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

Research output: Contribution to journalJournal articleResearchpeer-review


  • Fulltext

    Final published version, 1.35 MB, PDF document

  • 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
  • Hallgreen, Christine Erikstrup
  • Sallie-Anne Pearson
  • Ruth Lopert
  • Lisa Bero
  • Richard Ofori-Asenso
  • Danijela Gnjidic
  • Ameet Sarpatwari
  • Lucy T. Perry
  • Colin R. Dormuth

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.

Original languageEnglish
JournalBMJ quality & safety
Issue number3
Pages (from-to)179–190
Publication statusPublished - 2022

    Research areas

  • health policy, health services research, medication safety, pharmacoepidemiology

Number of downloads are based on statistics from Google Scholar and

No data available

ID: 291805755