Evidence map›Paper›PMID 35058332›Full record

SynthesisBMJ quality & safety2022

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

Richard L Morrow, Barbara Mintzes, Patrick C Souverein, Marie L De Bruin, Elizabeth Ellen Roughead, Joel Lexchin, Anna Kemp-Casey, Lorri Puil, Ingrid Sketris, Dee Mangin and 9 more

Abstract readMeta-Analysis
In one paragraph

Synthesis in BMJ quality & safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Richard L MorrowDepartment of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada richard.morrow@ubc.ca.ORCID 0000-0002-5869-5197
Barbara MintzesSchool of Pharmacy, Faculty of Medicine and Health, and Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-8671-915X
Patrick C SouvereinDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University Faculty of Science, Utrecht, The Netherlands.
Marie L De BruinDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University Faculty of Science, Utrecht, The Netherlands.
Elizabeth Ellen RougheadClinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
Joel LexchinSchool of Health Policy & Management, York University, Toronto, Ontario, Canada.
Anna Kemp-CaseyClinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
Lorri PuilSchool of Population and Public Health, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.
Ingrid SketrisDalhousie University, College of Pharmacy, Halifax, Nova Scotia, Canada.
Dee ManginDepartment of Family Medicine, McMaster University, Hamilton, Ontario, Canada.
Christine E HallgreenCopenhagen Centre for Regulatory Science, Department of Pharmacy, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.ORCID 0000-0002-7916-3915
Sallie-Anne PearsonCentre for Big Data Research in Health, UNSW Sydney, Sydney, New South Wales, Australia.
Ruth LopertDepartment of Health Policy and Management, George Washington University, Washington, District of Columbia, USA.
Lisa BeroSchool of Medicine and Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Richard Ofori-AsensoCopenhagen Centre for Regulatory Science, Department of Pharmacy, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.
Danijela GnjidicSchool of Pharmacy, Faculty of Medicine and Health, and Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.
Ameet SarpatwariDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Lucy T PerrySchool of Pharmacy, Faculty of Medicine and Health, and Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.
Colin R DormuthDepartment of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.

Funding

CIHR PJT-153275
6 · The paper itself

Abstract

objectiveTo evaluate the association between regulatory drug safety advisories and changes in drug utilisation.

designWe 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 measuresChange 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.

resultsAmong 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.

conclusionsAmong 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.

Indexed as

Drug PrescriptionsDrug UtilizationCanadaHumansInterrupted Time Series Analysishealth policyhealth services researchmedication safetypharmacoepidemiology

Identifiers

PMID35058332
PMCPMC8899478

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.