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XQS Service's research objective is to identify and prevent counterfeit drugs from appearing on the market in the first place. RFID labels are currently more competent because they are tamper proof, chemically and mechanically stable, posses bulk-reading capability, fault-tolerant reading and allow additional sensors. Xqs service is a subdivision of an oncological company which commissions our research and development.
XQS Service's research objective is to identify and prevent counterfeit drugs from appearing on the market in the first place. RFID labels are currently more competent because they are tamper proof, chemically and mechanically stable, posses bulk-reading capability, fault-tolerant reading and allow additional sensors. Xqs service is a subdivision of an oncological company which commissions our research and development.
XQS Service's research objective is to identify and prevent counterfeit drugs from appearing on the market in the first place. RFID labels are currently more competent because they are tamper proof, chemically and mechanically stable, posses bulk-reading capability, fault-tolerant reading and allow additional sensors. Xqs service is a subdivision of an oncological company which commissions our research and development.
he vast amount of counterfeit drugs appearing in develo-
ping nations as well as the exponentially rising emergence of fraudulent medicine in developed countries has motivated research into introducing advanced RFID instruments into the pharmaceutical world. The comprehensive research objective is to identify and prevent counterfeit drugs from appearing on the market in the rst place; and ultimately, to preserve the quality and security of pharmaceutical products. Bulk- reading technology enables our partners to rapidly read a lar- ge quantity of medicines specic Tag IDs. These IDs display each unique medicines history of movement, both indoor as well as outdoor-delivery temperature logs for climate sensiti- ve pharmaceuticals, shock logs in order to ascertain if medi- cine has been intentionally or even unintentionally damaged and all other pertinent details related to each drug. Similarly, GPS is used for indoor and outdoor observation functions. Research on process optimization has enabled monitoring of personnel and products in order to create new models and software which advance secure medical distribution. Indoor and outdoor tracking has recently been implemented at a va- riety of clinics to survey and protect admittance to critical assets such as medicine, expensive machinery and even ac- cess to hospital patients. As the debate between RFID versus barcode technologies continues to persist, it is our contention that RFID labels are currently more competent because they are tamper proof, chemically and mechanically stable, posses bulk-reading capability, support fault-tolerant reading and allow additional sensors; whereas barcode labels lack all of these qualities. Through the use of RFID technology, we have ventured to actualize an encompassing distribution model for the pharmaceutical industry which guarantees both the qua- lity as well as the authenticity of medicine from the moment it is created to the instant it reaches the patient. In our re- search to solve the problem of counterfeit and unsafe medici- ne, a comprehensive and overall safer model for medical life cycles has been developed and thus validated. XQS Services Research and Development teams are pioneering innovative projects utilizing RFID technology. XQS Services research is a subdivision of an oncological company which commissions our research and motivates the teams to implement and va- lidate solutions to our parent companys customers and part ners. These partners include manufacturers as well as both wholesale and local pharmacies. Background and Necessity Any falsication of drugs is an attempted mass murder. (Ex-Commissioner Gnter Verheugen) In a mere two months the European Union conscated 34 million counterfeit medical tablets in targeted customs cont- rolled areas in all member countries 1 . According to the World Health Organization, 60% of counter- feit medicines contain no active ingredient, 19% contain in- correct amounts of active ingredients and 16% are composed of completely wrong ingredients. Few counterfeit drugs have comparable quality and size to their legitimate counterparts 2 . 70% of fraudulent drugs appear in developing countries 3 . The annual volume of sales for counterfeit drugs is estimated at 100 billion U.S. dollars. 