Contact:
National offices:
Graham Smith, Commercial Director
Belgium
Aegate Ltd
Buro & Design Center
Esplanade 1 box 98
1020 Brussels
Tel:
+44 1763 268 160
Email: [email protected]
Tel: +32 2 290 34 00
Fax: +32 2 290 34 10
www.aegate.be
Italy
Aegate Ltd
Via Venezia, 23
20099 Sesto San Giovanni (MI)
Tel: +39 02 2412 6796
Fax: +39 02 2412 6794
www.aegate.it
United Kingdom
Aegate Ltd
H9 The Courtyard
Melbourn Science Park
Melbourn
Herts
SG8 6HB
UK
Tel: +44 1763 268 160
www.aegate.com
Aegate Holdings Ltd
H9 The Courtyard
Melbourn Science Park
Melbourn
Herts
SG8 6HB
UK
Tel: +44 1763 268 160
www.aegate.com
Aegate: experts in medicines authentication
“
”
I’m delighted to have joined Aegate at this exciting time. The
Falsified Medicines Directive will require the digitisation of the
pharmaceutical supply chain and Aegate are well placed to work
with the European and National stakeholders to deliver this.
Aegate are currently scanning over 200,000 packs of medicine
an hour and are experts in the field of medicines authentication.
This expertise has been gained over the last decade and Aegate
has invested over €65m during this time to get the process
right. My experience of scaling systems and of working with
ecosystem partners to deliver reliable fault tolerant services will
be of great benefit as we look to expand the Aegate service into
other European markets. The Aegate service is
like an advanced communications services
network, with high reliability and the ability to
deal with complex protocols in a secure way with
trusted service level agreements.
Mark De Simone (CEO)
2
Brussels
BELGIUM
Sir David Cooksey (Chairman)
“
What the Aegate system can do
Aegate’s medicines authentication service has
been protecting the European pharmaceutical
supply chain since 2006. During this time, the
Aegate system has alerted pharmacists to just
under two million packs of recalled, expired or
suspect medicines before they were dispensed
to patients. The Aegate system is a highly
secure, fully end-to-end service operating from
manufacturer to dispensing point. Fully proven and
operational, the Aegate service works in real-time with a rapid
250 millisecond round trip response time, checking every pack
of medicine before it is dispensed and protecting patients from
falsified medicines.
”
Real-time action to recall
suspicious packages
Helping pharmacists deliver
best practice to patients
In June 2009 at 14.53, a package of medicine was
dispensed without any problems at a pharmacy in
the centre of Brussels. At 14.55, a package with
an identical code was scanned 40 miles away at
Namur and over the next ten minutes, 14 identical
packages were scanned at different pharmacies
throughout the country. In total 73 duplicates of
the code were scanned in 69 different
pharmacies.
In September 2012, a study was carried out by the
University of Leuven. Forty-two pharmacists
participated. These were split into two groups; a
control group (20 pharmacists) who received no
training; and an intervention group (22 pharmacists)
who received training in how to coach and follow
osteoporosis patients in their use of Calcium.
The code in question appeared to come
from a manufacturer who was
participating in the Aegate scheme.
The manufacturer and regulator were
informed and while an investigation was
being carried out, a message on the system
continued to alert pharmacists to the
suspicious packages. It became clear that this
was not a case of counterfeiting, but was due to a
labelling error. As there was no quality issue with
the product, a low level alert was issued to
pharmacists and the manufacturer and regulator
ensured there were no reimbursement issues.
Due to the real time operation of the Aegate
system, it is possible for the Aegate local country
operator to contact the dispensing pharmacy
immediately and order the pharmacist to retrieve
a package from a patient. Unlike other systems,
the Aegate operator knows the location of each
terminal and can call the pharmacy in person, or
send an urgent alert so that the pharmacist can
retrieve the medicine from the patient before any
harm is done.
