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Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656
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Book Description
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. - Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues - Describes current achievements of drug safety practice in developing countries - Addresses the challenges of drug safety in developing countries - Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety
Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Medical
Languages : en
Pages : 656
Get Book Here
Book Description
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. - Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues - Describes current achievements of drug safety practice in developing countries - Addresses the challenges of drug safety in developing countries - Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety
Author: I. Ralph Edwards
Publisher: Springer
ISBN: 3319404008
Category : Medical
Languages : en
Pages : 227
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Book Description
Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate. The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author: Gary W. Saunders
Publisher:
ISBN:
Category : Adverse Drug Reaction Reporting Systems
Languages : en
Pages : 792
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Book Description
Author: Miriam Sturkenboom
Publisher: Springer Nature
ISBN: 3030514552
Category : Medical
Languages : en
Pages : 276
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Book Description
This book allows readers to gain an in-depth understanding of the role of real-world data in pharmacoepidemiology, and highlights the strengths and limitations of the respective databases with regard to pharmacoepidemiological research. Over the past decade, the increasing use of real-world data in pharmacoepidemiological research has been accompanied by a growing recognition of the value of real-world evidence in clinical and regulatory decision-making. Electronic healthcare databases allow analyses of drug and vaccine utilization in routine care after approval, as well as investigations of their comparative effectiveness and safety. They are especially useful for the identification of rare risks and rare drug exposures over long periods of time, and as such sustainably extend the basis for drug safety research. This book provides an introduction to the role of real-world data in pharmacoepidemiological research and the main developments in the last 15 years. It also offers a comprehensive overview of the general classification characteristics of databases, together with their strengths and limitations, and a detailed description of 21 individual databases, written by professionals who work with or maintain them.
Author: William Wang
Publisher: CRC Press
ISBN: 0429950004
Category : Mathematics
Languages : en
Pages : 402
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Book Description
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.
Author: Michael Kaeding
Publisher: Springer
ISBN: 3658172762
Category : Political Science
Languages : en
Pages : 136
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Book Description
This book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level.
Author: Amy Tang
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Introduction: It has been said that through monitoring of drug safety, pharmacovigilance (PV) systems have been instrumental in assisting regulatory decisions on product safety. However, there has been no, systematic, in-depth study of this role. This thesis reports such a study conducted in the UK. On the basis of the results, suggestions are made on how PV data might be produced and used more effectively. Methods: In Phase 1, a scoping study was conducted to document all changes made to UK product labelling on safety grounds over a 10 year period (September 1st 1995 to August 31st 2005). In Phase 2, all product withdrawals and major labelling changes made during the 10 year study above, were investigated in depth to determine the therapeutic group, source of ADR data cited as the reason for the change; and product survival probability, using Kaplan-Meier modelling. Phase 3, informed by Phases 1 and 2, used a web-based survey (150 respondents) and structured interviews (13 subjects) with healthcare professionals and scientists with a PV role in the NHS, pharmaceutical companies and the UK regulator, to gain views on the current procedures for handling safety issues in the UK and how these might be improved. Inferences were drawn using interpretative phenomenological analysis with NVivo 8 software. Key findings Phases 1 and 2 revealed the fragmentary nature of information in the public domain and the difficulties of obtaining unpublished information. Based on public information, Phase 1 showed that 2,630 safety notices were issued affecting 688 individual products. The two main safety notice categories were drug interactions (841;32%) and side effects (537;20%). The rank order of the four most common therapeutic areas in which safety notices occurred was: CNS (23.5%)> anti-infectives (21.6%)> cardiovascular (15.2%)> cancer chemotherapy (10.8%). The ratio of Type A : Type B side effects (ADRs) was 1:3.3. Phase 2 found that of 518 eligible products launched during the study period, 9 (1.7%) were licensed and withdrawn for safety reasons. The ten-year Kaplan-Meier probability of adverse drug reactions causing the withdrawal of a new product, postmarketingwas 2.2%. All decisions were based on more than one safety data type and all involved UK yellow cards. One decision considered prescription event monitoring (PEM) data. A total of 164 important safety notices affecting 818 individual products were identified. Of 518 products launched during the study period, 56 experienced at least one major labelling change for safety reasons. The ten-year Kaplan-Meier risk of a product experiencing at least one major labelling change on safety grounds was 13.8%. As with product withdrawals, safety decisions were based on a wide range of data sources of variable quality and quantity. Variation in dissemination of the new safety information was observed. Only one fifth of safety notices warranting a 'Dear Healthcare Professional' letter or a monograph in 'Current Problems in Pharmacovigilance', were accompanied by a boxed warning in the BNF, representing an important inconsistency in notifying prescribers. As with interview participants, respondents to the on-line questionnaire had difficulties placing the yellow card reports in a formal hierarchy of evidence whilst acknowledging that the data were valuable in the decision making process. Suggested ways of improving the quality of such reports included making the reporting more accessible and training all those eligible to report. PEM studies were cited by the majority of respondents as a means of generating credible safety data and raising the general quality of the drug safety database. In terms of dissemination and education about ADRs, Drug Safety Updates (which replaced the 'Current Problems' publication from the MHRA in August 2007) were highly thought of; they appeared to be more popular than 'Dear Healthcare Professional' letters and because they were web-based, ought to be accessible by a wider audience. Conclusions Safeguarding public health is of utmost importance when making a decision whether or not to withdraw a product or amend its labelling upon the emergence of new safety data. Labelling changes should be made only on the best evidence available at the time and appropriate risk management strategies should be instigated where feasible; not only when a safety signal arises post-marketing, but when a drug is first granted a marketing authorisation. There is no general consensus on what constitutes 'best evidence' and rating evidence using traditional hierarchies is problematic, The GRADE hierarchy may be an exception. Improving ADR reporting should lead to improved data bases from which to draw safety conclusions. Methods of improving reporting include early instigation and enforcement of risk management plans by the regulator, education of all those eligible to report, greater transparency of regulatory decisions and better and more rapid dissemination of safety change information.
Author: Régis Beuscart
Publisher: IOS Press
ISBN: 1607500434
Category : Medical
Languages : en
Pages : 236
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Book Description
Presents papers from the workshop 'Patient Safety through Intelligent Procedures in medication' focusing on: identification of ADE and medication errors in hospital settings; the role of human and organizational factors on ADE and medication errors; and information and communication technologies to prevent or correct ADEs and medication errors.
Author: Mukesh Nandave
Publisher: Springer Nature
ISBN: 9819989493
Category :
Languages : en
Pages : 478
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Book Description
