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.
References
Olivier P, Montastruc JL. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiol Drug Saf 2006; 15(11): 808–12
Clarke A, Deeks J, Shakir SAW. An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets. Drug Saf 2006; 29(2): 175–81
Hauben M, Aronson JK. Gold standards in pharmaco-vigilance: the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore. Drug Saf 2007; 30(8): 645–55
Blenkinsopp A, Wilkie P, Wang M, et al. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol 2006; 63(2): 148–56
Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reactions. Pharmacoepidemiol Drug Saf 2001; 10: 483–6
Arnaiz JA, Carné X, Riba N, et al. The use of evidence in pharmacovigilance: case reports as the reference source for drug withdrawals. Eur J Clin Pharmacol 2001; 57(1): 89–91
Report of CIOMS Working Group V. Current challenges in pharmacovigilance: pragmatic approaches. Geneva: CIOMS, 2001
Inman WHW. Assessment of drug safety problems. In: Gent M, Shigamatsu I, editors. Epidemiological issues in reported drug-induced illnesses: proceedings of an international symposium held on 19th–21st January 1976 in the East-West Centre, Honolulo. 1st ed. Hamilton (ON): McMaster University Library Press, 1978: 17–24
Belton KJ, Lewis SC, Payne S, et al. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol 1995; 39: 223–6
Martin RM, Kapoor KV, Wilton LV, et al. Underreporting of suspected adverse drug reactions to newly marketed (“black triangle”) drugs in general practice: observational study. BMJ 1998; 317: 119–20
Cornelissen L, van Puijenbroek E, van Grootheest K. Expectations of general practitioners and specialist doctors regarding the feedback received after reporting an adverse drug reaction. Pharmacoepidemiol Drug Saf 2007; 17: 76–81
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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