China Grapples To Get A Handle On Reporting Mechanisms For Adverse Drug Reactions

HONG KONG - When China's State FDA released figures for cases of adverse drug reactions in late January, it touched on an underreported issue and one that may prove difficult to tackle.

SFDA said more than 630,000 cases of adverse drug reactions (ADRs) were reported to a monitoring center. Of these, 94,000 were new or severe reactions.

But the numbers are most likely low as China's reporting system for drug-linked adverse events remains underdeveloped.

In theory, China has had a national network for reporting and monitoring ADR for years.

As far back as 2004, the Measures on Administration of Reporting and Monitoring of Adverse Drug Reactions were promulgated. By 2007, there were 400 cases per million people reported.

In the next year, activity picked up, with various departments publishing some 13 bulletins by the end of June 2008, according to SFDA, which issued a white paper on the matter later that year.

In 1989, the government set up a National Center for Adverse Drug Reaction Monitoring, and in 1998 it joined the World Health Organization's Collaborating Center for International Drug Monitoring.

It wasn't until 2001, however, that China set up the ADR reporting system, which in theory should bring together statistics and track events from across the country. However, statistics are not always reported accurately and provinces have not always been quick in putting their own reporting systems in place.

In a study by doctors from China Pharmaceutical University and Ordos Center Hospital published late last year in Pharmacoepidemiology and Drug Safety, about 70 percent of doctors interviewed in Inner Mongolia in 2007 could define adverse drug reactions, but "only one-third were clear as to what should be reported."

The same study also found that most pharmacists thought ADRs should be reported but only 14.6 percent had ever done so.

Even with years of work, China's reporting system remains heavily fragmented. Both drug makers and the government are responsible for tracking ADR.

Multinational drug makers typically have well-developed systems linked to either R&D departments or sales. Domestic companies, on the other hand, may be trailing in this regard, said Beatrijs Van Liedekerke, a pharmaceutical industry consultant at the Beijing office of PriceWaterhouseCoopers.

"All systems are very fragmented," said Van Liedekerke. "Adverse effects are going to be much higher than (these) numbers."

SFDA began a national campaign in July to reevaluate the safety of all herbal injections in the country. SFDA Deputy Director Wu Zhen said the agency would focus on safety assurance and carry out the work on three levels - risk inspection, comprehensive evaluation and standards elevation (Also see "Safety Of Traditional Chinese Medicine Injections Questioned Following Three Deaths" - Scrip, 1 Oct, 2009.).

Regulators in Beijing also have made international manufacturers of medical devices with operations in China, along with their Chinese agents, jointly liable in terms of adverse event reporting and product recall, according to Yang Chen, an expert on life sciences-related issues and regulations at the Beijing office of the law firm Sidley Austin (Also see "China’s 2009 Regulatory Changes Will Affect Makers of Drugs, APIs and Devices" - Scrip, 5 Jan, 2009.).

One of the main difficulties of improving the overall adverse drug reaction reporting network is systemic. China is working hard and is spending heavily to reform its healthcare system, but the lack of record keeping is a chronic issue. There are, for example, virtually no patient records in many state-run hospitals. Every time a patient goes to the hospital, it is as if he or she is starting from scratch with a doctor that may or may not track history and future performance with a particular treatment or an ADR.

Ultimately, a more effective ADR reporting system would likely require more complete hospital records, and that is a slow process.

"You have to reform your whole hospital system," said Van Liedekerke.

- Alfred Romann ([email protected])