02 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model A s a result of drug counterfeiting in 2009, charges of anti-HIV drugs have led to a mass recall of Viramune in German pharmacies. The manufacturers, Boehringer Ingel- heim, as well as countless individuals were affected by the recall. Similarly, GlaxoSmithKline (GSK) recalled the charges R343741 of the drug Combivir. In the same year there were more charge recalls relating to (hazardous) quality defects such as bacterial contamination. Examples include Vicks Sinex with the charges 92240288 (33.32) 9,239,028,831 in Germany, Great Britain and the United States and the contaminated charges LOT 0900 (1, 2, 3) / 01 of the drug Doreperol in Germany and Luxembourg. In 2010, three infants died from a contaminated infusion caused by a broken bottle in the Clinic of Mainz. Earlier this year, the integrated evaluation unit Saxony (INES) launched investigations into gang or professionally bribery of doctors and pharmacists by a manufacturer in Leipzig. For- mally, this manufacturer remunerates doctors for their par- ticipation in trials or observational studies, when they order products from him. Other than the above described case, where case studies are used as bait for revenue sharing, according to Prof. Dr. Da- vid Klemperer University of Regensburg, drug trials are under the principle of Marketing have priority over evidence, Sales over Security which can be manipulated when large phar- maceutical companies are involved 1 . If a cooling chain is interrupted, damaged or sensitive medi- cation bottles are shaken, their use has serious consequences. A study from Ireland found that 37.8% of family physicians allowed their vaccines to be stored outside the specied temperature range 2 . According to the researchers Weir and Hatch 3 humans pose a dangerous security risk for the cool chain. In Germany there are currently about 250 drugs which requi- re such cooling chains 1 . In most cases, the active ingredients are rich in protein. These include vaccines, antibiotics, insulin, blood products, different eye drops and botulinum toxin pre- parations 2 . The volume of drugs which must go through a cooling chain is steadily increasing. Since the enlightenment of the human genome, the number of known targets of endogenous prote- ins, such as antibodies, cytokines and hormones, are growing rapidly Many of them are genetically manufactured in order to use them therapeutically. A special feature of the recombinant proteins with Natu- ral models in common: a high sensitivity to environmental factors 3 . Temperature uctuations, which exceed the allowed range of storage and transport temperature often lead to irreversible changes to the active ingredients. Patient safety is at risk without them explicitly knowing it: for example, if diabetics inject too little effective insulin ad- vised by hyperglycaemia, it can lead up to the hyperglycemic shock. Children, especially premature babies and those with birth defects, are often unable to receive proper vaccinations. Cytotoxic drugs, which have lost chemical effectiveness due to the violation of the prescribed temperature range in effec- tiveness can ultimately lead to treatment failure for oncology patients. Large variations in temperature, low temperatures or harsh impacts are all factors which can lead to hairline cracks in ampules or syringes, through which impurities (toxins or in- fectious agents) can get into the medicine. These unexpec- ted adverse side effects carry potentially fatal consequences, such as the above-mentioned case in Mainz. The legislature has recognized the difculties associated with the cooling chain and laid down basic requirements for sto- rage and transport in the Pharmaceutical and drug manu- facturing Regulation (AMWHV), which became effective in November 20064. The manufacturer may refuse to assume liability for consequential harm caused if someone has not taken into account the proper transfer guidelines. Knowin- gly submitting inappropriately kept cool-only drug items to a pharmacy violates several laws, including those against the Medicines Act (AMG). From the vantage point of criminal law, it constitutes delibe- rate fraud. These security requirements are related to material manage- ment and supply management. Materials and supplies relate to security-sensitive drugs. Specically, urgent deliveries and special transportation of essential goods have high demands on the supply management. 03 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model F alse designations cost pharmaceutical companies millions of dollars in nancial damages that can be avoided with RFID-based serialization. The legally enforced mandatory discount of 16% since the 15th amendment of AMG from 1 August 2010 caused false, incorrect and superuous identications for pharmaceutical companies. Due to the data complexity and diversity, phar- macies cannot understand the route of their goods and the subsequent misused data leads to liability of these compa- nies. An aggravating factor is that on 08/01/2010 retroactive to 08/01/2009 there was a forced price reduction, which in addition to the 16% discount, must be paid by companies and can reach a percentage of almost 20%. With