Pharmaceutical companies are experimenting with RFID technology in order to keep ordinary people free of counterfeit medicines, but RFID technology currently has serious security limitations.
In the two years so far, every bottle of Oxy Contin medicine sent to Wal-Mart, the world ’s largest retailer, or HD Smith, a medium-sized drug wholesaler, has been given a special label, which is considered to be the world ’s A good solution to counterfeit medicines.
An ordinary-looking tag hides a radio frequency identification (RFID) tag, which allows PurduePharma, which produces this controversial painkiller, to track the trajectory of the drug throughout the supply chain-no matter how many pills are loaded into it. Which medicine bottles, and how many cardboard boxes are stuffed, and then transported away by the conveyor belt. Its purpose is that distributors can scan the RFID tags on all Oscondine bottles to understand the entire origin of each bottle of medicine, which is the "lineage", to identify and return medicines that are not produced by Purdue.
Aaron Graham, vice president and chief security officer of Purdue Pharma, said: "This label is very effective and accurate. It meets our requirements from a safety perspective and does not cause problems with the drug distribution system." Infrastructure investment is $ 20 million, and the cost of each label is between 30 cents and 50 cents.
What Graham said (along with the numbers he mentioned) sounds familiar, that's because he has been saying it for years. But even now, he can't tell how many details this system can prevent someone from selling counterfeit Oscondine. After all, Purdue has never encountered the problem of counterfeiting Oscondine. However, recently this company has faced the problem of Osconding being stolen and used for other purposes, in addition to government pressure. The government is demanding stricter control of this addictive drug, and the media has paid more attention to this drug abuse than its proper use.
Indeed, Graham admits that the main security advantage of Purdue ’s RFID system is that after the investigator scans and confiscates a bottle or box of Oscondine, he can accurately find out where it came from. Graham said that if you want to really curb counterfeit medicines, you need to have the information exchange center centralized, so that each dealer and pharmacy can check and verify the pedigree of each medicine-this task is more than tracking a single delivery to one or two distribution outlets. Variety medicines are much more complicated, and Purdue is engaged in this complex work.
There is an urgent need to prevent counterfeit drugs from entering the legal supply chain. The World Health Organization believes that fake drugs account for more than 10% of global drug sales, and they cause thousands of deaths each year. The problem is that although RFID technology was invented decades ago, although the US Food and Drug Administration (FDA) began to promote the technology as the most promising method to identify the authenticity of drugs a few years ago, RFID is an anti-counterfeiting technology It ’s still just “promisingâ€, far from being confirmed.
Even if companies like Purdue continue to test RFID applications, can this technology live up to expectations? It ’s still unknown—whether it ’s in the pharmaceutical industry (which is the leader in testing this hyped technology) or in any other industry. The reason is not only limited to the frequently mentioned issues of technology, standards and privacy, but also involves a very essential question: What exactly is RFID? What benefits can it bring to the counterfeit plan?
Roger Johnston, the head of the vulnerability assessment team of Los Alamos National Laboratory, said: "We are looking at this technology from the perspective of security." He conducted an in-depth study on RFID technology and concluded that RFID technology may not bring Higher security than ordinary barcodes. He said: "Providing high security is a daunting challenge, and people are looking for a recipe. The problem is that if you just put the RF tag on it and think it will be magically safe, then you are wrong. "The reason?" The following are the five main reasons.
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Myth 1: RFID is an anti-counterfeiting device
Myth 2: RFID technology is essential for tracking the movement of legal drugs [next]
Myth 1: RFID is an anti-counterfeiting device
If you call most pharmaceutical companies and talk to the department that is primarily responsible for testing RFID technology, then it is likely that the security department is not the one who ultimately answers the phone. The three major US drug wholesalers are currently working on RFID projects. At McKesson, the RFID project is under the charge of the pharmaceutical distribution department. At Amerisource Bergen, the project leader belongs to the "Integrated Solutions Department", which is responsible for testing and implementing new technologies. At CardinalHealth, this work is carried out in the medical supply chain service department, which belongs to the business operation department. This is because RFID tags are first and foremost a tracking device, not a security device.
Johnston always complains that even RFID tag manufacturers are not security companies themselves. He said: "They are companies established by semiconductor companies for the purpose of inventory inspection."
Admittedly, if integrated into a larger security plan, RFID tags are expected to serve as a security device. But it is not a fake device, nor is it like a hologram label. After reading the information on the RF tag (even the encrypted information), the RF reader cannot guarantee to everyone that the product is genuine. RFID technology is a method that is easy to register-it can create an electronic pedigree of the drug (the record that the drug moves through the supply chain) needs to be registered, or it is part of an extremely complex tracking and tracing system-the system Including contact with the source of the drug, that is, the party that knows the source of the drug. This leads to a second misunderstanding.
Myth 2: RFID technology is essential for tracking the movement of legal drugs
Amerisource Bergen is working on a complex tracking pilot project where this $ 61 billion annual distributor can inspect the source of any drugs shipped through its distribution center in Sacramento, California. Interestingly, RFID technology is only a small part of this project-the company hopes that this small part allows business processes to operate quickly, rather than safely. The part of the technology that truly verifies the authenticity of medicines is provided by the registration service of VeriSign, a company that provides digital certificate products.
Shay Reid, Amerisource Bergen's vice president for integrated solutions, explained. Drugs with RFID tags are read by RF readers. From a security perspective, the next step is the key part: two-way communication. Reid said: "If I am the legal owner of the drug, VeriSign can confirm that I did receive the drug from the upstream trading partner and then give me a certification number so that I can further distribute the product downstream. If VeriSign I cannot prove that I am the legal owner, and the transaction will be rejected. "
The problem is that, in general, products marked with RFID tags are also marked with two-dimensional bar codes. This bar code is similar to the traditional bar code, but it can carry more information. Reid explained: "Two-dimensional bar code is a backup mechanism."
