L Shi

An analysis of China's national essential medicines policy

Although China embraced the concept of essential medicines in 1979 and issued its first National Essential Medicines List in 1982, until recently China has lacked a comprehensive national essential drug policy. In its most recent health-care reform (2009–2012), the Chinese government explicitly proposed the establishment of a national essential medicines system, and made it one of five top priorities in the coming years. We review the evolution of Chinas essential medicines policies, explain the importance of fully implementing the essential medicines policy, and analyze recent policy developments surrounding essential medicines.

Can Price Controls Reduce Pharmaceutical Expenses? A Case Study of Antibacterial Expenditures in 12 Chinese Hospitals from 1996 to 2005

The objective of this article is to investigate whether the Chinese governments pricing policies have reduced pharmaceutical expenses. The purchasing records for systemic antibacterial drugs of 12 hospitals in Beijing from 1996 to 2005 were analyzed by separating the expenditure growth into three components: the price change, the volume change, and the structure change. Our results reveal that the structure change is the dominant determinant of drug expenditure growth. Despite lowered prices, the antibacterial drug expenditure was raised because more expensive drugs in the same therapeutic category were prescribed. It is insufficient to rely only on pricing policies to reduce drug expenses, given that physicians could circumvent the policy by prescribing more expensive drugs. In addition, physician behaviors need to be regulated to eliminate unnecessary overprescribing.

TRIPS-plus and access to medicines in China.

Ample evidence shows that Trade-related aspects of intellectual property rights (TRIPS)-plus provisions have seriously affected access to and availability of drugs in the developing countries. In recent years, developed countries have pressured many developing countries to implement TRIPS with stronger intellectual property (IP) protection than required by the TRIPS Agreement. The stronger provisions are called TRIPS-Plus provisions. This article focuses on IP and the health implications of limited access to medicines in China, explores the TRIPS-plus arrangements in Chinese IP laws and regulations, and makes suggestions for Chinas negotiation strategy in resisting pressure from developed countries to tighten IP laws and regulations.

Genetic mutations in PEAR1 associated with cardiovascular outcomes in Chinese patients with acute coronary syndrome

OBJECTIVE To investigate the association between PEAR1 (platelet endothelial aggregation receptor-1) polymorphisms and cardiovascular outcomes in acute coronary syndrome (ACS) in patients treated with aspirin and clopidogrel. METHODS We genotyped eight common PEAR1 SNPs (rs2768759, rs12566888, rs12041331, rs11264579, rs2644592, rs822441, rs822442, and rs4661012), also CYP2C19*2 (rs4244285) and CYP2C19*3 (rs4986893) in 196 Chinese patients with ACS. We assessed the association between PEAR1 polymorphisms and platelet inhibition rate (PIR) measured by thromboelastography (TEG). The ischemic events over 12 months were recorded, and the relationship between PEAR1 polymorphisms and ischemic events was analyzed. RESULTS Genetic mutations in rs822441, rs822442, and CYP2C19⁎2/⁎3 alleles were significantly associated with a decrease in PIR induced by adenosine diphosphate (ADP). Carriers of the T allele in rs11264579 were less likely to have ischemic events compared with non-carriers (HR: 0.53, 95% CI: 0.30-0.94, P = .031). By contrast, carriers of the A allele in rs822442 had increased risk of ischemic events (HR: 1.82, 95% CI: 1.02-3.24, P = .043). However, these significant associations disappeared after controlling family-wise error rate. CONCLUSIONS For Chinese patients with ACS treated with aspirin and clopidogrel, genetic mutations in rs822441/rs822442 in PEAR1 correlated significantly with platelet activity after adjusting for CYP2C19 *2/*3 alleles. The rs11264579 T allele might be a protective factor for ischemic events; rs11264579, rs822441, and rs822442 might be genetic markers worthy of further research.

Association between P2RY12 gene polymorphisms and adverse clinical events in coronary artery disease patients treated with clopidogrel: A systematic review and meta-analysis

OBJECTIVE Investigate the association between P2Y12 Purinoceptor (P2RY12) polymorphisms and adverse clinical events in coronary artery disease (CAD) patients treated with clopidogrel. METHODS We performed a comprehensive database search, with a particular focus on P2RY12 polymorphisms and their effects on clopidogrel-treated CAD patients, in the PubMed, EMBASE, Cochrane Library, clinicaltrials.gov, Web of Science, and Chinese databases from their inceptions to April 8, 2017. The primary endpoints were composite ischemic events (including cardiovascular and cerebrovascular ischemic events), the secondary endpoints were independent cardiovascular events (mortality, non-fatal myocardial infarction, stent thrombosis, unstable angina, and target vessel revascularization) and the safety endpoints were bleeding events. RESULTS Overall 10 studies and 10,810 clopidogrel-treated CAD patients were studied in the present work. Subjects of the common alleles of P2RY12 polymorphisms showed higher risk for composite ischemic events compared to non-carriers (n = 434 of 3268[13.3%] vs. n = 646 of 6133[10.5%]; RR: 1.39, 95%CI: 1.14-1.69; p = 0.001). These allele carriers also showed increased risk for stent thrombosis (RR: 2.67, 95%CI: 1.03-6.91; p = 0.04), myocardial infarction (RR: 1.60, 95%CI: 1.06-2.42; p = 0.03), and unstable angina (RR: 1.72, 95%CI: 1.37-2.16; p < 0.00001) (vs. non-carriers). There was no significant difference between two groups in terms of mortality risk, target vessel revascularization or bleeding (p = 0.29; p = 0.48, respectively). CONCLUSIONS P2RY12 gene polymorphisms might associate with higher risk of composite ischemic events, stent thrombosis, non-fatal myocardial infarction, unstable angina. While we found no significant effect on mortality, target vessel revascularization or bleeding.