  
Medical College ◽  
Significant Burden ◽  
Ocular Injuries ◽  
Prior Trauma

Background: Ocular trauma is one of the main causes of severe ocular morbidity. The goals of this study were to describe epidemiology, causations, clinical features of ocular trauma, to analyse visual outcomes of ocular trauma.Methods: The patient was enquired about the time of occurrence of the injury, place, types of injury inflicted, any prior trauma or surgery, any treatment received before attending to the hospital. Visual acuity of each eye was recorded by using Snellen’s chart. In patients with poor vision gross assessment was done by counting fingers at specific distance, hand movements, perception of light present or not, projection of rays- accurate or not. Ocular motility testing was done in all patients.Results: Patients suffering from ocular injuries in one or both eyes, were examined clinically at the eye department of R G Kar Medical College and Hospitals, Kolkata, from December 2011 through August 2012. Approximate 757 persons had injury in one eye and 100 had injuries in both eyes (totalling 957 eyes with injuries in 857 patients). Males, 640 (74.7%) had more number of injuries than females 217 (25.3%) and injury was more common between 21 and 50 years of age groups in both sexes.Conclusions: A significant burden of ocular trauma in the community requires that its prevention and early management be a public health priority.

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 Study of the clinical spectrum of AUB (FIGO AUB Systems) and women’s attitude towards its management at Anugrah Narayan Magadh Medical College and Hospital, Gaya, Bihar, India

2020 ◽  
Vol 10 (1) ◽  
pp. 178
Author(s):  
Ruby Kumari ◽  
Lata Shukla Dwivedy ◽  
Sweta Gupta ◽  
Surabhi . ◽  
Madhuri Choudhary ◽  
...  
Keyword(s):  
Care Center ◽  
Tertiary Care ◽  
Age Groups ◽  
Abnormal Uterine Bleeding ◽  
Clinical Spectrum ◽  
Cross Sectional ◽  
Medical College ◽  
Obstetrics And Gynaecology ◽  
Ovulatory Dysfunction

Background: AUB has significant impact on quality of life of women related to health specially in developing countries including India. FIGO AUB systems are universally accepted. Aim was to study the clinical spectrum of AUB according to the FIGO AUB systems and women’s attitude towards its management.Methods: Cross sectional prospective study was carried out in the department of Obstetrics and Gynaecology, ANMMCH, Gaya, a tertiary care center, among women of 15-55 years age groups having complain related to abnormal uterine bleeding, for 1 year from 1st May 2019 to 30th April 2020 on 1000 patients. Data was collected and analyzed by percentage and proportions.Results: Prevalence of AUB was maximum among 15-30 years age group of patients (46.80%). Most of the patients belong to lower (62.5%) class, rural area (68%) and were anaemic (62.5%). Ovulatory dysfunction (55%) was most common cause for AUB, maximum patients choose surgical management (hysterectomy) but after counselling, most of them shifted to medical management.Conclusions: This study suggests more conservative approach for management of AUB and emphasizes the importance of awareness for clinical spectrum of AUB among women so that they can be self-motivated for early treatment and unnecessary hysterectomy can be avoided.

Sign in / Sign up

Export Citation Format

Share Document