pharmaceu- tical sales of one billion euros a potential risk of approxi- mately 50 million euros can plausibly now arise. This amount is imposed on pharmaceutical companies, alt- hough there is no turnover. These wrongful charges can be detected, and prevented so- lely by a serialization of the drugs. Though RFID technology is optimal for serialization purposes, it also offers additional options like sensory (temperature, shock, etc.) which make an RFID-based system an ideal sup- port structure for the supply reliability and cost efciency in health care. Such a system is a cost-neutral investment for pharmaceutical companies because the ROI can be less than twelve months. Requirements for a model The requirements for the model presented here arise from the starting conditions and needs described. The main problems are: weaknesses in the pharmaceutical value chain, which interlopers use on a targeted basis to counterfeit drugs and for illegal exports and imports quality defcits in drugs which decrease their effect- iveness and which may be caused by failure to comply with mandatory refrigeration or are due to external factors. This creates a requirement for transparency and security, in line with the concept of Real World Awareness (RWA). The term RWA was originally coined by SAP and is dened as follows 1 : Real World Awareness is the ability to sense information in real-time from people, IT sources, and physical objects by using technologies like RFID and sensors and then to res- pond quickly and effectively. From an RWA perspective, a media break may be a contribu- tory factor to a lack of transparency. RWA is intended to redu- ce or resolve media breaks and thus narrow or even close the gap between the natural and the virtual world. The natural world comprises physical and operational reality, i.e. people, products, inputs and resources, while the virtual world con- sists of the depiction of reality in IT, such as ERP and SCM systems and local, regional and global information networks. The RWA concept is based on the growing trend towards au- tomatic data entry and retrieval processes and an ever-incre- asing wealth of stored information. The basic concept of Real World Awareness as reected in the literature 2 guides us pri- marily towards a logistics/supply chain management (SCM) approach and can be summed up in the following three key points: The natural world is depicted in near real time and in accurate detail in an IT system transparency in businesses supply networks/along the entire value chain is increased an appropriate response can be made to short-term exceptional circumstances and also to constantly changing market conditions. Through feedback with a Trust Center, pharmacists, doctors and patients can always be sure that drugs and medicinal products are original and come from an authentic source. Here, counterfeit security applies to the supply chain from the manufacturer to the wholesaler and then to the pharmacy or hospital. Each drug is given a unique feature, generally a code or ID number. 04 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model Broadly speaking, two systems can be identied: Printing of a barcode/Datamatrix on a package Affxing or printing of an RFID label on the package. A comparison of these two systems will be provided in a mo- ment. To ensure that a pack is not opened by stealth and that the original drug that it contains is not exchanged, the package is equipped with a security seal. Whereas conventional adhesive tapes can be cut open and invisibly resealed using the same tape later, manipulation of the package seal is immediately obvious. A strong adhesive will resist any attempt to remove it. A special security stamp will tear on opening and irrevocably destroy or damage the package. Other features, such as a wavy edge, continuous pattern or semi-transparent basic co- lour, also make invisible resealing impossible. The drug packages ID number, including the PZN, batch num- ber and other attributes, is linked to a database hosted on a server. This server forms the Trust Center. At any stage in the supply chain whether it be the wholesalers outbound logi- stics or the pharmacists receipt of the goods feedback with the Trust Center can take place. This means that the ID num- ber is read and compared with the data held on the server. Ambient conditions (temperature, shock) affecting the drug are recorded, monitored and stored so that the pharmacist, doctor and patient can all be sure of the products quality and effectiveness. Quality assurance also applies to the entire supply chain. Drugs which must be kept refrigerated, and es- pecially those for which a cool chain applies, must be stored and transported at the prescribed temperature range (2-8C). Some drugs, as mentioned before, must not be shaken. In order to monitor compliance with ambient conditions, sen- sory components are used. A temperature monitoring