Over the years, drug products, including those indicated for diabetes, have been withdrawn from the marketplace because of quality concerns and/or severe adverse drug reactions.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