Advances in Pharmacoepidemiology and Drug Safety最新文献

{"title":"Acute Hepatitis Caused by Green Tea Infusion: A Case Report","authors":"E. Arzenton, L. Magro, Paon, F. Capra, P. Apostoli, F. Guzzo, A. Conforti, R. Leone","doi":"10.4172/2167-1052.1000170","DOIUrl":"https://doi.org/10.4172/2167-1052.1000170","url":null,"abstract":"The green tea is obtained by an unfermented process of leaves of Camellia sinensis and the main chemical components are polyphenols, particularly epigallocatechin-3-gallate and epicatechin-3-gallate that could be associated to adverse hepatic reactions. We present a case of acute hepatitis caused by the use of green tea.A 62-year-old woman was hospitalized because of the persistent high levels of liver function tests. After the hospitalization a lot of instrumental exams and blood checks were performed. The search of metallic elements in the used green tea infusions was performed using an inductively coupled-plasma mass spectrometry; high performance liquid chromatography-electro spray ionization-mass spectrometry analysis was done to characterize the metabolite profiles of the infusions of green tea. The blood check showed in particular alanine aminotransferase (780 U/L) and total bilirubin (1.15 mg/dL) levels abnormal. The abdominal echography and other blood parameters were normal, but liver biopsy described a “drug toxic damage”. Every day over the previous 9 months the patient drank two or three cups of several brands of green tea infusions and she stopped this behavior when abdominal pain was persistent. Her medical history didn’t report the use of other drugs or toxic products. After four months of stopping the use of green tea infusions, the liver function tests were normalized. The presence of metallic elements in tea infusion cannot justify the observed liver toxicity in our patient. Instead, the highest levels of epigallo catechin methyl gallate derived from epigallocatechin-3-gallate observed in one of the samples consumed by the patient, arise a possible correlation between some of the catechins in green tea and the hepatotoxic effect. It is conceivable that the mechanism of damage can be idiosyncratic-metabolic or allergic.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"32 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2014-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77095642","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}

{"title":"A Reachable Goal: Application of Pharmacogenomics Biomarkers to ImproveDrug Efficacy and Safety","authors":"Chang Cw, B. Ning","doi":"10.4172/2167-1052.1000E129","DOIUrl":"https://doi.org/10.4172/2167-1052.1000E129","url":null,"abstract":"Ensuring drug efficacy and safety are unremitting challenges for drug manufacturers and public health organizations worldwide. It has been estimated that, when all of the drugs in the market used to treat common diseases are considered, only 25% to 60% of patients exhibit the expected pharmacological response [1], while a small portion of patients could develop adverse reactions (ADRs). ADRs are one of the leading causes of illness and death associated with prescription medications, and ADRs are estimated to occur in 6.2-6.7% of all hospitalized patients, resulting in more than 2 million adverse drug reaction cases annually, including approximate 100,000 incidences of death in the United States [2].","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"210 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2014-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78080502","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}

{"title":"Itâs All about Signals, Risk Management and How Important These Are?","authors":"S. Garlapati, Anireddy Kr","doi":"10.4172/2167-1052.1000E127","DOIUrl":"https://doi.org/10.4172/2167-1052.1000E127","url":null,"abstract":"Pharmacovigilance is the study that amplifies safety of drugs with the fundamental objective of complete abstain on the ADRs and timely identification/detection of new adverse drug reactions. The fundamental principle of the pharmacovigilance is to figure out and valuate the benefit and risk profile of the pharmacological activity and to increase the rational usage of drugs. Adverse Drug Reactions (ADR) are a major cause of patient morbidity and mortality. Spontaneous reporting of ADRs is found to be crucial in maintaining patient safety.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"90 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2014-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80213431","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}

