Pub Date : 2014-09-27DOI: 10.4172/2167-1052.1000161
Svetla Gadzhanova, E. Roughead
Background: Comorbidity is common in individuals with atrial fibrillation (AF). The predominant treatment for AF is warfarin and medicine interactions with warfarin represent a challenge for optimising treatment of AF in older people with comorbidities. Statins and Proton Pump Inhibitors are commonly prescribed therapies and in both classes, there are medicines with greater or lesser potential to interact with warfarin. Objective: The aim of this study was to examine use of antithrombotic treatment in elderly Australians, and the extent of concurrent use of interacting statins and proton pump inhibitors (PPIs) with warfarin. Methods: A retrospective cohort study was conducted using data from the Australian Government Department of Veterans’ Affairs. The cohort included all patients who had at least one hospitalisation with a primary diagnosis for AF between 2007 and 2011. Individuals contributed person-months from the date of first AF hospitalisation to death or end of study (December 2011). Monthly utilisation of antithrombotics was assessed. A sub-cohort of warfarin users was defined as those with AF who received warfarin as monotherapy and the proportions of those co-dispensed statins or PPIs were established. Results: Around 70% of patients with AF were receiving antithrombotic treatment, with 35% dispensed warfarin, 17% aspirin, and 7% clopidogrel as monotherapy. In December 2011, 54% of patients with AF on warfarin monotherapy were co-dispensed a statin, with the statins with potential for interaction dispensed at highest rates; atorvastatin followed by simvastatin and rosuvastatin. At study end, 43% of the warfarin cohort were also dispensed PPIs, with one-third using esomeprazole, followed by pantoprazole, both of which have the potential to interact with warfarin. Conclusion: 30% of patients with AF were not receiving antithrombotic treatment. In those receiving an antithrombotic agent, warfarin was the most commonly dispensed (35%). The most common statin and PPI coprescribed with warfarin were agents with the potential to interact with warfarin, despite alternative agents being available. Raising awareness of the safer alternative for people with comorbidities may improve warfarin management.
{"title":"Co-prescribing of Warfarin with Statins and Proton Pump Inhibitors in Elderly Australians","authors":"Svetla Gadzhanova, E. Roughead","doi":"10.4172/2167-1052.1000161","DOIUrl":"https://doi.org/10.4172/2167-1052.1000161","url":null,"abstract":"Background: Comorbidity is common in individuals with atrial fibrillation (AF). The predominant treatment for AF is warfarin and medicine interactions with warfarin represent a challenge for optimising treatment of AF in older people with comorbidities. Statins and Proton Pump Inhibitors are commonly prescribed therapies and in both classes, there are medicines with greater or lesser potential to interact with warfarin. Objective: The aim of this study was to examine use of antithrombotic treatment in elderly Australians, and the extent of concurrent use of interacting statins and proton pump inhibitors (PPIs) with warfarin. Methods: A retrospective cohort study was conducted using data from the Australian Government Department of Veterans’ Affairs. The cohort included all patients who had at least one hospitalisation with a primary diagnosis for AF between 2007 and 2011. Individuals contributed person-months from the date of first AF hospitalisation to death or end of study (December 2011). Monthly utilisation of antithrombotics was assessed. A sub-cohort of warfarin users was defined as those with AF who received warfarin as monotherapy and the proportions of those co-dispensed statins or PPIs were established. Results: Around 70% of patients with AF were receiving antithrombotic treatment, with 35% dispensed warfarin, 17% aspirin, and 7% clopidogrel as monotherapy. In December 2011, 54% of patients with AF on warfarin monotherapy were co-dispensed a statin, with the statins with potential for interaction dispensed at highest rates; atorvastatin followed by simvastatin and rosuvastatin. At study end, 43% of the warfarin cohort were also dispensed PPIs, with one-third using esomeprazole, followed by pantoprazole, both of which have the potential to interact with warfarin. Conclusion: 30% of patients with AF were not receiving antithrombotic treatment. In those receiving an antithrombotic agent, warfarin was the most commonly dispensed (35%). The most common statin and PPI coprescribed with warfarin were agents with the potential to interact with warfarin, despite alternative agents being available. Raising awareness of the safer alternative for people with comorbidities may improve warfarin management.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"9 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2014-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87397091","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 : 2014-09-26DOI: 10.4172/2167-1052.1000163
B. Rajendra