Medication records of 1161 osteoporosis patients were
reviewed. A baseline, pre intervention, was recorded
and results taken again at the end of the study.
Following the training, every time a member of the
intervention group dispensed an osteoporosis
medication, The Aegate system delivered a message
(via the dispensing software) that reminded the
pharmacist of what they had learned during the
training. The control group members did not receive
this information.
Results4: In the intervention group, 19.73% of
patients at the start of the study were taking an
optimal treatment regimen. At the end of the study,
this percentage had increased to 44.9%
(P=0.000001).
9.45% more patients received a correct dose of
Calcium in the intervention group compared to
the control group. Similarly 9.39%
more patients received the
correct dose of Vitamin D.
Although this was not a example of counterfeiting,
the real-time nature of the Aegate security system
demonstrates that counterfeiters can, at best,
hope to get away with selling only one copy of a
fake drug. This clearly severely constrains their
activities and improves patient safety.
4. Use of calcium and vitamin D supplementation in
osteoporosis: study of the impact of counselling by
the pharmacist - Veerle Foulon, Research Centre for
Pharmaceutical Care and Pharmaco-economics,
KU Leuven
7
Why choose Aegate?
Aegate is one of the largest and most experienced specialised providers of medicine verification and
authentication services in the World. Through integration with pharmacy Patient Medical Record
(PMR) systems, Aegate services protect over 17 million patients across Europe.
Since our inception in 2004, we have devoted considerable resources to developing and enhancing
our specialist services. This investment in people, partnerships and systems enables us to
consistently deliver to ‘six sigma’ quality standards.
•
•
•
2
The Aegate system is a straightforward, universally applicable, authentication and
traceability system for medicines. With a unique code affixed to each pack and a
barcode scanner in the pharmacy, the Aegate system checks each pack of medicine
against original data provided by the manufacturer and helps to ensure that patients
are given only genuine and correct medicines. The Aegate system also offers
Aegate takes patient safety seriously. We have invested €65 million in intellectual property to
develop highly secure systems which check over 200,000 medicines an hour in real time.
Benefiting from the lowest cost curve in the industry, Aegate also provides the highest quality
service as measured against standards set by pharmacies.
additional benefits such as improved product recall, more comprehensive adverse
Aegate does not operate in isolation. Our ecosystem partner programme brings together 46 PMR
suppliers and project management specialists who act as an extension to Aegate’s operations
team, providing scalability when required. As stakeholders prepare for the implementation of the
Falsified Medicines Directive, this partnership programme gives us the flexibility and scale
required to act.
Aegate is a specialist healthcare company with technical and security expertise. Our
Aegate has specialist expertise. Together with our ecosystem partners Aegate can leverage over
1,000 specialists in this field; we are ready to implement the FMD in all Member States. This in
depth knowledge allows us to de-risk the implementation of our service and its operation in
pharmacy. No one else in Europe can count on such a large and specialised team.
There is no substitute for practical experience, gained over a decade. Our medicine verification and
authentication system is operational in multiple European countries, giving us a profound
understanding of the challenges faced by companies as they prepare for the Falsified Medicines
Directive. This first-hand expertise cannot be gained overnight and ensures we have access to the
biggest specialised resources for the deployment of the Falsified Medicines Directive. Aegate has the
competence and experience which is key to delivering the service required.
events monitoring, up-to-the-minute drug safety advice and the opportunity for
patient education and patient information at the point of dispense.
experience in authenticating individual packages of medicines has been built up over
a decade. Aegate has already completed installations with 33 different pharmacy
systems, representing one-quarter of Europe’s 160,000 pharmacies. The system is
fully compatible across national borders or regions. To date Aegate has checked
2.7 billion packs of medicine, whilst maintaining a round trip response time to
pharmacies of 250 milliseconds.
