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107 records – page 1 of 11.

Advocating safety. "Whistle-blowing" in the U.S. and Canada.

https://arctichealth.org/en/permalink/ahliterature190858
Source
AWHONN Lifelines. 2002 Feb-Mar;6(1):18-20
Publication Type
Article
Author
Merry Little
Author Affiliation
Women's Health Care Centre, St. Michael's Hospital, Toronto, ON, Canada.
Source
AWHONN Lifelines. 2002 Feb-Mar;6(1):18-20
Language
English
Publication Type
Article
Keywords
American Nurses' Association
Canada
Consumer Product Safety - legislation & jurisprudence
Disclosure
Humans
Patient Advocacy - legislation & jurisprudence
Societies, Nursing
United States
PubMed ID
11913197 View in PubMed
Less detail

An overview of Canadian and U.S. approaches to drug regulation and responses to postmarket adverse drug reactions.

https://arctichealth.org/en/permalink/ahliterature114900
Source
J Diabetes Sci Technol. 2013;7(2):313-20
Publication Type
Article
Date
2013
Author
Richard Y Cheung
Sarah H Goodwin
Author Affiliation
Fasken Martineau DuMoulin LLP, 333 Bay St., Suite 2400, Toronto, Ontario, Canada M5H 2T6. rcheung@fasken.com
Source
J Diabetes Sci Technol. 2013;7(2):313-20
Date
2013
Language
English
Publication Type
Article
Keywords
Canada
Diabetes Mellitus, Type 2 - drug therapy
Drug and Narcotic Control - legislation & jurisprudence - methods - organization & administration - trends
Humans
Hypoglycemic agents - therapeutic use
Patient Safety - legislation & jurisprudence
Product Surveillance, Postmarketing - methods - trends
Thiazolidinediones - therapeutic use
United States
United States Food and Drug Administration - legislation & jurisprudence - organization & administration
Abstract
Over the years, drug products, including those indicated for diabetes, have been withdrawn from the marketplace because of quality concerns and/or severe adverse drug reactions. While the drug regulatory process is designed to detect, among other things, adverse drug reactions before a drug receives marketing authorization, for various reasons, premarket detection of all potential adverse reactions associated with a drug may not be possible. As such, regulatory authorities must also react to and manage adverse reactions identified at the postmarket stage. In this article, we provide a general overview of drug regulation in Canada and the United States and consider an example of a drug indicated for the treatment of diabetes and how newly identified potential safety concerns were managed in the postmarket environment.
Notes
Cites: N Engl J Med. 2007 Jun 14;356(24):2457-7117517853
Cites: J Am Board Fam Pract. 2001 Sep-Oct;14(5):362-711572541
PubMed ID
23566987 View in PubMed
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Bacterial contamination of animal feed and its relationship to human foodborne illness.

https://arctichealth.org/en/permalink/ahliterature51655
Source
Clin Infect Dis. 2002 Oct 1;35(7):859-65
Publication Type
Article
Date
Oct-1-2002
Author
John A Crump
Patricia M Griffin
Frederick J Angulo
Author Affiliation
Foodborne and Diarrheal Diseases Branch, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. jcrump@cdc.gov
Source
Clin Infect Dis. 2002 Oct 1;35(7):859-65
Date
Oct-1-2002
Language
English
Publication Type
Article
Keywords
Animal Feed - microbiology
Consumer Product Safety - legislation & jurisprudence
Disease Outbreaks
Food Contamination
Humans
Meat Products - microbiology
Salmonella Infections - epidemiology
Salmonella enterica
Sweden
Typhoid Fever - prevention & control
United States - epidemiology
Abstract
Animal feed is at the beginning of the food safety chain in the "farm-to-fork" model. The emergence of variant Creutzfeldt-Jakob disease has raised awareness of the importance of contaminated animal feed, but less attention has been paid to the role of bacterial contamination of animal feed in human foodborne illness. In the United States, animal feed is frequently contaminated with non-Typhi serotypes of Salmonella enterica and may lead to infection or colonization of food animals. These bacteria can contaminate animal carcasses at slaughter or cross-contaminate other food items, leading to human illness. Although tracing contamination to its ultimate source is difficult, several large outbreaks have been traced back to contaminated animal feed. Improvements in the safety of animal feed should include strengthening the surveillance of animal feed for bacterial contamination and integration of such surveillance with human foodborne disease surveillance systems. A Hazard Analysis and Critical Control Point program should be instituted for the animal feed industry, and a Salmonella-negative policy for feed should be enforced.
Notes
Comment In: Clin Infect Dis. 2003 Apr 1;36(7):933-4; author reply 934-512652398
PubMed ID
12228823 View in PubMed
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Benefits of Water Safety Plans: microbiology, compliance, and public health.

