The document proposes several packaging solutions that integrate electronic timers and reminders to increase patient compliance in taking osteoporosis medications correctly. It analyzes current compliance rates and the needs and interests of stakeholders. The solutions aim to differentiate drug brands and optimize treatment through features like automatic timers, reminders, and a deposit return program.

1. Optimized drug administration
in treatment of osteoporosis
through increased compliance in
Packaging Support Programme
Developed by:
Medicompliance
ProjektGruppen A/S
Copenhagen, Denmark
Copyright 2007

2. 1. Market
2. Stakeholders
3. Packaging

3. 1. Market

4. Definition
For this project compliance is defined as the
patients ability to:
✜ take the drug at the right time
✜ take the drug with the right frequency
✜ take the drug in the right quantity
✜ renew prescription/redeem in case of a multiple dispensing
prescription

5. Benefits through increased
compliance
✜ Faster market penetration at launch
✜ Increased sales during product life cycle
✜ Treatment end-points are met
✜ Patient/payers expected return on purchase is met

6. Current situation
✜ It is commonly agreed that existing administration systems for
oral drug delivery do not deliver optimal patient compliance
✜ Medline and internet search however reveals that little
systematic research exists that can quantify the compliance
levels in various drug categories

7. Compliance in treatment of
osteoporosis
✜ SERM (Evista) 70,5 - 78% 1, 2)
✜ Alendronat (Fosamax) 75,6% 2, 3)
✜ Etidronat (Didronate/Didronel) 70% 4)
Numbers reflect the share of patients that take medication as directed in terms of quantity and frequency.
• The research results are not directly comparable as treatment lenght and research design differs. It is however fair to assume,
that there is room for improvement.

8. Sales scenarios
(inflow 60 pts. annually)
Case 1 (Without compliance facility):
annual drop out rate 70%
✜ 5% from death
✜ 5% from reduced frequency
✜ 10% discontinuation from sideeffects
✜ 10% from lack of motivation
Case 2 (With compliance facility):
annual drop out rate 85%
✜ 5% from death
✜ 0% from reduced frequency
✜ 5% discontinuation from sideeffects
✜ 5% from lack of motivation
0
5 0
1 0 0
1 5 0
2 0 0
2 5 0
1 2 3 4 5 6 7 8 9 1 0
Case 1
Case 2
Year
Pts.
The graphs clearly demonstrates how an increase in
compliance of 15 percentage points in year 10 results in
64% higher sales - and accumulated in 10 years of 45%

9. Existing compliance solutions
Mainly targeted towards the 100% compliance requirements in
clinical trials. The solutions basically are the same in terms of:
✜ records the moment of first drug intake
✜ signals (audio/visual) when time is up for next intake
✜ registers if drug is actually taken/dispensed from pack
The solutions do not form an integrated part of the drug packaging
thus requiring
✜ more stock keeping units
✜ ordering at the same time as the drug is prescribed/prescription is
redeemed
✜ assembly with drug
✜ recording time between intake

10. 2. Stakeholders

11. Patient
Woman 50+
with PMO
Stakeholders in a compliance
programme
Pharmacy
GP/Hospital
Insurer/
public payer
Relatives
Nursing staff
Pharmacy
wholesalers
Manufacturer

12. Stakeholder requirement/interest
Patients
non-compliance due to
✜ not properly instructed
✜ patient package insert difficult to understand
✜ forgets
✜ asymptomatic disease
✜ lack of motivation
✜ disturbed routines (holiday)
✜ complex intake/dosing regimes
✜ bisphonates require fasting period around time of intake
✜ weekly (alendronate) and quarterly (etidronate) intervals
✜ our proposal of an integrated solution minimizes the effect of the non-
compliance parameters

13. Stakeholder requirement/interest
Pharmacy wholesaler
✜ increased focus on Direct Product Profitability (DPP) through handling and
reduced number of Stock Keeping Units (SKU’s)
✜ our proposal of an integrated solution fulfils this requirment
Pharmacy
✜ increased pressure on profitability reduces staffing and time for patient
advice/education
✜ increased usage of internet PCY reduces prescription redemption with
face-to-face contact
✜ our proposal of an integrated solution ensures that the patient recieves the
complete package including easy to understand directions for use

14. Stakeholder requirement/interest
Insurer/public payer
✜ reimbursement decisions are based on efficacy demonstrated in clinical
trials with close to 100% compliance rates
✜ in future assurance that the same compliance rate is met in real life will be
a determining factor in reimbursement decisions
✜ our proposal of an integrated approach increases cost efficiency
GP´s/Hospital/nursing staff/relatives
✜ increasing time pressure reduces time for instruction of patients leading to
the need of a self-explanatory proactive solution
✜ increasing reliance on relatives to help
✜ our proposal of an integrated approach enables the patient to take drugs as
directed with minimum or no instruction

15. Stakeholder requirement/interest
Manufacturer
✜ correct quantity and frequency to ensure treatment endpoint
✜ differentiation
✜ optimized sales
✜ faster uptake after launch
✜ higher patient lifetime value
✜ no major investment in new production facilities
✜ optionally no need for new stability/shelf life tests
✜ no contractual long term bonding to specific supplier
✜ continues developement in line with market demands
✜ cost efficient
✜ inhouse production and quality assurance
✜ multiple sources for subcontraction
✜ Our proposal of an integrated solution supports manufactures key success
drivers

