Skip to main content
Top
Published in: Drug Safety 7/2013

01-07-2013 | Original Research Article

The Impact of Direct Healthcare Professional Communication on Prescribing Practice in the UK Hospital Setting: An Interrupted Time Series Analysis

Authors: Sarah K. Thomas, James Hodson, Graham McIlroy, Annjeet Dhami, Jamie J. Coleman

Published in: Drug Safety | Issue 7/2013

Login to get access

Abstract

Background

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.

Objective

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.

Methods

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.

Results

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).

Conclusion

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.
Literature
4.
go back to reference Wagner AK, Chan KA, Dashevsky I, Raebel MA, Andrade SE. Elston Laffata J, et al. FDA drug prescribing warnings: is the black box half empty or half full? Pharmacoepidemiol Drug Saf. 2005;15(6):369–86.CrossRef Wagner AK, Chan KA, Dashevsky I, Raebel MA, Andrade SE. Elston Laffata J, et al. FDA drug prescribing warnings: is the black box half empty or half full? Pharmacoepidemiol Drug Saf. 2005;15(6):369–86.CrossRef
5.
go back to reference Piening S, Reber KC, Wieringa JE, De Graeff PA, Haaijer-Ruskamp FM, Mol PGM. Impact of safety-related regulatory action on drug use in ambulatory care in the Netherlands. Clin Pharmacol Ther. 2012;91(5):838–45.PubMedCrossRef Piening S, Reber KC, Wieringa JE, De Graeff PA, Haaijer-Ruskamp FM, Mol PGM. Impact of safety-related regulatory action on drug use in ambulatory care in the Netherlands. Clin Pharmacol Ther. 2012;91(5):838–45.PubMedCrossRef
6.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
7.
go back to reference Carracedo-Martínez E, Pia-Morandeira A, Figueiras A. Impact of a health safety warning and prior authorisation on the use of piroxicam: a time-series study. Pharmacoepidemiol Drug Saf. 2012;21(3):281–4.PubMedCrossRef Carracedo-Martínez E, Pia-Morandeira A, Figueiras A. Impact of a health safety warning and prior authorisation on the use of piroxicam: a time-series study. Pharmacoepidemiol Drug Saf. 2012;21(3):281–4.PubMedCrossRef
8.
go back to reference Dorsey ER, Rabbani A, Gallagher SA, Conti RM, Alexander GC. Impact of FDA black box advisory on antipsychotic medication use. Arch Intern Med. 2010;170(1):96–103.PubMedCrossRef Dorsey ER, Rabbani A, Gallagher SA, Conti RM, Alexander GC. Impact of FDA black box advisory on antipsychotic medication use. Arch Intern Med. 2010;170(1):96–103.PubMedCrossRef
9.
go back to reference Kales HC, Zivin K, Kim HM, Valenstein M, Chiang C, Ignacio RV, et al. Trends in antipsychotic use in dementia 1999–2007. Arch Gen Psychiatry. 2011;86(2):190–7.CrossRef Kales HC, Zivin K, Kim HM, Valenstein M, Chiang C, Ignacio RV, et al. Trends in antipsychotic use in dementia 1999–2007. Arch Gen Psychiatry. 2011;86(2):190–7.CrossRef
11.
go back to reference Dusetzina SB, Higashi AS, Dorsey ER, Conti R, Huskamp HA, Zhu S, et al. Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review. Med Care. 2012;50(6):466–78.PubMedCrossRef Dusetzina SB, Higashi AS, Dorsey ER, Conti R, Huskamp HA, Zhu S, et al. Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review. Med Care. 2012;50(6):466–78.PubMedCrossRef
14.
go back to reference O’Donoghue ML, Braunwald E, Antman EM, Murphy SA, Bates ER, Rozenman Y, et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet. 2009;374(9694):989–97.PubMedCrossRef O’Donoghue ML, Braunwald E, Antman EM, Murphy SA, Bates ER, Rozenman Y, et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet. 2009;374(9694):989–97.PubMedCrossRef
15.
go back to reference Rassen JA, Choudhry NK, Avorn J, Schneeweiss S. Cardiovascular outcomes and mortality in patients using clopidogrel with proton pump inhibitors after percutaneous coronary intervention or acute coronary syndrome. Circulation. 2009;120(23):2322–9.PubMedCrossRef Rassen JA, Choudhry NK, Avorn J, Schneeweiss S. Cardiovascular outcomes and mortality in patients using clopidogrel with proton pump inhibitors after percutaneous coronary intervention or acute coronary syndrome. Circulation. 2009;120(23):2322–9.PubMedCrossRef
16.
go back to reference Charlot M, Ahlehoff O, Norgaard ML, Jørgensen CH, Sørensen R, Abildstrøm SZ, et al. Proton-pump inhibitors are associated with increased cardiovascular risk independent of clopidogrel use: a nationwide cohort study. Ann Intern Med. 2010;153(6):378–86.PubMedCrossRef Charlot M, Ahlehoff O, Norgaard ML, Jørgensen CH, Sørensen R, Abildstrøm SZ, et al. Proton-pump inhibitors are associated with increased cardiovascular risk independent of clopidogrel use: a nationwide cohort study. Ann Intern Med. 2010;153(6):378–86.PubMedCrossRef
17.
go back to reference Tentzeris I, Jarai R, Farhan S, Brozovic I, Smetana P, Geppert A, et al. Impact of concomitant treatment with proton pump inhibitors and clopidogrel on clinical outcome in patients after coronary stent implantation. Thromb Haemost. 2010;104(6):1211–8.PubMedCrossRef Tentzeris I, Jarai R, Farhan S, Brozovic I, Smetana P, Geppert A, et al. Impact of concomitant treatment with proton pump inhibitors and clopidogrel on clinical outcome in patients after coronary stent implantation. Thromb Haemost. 2010;104(6):1211–8.PubMedCrossRef
