JSS Academy of Higher Education & Research, Mysuru has signed a MoU with Uppsala Monitoring Centre (UMC), Sweden to conduct training programmes for capacity building in Pharmacovigilance for the Asia Pacific region. The UMC is a Collaborating Centre for WHO International Drug Monitoring Programme.
Uppsala Monitoring Centre (UMC), Sweden, a Collaborating Centre for WHO International Drug Monitoring Programme
| Sl. No | Title of the Training Course | Date |
|---|---|---|
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1 |
Report on Asia Pacific Pharmacovigilance Training Program - MoU Between JSSU & UMC |
2015 to 2018 |
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2 |
Fifth Asia Pacific Pharmacovigilance Training Course |
4th March to 15th March 2019 |
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3 |
Fourth Asia Pacific Pharmacovigilance Training Course |
29th January to 9th February 2018 |
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4 |
Third Asia Pacific Pharmacovigilance Training Course |
16th January to 28th January 2017 |
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5 |
Second Asia Pacific Pharmacovigilance Training Course |
18th January to 29th January 2016 |
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6 |
First Asia pacific Pharmacovigilance Training Course |
16th February to 27th February 2015 |
| Sl. No. | Title | Authors | Journal | Volume | Pages | Abstract |
|---|---|---|---|---|---|---|
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1 |
Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia Weblink: https://www.nejm.org/doi/full/10.1056/nejmoa1812792#article_citing_articles |
Bhatt, Ramesh M, & SH Chalasani |
NewEngland Journal of Medicine |
380; 2019 |
11-22 |
BACKGROUND: Patients with elevated triglyceride levels are at increased risk for ischemic events. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, lowers triglyceride levels, but data are needed to determine its effects on ischemic events. METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled trial involving patients with established cardiovascular disease or with diabetes and other risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135 to 499 mg per deciliter (1.52 to 5.63 mmol per liter) and a low-density lipoprotein cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter). The patients were randomly assigned to receive 2 g of icosapent ethyl twice daily (total daily dose, 4 g) or placebo. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. RESULTS: A total of 8179 patients were enrolled (70.7% for secondary prevention of cardiovascular events) and were followed for a median of 4.9 years.A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001); the corresponding rates of the key secondary end point were 11.2% and 14.8% (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001).The rates of additional ischemic end points, as assessed according to a prespecified hierarchical schema, were significantly lower in the Icosapent ethyl group than in the placebo group, including the rate of cardiovascular death (4.3% vs. 5.2%; hazard ratio, 0.80; 95% CI, 0.66 to 0.98; P=0.03). A larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for atrial fibrillation or flutter (3.1% vs. 2.1%, P=0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06). CONCLUSIONS: Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo. (Funded by Amarin Pharma; REDUCE-IT ClinicalTrials.gov number,NCT01492361. opens in new tab.) |
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2 |
Polypill with or without Aspirin in Persons without Cardiovascular Disease. Weblink: https://www.nejm.org/doi/full/10.1056/NEJMoa2028220?query=recirc_artType_railA_article |
Yusuf, Ramesh M, & Ann VK |
NewEngland Journal of Medicine |
384; 2020 |
216 - 228 |
BACKGROUND: A polypill comprising statins, multiple blood-pressure–lowering drugs, and aspirin has been proposed to reduce the risk of cardiovascular disease. METHODS: Using a 2-by-2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the outcomes for the polypill alone as compared with matching placebo, for aspirin alone as compared with matching placebo, and for the polypill plus aspirin as compared with double placebo. For the polypill-alone and polypill-plus-aspirin comparisons, the primary outcome was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization. For the aspirin comparison, the primary outcome was death from cardiovascular causes, myocardial infarction, or stroke. Safety was also assessed. RESULTS: A total of 5713 participants underwent randomization, and the mean follow-up was 4.6 years. The low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo. The primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.63 to 1.00). The primary outcome for the aspirin comparison occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.67 to 1.10). The primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and in 83 (5.8%) in the double-placebo group (hazard ratio, 0.69; 95% CI, 0.50 to 0.97).The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups. CONCLUSIONS: Combined treatment with a polypill plus aspirin led to a lower incidence of cardiovascular events than did placebo among participants without cardiovascular disease who were at intermediate cardiovascular risk. (Funded by the Wellcome Trust and others; TIPS-3 ClinicalTrials.gov number,NCT01646437. opens in new tab.) |
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3 |
Assessment of the Sociodemographic Profile, Pattern, and Outcomes of Intentional Poisoning Cases in an Emergency Department of a Tertiary Care Teaching Hospital. Weblink: https://pubmed.ncbi.nlm.nih.gov/32238074/ |
P. Abhimanyu & Ramesh M |
Crisis: The Journal of Crisis Intervention and Suicide Prevention |
41 (6); 2020 |
490 - 494 |