Purpose: To review the changing paradigms in the diagnosis, investigation and management of Urinary Tract Infections (UTIs) in children beyond the neonatal period. Methods: A literature search was done using PUBMED, EBSCO host database and GOOGLE SCHOLAR of all articles including reviews and guidelines on UTIs in children for the last ten years. A total of 2725 articles including review articles and guidelines published over the last 10 years were searched and reviewed. Results: UTIs are the second most common cause of serious bacterial infections in early childhood, thus placing a huge financial burden on the health budget. Despite increasing resistance to several first-line antibiotics, appropriate antibiotic treatment has almost eliminated mortality. Early guidelines advocated aggressive treatment and extensive imaging studies, particularly for the detection of serious ureteric reflex and kidney scarring. Treatment in the acute episode is aimed at eradication of bacteriuria and alleviation of symptoms. Long-term goals include prevention of recurrent attacks of UTIs, kidney scarring and correction of urological lesions that may predispose to recurrent infections. Although there is increasing evidence to show that long-term antimicrobial prophylaxis may be associated with a reduced risk of recurrent infection in selected groups of patients, but not renal scarring, more studies are needed to confirm this. Surgical intervention is now restricted to cases with severe vesicoureteric reflux and failed medical management with endoscopic surgery being increasingly used in most centres compared to open surgery. Conclusion: Following extensive research, a more tangible approach to UTIs is advocated providing for more judicious use of resources with reduced harm from procedures, without affecting outcome. This review addresses the diagnosis, management and treatment of UTIs in children beyond the neonatal period.
{"title":"Urinary Tract Infections in Children: A Changing Paradigm","authors":"B. Rajendra","doi":"10.4172/2167-1052.1000163","DOIUrl":"https://doi.org/10.4172/2167-1052.1000163","url":null,"abstract":"Purpose: To review the changing paradigms in the diagnosis, investigation and management of Urinary Tract Infections (UTIs) in children beyond the neonatal period. \u0000Methods: A literature search was done using PUBMED, EBSCO host database and GOOGLE SCHOLAR of all articles including reviews and guidelines on UTIs in children for the last ten years. A total of 2725 articles including review articles and guidelines published over the last 10 years were searched and reviewed. \u0000Results: UTIs are the second most common cause of serious bacterial infections in early childhood, thus \u0000placing a huge financial burden on the health budget. Despite increasing resistance to several first-line antibiotics, appropriate antibiotic treatment has almost eliminated mortality. \u0000Early guidelines advocated aggressive treatment and extensive imaging studies, particularly for the detection of serious ureteric reflex and kidney scarring. Treatment in the acute episode is aimed at eradication of bacteriuria and alleviation of symptoms. Long-term goals include prevention of recurrent attacks of UTIs, kidney scarring and correction of urological lesions that may predispose to recurrent infections. Although there is increasing evidence to show that long-term antimicrobial prophylaxis may be associated with a reduced risk of recurrent infection in selected groups of patients, but not renal scarring, more studies are needed to confirm this. \u0000Surgical intervention is now restricted to cases with severe vesicoureteric reflux and failed medical management with endoscopic surgery being increasingly used in most centres compared to open surgery. \u0000Conclusion: Following extensive research, a more tangible approach to UTIs is advocated providing for more judicious use of resources with reduced harm from procedures, without affecting outcome. This review addresses the diagnosis, management and treatment of UTIs in children beyond the neonatal period.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"3 1","pages":"1-10"},"PeriodicalIF":0.0,"publicationDate":"2014-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86741914","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 : 2014-09-26DOI: 10.4172/2167-1052.1000160
A. Boekhout, Werkhoven Ed, R. Liebergen, C. Korse, A. Burylo, Trip Ak, J. Beijnen, J. Schellens
Background: Trastuzumab treatment is associated with cardiac dysfunction. We evaluated the incidence of cardiotoxicity during and long-term after trastuzumab treatment in an unselected early breast cancer population. Methods: This study included a retrospective part, the chemotherapy- and trastuzumab treatment period and a prospective part, the period of data collection long-term after trastuzumab treatment. Cardiac evaluation included left ventricular ejection fraction (LVEF) changes and an evaluation of symptomatic cardiotoxicity. Cardiac events were defined as a decrease of 10 percentage points in LVEF compared with baseline and to an absolute LVEF of below 50%. Secondary outcomes included the evaluation of cardiac markers (B-type natriuretic peptide and troponins) and single nucleotide polymorphisms (SNPs) in the HER2 gene as parameters to detect or predict trastuzumab-related cardiotoxicity. Results: Overall, 105 patients were evaluable for the primary endpoint. The 3-year cumulative incidence of cardiac events was 12% (95 CI, 4%-19%). All 8 patients with a cardiac event were pre-treated with anthracyclines and cyclophosphamide and 7 of them recovered partially or completely. Four patients experienced symptomatic cardiotoxicity, of who 2 recovered completely and the other 2 recovered partially. No statistically significant association was observed between cardiac events and cardiac markers or SNPs. Conclusion: Trastuzumab treatment in combination with anthracy cline-based chemotherapy is associated with significant and only partly reversible cardiac dysfunction. Baseline LVEF value is a prominent predictor for long-term LVEF especially, in patients who are not treated with anthracycline-based chemotherapy. These findings can be used to establish optimal monitoring strategies in trastuzumab treatment.