18.
go back to reference Douglas IJ, Evans SJW, Hingorani AD, Grosso AM, Timmis A, Hemingway H, et al. Clopidogrel and interaction with proton pump inhibitors: comparison between cohort and within person study designs. BMJ. 2012;10(345):e4388.CrossRef Douglas IJ, Evans SJW, Hingorani AD, Grosso AM, Timmis A, Hemingway H, et al. Clopidogrel and interaction with proton pump inhibitors: comparison between cohort and within person study designs. BMJ. 2012;10(345):e4388.CrossRef
19.
go back to reference Neubauer H, Engelhardt A, Kruger JC, Lask S, Borgel J, Mugge A, et al. Pantoprazole does not influence the antiplatelet effect of clopidogrel-a whole blood aggregometry study after coronary stenting. J Cardiovasc Pharmacol. 2010;56(1):91–7.PubMedCrossRef Neubauer H, Engelhardt A, Kruger JC, Lask S, Borgel J, Mugge A, et al. Pantoprazole does not influence the antiplatelet effect of clopidogrel-a whole blood aggregometry study after coronary stenting. J Cardiovasc Pharmacol. 2010;56(1):91–7.PubMedCrossRef
20.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
21.
go back to reference Juurlink DN, Gomes T, Ko DT, Szmitko PE, Austin PC, Tu JV, et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009;180(7):713–8.PubMed Juurlink DN, Gomes T, Ko DT, Szmitko PE, Austin PC, Tu JV, et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009;180(7):713–8.PubMed
22.
go back to reference Pezalla E, Day D, Pulliadath I. Initial assessment of clinical impact of a drug interaction between clopidogrel and proton pump inhibitors. J Am Coll Cardiol. 2008;52(12):1038–9.PubMedCrossRef Pezalla E, Day D, Pulliadath I. Initial assessment of clinical impact of a drug interaction between clopidogrel and proton pump inhibitors. J Am Coll Cardiol. 2008;52(12):1038–9.PubMedCrossRef
23.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
24.
go back to reference Yasuda H, Yamada T, Sawada S, Endo Y, Inoue K, Takeyama Y, et al. Upper gastrointestinal bleeding in patients receiving dual antiplatelet therapy after coronary stenting. Intern Med. 2009;48(19):1725–30.PubMedCrossRef Yasuda H, Yamada T, Sawada S, Endo Y, Inoue K, Takeyama Y, et al. Upper gastrointestinal bleeding in patients receiving dual antiplatelet therapy after coronary stenting. Intern Med. 2009;48(19):1725–30.PubMedCrossRef
25.
go back to reference Ho PM, Maddox TM, Wang L, Fihn SD, Jesse RL, Peterson ED, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009;301(9):937–44.PubMedCrossRef Ho PM, Maddox TM, Wang L, Fihn SD, Jesse RL, Peterson ED, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009;301(9):937–44.PubMedCrossRef
26.
go back to reference Ray WA, Murray KT, Griffin MR, Chung CP, Smalley WE, Hall K, et al. Outcomes with concurrent use of clopidogrel and proton-pump inhibitors: a cohort study. Ann Intern Med. 2010;152(6):337–45.PubMedCrossRef Ray WA, Murray KT, Griffin MR, Chung CP, Smalley WE, Hall K, et al. Outcomes with concurrent use of clopidogrel and proton-pump inhibitors: a cohort study. Ann Intern Med. 2010;152(6):337–45.PubMedCrossRef
28.
go back to reference Nightingale PG, Adu D, Richards NT, Peters M. Implementation of rules based computerised bedside prescribing and administration: intervention study. BMJ. 2000;320(7237):750–3.PubMedCrossRef Nightingale PG, Adu D, Richards NT, Peters M. Implementation of rules based computerised bedside prescribing and administration: intervention study. BMJ. 2000;320(7237):750–3.PubMedCrossRef
29.
go back to reference Lankshear A, Lowson K, Weingart SN. An assessment of the quality and impact of NPSA medication safety outputs issued to the NHS in England and Wales. BMJ Qual Saf. 2011;20(4):360–5.PubMedCrossRef Lankshear A, Lowson K, Weingart SN. An assessment of the quality and impact of NPSA medication safety outputs issued to the NHS in England and Wales. BMJ Qual Saf. 2011;20(4):360–5.PubMedCrossRef
30.
go back to reference Chief Medical Officer. Safety first: a report for patients, clinicians and managers. London: Department of Health; 2006. Chief Medical Officer. Safety first: a report for patients, clinicians and managers. London: Department of Health; 2006.
31.
go back to reference Wagner AK, Soumerai SB, Zhang F. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002;27:299–309.PubMedCrossRef Wagner AK, Soumerai SB, Zhang F. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002;27:299–309.PubMedCrossRef
Metadata
Title
The Impact of Direct Healthcare Professional Communication on Prescribing Practice in the UK Hospital Setting: An Interrupted Time Series Analysis
Authors
Sarah K. Thomas
James Hodson
Graham McIlroy
Annjeet Dhami
Jamie J. Coleman
Publication date
01-07-2013
Publisher
Springer International Publishing AG
Published in
Drug Safety / Issue 7/2013
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-013-0057-3

Other articles of this Issue 7/2013

Drug Safety 7/2013 Go to the issue