Frequency of adverse drug reactions

Frequency of adverse drug reactions

Whenever possible, an estimate of frequency should be provided, expressed in standard category of frequency. It is always difficult to estimate incidence on the basis of spontaneous reports, owing to the uncertainty inherent in estimating the denominator and degree of under-reporting. However, whenever possible, an estimate of frequency should be provided and in a standard form.
The following standard categories of frequency are recommended:

Very common
> 1/10 (> 10%)
Common (frequent)
> 1/100 and < 1/10 (> 1% and < 10%)
Uncommon (infrequent)
> 1/1,000 and < 1/100 (> 0.1% and < 1 %)
Rare
> 1/10,000 and < 1,000 (> 0.01% and < 0.1%)
Very rare
< 1/10,000 (< 0.01%)

Current status of clinical research in India

 

Clinical research has grown exponentially over the past decade in India because of cost advantage, treatment naïve patient, qualified doctors conversant in English etc. India was the second most preferred country to conduct clinical trials outside the US in 2009. However, recent years have witnessed a decline in number of trials in India (529 in 2010; 253 in 2012). The number of drugs entering the Indian markets had been gradually reducing even before the current slump in clinical research activity (270 in 2008;140 in 2011; 44 in 2012 and 25 in 2013). This necessitates a relook on the strategy so as to optimise clinical research in Indian context. The problems and possibilities around the clinical research arena can be broadly grouped as capacity building issues and ethico – regulatory ones.

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Omega (Ω)

A measure of disproportionate reporting for drug-drug-ADR triplets in ICSR databases, designed to highlight potential signals of drug-drug interactions. Just like the more established disproportionality measures for drug-ADR pairs, Ω is based on a contrast between the observed and expected number of reports. A positive Ω indicates higher reporting than expected.

Rechallenge

The point at which a drug is again given to a patient after its previous withdrawal.

Dechallenge

The withdrawal of a drug from a patient; the point at which the continuity, reduction or disappearance of adverse effects may be observed.

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