Drug information journal : DIJ / Drug Information Association最新文献_第2页

Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D: Results From a Pilot Program 利益-风险行动小组(BRAT)框架在药物研发中的应用:来自试点项目的结果

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-09-12 DOI: 10.1177/0092861512458908

R. Noel, R. Hermann, B. Levitan, D. Watson, K. Van Goor

{"title":"Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D: Results From a Pilot Program","authors":"R. Noel, R. Hermann, B. Levitan, D. Watson, K. Van Goor","doi":"10.1177/0092861512458908","DOIUrl":"https://doi.org/10.1177/0092861512458908","url":null,"abstract":"Benefit-risk (B-R) assessments inform decisions regarding drug development and lifecycle management, serve as a basis for regulatory determinations, and help clinicians, patients, and payers make rational, value-based treatment decisions. Nevertheless, no widely accepted, systematic methods exist to guide, justify, and communicate benefit-risk decisions in a transparent and consistent manner. The B-R Action Team (BRAT), formed by the Pharmaceutical Research and Manufacturers of America (PhRMA), has developed a structured approach to B-R assessment—the “BRAT Framework”—that assists decision makers in selecting, organizing, summarizing, and communicating evidence relevant to B-R decisions. The BRAT Framework’s functionality has been demonstrated previously in a series of scenarios with hypothetical drugs as well as in a few real-world applications. Here we report results of a pilot program to assess the value of the Framework in pharmaceutical development and postmarketing settings, for the purpose of informing PhRMA’s regulatory advocacy. A third-party consultant conducted the assessment through a survey of pharmaceutical companies’ experiences using the Framework. We also identify aspects of the Framework that require further development.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"40 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116591180","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}

引用次数: 20

Development of a Web-Based Compliance Metrics Reporting Dashboard (CMR^©) for Medical Information Inquiries 基于web的医疗信息查询合规指标报告仪表板(CMR^©)的开发

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-09-12 DOI: 10.1177/0092861512458097

R. J. Fuentes, K. Idowu, S. Sahoo

引用次数: 3

Are Pharmaceutical Market Withdrawals Preventable? A Preliminary Analysis 药品市场撤回是否可预防?初步分析

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-09-07 DOI: 10.1177/0092861512458776

Jaya Sai V. Daggumalli, Irwin G. Martin

{"title":"Are Pharmaceutical Market Withdrawals Preventable? A Preliminary Analysis","authors":"Jaya Sai V. Daggumalli, Irwin G. Martin","doi":"10.1177/0092861512458776","DOIUrl":"https://doi.org/10.1177/0092861512458776","url":null,"abstract":"Some drugs have been removed from the market once it had been determined that their risks outweighed their benefits. Withdrawals negatively impact patients using the drugs as well the pharmaceutical companies who devoted tremendous resources to research, development, and marketing. Therefore, there is a desire to minimize drug withdrawals by learning from previous incidents. Hints of the problems that lead to eventual market withdrawal might be found in the initial New Drug Application (NDA). If inappropriate approvals could be prevented, patients’ safety might be protected and withdrawals would not be necessary. Drugs withdrawn between 2001 and 2010 (n = 15) were considered for this investigation. The primary adverse events that led to the withdrawal of these 15 drugs were compared with the data available in the original NDA medical review. From the 15 drugs considered, sufficient information for analysis was available for only 7 drugs. Among the 7 drugs analyzed, the safety data found for 2 particular drugs suggested potential safety signals. Preliminary analyses suggest that the drug withdrawals could not have been predicted for the majority of drugs removed from the market.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"30-31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133477362","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}

引用次数: 4

Who Advises the Data Monitoring Committee (DMC)? A Review of Regulatory Guidance for Sponsors on DMCs After 5 Years and Advice for DMC Members 谁向数据监察委员会提供意见?五年后对DMC保荐人的监管指引检讨及对DMC成员的建议

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-09-01 DOI: 10.1177/0092861512452123

J. Glover, R. Kay

引用次数: 1

Mathematical Derivation of Therapeutic Index Based on hERG IC_50 Taking Into Account Fraction Unbound in Plasma and Clinical C_max 考虑血浆未结合分数和临床C_max的hERG IC_50治疗指标的数学推导

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-09-01 DOI: 10.1177/0092861512456285

R. Fryer

引用次数: 1

Linguistic Validation of the French Canadian Work Productivity and Activity Impairment Questionnaire–General Health Version 法语加拿大工作效率和活动障碍问卷-一般健康版的语言验证

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-09-01 DOI: 10.1177/0092861512451741

M. Gawlicki, S. McKown, M. Talbert, B. Brandt, Eric Bullington

{"title":"Linguistic Validation of the French Canadian Work Productivity and Activity Impairment Questionnaire–General Health Version","authors":"M. Gawlicki, S. McKown, M. Talbert, B. Brandt, Eric Bullington","doi":"10.1177/0092861512451741","DOIUrl":"https://doi.org/10.1177/0092861512451741","url":null,"abstract":"Objectives The objective of this study was to evaluate the linguistic validity of the French Canadian Work Productivity and Activity Impairment–General Health questionnaire (WPAI-GH). When ill, employees may take a sick day (absenteeism) or work despite the illness and experience a loss of efficiency (presenteeism), which may then result in organizational productivity loss. The WPAI-GH, a leading measure of work productivity indicators, was not previously tested among French Canadians for clarity of translation and item comprehension. Before using a French translation of an available US-English questionnaire, the linguistic validity must be established to ensure its conceptual equivalence to the original as well as establishing cultural appropriateness. Methods A French Canadian translation of the US-English WPAI-GH was produced through a reiterative process in which harmonized forward and back translations were created by independent translators. French-speaking subjects residing in Canada self-administered the WPAI-GH and were subsequently debriefed by a bilingual (French-English) interviewer. Results Thirty French Canadian subjects were interviewed, all of whom were employed at the time. The group was stratified by educational level, including an equal number of participants with and without a high school degree. Responses to hypothetical scenarios indicated that the French Canadian version adequately differentiates between sick time taken for health and non-health reasons as well as differentiations between absenteeism and presenteeism. Conclusion The linguistic validity of the French Canadian translation of the WPAI-GH was established among a diverse French Canadian population, including those with minimal education.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124711667","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}

