Classification and applying pharmacovigilance principles to study adverse drug reaction and its management

Srihitha, Pendota; Surabhineni, Sre Akshaya Kalyani; Katnapally, Abhinay Sharma; Porandla, Dharanija; Beemreddy, Sandeep Kumar

doi:10.18203/2319-2003.ijbcp20174767

Cited by 4 publications

(3 citation statements)

References 6 publications

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“…Schumock and Thornton preventability scale does not give a proper outcome, as the scale is not differentiated and interpreted properly. 35,36 As there is less time period to assess large population with ADRs, so assessing each and every single ADR was a tough task because most of the patients were not included in the study due to various reasons such as no follow up of the patient, patients left under medical advice without treatment, intensive care patients were tough to assess with ADR and surgical department cases were with many number of drugs which lead to confusion of suspected drug.…”

Section: Incidence Of Antibiotic Classesmentioning

confidence: 99%

A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study

Kalyani¹,

Srihitha²,

Sharma³

et al. 2019

Int J Basic Clin Pharmacol

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Background: An adverse drug reaction (ADRs) is determined as response to a drug that is noxious unintended excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The main aim of the study is to detect, understand and report ADR’S.Methods: This study is prospective observational study conducted for 6 months in in-patient setting in a tertiary care hospital. Naranjo’s, WHO causality scale, Siegel scale, Schumock and Thornton scale are used to assess ADR. Graph Pad Prism and SAS software’s are used.Results: Data was collected from a total of 1000 patients of which 121 (12.1%) patients were effected with 150 ADRs. Among 121 patients AdrAd was 60.66% and AdrIn was 39.33%. Of 121 patients 97 patients with single ADR, 28 patients with 2 ADRs, 10 patients were with three ADRs. ADR onset divides acute (10%), Latent (39%) and sub-acute (51%). ADR occurred are recovered (54%), Recovering (13%). Naranjos scale interprets definite (0.9%), probable (50.9%), possible (42.97%). According to WHO scale certain (2.7%), unlikely (2.7%), possible (38.84%). Hartwig and Siegel scale results are mild (12.4%), moderate (66.12%) and severe (12.4%). Schumock and Thornton preventability results are definitely (25.45%), probably (68.18%) and not preventable (6.36%).Conclusions: Every health care professional should be aware of the Pharmacovigilance principles and also should be aware of suspected ADR reporting form of PVPI. By applying the above scales it is easy for health care professionals to assess an ADR.

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Section: Incidence Of Antibiotic Classesmentioning

confidence: 99%

A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study

Kalyani¹,

Srihitha²,

Sharma³

et al. 2019

Int J Basic Clin Pharmacol

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“…For example, most of the elderly have memory problems related to age, while most of elderly patients have vision and hearing problems that might increase the potential of mistakes in taking medications. [26][27][28] Another problem with elderly is that most of them have comorbid conditions and are prescribed with several drugs at the same time which might be confusing to remember. [29][30][31] According to Chythra R Rao women were found to be more compliant to Prescription than men, but gender was not identified as a significant factor in other studies.…”

Section: Discussionmentioning

confidence: 99%

Cross sectional study on prevalence and medication adherence of hypertension and diabetes in a tertiary care hospital in Karimnagar, India

