Almost 160,000 adverse drug events (ADE) were reported in the first half of the year, through a surveillance system operated by the State Food and Drug Administration, up 50 percent on the same period of last year, Yan Jiangying, the agency's spokesperson said yesterday.
"For a long time to come, this populous nation will see a steady rise in the number of reported ADEs," she said at a regular press conference.
Wu Zhi'ang, deputy director of the National Adverse Drug Reaction Monitoring Center, affiliated to the SFDA, said the numbers reflect an enhanced and more effective supervision and control system for monitoring existing and potential risks relating to pharmaceuticals.
Over the past 10 years, the ADE reporting and surveillance mechanism has been substantially improved both in terms of speed and quality, Yan said.
In 1998, just 500 ADE cases were reported through sporadic local surveillance. In 2006, that number rose to almost 370,000, and last year it was up to 547,000, according to official figures.
"A considerable number of the cases failed to be identified in the past due to poor surveillance," Yan said.
In 2001, the SFDA launched a nationwide ADE reporting and surveillance system, which connects stakeholders from drug producers to medical institutions and drug dealers.
By the end of last year, the system had established a State-level ADE monitoring center, with about 34 branches at provincial level, and more than 200 at city level, Wu said.
Meanwhile, laws and regulations have been issued to encourage and require hospitals and drug producers to more actively and willingly notify drug authorities of identified or suspected drug hazards, he said.
"To be the first in line to be responsible for the drug quality and safety, drug companies are obliged to report ADE," Yan said.
Currently, most of the reported ADE cases in China came from hospitals, she said.
However, in many developed countries, nearly 90 percent of the reports come from drug producers. "Generally speaking, China still lags far behind developed countries in terms of ADE reporting and surveillance," Wu said.
Based on the experience of other countries, the SFDA is currently developing an information technology-based system to help speed up response times to cases and provide earlier warnings and cautions, he said.
"We expect it to be finished in three to five years," he said.
The SFDA is also working on a mechanism for compensation for victims, Yan said.
ADE cannot be eradicated, so we have to put it under control and address the potential health hazards, she said.
(China Daily July 9, 2008)