Pharmacovigilence practice for safety of medication system in India

2018 ◽  
Vol 7 (2) ◽  
pp. 216-221
Author(s):  
Shobharam Sahu ◽  
◽  
Poonam Rishishwar ◽  
Chhaya Rathod ◽  
◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
India Institute ◽  
Family Welfare ◽  
New Delhi ◽  
Drug Reactions ◽  
Medical Sciences ◽  
Ministry Of Health ◽  
Regulatory Authorities ◽  
Pharmacovigilance Center ◽  
Uppsala Monitoring

Pharmacovigilance is very essential tool to ensure the safety of drug. It provides safety to patients in case of medication. Activity of pharmacovigilance is coordinates by National pharmacovigilance center in collaboration with international regulatory authorities (WHO, The Uppsala Monitoring center). Under the aegis of Ministry of Health & Family Welfare, Government of India, the Central Drugs Standard Control Organisation (CDSCO), New Delhi, has initiated a nation-wide pharmacovigilance programme, with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) for monitoring Adverse Drug Reactions (ADR)

scholarly journals An overview of the worldwide master key for pharmacovigilance and its role in India

2021 ◽  
Vol 2 (2) ◽  
pp. 19-26
Author(s):  
Janmejay Pant ◽  
Harneet Marwah ◽  
Ripudaman M Singh ◽  
Subhajit Hazra
Keyword(s):  
World Health Organization ◽  
Adverse Drug Reactions ◽  
Marketing Authorisation ◽  
World Health ◽  
Drug Reactions ◽  
Regulatory Authorities ◽  
The World ◽  
Health Organization ◽  
Positive Results ◽  
Uppsala Monitoring

Introduction: Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. Methods: In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. Results: The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Organization (WHO) Uppsala Monitoring Center (UMC) based on the data gathered from this process. Indian regulatory have sent several alerts to stakeholders and provided the Central Drugs Standard Control Organization (CDSCO) with several recommendations. CDSCO has since advised Marketing Authorisation Holders (MAHs) to follow the same guidelines and has amended the Drugs and Cosmetics Act and Regulations to reflect this. Conclusions: The time has come for Indian regulatory authorities to take the required action based on data generated in our country rather than data generated in several other countries.

Application of Stem Cell Technology for Coronary Artery Disease at the All India Institute of Medical Sciences, New Delhi, India

2007 ◽  
Vol 10 (3) ◽  
pp. E231-E234 ◽  
Author(s):  
Balram Airan ◽  
Sachin Talwar ◽  
Shiv Choudhary ◽  
Akshay Bisoi ◽  
Ujjwal Chowdhury ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Stem Cell ◽  
Coronary Artery ◽  
India Institute ◽  
New Delhi ◽  
Medical Sciences ◽  
Stem Cell Technology ◽  
Cell Technology ◽  
Artery Disease

scholarly journals Common Causes and Characteristics of Adverse Drug Reactions in Older Adults: A Retrospective Study

2020 ◽  
Author(s):  
Seong-Dae Woo ◽  
Jiwon Yoon ◽  
Go-Eun Doo ◽  
Youjin Park ◽  
Youngsoo Lee ◽  
...  
Keyword(s):  
Older Adults ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Younger Patients ◽  
Iodinated Contrast ◽  
Common Causes ◽  
Aging Populations ◽  
Pharmacovigilance Center ◽  
Inflammatory Drugs ◽  
Rate Ratios

