Nurses are increasingly involved in pharmacovigilance in Sweden.
BACKGROUND
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.


OBJECTIVE
To analyse the ADR reporting by nurses in Sweden.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Ulfvarson
Johanna
J
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
Mejyr
Stefan
S
Bergman
Ulf
U
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000779:Anesthetics, Local / Q000009:adverse effects; D003276:Contraceptives, Oral / Q000009:adverse effects; D003815:Dentists / Q000592:standards; D004358:Drug Therapy / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D006634:Histamine H1 Antagonists / Q000009:adverse effects; D006801:Humans; D024802:Nurse's Role; D009726:Nurses / Q000592:standards*; D010820:Physicians / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000639:trends; D012189:Retrospective Studies; D013548:Sweden / Q000453:epidemiology; D013997:Time Factors; D014611:Vaccination / Q000009:adverse effects / Q000706:statistics & numerical data
D000779:Anesthetics, Local; D003276:Contraceptives, Oral; D006634:Histamine H1 Antagonists