European Legislation
European legislation was published on 1st July 2011 to protect EU citizens from the
dangers of falsified medicines. This legislation became applicable on 2nd January
How the Aegate system works
Unique machine-readable product codes are affixed
by the manufacturer to each box or pack of
medicine and the data files containing these unique
codes and other important security information are
transferred securely to Aegate. At the pharmacy,
the code is scanned and authenticated by Aegate
software installed in the pharmacy system. No
additional technology is required as the system is
integrated into existing pharmacy software. The
process of scanning and authentication is rapid and
does not interrupt the dispensing process.
2013 in all European Member States. In parallel, the Commission have been working
on the content of a Delegated Act to ensure the standardisation of the key safety
features required by the legislation. The adoption and subsequent publication of this
Delegated Act, will start a three year implementation timeline that will require the
creation of the repository system (database) that will enable the verification of the
authenticity of all prescription medicines and others considered to be at risk, at the
point of dispense, in all Member States.
Aegate’s end-to-end medicines authentication service fully meets the technical
requirements outlined by the legislation and Aegate are fully supportive of the
establishment and management by stakeholders of the repositories system with
supervision by the relevant competent authorities.
The Aegate system has been fully operational in Europe since 2006 and reliability tests under an
independent audit carried out by the University of Leuven in 2008 achieved statistical significance.
In 2011, the Aegate system was awarded ISO 27001, meaning that the security management system
meets exacting standards relating to data back-up procedures, protection from viruses and hackers,
security incident reporting, business continuity and contingency plans. The system is regularly
stress-tested to ensure safety and continuity of supply. Customers can, therefore, be assured of a
robust and secure service that meets demanding international standards.
6
3
How Aegate is improving the quality of
medicines dispensed to patients
Authentication of
medicines
Improving the recall
process
“With scanners in a growing number of
pharmacies across Europe, Aegate is
helping to eliminate the economic
rewards to be gained from producing
fake medicines”
A recall may be needed to remove
counterfeits from the market, or because
of product defects, faulty packaging, or
an unexpected safety issue. Recalling a
medicine is costly and very difficult to
achieve. High levels of publicity are
required to alert pharmacists and
consumers, with all the collateral
damage this can have on the brand.
Counterfeit and recalled drugs have a
detrimental impact on patients,
pharmacists and the pharmaceutical
industry. They are a serious loss of
revenue and may cause harm to
patients, either through toxic
ingredients or lack of efficacy. The new
EU legislation requires pharmaceutical
manufacturers to uniquely identify and
tamper-proof their products, in order for
these to be authenticated. These
actions will substantially reduce the
economic gains that can be achieved by
counterfeiters.
The AegatePROTECTTM system has been
developed to make authentication
straightforward and reliable for all
members of the pharmaceutical supply
chain. The Aegate security software
compares each package with an original
list supplied by the manufacturer and
ensures that suspicious packages are
identified before being handed to
patients. Although authentication can
be carried out at any point in the supply
chain, the pharmacist is critical to
success. Scanning in the dispensary
takes each individual package out of the
system, ensuring that no further copies
of the same pack can be dispensed
anywhere in Europe.
4
Current recall methods are highly
inefficient. The MHRA (Medicines and
Healthcare Products Regulatory Agency),
noted that in 2007, only 40,000 out of
70,000 packs of counterfeit medicine
were identified; it is not known what
happened to the remainder1. In 2006,
only seven out of 1,867 packs of fake
Lipitor were recovered2.
However, with a unique identifier on
every single pack of medicine, the
AegatePROTECTTM system can
immediately confirm whether a product
is the subject of a recall before being
dispensed and pharmacists can rapidly
scan their stock and identify recalled
batches. Furthermore, with total
cross-border compatibility,
AegatePROTECTTM can identify all
medicines subject to recall notices in any
participating country.
In 2013, the Aegate system enabled
pharmacists to identify more than
18,000 recalled packs BEFORE
dispensing. Pharmacists were also
alerted to check the batch numbers of
over 450,000 packs that may have been
subject of a recall and a further 5,170
packs that were expired.