device, about the size of a credit card, is placed in the package along with the drugs which must be refrigerated, while a credit card-sized shock sensor is used for shock-sensitive medicinal products. The recipient in the pharmacy or clinic then reads the tempe- rature and/or shock values on his computer in order to vali- date the products authenticity. The origin, interim stages and ambient conditions arising along the entire value chain for drugs and medicinal products can be traced independently of time and place. Traceability in other words, the gap-free tracing of every stage in the entire value chain requires persistent storage of data re- lating to drugs immediately after production, including the information on packages to be dispatched, their content and ambient conditions, delivery information and time of receipt. Traceability includes temperature and order histories, drug ows and statistical evaluations. The latter are used to detect irregularities, such as the purchase of large quantities which never reappear in the market. In this sector, these black holes may be linked to illegal exports, counterfeiting and product manipulation. Traceability encompasses by this model 1 : Flow of goods along the supply chain Manufacturing steps Route to all distribution channels Formulation and consignment, which is patient- related Hand over Medication (Bedside verifcation) Medicines Control (Drug Utilization Review) Operational data about materials such as drugs, medicinal products and supply data, e.g. recipient, items, quantity, batch number etc., are equipped with an ID tag and can be inputted directly into pharmacy and hospital systems. Freedom from media breaks relates to the pharmaceutical supply chain and means the technological integration of business functions all along this chain. This helps to reduce transaction costs, boosting the companys competitiveness. For example, an electronic pharmaceutical delivery note contains an RFID label which is linked to all the supply data. 05 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model I n line with the concept of freedom from media breaks, this supply data is incorporated into the pharmacy or hospitals ERP system automatically without any human input. This is closely linked with traceability. Awareness applications generate information, updated to the minute, about the sta- tus of the supply chain as well as any irregularities (which may point to counterfeiting), ambient conditions affecting the drugs and medicinal products and drug ows. These applications are real time systems for monitoring and visualization. Implementation of the model There are currently two technical systems which take account of the fundamental aspects mentioned: these are Datamatrix and RFID. Both systems are currently in widespread use. Datamatrix is often used on ight tickets, rail tickets or telecoms bills, for example. RFID is used on passports, ID cards and in access control systems in companies, sports venues and leisure facilities. The advantages of the RFID system are almost indispensable, especially in the pharmaceutical environment. After all, counterfeiting of medicinal products has far more serious consequences than the counterfeiting of high-quality watches and jewelry. Order picking in outbound logistics in the pharmaceuticals industry generally uses containers with a chaotic mixture of packs. Error-free reading is impossible without the use of RFID bulk readers. If Datamatrix is used, each individual pack must be held in front of a camera. The centrepiece of the Track & Trace system is the data car- rier that is attached to the drug to be identied. Radio Frequency Identication (RFID), which is based on the detection of electromagnetic signals, is the best and most in- novative solution. The UIDs stored in a chip are activated by the magnetic eld, accessed on XQS database and transmit- ted to the reader. In a matter of seconds, a wealth of data can be read, and no line of sight is required. The RFID transponder also known as a tag incorporates an electronic circuit embedded In thin foil. 06 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model PROS CONS DATA MATRIX RFID Inexpensive to print the package (0.1 to 1 cent) EFPIA* support Tamper-proof Chemically, mechanically stable Bulk reading ability Fault-tolerant reading Additional sensors available FDA* support Chemically, mechanically unstable No Bulk reading ability Each package must be shown to the camera No additional sensors Costs are approx. 