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Improving Follow-Up Rates in Spontaneous Adverse Drug Reaction Reporting

Effectiveness of a Targeted Letter Used by a Regional Centre in the UK

Abstract

Background: Spontaneous reports of suspected adverse drug reactions to regulatory bodies and market authorization holders are important in pharmacovigilance. Follow-up information, which can be difficult to obtain, is often required from reporters; therefore, we developed targeted follow-up letters that we hoped would make replying easier.

Objective: To examine the effects of introducing targeted letters on responses to follow-up requests from a regional pharmacovigilance centre in the UK.

Method: In January 2001 we redesigned our follow-up request letter to include tick-boxes targeted to obtain the appropriate information from reporters. Response rates and the requirement for a second follow-up letter were examined for the 5-year period before introduction of the targeted follow-up letter (1996–2000) and the 5 years after the change to the targeted follow-up system (2001–5). In an 18-month sub-study examining data from 2001–2, time from the production of the first targeted follow-up letter to receipt of a response from reporters was also measured.

Results: The introduction of targeted follow-up letters was associated with an increase in the mean annual response rate for follow-up from 36.4% in the 5 years pre-targeted follow-up to 60.5% in the 5 years post-targeted follow-up (p < 0.0001). Fifty percent of all successful follow-up responses were obtained within 70 days.

Conclusion: Targeted follow-up letters were associated with increased follow-up success rates. Results also indicate that closing cases to follow-up information at 70 days would allow collection of 78% of all follow-up that would ever arrive.

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Correspondence to Anthony R. Cox.

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Anton, C., Cox, A.R. & Ferner, R.E. Improving Follow-Up Rates in Spontaneous Adverse Drug Reaction Reporting. Drug-Safety 32, 1135–1140 (2009). https://doi.org/10.2165/11318940-000000000-00000

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  • DOI: https://doi.org/10.2165/11318940-000000000-00000

Keywords

  • Adverse Drug Reaction
  • Suspected Adverse Drug Reaction
  • Yellow Card Scheme
  • Spontaneous Adverse Drug Reaction
  • Spontaneous Adverse Drug Reaction Report