1 BBC News 3 Feb 2009 http://news.bbc.co.uk/1/hi/health/7865246.stm
2 The Sunday Times, September 23, 2007 Factory for fake prescription drugs http://www.timesonline.co.uk/tol/news/uk/health/article2511583.ece
o.uk/tol/news/uk/health/article2511583.ece
.uk/tol/news/uk/health/article2511583.ece
AegateREACH™
Improving the services to
patients
Improving
pharmacovigilance
The Aegate product security system offers
more than just an authentication service.
As a medicine is scanned, the
AegateREACHTM service can send prompts
to the pharmacist, encouraging
interventions designed to optimise correct
usage or dosage. At the precise moment
that the product is dispensed, the
pharmacist can be prompted to talk to the
patient about how to take the medicine,
what side effects can be expected, or to
deliver other educational messages.
Pharmacist prompts can also be used to
enrol patients for medication reminder
services or to identify patients in need of a
treatment review.
The full safety profile of a medicinal product
is often only known once the product is on
the market. Some side effects, particularly
if they occur rarely, only appear after
long-term use or through interaction with
other drugs. The new EU Pharmacovigilance
directive encourages the reporting of
adverse reactions both by healthcare
professionals and patients, allowing patients
to report adverse reactions directly to the
competent authorities.
AegateREACHTM has already been used to
identify poorly controlled asthma patients;
and was successfully used to refer patients
back to their doctor to discuss a new
formulation. Pharmacist intervention and
counselling at the point of dispensation is
highly effective and can increase treatment
compliance by 15%.3 AegateREACHTM
helps pharmacists to achieve best practice
in their dealings with patients.
With AegateASSURETM, the manufacturer can
develop a plan in conjunction with the
regulator to monitor adverse events (AEs).
When a product that is being monitored
under the black triangle scheme is scanned,
the pharmacist can be prompted to question
the patient about adverse events and an
electronic link will enable the pharmacist or
the patient to report any problems directly.
This valuable service will enable more
extensive and rapid reporting of AEs and
facilitate the approvals and licensing
process.
Reimbursement
The unique number affixed to each pack
may also be used to support other
healthcare systems such as reimbursement.
When an item is scanned by the pharmacist,
the authentication software can also
generate an automatic signal for payment,
ensuring that the pharmacist receives
accurate payment for genuine dispensation
of medicines. As each package can only be
scanned once, this also has obvious
advantages in limiting falsified claims for
reimbursement. This has already been
recognised by the EU legislation which notes
that the same system that is used to
authenticate a medicine can also be used to
manage reimbursement.
3 E. Mehuys, L. Van Bortel, L. De Bolle, I. Van Tongelen, L. Annemans, J.P. Remon, and G. Brusselle Effectiveness of
pharmacist intervention for asthma control improvement, Eur. Respir. J., Apr 2008; 31: 790-799
5
Contact:
National offices:
Graham Smith, Commercial Director
Belgium
Aegate Ltd
Buro & Design Center
Esplanade 1 box 98
1020 Brussels
Tel:
+44 1763 268 160
Email: [email protected]
Tel: +32 2 290 34 00
Fax: +32 2 290 34 10
www.aegate.be
Italy
Aegate Ltd
Via Venezia, 23
20099 Sesto San Giovanni (MI)
Tel: +39 02 2412 6796
Fax: +39 02 2412 6794
www.aegate.it
United Kingdom
Aegate Ltd
H9 The Courtyard
Melbourn Science Park
Melbourn
Herts
SG8 6HB
UK
Tel: +44 1763 268 160
www.aegate.com
Aegate Holdings Ltd
H9 The Courtyard
Melbourn Science Park
Melbourn
Herts
SG8 6HB
UK
Tel: +44 1763 268 160
www.aegate.com
Aegate: experts in medicines authentication