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Safe and efficient for OST medicine
The worldwide
when it comes
leading company
to IT-based OST management

The present state
of OST medicine
SAFE AND EFFICIENT FOR OST MEDICINE
The substitution therapy practised today
represents the most accepted standard in the
treatment of heroin users.
The two main and worldwide approved substances
used in the substitution treatment are:
. Methadone
. Buprenorphine
In Asia, there are more than 8 million injecting
drug users, a quarter of them living in Southeast
Asia. In many Asian countries, injecting
drug use is the main route for the transmission
of HIV/Aids. Less than 10 % of the injecting
drug users in Asia have access to prevention
programmes.
In Europe, there is an estimated number of
3.5 to 4 million drug users, the largest group
of injecting drug consumers on the American
continent amounting to 1.2 million can be
found in the United States. *
Injecting drug use is responsible for an
increasing proportion of HIV infections in many
parts of the world, including countries in
Eastern Europe, South America, East and
Southeast Asia.
In some countries 40 % of the injecting drug
users are HIV positive.
Such a large number of patients requires a
comprehensive system for a safe and efficient
treatment at a reasonable price.
* World Drug Report 2009 UNODC
The solution
CompWare Medical ® is specialized on facilitating
the substitution therapy process in
outpatient facilities, clinics, prisons and
surgeries, relying on many years of experience
in this field and providing a comprehensive
IT-based documentation and dosing system
for OST.
As a consultant and project developer,
CompWare Medical ® is not only a provider of
IT-products but also an important partner to
those involved in OST medicine.
The worldwide service concept guarantees
that the customers can rely on a system
working smoothly at any time - even at weekends
and on holidays.
CompWare Medical ® supports the safe and
cost-efficient treatment of large numbers of
patients nationwide .

Safe handling of OST drugs is given priority
but it costs time and money
The nation-specific narcotic drug laws aim at
preventing any kind of misuse of dangerous
substances and approved substitute drugs.
Therefore, the law makers oblige all those
involved in the organisation of the treatment
process to document each individual step,
ranging from
the acquisition to
the usage and
.
the fate - up to
the destruction of OST drugs
In order to ensure - according to WHO
guidelines - medical care for a large number
of drug users based on a uniform, high-quality
standard, an IT- assisted solution is mandatory.
Only a uniform nationwide solution enables
the OST service centers to keep a standard
that can be controlled and evaluated and thus
to guarantee an adequately high level of
quality.
CWM has such a solution: MeDoSys ® , an ITbased
documentation and dispensing
system for methadone and buprenorphine.
In addition, thanks to a "comprehensive
approach", the CompWare Medical ® ITsolution
allows the treatment of concomitant
diseases like HIV/AIDS and TB according to
the "one-point-of-treatment" principle.
What are the challenges For the treatment
of a large number of patients treatment
faciltites covering a large area are needed.
They demand a sufficient number of qualified
medical personnel. The OST drugs used in
the facilities require safe handling. Measures
against misuse and theft have to be taken. In
order to guarantee a long-term and safe care
of a vast number of patients, the treatment
has to be cost-effective while keeping a high
quality standard.
With all this, CompWare Medical ® 's long-time
international knowledge and its technical
solutions can help.
Everything included
everything under control
Safety and efficiency - this is what CompWare
Medical ® guarantees its customers with its ITsupported
systems, ranging from countrywide
linked solutions to documentation and dosing
systems used in outpatient clinics.
CompWare Medical ® mainly focuses on four
basic requirements:
safe handling of methadone/burprenorphine
.
accurate documentation and dosing
efficiency in managing a large number of
patients with less medical staff
. cost efficiency as well as conditions for
reasonable treatment costs
For many years, CompWare Medical ® 's
experts have known the OST business from
the different points of view of those involved:
treatment sites
clinics
prisons
pharmacies
supervisory authorities
national and international relief organisations
.
health insurance companies
pharmaceutical companies
In cooperation with these partners CompWare
Medical ® has repeatedly developed solutions
for the controlled and safe dispensation of
substitute drugs.
Today, customers all over the world make use
of this knowledge.
Yale University and renowned universities in
Germany cooperate with CompWare Medical ® .
The scientists need epidemiological data for
their research acitivities which the company
and the respective substitution sites can
provide - after anonymising the data, of course.
Thus, CompWare Medical ® contributes to the
scientific assessment of drug-related medicine
and to the improvement of quality and safety
in OST treatment.