Background:Intentional self-poisoning has become a major health problem in low- and middle-income countries. Aims:We aimed to assess the sociodemographic profile, pattern, and outcomes of intentional poisoning cases in the emergency department of a tertiary care teaching hospital. Method:A prospective observational study was conducted at the department of emergency medicine of a South Indian tertiary care hospital for 1 year to study the sociodemographic profile, pattern, and outcomes of intentional poisoning cases. Results:The majority of poisonings were observed in the male population (64.5%) and among the age group of 19-40 years (65.2%). Poisoning was prevalent in rural/semi-urban populations (77.5%) and in people engaged in agriculture (28.4%) for their livelihood. Pesticides were the most common agents implicated (65.9%) in poisonings. Based on the Glasgow Coma Scale (GCS) and Poison Severity Scale (PSS), the majority of people with poisoning presented with mild (53.9%) and minor symptoms (36.3%). In 78.5% of the cases, patients recovered while mortality was observed in 5.4% of cases. Conclusion:There was a strong association between outcomes of poisoning and age. Organophosphate pesticides were the most commonly implicated substances in poisonings. Regulation policies should be made by the government to regulate the transport, distribution, and use of insecticides and pesticides. |
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4 |
Impact of pharmacist care in the management of autoimmune disorders: A systematic review of randomized control trials and non-randomized studies. Weblink: https://www.sciencedirect.com/journal/research-in-social-and-administrative-pharmacy/articles-in-press |
Sujith SK & Ramesh M |
Research in Social and Administrative Pharmacy |
S1551-7411 (20) |
-- |
Introduction:Autoimmune disorders are chronic, self-mediated, misdirected immune responses against their own immune system. It required intensive, complex and costly drug treatment regimen increased the risk of pharmacotherapy error and adversely affects patients. Hence, pharmacist care will have vital roles in autoimmune disorders to achieve health related outcomes. Objectives:This review aimed to gather evidence on the impact of pharmacist care on clinical, humanistic and economic outcomes, adherence to medications, and drug related problems in the management of autoimmune disorders among the usual care group. Methodology:A comprehensive review conducted in compliance with the PRISMA statement and systematic search was performed across five databases included PubMed Central, Web of Sciences, Scopus, Cochrane Library and google scholar from inception until August 2020. This research included full-text articles of randomized and non-randomized studies that evaluated impact of pharmacist care in autoimmune disorders. Results:A total of nine studies were included (seven RCTs and two non-RCTs), including 829 patients with autoimmune disorders. A total of four studies (80%) show an enhancement in at least one clinical parameter due to pharmacist care. A substantial improvement in at least one humanistic parameter observed in all five studies (100%). While four out of five studies (80%) clearly displayed a remarkable improvement in medication adherence in the pharmacist care group from baseline to the completion of follow-ups. One study quantified a 99.08% resolution of DRPs in the pharmacist care group. Another study estimated the cost of medical resources uses per patient and found no difference in cost-effectiveness over six months between groups. Conclusion:This review reinforces the vital contribution of pharmacists to achieve clinical outcomes, humanistic outcomes, adherence to medications and DRPs in the efficient management of autoimmune disorders. However, no notable changes in economic outcomes were observed in this review. |
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5 |
Assessment of Clinical Pharmacists' Assistance for Patients With Established Cardiovascular Diseases During the COVID-19 Pandemic: Insights From Southern India. Weblink: https://www.frontiersin.org/articles/10.3389/fcvm.2020.599807/full |
Oliver GJ, Sunil Kumar SK & Ramesh M |
Frontiers in Cardiovascular Medicine |
7; 2020 |
1 – 8 |
Objectives:We aimed to assess the clinical pharmacist-initiated telephone-based patient education and self-management support for patients with cardiovascular disease during the nationwide lockdown during COVID-19 pandemic. Methods:A prospective single-center telephone-based cross-sectional study was conducted among patients at the Cardiology Department and its speciality clinic at a 1,800-bed tertiary care hospital in Southern India. A validated 8-item clinical pharmacist aided on-call questionnaire with two Domains was administered during and after lockdown (15 March and 8 June 2020). Clinical pharmacist-provided educational assistance on self-management practices were in accordance with the guidelines of Indian Council of Medical Research (ICMR) and World Health Organization. Comparisons was performed using sign test and association of responses were analyzed using the Goodman and Kruskal's gamma test. All the tests were two-tailed,p< 0.05 was considered to be statistically significant. Results:Of the 1,080 patients, 907 consented with a response rate of (83.9%) and 574 (96.36%) patients were analyzed post-intervention. Majority of the patients were male (54.7%) and had Acute Coronary Syndrome [NSTEMI (42.10%), STEMI (33.92%) and Unstable Angina (9.86)]. The majority of subjects had at least two co-morbid conditions [(Type II Diabetes (48.33%), Hypertension (50.11%)] and were rural population (82.5%) as self-employed (43.1%) with a middle-class economy (31.6%). In the Domain-1 of checklist the awareness toward complications caused by COVID-19 in cardiovascular diseases (Z= −19.698,p= 0.000) and the importance of universal safety precautions enhanced after clinical pharmacist assistance [(Z= −8.603,p= 0.000) and (Z= −21.795,p= 0.000)]. In Domain-II of checklist there was a significant improvement in patients awareness toward fatal complications caused by COVID-19 (Z= −20.543,p= 0.000), maintenance of self-hygiene (Z= −19.287,p= 0.000), practice of universal safety precautions (Z= −16.912,p= 0.000) and self-isolation (Z= −19.545,p= 0.000). The results of our study population varied from baseline evaluation (41.7%,n= 907) to post-intervention (95%,n= 574) based on Literacy, employment status and economic status. Conclusions:The proactive role of clinical pharmacists in providing instructional services in collaboration with cardiologist during the pandemic circumstances increased patients understanding and mitigated infection exposure among patients, health care professionals and also assuring the continuity of care in patients with established cardiovascular diseases. |