Review Practices (review + practice)

Distribution by Scientific Domains


Selected Abstracts


Model competencies in regulatory therapeutic product assessment: Health Canada's good review guiding principles as a reviewing community's code of intellectual conduct,,§¶

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2007
Robyn R. Lim PhD
Abstract Purpose This article describes some work from the Therapeutic Products Directorate of Health Canada regarding Good Review Practices (GRP). Methods and Results Background information is provided on the Therapeutic Products Directorate (TPD) and its regulatory activities regarding drug and medical device assessment in both the pre- and post-market setting. The TPD Good Review Guiding Principles (GRGP) are described which include a Definition of a Good Therapeutic Product Regulatory Review, Ten Hallmarks of a Good Therapeutic Product Regulatory Review and Ten Precepts. Analysis of the guiding principles discusses possible linkages between the guiding principles and intellectual virtues. Conclusions Through this analysis an hypothesis is developed that the guiding principles outline a code of intellectual conduct for Health Canada's reviewers of evidence for efficacy, safety, manufacturing quality and benefit-risk regarding therapeutic products. Opportunities to advance therapeutic product regulatory review as a scientific discipline in its own right and to acknowledge that these reviewers constitute a specific community of practice are discussed. Integration of intellectual and ethical approaches across therapeutic product review sectors is also suggested. Copyright © 2007 Crown in the right of Canada. Published by John Wiley & Sons, Ltd. [source]


Barriers to reducing the use of restraints in residential elder care facilities

JOURNAL OF ADVANCED NURSING, Issue 6 2007
Kirsten Moore
Abstract Title.,Barriers to reducing the use of restraints in residential elder care facilities Aim., This paper is a report of a study to compare perspectives of staff in residential elder care facilities with those of residents and family members from the same facilities about barriers to reducing the use of physical, chemical and environmental restraints. Background., There is growing research evidence of the potential risk of physical and emotional harm of restraining residents in residential elder care facilities. Despite the potential harms, restraints continue to be a common practice in facilities across Australia. Little research has been undertaken to explore the barriers to reducing the use of restraints. Method., Eighteen individual interviews were conducted with staff, general practitioners and a pharmacist and three focus groups were conducted with a total of 12 residents and 17 family members associated with three residential elder care facilities in Melbourne, Australia in 2004. Findings., The three participating facilities were committed to reducing the use of restraints, although physical, chemical and environmental restraints were used in all three facilities. Barriers to reducing restraint use included fear of resident injury, staff and resource limitations, lack of education and information about alternatives to restraints, environmental constraints, policy and management issues, beliefs and expectations (of staff, family and residents), inadequate review practices and communication barriers. Conclusion., Further education and support for staff and family members in evidence-based practice in relation to resident care and restraint use is needed in at least some residential elder care facilities. [source]


Review of psychotropic medication in Tasmanian residential aged care facilities

AUSTRALASIAN JOURNAL ON AGEING, Issue 2 2010
Juanita Westbury
Aim:, To examine psychotropic medication review practices in residential aged care facilities. Methods:, Psychotropic medicine use data were collected from residents from 40 residential aged care facilities throughout Tasmania. As an indication of review practices, the measure was repeated at 33 of the original facilities a year later. Results:, A total of 2389 residents' medication records were examined in 2006. Regular doses of antipsychotics and benzodiazepines were taken by 42% and 21% of residents, respectively. Medication data were available for 1307 of the residents in 2007. Over 60% were taking the same antipsychotic or benzodiazepine agent, at the same dose in 2007, as they were in 2006. Dosage reduction or cessation occurred in less than a quarter of the residents. Conclusion:, The utilisation of psychotropic medication is high in Tasmanian residential aged care facilities. Attempts to reduce psychotropic doses happen infrequently. Further research is required to establish the barriers to appropriate psychotropic medication review in this setting. [source]


Between spin and reality: examining disclosure practices in three African countries

PUBLIC ADMINISTRATION & DEVELOPMENT, Issue 3 2007
George A. LarbiArticle first published online: 28 JUN 200
Abstract The declaration of assets and liabilities represents a growing trend in the avoidance and resolution of conflict of interest and has become a part of an integrated strategy to control corruption. This article reviews practices in Ghana, Tanzania and Uganda by addressing questions of who must declare, what must be declared, where to declare and how often to declare. It argues that like all the other mechanisms for controlling corruption, its efficacy depends on enforcement and compliance. The three cases reviewed suggest that there is a significant gap between the rhetoric of declaration and the reality of effective monitoring and compliance to make the system work to ensure transparency and public trust. Copyright © 2007 John Wiley & Sons, Ltd. [source]