The Impact of Direct Healthcare Professional Communication on Prescribing Practice in the UK Hospital Setting: An Interrupted Time Series Analysis
- 469 Downloads
Direct Healthcare Professional Communications (DHPCs) aim to quickly disseminate information to key healthcare professionals to inform practice and minimize patient harm. The Medicines and Healthcare products Regulatory Agency (MHRA) issues warnings and alerts to communicate safety information effectively in the UK.
To investigate the impact of MHRA DHPCs on prescribing practice in the secondary-care setting, looking specifically at a drug-drug interaction–the concomitant use of clopidogrel and proton pump inhibitors (PPIs) [as omeprazole]–and a drug-disease contraindication–the use of conventional (typical) antipsychotics in dementia.
The effects of the MHRA DHPCs were analysed using segmented binary logistic regression of interrupted time series. This allowed for the detection of any significant changes in prescribing practice occurring after the MHRA warnings were issued, whilst controlling for the baseline period.
Of the patients concomitantly prescribed clopidogrel and omeprazole on admission, the rate at which omeprazole was substituted for either another PPI (with the exception of esomeprazole), or for a histamine H2-antagonist showed a significant step-change increase after the DHPC was issued. The modelled rate increased from 5.1 % in the month directly before the intervention to 25.1 % in the following month (odds ratio [OR] 6.18; p < 0.001). However, the action taken in the switching of therapy was not always consistent with the advice from the current MHRA warning. The rate of typical antipsychotic prescribing in patients with dementia was declining significantly by 3.9 % per quarter prior to the DHPC being issued (OR 0.970; p = 0.035). No significant step-change was detected immediately after the DHPC (p = 0.962). However, the rate of decline increased significantly in the post-warning period to 12.3 % per quarter (OR 0.938; p = 0.006).
This study has shown that DHPCs issued by the MHRA as warnings are associated with changes in prescribing practices in secondary care. However, their impact is variable depending on the intervention described by the warning. A national initiative to ensure patient safety information is effectively translated into practice and the effect of the warning continues beyond the period of the issue would be beneficial.
KeywordsDementia Clopidogrel Omeprazole Esomeprazole Interrupted Time Series
We would like to thank the Data Analysts, David Westwood and Mariam Afzal, for obtaining the information from the PICS and LORENZO systems in order to carry out this research.
Statements of contribution
All authors had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. All authors contributed to the writing of the manuscript, the interpretation of data, and approved the final version.
Jamie Coleman is a member of the Pharmacovigilance Expert Advisory Group of the MHRA. The views expressed in this study are, however, his own.
This work was funded by the National Institute for Health Research (NIHR) through the Collaborations for Leadership in Applied Health Research and Care for Birmingham and Black Country (CLAHRC-BBC) programme. The views expressed in this study are not necessarily those of the NIHR, the Department of Health, University Hospitals Birmingham NHS Foundation Trust, University of Birmingham or the CLAHRC-BBC Theme 9 Management Steering Group.
Conflict of interest
Sarah Thomas, James Hodson, Graham McIlroy, Annjeet Dhami and Jamie Coleman have no conflicts of interest to declare that are directly relevant to the content of this study.
- 1.Department of Health. Building a safer NHS for patients: implementing an organisation with a memory. 2001. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4006525. Accessed 30 Mar 2012.
- 2.European Medicines Agency. 2012. http://www.ema.europa.eu/ema/. Accessed 7 May 2012.
- 3.Medicines and Healthcare products Regulatory Agency. Medicines and medical devices regulation: what you need to know. 2008. http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf. Accessed 7 May 2012.
- 6.Ruiter R, Visser LE, van Herk-Sukel MP, Geelhoed-Duijvestijn PH, de Bie S, Straus SM, et al. Prescribing of rosiglitazone and pioglitazone following safety signals: analysis of trends in dispensing patterns in the Netherlands from 1998 to 2008. Drug Saf. 2012;35(6):471–80.PubMedCrossRefGoogle Scholar
- 10.Action Against Medical Accidents. Adding insult to injury: NHS failure to implement patient safety alerts. 2010. http://www.avma.org.uk/data/files/patient_safety_alerts.pdf. Accessed 28 May 2012.
- 12.Medicines and Healthcare products Regulatory Agency. Clopidogrel and proton pump inhibitors: interaction. 2009. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON087962. Accessed 10 Mar 2012.
- 13.Medicines and Healthcare products Regulatory Agency. Conventional (typical) antipsychotics: increased mortality in dementia. 2008. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON087985. Accessed 7 Mar 2012.
- 20.Zuern CS, Geisler T, Lutilsky N, Winter S, Schwab M, Gawaz M. Effect of comedication with proton pump inhibitors (PPIs) on post-interventional residual platelet aggregation in patients undergoing coronary stenting treated by dual antiplatelet therapy. Thromb Res. 2010;125(2):e51–4.PubMedCrossRefGoogle Scholar
- 23.Gilard M, Arnaud B, Cornily J-C, Le Gal G, Lacut K, Le Calvez G, et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA (Omeprazole CLopidogrel Aspirin) study. J Am Coll Cardiol. 2008;51(3):256–60.PubMedCrossRefGoogle Scholar
- 27.Medicines and Healthcare products Regulatory Agency. Clopidogrel and proton pump inhibitors: interaction–updated advice. 2010. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON087711. Accessed 7 May 2012.
- 30.Chief Medical Officer. Safety first: a report for patients, clinicians and managers. London: Department of Health; 2006.Google Scholar