Use of a Patient-Friendly Terms List in the Adverse Drug Reaction Report Form: A Database Study

Sieta T. de Vries, Judy Harrison, Patrick Revelle, Alicia Ptaszynska-Neophytou, Anna Radecka, Gowthamei Ragunathan, Phil Tregunno, Petra Denig and Peter G. M. Mol ()
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Sieta T. de Vries: University of Groningen, University Medical Center Groningen
Judy Harrison: MedDRA® Maintenance and Support Services Organization
Patrick Revelle: MedDRA® Maintenance and Support Services Organization
Alicia Ptaszynska-Neophytou: Medicines and Healthcare products Regulatory Agency
Anna Radecka: Medicines and Healthcare products Regulatory Agency
Gowthamei Ragunathan: Medicines and Healthcare products Regulatory Agency
Phil Tregunno: Medicines and Healthcare products Regulatory Agency
Petra Denig: University of Groningen, University Medical Center Groningen
Peter G. M. Mol: University of Groningen, University Medical Center Groningen

Drug Safety, 2019, vol. 42, issue 7, No 6, 886 pages

Abstract: Abstract Introduction When reporting adverse drug reactions to pharmacovigilance centres, patients and consumers can describe adverse drug reactions experienced in free-text format. Recently, a patient-friendly adverse drug reaction terms list was introduced in the adverse drug reaction report form in the UK to facilitate this reporting. Objective The objective of this study was to evaluate the actual use of the patient-friendly terms list in the adverse drug reaction report form and its association with the type of adverse drug reactions reported. Methods We conducted a database study in which we reviewed the list’s use for all reported adverse drug reactions by patients and consumers to the pharmacovigilance centre in the UK via the online report form between August and September 2017. Descriptive statistics were used. In addition, for adverse drug reactions reported more than 20 times, Chi-squared tests were used to test for differences in the number of reports in which the patient-friendly terms list was used and those in which the adverse drug reaction was entered as free text. Results In total, 888 reports were received. In 185 reports (21%), the patient-friendly terms list was used to enter an adverse drug reaction. In total, the reports contained 3227 adverse drug reactions. Nausea, headache, diarrhoea, dizziness, insomnia, anxiety, depression, fatigue, tiredness, vomiting, appetite lost, joint pain, chest pain, constipation and pain were reported more than 20 times. Five of these adverse drug reactions (i.e. nausea, diarrhoea, dizziness, insomnia and constipation) were reported significantly more often in reports where the adverse drug reactions were selected from the patient-friendly terms list. Conclusions Most people chose to describe adverse drug reactions in their own words rather than selecting adverse drug reactions from a patient-friendly terms list. Although the patient-friendly terms list may be a useful feature for some patients or for some adverse drug reactions, it should not replace the option for patients to describe adverse drug reactions in their own words.

Date: 2019
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DOI: 10.1007/s40264-019-00800-x

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