{"title":"Factors Affecting Long-Term Safety of Trastuzumab in Patients with Early HER2-Positive Breast Cancer","authors":"A. Boekhout, Werkhoven Ed, R. Liebergen, C. Korse, A. Burylo, Trip Ak, J. Beijnen, J. Schellens","doi":"10.4172/2167-1052.1000160","DOIUrl":"https://doi.org/10.4172/2167-1052.1000160","url":null,"abstract":"Background: Trastuzumab treatment is associated with cardiac dysfunction. We evaluated the incidence of cardiotoxicity during and long-term after trastuzumab treatment in an unselected early breast cancer population. \u0000Methods: This study included a retrospective part, the chemotherapy- and trastuzumab treatment period and a prospective part, the period of data collection long-term after trastuzumab treatment. Cardiac evaluation included left ventricular ejection fraction (LVEF) changes and an evaluation of symptomatic cardiotoxicity. Cardiac events were defined as a decrease of 10 percentage points in LVEF compared with baseline and to an absolute LVEF of below 50%. Secondary outcomes included the evaluation of cardiac markers (B-type natriuretic peptide and troponins) and single nucleotide polymorphisms (SNPs) in the HER2 gene as parameters to detect or predict trastuzumab-related cardiotoxicity. \u0000Results: Overall, 105 patients were evaluable for the primary endpoint. The 3-year cumulative incidence of cardiac events was 12% (95 CI, 4%-19%). All 8 patients with a cardiac event were pre-treated with anthracyclines and cyclophosphamide and 7 of them recovered partially or completely. Four patients experienced symptomatic cardiotoxicity, of who 2 recovered completely and the other 2 recovered partially. No statistically significant association was observed between cardiac events and cardiac markers or SNPs. \u0000Conclusion: Trastuzumab treatment in combination with anthracy \u0000cline-based chemotherapy is associated with significant and only partly reversible cardiac dysfunction. Baseline LVEF value is a prominent predictor for long-term LVEF especially, in patients who are not treated with anthracycline-based chemotherapy. These findings can be used to establish optimal monitoring strategies in trastuzumab treatment.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"25 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2014-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73445771","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 : 2014-08-22DOI: 10.4172/2167-1052.1000159
A. J. Scheepers-Hoeks, R. Grouls, C. Neef, Anne-Marie J Doppen, Erik H M Korsten
Objective: The objective of this study was: (1) to develop and validate an electronic clinical rule for ‘Opioid-Laxative Use’ and to implement this rule in clinical pharmacy practice; (2) to improve guideline compliance by using this refined clinical rule; and (3) to investigate if opioid-induced constipation (OIC) can be reduced in hospitalised patients by the application of this clinical rule. Methods: Interventions using clinical rule alerts were performed between June and September 2009. We compared guideline compliance before and after the intervention to determine the difference. Interventions consisted of telephone consultations by a clinical pharmacist advising physicians to add a laxative to opioid therapy. Patient files were matched to a historical control group using an opioid without a laxative to examine the difference between intervention- and control patients in the presence of OIC. Results: Prospective validation of the rule resulted in several refinements. In the intervention period, 140 alerts were generated, 60 of which (43%) led to co-prescription of a laxative. Therefore, guideline compliance increased from 70% to 83%. A significant difference in OIC was found between the intervention group (12%) and the control group (56%). Conclusions: This study showed that pharmacy intervention based on an electronic clinical rule for ´Opioid-Laxative Use´ led to more adequate co-prescription of opioids and laxatives. This led to a better compliance with the guideline as well as a better outcome, as measured by the significant decrease in the prevalence of OIC.
