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

Mamoon A. Aldeyab, Sheila C. Noble, Melinda Cuthbert, Simon Maxwell, James Dear, Anne 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.

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
Externally publishedYes

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Health Promotion
Drug-Related Side Effects and Adverse Reactions
Public Health
Scotland
General Practitioners
Pharmacies
Cost-Benefit Analysis
Delivery of Health Care
Research

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Aldeyab, Mamoon A. ; Noble, Sheila C. ; Cuthbert, Melinda ; Maxwell, Simon ; Dear, James ; Boyter, Anne. / Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions. In: Drugs and Therapy Perspectives. 2016 ; Vol. 32, No. 5. pp. 209-218.
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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.",
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Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions. / Aldeyab, Mamoon A.; Noble, Sheila C.; Cuthbert, Melinda; Maxwell, Simon; Dear, James; Boyter, Anne.

In: Drugs and Therapy Perspectives, Vol. 32, No. 5, 05.2016, p. 209-218.

Research output: Contribution to journalArticle

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T1 - Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions

AU - Aldeyab, Mamoon A.

AU - Noble, Sheila C.

AU - Cuthbert, Melinda

AU - Maxwell, Simon

AU - Dear, James

AU - Boyter, Anne

PY - 2016/5

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N2 - 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.

AB - 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.

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KW - Varenicline

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