35 cents per package Axing the tags is less trivial * EFPIA European Federation of pharmaceutical Industries and Associates FDA Food and Drug Administration Data Matrix and RFID compared T his takes the form of a label, slightly larger than a nger- nail, consisting of the chip and a small antenna. Thanks to the precision, Storage capacity and technological diversi- ty achieved, RFID offers Massive advantages compared with barcodes or magnetic strips. Implementation of the model links individual components, which are loosely coupled and can be assigned to individual steps in the value chain. The value chain 1 makes a distinc- tion between primary and secondary activities which either create or destroy value. The primary value-creating activities cover the physical product creation process, transportation to the purchaser and customer service. The secondary value- creating activities support the primary activities, e.g. through the provision of personnel, etc. Inbound logistics, i.e. the division which ensures that required inputs and goods are available at the right time, is covered by the XQS Platform, the indoor tracking system QS-Locate and the XQS Terminal. Temperature sensors which monitor and track the ambient temperature of medicinal products during storage and trans- portation are an important feature of the Platform. Each XQS temperature sensor has the exact form of a credit card and it is simply placed in the package along with the temperature-sensitive medicines. The core functions include starting, stopping and reseting the sensor; readout of the recorded temperature data, and con- guring logging interval; delay time and temperature limits. The latter two congurations are optional. 07 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model Inbound- Logistics Operations Outbound- Logistics Service Compliance Procurement Technology Development Human Resource Management Firm Infrastructure PRIMARY ACTIVITIES S U P P O R T A C T I V I T I E S M a r g i n M a r g i n XQS-Plattform QS-LOCATE QS-Track XQS-Terminal Structure of XQS components in value chain activities U nlike the temperature sensor, it is not possible to store sensor data on a continuous basis, as the storage capa- city of an RFID tag is very limited and the time intervals of continuous recording would have to be much less than one second to ensure that no shock effect is missed. This would generate an extremely large quantity of sensor data in a very short time. Instead, sensor data are only stored if a predeter- mined limit value is exceeded. The acceleration sensor has a sampling rate which is high enough to guarantee that no shock effects are overlooked. The monitoring of changes in inclination is useful for pa- ckages which must always be transported the right way up. An RFID card with an inclination sensor (tilt sensor) can mo- nitor this with no problem, making it difcult for the delivery agent to deny that the package had been incorrectly trans- ported if the RFID card has detected and recorded excessive tilt or inclination. At the terminal, the position of the package at every stage during transport can be traced in 3D. The package is displayed as a three-dimensional cuboid and the user can jump to any point on the time axis using the scroll function. This enables the user to track the packs progress with a time lapse. Shock effects on the package, e.g. if the package falls to the ground or is subjected to a sharp blow, can be monitored with the acceleration sensor. If this shock effect exceeds a specic threshold value, it may be assumed that the package contents have been damaged, perhaps making it too risky to open the package. Any shaking of the package, which can destroy protein struc- tures, is more difcult to detect. Shaking produces a shock effect far less than that associated with a fall from a great height or a sharp blow. With shaking, the shock effect is not a one-off occurrence but is continuous or occurs at intervals. This property should allow correct interpretation of the data and enable unwanted shaking to be detected. 08 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model Conguration and launch of temperature logger using the XQS Platform Chart showing the recorded temperature values. B ulk reading capacity is the key advantage of RFID, espe- cially in the pharmaceutical environment. This is because in real-world pharmaceutical logistics, containers with a cha- otic mix of packages tend to be used in the various processes. A bulk reader such as a tunnel reader allows simultaneous reading of a chaotic mix of transponders. These can all be captured simultaneously in a database, along with informati- on such as batch number and expiry date. A container with a chaotic mix of packs of drugs passes through a tunnel. The XQS Platform then displays all the drugs. Two packs have been removed from the tunnel: The XQS Terminal is a reading station which is installed in the inbound logistics department in pharmacies or hospitals. The electronic delivery note for pharmaceuticals is placed on the terminal, which then displays the items including details such as PZN, batch number, expiry date and quantity. The delivery note data which are read at the terminal can then be exported directly into a materials management and control system such as