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

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.