Pub Date : 2015-02-26DOI: 10.4172/2167-1052.1000177
Kothari Dj, A. Tabor
Objectives: Anti-Psychotics are a group of medications that are used to treat schizophrenia group of conditions, Mania caused by Bipolar disorder, and other conditions that can cause visual or auditory hallucinations. These hallucinations cause an individual to lose balance with reality and force their inner well being to lose self-control. The purpose of this research design is to identify the relationship between the atypical anti-psychotics and their associations with weight gain. The design is set to distinguish which of the three drugs leads to more weight gain and diabetogenic complications and added side effects in the patients at Griffin Memorial Hospital and Central Oklahoma Community Mental Health Center from 1/1/2010 to 12/31/2013. Methods: Data from 555 patients were analyzed using a one-way ANOVA from Excel and R-version 3.0.3 statistics. Data was statistically analyzed using p tests. Results: All of the atypical antipsychotics (Quetiapine, Olanzapine, Clozapine) led to weight gain with Risperidone having a synergistic effect. Diabetes was associated with all of the drugs and Quetiapine showed more GI complications than the other drugs and combinations (p>0.05). Conclusion: Our study suggests that atypical antipsychotics that were studied were associated with weight gain. Our findings demonstrated that no one drug was overwhelmingly led to more weight gain than the other. Adding risperidone had a synergistic effect and further enhanced weight gain. If replicated, the data may lead to clarification of the results and concluded analysis of the pharmacologic treatment plans of patients at Griffin Memorial Hospital and Central Oklahoma Mental Health Center.
{"title":"Retrospective Review of Weight Gain with Atypical Antipsychotics at GMH and COCMHC","authors":"Kothari Dj, A. Tabor","doi":"10.4172/2167-1052.1000177","DOIUrl":"https://doi.org/10.4172/2167-1052.1000177","url":null,"abstract":"Objectives: Anti-Psychotics are a group of medications that are used to treat schizophrenia group of conditions, Mania caused by Bipolar disorder, and other conditions that can cause visual or auditory hallucinations. These hallucinations cause an individual to lose balance with reality and force their inner well being to lose self-control. The purpose of this research design is to identify the relationship between the atypical anti-psychotics and their associations with weight gain. The design is set to distinguish which of the three drugs leads to more weight gain and diabetogenic complications and added side effects in the patients at Griffin Memorial Hospital and Central Oklahoma Community Mental Health Center from 1/1/2010 to 12/31/2013. \u0000 \u0000Methods: Data from 555 patients were analyzed using a one-way ANOVA from Excel and R-version 3.0.3 \u0000statistics. Data was statistically analyzed using p tests. \u0000 \u0000Results: All of the atypical antipsychotics (Quetiapine, Olanzapine, Clozapine) led to weight gain with \u0000Risperidone having a synergistic effect. Diabetes was associated with all of the drugs and Quetiapine showed more GI complications than the other drugs and combinations (p>0.05). \u0000 \u0000Conclusion: Our study suggests that atypical antipsychotics that were studied were associated with weight gain. Our findings demonstrated that no one drug was overwhelmingly led to more weight gain than the other. Adding risperidone had a synergistic effect and further enhanced weight gain. If replicated, the data may lead to clarification of the results and concluded analysis of the pharmacologic treatment plans of patients at Griffin Memorial Hospital and Central Oklahoma Mental Health Center.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"228 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2015-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73831229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-02-04DOI: 10.4172/2167-1052.1000176
Caffrey, Noh, Morrill Hj, LaPlante Kl
Background: Methicillin-Resistant Staphylococcus aureus (MRSA) has become a leading cause of pneumonia in the United States and there is limited data on treatment outcomes in obese patients.We evaluated the effectiveness of linezolid compared to vancomycin for the treatment of MRSA pneumonia in a national cohort of obese Veterans. Methods: This retrospective cohort study included obese patients (body mass index ≥ 30) admitted to Veterans Affairs hospitals with MRSA-positive respiratory cultures and clinical signs of infection between 2002 and 2012. Patients initiating treatment with either vancomycin or linezolid, but not both, were selected for inclusion. Propensity matching and adjustment of Cox proportional hazards regression models quantified the effect of linezolid compared with vancomycin on time to hospital discharge, intensive care unit discharge, 30-day mortality, inpatient mortality, therapy discontinuation, therapy change, 30-day readmission, and 30-day MRSA reinfection. We performed sensitivity analyses by vancomycin Minimum Inhibitory Concentrations (MICs) and true trough levels. Results: We identified 101 linezolid and 2,565 vancomycin patients. Balance in baseline characteristics between the treatment groups was achieved within propensity score quintiles and between propensity matched pairs (76 pairs). No significant differences were observed for the outcomes assessed. Among patients with vancomycin MICs of ≤ 1 μg/mL, the linezolid group had a significantly lower mortality rate, increased length of hospital stay, and longer therapy duration. There were no differences between the linezolid and vancomycin MICs of ≥ 1.5 μg/mL groups. Clinical outcomes among those with vancomycin trough concentrations of 15-20 mg/L were similar to patients treated with linezolid. Conclusions: In our real-world comparative effectiveness study among obese patients with suspected MRSA pneumonia, linezolid was associated with a significantly lower mortality rate as compared to the vancomycin-treated patients with lower vancomycin MICs. Further studies are needed to determine whether this beneficial effect is observed in other study populations.
