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Adverse Drug Reaction (ADR) Monitoring in China

By Tommy Tang, GBI Analyst

The State Food and Drug Administration (SFDA) recently released its “2010 Adverse Drug Reactions (ADRs) Report,” outlining statistical data on ADR-related events, quality of ADR reporting, and current status of the newly implemented ADR monitoring network. Per the SFDA report, the incidence of ADRs has been increasing in recent years. In 2010, it has received a total of 692,904 ADR cases, of which 109,991 are new/serious events- an increase of 8.4% and 16.2%, respectively, over the year 2009. Of the total number of reported ADRs, 84.7% were reports received from medical institutions (physicians and pharmacists), 12.7% from drug companies (including manufacturers and trading companies), and only 2.5% from patients.
In addition, ADR reports varied accordingly by drug characteristics and medication status. For instance in specific therapeutic areas (TAs), the most common ADR-inducing drugs are anti-infective agents from chemicals (53.6%). Of the leading list of ADR-inducing drugs in general, 15 were anti-infectives and the rest were cardiovascular drugs, analgesics, alimentary tract system drugs and electrolytes/acid–base balance/nutrition agents. For serious ADR cases, drugs for oncology and central nervous system indications top the list of ADR-inducing agents. Injections and oral formulations were also the most common type of drug formulations causing ADRs with 59.5% and 37%, respectively. In terms of damage caused to the body, statistics showed no significant difference from that of 2010 with ADR cases involving damage to skin and its appendages (28.9%), gastrointestinal system lesions (26.1%) and systemic damages (13.6%).
ADR reporting is voluntary in China as it is in many other countries. A case is typically initially reported by consumers and/or related organizations to local ADR-monitoring units, who will then transfer the case to provincial ADR center and finally to the National ADR Monitoring Center of the SFDA. The case passed to the national-level ADR monitoring level may also then be transferred to the Ministry of Health (NYSE:MOH) and the World Health Organization (WHO) for pharmacovigilance-related collaboration efforts. In the recently released SFDA statistics on ADRs, there is a palpable shift from passive to more active ADR monitoring and pharmacovigilance in 2010; more issues/concerns were reported on the Chinese ADR Information Bulletin as well as via the “Pharmacovigilance Express,’ including the restrictions placed on rosiglitazone and nimesulide, and the market withdrawal of sibutramine. However, there still remain serious problems related to ADR monitoring such as concerns related to regional imbalance, lack of effective incentives and supporting mechanisms, and non-compliance with guidelines as the execution/supervision of the monitoring network is still at an early stage.