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

Authors

• 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.

APA Citation

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.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/182

Department

Health Policy and Management