{"title":"The Effects of Obesity on the Comparative Effectiveness of Linezolid and Vancomycin in Suspected Methicillin-Resistant Staphylococcus aureus Pneumonia","authors":"Caffrey, Noh, Morrill Hj, LaPlante Kl","doi":"10.4172/2167-1052.1000176","DOIUrl":"https://doi.org/10.4172/2167-1052.1000176","url":null,"abstract":"Background: Methicillin-Resistant Staphylococcus aureus (MRSA) has become a leading cause of pneumonia in the United States and there is limited data on treatment outcomes in obese patients.We evaluated the effectiveness of linezolid compared to vancomycin for the treatment of MRSA pneumonia in a national cohort of obese Veterans. \u0000Methods: This retrospective cohort study included obese patients (body mass index ≥ 30) admitted to Veterans Affairs hospitals with MRSA-positive respiratory cultures and clinical signs of infection between 2002 and 2012. Patients initiating treatment with either vancomycin or linezolid, but not both, were selected for inclusion. Propensity matching and adjustment of Cox proportional hazards regression models quantified the effect of linezolid compared with vancomycin on time to hospital discharge, intensive care unit discharge, 30-day mortality, inpatient mortality, therapy discontinuation, therapy change, 30-day readmission, and 30-day MRSA reinfection. We performed sensitivity analyses by vancomycin Minimum Inhibitory Concentrations (MICs) and true trough levels. \u0000Results: We identified 101 linezolid and 2,565 vancomycin patients. Balance in baseline characteristics \u0000between the treatment groups was achieved within propensity score quintiles and between propensity matched pairs (76 pairs). No significant differences were observed for the outcomes assessed. Among patients with vancomycin MICs of ≤ 1 μg/mL, the linezolid group had a significantly lower mortality rate, increased length of hospital stay, and longer therapy duration. There were no differences between the linezolid and vancomycin MICs of ≥ 1.5 μg/mL groups. Clinical outcomes among those with vancomycin trough concentrations of 15-20 mg/L were similar to patients treated with linezolid. \u0000Conclusions: In our real-world comparative effectiveness study among obese patients with suspected MRSA pneumonia, linezolid was associated with a significantly lower mortality rate as compared to the vancomycin-treated patients with lower vancomycin MICs. Further studies are needed to determine whether this beneficial effect is observed in other study populations.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"124 1","pages":"1-10"},"PeriodicalIF":0.0,"publicationDate":"2015-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87989966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-16DOI: 10.4172/2167-1052.1000174
Rao Kn, Reddy Gn, N. Vinny, S. Das, C. Dhanapal, S. Selvamuthukumaran
Background: The present research deals with pharmacoepidemiology and pharmacoeconomic study of Acute Coronary Syndrome (ACS) and its impact on patient’s therapeutic outcome and cost of therapy. According to a recent World Health Origination (WHO) report around 100 million people died every year due to poverty associated with illness. Contributing to the growing literature on the economic burden of illness, this article examines the indirect and direct costs of illness that occurs on household level, describes its influence on treatment seeking behavior and assesses its impact on household welfare. Methods: The contemporary research was performed in Coronary Care Unit (CCU) and medicine ward department of medicine, RMMC and Hospital over 65 patients to illustrate the expenditure in harmony with achieved desired therapeutic outcomes by analyzing therapy cost of Acute Coronary Syndrome (ACS) supplemented via therapeutic outcomes using Minnesota Living with Heart Failure and Condition Questionnaire (MLHFCQ). Results: The values were observed and recorded using appropriate data collection forms and MLHFC questionnaire. The total cost (TC) spent was recorded as 7,096.2 USD with most patients (n=16; 35.61%) paying in cost range of (110.1 to 141.5 USD). The total direct therapy cost was 6,278.6 USD accounting 88.47% of total cost and indirect cost 817.6 USD (11.52 % of TC). Significant improvement observed in overall mean MLHFC score of 62.93 compared to the baseline score of 37.94 rated moderate. Conclusion: The study was designed, planned and executed to estimate cost of the given therapy and direct effect on patient therapeutic outcome.