Abstract Background: Aging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs). We sought to evaluate the causes and characteristics of ADRs in older Korean adults (≥65 years) in comparison to younger individuals (<65 years). Methods: Of 37,523 cases reported at a Korean pharmacovigilance center from 2011 to 2018, we reviewed 18,842 ADRs of certain or probable causality on the basis of WHO-UMC criteria. We estimated the number of ADRs per 1,000 patients exposed to the major culprit drugs, and incidence rate ratios were obtained to assess high- and low-risk medications in older adults. Results: In total, 4,152 (22.0%) ADRs were reported for 3,437 older adults (mean age, 74.6 years and 57.3% female). Tramadol (rate ratio, 1.32; 95% confidence interval [CI], 1.21-1.44; P <0.001) and fentanyl (1.49, 1.16-1.92, P =0.002) posed higher risks of ADRs in the older adults, whereas nonsteroidal anti-inflammatory drugs (NSAIDs) (0.35, 0.30-0.40, P <0.001) and iodinated contrast media (ICM) (0.82, 0.76-0.89, P <0.001) posed lower risks. Ratios of serious ADRs to NSAIDs (odds ratio, 2.16; 95% CI, 1.48-3.15; P <0.001) and ICM (2.09, 1.36-3.21, P= 0.001) were higher in the older adults than in the younger patients. Analgesics primarily elicited cutaneous ADRs in the younger patients and gastrointestinal reactions in the older adults. ICM more commonly led to anaphylaxis in the older adults than the younger patients (3.0% vs. 1.6%, P =0.019). Conclusion: For early detection of ADRs in older adults, better understanding of differences in the causes and characteristics thereof in comparison to the general population is needed.

scholarly journals Pattern of adverse drug reactions reported to the regional Pharmacovigilance center at Nepal Medical College and Teaching Hospital, Kathmandu

2012 ◽  
Vol 26 (1) ◽  
pp. 54-61 ◽  
Author(s):  
Durga Bista ◽  
Bal Ram Shrestha ◽  
Prakash Rai ◽  
Akhilesh Chandra Jauhari ◽  
Vishnu Kant Kulshrestha
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Causality Assessment ◽  
Age Group ◽  
Drug Reactions ◽  
Preliminary Stage ◽  
Medical College ◽  
Probable Relationship ◽  
Pharmacovigilance Center ◽  
Inflammatory Drugs

The Pharmacovigilance program in Nepal is at very preliminary stage. Present study analyzed the pattern, causality, severity and preventability of the reported adverse drug reactions (ADRs) to the Pharmacovigilance center at Nepal Medical College and Teaching Hospital (NMCTH), from June 2007 to July 2011. A total of 40 ADR cases were reported, among which 23 (57.5%) were in males and 17 (42.5%) in females. Nineteen (47.5%) ADRs were reported in the age group between 21-40 years. Department of Medicine reported 12(30%) ADRs. Among the total ADRs, antibiotics [n=17, (42.5%)] were responsible for most of the reactions followed by non steroidal anti-inflammatory drugs [n=5, (12.5%)]. Most of the drugs were found to affect dermatological system [n=14, (35%)]. Carbamazepine accounted for 5 (12.5%) ADRs. The causality assessment showed 34 (85%) of the ADRs to have a ‘probable’ relationship with the suspected reaction.DOI: http://dx.doi.org/10.3126/jnpa.v26i1.6633JNPA. XXVI(1) 2012 54-61

Online Reporting of Adverse Drug Reactions: A Study from a French Regional Pharmacovigilance Center

Therapies ◽  
2014 ◽  
Vol 69 (5) ◽  
pp. 395-400 ◽  
Author(s):  
Delphine Abadie ◽  
Leyla Chebane ◽  
Max Bert ◽  
Geneviève Durrieu ◽  
Jean-Louis Montastruc
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Pharmacovigilance Center

Solitary plasmacytoma: 10 years’ experience at All India Institute of Medical Sciences, New Delhi

2012 ◽  
Vol 54 (8) ◽  
pp. 1665-1670 ◽  
Author(s):  
Saphalta Baghmar ◽  
Bidhu K. Mohanti ◽  
Atul Sharma ◽  
Lalit Kumar ◽  
Gaurav Prakash ◽  
...  
Keyword(s):  
India Institute ◽  
New Delhi ◽  
Solitary Plasmacytoma ◽  
Medical Sciences
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