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Countering risks and side effects

Radio technology makes pharmaceuticals forgery-proof
Countering risks and side effects

Each year, pharmaceuticals worth 40 billion dollars disappear on their way from the plant to the pharmacy in the U.S. alone. In light of these numbers, the FDA has called for the introduction of batch tracking by 2007 and recommends RFID technology for this purpose. Intelligent radio technology protects patients against forgeries and provides a new level of safety.

Dr. Markus Fuchslocher

Since the pharmaceuticals industry has a major interest in protecting its products against forgeries, more and more companies are considering RFID. After all, these companies live and die with the quality and safety of their products and the trust their customers place in them. Since the chips – unlike barcodes – can be made forgery-proof, they are particularly well suited to the fight against knock-offs.
Several major pharmaceutical firms like Purdue Pharma or GlaxoSmithKline have announced plans to increasingly deploy this radio technology. Pfizer uses RFID to ensure the authenticity of its erectile dysfunction drug Viagra and prevent the further spread of knock-offs. Unique au-thentication codes identify each package as an original product. Using RFID scanners, the product code is transmitted to a secure Pfizer website which identifies the package as either authentic or a knock-off.
RFID records cooling history
In addition to authenticating medications, radio tags can supply data with no direct visual contact and over greater distances. Even chips that are hidden or inserted in the product can be read correctly. Unlike barcodes, which can only be read one at a time, RFID can read entire packaging units in one step, which saves both time and money. In addition, the radio technology is so resistant against environmental factors that it works even in very dirty environments or in very cold temperatures like those encountered in connection with the transportation of blood supplies. So-called active RFID tags, which can be connected to sensors, are even able to store the temperature history of their surroundings, making it possible for manufacturers to check whether the temperature of blood or medications has exceeded the permissible range at any time during transport.
Data protection a concern
A July 2005 study commissioned by Berlecon has shown that many pharmaceutical companies are still hesitant to deploy RFID. One of the main reasons is their fear that RFID will lead to the creation of massive databases with individual customer information. The danger they see here is that radio technology makes it theoretically possible to show at the click of a button who has received which medication when and where. This is a particularly delicate question with medications that are indicative of specific diseases. Although RFID experts are quite familiar with these reservations, they are frequently unfounded, particularly where the end user is concerned. If necessary, a chip can be deactivated or removed at the point of sale. And in the supply chain, sensitive data is safe because the necessary data security and protection mechanisms are in place. The spectrum ranges from duplicate EPC (Electronic Product Code) numbers and au-thentication through tag memory zoning to differentiating between read and write accesses and tag data encryption.
Another tricky issue slowing down the technology’s widespread introduction is standardisation. The use of RFID in open systems across company borders requires a standardised infrastructure, i.e. harmo-nised frequencies, transmission speeds and codes. In addition to ID numbers based on ISO 15693, there is also the EPC which identifies the item carrying the radio chip. At present, EPCs are used mainly by retailers like Wal-Mart and Metro, but experts are in no doubt that they will soon become accepted in the pharmaceutical industry as well.
Wireless manufacturing data
While standardisation and data protection problems are factors in open supply chains, they play virtually no role in closed loops, for example during the manufacture of pharmaceuticals. “For quite some time now, companies have been using RFID very successfully,” confirms Helmut Gierse, President of Siemens A&D. Users’ main objective is to control all movements and processing of raw materials and products and to link the collected data with product information. The preparations and formulation for medication production, i.e. mixing active and inactive ingredients, take place under cleanroom conditions. This process, which consists of steps like filtering, sifting, drying, blending and/or granulating, places great demands on ingredient consistency and manufacturing safety and can be monitored with the help of radio tags. RFID tags can archive information about which ingredient is stored in which container, for example. The chips, which frequently come into contact with harsh cleaning chemicals and essences, have to meet strict requirements for this purpose. In addition, most of the equipment is made of stainless steel, which is why special mount-on-metal transponders are used for trouble-free scanning. The final step in the manufacturing process involves getting the medication ready for dispensation in the form of capsules, bottles, syringes, powders or pills. Once again, the logistics process plays a major role, because all the necessary components must be in the right place at the right time. Here, too, RFID can help.
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More informations about RFID
Process optimization with RFID

RFID for all industries
Siemens is one of the world’s leading suppliers of RFID solutions and provides services for all industries along the complete value chain – from products and systems to complete services and solutions for RFID projects. Siemens Automation & Drives (A&D) develops transponders and read/write equipment on the basis of state-of-the-art UHF technology. Siemens IT Solutions and Services provides process consulting, system integration and project management services for RFID projects. Siemens has implemented projects for KarstadtQuelle, Otto and Unilever, amongst others. For the pharmaceuticals/healthcare sector, Siemens develops RFID-based solutions that assure total product identification from the plant floor to the point of sale. At the point of care – in the hospital – this can even be combined with patient identification technology that guarantees instant access to the electronic patient file.
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