Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2020 Apr;86(4):698-710.
doi: 10.1111/bcp.14104. Epub 2019 Dec 16.

Impact of medicines regulatory risk communications in the UK on prescribing and clinical outcomes: Systematic review, time series analysis and meta-analysis

Christopher J Weatherburn  1 , Bruce Guthrie  2 , Tobias Dreischulte  3 , Daniel R Morales  4
Affiliations
Meta-Analysis

Impact of medicines regulatory risk communications in the UK on prescribing and clinical outcomes: Systematic review, time series analysis and meta-analysis

Christopher J Weatherburn et al. Br J Clin Pharmacol. 2020 Apr.

Erratum in

  • Correction.
    [No authors listed] [No authors listed] Br J Clin Pharmacol. 2020 Sep;86(9):1894. doi: 10.1111/bcp.14497. Br J Clin Pharmacol. 2020. PMID: 33464570 Free PMC article. No abstract available.

Abstract

Aims: Regulatory risk communications are important to ensure medication safety, but their impact is poorly understood. The aim was to quantify the impact of UK risk communications on medication use and other outcomes.

Methods: We conducted a systematic review of studies reporting prescribing/health outcome data relevant to UK regulatory risk communication. Data were reanalysed using interrupted time series regression 12 months after each regulatory intervention. Mean changes were pooled using random-effects generic inverse variance examining the following subgroups: drug withdrawals; restrictions/changes in indications; be aware messages without specific recommendations for action; communication via direct healthcare practitioner communications; communication via drug bulletins.

Results: Of 11 466 articles screened, 40 studies examining 25 UK regulatory risk communications were included. Product withdrawals, restriction in indications and be aware communications were associated with relative mean changes of -78% (95% confidence interval [CI] -60 to -96%), -34% (95% confidence interval [CI] -12 to -55%) and -11% (95%CI -8 to -15%) in targeted drug prescribing respectively. Direct healthcare professional communications were associated with relative mean changes of -47% (95%CI -27 to -68%) compared to -13% (95%CI -6 to -20%) for drug bulletins. Of 7 studies examining unique health outcomes related to the safety concern, risk communications were associated with a mean -10% (95%CI -3 to -16%) decrease in intended and a 7% (95%CI 4 to 10%) increase in unintended health outcomes.

Discussion: UK regulatory risk communications were associated with significant changes in targeted prescribing and potential changes in clinical outcomes. Further research is needed to systematically study the impact of regulatory interventions.

Keywords: clinical pharmacology; drug regulation; drug safety; epidemiology; pharmacovigilance; public health.

PubMed Disclaimer

Conflict of interest statement

All authors have no conflicts of interest to declare.

No approvals were required to conduct this study as it uses published data.

The views expressed in this article are the personal views of the author(s) and may not be not be understood or quoted as reflecting the views of any particular organisation.

Figures

Figure 1
Figure 1
Impact at 12 months on prescribing of the targeted drug stratified by type of regulatory action communicated by the risk communication. a Guthrie 2013 and Stocks 2017 related to ANTIPSYCHOTICS1. b Guthrie 2013 and Stocks 2017 related to ANTIPSYCHOTICS2
Figure 2
Figure 2
Impact at 12 months on prescribing of the targeted drug stratified by method of dissemination. a Guthrie 2013 and Stocks 2017 related to ANTIPSYCHOTICS1. b Guthrie 2013 and Stocks 2017 related to ANTIPSYCHOTICS2
Figure 3
Figure 3
Impact at 12 months on substitute prescribing and health outcomes. a Sandilands 2008 ANALGESIC1. Bedson 2013 ANALGESIC1. Guthrie 2013 ANTIPSYCHOTICS1. Leal 2012 DIABETES1. Wheeler 2009 NSAID1. Watson 2007 HRT1. Mt‐Isla 2015 CISAPRIDE. Stocks 2017 ANTIPSYCHOTICS1. b Intended: Farmer 2000 = venous thromboembolisms COCP. Narayan 2015 = hospital admissions for paracetamol poisoning (reciprocal value) ANALGESIC2. Hawton 2012 = suicides ANALGESIC1. Wheeler 2009 = myocardial infarction NSAID1. Unintended: Shickle 2000 = abortions COCP. Wheeler 2008 = episodes of self‐harm DEPRESSION1. Wheeler 2009 = gastrointestinal bleeds NSAID1
See this image and copyright information in PMC

Comment in

References

    1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta‐analysis of prospective studies. JAMA. 1998;279(15):1200‐1205. - PubMed
    1. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004;329(7456):15‐19. - PMC - PubMed
    1. Guthrie B, Makubate B, Hernandez‐Santiago V, Dreischulte T. The rising tide of polypharmacy and drug‐drug interactions: population database analysis 1995‐2010. BMC Med. 2015;13(1):74. - PMC - PubMed
    1. Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross‐sectional study. Lancet. 2012;380(9836):37‐43. - PubMed
    1. European Medicines Agency. PRAC recommends new measures to avoid valproate exposure during pregnancy. 09/02/2018. Available at: https://www.ema.europa.eu/en/news/prac-recommends-new-measures-avoid-val... .