This is because the most frequent complaint about RFID tags is that they are easily damaged. According to media reports, the reading rate is only 70%; if liquid pharmaceutical or foil packaging is involved, accuracy is particularly problematic (fairly speaking, RFID technology has made great progress in the past few years; the test results for the latest labels It ’s much better. CardinalHealth claims that the latest RFID test shows that its accurate reading rate is as high as 99%, and liquid medicine or foil packaging will not cause errors.)
But for now, the two-dimensional bar code is generally considered to be more reliable than the RFID tag-although the former has a longer reading time, it is because radio waves cannot be used to scan the two-dimensional bar code through the packaging material.
Regardless of the marking mechanism, the key is that each container must be labeled with a unique serial number. As a result, once a bottle of serial number # 1894892432 has been received by a pharmacy in Silver City, New Mexico, another pharmacy in Brunswick, Maryland, cannot identify a bottle with the same serial number # 1894892432 The authenticity of the medicine. Otherwise, counterfeiters can easily create counterfeit RF tags or two-dimensional bar codes as they do for counterfeit medicines; and there is no centralized exchange center to identify identical medicines.
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Myth 3: RFID technology can be used to administer pills, pills and other drugs themselves
Myth # 4: RFID technology allows consumers to verify that they are buying legal drugs. [next]
Myth 3: RFID technology can be used to administer pills, pills and other drugs themselves
RFID proponents hailed the technology as a solution to counterfeit drugs, but James Christian of Novartis Pharmaceuticals will raise a voice of opposition: no one is marking the drugs, only the outer packaging.
Novartis is a pharmaceutical company headquartered in Basel, Switzerland. It produces many prescription and over-the-counter medicines and has an annual revenue of $ 37 billion. Christian, the company's chief security officer, said: "We have encountered situations where the medicine is fake but the outer packaging is real, and the medicine is true but the outer packaging is fake. The outer packaging is not important."
In addition, drugs are often legally repackaged in the US and EU countries. He said: "If a pharmaceutical company has invested a lot of money to add safety devices to the outer packaging, these drugs can easily be legally repackaged into the outer packaging without safety devices. This is good, some people have a lot of safety devices The real outer packaging, these outer packaging may be thrown away, or it may be used in another way. "
At least in Christian's view, revising regulations governing the distribution of legal drugs may be more effective in combating counterfeit drugs than using RFID technology. This may mean that the repackaging regulations must be revised, or the penalties for counterfeiters must be increased. But as to which method is easier to implement, no one is sure.
Myth four: RFID technology allows consumers to verify that they are buying legal drugs
Using RFID technology as part of an electronic pedigree or tracking program, the ultimate goal is to let customers know that the medicines placed in the medicine cabinet are genuine. Julie Kuhn is the vice president of medical supply chain services for Cardinal Health, an Ohio-based wholesaler with annual revenue of $ 81 billion. She said: "The benefits are on the consumer side-they know that the products they buy come from legitimate channels . "
However, no matter whether it is the FDA or any pilot program carried out by the private sector, no one has really proposed a method for consumers to verify the authenticity of the drug. In fact, RFID tags may be disabled before medicines reach consumers, mainly due to concerns about privacy. For example, with the information on the RFID tag, the pharmacy can know which bottles of pills are in the customer's backpack.
Even if the United States does eventually have a tracking plan that relies on RFID technology, consumers will eventually rely on old-fashioned methods like ice cream soda: trust local pharmacies. Carmen Catizone, executive director of the National Association of Pharmacy Committees (NABP), said: "Patients believe in the local state government that issues licenses to pharmacies; they believe that pharmacists only buy legal drugs. But for now, they ca n’t do this because they do n’t Indicate which series the medicine comes from. "
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Myth # 5: The pharmaceutical industry will soon adopt RFID [next] on a large scale
Myth # 5: The pharmaceutical industry will soon adopt RFID on a large scale
Considering all these challenges and limitations, it is not surprising that the implementation of RFID technology to protect the safety of the nation ’s drug supply encountered obstacles, although it was hailed as the next hot technology of pharmaceutical companies many years ago. Over the years, the FDA has repeatedly postponed the industry ’s implementation of the electronic pedigree (FDA claims that it is highly likely that the electronic pedigree will rely on RFID technology), and recently announced the final decision: it no longer sets a deadline.
FDA's pharmaceutical director Ilisa Bernstein explained that as early as 2004, "we thought that RFID will be widely adopted by 2007, but this goal has not been achieved. So instead of setting a separate deadline, we handed over this work. Stakeholders were given to set deadlines themselves (the “Prescription Drug Marketing Act†prohibition order does not help, this law introduced in 1987 allows the FDA to make this regulation). However, as always, FDA believes that RFID technology is The "most promising" method for identifying the authenticity of medicines.
Bernstein said: "Everyone has been saying that this solution is very promising; and we think this is a practical solution, but we have not yet succeeded because people have not adopted it. There is a lot of work to be done later, everyone needs to step out The step is to move from the original wait and see to the actual hands. "
In the end, RFID supporters and opponents may be right: RFID technology may actually be the most promising way to alleviate a problem that cannot be solved, but only time will tell.
ABI Research ’s research director for research on RFID, Michael Liard, said: “We need more customers to confirm the solutions currently in use. If the company sees return on investment or economic benefits, it is difficult for them to share these experiences with others because these are Get the source of the difference in competition. So letting them share the benefits gained with others is a challenge that our entire industry must strive to meet. "
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