1. The adverse drug reaction reporting assignment for specialist oncology nurses
- Author
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Eugène van Puijenbroek, Rike van Eekeren, Milan C. Richir, Jojanneke van Staveren, Tim Schutte, Jelle Tichelaar, Michiel A. van Agtmael, Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), CCA - Cancer Treatment and quality of life, Other Research, and Internal medicine
- Subjects
Oncology ,Male ,MEDICAL-STUDENTS ,INFORMATION ,030226 pharmacology & pharmacy ,Cohort Studies ,0302 clinical medicine ,Documentation ,Surveys and Questionnaires ,030212 general & internal medicine ,Prospective Studies ,Summary of Product Characteristics ,Prospective cohort study ,Education, Nursing ,Oncology Nursing ,ADR reporting ,General Medicine ,Middle Aged ,Original Article ,Female ,Adult ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,FEASIBILITY ,DOCTORS ,Nurse's Role ,EVENTS ,03 medical and health sciences ,Patient safety ,Pharmacotherapy ,Internal medicine ,Pharmacovigilance ,medicine ,Journal Article ,Adverse Drug Reaction Reporting Systems ,Humans ,Nurse education ,ATTITUDES ,Oncology nurses ,Pharmacology ,HEALTH-CARE PROFESSIONALS ,business.industry ,DOCUMENTATION ,medicine.disease ,Family medicine ,PHARMACOVIGILANCE ,Nursing education ,business ,Adverse drug reaction - Abstract
In a new prescribing qualification course for specialist oncology nurses, we thought that it is important to emphasize pharmacovigilance and adverse drug reaction (ADR) reporting. We aimed to develop and evaluate an ADR reporting assignment for specialist oncology nurses. 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. 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 five cases (15%), the suspect drugs were listed for additional monitoring by EMA and in seven cases (21%), the ADR was not mentioned in the Summary of Product Characteristics. Twenty-five (78.1%) 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 fitted in daily practice and that it increased their attention for medication/patient safety. A large majority (84.0%) agreed the assignment changed how they dealt with ADRs. 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. Electronic supplementary material The online version of this article (10.1007/s00210-017-1430-z) contains supplementary material, which is available to authorized users.
- Published
- 2018
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