MeDoSys -
Safety and efficiency
MeDoSys ® is a computer-aided documentation and dosing system designed for the safe and
controlled conduction of the OST treatment of opioid users. It controls and monitors all
necessary steps of the therapy automatically - including the registration and deregistration of
patients with a central OST register.
Safety
is based on quality
CompWare Medical ® considers high
international quality standards:
Quality management according to DIN EN
ISO 9001, Manufacturer of medical devices
according to DIN EN ISO 13485, Software
life cycle for medical devices according to
DIN EN 62304.
MeDoSys ® allows the exact dosing of the liquid OST drug methadone and the complete
documentation of the dispensing process.
In the same way, the administration of substitute drugs in the form of tablets, e.g. buprenorphine,
can be documented correctly - strictly according to the valid narcotic drug regulations.
The MeDoSys ® software considers all requirements of the narcotic drug law.
MeDoSys ® guarantees the safety and efficiency of the substitution processes. Thus, the system
helps saving time, personnel and costs while allowing the treatment of a large number of
patients in treatment sites, prisons, e.g.
When developing and creating IT-based
solutions for the substitution therapy the
worldwide market leader makes sure that
priority is given to quality and safety.
CompWare Medical ® 's software solutions meet
all requirements of the respective narcotic
drug laws and can be adapted to countryspecific
demands.
The quality of production and services which
is constantly monitored and controlled by
official authorities guarantees the user the
best possible product quality and reliability.
This makes the staff's performance highly
effective and saves a lot of costs.
MeDoSys ® international
The IT-based system for treatment sites and prisons
MeDoSys ® international has been designed for treatment sites dispensing to a large number
of patients. It guarantees the exact dosing per patient as well as the automatic documentation
of the dispensed substitute drugs.
Apart from dosing and dispensing liquid methadone via the automatic dispenser it is also
possible to administer tablets, e.g. buprenorphine.
Undefined residues no longer occur. All steps can be traced back at any time. Clarity provides
safety and prevents manipulation.
Clearly defined access rights and processes facilitate the cooperation within the team even
in large-scale treatment sites.
Processes, registration and deregistration with the central OST register as well as the automatic
printing and settlement of reports and journals can be managed easily via the system.
Thus, even large groups of patients can be managed smoothly and efficiently.

Networking solutions
Central Register Solution
Central registration of substitution
treatment to avoid double treatment
This is a solution for national authorities.
It helps avoiding unintended double dosing
and double treatment of patients, and provides
a complete list of doctors certified for the
treatment. The system further allows an
overview of the number of patients currently
being under treatment.
Benefits
high safety in handling OST drugs
prevention of methadone diversion
requiring less medical staff for large numbers of patients
.
information on OST at a glance
high cost effectiveness
CRS and IRS
IRS - Information and Reporting Solution
All nationwide important information on
OST at a glance
Treatment site
Clinic
IRS is a central information and reporting
system designed to collect and analyse
relevant data on OST and concomitant
diseases on a nationwide and largely
automated basis. The data will be send
anonymized and automatically via MeDoSys ® .
CRS - Central Register Solution
IRS - Information and Reporting Solution
Treatment site
IRS provides authorities, quality assurcance
managers and donors with all information
relevant to their fields of activity - precisely,
promptly and clearly structured.
Treatment site
Mega-City Solution
Mega-City Solution
keeps mobile patients in treatment in
major cities
Clinic
This solution allows the storage of patients
data on a central server. The treatment sites
are connected by Internet. This keeps mobile
patients in treatment. It prevents double
dispensing to patients and allows an uninterrupted
treatment for the patient including his
treatment and diagnosis of other concomitant
diseases at any treatment sites he visits.
In order to support the identification of the
patient, biometric authentication methods such
as fingerprint recognition can be used in
addition to the patient's photo.
Mega-City solution
Clinic
data exchange
data exchange
Treatment site
Safety is our first Priority
authentication and medical database
server
Of course, all data are protected by modern
encryption methods against unauthorized
access and misuse.
Treatment site
Treatment site
Clinic