{"title":"Analyzing Burden of Cost of Therapy in Patients Affected with Acute Coronary Syndrome in Tertiary Care Hospital","authors":"Rao Kn, Reddy Gn, N. Vinny, S. Das, C. Dhanapal, S. Selvamuthukumaran","doi":"10.4172/2167-1052.1000174","DOIUrl":"https://doi.org/10.4172/2167-1052.1000174","url":null,"abstract":"Background: The present research deals with pharmacoepidemiology and pharmacoeconomic study of Acute Coronary Syndrome (ACS) and its impact on patient’s therapeutic outcome and cost of therapy. According to a recent World Health Origination (WHO) report around 100 million people died every year due to poverty associated with illness. Contributing to the growing literature on the economic burden of illness, this article examines the indirect and direct costs of illness that occurs on household level, describes its influence on treatment seeking behavior and assesses its impact on household welfare. \u0000 \u0000Methods: The contemporary research was performed in Coronary Care Unit (CCU) and medicine ward department of medicine, RMMC and Hospital over 65 patients to illustrate the expenditure in harmony with achieved desired therapeutic outcomes by analyzing therapy cost of Acute Coronary Syndrome (ACS) supplemented via therapeutic outcomes using Minnesota Living with Heart Failure and Condition Questionnaire (MLHFCQ). \u0000 \u0000Results: The values were observed and recorded using appropriate data collection forms and MLHFC questionnaire. The total cost (TC) spent was recorded as 7,096.2 USD with most patients (n=16; 35.61%) paying in cost range of (110.1 to 141.5 USD). The total direct therapy cost was 6,278.6 USD accounting 88.47% of total cost and indirect cost 817.6 USD (11.52 % of TC). Significant improvement observed in overall mean MLHFC score of 62.93 compared to the baseline score of 37.94 rated moderate. \u0000 \u0000Conclusion: The study was designed, planned and executed to estimate cost of the given therapy and direct effect on patient therapeutic outcome.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"49 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2015-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82634727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-06DOI: 10.4172/2167-1052.1000172
M. Cáceres, P. Moyano, H. Fariñas, J. Cobaleda, A. Pijierro, P. Dorado, A. Llerena
Objective: This study aimed to describe the use of antihypertensive in Extremadura (Spain) from 1990 to 2012 and its economic impact. Method: Information on antihypertensive drug (ATC C02, C03, C07, C08, C09) utilization was obtained from the community pharmacy sales figures reimbursed by the Health System of Extremadura (Spain). Data were expressed in Defined Daily Dose (DDD) and DDD per 1000 inhabitants per day (DHD). Results: Antihypertensive consumption in Extremadura increased from 67.1 DHD in 1990 to 315.2 in 2012 (an increase of 3.7 times). Agents acting on the Renin-Angiotensin System (C09) are responsible for 75% of the total increase. Since 2007 the use of Angiotensin II antagonist increased over ACE inhibitors. Conclusions: The consumption of antihypertensive drugs in Extremadura increased remarkably in the last 23 years. In the last years the use of angiotensin II antagonist drugs is having a significant economic impact.
