Sunteți pe pagina 1din 15

T

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
&

S-ar putea să vă placă și