scholarly journals Pharmacovigilance by World Health Organisation Uppsala Monitoring Center Causality Assessment Algorithm in Medicine Ward of Tertiary Care Hospital of New Delhi

2017 ◽  
Vol 1 (1) ◽  
pp. 61-64
Author(s):  
R.C. Shah ◽  
S. Karki ◽  
S.B. Parajuli ◽  
P. Bhattarai ◽  
P.K. Chowdhary

Introduction Pharmacovigilance is not new to India and has in fact been going on since 1998. Adverse drugs reaction (ADRs) are important causes of morbidity and mortality all over the world. They account for approximately 10-20% of all hospitalized patients. The overall incidence of serious ADRs is 6.7% and that of fatal is 0.32%.Objective The objectives of the study was to find the pattern of adverse drug reactions in patients attending medicine ward of a tertiary care center of New Delhi.Methodology A prospective study was conducted from March 2013 to December 2013. On the basis of WHO-UMC causality assessment algorithm, the incidence and pattern of ADRs were assessed from 300 patients of 18 to 70 years of age. The collected data was entered in Microsoft Excel, Common Terminology Criteria for Adverse Events (CTCAE) and analysed by SPSS.Results The incidence of ADRs was found to be 13.67%. More than one ADRs has been reported from some patients. The gender of the patients has no significance in the occurance of ADRs (p=0.194). Highest number of ADRs were found in gastrointestional system followed by central nervous system. Gastrointestional ADRs were must commonly associated with the uses of antimicrobials. The most frequently seen ADRs were diarrhea, gastritis, abdominal pain followed by nausea and vomiting. Decreased level of consciousness (sedation, drowsiness) followed by dizziness and tremors were the frequent ADRs related to the central nervous systems. Based on WHO-UMC causality assessment algorithm, it was observed that a total of 57 ADRs were possible and 2 were probable. No other causality assessment category was observed.Conclusion The ADRs incidence was common even in a tertiary care center. The Gastrointestional and central nervous system disorder were common. The concern of Pharmacovigilance should be initiated.Birat Journal of Health Sciences 2016 1(1): 61-64

2013 ◽  
Vol 02 (04) ◽  
pp. 245-249
Author(s):  
Rashmi Patnayak ◽  
Amitabh Jena ◽  
Bodagala Vijaylaxmi ◽  
Amancharla Y. Lakshmi ◽  
BCM Prasad ◽  
...  

Abstract Background: Secondary central nervous system (CNS) tumors are common in Western countries, but in Indian literature, scant data are available. With the advent of newer imaging techniques, the confirmatory histopathological diagnosis has become comparatively easier. Hereby, we have analyzed our data from a single tertiary care center in south India. Materials and Methods: In this retrospective study from January 2000 to December 2010, histopathologically diagnosed secondary CNS tumors were reviewed along with clinical, imaging, and relevant immunohistochemical findings. Meningeal, lymphoproliferative, and myeloproliferative tumors and autopsy data were not included in the study group. Results: There were 40 secondary CNS tumors. Male to female ratio was 2.3:1. Age range was wide (28-75 years). Majority of cases were seen in the fourth and fifth decade. Imaging-wise, (computed tomography and magnetic resonance imaging) majority were single lesions (n = 34, 85%). Most commonly, these single lesions were present in the cerebral hemisphere (n = 20, 50%) followed by cerebellum (n = 10, 25%). Adenocarcinoma accounted for maximum number of cases (n = 25, 62.5%) with lungs being the most common primary. Conclusion: We have noted 25% metastatic adenocarcinomas in cerebellar location, which is higher when compared with available world literature. However, we also encountered a good number of cases (30%) due to unknown primary. Though histopathological examination with use of immunohistochemical markers can reliably distinguish primary from secondary CNS tumors in addition to available clinical and imaging data, particularly in developing countries, still a better work-up with an array of immunohistochemical markers and newer imaging modalities is desirable.


2015 ◽  
Vol 72 ◽  
pp. 146-151 ◽  
Author(s):  
Usha Kant Misra ◽  
Jayantee Kalita ◽  
Vinita Elizabeth Mani ◽  
Prashant Singh Chauhan ◽  
Pankaj Kumar

2011 ◽  
Vol 27 (8) ◽  
pp. 1257-1263 ◽  
Author(s):  
Jaya Ruth Asirvatham ◽  
A. Narasimhaiah Deepti ◽  
Rila Chyne ◽  
M. S. N. Prasad ◽  
Ari G. Chacko ◽  
...  

2019 ◽  
Vol 9 (4-A) ◽  
pp. 15-18
Author(s):  
B.P Anilasree ◽  
K.P Anuroopa ◽  
S Arun Jyothi ◽  
T. Basila ◽  
Swathi Saji

Objectives: To analyze the rationality of central nervous system fixed dose combinations used in a tertiary care hospital. Methodology: The study was an hospital based observational study. The data was collected from an annual drug compendium entitled “Hospital Drug List”. Fixed dose combinations (FDCs) enlisted in central nervous system (CNS) sections were selected for the study purpose. The active pharmacological ingredients (APIs) in FDC was checked for approval by Drug Control General of India (DCGI), World Health Organization (WHO) and essential medicine (EML)/national essential medicine list (NEML),both or none and all the ingredients (molecule, excipients) present in the FDC was checked whether banned or under any controversies in India as well as worldwide.  Efficacy and safety of the individual active pharmacological ingredients (APIs) and their combination were searched. Details of each drug were collected [Generic name, Pharmacokinetics, Interaction affected, Pharmacodynamics, and Advantages of FDCs]. The data collected was analyzed by a tool to assess the rationality of fixed dose combinations which is pre-tested and validated by Shah et al., based on WHO guidelines. Result and Discussion: A total of 25 CNS FDCs were taken, on assessment of CNS FDCs 21 (84%) were found to be rational and 4 (16%) were found to be irrational with the mean rationality score of 7.2. By winding up, state of nonbeing, absenteeism of legality and effectiveness of the formulations appeared in to a peculiar combinations and inadequate practice. The approval process of these combinations by various committees should be robust. Keywords:  Rationality; Fixed Dose Combinations; CNS Drugs; Safety and Efficacy.


2015 ◽  
Vol 63 (1) ◽  
pp. 77 ◽  
Author(s):  
Geeta Chacko ◽  
Sheila Nair ◽  
Jamie Anandan ◽  
AriG Chacko ◽  
Vedantam Rajshekhar ◽  
...  

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