Comparative, cross-sectional study of the format, content and timing of medication safety letters issued in Canada, the USA and the UK

Lise M Bjerre, Simon Parlow, David de Launay, Matthew Hogel, Cody D Black, Donald R Mattison, Jeremy M Grimshaw, Margaret C Watson

Research output: Contribution to journalArticle

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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 languageEnglish
Article numbere020150
Number of pages8
JournalBMJ Open
Volume8
Issue number10
DOIs
Publication statusPublished - 8 Oct 2018

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Canada
Cross-Sectional Studies
Safety
Health Personnel
Health
Outcome Assessment (Health Care)
United States Food and Drug Administration
Patient Safety
Consensus
Communication
Databases
Delivery of Health Care
Research

Keywords

  • adverse events
  • direct healthcare professional communication
  • health advisory letters
  • medication management
  • medication safety
  • potentially inappropriate prescribing

Cite this

Bjerre, Lise M ; Parlow, Simon ; de Launay, David ; Hogel, Matthew ; Black, Cody D ; Mattison, Donald R ; Grimshaw, Jeremy M ; Watson, Margaret C. / Comparative, cross-sectional study of the format, content and timing of medication safety letters issued in Canada, the USA and the UK. In: BMJ Open. 2018 ; Vol. 8, No. 10.
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title = "Comparative, cross-sectional study of the format, content and timing of medication safety letters issued in Canada, the USA and the UK",
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.",
keywords = "adverse events, direct healthcare professional communication, health advisory letters, medication management, medication safety, potentially inappropriate prescribing",
author = "Bjerre, {Lise M} and Simon Parlow and {de Launay}, David and Matthew Hogel and Black, {Cody D} and Mattison, {Donald R} and Grimshaw, {Jeremy M} and Watson, {Margaret C}",
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Comparative, cross-sectional study of the format, content and timing of medication safety letters issued in Canada, the USA and the UK. / Bjerre, Lise M; Parlow, Simon; de Launay, David; Hogel, Matthew; Black, Cody D; Mattison, Donald R; Grimshaw, Jeremy M; Watson, Margaret C.

In: BMJ Open, Vol. 8, No. 10, e020150, 08.10.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparative, cross-sectional study of the format, content and timing of medication safety letters issued in Canada, the USA and the UK

AU - Bjerre, Lise M

AU - Parlow, Simon

AU - de Launay, David

AU - Hogel, Matthew

AU - Black, Cody D

AU - Mattison, Donald R

AU - Grimshaw, Jeremy M

AU - Watson, Margaret C

PY - 2018/10/8

Y1 - 2018/10/8

N2 - 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.

AB - 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.

KW - adverse events

KW - direct healthcare professional communication

KW - health advisory letters

KW - medication management

KW - medication safety

KW - potentially inappropriate prescribing

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DO - 10.1136/bmjopen-2017-020150

M3 - Article

VL - 8

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 10

M1 - e020150

ER -