Cypro. This transmission is very ef- cient, being free from media breaks, and is less error-prone than manual transmission.The temperature and shock data can also be read at the terminal. Items on an electronic delivery note for pharmaceuticals, which have been read at the terminal: 09 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model Q S-LOCATE is an RFID- based indoor location system for objects and peop- le. Knowing where a specic object is located at any given time is essential, not only in hospitals; the technology can also be used successfully in department stores or logi- stics centers, for example. Outdated surveillance me- thods such as cameras or se- curity personnel are no lon- ger sufcient in many areas. Another highly sensitive area in which the system can be used is the infant unit of a hospital where newborns can be tted with QS-LOCA- TE baby wristbands. This can prevent devastating mix-ups or even child abductions. As the rst step, products, objects or people are tted with a beacon, a program- med RFID tag, which activates itself after a pre-congured interval and transmits its data (in this case a unique ID) by ra- dio to the nearest receiver. Beacons are mounted on movable objects. The position of the object can be determined with the aid of several receivers. The beacon thus reveals the location of the tagged object. With a highly energy efcient design, a battery life of more than ve years is possible, re- ducing maintenance to a minimum. The electricity for the wall-mounted receivers comes either from a po- wer supply unit (PSU) or from Power over Ethernet. They are linked to Ethernet via a server and re- gister whenever an object equipped with a beacon co- mes into range. They then transmit this information to a central server. Equipping of the buildings or sites with hardware is based on local needs. In a minor case, the system may be needed to detect whether an object or a per- son has left the building or a room within the building. In this case, it is sufcient to install a receiver at each entrance or exit. If the com- plete system is put in place, the entire site is covered by receivers, thus enabling gap- free locating in real time. The tag thus transmits its ex- act position, in real time, to the QS-LOCATE software which displays its precise where- abouts at that given moment. If the object is moved, or an attempt is made to move it outside a designated radius, the system sends an alert and even sets off an alarm if required, provided that the system has been congured in this way. The same process can be applied to people. If a person wea- ring a tag attempts to enter a secure area without authoriza- tion, the system blocks access to the area. The sensor system is also able to tell whether an object or person leaves or en- ters a room. Since the software is customizable and adapted to the buil- ding concerned, there is no need for barriers at entrances and exits (such as those found in department stores). 10 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model 11 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model RECEIVER ON THE WALL BEACON RECEIVER XQS-SERVER MOUNTING THE RECEIVERS IN THE ROOM PROCEDURE: BEACONS FOR MOBILE OBJECTS: L CATE L CATE
E T H ERN E T Architecture of the QS-LOCATE System Q S-Track is a logistics software developed specically for pharmacies supply service with open interfaces to ERP systems. The application is used to manage supply contracts and monitor their delivery status in real time. The software consists of a server, a stationary client for mo- nitoring and displaying the status of all deliveries, as well as a mobile device equipped with GPS for the delivery agent (PDA). The pharmacy is linked up via a secure internet con- nection. The system can be operated in conjunction with exis- ting ERP systems and can incorporate the data from each database (no media breaks). The vehicles in use at any given time can be visualized in real time on a map (tracking). The route of a vehicle over several hours or days can also be traced afterwards (tracing). When an order is inputted into the pharmacys ERP system, QS-TRACK takes it over. As soon as all the items to be delivered are available, the order is marked as ready for collection and a label containing a bar-code and the delivery address is printed to afx to the delivery box. The order is simultaneously assigned to a driver during the process. In a matter of seconds, the driver receives the new order automatically on his PDA. As soon as he collects the box to be delivered and reads it in with the bar-code scanner/RFID scanner, the order status switches to collected. When he selects the order, the QA navigation system takes him right to the delivery address. On arrival, the driver scans the box and the delivery status is updated. The entire process can be mo- nitored and managed from the work station at the pharmacy, enabling orders to be recalled or canceled, allocated to other drivers or assigned for redelivery. While the driver is on the road, the pharmacist can track his current location on a map in real time and can also see the estimated delivery time of all the deliveries on his computer. He is therefore always infor- med of any potential delays and can take action if required. An alarm function immediately alerts the pharmacist and the driver if the condition of the delivery goods becomes critical. This management of supply contracts and monitoring of their delivery status in real time, which enhances existing ERP sys- tems, is an RWA function which is in line with the denition provided at the start. 