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20-10-2011 | Article

Pharmacovigilance shows improvement in Asian countries

Abstract

Free abstract

MedWire News: The spontaneous reporting of adverse drug reactions (ADR) has increased in Korea and Taiwan in the past 2-3 years, party owing to the implementation of more automated reporting methods, study results show.

However, reporting in Japan - where databases have been in place for some time - remained relatively stable during the period. Furthermore, the sources of reports were considerably different among the three Asian countries, as well as from the USA.

"Spontaneous reporting from the Asian populations is globally valuable, and systematic data mining should be encouraged for reproducibility of the signal, similarity, and difference among the regions, and comparison with results from Western countries," Tomomi Kimura (Janssen Pharmaceutical KK, Tokyo, Japan) and colleagues comment.

In the current borderless market, many drugs have been developed after multiregional trials, and been launched worldwide, they add.

However, ethnic sensitivities of safety issues are not always sufficiently identified and evaluated in multiregional trials because of the limited number of participants from individual countries.

The aim of the current study was to better understand the characteristics and differences of pharmacovigilance systems in Korea, Japan, and Taiwan.

The researchers reviewed national statistics and published literature for spontaneous reports, mode of transmission, availability of reports, and quantitative methods for signal detection.

The number of annual domestic spontaneous reports in 2007 from Korea, Japan, and Taiwan were 3751, 32,391, and 6971, respectively, which increased to 26,827, 34,649, and 10,320, respectively, over the following 2 years.

If adjusted by total population, the reporting rate would be a respective 5.59, 2.71, and 4.49 cases per 10,000 persons, for the three countries.

The reports were directly submitted mainly by physicians (51%) in Korea and hospital pharmacists (65%) in Taiwan, whereas 89% of the reports in Japan were submitted by drug manufacturers.

The researchers note that in the US Adverse Event Reporting System (AERS) database, the number of AE reports received by Food and Drug Administration (FDA) in 2009 was 580,904, with most originating from health professionals (54%), followed by consumers (46%), and submitted mostly by manufacturers (94%).

Clearly, variation in professional training, sensitivity to adverse drug events, and motives of reporting ADR for the reporters are contributory to the quantity and quanlity of the reports, which may impact the performance of signal detection, Kimura et al note.

They comment: "The Korean PVNet [database] is a successful example of such an effort leading to a rapid increase of reports in a short period.

"The increasing number of spontaneous reports from Korea and Taiwan suggests quantitative data mining, such as disproportionality analysis, in these counties will add value to Asian, as well as worldwide evaluation of safety issues."

The research is published in the journal Pharmacoepidemiology and Drug Safety.

By Andrew Czyzewski