{"title":"The Role of Transporters in the Pharmacokinetics of Antibiotics","authors":"Huang Wj, Hu Wx","doi":"10.4172/2167-1052.1000168","DOIUrl":"https://doi.org/10.4172/2167-1052.1000168","url":null,"abstract":"Aims: Various transporters including efflux transporters and uptake transporters play an important role in the pharmacokinetics of drugs. At present, interestingly, more and more studies had found that numbers of antibiotics were the substrates of transporters, and these antibiotics were usually combined with other drugs to treat disease more effectively in clinic. Therefore, it is necessary to focus on the role of transporters in pharmacokinetics and drugdrug interactions of antibiotics. \u0000Methods: This review summarized the findings of recent studies as well as information obtained from several databases (update to June 2012): ISI Web of Knowledge SM (ISI WoK), SciFinder (Caplus, Medline, Registry,Casreact, Chrmlist, Chemcasts) and PubMed (indexed for Medline). \u0000Results: The present review will provides useful information for studying the role of transporters in pharmacokinetics and drug-drug interactions of antibiotics, and should be of help to those intending to further research on these topics. \u0000Conclusions: The drug transporter plays a significant role in the pharmacokinetics and drug-drug interactions of antibiotics.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"10 28 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2014-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80650042","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}

{"title":"Traineesâ Attitudes and Preferences towards the Use of Over the CounterAnalgesics in Patients with Chronic Liver Disease","authors":"D. Nguyen, N. Banerjee, D. Abdelaziz, Lewis Jh","doi":"10.4172/2167-1052.1000167","DOIUrl":"https://doi.org/10.4172/2167-1052.1000167","url":null,"abstract":"Background: The use of certain medications in patients with chronic liver disease and cirrhosis remains controversial. No formal evidence-based guidelines have been published regarding the use of acetaminophen or nonsteroidal anti-inflammatory drugs in patients in this setting. As a result, whether or not to prescribe these medications and at what dosages in patients with chronic liver disease or cirrhosis is often met with much consternation. Objective: We assessed the prescribing preferences of senior medical students, internal medicine residents, and gastroenterology fellows for using NSAIDs and acetaminophen in patients with chronic liver disease (CLD), including those with cirrhosis. Methods: A 21-question web-based survey was distributed to several major teaching hospitals in Washington, DC. An online survey software (Survey Monkey) was used to collect and analyze responses. Results: A total of 543 trainees were sent the survey with 174 (32%) responding. The majority of respondents who were willing to use acetaminophen recommended a daily dose of 2 gms or less regardless of their level of training. Internal medicine residents and senior medical students tended to recommend against acetaminophen at any dose in favor of NSAIDs in decompensated cirrhotics. All trainee levels showed a diminishing preference towards using a therapeutic dose of 4 gms acetaminophen per day as a function of CLD severity. Conclusions: There is a wide divide at the trainee level regarding the usage and dosing for acetaminophen in patients with chronic liver disease. Additional education on the safe use of NSAIDs and acetaminophen in CLD and cirrhosis needs to begin in medical school. Senior students in particular voiced the need for controlled prospective studies in order to develop evidence-based guidelines to determine the appropriate indications for use of NSAIDs and acetaminophen along the spectrum of hepatic impairment in chronic liver disease.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"72 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2014-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82933628","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}