12 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model Create a new delivery order Product is ready to be picked up Assign the procuct to a driver Data is synchronized on the driver`s smartphone Driver A S Driver A ! 1 2 NEW READY 3 Driver picks up the package PICKED UP The package appears in the QS-System as picked up 4 The QS-Navigation System guides the driver to the destination The driver`s location can be tracked in real time Driver A A DELIVERED Driver A hands the package to the customer QS-TRACK State: delivered 5 6 How it works: QS-Track Field Testing Sun Pharmaceuticals works with specialist wholesaler Max Pharma and IT specialist XQS-Service. Attaching the RFID transponder (tag) is part of a routine and automated logi- stical process. Data collection and processing, on the other hand, are currently being tested in a pilot project involving a number of pharmacies. Distribution is currently under way of various packs containing oncology drugs, which are marked or secured using RFID. Gemcitabine is one of Suns products on the market, which are labeled with RFID and controlled by the XQS-System: Literature [01] Schiltz, C. B., EU warnt vor Boom bei geflschten Medi- kamenten, Welt Online, 07.12.2009 [02] Schweim, H. G., Geflschte Arzneimittel aus der Dritten Welt in die Industrienationen [03] Klemperer, D., Arzneimittelforschung: Marketing vor Evidenz, Umsatz vor Sicherheit. Deutsches rzteblatt, Jg. 107, Heft 16, 23. April 2010 13 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model Eldar Sultanow Eldar Sultanow is CIO of XQS Service GmbH and active at the University of Potsdam as an external Ph.D candidate. He graduated in Software Systems Engineering at the Hasso- Plattner-Institut and in Computer Science at the University of Potsdam. Since 2006 he acts as a software engineer and JEE-architect in the industry. Eldar has authored one book and published at a number of conferences including those from the Institute of Electrical and Electronics Engineers (IEEE), International Institute of Informatics and Systemics (IIIS), and Association for Information Systems (AIS). Sultanows primary research interests preside in the areas of web development, RFID, and geographic information systems (GIS). Michael Kretzer Mr. Kretzer is educated as a state-certied child care in 1981, state-certied nursing 1985, Paramedic and Pharmaceutical Speaker in 1989. He was active in neurosurgery from 1985 to 1989 in Bavaria, as a Clinic Speaker at Lipha Corporation from 1989 to 1992. From 1993 to 2000 he worked at Chiron USA as Oncology specialty sales dept., as project leader at Target Corp. from 2000 -2001,as Head of Marketing & Sales Fresenius Biotech- nology until 2003 and nally as CEO Max Pharma beginning from 2004. 14 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer Controlling fraudulent & quality-impaired medicine: An Awareness Model About XQS XQS-Service GmbH was founded in 2006 with the aim of setting a new milestone in the security and distribution of medicinal products. The electronic monitoring of distribution channels is new in the pharmaceuticals sector. The QS on Demand quality assurance system allows real-time monito- ring at every stage, and its rapid acceptance in the market has driven further development using RFID to guarantee op- timum security with additional benets. Thanks to this de- velopment, XQS-Service GmbH and its customers are now uniquely positioned in Europe and the world. A live demonstration of all the hardware and software equip- ment can be seen at the companys showroom in Gattendorf near Hof. XQS-Service GmbH supports customers from the pl- anning stage right through to the implementation phase, so you will receive all the system-relevant information that you need to give to your customers. With locations in Europe and Asia, international expansion is possible at any time. Contact us XQS-Service GmbH Am Gewerbegebiet 5 95185 Gattendorf Tel. +49 (0) 9281- 84016-200 Fax +49 (0) 9281 84016-222 info@xqs-service.de www.xqs-service.com CEO: Michael Kretzer Visit us at the MEDICA 2011 16-19 November, Trade Fair Dusseldorf, Germany For futher information click our website! 15 2011 XQS-Service GmbH Eldar Sultanow & Michael Kretzer &