There are about 700,000 people in the world who die of counterfeit drugs every year, according to statistics of the World Health Organization (WHO). And the annual losses of the pharmaceutical industry due to counterfeit drugs and patient safety issues reach up to USD200 billion. To curb such trends and ease concerns of patients, there have been many preventive measures introduced in the pharmaceutical industry:
EU:
As one of the strictest markets in terms of pharmaceutical product access requirements, the EU has been raising the thresholds in recent years, to prevent counterfeit drugs from flowing into the regular sales channels. In 2011, the EU made big amendment to the 2001 community code relating to medicinal products for human use (Directive 2001/83/EU), and issued the Directive 2011/62/EU, i.e., the EU Falsified Medicines Directive (EU FMD), to protect the pharmaceutical product supply chain from penetration by falsified (or counterfeit) drugs, and also introduced new rules to regulate the supply chain more strictly; the Official Journal of the European Union officially released the Directive 2016/161/EU on Feb. 9, 2016, which lays down in detail the safety features appearing on the packaging of medicinal products for human use, and has come into force on Feb. 9, 2019; and the newly upgraded version of the European Medicines Verification System (EMVS) that runs via the FMD has begun to be promoted in the Europe as of Feb. 9, 2019, which will be used by parties on the pharmaceutical product supply chain, including manufacturers, hospital supplies manufacturers, wholesalers, pharmacies, and hospitals. The system is connected to a trans-European database, to verify pharmaceutical products distributed in any place of the EU.
Fig. 1 Schematic Diagram of EMVS
制药企业 | Pharmaceutical manufacturer |
产品流通 | Product circulation |
批发商 | Wholesaler |
药店 | Pharmacy |
患者 | Patient |
赋码 | Unique serialization with random numbers |
上传序列号 | Upload number |
产品代码批号 | Product code batch |
到期S/N | Expiry S/N |
按风险验证 | Risk-based verification |
药品检验系统 | Medicines Verification System |
验证序列号 | Authenticate number |
发药时验证序列号 | Verification upon dispense to patient |
U.S.:
The Drug Supply Chain Security Act (DSCSA) has come into force in the U.S. on Nov. 27, 2013, which proposes requirements and steps for constructing an electronic supply chain tracking system and constructing of an electronic interoperable system that can identify and track some prescription drugs distributed in the U.S. DSCSA constructs a 10-year framework, with contents including...
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