{"title":"Trends in Antihypertensive Drug Use in Spanish Primary Health Care (1990- 2012)","authors":"M. Cáceres, P. Moyano, H. Fariñas, J. Cobaleda, A. Pijierro, P. Dorado, A. Llerena","doi":"10.4172/2167-1052.1000172","DOIUrl":"https://doi.org/10.4172/2167-1052.1000172","url":null,"abstract":"Objective: This study aimed to describe the use of antihypertensive in Extremadura (Spain) from 1990 to 2012 and its economic impact. \u0000Method: Information on antihypertensive drug (ATC C02, C03, C07, C08, C09) utilization was obtained from the community pharmacy sales figures reimbursed by the Health System of Extremadura (Spain). Data were expressed in Defined Daily Dose (DDD) and DDD per 1000 inhabitants per day (DHD). \u0000Results: Antihypertensive consumption in Extremadura increased from 67.1 DHD in 1990 to 315.2 in 2012 (an increase of 3.7 times). Agents acting on the Renin-Angiotensin System (C09) are responsible for 75% of the total increase. Since 2007 the use of Angiotensin II antagonist increased over ACE inhibitors. \u0000Conclusions: The consumption of antihypertensive drugs in Extremadura increased remarkably in the last 23 years. In the last years the use of angiotensin II antagonist drugs is having a significant economic impact.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"58 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2015-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91272321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-01DOI: 10.4172/2167-1052.1000E134
Patil Js
The biopharmaceutical performance of an existing drug molecule can be significantly improved through its evolution from a conventional form to a novel delivery system. Apart from biopharmaceutical performances, the safety, efficacy and patient compliance are also improved for a drug molecule. Present day drug delivery companies are emphasizing prominently on development of multiple platform technologies for getting competitive merits, expand patent span, and enhance market share of their products. The quantum of novel drug delivery products has significantly increased in the past few years, and this growth is expected to continue in the near future. Today large numbers of companies are busy developing protein and peptide based drug molecules due to advancement in the field of genomics which in turn accelerated research of biopharmaceuticals. Due to the unique nature of biopharmaceuticals it is difficult to deliver them by conventional routes and this presents challenges to the drug delivery scientists. Therefore, present research is focusing on the delivery of these complex molecules through different routes including oral, nasal, pulmonary, vaginal, rectal, buccal, colon specific, etc. [1].
{"title":"Novel Drug Delivery Strategies: New Concepts","authors":"Patil Js","doi":"10.4172/2167-1052.1000E134","DOIUrl":"https://doi.org/10.4172/2167-1052.1000E134","url":null,"abstract":"The biopharmaceutical performance of an existing drug molecule can be significantly improved through its evolution from a conventional form to a novel delivery system. Apart from biopharmaceutical performances, the safety, efficacy and patient compliance are also improved for a drug molecule. Present day drug delivery companies are emphasizing prominently on development of multiple platform technologies for getting competitive merits, expand patent span, and enhance market share of their products. The quantum of novel drug delivery products has significantly increased in the past few years, and this growth is expected to continue in the near future. Today large numbers of companies are busy developing protein and peptide based drug molecules due to advancement in the field of genomics which in turn accelerated research of biopharmaceuticals. Due to the unique nature of biopharmaceuticals it is difficult to deliver them by conventional routes and this presents challenges to the drug delivery scientists. Therefore, present research is focusing on the delivery of these complex molecules through different routes including oral, nasal, pulmonary, vaginal, rectal, buccal, colon specific, etc. [1].","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87714330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-01DOI: 10.4172/2167-1052.1000005-R
Jhansi Konduru
Adverse drug reactions are also known as side effects. Adverse drugs reactions (Adrs), are toxic, unintended, and undesirable impacts which occur as result of drug treatment. These reactions occur due to self-medication or due to intake of over dose of medicines without prescription. The prescribed drugs may produce undesirable effects along with main effect which leads to adverse drug reactions. Most of the adverse drug reactions are preventable. Hence, in order to avoid adverse drug reactions one should take only properly prescribed drugs
{"title":"Review on Adverse Drug Reactions","authors":"Jhansi Konduru","doi":"10.4172/2167-1052.1000005-R","DOIUrl":"https://doi.org/10.4172/2167-1052.1000005-R","url":null,"abstract":"Adverse drug reactions are also known as side effects. Adverse drugs reactions (Adrs), are toxic, unintended, and undesirable impacts which occur as result of drug treatment. These reactions occur due to self-medication or due to intake of over dose of medicines without prescription. The prescribed drugs may produce undesirable effects along with main effect which leads to adverse drug reactions. Most of the adverse drug reactions are preventable. Hence, in order to avoid adverse drug reactions one should take only properly prescribed drugs","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"30 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82755704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-01DOI: 10.4172/2167-1052.1000173