A worldwide
asked-for consultant
CompWare Medical ® ' s technical knowledge
and manifold experience in the field of OST
medicine - on a national and international
basis - makes the company a competent
consultant.
When government authorities, the WHO or
UN-organisations are planning nationwide
substitution programmes, the specialists from
Germany are highly appreciated.
Their assistance and knowledge is required
in India, Nepal, Malaysia, Russia and the
Central Asian countries.
Timely planning, sustainable implementation
The questions are:
. How can an optimum treatment of large patient populations be guaranteed today and in
future
. How can doctors and medical personnel be trained in such a way that a nationwide high
quality standard can be guaranteed
. How can processes, organization and linked systems - e.g. Mega-City solutions - be
managed in the best possible way
. How can clear structures guarantee efficiency, cost awareness, quality and safety in the
long run
.
How can manipulations be prevented and the safety of OST drugs be improved
How can optimum results be achieved despite the existing shortage of medical staff
CompWare Medical ® assumes the responsibility
- either as a general contractor or as a
partner to government authorities - for the
development, implementation and control of
local or nationwide OST projects.
CompWare Medical ® provides solutions and
support when it comes to project management,
software development and the nationwide
implementation of the project.
Best Practices for the development of
substitution projects
In Asia, for example, the consultants advise
several international aid organisations and
national governments on the countrywide
implementation of OST projects. In the same
way as it is practised on the level of individual
treatment sites, they support projects on a
nationwide level by providing solutions that
are efficient, safe and economical.
The consultants help avoiding mistakes,
unlocking potentials and identifying savings
opportunities. A company which has been
working in such a complex environment for
so many years knows all challenges and finds
solutions even in particularly hard cases.
This is why individual sites as well as large
organisations rely on CompWare Medical ® .
Projects
international
For several years CompWare Medical ® has been operating on an international basis. The worldwide activities are controlled by the Swiss banch.
Asia:
One point of Treatment – in cooperation
with the giz*
Target: CompWare Medical ® is realizing PPPs
(public private partnership) in India, Nepal
and Malaysia in cooperation with the giz* and
other partners.
The project aims at establishing model
treatment sites for OST which are supposed
to offer an integrated substitution therapy.
Prisons as well as clinics are going to be
included in the project.
The therapy covers the regular supply of
methdone / buprenorphine to the patients and
above all the treatment of HIV and TB patients.
The project comprises the installation of
MeDoSys ® and the training of the staff.
MeDoSys ® is an automatic IT-based
comprehensive system for dosing and
dispensing methadone and documenting the
administration of buprenorphine tablets.
It has been designed to manage the largescale
opioid substitution treatment of drug
users primarily in treatment centers, hospitals,
clinics and prison settings.
Challenge: Apart from implementing the
prototype of an outpatient clinic, there are still
more challenges to face: The medical
personnel has to be trained and made familiar
with the substitution therapy, methadone has
to be approved as a drug in India, safe transport
has to be defined and legal conditions
have to be created.
The giz's job is to keep in touch with the
authorities and ministries and to create the
basic conditions required for running an outpatient
clinic on an official basis.
The giz will send a doctor who is to support
the medical part of the project on site from
the beginning to the end.

