Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions

M.A. Aldeyab, S.C. Noble, M. Cuthbert, S. Maxwell, J. Dear, A. Boyter

    Research output: Contribution to journalArticle

    Abstract

    Objective: The aim was to assess patterns in reporting of adverse drug reactions (ADRs) via the Yellow Card (YC) Scheme following a Scottish community pharmacy patient YC promotional campaign (January–February 2011). Methods: YC data were obtained from the Medicines and Healthcare Products Regulatory Agency (MHRA) [January 2009–February 2012]. The impact of the campaign on YC reporting rates was assessed by comparing YC submission rates before and after the intervention, using the segmented regression of interrupted time-series analysis. Results: The mean weekly reported ADRs [excluding general practitioner (GP) reports] before, during, and after the campaign were 0.029, 0.019, and 0.023 (per 10,000 inhabitants), respectively. In relation to patients’ YC reporting, the mean weekly patient-reported ADRs before, during, and after the campaign in Scotland were 0.005, 0.002, and 0.004 (per 10,000 inhabitants), respectively. The time-series analysis for monthly reported ADRs in Scotland (excluding GP reports) demonstrated no statistically significant level change (p = 0.706) and no significant trend change (p = 0.509) post-campaign. Similarly, there was no statistically significant level change (p = 0.983) and no significant trend change (p = 0.591) in patient YC reporting. Conclusions: The campaign had no statistically significant impact on influencing the reporting of ADRs. This study adds to a growing body of required information in this area, and suggests improvements if future patient ADR-reporting promotional campaigns are to be considered; the cost-effectiveness of such efforts requires further research. It is recommended that any similar future campaigns should include qualitative attitudinal data collection and evaluation to help further explore this more robustly. © 2016, Springer International Publishing Switzerland.
    Original languageEnglish
    Pages (from-to)209-218
    Number of pages10
    JournalDrugs and Therapy Perspectives
    Volume32
    Issue number5
    Early online date3 Feb 2016
    DOIs
    Publication statusPublished - May 2016

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    Keywords

    • adalimumab
    • amoxicillin
    • atomoxetine
    • candesartan
    • ciprofloxacin
    • clomipramine
    • cyclizine
    • desogestrel plus ethinylestradiol
    • dextromethorphan
    • diclofenac
    • drug
    • etanercept
    • etonogestrel
    • exendin 4
    • fluorescein
    • influenza vaccine
    • levonorgestrel
    • nitrofurantoin
    • omeprazole
    • paracetamol
    • pseudoephedrine
    • ramipril
    • rivaroxaban
    • sertraline
    • simvastatin
    • tramadol
    • unindexed drug
    • varenicline
    • venlafaxine
    • Wart virus vaccine
    • abdominal pain
    • adverse drug reaction
    • anxiety
    • arthralgia
    • Article
    • blister
    • breast tenderness
    • breathing disorder
    • depression
    • dizziness
    • dyspnea
    • epidemiology
    • erythema
    • fatigue
    • general practitioner
    • guilt
    • headache
    • health promotion
    • hearing impairment
    • human
    • indigestion
    • injection site swelling
    • insomnia
    • myalgia
    • nausea
    • pain
    • pharmacist
    • pruritus
    • public health campaign
    • rash
    • self report
    • side effect
    • swelling
    • tachycardia
    • thorax pain
    • time series analysis
    • United Kingdom
    • unspecified side effect
    • urticaria
    • vivid dream
    • voluntary reporting
    • vomiting
    • weakness
    • weight gain

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