{"title":"Preventive Prescribing of Laxatives for Opioid-induced Constipation Using Electronic Clinical Rule Implementation by Cinical Pharmacists","authors":"A. J. Scheepers-Hoeks, R. Grouls, C. Neef, Anne-Marie J Doppen, Erik H M Korsten","doi":"10.4172/2167-1052.1000159","DOIUrl":"https://doi.org/10.4172/2167-1052.1000159","url":null,"abstract":"Objective: The objective of this study was: (1) to develop and validate an electronic clinical rule for ‘Opioid-Laxative Use’ and to implement this rule in clinical pharmacy practice; (2) to improve guideline compliance by using this refined clinical rule; and (3) to investigate if opioid-induced constipation (OIC) can be reduced in hospitalised patients by the application of this clinical rule. \u0000Methods: Interventions using clinical rule alerts were performed between June and September 2009. We \u0000compared guideline compliance before and after the intervention to determine the difference. Interventions consisted of telephone consultations by a clinical pharmacist advising physicians to add a laxative to opioid therapy. Patient files were matched to a historical control group using an opioid without a laxative to examine the difference between intervention- and control patients in the presence of OIC. \u0000Results: Prospective validation of the rule resulted in several refinements. In the intervention period, 140 alerts were generated, 60 of which (43%) led to co-prescription of a laxative. Therefore, guideline compliance increased from 70% to 83%. A significant difference in OIC was found between the intervention group (12%) and the control group (56%). \u0000Conclusions: This study showed that pharmacy intervention based on an electronic clinical rule for ´Opioid-Laxative Use´ led to more adequate co-prescription of opioids and laxatives. This led to a better compliance with the guideline as well as a better outcome, as measured by the significant decrease in the prevalence of OIC.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"11 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2014-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82126603","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 : 2014-08-07DOI: 10.4172/2167-1052.1000004-R
Jhansi Konduru
Abstract Drugs are more poisons. These are very harmful to the body, when people take the drug make you feel relaxed and happy, but sometimes make people it leads to allergic, anxious finally leads to death. So that people will change the lifestyle when they have to maintain good health to control it.
{"title":"Effects of Drugs","authors":"Jhansi Konduru","doi":"10.4172/2167-1052.1000004-R","DOIUrl":"https://doi.org/10.4172/2167-1052.1000004-R","url":null,"abstract":"Abstract \u0000 \u0000Drugs are more poisons. These are very harmful to the body, when people take the drug make you feel relaxed and happy, but sometimes make people it leads to allergic, anxious finally leads to death. So that people will change the lifestyle when they have to maintain good health to control it.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"36 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2014-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79978711","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 : 2014-06-30DOI: 10.4172/2167-1052.1000158
F. Janssen, E. Hak
Within the field of pharmacoepidemiology and drug safety as in the wider field of epidemiology focus has been on individual-level studies. However, the impact of drug use for the society as a whole cannot directly be inferred from such studies and population-level causal designs are required. For example, for health policy it is crucial to know the role of drugs in affecting regional, national or international morbidity and mortality trends. Similarly, predicting (future) levels of local health care and drug use is essential for prevention purposes, targeted allocation of care and meeting health demands. Moreover, actual end users of drugs in society may largely differ from clinical trial populations [1,2] used to study the efficacy of drugs for registration purposes [3].