Y. Guo, Y. Li, Y. Jia
Purpose: The aim of this study was to analyze the clinical characteristics of Systemic Lupus Erythematosus (SLE) patients with Coronary Artery Disease (CAD). Methods: This study used data from electronic medical records system from Fuwai Hospital. Subjects included SLE patients with CAD and gender-and, age-matched CAD patients without autoimmune connective tissue diseases in a ratio of 1:4. All CAD patients were confirmed by Coronary Angiography (CAG). Data from all subjects was abstracted for Cardiovascular Disease (CVD) risk factors, laboratory test results, echocardiography and CAG. Results: The proportion of old myocardial infarction (OMI) (p=0.000), myocardial infarction (MI) (p=0.001), family history of premature CAD (p=0.023), hypercholesterolemia (p=0.005), menopause (p=0.015), renal disease manifestation (p=0.000), and higher CRP (p=0.000) in SLE patients with CAD (n=22) were significantly higher than in CAD patients (n=88). CAG showed more multi-vessel lesions (p=0.015) and vascular occlusion lesions (p=0.006) in SLE patients with CAD. Total cholesterol (TC), serum creatinine, urine protein and B-type natriuretic peptide precursor (pro-BNP) were significantly higher in SLE patients with CAD (p=0.000). SLE patients with CAD had higher mortality than CAD patients (p=0.029). Conclusions: These results indicate that SLE patients with CAD have more renal insufficiency, hypercholesterolemia, and family history of premature CAD than matched patients. In addition, SLE patients with CAD have more extensive and severe coronary artery lesions, and are easily combined with cardiac dysfunction.
{"title":"Clinical Characteristics of Systemic Lupus Erythematosus Patients with Coronary Artery Disease: A Matched Study","authors":"Y. Guo, Y. Li, Y. Jia","doi":"10.4172/2167-1052.1000173","DOIUrl":"https://doi.org/10.4172/2167-1052.1000173","url":null,"abstract":"Purpose: The aim of this study was to analyze the clinical characteristics of Systemic Lupus Erythematosus (SLE) patients with Coronary Artery Disease (CAD). Methods: This study used data from electronic medical records system from Fuwai Hospital. Subjects included SLE patients with CAD and gender-and, age-matched CAD patients without autoimmune connective tissue diseases in a ratio of 1:4. All CAD patients were confirmed by Coronary Angiography (CAG). Data from all subjects was abstracted for Cardiovascular Disease (CVD) risk factors, laboratory test results, echocardiography and CAG. Results: The proportion of old myocardial infarction (OMI) (p=0.000), myocardial infarction (MI) (p=0.001), family history of premature CAD (p=0.023), hypercholesterolemia (p=0.005), menopause (p=0.015), renal disease manifestation (p=0.000), and higher CRP (p=0.000) in SLE patients with CAD (n=22) were significantly higher than in CAD patients (n=88). CAG showed more multi-vessel lesions (p=0.015) and vascular occlusion lesions (p=0.006) in SLE patients with CAD. Total cholesterol (TC), serum creatinine, urine protein and B-type natriuretic peptide precursor (pro-BNP) were significantly higher in SLE patients with CAD (p=0.000). SLE patients with CAD had higher mortality than CAD patients (p=0.029). Conclusions: These results indicate that SLE patients with CAD have more renal insufficiency, hypercholesterolemia, and family history of premature CAD than matched patients. In addition, SLE patients with CAD have more extensive and severe coronary artery lesions, and are easily combined with cardiac dysfunction.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"50 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91543354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-01DOI: 10.4172/2167-1052.1000186
Dominique M. Ijff, Kinderen Rj, C. I. Vader, Majoie Mhjm, A. Aldenkamp
Purpose: Antiepileptic drugs (AEDs) can cause side-effects. Patient-reported side-effects due to this type of medication are very common, but thus far only investigated in community based populations. We investigated the subjectively perceived side-effects of anti-epileptic drug treatment in patients with refractory epilepsy. Methods: A non-selected group, of patients visiting the outpatient department between September 2011 and November 2011 was invited to complete a questionnaire only if they had experienced side-effects of their AED treatment during last year. The questionnaire, the SIDAED, assessed four different categories; cognition, mood, cosmetics and general health. Subgroup analyses were based on their medication use: mono- or polytherapy, older and newer AEDs and AEDs with a high or a low risk for cognitive and behavioral/mood side-effects. Results: In total, 203 patients or their relatives completed the questionnaire. Mean age of the patients was 37 years (2-81). Most reported complaints (85%) were about their general health followed by cognition, mood and cosmetics. Subgroup analyses showed no differences between patients using monotherapy or polytherapy. Also, no differences were found between patients using older AEDs or newer drugs. Patients using AEDs with a high risk for side-effects did complain more about their mood but not about their cognition. Regression analysis showed that using a high risk AED for behavioral side-effects contributed significantly to the total experienced side-effects. Conclusion: In conclusion, our study illustrates that patients are a reliable respondent to indicate side-effects despite of their refractory epilepsy. Particularly, mood complaints due to antiepileptic drugs (such as levetiracetam) are correctly noticed.