引用次数: 1

Editor’s Commentary: A New Category of Articles— Regulatory Commentaries 编者评论:一种新的文章类别——监管评论

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-09-01 DOI: 10.1177/0092861512457774

J. R. Turner

引用次数: 0

Corrigendum: Improvement of the Drug Allergy Alert for Nonprescription NSAIDs 勘误:改进非处方非甾体抗炎药的药物过敏警报

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-09-01 DOI: 10.1177/0092861512460231

R. Soller, C. Shaheen, J. Yen, J. Rose, J. Lightwood

引用次数: 0

Use of Proprietary Names by Prescribers for Discontinued Brand Drug Products With Existing Generic Equivalents 处方医师对已有仿制药的已停用品牌药品使用专有名称

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-08-21 DOI: 10.1177/0092861512456282

Chi-Ming Tu, Kellie Taylor, Grace P Chai

{"title":"Use of Proprietary Names by Prescribers for Discontinued Brand Drug Products With Existing Generic Equivalents","authors":"Chi-Ming Tu, Kellie Taylor, Grace P Chai","doi":"10.1177/0092861512456282","DOIUrl":"https://doi.org/10.1177/0092861512456282","url":null,"abstract":"Purpose To describe the endurance of continued use of proprietary names by prescribers for discontinued brand drug products with existing generic equivalents and to identify prescribing practice trends that can inform the formulation and evaluation of new proprietary names. Methods A national outpatient prescription database, IMS’s Vector One®: National, was used to identify prescribing trends by examining drug use data for proprietary and generic names as they were written on actual prescriptions for 7 discontinued brand drug products from the years 2003 to 2010. Results Drug use data from years 2003 to 2010 showed the endurance of continued use of proprietary names by prescribers for all 7 studied discontinued brand drug products. Overall, the number of prescriptions written in the proprietary name decreased over time but did not cease after brand drug product discontinuation. Of the 7 drugs studied, “Aldomet” was the proprietary name with the longest continued use, such that approximately 8 out of 100 new prescriptions for methyldopa were still written in the proprietary name after 10 years of brand drug product discontinuation. Conclusions This research identified that prescribers continued to prescribe by the proprietary names for many years after the discontinuation of brand drug products. This prescribing practice confirms the need to account for the proprietary names of discontinued brand drug products when formulating and evaluating new proprietary names.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126371532","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}

引用次数: 1

Dispensed Medications: Labeling Patterns and Patient Knowledge at a Tertiary Care University Hospital in Southwest Ethiopia 分配的药物:标签模式和患者知识在三级护理大学医院在埃塞俄比亚西南部

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-08-16 DOI: 10.1177/0092861512456977

Hawi Yabite, S. Tessema, N. Wabe

{"title":"Dispensed Medications: Labeling Patterns and Patient Knowledge at a Tertiary Care University Hospital in Southwest Ethiopia","authors":"Hawi Yabite, S. Tessema, N. Wabe","doi":"10.1177/0092861512456977","DOIUrl":"https://doi.org/10.1177/0092861512456977","url":null,"abstract":"The label on dispensed medicines should provide the patient with clear and complete instructions on how to take the drugs. Without sufficient knowledge about risks and benefits of using medicines, people will often not receive the expected clinical outcomes and may suffer adverse effects. The aim of this study was to assess the quality of labeling and patient knowledge of dispensed drugs in Jimma University Specialized Hospital. A cross-sectional prospective study was conducted from January 19 to February 24, 2009. Quality of labeling was assessed by calculating the mean labeling scores. The patient knowledge scores were obtained from patient recall of knowledge indicators. Mean dispensing and dispensing counseling was calculated. A total of 640 drugs were prescribed for 384 patients, and 544 (85.0%) were actually dispensed. The mean labeling score of the dispensed drugs was found to be 3.3 out of 7 essential dispensing quality attributes. All of the dispensed drugs were labeled with their generic name, while no drug was labeled with the patient’s name. The remaining labeling attributes such as strength (91.9%), duration of treatment (57.4%), frequency (47.4%), dose (38.6%), and amount of the drugs (15.8%) were written on dispensed drugs. The mean patient knowledge score was 3.7 out of 7. Routes of administration (100.0%), dose (96.1%), frequency (95.5%), reason for prescribing (89.3%), duration of treatment (49.6%), and name of medicine (15.1%) were recalled among the dispensed drugs. The mean dispensing and dispensing counseling times were found to be 130.2 and 29.2 seconds, respectively. Patients’ knowledge was satisfactory. However, labeling of dispensed drugs was the main problem identified. Dispensing counseling time was also too short to allow for optimal information to be given on drugs and answering questions from patients.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121424665","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}

引用次数: 4