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In 2004, the U.S. Food and Drug Administration (FDA) recognized the use of RFID in drug tracking and traceability as a solution for anti-counterfeiting drugs. Although this recognition is not a mandatory requirement, the FDA hopes that in 2006 Before the end of the year, RFID tags can be fully applied at the unit level, including boxes, pallets, etc.
In order to implement the comprehensiveness of the electronic drug resume, American drug manufacturers strongly urge the FDA to include drug distribution-related companies, including manufacturers, distributors, and retailers, into the joint discussion, which will be held on February 8th and 9th this year. After the two-day and one-night FDA Anti-Counterfeit Drug Initiative Public Workshop, it was determined that the obstacle to the popularization of RFID lies in the testing and development of RFID, and a key recommendation was made to the FDA by the end of May.
The workshop included the well-known pharmaceutical companies Pfizer and Johnson & Johnson to propose their RFID test situation and electronic resume planning. Public associations include NABP (National Association of Boards of Pharmacy), PHRMA (Pharmaceutical Research) and Manufacturers Association) and HDMA (Healthcare Distribution Management Association) jointly stated that the FDA’s recommendations for RFID application promotion in 2004 should be implemented.
Up to now, Purdue Pharma is the only pharmaceutical manufacturer that has announced the application of RFID in the supply chain and has launched a pilot project for RFID. Pfizer has used RFID tags on Viagra bottles as anti-counterfeiting drugs, but it has not yet been used as part of the electronic resume system.
In July 2005, the first batch of OxyContin medicines with RFID tags were shipped
Purdue Pharma is well-known for its production of prescription drugs, over-the-counter drugs and medical products. Based on its own needs for drug tracking and anti-counterfeiting, it will affix EPC-compliant labels on OxyContin drug packaging bottles.
From May 2005, Purdue Pharma started this pilot program, becoming the first in the pharmaceutical industry to apply RFID tags to product history. This pilot project also complies with the drug tracking regulations of various states in the United States, including Florida, California, Virginia, Nevada and Indiana. The FDA’s encouraging application is also one of the reasons.
In July 2005, the first batch of OxyContin drugs with RFID tags were shipped to HD Smith of Springfield, Ill., which is also the seventh largest drug distributor in the United States. HD Smith confirms the EPC electronic code of the RFID tag on each product bottle after receiving the product and verifying it with a digital signature.
Todd Skrinar, an expert in the medical industry, believes that “this pilot project has two difficulties. One is to clarify the information contained in the RFID tag and use it to promote patient safety; the other is to make the exchange of information between different trading partners clearer. To promote the efficiency of the supply chain. 』
In order to accomplish this arduous task, Purdue Pharma specially established an RFID executive team. From the beginning, the executive team abandoned the “applied and then shipped” method used by most businesses and sought an automated method to incorporate RFID label operations into the “packaging production line” process and integrate it into the back-end IT system. Purdue Pharma then found Symbol to cooperate with SAP. When the product is automatically packaged, the label is placed in an easy-to-read middle position, so that the readers installed on both sides of the production line can effectively read the data and send the data to the ERP. With the SCM system. Purdue Pharma’s Quality Assurance staff is responsible for randomly checking the integrity and readability of the label, performing a series of tests including shock stress and high and low temperature tests, and checking whether the label will be affected by the heat generated during the processing process And destroyed.
In order to achieve the 100% read rate of Wal-Mart suppliers
Wal-Mart, Purdue’s major customer.
Based on Wal-Mart’s requirements in the second stage of RFID introduction and its own planning for drug tracking and anti-counterfeiting, Purdue decided to pack the original 72 bottles into boxes in order to achieve Wal-Mart’s demand for a 100% read rate of supplier items The type is changed to the 48-bottle boxing model. OxyContin pills can be divided into 10, 20, 40; 80 mg types, and each type is divided into its own SKU. On average, it takes half a second to read an RFID tag, plus reading the back-end system data to compare whether the EPC corresponds to the correct SKU, so it needs to be able to read about 120 to 140 medicine bottles per minute.
Up to now, Purdue Pharma has invested a lot of cost and time in the RFID technology packaging production line and system integration technology. In the short term, it focuses on the powerful potential effects of RFID on the operation of the supply chain, rather than just relying on the capital recovery of OxyContin; in the long term, RFID is important for the certification and electronic pedigree of products circulating in the supply chain. The benefits have allowed Purdue Pharma to successfully integrate the RFID labeling operation with the process of a single medicine bottle packaging production line with confidence.
In the anti-counterfeiting drug training camp held in February this year, the staff of Purdue Pharma said that the electronic resume and RFID application matched well. OxyContin, which has been affixed with RFID tags since November 2005, and Palladone, the second drug in January this year, has shipped 200,000 bottles as of February 2006. Even if Purdue believes that their products are not yet fully anti-counterfeiting like other companies’ drugs, the company has ensured its supply chain and consumer use of genuine drugs through the success of their own pilot projects.
Aaron Graham, Vice President of Purdue Pharma said, “This is a natural extension to our RFID pilot program.” “We started out for patient safety. However, this pilot program allowed us to satisfy most of the electronic resumes. Require. 』
Purdue Pharma’s application in RFID is fermenting
In the FDA Anti-Counterfeit Drug Initiative Public Workshop on 2/8-2/9, the pharmaceutical industry representatives also pointed out that the RFID tags on the electronic resume lack a single frequency standard. Some pharmaceutical companies that follow Wal-Mart’s requirements use UHF RFID tags, and they have also found that UHF RFID tags are not as good as high-frequency tags at the item level. For example, Pfizer uses high-frequency tags on Viagra.
