Drug Exposure

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Transcript Drug Exposure

The Technology
THE MISSING LINK IN BIOPHARMACEUTICAL SCIENCESTM
A basic principle
“Anything that can be
measured can be managed”
AARDEX
AARDEX
Advanced Analytical Research on Drug Exposure
Reliable assessment of drug exposure
Single point in
time assessment
Continuous
assessment over
time
Biased
•Pill counts
•Pharmacy refill data
•Patient diary
•Retrospective
questionnaire
Reliable
•Therapeutic drug
monitoring (TDM)
•Electronic monitoring
(EM)
Vrijens & Urquhart, 2004 Journal of Antimicrobial Chemotherapy
The MEMS® monitor
The MEMS 6 monitor is an electronic cap that shows the number of openings
since the start of the current 24-hour period and of hours elapsed since the last
medication event.
• Stores up to 3800 medication events in non-volatile EEPROM memory
• Wireless data transfer,
• Fits standard pharmacy bottles 38mm-400 thread closure,
• Available with or without child resistant security,
• Unique serial number identification is indelibly printed on the monitor and
stored in its electronic memory,
• Waterproof,
• CE marked,
• 18 months battery life.
Introducing advanced technology on monitoring adherence
Medication Event Monitoring System (MEMS®)
Events recording and storage
MEMS VI®
Communication device
Communicator MEMS VI®
Internet
www.viewcompliance.com
Ourbut
web-based
platform
Need a simple
robust taxonomy
FDA 21 CFR, 11 & HIPAA compliant
Physician, Pharmacist
Sion, Switzerland
Internet
www.viewcompliance.com
Individual reports back to
Physician, Pharmacist
Anonymous, but drug-specific,
aggregated database
Log into
the web
portal
Need
a simple
butcompliance
robust taxonomy
EN / FR / D version
Individual compliance
report
(forgetful
patient)
Need a data
simple
but robust
taxonomy
Individual compliance data report (weekend effect)
Individual compliance data report (perfect patient)
Individual compliance data report (BID: evening variability)
Evolving Technology
•
•
•
•
Over 400,000 patients monitored to
date with the various version of
MEMS (Medication Event Monitoring
System)
Currently used version (MEMS 6) has
a proven track record on >140,000
patients
AARDEX®
MEMS 6
>15,000 patients from controlled
clinical trials with available data
– Data on >3 Million monitoring
days
Ongoing device development:
– MEMS 7 (Wireless)
– Polypharmacy
– Blister packaging
AARDEX®
AARDEX®