Pharmacovigilance in India

Prakash, Shiva

doi:10.4103/0253-7613.33430

Cited by 28 publications

(25 citation statements)

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“…15 India rates below 1% in pharmacovigilance as against the world rate of 5%, this is due to ignorance of the subject and lack of training. 16 Hence this study was conducted to assess the pattern of adverse drug reactions (ADRs) reported with cardiovascular drugs in a tertiary care institute.…”

Section: Introductionmentioning

confidence: 99%

An assessment of pattern of adverse drug reactions of cardiovascular drugs in a tertiary care institute

Wankhede

Pardeshi

Ghorpade

et al. 2018

Int J Basic Clin Pharmacol

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INTRODUCTIONWorldwide, the number of deaths from cardiovascular diseases (CVDs) was estimated at 17.3 million per year, and it is expected to increase to approximately 23.6 million patients by 2030.1 While the prevalence and mortality due to CHD is declining in the developed nations the same cannot be held true for developing countries. There has been an alarming increase over the past two decades in the prevalence of CHD and cardiovascular mortality in India and other south Asian countries. 2 The incidence of cardiovascular diseases has been increasing in recent decade. It is the most common cause of death in the developed as well as developing countries. Over 30% of all deaths every year attributed to cardiovascular disease. Currently, important interventions to prevent and to treat CVD are available, e.g. pharmacological treatment of elevated low density lipoprotein (LDL) cholesterol levels elevated blood pressure and inhibiting platelet function with statins, anti-hypertensive agents (thiazides, beta blockers, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, or angiotensin II receptor blockers (ARBs), etc. and antiplatelet agents e.g. Low dose aspirin, respectively. [4][5][6][7][8][9] In this scenario, the large number of cardiovascular agents are used in population worldwide. Considering the increased use of cardiovascular drugs and its limitations in pre-marketing ABSTRACT Background: Cardiovascular disease is very prevalent in India. So, use of cardiovascular drugs is also more. So, it is very important to keep watch on adverse drug reactions. Aim of this study was to assess the pattern of adverse drug reactions (ADRs) reported with cardiovascular drugs in a tertiary care institute. Methods: The study was carried out in medicine department of a tertiary care hospital over a period of one year. Each ADR was analysed for demographic data, causality, relationship between frequency of ADRs and the number of drugs used etc. In statistical analysis Microsoft excel 2013, SPSS software was used. Results: A total of 136 patients, 58 (43%) men and 78 (57%) women, using cardiovascular medications reported ADRs during the entire study period. Total 168 ADRs were reported out of which, Amlodipine (causing headache and edema feet) was the most common drug with 51 (30.3%) ADR's followed by Enalapril, Aspirin and Isosorbide Dinitrate with 37 (22%), 24 (14.2%), 23 (13.6%) ADRs respectively. Most common ADR was headache (due to amlodipine and Isosorbide di nitrate) affecting 38 (22.62%) cases followed by dry cough 37 (22.02%) cases, edema feet 36 (21.43%), gastritis 24 (14.29%) and 10 (5.95%) of nausea. Conclusions: Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines are mostly used as multidrug therapy and always prone for ADRs.

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Section: Introductionmentioning

confidence: 99%

An assessment of pattern of adverse drug reactions of cardiovascular drugs in a tertiary care institute

Wankhede

Pardeshi

Ghorpade

et al. 2018

Int J Basic Clin Pharmacol

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“…6,7 India has a ADR reporting rate of 1 % which is much less when compared to the global ADR reporting rate of 5 %. 8 To address this problem, the Ministry of Health and Family Welfare has initiated a nationwide program known as "Pharmacovigilance Programme of India" (PvPI), which went ahead with its functioning in July of 2010. 9 The function of PvPI is to collect ADR data, analyse it and utilize its results as a means to recommend informed regulatory interventions, along with communicating the potential risks related to a drug to the health care personals and also to the common population.…”

Section: Introductionmentioning

confidence: 99%

A cross-sectional study evaluating the awareness of pharmacovigilance among MBBS interns of a teaching hospital in south India

Nadeem

Vaseem

Maqdoom

2016

Int J Basic Clin Pharmacol

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“…The awareness regarding reporting can be well recognized by the fact that during one calendar year, not even a single ADR report was sent to Uppsala monitoring centre (UMC) from a country of 1billion thus, ADR reporting rate in India is below 1% as compared to world rate of 5% [12]. and will take a lot of planning and management.…”

Section: Lack Of Adverse Event Reporting:-mentioning

confidence: 99%