Pharmacovigilance Training for Specialist Oncology Nurses —A Two Way Evaluation

Abstract

Background: In a new prescribing qualifcation course for specialist oncology nurses, we thought it important to emphasize pharma-covigilance and adverse drug reaction (ADR)-reporting. To this end, our aim was to develop and evaluate an ADR reporting assignment for specialist oncology nurses. Methods: The quality of report documentation was assessed with the 'Clinical Documentation tool to assess Individual Case Safety Reports' (ClinDoc). The relevance of the reports was evaluated in terms of ADR seriousness, the listing for additional monitoring of the drug by European Medicines Agency (EMA), and lack of labelling information about the ADR. Nurses' opinions of the assignment were evaluated using an E-survey. Results: Thirty-three ADRs were reported, 32 (97%) of which were well documented according to ClinDoc. Thirteen ADRs (39%) were 'serious' according to CIOMS criteria. In 5 cases (15%) the suspect drugs were listed for additional monitoring by EMA and in 7 cases (21%) the ADR was not mentioned in the Summary of Product Characteristics. Twenty-fve (78%) of the 32 enrolled nurses completed the E-survey. Most were > 45 years of age (68%), female (92%), and had extensive clinical experience (6-33 years). All agreed or completely agreed that the reporting assignment was useful, that it ftted in daily practice, and that it increased their attention for medi-cation/patient safety. A large majority (84%) agreed the assignment changed how they dealt with ADRs. Conclusions: Specialist oncology nurses are capable of reporting ADRs, and they considered the assignment useful. The assignment yielded valuable, relevant, and well-documented ADR reports for pharmacovigilance practice.