{"title":"A Pharmacovigilance Study Using Tracer Techniques","authors":"A. Yerramilli, S. Veerla, E. Chintala, M. Guduguntla, P. Velivelli, S. Sharma, R. Paul","doi":"10.4172/2167-1052.1000165","DOIUrl":"https://doi.org/10.4172/2167-1052.1000165","url":null,"abstract":"Objective: To identify adverse drug reactions by using a comprehensive trigger tool method. To categorize the identified adverse drug reactions based upon their Probability, Severity, Harm and Preventability by using different scales. \u0000Methods: A single-center, Cross-sectional, observational study based on medication and laboratory trigger tool methodology was conducted over a period of six months. The World Health Organization definition of adverse drug reactions was adopted. A list of 17 triggers were used to trace the adverse drug reactions which were then analyzed to assess the causality by using Naranjo’s scale, severity by Hartwig and Siegel scale, and harm by the National Coordinating Council for Medication Error Reporting and Preventing Index and preventability by Modified Schumock and Thornton scale. \u0000Results: A total of 100 suspected ADRs were collected and analyzed. The drug classes most commonly implicated with ADRs were cephalosporins (25%) followed by anti-diabetic agents (19%). According to Naranjo’s scale, the reactions were categorized as probable (80%), possible (10%) and definite (5%). According to the modified Schumock and Thornton preventability scale, 20 cases (20%) were possibly preventable while 80 cases (80%) were not preventable. In 85 cases (85%) the suspected drug was withdrawn while in 10 cases (10%) no change in dose was made and in 5 cases (5%) the dose was altered. \u0000Conclusion: Pharmacovigilance using tracer techniques significantly increases the identification and reporting of ADRs. The tracer technique is relatively simple, sensitive, less expensive and largely effective compared to traditional methods. The Trigger tool provides an additional instrument in improving patient safety. This technique leads to an increase in awareness and reporting of ADRs and provide opportunities for the health care system to review drug selection and prescribing practices affecting patient outcomes.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"4 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2014-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87509062","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}

{"title":"Development of Opthalmic Formulation for Dry Eye Syndrome","authors":"P. Datar","doi":"10.4172/2167-1052.1000166","DOIUrl":"https://doi.org/10.4172/2167-1052.1000166","url":null,"abstract":"Opthalmic formulation was prepared considering the essential requirements for the healthy eye. Acacia gum was used along with zinc sulphate as essential nutrients. The pH was adjusted to make the solution isotonic by using NaCl and other buffer solutions. The formulation was evaluated for viscosity and eye irritation test. The formulation was made in concerned with dry eye syndrome and associated disease due to old age. Formulation was observed for particle size and sterility test and finally stability test.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"11 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2014-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76819658","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}

{"title":"Are Novel Oral Anticoagulants (Noacs) as Safe as They are Said to Be","authors":"F. Kamali","doi":"10.4172/2167-1052.1000E126","DOIUrl":"https://doi.org/10.4172/2167-1052.1000E126","url":null,"abstract":"The main advantages of NOACs over warfarin are their predictable pharmacokinetics and clinical response thus obviating the need for routine anticoagulation monitoring or monitoring of plasma drug levels, fewer drug interactions and the lack of interaction with diet. More crucially NOACS were developed and marketed to be used as fixed-dose regimens, which is considered to be a substantial advantage over warfarin. Prescription numbers for NOACs have risen sharply since their launch for both newly diagnosed patients requiring initiation of anticoagulant therapy and existing patients on warfarin with poor anticoagulation control being switched to a NOAC, with prescriptions in England for dabigatran in 2012 compared to 2011 increasing 1,600%, from around 3,000 to around 48,000, and prescriptions for rivaroxaban in 2012 being around 16,000 [2]. Whilst non-inferiority of NOACs to warfarin in their clinical effectiveness for stroke prophylaxis in patients with atrial fibrillation in the RE-LY, ROCKET-AF, and ARISTOTLE studies has been established, the bleeding adverse reactions reported in those trials, may be contributed to by patient age, with the noted incidence of bleeding being greater in those aged 75 years and over [3-5]. It is of concern that in view of the use of NOACs in atrial fibrillation the more elderly were not well represented in the trials, and clinical experience is too short to provide models of use which optimise the benefits of therapy and ensure therapy can be safely prescribed. Although prescribing rates for NOACs have grown rapidly since their launch, concerns about fatal bleeds have emerged particularly in elderly people, who are at a greater risk. A later sub-analysis of the RE-LY trial data by the manufacturer of dabigatran, Boehringer Ingleheim, showed that there were 5-fold variations in plasma dabigatran concentration for each of the two doses (110 and 150 mg) that were tested [6]. Further analysis of the data showed that renal function is the most important determinant for","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2014-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77644187","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}