{"title":"Modelling population-level drug use with demographic and geographic approaches and techniques","authors":"F. Janssen, E. Hak","doi":"10.4172/2167-1052.1000158","DOIUrl":"https://doi.org/10.4172/2167-1052.1000158","url":null,"abstract":"Within the field of pharmacoepidemiology and drug safety as in the wider field of epidemiology focus has been on individual-level studies. However, the impact of drug use for the society as a whole cannot directly be inferred from such studies and population-level causal designs are required. For example, for health policy it is crucial to know the role of drugs in affecting regional, national or international morbidity and mortality trends. Similarly, predicting (future) levels of local health care and drug use is essential for prevention purposes, targeted allocation of care and meeting health demands. Moreover, actual end users of drugs in society may largely differ from clinical trial populations [1,2] used to study the efficacy of drugs for registration purposes [3].","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"10 1","pages":"2167"},"PeriodicalIF":0.0,"publicationDate":"2014-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84289171","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 : 2014-06-30DOI: 10.4172/2167-1052.1000157
G. Goh, S. Dasarathy, A. McCullough
Background: Non-alcoholic fatty liver disease (NAFLD) is a common complex chronic liver disease that encompasses a spectrum of disease from simple steatosis to non-alcoholic steatohepatitis (NASH). NASH has the potential to progress to advanced fibrosis and cirrhosis and is associated with increased morbidity and mortality. Currently, there are no definitive universally accepted treatment options available for NASH. Most pharmacological agents that have been investigated are limited by inconsistent efficacy or side effects. We reviewed the current literature on the principle drugs that have been tested for NAFLD in the adult population, with special emphasis on clinical data and safety profiles. Methods: A comprehensive PUBMED/MEDLINE search was conducted to identify principal therapeutic intervention studies for NAFLD, from which a summary of the studies were formulated in this review. Results: A variety of studies, including retrospective, open-label and randomised controlled trials were reviewed in terms of clinical efficacy and side effect profiles. In addition to the most commonly studied therapeutic agents (insulin sensitizers, vitamin E, pentoxifylline, UDCA, PUFA, statins and ezetimibe), emerging pharmacologic agents showing potential efficacy in NAFLD were also explored. Conclusion: Based on risk-benefit profiles, pentoxifylline seems to have the best treatment outcomes currently, with significant improvement in histology while having minimal tolerable side effects. Further clinical research is warranted to understand and improve our repertoire of treatment options, including potential combination therapy, towards this complex disease.
{"title":"Pharmacologic Management of Non-Alcoholic Fatty Liver Disease","authors":"G. Goh, S. Dasarathy, A. McCullough","doi":"10.4172/2167-1052.1000157","DOIUrl":"https://doi.org/10.4172/2167-1052.1000157","url":null,"abstract":"Background: Non-alcoholic fatty liver disease (NAFLD) is a common complex chronic liver disease that encompasses a spectrum of disease from simple steatosis to non-alcoholic steatohepatitis (NASH). NASH has the potential to progress to advanced fibrosis and cirrhosis and is associated with increased morbidity and mortality. Currently, there are no definitive universally accepted treatment options available for NASH. Most pharmacological agents that have been investigated are limited by inconsistent efficacy or side effects. We reviewed the current literature on the principle drugs that have been tested for NAFLD in the adult population, with special emphasis on clinical data and safety profiles. Methods: A comprehensive PUBMED/MEDLINE search was conducted to identify principal therapeutic intervention studies for NAFLD, from which a summary of the studies were formulated in this review. Results: A variety of studies, including retrospective, open-label and randomised controlled trials were reviewed in terms of clinical efficacy and side effect profiles. In addition to the most commonly studied therapeutic agents (insulin sensitizers, vitamin E, pentoxifylline, UDCA, PUFA, statins and ezetimibe), emerging pharmacologic agents showing potential efficacy in NAFLD were also explored. Conclusion: Based on risk-benefit profiles, pentoxifylline seems to have the best treatment outcomes currently, with significant improvement in histology while having minimal tolerable side effects. Further clinical research is warranted to understand and improve our repertoire of treatment options, including potential combination therapy, towards this complex disease.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"129 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2014-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86383590","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 : 2014-05-30DOI: 10.4172/2167-1052.1000155
Alkesh K Lokh, M. Prabhu, M. Unnikrishnan, G. Thunga, M. S. Rajan
A Periodic Safety Update Report (PSUR) is comprise of most complete safety experience of drug submitted to the competent drug regulatory authorities at defined period of time. In India, PSURs for all newer drugs must be submitted every six month for first two years followed by annually for next two years to the Drug Controller General of India [DCG(I)], New Delhi. So far, it’s been mandatory only to Marketing Authorization Holders (MAHs) to submit PSURs periodically to DCG(I), New Delhi. But, since 28 August 2012 DCG(I) has made it mandatory for hospitals in India to implement PSUR system for newly introduced drugs. In country like India where, lots of irregularity seen in safety surveillance of patients. We have very less active Adverse Drug Reaction (ADR) monitoring centers in function and a lot of determination is needed in order to collect drug safety data which may be carried out through active safety surveillance of therapeutic agents. Thus it has become important to comply with the requirement of DCG(I) and address the safety concern of our hospitalized patients. PSUR is the need of the hour to in our hospitals. We have to take steps for monitoring patients who are on newly introduced drugs and generate data for the reporting of PSURs to the DCG(I). This pioneering hospital based PSUR setup will create an environment for healthy safety reporting and helps the regulatory authorities for drug safety related decisions.
