Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis

Richard L. Morrow, Department of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada richard.morrow@ubc.ca.
Barbara Mintzes, School of Pharmacy, Faculty of Medicine and Health, and Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.
Patrick C. Souverein, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University Faculty of Science, Utrecht, The Netherlands.
Marie L. De Bruin, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University Faculty of Science, Utrecht, The Netherlands.
Elizabeth Ellen Roughead, Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
Joel Lexchin, School of Health Policy & Management, York University, Toronto, Ontario, Canada.
Anna Kemp-Casey, Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
Lorri Puil, School of Population and Public Health, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.
Ingrid Sketris, Dalhousie University, College of Pharmacy, Halifax, Nova Scotia, Canada.
Dee Mangin, Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.
Christine E. Hallgreen, Copenhagen Centre for Regulatory Science, Department of Pharmacy, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.
Sallie-Anne Pearson, Centre for Big Data Research in Health, UNSW Sydney, Sydney, New South Wales, Australia.
Ruth Lopert, Department of Health Policy and Management, George Washington University, Washington, District of Columbia, USA.
Lisa Bero, School of Medicine and Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Richard Ofori-Asenso, Copenhagen Centre for Regulatory Science, Department of Pharmacy, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.
Danijela Gnjidic, School of Pharmacy, Faculty of Medicine and Health, and Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.
Ameet Sarpatwari, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Lucy T. Perry, School of Pharmacy, Faculty of Medicine and Health, and Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.
Colin R. Dormuth, Department of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.

Document Type

Journal Article

Publication Date

3-1-2022

Journal

BMJ quality & safety

Volume

31

Issue

3

DOI

10.1136/bmjqs-2021-013910

Keywords

health policy; health services research; medication safety; pharmacoepidemiology

Abstract

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.

Department

Health Policy and Management

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