{"title":"Subjectively Perceived Side-Effects of Anti-Epileptic Drugs in Chronic Refractory Epilepsy","authors":"Dominique M. Ijff, Kinderen Rj, C. I. Vader, Majoie Mhjm, A. Aldenkamp","doi":"10.4172/2167-1052.1000186","DOIUrl":"https://doi.org/10.4172/2167-1052.1000186","url":null,"abstract":"Purpose: Antiepileptic drugs (AEDs) can cause side-effects. Patient-reported side-effects due to this type of medication are very common, but thus far only investigated in community based populations. We investigated the subjectively perceived side-effects of anti-epileptic drug treatment in patients with refractory epilepsy. Methods: A non-selected group, of patients visiting the outpatient department between September 2011 and November 2011 was invited to complete a questionnaire only if they had experienced side-effects of their AED treatment during last year. The questionnaire, the SIDAED, assessed four different categories; cognition, mood, cosmetics and general health. Subgroup analyses were based on their medication use: mono- or polytherapy, older and newer AEDs and AEDs with a high or a low risk for cognitive and behavioral/mood side-effects. Results: In total, 203 patients or their relatives completed the questionnaire. Mean age of the patients was 37 years (2-81). Most reported complaints (85%) were about their general health followed by cognition, mood and cosmetics. Subgroup analyses showed no differences between patients using monotherapy or polytherapy. Also, no differences were found between patients using older AEDs or newer drugs. Patients using AEDs with a high risk for side-effects did complain more about their mood but not about their cognition. Regression analysis showed that using a high risk AED for behavioral side-effects contributed significantly to the total experienced side-effects. Conclusion: In conclusion, our study illustrates that patients are a reliable respondent to indicate side-effects despite of their refractory epilepsy. Particularly, mood complaints due to antiepileptic drugs (such as levetiracetam) are correctly noticed.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"15 1","pages":"4"},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85233029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-01DOI: 10.4172/2167-1052.1000E128
S. Garlapati, Nag, S. La
Risk is probability of harm being caused. Risks related to the medicinal products may be any risk relating to quality, safety or efficacy of medicinal product as regards to patient’s health or public health and any risk of undesirable effect on environment. Risk management system is a series of pharmacological activities for identification of risk, its assessment, minimization or prevention and its communication [1,2]. Risk management plan (RMP) is the complete description of risk management system. Main aim of RMP is to ensure safety of the patient using the drug. RMP’s are required to be submitted during the authorization of a drug. An updated RMP should now be submitted at the request of the national competent authority, whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the risk-benefit balance or as a result of an important pharmacovigilance or risk minimization milestone being reached.
{"title":"Risk Management Plan Its Importance and Emphasys on Pharmacovigilance Activities","authors":"S. Garlapati, Nag, S. La","doi":"10.4172/2167-1052.1000E128","DOIUrl":"https://doi.org/10.4172/2167-1052.1000E128","url":null,"abstract":"Risk is probability of harm being caused. Risks related to the medicinal products may be any risk relating to quality, safety or efficacy of medicinal product as regards to patient’s health or public health and any risk of undesirable effect on environment. Risk management system is a series of pharmacological activities for identification of risk, its assessment, minimization or prevention and its communication [1,2]. Risk management plan (RMP) is the complete description of risk management system. Main aim of RMP is to ensure safety of the patient using the drug. RMP’s are required to be submitted during the authorization of a drug. An updated RMP should now be submitted at the request of the national competent authority, whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the risk-benefit balance or as a result of an important pharmacovigilance or risk minimization milestone being reached.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"76 3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77392410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2014-12-14DOI: 10.4172/2167-1052.1000171
Kim Sh, Jongwha Chang
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