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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Over the years, drug products, including those indicated for diabetes, have been withdrawn from the marketplace because of quality concerns and/or severe adverse drug reactions.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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Nurses are increasingly involved in pharmacovigilance in Sweden.

https://arctichealth.org/en/permalink/ahliterature166841
Source
Pharmacoepidemiol Drug Saf. 2007 May;16(5):532-7
Publication Type
Article
Date
May-2007
Author
Johanna Ulfvarson
Stefan Mejyr
Ulf Bergman
Author Affiliation
Division of Clinical Pharmacology, Stockholm Söder Hospital, and Department of Clinical Neurobiology, Care Sciences and Society, Section of Nursing, Karolinska Institutet, Stockholm, Sweden. Johanna.Ulfvarson@sodersjukhuset.se
Source
Pharmacoepidemiol Drug Saf. 2007 May;16(5):532-7
Date
May-2007
Language
English
Publication Type
Article
Keywords
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Anesthetics, Local - adverse effects
Contraceptives, Oral - adverse effects
Dentists - standards
Drug Therapy - statistics & numerical data
Drug-Related Side Effects and Adverse Reactions - chemically induced - epidemiology - prevention & control
Histamine H1 Antagonists - adverse effects
Humans
Nurse's Role
Nurses - standards
Physicians - standards
Product Surveillance, Postmarketing - methods - trends
Retrospective Studies
Sweden - epidemiology
Time Factors
Vaccination - adverse effects - statistics & numerical data
Abstract
In Sweden, voluntary adverse drug reaction (ADR) reporting started over 40 years ago to detect rare, serious, unexpected adverse, mainly type B, reactions. During the period 1965-2004, 92,000 reports were assessed. Since certain nurses are licensed to prescribe a limited number of drugs, nurses also form part of the reporting team.
To analyse the ADR reporting by nurses in Sweden.
All reports by nurses and other health-care personnel entered into the Swedish ADRs database SWEDIS (Swedish Drug Information System) were retrieved for the 10-year period 1995-2004 (Swedish population: 9 million). The intention was to analyse the nurses' reports from a quantitative and qualitative point of view.
The total number of ADR reports has gradually increased during the past 10 years from 3000 to over 4000 in 2004 (465 per million inhabitants), an increase by 28%. All ADR reports originate from health care personnel. The nurses' contribution to the ADR reporting increased from 2-3% in the mid-90s to 12% in 2004. The most common drugs involved in the nurses' reporting were various kinds of vaccines. Skin reactions dominated among the nurses' ADR reports. The ADRs reported by nurses were, as a consequence of many vaccine reports, compared to all reports, not so often classified as serious, but were on the other hand more often assessed with a causal relationship.
Nurses, in their position as drug administrators who record signs and symptoms of the patients, play an increasingly important role for detection of suspected ADRs and are now contributing to a significant amount of the ADR reporting in Sweden.
PubMed ID
17072915 View in PubMed
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