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

Author(s):  
Sunil Nettath

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.

Author(s):  
E. Bhuvaneshwari ◽  
T. Chakradhar ◽  
M. Sravani

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.


Author(s):  
Deepak A. V. ◽  
K. J. Jacob ◽  
Sumi P. Maria

Background: Peripartum hysterectomy is a life-saving procedure resorted to when conservative measures fail to control obstetric haemorrhage. Several predisposing factors, suboptimal care and lack of infrastructure may lead to this emergency procedure. We wanted to find out factors associated with peripartum hysterectomy and the adverse maternal outcomes at our centre.Methods: A retrospective case series analysis of 40 cases of peripartum hysterectomy performed over a period of 5 years from January 2010 to December 2014 at Government Medical College Hospital, Thrissur, Kerala was done.Results: The incidence of peripartum hysterectomy was 0.29%. The most common indication for peripartum hysterectomy was hysterectomy was uterine atony (50%). Thirty-five women (88%) were between 20 and 35 years. Most of the subjects were unbooked. There were two maternal deaths (case fatality rate of 5%) following peripartum hysterectomy during this period. All the subjects required blood transfusion.Conclusions: Prompt performance hysterectomy before the patient’s clinical condition deteriorates is the key to success. The incidence of adherent placenta is increasing, so every effort should be taken to reduce the caesarean section rates globally. 


2020 ◽  
Vol 5 (4) ◽  
pp. S44
Author(s):  
Ritika Khurana ◽  
Ajay Sharma ◽  
Parth Ganatra ◽  
V.P. Krishnan ◽  
Purva Kanvinde ◽  
...  

2021 ◽  
pp. 32-34
Author(s):  
Anita Sanker ◽  
G Nandakumar ◽  
Swapna Balkrishnan

There are signicant differences in the histopathology of leprosy lesions which is inuenced by the host immune response to Mycobacterium leprae. Objective - To nd the histopathological changes in newly diagnosed multibacillary leprosy(MB) cases registered in the skin department Government Medical College, Thiruvananthapuram. Method- skin biopsy performed in 40 multibacillary leprosy cases and histopathological ndings were evaluated. 70% showed epidermal atrophy. Granulomas, composed of sheets of foamy macro Results- phages, lymphocytes and epithelioid cells, were seen in 21 cases & twenty two cases were AFB positive. Eight cases each were lepromatous, borderline tuberculoid, mid boderline, borderline lepromatous types. Conclusion- Presence of 60% cases of borderline leprosy indicates the unstable immune response in leprosy patients. Majority were either borderline lepromatous or lepromatous showing the infective nature of multibacillary leprosy. Histopathological examination with Fite- Foroco staining is a crucial method and the gold standard for accurate diagnosis and typing of leprosy.


2021 ◽  
pp. 65-66
Author(s):  
R. K. Maurya ◽  
Shraddha Verma ◽  
R. K. Tripathi ◽  
Amit Yadav

Background: Hypospadias is a common congenital anomaly in which the anterior urethra is incompletely developed and does not extend to the tip of the glans penis. The present study was aimed to study the clinical prole of hypospadias. Settings and Design:This was a prospective, observational study. Methods: This prospective study was conducted at Department of General Surgery, LLR & Associated Hospitals, GSVM Medical College, Kanpur, India, from January 2019 to October 2020, on 72 patients of hypospadias, after taking clearance from the Institutional Ethical Committee, and taking proper informed consent for participation. Data collected for each patient included age, sex, demography, symptoms with duration, and relevant past and treatment history. Results: The most common age of presentation was between 1-5years of age (48.61%, n=35). Distal hypospadias (DH) was the most common site. (47.22%, n=34). 4.16% (n=3) patients presented with urethrocutaneous stula. Chordee was more commonly seen in patients with mid & proximal penile hypospadias (64.70%, n=33). In the present study, 4.1% (n=3) had associated undescended testis, 4.1% (n=3) had an associated bid scrotum and 1.3% (n=1) had an associated congenital hernia. Conclusions: Most cases of hypospadias present before 10 years of age. Distal hypospadias is the most common type. Chordee is associated most commonly with proximal penile and mid penile hypospadias. It may also be associated with other congenital anomalies like, undescended testis, bid scrotum or congenital hernias


Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil

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


2021 ◽  
Vol 10 (27) ◽  
pp. 2001-2006
Author(s):  
John Britto Augustin ◽  
Sureshbaboo Variamkandi

BACKGROUND Corneal ulcer is the leading cause of ocular morbidity and monocular blindness worldwide. To effectively prevent blindness in patients with corneal ulcer, a proper understanding of the risk factors predisposing to ulceration, its clinical and microbiological characteristics are essential. Timely identification of aetiological agents causing corneal ulcers and their prompt treatment helps to save the vision. We wanted to detect aetiological agents of corneal ulcer with special references to fungal causes and characterize the fungal aetiological agents to species level. METHODS This is a cross sectional study, conducted in Government Medical college, Kozhikode, between January 2016 and June 2017. All patients who were clinically diagnosed as cases of infectious corneal ulcer in the Ophthalmology department, Government Medical College, Kozhikode were included in the study. Corneal scrapings collected from the infected eye were subjected to microbiological examination and culture. A total of 120 cases were analysed. Each patient was examined with the slit lamp bio microscope after staining with fluorescein. Scrapings from cornea at the site of corneal ulcer were collected by ophthalmologist after a detailed clinical history and examination of the affected eye. The laboratory procedures used in the diagnosis of infectious keratitis were based on direct visualization of organisms by subjecting corneal scrapings to Gram stain and KOH wet mount and inoculation of material on to blood agar and Sabouraud dextrose agar. RESULTS Among the 120 cases, a total of 49 cases were culture positive. Twenty-one [17.5 %] were bacterial, twenty-two [18.34 %] were fungal and six [5.0 %] were poly microbial [bacteria and fungus]. Among the fungal aetiology, fusarium species was most common [32.14 %], followed by aspergillus species - 25.0 %. Trauma was the major risk factor. Diabetes mellitus, exposure keratitis were the other comorbidities / risk factors. CONCLUSIONS This study shows majority of infected corneal ulcers are associated with risk factors and the aetiology are mainly fungi. Microscopy, culture, and clinical correlation helped in adequate management. Thus, prognosis and outcome of corneal ulcers rely on timely identification of their aetiology and prompt treatment. KEY WORDS Corneal ulcer, Fungal Keratitis


Author(s):  
Divya Gupta ◽  
Premlata Mital ◽  
Bhanwar Singh Meena ◽  
Devendra Benwal ◽  
. Saumya ◽  
...  

Background: Multiple pregnancy remains one of the highest risk situations for the mother, foetus and neonate despite recent advances in obstetrics, perinatal and neonatal care. Twin pregnancies have increased rates of obstetric and perinatal complications compared to singletons Objective of present study was comparative assessment of fetomaternal outcome in twin pregnancy with singleton pregnancy in Obstetrics and Gynaecology Department of S.M.S. Medical College, Jaipur.Methods: This was a hospital based, prospective observational study done in the Department of Obstetrics and Gynaecology. S.M.S. Medical College, Jaipur from April 2015 to March 2016. 150 women with twin pregnancy and 150 women with singleton pregnancies at gestation age of 28 weeks and above coming for delivery and consented for the study were included in the study. Women with chronic medical disorder or chronic hypertension were excluded from the study. Maternal and neonatal outcome recorded and analysed.Results: Occurrence of twin in our study was 2.82%. Risk of preterm labour was about nine times higher in twin pregnancies than the singleton (OR: 2.74, 95% CI; 1.4494-5.1884, P value 0.001). The risk of premature rupture of membrane was increased by 2.74 times in twin pregnancies (OR:2.74; 95% CI: 1.4494-5.1884, p value .001). There was 3-time increased risk of malpresentation (OR 3.14; CI:1.7184-5.7480, p value .00002) and 2.28 times increase in hypertensive disorder (OR 2.28; 95% CI: 1.0727-4.8823, p value .03) in twin pregnancies. The risk of asphyxia and septicaemia was 2.5 times more in twins.Conclusions: Twin pregnancy is a high-risk pregnancy with more complications in mother and foetus and is a great challenge for obstetrician. So, it should be managed carefully at tertiary care centre to reduce the maternal and perinatal mortality and morbidity.


Author(s):  
Toshan L. Todar ◽  
Manju Agrawal ◽  
Rajesh Hishikar ◽  
Anuja Jha ◽  
Basant Maheshwari ◽  
...  

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.  


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