Thought Leadership
A Message from Gary Noon, CEO of Aegate:
The European Commission has outlined the need to find a workable solution to ensure patient safety and improve information to patients across Europe - a decision Aegate supports wholeheartedly. As the Commission now determines which compulsory safety features should be implemented, the pressing question is whether a solution adopted now will work as effectively in five year's time - can we truly future-proof it?
Aegate believes that, as an industry working collaboratively, we
can.
Fundamentally, as long as the security feature employed is
machine-readable, it will not become redundant - its effectiveness
and impact will be long-term.
Equally important is the need to harmonise the requirement for the same safety feature across Europe. Harmonisation will allow pharmacists to authenticate medicines regardless of where they commenced distribution, whilst simultaneously prevent illegal importation from outside of the EU. Implementation of harmonisation may also save the industry as much as €1 billion but more importantly protect all European patients.
Aegate's authentication system - which reads any machine readable form of serialisation code -is currently authenticating several millions of medicinal items each month, with the full support of the pharmacy associations, pharmacists and indeed many pharmaceutical companies in each country we operate in.
Click here to listen to the podcasts from this meeting.
The EU's legislation marks an important and
positive turning point in the European pharmaceutical industry.
As a company committed to patient safety,
Aegate commends the European Union for tackling both the issues of
information to patients and patient safety in its consultation
findings. Medicine authentication is known to be an effective
mechanism to protect patients and legislation that allows patients
to receive up-to-date, accurate information on the drugs they are
being prescribed, is a positive safety measure.
Only recently, an independent audit of Aegate's
authentication system operating in Belgium pharmacies showed it to
be 100% accurate in identifying suspicious, recalled and expired
products before they are dispensed to patients.
The EU's legislation marks an important and positive turning
point in the European pharmaceutical industry. The most important
factor now is the speed at which this can be put in place across
the European Union. Consequently, we will commit to accelerating
the speed of provision of Aegate's authentication service,
which is in operation in Belgium, Italy and Greece, to other
countries as a result of these findings.
We fully support any initiative that addresses patient safety and
look forward to continued collaboration with the industry,
government and professional organisations to ensure patients
receive the best quality medicines as prescribed.
Aegate's drug authentication service is 100 per
cent reliable and effective, corroborates report
Consumers can be protected from receiving
counterfeit or substandard pharmaceuticals when their pharmacist is
able to authenticate their medicines at the point of dispensing,
concludes the world's first audit of a working drug
authentication system.
The report, "Reliability and impact of drug authentication at
the point of dispensing" written by the Prof Steve Simoens of
the Katholieke Universiteit Leuven, documents the findings from an
independent audit of Aegate's drug authentication
service.
To download a copy of the report summary
click here
If you would like to see the full report - please email
leanne.huff@aegate.com
Using Information Technology to Combat Counterfeiting in the EU (appeared in Regulatory Affairs Journal, July 2009)
Gary Noon explains how using information technology to enhance
communications can help industry better deliver quality assured
medicines in the European Union.
The advent of information technology has had a profound impact on
industry and the pharmaceutical community is no exception. With a
complex supply chain and a growing need to guarantee the safety and
well-being of consumers, information technology is a powerful
enabler. Increasingly, technology is critical to ensure all
industry stakeholders are kept up-to-date with the latest
regulatory and legislative changes.
As the last point of professional contact between the patient and
the industry, pharmacists are on the front line when it comes to
ensuring patient safety. The quality and timeliness of information
flowing to pharmacists about medicines is vital in this endeavour.
Providing the pharmacist with information in real-time - as the
medication is dispensed - creates the opportunity to provide new
levels of patient safety previously not available. Implementing a
communications network between pharmacies, manufacturers and
regulatory authorities that operates in real time on a pan-European
basis will revolutionise the pharmaceutical industry...
Working Together on Mass Serialisation: Whose
Responsibility is Ensuring Patient Safety
This report, written by Frost & Sullivan and commissioned by Aegate,
reviews the steps that have been taken to try and address this
burgeoning issue both from a national legislative level and via the
use of new technologies.
To download a copy of the executive summary
click here
If you would like to see the full report - please email leanne.huff@aegate.com
Movers & Shakers interview
An interview with Gary Noon, CEO of Aegate, on
the need for mass serialisation as the key driver to enhance
patient safety:
Full inteview available at the following link:
http://www.frost.com/prod/servlet/exec-brief-movers-feature.pag?sid=140061509
Verily Validated (Appeared in PMPS in
Winter 2008 issue)
The number of drug recalls, substandard medicines and counterfeit
products continues to increase. In the UK alone there have been
over 20 product recalls since Jan 2007 with The World Health
Organization (WHO) believing up to10% of the world's drug
supply may be counterfeit. As a result, now more than ever, the
pharmaceutical sector is facing significant challenges in the area
of patient safety. Recognizing this need, validation through
authentication at the point of dispensing, is already being
deployed by pharmacies throughout Europe with co-operation from
some of the biggest pharmaceutical companies...
Full article available at the following link: http://www.samedanltd.com/magazine/15/issue/92/article/2059
Playing Safe with Patient Safety
(Appeared in PMPS Autumn 2007 issue)
The
pharmaceutical supply chain is complex and provides numerous
opportunities for the unscrupulous to interfere with drugs. In
Europe today, with EU legislation that encourages the free movement
of goods, and coupled by price differentials between countries,
trading in pharmaceuticals is widespread and lucrative/ Companies
and regulators have common goals: to ensure the integrity of the
supply chain, prevent counterfeiting, and respond rapidly if a
problem occurs (in other words, withdrawing a product from the
market should a recall be necessary.) However, at the moment, there
is no common approach to these goals. There is growing complexity,
confusion and fragmentation within the industry...
Full article available at the following link: http://www.samedanltd.com/magazine/15/issue/86/article/1973
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