Over the years, drug products, including those indicated for diabetes, have been withdrawn from the marketplace because of quality concerns and/or severe adverse drug reactions.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.
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
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. firstname.lastname@example.org
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.
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
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 (
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
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.
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.