Towards medicines regulatory authorities' quality performance improvement: value for public health

2014 ◽  
Vol 31 (1) ◽  
pp. E22-E40 ◽  
Author(s):  
Gordana Pejović ◽  
Jovan Filipović ◽  
Ljiljana Tasić ◽  
Valentina Marinković
NSPI Journal ◽  
1979 ◽  
Vol 18 (3) ◽  
pp. 13-15
Author(s):  
Seth N. Leibler ◽  
Susan F. Holly ◽  
Wayne G. Brown ◽  
Susan B. Toal

2013 ◽  
Vol 37 (5) ◽  
pp. 682 ◽  
Author(s):  
Marie M. Bismark ◽  
Simon J. Walter ◽  
David M. Studdert

Objectives To determine the nature and extent of governance activities by health service boards in relation to quality and safety of care and to gauge the expertise and perspectives of board members in this area. Methods This study used an online and postal survey of the Board Chair, Quality Committee Chair and two randomly selected members from the boards of all 85 health services in Victoria. Seventy percent (233/332) of members surveyed responded and 96% (82/85) of boards had at least one member respond. Results Most boards had quality performance as a standing item on meeting agendas (79%) and reviewed data on medication errors and hospital-acquired infections at least quarterly (77%). Fewer boards benchmarked their service’s quality performance against external comparators (50%) or offered board members formal training on quality (53%). Eighty-two percent of board members identified quality as a top priority for board oversight, yet members generally considered their boards to be a relatively minor force in shaping the quality of care. There was a positive correlation between the size of health services (total budget, inpatient separations) and their board’s level of engagement in quality-related activities. Ninety percent of board members indicated that additional training in quality and safety would be ‘moderately useful’ or ‘very useful’. Almost every respondent believed the overall quality of care their service delivered was as good as, or better than, the typical Victorian health service. Conclusions Collectively, health service boards are engaged in an impressive range of clinical governance activities. However, the extent of engagement is uneven across boards, certain knowledge deficits are evident and there was wide agreement among board members that further training in quality-related issues would be useful. What is known about the topic? There is an emerging international consensus that effective board leadership is a vital element of high-quality healthcare. In Australia, new National Health Standards require all public health service boards to have a ‘system of governance that actively manages patient safety and quality risks’. What does this paper add? Our survey of all public health service Boards in Victoria found that, overall, boards are engaged in an impressive range of clinical governance activities. However, tensions are evident. First, whereas some boards are strongly engaged in clinical governance, others report relatively little activity. Second, despite 8 in 10 members rating quality as a top board priority, few members regarded boards as influential players in determining it. Third, although members regarded their boards as having strong expertise in quality, there were signs of knowledge limitations, including: near consensus that (additional) training would be useful; unfamiliarity with key national quality documents; and overly optimistic beliefs about quality performance. What are the implications for practitioners? There is scope to improve board expertise in clinical governance through tailored training programs. Better board reporting would help to address the concern of some board members that they are drowning in data yet thirsty for meaningful information. Finally, standardised frameworks for benchmarking internal quality data against external measures would help boards to assess the performance of their own health service and identify opportunities for improvement.


2009 ◽  
Vol 15 (2) ◽  
pp. E22-E33 ◽  
Author(s):  
Anjum Hajat ◽  
Dorothy Cilenti ◽  
Lisa M. Harrison ◽  
Pia D.M. MacDonald ◽  
Denise Pavletic ◽  
...  

2016 ◽  
Vol 59 (2) ◽  
pp. 245-266 ◽  
Author(s):  
Alex Price ◽  
Robert Schwartz ◽  
Joanna Cohen ◽  
Fran Scott ◽  
Heather Manson

2021 ◽  
Vol 11 (8) ◽  
pp. 143-148
Author(s):  
Mohammed Gharba ◽  
Abdullah A. Balahmar ◽  
Zohdi A. Saif

Anemia is common among critically ill patients, despite guidelines recommendations for restrictive transfusion practices, blood transfusion continues beyond recommended triggers. Frequency of blood transfusion in ICU calls for auditing of practices. Method: Two audit cycles a month each, separated by interventional period, audit standards were order issuing personnel, documentation of trigger, trigger according to policy, checking of received unit documentation, monitoring during transfusion, and reporting of adverse events. Results: Standards of trigger documentation, trigger according to policy, and checking documentation were very low in the first cycle, but showed significant improvement in the second cycle, after the performance improvement project. The transfusion rate was significantly lower in the second cycle (18.8/100 patient days vs 14.8 /100 patient days; p = 0.04). Conclusion: Blood transfusion practices remain unsatisfactory in several aspects, however, they could be improved by quality performance improvement projects. Key words: Blood transfusion, intensive care unit, ICU, clinical audit, performance improvement project.


2016 ◽  
Vol 1 ◽  
pp. maapoc.0000001
Author(s):  
Valerio Reggi

Over the past 30 years, many national drug regulatory authorities have embarked on a process of gradual harmonization of all the technical aspects of studies, processes, and tests that generate the data necessary to support claims of quality, safety, and efficacy of medicines. This has been mainly a trade-driven process characterized by “region-specific” harmonization initiatives; the less-resourced authorities started this processes much later than the better-resourced ones. The immediate outcome of harmonized requirements is the eliminating of country-specific tests and studies, and the narrowing of gaps in the interpretation of data. This reduced the costs for pharmaceutical companies by enabling them to develop one single set of data and documentation to be submitted to several different countries. In addition, the harmonization processes are beneficial for public health: open-minded technical discussions and the exchange of ideas and experience among regulators of different countries contributes to strengthening the capacity of national authorities to expedite the assessment of priority medicines, and to filter out unsafe or substandard products.


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