Is reporting rate a good predictor of risks associated with drugs? - PubMed (original) (raw)

Comparative Study

Is reporting rate a good predictor of risks associated with drugs?

C Pierfitte et al. Br J Clin Pharmacol. 1999 Mar.

Abstract

Aims: Uncertainty as to relative under-reporting plagues the comparisons of spontaneous reporting rates as a tool for decision-making in pharmacovigilance. However, it is generally accepted that under-reporting should be reasonably similar for similar drugs sharing the same indication, country and period of marketing. To test this, we compared the adverse drug reaction reporting rates to the French regional pharmacovigilance centres for six pairs of identical drug marketed at the same time by different companies under different brand names (co-marketing).

Methods: All reaction reports were related to sales, to compute reporting rate; within each pair, the reporting rate ratio and its confidence interval were calculated.

Results: The rate ratios were all between 0.76 and 1.33. Two of them were significantly different from 1 (1.28; 95% C.I. [1.01; 1.60] and 1.33; 95% C.I. [1.06; 1.74]).

Conclusions: These small differences in reporting rates would not warrant regulatory action and support the usual assumption of similar reporting for similar drugs.

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References

1. Rawlins MD. Spontaneous reporting of adverse drug reactions. I: the data. Br J Clin Pharmacol. 1988;26:1–5. - PMC - PubMed
1. Smith CC, Bennet PM, Pearce HM, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol. 1996;42:423–429. - PMC - PubMed
1. Praus M, Schindel F, Fescharek R, et al. Alert system for post-marketing surveillance of adverse drug reactions. Stat Med. 1993;12:2383–2393. - PubMed
1. Lumley CE, Walker SR, Hall GC, et al. The under-reporting of adverse drug reactions seen in general practice. Pharm Med. 1986;1:205–212.
1. Bégaud B, Tubert P, Haramburu F, et al. Comparing toxicity of drugs: use and misuse of spontaneous reporting. Post-Marketing Surveillance. 1991;5:69–76.

Is reporting rate a good predictor of risks associated with drugs? - PubMed (original) (raw)