{"title":"Periodic Safety Update Reporting of Newly Launched Drugs through Hospitals–Need of the Hour: A Drug Controller General of India Initiative","authors":"Alkesh K Lokh, M. Prabhu, M. Unnikrishnan, G. Thunga, M. S. Rajan","doi":"10.4172/2167-1052.1000155","DOIUrl":"https://doi.org/10.4172/2167-1052.1000155","url":null,"abstract":"A Periodic Safety Update Report (PSUR) is comprise of most complete safety experience of drug submitted to the competent drug regulatory authorities at defined period of time. In India, PSURs for all newer drugs must be submitted every six month for first two years followed by annually for next two years to the Drug Controller General of India [DCG(I)], New Delhi. So far, it’s been mandatory only to Marketing Authorization Holders (MAHs) to submit PSURs periodically to DCG(I), New Delhi. But, since 28 August 2012 DCG(I) has made it mandatory for hospitals in India to implement PSUR system for newly introduced drugs. In country like India where, lots of irregularity seen in safety surveillance of patients. We have very less active Adverse Drug Reaction (ADR) monitoring centers in function and a lot of determination is needed in order to collect drug safety data which may be carried out through active safety surveillance of therapeutic agents. Thus it has become important to comply with the requirement of DCG(I) and address the safety concern of our hospitalized patients. PSUR is the need of the hour to in our hospitals. We have to take steps for monitoring patients who are on newly introduced drugs and generate data for the reporting of PSURs to the DCG(I). This pioneering hospital based PSUR setup will create an environment for healthy safety reporting and helps the regulatory authorities for drug safety related decisions.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"45 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2014-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84964465","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 : 2014-05-29DOI: 10.4172/2167-1052.1000R002
Jhansi Konduru, P. Vanita
Birth control drugs are those which can prevent the pregnancy. In some times people do not want to get pregnancy, in these cases they want to use by doctors prescription. Birth control drugs have many medical uses for women. Sometimes these are harmful. So we can use by drugs within limit, proper suggestion from doctors only.
{"title":"Review on Birth Control Drugs","authors":"Jhansi Konduru, P. Vanita","doi":"10.4172/2167-1052.1000R002","DOIUrl":"https://doi.org/10.4172/2167-1052.1000R002","url":null,"abstract":"Birth control drugs are those which can prevent the pregnancy. In some times people do not want to get pregnancy, in these cases they want to use by doctors prescription. Birth control drugs have many medical uses for women. Sometimes these are harmful. So we can use by drugs within limit, proper suggestion from doctors only.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"11 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2014-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74744433","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 : 2014-05-18DOI: 10.4172/2167-1052.1000154
Jindřich Srba
New pharmacovigilance legislation (Regulation (EU) No. 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament in December 2010. The European Medicines Agency (EMA) is responsible for implementing much of the new legislation, which has been effective since July 2012. One of the impacts concerned to marketing authorisation holders (MAH) is to submit adverse drug reaction (ADR) reports only into EudraVigilance, a safety database superintended by EMA.
欧洲议会于2010年12月通过了新的药物警戒立法(法规(EU) No 1235/2010和指令2010/84/EU)。欧洲药品管理局(EMA)负责实施大部分新法规，该法规自2012年7月起生效。上市许可持有人(MAH)关注的影响之一是仅向EMA监管的安全数据库EudraVigilance提交药物不良反应(ADR)报告。
{"title":"The Missing Voice of Non-Serious Adverse Drug Reactions from Marketing Authorisation Holders","authors":"Jindřich Srba","doi":"10.4172/2167-1052.1000154","DOIUrl":"https://doi.org/10.4172/2167-1052.1000154","url":null,"abstract":"New pharmacovigilance legislation (Regulation (EU) No. 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament in December 2010. The European Medicines Agency (EMA) is responsible for implementing much of the new legislation, which has been effective since July 2012. One of the impacts concerned to marketing authorisation holders (MAH) is to submit adverse drug reaction (ADR) reports only into EudraVigilance, a safety database superintended by EMA.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"41 4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2014-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83824552","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：