The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study

Tim Schutte, Rike van Eekeren, Milan Richir, Jojanneke van Staveren, Eugène van Puijenbroek, Jelle Tichelaar, Michiel van Agtmael

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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.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalNaunyn-Schmiedeberg's Archives of Pharmacology
DOIs
Publication statusPublished - Jan 2018

Cite this

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title = "The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study",
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.",
keywords = "ADR reporting, Nursing education, Oncology nurses, Pharmacotherapy, Pharmacovigilance",
author = "Tim Schutte and {van Eekeren}, Rike and Milan Richir and {van Staveren}, Jojanneke and {van Puijenbroek}, Eug{\`e}ne and Jelle Tichelaar and {van Agtmael}, Michiel",
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T2 - a preliminary evaluation of quality, relevance and educational value in a prospective cohort study

AU - Schutte, Tim

AU - van Eekeren, Rike

AU - Richir, Milan

AU - van Staveren, Jojanneke

AU - van Puijenbroek, Eugène

AU - Tichelaar, Jelle

AU - van Agtmael, Michiel

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N2 - 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.

AB - 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.

KW - ADR reporting

KW - Nursing education

KW - Oncology nurses

KW - Pharmacotherapy

KW - Pharmacovigilance

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U2 - 10.1007/s00210-017-1430-z

DO - 10.1007/s00210-017-1430-z

M3 - Article

SP - 1

EP - 10

JO - Naunyn-Schmiedeberg's Archives of Pharmacology

JF - Naunyn-Schmiedeberg's Archives of Pharmacology

SN - 0028-1298

ER -