Editor's note With the gradual globalization of the pharmaceutical supply chain, violations of laws and regulations such as fake and genuine drugs are increasing. How does the drug regulatory department ensure the safety of drug use by the public? How to quickly recover problematic drugs from circulation channels when problems arise? Problem drugs, drug manufacturers how to trace back to the raw material manufacturers? How do pharmaceutical production and distribution enterprises dynamically grasp product marketing and inventory through the network? How do sales terminals and consumers check the authenticity of drugs on the public service platform? In order to solve the different demands of the above roles, it is imperative to establish a set of controllable and traceable drug traceability system based on the "Internet.

Figure 1 Example of sNDC

Figure 2 Operation of the U.S. Prescription Drug Tracking and Traceability System

This edition will open the "Focus on the Construction of Drug Traceability System" column from this issue, systematically introduce the construction of drug traceability system at home and abroad and how to establish a drug traceability system, and give some suggestions on the construction of my country's drug traceability system, so stay tuned.

As early as the 1990 s, some developed countries and regions have begun to explore the establishment of traceability systems to promote drug quality and safety management. The United States and the European Union are the countries and regions that have carried out the standardization of drug traceability earlier, and their established legal and regulatory systems and supporting organization and implementation agencies are the most complete in the world. This kind of drug quality and safety traceability supervision system characterized by prevention, control and traceability can make all links of drug safety production, circulation and use be monitored throughout the process. In addition, most other countries have not yet formed a more mature drug traceability system.

Development of American Drug Traceability System

In September 2007, the current U.S. Food and Drug Administration Amendment Act (FDAAA) was promulgated and implemented. Part 913 of it created Part 505D of the Federal Food, Drug and Cosmetic Act (FDCA). This part requires the U.S. Department of Health and Human Services (HHS) to issue FDAAA within 30 months (that is, before March 2010), develop an SNI (Standardized Digital Identification for Prescription Drug Tracking and Tracing Systems) applicable to prescription drug manufacturers and distributors to identify, verify, confirm, track and trace prescription drugs. The SNI used for distribution shall be linked to the SNI used for production, and the SNI shall be consistent with internationally recognized standards for such identification.

On February 15, 2011, the US FDA held a public seminar on prescription drug tracking and traceability system to introduce the application of SNI for the first time. SNI is a serialized set of National Drug Codes (sNDC). sNDC consists of the "National Drug Code" (NDC) as described in Part 207 of Title 21 of the U.S. Code of Federal Regulations. It is a set of unique serial numbers consisting of 10 characters in label code, drug code, and packaging code. The NDC is generated by the manufacturer or packager of each individual package and can be guaranteed to be one item one code and printed on the pharmaceutical package in the form of a bar code, and the serial number should be numeric or alphanumeric (including numbers and/or letters) and not more than 20 characters (letters and/or numbers). An example of sNDC is shown in Figure 1.

Principle and Application of American Drug Traceability System

For retailers suitable for pharmacies or other drug vending machines, prescription drug packaging is the smallest unit of interstate commerce for manufacturers or distributors. If the manufacturer's minimum commercial packaging unit is 6 boxes of the drug, then an SNI is the label of the container package containing the 6 boxes of the drug. SNI is not required for single-box drugs. The manufacturer automatically generates sNDC(SNI) by serializing NDC with software, then records SNI and drug information by using data software that stores tracking and tracing information, and links SNI on the packaging of 6 boxes of drug containers with drug information in the database of stored tracking and tracing information through data carrier technology (RFID, two-dimensional bar code, etc.).

When the container containing the 6 boxes of drugs arrives at the primary distributor, the primary distributor scans the SNI label through a label scanner and tracks the drugs using traceability and verification software to verify the legitimacy of the SNI and supply chain participants. Then use data software that stores tracking and tracing information to record SNI and transaction information. When the container containing the 6 boxes of drugs arrives at the sub-packer, after a similar round of verification, the sub-packer will open the container containing the 6 boxes of drugs and sell each box of drugs separately, not only to ensure that each box of drugs has the appropriate label, but also to ensure that each box of drugs must have a unique SNI on the new package. Packagers use software to serialize NDCs, automatically generate SNI, and then use data software that stores tracking and tracing information to record SNI and drug information. The packager also connects the SNI of each box of drug packaging to the SNI of the manufacturer's 6-box drug container packaging, so that any information about the drug before it is packaged can be queried. When a single box of a drug reaches the secondary distributor, the procedure is similar to that of the primary distributor. When the single box of drugs arrives at the pharmacy, the pharmacy staff also performs similar work as the 1. two distributor. The operation of the U.S. prescription drug tracking and traceability system in the drug supply chain is shown in Figure 2.

Through the operation of the prescription drug tracking and tracing system in the drug supply chain, it can be seen that the system can capture the information of drug SNI and SNI quantity, so that the supply chain participants can safely capture, store, and exchange tracking and tracing data accurately and effectively. It can verify the distribution information of SNI and the whole drug supply chain of each drug package.

Through layer-by-layer verification, this system can greatly improve the transparency and accountability of the entire supply chain to prevent counterfeit drugs, diverted drugs, stolen drugs and other unqualified drugs from entering the drug supply chain; In the case of drugs should not be sold to the final consumer, reverse logistics (such as recalls, drug defects, etc.) is performed to make recalls faster and easier by collecting drug location and holder information; the replacement time can be determined when the drug enters the supply chain and when it leaves the supply chain, so as to achieve better communication with supply chain partners.