Next Article in Journal
Prodigiosin-Emerged PI3K/Beclin-1-Independent Pathway Elicits Autophagic Cell Death in Doxorubicin-Sensitive and -Resistant Lung Cancer
Previous Article in Journal
Hand Laser Perfusion Imaging to Assess Radial Artery Patency: A Pilot Study
Article Menu
Issue 10 (October) cover image

Export Article

Open AccessArticle
J. Clin. Med. 2018, 7(10), 320; https://doi.org/10.3390/jcm7100320

Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron

1
HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, 123 St Stephen’s Green, Dublin, D02 YN77, Ireland
2
Cancer Epidemiology and Health Services Research Group, Centre for Public Health, Queen’s University Belfast, Belfast BT12 6BA, UK
*
Author to whom correspondence should be addressed.
Received: 1 September 2018 / Revised: 28 September 2018 / Accepted: 2 October 2018 / Published: 3 October 2018
(This article belongs to the Section Epidemiology & Public Health)
Full-Text   |   PDF [1521 KB, uploaded 3 October 2018]   |  

Abstract

Introduction: Pharmacovigilance may detect safety issues after marketing of medications, and this can result in regulatory action such as direct healthcare professional communications (DHPC). DHPC can be effective in changing prescribing behaviour, however the extent to which prescribers vary in their response to DHPC is unknown. This study aims to explore changes in prescribing and prescribing variation among general practitioner (GP) practices following a DHPC on the safety of mirabegron, a medication to treat overactive bladder (OAB). Methods: This is an interrupted time series study of English GP practices from 2014–2017. National Health Service (NHS) Digital provided monthly statistics on aggregate practice-level prescribing and practice characteristics (practice staff and registered patient profiles, Quality and Outcomes Framework indicators, and deprivation of the practice area). The primary outcome was monthly mirabegron prescriptions as a percentage of all OAB drug prescriptions and we assessed the change following a DHPC issued by the European Medicines Agency in September 2015. The DHPC stated mirabegron use was contraindicated with severe uncontrolled hypertension and cautioned with hypertension. Variation between practices in mirabegron prescribing before and after the DHPC was assessed using the systematic component of variation (SCV). Multilevel segmented regression with random effects quantified the change in level and trend of prescribing after the DHPC. Practice characteristics were assessed for their association with a reduction in prescribing following the DHPC. Results: This study included 7408 practices. During September 2015, 88.9% of practices prescribed mirabegron and mirabegron comprised a mean of 8.2% (SD 6.8) of OAB prescriptions. Variation between practices was classified as very high and the median SCV did not change significantly (p = 0.11) in the six months after the September 2015 DHPC (12.4) compared to before (11.6). Before the DHPC, the share of mirabegron over all OAB drug prescriptions increased by 0.294 (95% confidence interval (CI), 0.287, 0.301) percentage points per month. There was no significant change in the month immediately after the DHPC (−0.023, 95% CI −0.105 to 0.058), however there was a significant reduction in trend (−0.036, 95% CI −0.049 to −0.023). Higher numbers of registered patients, patients aged ≥65 years, and practice area deprivation were associated with having a significant decrease in level and slope of mirabegron prescribing post-DHPC. Conclusion: Variation in mirabegron prescribing was high over the study period and did not change substantively following the DHPC. There was no immediate prescribing change post-DHPC, although the monthly growth did slow. Knowledge of the degree of variation in and determinants of response to safety communications may allow those that do not change prescribing habits to be provided with additional support. View Full-Text
Keywords: pharmacovigilance; drug safety; segmented regression; interrupted time series; variation pharmacovigilance; drug safety; segmented regression; interrupted time series; variation
Figures

Figure 1

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

Supplementary materials

  • Supplementary File 1:

    PDF-Document (PDF, 133 KB)

  • Externally hosted supplementary file 1
    Doi: http://doi.org/10.5281/zenodo.1409023
    Description: Link to dataset and code.
SciFeed

Share & Cite This Article

MDPI and ACS Style

Moriarty, F.; Razzaque, S.; McDowell, R.; Fahey, T. Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron. J. Clin. Med. 2018, 7, 320.

Show more citation formats Show less citations formats

Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Related Articles

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
J. Clin. Med. EISSN 2077-0383 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top