Projects
international
CompWare Medical ® will be responsible for
establishing and organising the outpatient
clinic and for training the personnel who, for
this purpose, are supposed to stay with
CompWareMedical ® in Germany for several
weeks. Furthermore, the company will provide
the documentation and dosing system. The
necessary long-term support on site will be
ensured by local partner companies.
Second level service will be guaranteed by
CompWare Medical ® on 365 days a year.
Success: CompWare Medical ® and its
partners have succeeded in establishing
comprehensive systems for an integrated
substitution therapy including the treatment
of accompanying illnesses in Nepal and
Malaysia. This is going to be a great success
for all parties involved, above all for the
patients.
* giz Deutsche Gesellschaft für Internationale
Zusammenarbeit GmbH
Projects
national
In Germany, CompWare Medical ® - in cooperation with leading organisations and institutions - has developed innovative projects for the purpose
of improving the quality and safety in OST medicine.
Server for OST drug prescriptions for the
Federal Ministry of Health and Federal
Opium Agency
Target: The server for OST drug prescriptions
is supposed to facilitate the process of ordering
drug prescriptions by means of digital data
exchange, at the same time guaranteeing a
higher level of safety as compared to the
former system. This procedure is to optimise
the safety of the OST drug prescription and
distribution process, while significantly
reducing the administrative work to be done
by the physicians and the Federal Opium
Agency, a department of the Federal Institute
for Drugs and Medical Devices.
Challenge: The prescription server is based
on an electronic procedure to order, issue
and cancel safety marks which replace
complete drug prescriptions.
In future, even standard prescription forms
will have these safety marks and thus become
drug prescriptions. 100 000 physicians and
31 000 pharmacies should be connected to
this system.
Success: Our test system is running smoothly,
which means that the first step of the project
development has been successfully completed.
The next step is the integration of the project
into the new nationwide electronic prescription
system.
Automatic data transfer for the Central
Data Registration System of the German
Federal Opium Agency
Target: The project's target is to establish a
system which allows the electronic encryption
and transfer of data to the central register of
the Federal Opium Agency for the registration
and deregistration of OST patients.
It is supposed to prevent unintended double
dosings.
The former complicted and error-prone manual
encryption of patient data according to the
BtMVV (Narcotic Drugs Prescription Guidelines)
is to get simpler and safer. The shipping
by mail is to become a thing of the past.
Challenge: For the data transfer via Internet
CompWare Medical ® had to develop a safe
and digital method of identifying all those
involved in the substitution process.
Any doctor authorized to carry out substitution
therapies had to be registered.
Success: For several years, the automatic
registration and deregistration of the
substitution patients has been carried out
successfully. Unintended double dosings do
no longer occur. Only authorized doctors can
carry out the substitution treatment.
HepatitisC SUPPORT in cooperation with
Shering Plough
Target: Of all the illnesses afflicting opiate
users, Hep C is one of those that is difficult to
treat.
Recent regulations are now recommending
a therapy of this illness which often accompanies
drug addiction. In order to assure the
quality of this treatment, CompWare Medical ®
was asked to develop a software solution
designed to support and document the entire
therapy within a study.
Challenge: In order to make the therapy of
drug addicts more effective, the treatment
demands an intense medical attendance, with
the patients seeing the doctor at regular intervals.
The software solution SUPPORT was
expected to back up all details of the therapy
(the treatment of substitution patients with
PegIntron ® and Rebetol ® ). The programme
was to support the therapy by structuring the
complex treatment and documenting the
results.
Success: Having successfully completed the
stage of development, SUPPORT started in
practice in October 2005.
600 patients suffering from an infection with
chronic hepatitis C have been treated in 60
medical institutions.

Certified manufacturer
of medical devices RZCWImage-E- A4 28/04/2011
CompWare Medical ® is a German company
founded in the year 1986 and certified to ISO
as a producer of medical devices.
CompWare Medical ® is a pioneering company
and a worldwide leading manufacturer of selfregulating
IT-based solutions in the field of
OST medicine. Thanks to its sound technology
and its competence based on many years of
experience in the field of OST, CompWare
Medical ® has established itself even internationally
as a much asked-for consultant when
it comes to the implementation of qualitybased,
lawful substitution programmes.
Global market
leader
MeDoSys ® is a worldwide unique and universally
used documentation and dispensing system
for methadone and buprenorphine.
CompWare Medical ® has gained a comprehensive
knowledge and a vast experience in
the field of OST over the past twenty years:
. IT-based documentation and management
of records and data for medical diagonosis
including HIV, TB and Hep C treatment
. management and organisation of the oral
substitution process within treatment centres
. technical advise on financial management
and concepts
. comprehensive knowledge on the safe
handling of OST medicines
. profound knowledge and expertise in the field
of narcotic drug laws
. IT-based medical studies, analyses, reports
. IT-based regional and national networking
systems
. expertise in linking oral substitution facilities,
clinics and involved organisations through
an IT-based networking system
. profound knowledge on data protection through
modern encryption methods against unauthorized
access and misuse.
. References and partners
- more than 200 treatment centers
- prisons
- German Federal Ministry of Health /
Federal Opium Agency
- ministries and authorities of other countries
- health insurance companies, Germany
- giz GmbH (German company for
International Cooperation)
- WHO
- UNODC
- AHRN
- Medical Association WL, Germany
- Nagarro Inc, India
- Rusan Pharma, India
- Shering Plough, USA
- microgenics / ThermoFischer, USA
- Sanofi-Aventis, France
- Draeger Medical, Germany
- Sandoz, Germany
- et al.
. OST Projects outside the EU
- India
- Nepal
- Malaysia
- Russia
- CADAP / EU
Contact
Information and Consulting
CompWare Medical ® GmbH Germany
Robert-Bunsen-Str. 4
D-64579 Gernsheim
Tel.: +49 (0) 62 58 / 94 92-0
Fax +49 (0) 62 58 / 94 92-21
E-Mail: Info@compwaremedical.de
Internet: www.compwaremedical.com