Abstract
Objectives To assess consistency in the format and content, and overlap of subject and timing, of medication safety letters issued by regulatory health authorities to healthcare providers in Canada, the USA and the UK. Design A cross-sectional study comparing medication safety letters issued for the purpose of alerting healthcare providers to newly identified medication problems associated with medications already on the market. Setting Online databases operated by Health Canada, the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency were searched to select medication safety letters issued between 1 January 2010 and 31 December 2014. Format, content and timing of each medication safety letter were assessed using an abstraction tool comprising 21 characteristics deemed relevant by consensus of the research team. Main outcome measures Main outcome measures included, first, characteristics (format and content) of medication safety letters and second, overlap of subject and release date across countries. Results Of 330 medication safety letters identified, 227 dealt with unique issues relating to medications available in all three countries. Of these 227 letters, 21 (9%) medication problems were the subject of letters released in all three countries; 40 (18%) in two countries and 166 (73%) in only one country. Only 13 (62%) of the 21 letters issued in all three countries were released within 6 months of each other. Conclusions Significant discrepancies in both the subject and timing of medication safety letters issued by health authorities in three countries (Canada, the USA and the UK) where medical practice is otherwise comparable, raising questions about why, how and when medication problems are identified and communicated to healthcare providers by the authorities. More rapid communication of medication problems and better alignment between authorities could enhance patient safety.
| Original language | English |
|---|---|
| Article number | e020150 |
| Journal | BMJ Open |
| Volume | 8 |
| Issue number | 10 |
| Early online date | 8 Oct 2018 |
| DOIs | |
| Publication status | Published - Oct 2018 |
Funding
1Department of Family Medicine, University of Ottawa, Ottawa, Ontario, Canada 2CT Lamont Primary Care Research Centre, Bruyère Research Institute, Ottawa, Ontario, Canada 3School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada 4Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada 5Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada 6School of Psychology, University of Ottawa, Ottawa, Ontario, Canada 7Risk Sciences International, (RSI), Ottawa, Ontario, Canada 8McLaughlin Center for Population Health Risk Assessment, University of Ottawa, Ottawa, Ontario, Canada 9Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada 10Department of Pharmacy and Pharmacology, University of Bath, Bath, UK Acknowledgements We would like to thank Katie Hood and Olivia Champagne for editorial support in the preparation of this manuscript. Funding DdL and SP contributed to this work with support from Undergraduate Research Opportunity Program (UROP) bursaries. For supervising their work, LMB also received some funding through UROP. Margaret Watson’s contribution was funded by a Leverhulme International Academic Fellowship and a Health Foundation Improvement Science Fellowship. JMG holds a Canada Research Chair in Health Knowledge Transfer and Uptake.
Keywords
- adverse events
- direct healthcare professional communication
- health advisory letters
- medication management
- medication safety
- potentially inappropriate prescribing
ASJC Scopus subject areas
- General Medicine