Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions
- 147 Downloads
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).
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.
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.
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.
KeywordsNational Health Service Community Pharmacy Varenicline Community Pharmacist Promotional Campaign
We would like to thank Ms. Sharon Suri (MHRA) for assistance in extraction of the YC data, and Dr. Alistair Millar (NHS Lothian) and Mrs. Anne MacKay (YC Centre Scotland) for their help with dataset manipulation. We are also indebted to Mrs. Moira Kinnear (NHS Lothian) for facilitating liaison with the University of Strathclyde, and to Ms. Sarah Smith (YC Centre Northern and Yorkshire) for assistance with clarification of the contents of their dataset.
Compliance with ethical standards
No sources of funding were used to conduct the study or prepare this report.
Conflicts of interest
M. A. Aldeyab S. C. Noble, M. Cuthbert, S. Maxwell, J. Dear, and A. Boyter declare that they have no conflicts of interest relevant to the content of this manuscript.
Because of the study design, NHS ethical review was not required. The project was approved by ISAC.
- 6.Winterstein AG, Hatton RC, Gonzalez-Rothi R, et al. Identifying clinically significant preventable adverse drug events through a hospital’s database of adverse drug reaction reports. Am J Health Syst Pharm. 2002;59(18):1742–9.Google Scholar
- 13.Kitto L. Patient reporting of adverse drug reactions: a quantitative study. 2009. http://www.yccscotland.scot.nhs.uk/publications/Pages/Journal-Articles-regarding-Adverse-Drug-Reactions.aspx. Accessed 27 Dec 2014.
- 15.Yellow Card Centre Scotland. Training posters. http://www.yccscotland.scot.nhs.uk/training/Pages/Posters.aspx. Accessed 6 July 2014.
- 16.MHRA-Yellow Card. Patient information cards 2010. https://yellowcard.mhra.gov.uk/_assets/files/Member-of-Public-Information-Card.pdf. Accessed 6 July 2014.
- 17.Natural Medicines Comprehensive Database. http://naturaldatabase.therapeuticresearch.com/home.aspx?cs=&s=ND&AspxAutoDetectCookieSupport=1. Accessed 6 July 2014.
- 18.MHRA. Trends in UK spontaneous Adverse Drug Reaction (ADR) reporting between 2008–2012. http://www.mhra.gov.uk/home/groups/plp/documents/websiteresources/con408250.pdf. Accessed 10 Aug 2014.
- 21.Van Hunsel F, Passier A, van Grootheest K. Comparing patients’ and healthcare professionals’ ADR reports after media attention: the broadcast of a Dutch television programme about the benefits and risks of statins as an example. Br J Clin Pharmacol. 2009;67(5):558–64.CrossRefPubMedPubMedCentralGoogle Scholar
- 24.The Met Office is the UK’s National Weather Service, 2011. http://www.metoffice.gov.uk/climate/uk/2011/january.html. Accessed 4 Aug 2014.
- 25.http://www.bbc.co.uk/news/uk-scotland-12141718. Accessed 4 Aug 2014.
- 31.Education for Scotland. Educational resources—patient safety: adverse drug reactions. Modules 1–6; http://www.nes.scot.nhs.uk/education-and-training/by-discipline/pharmacy/about-nes-pharmacy/educational-resources/resources-by-topic/clinical-governance/patient-safety-adverse-drug-reactions.aspx. Accessed 10 Aug 2014.