https://arctichealth.org/en/permalink/ahliterature123644
Source
Environ Sci Technol. 2012 Jul 17;46(14):7782-9
Publication Type
Article
Date
Jul-17-2012
Author
Maria J Gunnarsdottir
Sigurdur M Gardarsson
Mark Elliott
Gudrun Sigmundsdottir
Jamie Bartram
Author Affiliation
Faculty of Civil and Environmental Engineering, University of Iceland, Hjardarhaga 2-6, 107 Reykjavik, Iceland. mariag@hi.is
Source
Environ Sci Technol. 2012 Jul 17;46(14):7782-9
Date
Jul-17-2012
Language
English
Publication Type
Article
Keywords
Colony Count, Microbial
Diarrhea - epidemiology
Drinking Water - microbiology - standards
Guideline Adherence - standards
Heterotrophic Processes
Humans
Iceland - epidemiology
Incidence
Logistic Models
Public Health - legislation & jurisprudence - standards
Safety - legislation & jurisprudence
Social Control, Formal
Water Microbiology - standards
Water Quality - standards
Water Supply - legislation & jurisprudence
Abstract
The Water Safety Plan (WSP) methodology, which aims to enhance safety of drinking water supplies, has been recommended by the World Health Organization since 2004. WSPs are now used worldwide and are legally required in several countries. However, there is limited systematic evidence available demonstrating the effectiveness of WSPs on water quality and health. Iceland was one of the first countries to legislate the use of WSPs, enabling the analysis of more than a decade of data on impact of WSP. The objective was to determine the impact of WSP implementation on regulatory compliance, microbiological water quality, and incidence of clinical cases of diarrhea. Surveillance data on water quality and diarrhea were collected and analyzed. The results show that HPC (heterotrophic plate counts), representing microbiological growth in the water supply system, decreased statistically significant with fewer incidents of HPC exceeding 10 cfu per mL in samples following WSP implementation and noncompliance was also significantly reduced (p
PubMed ID
22679926 View in PubMed
Less detail

Bicycle helmet use after the introduction of all ages helmet legislation in an urban community in Alberta, Canada.

https://arctichealth.org/en/permalink/ahliterature134239
Source
Can J Public Health. 2011 Mar-Apr;102(2):134-8
Publication Type
Article
Author
Mohammad Karkhaneh
Brian H Rowe
L Duncan Saunders
Don Voaklander
Brent Hagel
Author Affiliation
School of Public Health, University of Alberta, Edmonton, AB.
Source
Can J Public Health. 2011 Mar-Apr;102(2):134-8
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Alberta
Bicycling - injuries - legislation & jurisprudence - statistics & numerical data
Head Protective Devices - utilization
Humans
Safety - legislation & jurisprudence
Young Adult
Abstract
Bicycle trauma is a common cause of recreational death and disability and helmets have been shown to reduce fatal and non-fatal head and face injuries. This study evaluated the effect of mandatory bicycle helmet legislation for all ages in St. Albert, Alberta.
We observed bicyclists from June to September of 2006 in St. Albert, a community subject to both provincial (
PubMed ID
21608386 View in PubMed
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Bicycle helmet use four years after the introduction of helmet legislation in Alberta, Canada.