Kalyani¹,

Srihitha²,

Katnapally³

et al. 2018

Int J Basic Clin Pharmacol

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INTRODUCTIONDM and HTN are most common and serious diseases with chronic complications and these both are risk factors for cardiovascular diseases which increases the risk of stroke, myocardial infarction, heart failure, and chronic kidney disease.1,2 The main objective of this study is to find out prevalence of both HTN and DM in hospitalized patients along with comparison of age and gender. Up to 75% of adults with diabetes also have HTN, and patients with HTN alone show insulin resistance. 3,4 ABSTRACT Background:The study aimed to assess the prevalence of Hypertension (HTN), Diabetes mellitus(DM) and other diseases along with comorbid conditions, disease complications and also to assess medication adherence in a tertiary hospital in Karimnagar, Telangana, India. Methods: A Cross sectional study is performed by analysing a total of 500 patient's individual case safety reports (ICSR). Prevalence of Hypertension and Diabetes along with most prescribed drugs are analysed. Medication adherence is analysed by using Morisky Medication adherence questionnaire scale (MMAS-4). Results: Patients with past history of DM, HTN and other diseases which was found to be 245 (49%) patients. Patients with highest disease prevalence were found to be with HTN (56.73%), DM (31.83%) followed by other diseases like asthma (8.57%), Cerebrovascular accident (4.89%) etc., Total of 66 Patients were ruled out with comorbid diseases. Patients with HTN+DM (47) were found to be highest followed by DM+HTN+CVA (4). MMAS-4 revealed 208 patients were using medication out of 245 patients with previous history. According to MMAS-4 most of the patients were with medium adherence (76). Prevalent drug used for HTN include Amlodipine and for DM Telmisartan+Hydrochlorthiazide. Conclusions: The study revealed that almost half of the admitted patients were with HTN and DM. The patients were counselled properly to adhere strictly to the prescription. Medication adherence to HTN and DM was found to be good in this study. Since the disease complications were also ruled out, the health care professionals are recommended to spread awareness on DM and HTN and disease management in order to control disease and improve health outcomes.

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“…Both groups were followed up for four months. At the end of the four-month follow-up period, biochemical parameters were repeated to assess for any change in nutritional indices [ 15 ]. The change in nutritional and biochemical indices was defined as the difference between the values at the end of the study (four months) and the baseline values.…”

Section: Methodsmentioning

confidence: 99%

Optimizing Nutrition in Renal Patients: Effects of a Low-Protein Diet Supplemented With Ketoacids

Aghwana¹,

Aiwuyo²,

Ovwasa³

et al. 2023

Cureus

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Background Chronic kidney disease (CKD) is a non-communicable disease; it is a major cause of morbidity and mortality in Nigeria as the incidence has been increasing in Nigeria over the last few years. A low-protein diet supplemented with ketoacids has been duly documented to reduce the malnutrition associated with CKD as well as improve estimated glomeruli filtration rate while delaying the onset of dialysis in predialysis CKD patients. Objective The aim of this study was to determine the effects of a low-protein diet supplemented with ketoacids compared to a conventional low protein on nutritional indices in predialysis CKD patients. Methods and materials A randomized controlled trial with a total of 60 participants was conducted at Delta State University Teaching Hospital (DELSUTH), Oghara, Nigeria. Participants were patients older than 18 years with CKD stage 3-5 who were not on dialysis. They were recruited and randomized into the intervention group (low-protein diet supplemented with ketoacids) with 30 participants and the non-intervention group (low protein with placebo) with 30 participants. The mean outcome was changed in the nutritional indices from baseline till the end of the study. Results A total of 60 patients were randomly allocated to receive a low-protein diet supplemented with ketoacids (n=30) or control (n=30). All participants were included in the analysis of all outcomes. The mean change score in serum total protein, albumin, and triglycerides between the intervention and non-intervention groups were 1.1±1.1 g/dL vs 0.1±1.1 g/dL (p<0.001), 0.2±0.9 g/dL vs -0.3±0.8 g/dL (p<0.001), and 3.0±3.5 g/dL vs 1.8±3.7 g/dL, respectively. Conclusion and recommendation The use of low-protein diet supplemented with ketoacids improved the anthropometric and nutritional indices in patients with stage 3-5 CKD.

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Classification and applying pharmacovigilance principles to study adverse drug reaction and its management

Cited by 4 publications

References 6 publications

A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study

A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study

Cross sectional study on prevalence and medication adherence of hypertension and diabetes in a tertiary care hospital in Karimnagar, India

Optimizing Nutrition in Renal Patients: Effects of a Low-Protein Diet Supplemented With Ketoacids

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