{"title":"A Review of Safety Data from Spontaneous Reports on Marketed Products Containing Tramadol and Celecoxib: A Vigibase Descriptive Analysis","authors":"A. Vaqué, M. Sust, Neus Gascón, A. Puyada, S. Videla","doi":"10.4172/2167-1052.1000164","DOIUrl":"https://doi.org/10.4172/2167-1052.1000164","url":null,"abstract":"Background: The concomitant administration of opioids and non-steroidal anti-inflammatory drugs is used to manage pain in clinical practice, given their synergistic analgesic effect. Among their possible combinations, tramadol and celecoxib are routinely used. The aim of this study was to explore the safety profile of tramadol and celecoxib administered individually compared to their concomitant administration in clinical practice. \u0000Methods: Retrospective analysis of adverse-drug-reactions from the safety database Vigibase, The WHO global individual case safety report database system. A case was defined as an adverse-drug-reaction included in a report of Vigibase between January 2000 and March 2012. Three groups were studied: ‘tramadol-no-celecoxib’ (tramadol was only reported as suspected or interacting drug), ‘celecoxib-no-tramadol’ (celecoxib was only reported as suspected or interacting drug) and ‘celecoxib+tramadol’ (both drugs co-administered and reported as suspected or interacting drug). MedDRA dictionary was used to code adverse-drug-reactions. Reporting proportions were calculated as the number of adverse-drug reactions of a given type divided by the overall total number of reported adverse-drug-reaction in each drug-group. \u0000Results: Reporting proportions for global profile, and for each studied group of adverse-drug-reaction, were lower for the concomitant administration than for each individual drug, specifically for the drug (either tramadol or celecoxib) primary involved in the particular adverse-drug-reaction. Therefore, no safety signals were found for ‘gastrointestinal bleeding’ and ‘gastrointestinal signs and symptoms’; ‘cardiovascular’ and ‘cerebrovascular events’ \u0000(related to ‘ischemic and embolic-thrombotic events’); ‘renal’ and ‘renovascular’ events (including cardiac failure related events); neither for ‘central nervous system’ effects; neither for ‘respiratory depression’; ‘development of tolerance with repeated administration’ (including abuse/dependence/withdrawal reported events); ‘hepatic disorders (drug-related)’; ‘skin events’; and neither for the most frequent preferred terms: ‘nausea’, ‘vomiting’, ‘constipation’, ‘myocardial infarction’ and ‘hypertension’. \u0000Conclusion: Based on reporting proportions, no trend was observed to an increased risk for any specific potential safety concern when both tramadol and celecoxib, are administered concomitantly.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"31 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2014-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86557938","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}

{"title":"Evaluating Educational Intervention to Improve Drug Administration Practice in Out-Patient Children in Northwestern Nigeria","authors":"C. Baz, I. Abdu-Aguye, K. Ho","doi":"10.4172/2167-1052.1000162","DOIUrl":"https://doi.org/10.4172/2167-1052.1000162","url":null,"abstract":"Drug administration practice of mothers from 20 facilities (12 primary and 8 secondary) in northwestern Nigeria were assessed prospectively with the aim of identifying the type, frequency and potential clinical significance of drug administration errors in paediatric outpatients. The data was analyzed and errors classified according to National Coordinating Council for Medication Error Reporting and Prevention taxonomy. Educational interventions were designed and administered to mothers of 10 (6 primary and 4 secondary) least performing facilities, while the remaining 10 facilities acted as control. The percentage of the parents that claimed to knew the correct dosage were relatively high (78% to 93%) and differ significantly between the secondary and primary facilities. Further assessment shows that the dose of the drugs dispensed, the time/frequency of administration, and the duration of use were not known by 68.2% (330/484), 63.0% (305/484), and 12.0% (58/484) of the mothers respectively. The overall total possibility of the drug administration errors significantly reduced in the right direction (p<0.0005; d=4.27) \u0000after the intervention.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"22 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2014-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73995905","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}