In this meeting, another question that was raised was why the electronic resume does not require the serialization of the item level (Serialization)? Since there is no requirement for consecutive serial numbers, it is not necessary to apply RFID tags? Therefore, Bruce Harder (VeriSign spokesperson) is also a member of the product resume working group. He believes that it is very important to establish a data sharing standard in the electronic resume system. This is also the product of individual companies in the electronic resume system. The basics that must be completed before item-level RFID data sharing.
Electronic Pedigree (Electronic Pedigree) is a document used to verify the legality of drugs. Pedigree files are transmitted from one drug supplier to another trading partner in the transaction network, just like a prescription drug is sold to different physical sellers. generally. Every transaction point and every transaction must be maintained and certified in accordance with the law, and Pedigree documents must be delivered. Pedigrees is a legally effective regulation, and any wholesale or distribution activities must be strictly followed.
Currently, the Pharmaceutical Association (PhRMA) recognizes electronic authentication methods, including two-dimensional barcodes and RFID tags, which can enhance the security of the supply chain to avoid the threat of counterfeit drugs. PhRMA also published a white paper inviting drug dealers, state legislative departments and the U.S. Food and Drug Administration (FDA) to discuss how to create a safer and more convenient medical system supply chain and support the FDA’s electronic resume bill. In addition to drug dealers, the Pharmaceutical Association also cooperates with wholesalers, pharmacies, and the U.S. federal government to establish a safe drug supply environment by building an international Electronic Pedigree System (Electronic Pedigree System).
This requirement will come into effect in Florida on July 1, 2006. According to this requirement, all medicines must have an electronic resume if they can be sold in Florida. Medical expert Shabbir Dahod claims that electronic resumes provide faster and more accurate authentication and authorization, while at the same time using fewer human errors.
Current status of related standards for Electronic Pedigree
EPCglobal Inc. has formulated a considerable plan for Electronic Pedigree, and has also formulated some standards to fulfill the requirements of electronic Pedigree. The standards listed below are not limited to any application of Pedigree, nor are they limited to only being applied to electronic resumes.
(1) Serialization ─ Each product and shipping container (box, pallet) needs a unique identification number, and the format and structure of data in each industry must be standardized.
(2) Electronic Documents-Pedigrees is regarded as a document, which records the transmission process of the merchant. The data format of this document must have industry commonality.
(3) Electronic Signatures-Pedigrees needs to sign to certify that different business entities need to form a common electronic signature framework.
(4) Secure Document Transmission-Pedigrees must be able to transmit safely in the supply chain, so it must choose a common transmission structure.
(5) RFID Tag Standards-common label standards applied to shipping containers need to be defined to achieve the consistency requirements of the supply chain. The label standard must also match the standard implemented by RFID technology.
The completion of a mature RFID tracking and tracing operation system to effectively combat counterfeit drugs seems to be the consensus of the American pharmaceutical industry. Because a large number of counterfeit drugs will paralyze the entire medical system, this is also the motivation for the birth of the Prescription Drug Marketing Act (Prescription Drug Marketing). Act, PDMA).
The U.S. Food and Drug Administration (FDA) attaches great importance to the development and development of EPCglobal Inc. standards, and is therefore active in meetings of various groups. The Co-Chairs, FDA, HDMA, NABP, NACDS, PhRMA of EPCglobal HLS BAG met with the health departments of California and Florida to discuss the Drug Pedigree Law curriculum regulations. The consensus reached is FDA, State Departments of Health, Trade Organizations ( HDMA, NABP, NACDS and PhRMA have Agreed to Participate), NABP and EPCglobal Inc. formed a new team to unify the relevant provisions of the Drug Spectrum Regulations. In the future, the health industry will only need to follow a single provision to replace the current 51 regulations, and the legal system will also strengthen the supply chain safety regulations.
The HLS BAG team also set out to define business requirements. At present, 32 case processes have been developed to support the processing procedures, information and requirements of the supply chain. The team has also developed a Straw-Person management plan, in which goals, scopes, responsibilities, data processing strategies, information flow, etc. will be defined for the needs of electronic resume management.
In addition to the above various laws and practical application development, EPCglobal US also included the medical industry in its 2005/2006 industry promotion plan, which included the medical industry as a key promotion plan; and neighboring Japan and South Korea also have many well-known pharmaceutical companies joining the ranks of EPCglobal Inc. to catch up. RFID technology train.
The FDA and EPCglobal Inc. standards organizations also work closely together to work together on derivative issues of standards, regulations, and applications. The health industry (HLS) also pays attention to the issue of product labeling, but its industrial characteristics are more focused on: small syringes, vials, sterile medicines, gamma radiation scanning instrument interference, electrostatic interference, temperature and humidity environment, etc. special needs .
In view of the increasing maturity of the Tagging environment, the members of EPCglobal Inc’s FMCG and HLS BAGs have reached a consensus: to pursue a single solution together and make it available to the circulation industry and the pharmaceutical industry. This development trend and the gradual maturity of the development of RFID technology are bound to provide a good medicine and direction for RFID for the complex domestic medical environmental industry system and hesitant industry players.
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