Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis
BMJ quality & safety
health policy; health services research; medication safety; pharmacoepidemiology
OBJECTIVE: To evaluate the association between regulatory drug safety advisories and changes in drug utilisation. DESIGN: We conducted controlled, interrupted times series analyses with administrative prescription claims data to estimate changes in drug utilisation following advisories. We used random-effects meta-analysis with inverse-variance weighting to estimate the average postadvisory change in drug utilisation across advisories. STUDY POPULATION: We included advisories issued in Canada, Denmark, the UK and the USA during 2009-2015, mainly concerning drugs in common use in primary care. We excluded advisories related to over-the-counter drugs, drug-drug interactions, vaccines, drugs used primarily in hospital and advisories with co-interventions within ±6 months. MAIN OUTCOME MEASURES: Change in drug utilisation, defined as actual versus predicted percentage change in the number of prescriptions (for advisories without dose-related advice), or in the number of defined daily doses (for dose-related advisories), per 100 000 population. RESULTS: Among advisories without dose-related advice (n=20), the average change in drug utilisation was -5.83% (95% CI -10.93 to -0.73; p=0.03). Advisories with dose-related advice (n=4) were not associated with a statistically significant change in drug utilisation (-1.93%; 95% CI -17.10 to 13.23; p=0.80). In a post hoc subgroup analysis of advisories without dose-related advice, we observed no statistically significant difference between the change in drug utilisation following advisories with explicit prescribing advice, such as a recommendation to consider the risk of a drug when prescribing, and the change in drug utilisation following advisories without such advice. CONCLUSIONS: Among safety advisories issued on a wide range of drugs during 2009-2015 in 4 countries (Canada, Denmark, the UK and the USA), the association of advisories with changes in drug utilisation was variable, and the average association was modest.
Morrow, Richard L.; Mintzes, Barbara; Souverein, Patrick C.; De Bruin, Marie L.; Roughead, Elizabeth Ellen; Lexchin, Joel; Kemp-Casey, Anna; Puil, Lorri; Sketris, Ingrid; Mangin, Dee; Hallgreen, Christine E.; Pearson, Sallie-Anne; Lopert, Ruth; Bero, Lisa; Ofori-Asenso, Richard; Gnjidic, Danijela; Sarpatwari, Ameet; Perry, Lucy T.; and Dormuth, Colin R., "Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis" (2022). GW Authored Works. Paper 182.
Health Policy and Management