Nurses are increasingly involved in pharmacovigilance in Sweden

Pharmacoepidemiol Drug Saf. 2007 May;16(5):532-7. doi: 10.1002/pds.1336.

Abstract

Introduction: 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.

Aim: 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.

MeSH terms

  • 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
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Drug-Related Side Effects and Adverse Reactions / prevention & control*
  • Histamine H1 Antagonists / adverse effects
  • Humans
  • Nurse's Role
  • Nurses / standards*
  • Physicians / standards
  • Product Surveillance, Postmarketing / methods*
  • Product Surveillance, Postmarketing / trends
  • Retrospective Studies
  • Sweden / epidemiology
  • Time Factors
  • Vaccination / adverse effects
  • Vaccination / statistics & numerical data

Substances

  • Anesthetics, Local
  • Contraceptives, Oral
  • Histamine H1 Antagonists