|
KMID : 1011520070020010021
|
|
Regulatory Research on Food, Durg and Cosmetic
2007 Volume.2 No. 1 p.21 ~ p.28
|
|
|
The Role of International Organizations for the International Harmonization of Pharmacovigilance
|
|
Shim Chang-Koo
Chung Suk-Jae
Nam Young-Hee
|
|
|
Abstract
|
|
|
In drug assessment, the issue of safety is generally regarded as a scientific concern and the socio-cultural aspects
of drug safety are often ignored, which is unfounded. Phenylpropanolamine (PPA), an agent that is believed to be
associated with an increased risk of a hemorrhagic stroke, was previously withdrawn from the market by the United States
Food and Drug Administration (FDA), although the drug is still in use in Europe and Japan. In 2004, after a year-long
epidemiological study found the lack of a clear correlation between use of the drug and the incidence of stroke, the Korea
FDA (KFDA) nonetheless decided that PPA should be withdrawn from the market because of public apprehension and the
existence of a viable substitute, pseudoephedrine. Despite the action of the KFDA, which was regarded as too harsh toward the domestic pharmaceutical industry at that time, the Korean public was not satisfied with the measure and worried about the fact that the agent had been used for the last 40 years. This isolated incident leads to a fundamental question. Why was the drug prohibited for use in the United States while still being marketed in Europe? If drug safety were determined solely by the scientific facts, only a single conclusion would be possible. Although there may be racial, genetic and other differences among countries, if drug safety were entirely a scientific issue, the interpretation of the same scientific data and conclusions in the decision-making process on restrictions in the use and availability of drugs would not differ among countries, but instead would be dictated solely by science. Considering the fact that a completely safe drug does not exist, it is necessary for the world, including international organizations for pharmacovigilance, to cooperate to develop “decisionmaking algorithms,” to bring about the comprehensive consideration of all the factors and the development of consistent conclusions on the issue of drug safety. Such decision-making algorithms would also make it possible, on the international level, to minimize exposure to drug-related risks and reduce the time and cost required for the assessment and management of drug safety. Consequently, such algorithms would contribute to the promotion of international harmonization of pharmacovigilance and thereby to human health and welfare. This paper explores the social-cultural aspects of drug safety, pharmacovigilance-relevant international organizations, the lessons learned from a specific incident involving phenylpropanolamine (PPA) that occurred in Korea, and the future direction of international harmonization in the field of pharmacovigilance.
|
|
|
KEYWORD
|
|
|
pharmacovigilance, international organizations, harmonization, drug safety, risk assessment, decision-making algorithm, phenylpropanolamine (PPA)
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|