https://arctichealth.org/en/permalink/ahliterature136454
Source
Accid Anal Prev. 2011 May;43(3):788-96
Publication Type
Article
Date
May-2011
Author
M. Karkhaneh
B H Rowe
L D Saunders
D C Voaklander
B E Hagel
Author Affiliation
School of Public Health, University of Alberta, Edmonton, Alberta, Canada.
Source
Accid Anal Prev. 2011 May;43(3):788-96
Date
May-2011
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Alberta
Bicycling - injuries - legislation & jurisprudence
Child
Cooperative Behavior
Craniocerebral Trauma - mortality - prevention & control
Data Collection
Facial Injuries - mortality - prevention & control
Follow-Up Studies
Head Protective Devices - utilization
Humans
Safety - legislation & jurisprudence
Young Adult
Abstract
Bicycle helmets reduce fatal and non-fatal head and face injuries. This study evaluated the effect of mandatory bicycle helmet legislation targeted at those less than 18 years old on helmet use for all ages in Alberta.
Two comparable studies were conducted two years before and four years after the introduction of helmet legislation in Alberta in 2002. Bicyclists were observed in randomly selected sites in Calgary and Edmonton and eight smaller communities from June to October. Helmet wearing and rider characteristics were recorded by trained observers. Poisson regression adjusting for clustering by site was used to obtain helmet prevalence (HP) and prevalence ratio (PR) (2006 vs. 2000) estimates.
There were 4002 bicyclists observed in 2000 and 5365 in 2006. Overall, HP changed from 75% to 92% among children, 30% to 63% among adolescents and 52% to 55% among adults. Controlling for city, location, companionship, neighborhood age proportion
PubMed ID
21376867 View in PubMed
Less detail

Brain-Computer Interface devices: risks and Canadian regulations.

https://arctichealth.org/en/permalink/ahliterature156376
Source
Account Res. 2008 Apr-Jun;15(2):63-86
Publication Type
Article
Author
Sheri Alpert
Author Affiliation
Novel Tech Ethics, Intellectual Commons, Dalhousie University, Halifax, Nova Scotia, Canada. salpert@dal.ca
Source
Account Res. 2008 Apr-Jun;15(2):63-86
Language
English
Publication Type
Article
Keywords
Canada
Consumer Product Safety - legislation & jurisprudence - standards
Device Approval - legislation & jurisprudence - standards
Equipment Design
Equipment Safety
Humans
Prostheses and Implants - adverse effects - standards
Risk assessment
Self-Help Devices - adverse effects - standards
User-Computer Interface
Abstract
Implantable Brain-Computer Interface (BCI) devices are currently in clinical trials in the U.S., and their introduction into the Canada could follow in the next few years. This article provides an overview of the research, developments, design issues, and risks in BCIs and an analysis of the adequacy of the regulatory framework in place for the approval of medical devices in Canada, emphasizing device investigational testing. The article concludes that until better safeguards are in place, to best protect potential research subjects, BCIs should not be approved for investigational testing in Canada.
PubMed ID
18593098 View in PubMed
Less detail

The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors.

https://arctichealth.org/en/permalink/ahliterature169089
Source
BMC Health Serv Res. 2006;6:63
Publication Type
Article
Date
2006
Author
Hina Laeeque
Heather Boon
Natasha Kachan
Jillian Clare Cohen
Joseph D'Cruz
Author Affiliation
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada. hina.laeeque@utoronto.ca
Source
BMC Health Serv Res. 2006;6:63
Date
2006
Language
English
Publication Type
Article
Keywords
Canada
Consumer Product Safety - legislation & jurisprudence
Dietary Supplements - standards
Drug Industry - legislation & jurisprudence
Government Regulation
Guideline Adherence - statistics & numerical data
Health Care Surveys
Humans
Interviews as Topic
Licensure - legislation & jurisprudence
Minerals - standards
Product Line Management - legislation & jurisprudence - standards
Questionnaires
Vitamins - standards
Abstract
The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance.
Twenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes.
The major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size.
The Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.
Notes
Cites: JAMA. 1998 Nov 11;280(18):1569-759820257
PubMed ID
16734916 View in PubMed
Less detail

107 records – page 1 of 11.