16. 3. Proposal
Packaging
Support Programme
A, B and C

17. Proposal no. A:
1-press-solution

18. 1-press-solution
✜ Intelligent and disposable Electronic Compliance Blistercard
with integrated timer and Audio Visual alert!
✜ Timer is activated and starts countdown when the first tablet is
pushed through the blister foil - thereby the electric current is
broken. The timer is reactivated similarly when tablets 2 and 3
are pushed through the blisterfoil. Directions for use is printed
on the back of the blister card in local language (optionally
through the blister).
✜ 30 min. visual countdown before intake
✜ Time to new intake is always visible.
✜ The green light indicates reneval of prescription (after 3
tablets*).
✜ Intelligent chip can store actual timespan between tablet
dispensing for later transfer to database, quick and
✜ convenient (opt. Industri standard 13.56 MHz RF compliant).
*If one tablet solution, the countdown will just indicate new
prescription time
Audio
signal
Countdow
ndisplay
Visual
signal Opt. 13.56
MHz
compliant
Printed
Conductor
– will not
be visible
Possible to
print
commercia
l info on
blistercard

19. Functionality
(1-press-solution)
Take the pill When time for
reneval of
prescription is
expired,
green light is
constantly on.
If pill is not taken
as prescripted
(button not
pushed), beep
audio signal and
negative
countdown starts
When timing is up
for drug intake, the
audio signal starts.
The process restart
when tablet is
pushed through
After third
countdown
commences, green
light flashes
Countdown
from 30 to 0
days starts
Audio signal indicates
countdown from 30 to 0 munites
and then audio signal indicates
time for intake.
Phase 1
Phase 2
Phase 3

20. Proposal no. B:
2-press-solution

21. 2-press-solution
Audio
signal
Countdow
ndisplay
Visual
signal Opt. 13.56
MHz
compliant
Push
button to
activate
timer
✜ Intelligent and disposable Electronic Compliance Blistercard
with built-in timer and AudioVisual reminder.
✜ The timer is manually activated and starts countdown when
the first tablet is taken - and is manually reactivated for the
following tablets.
✜ 30 min. visual countdown before intake
✜ Time to new intake is always visible.
✜ Directions for use is printed on the back of the blister card in
local language (optionally through the blister).
✜ The Beep indicates when time is up for new intake (stops
when button is pushed), and green light indicates reneval of
prescription (after 3 tablets*).
✜ Intelligent chip can store actual timespan between tablet
dispensing for later transfer to database, quick and
convenient (opt. Industri standard 13.56 MHz RF compliant).
*If one tablet solution, the countdown will just indicate new
prescription
Possible to
print
commercia
l info on
blistercard

22. Functionality
(2-press-solution)
Phase 1
Phase 2
Phase 3
Take the
pill
When time
for reneval of
prescription
is expired,
green light is
constantly
on.
If pill is not taken as
prescripted (button
not pushed), beep
audio signal and
negative
countdown starts
When timing is up for
drug intake, the audio
signal starts. The
process restart when
red button is pushed
After third
countdown
commences,
green light
flashes
Countdown
from 30 to 0
days starts
Push button to start countdown from 30
to 0 munites (audio signal indicates
start) and then audio signal indicates
time for intake

23. Proposal no. C:
Intelligent device
with protective
jacket

24. Proposal no. C:
Exploded view
Lockable counting device
with battery, chip, display,
loudspeaker and adjustment
button
Printed conductive material as
electric current (or other solution)
Contact points for
counter device
Protective jacket
Foil with coated
backside
Printing
on both
sides
Attachment
lock for device
Attachment
lock for device
Ahedsive area

25. Proposal no. C:
Attachment for
lockingOpening
Display adjustment button for
correct intake countdown at
the next purchase
Audio
signal
Visual
signal
Large display
for countdon to
next intake

26. Proposal no. C:
Intelligent device with
protective jacket
✜ Intelligent and disposable Electronic Compliance Blistercard with
integrated timer and Audio Visual alert!
✜ Jacket for EXTRA child protection and accidentiall disruption of blister foil
✜ Timer is activated and starts countdown when the first tablet is pushed
through the blister foil - thereby the electric current is broken. The timer is
reactivated similarly when tablets 2 and 3 are pushed through the
blisterfoil. Directions for use is printed on the back of the blister card in
local language (optionally through the blister).
✜ 30 min. visual countdown before intake
✜ Time to new intake is always visible.
✜ The green light indicates reneval of prescription (after 3 tablets*).
✜ Intelligent chip can store actual timespan between tablet dispensing for
later transfer to database, quick and convenient (opt. Industri standard
13.56 MHz RF compliant).
*If one tablet solution, the countdown will just indicate new
prescription time

27. Functionality
(1-press-solution with protective jacket)
Take the pill When time for
reneval of
prescription is
expired,
green light is
constantly on.
If pill is not taken
as prescripted
(button not
pushed), beep
audio signal and
negative
countdown starts
When timing is up
for drug intake, the
audio signal starts
and image of intake
appears . The
process restart when
tablet is pushed
through
After third
countdown
commences, green
light flashes
Countdown
from 30 to 0
days starts
Audio signal indicates
countdown from 30 to 0 munites
and then audio signal indicates
time for intake.
Phase 1
Phase 2
Phase 3

28. Closing remarks, Packaging
✜ Today multiple suppliers are offering cutting edge solutions combining
conductive blistercards and microchips at a low cost.
✜ based on patient behaviour insights we have developed the technology
one step further by adding the visual aids to provide repeat purchase,
loyalty and brand differentiation.
✜ as the solution must be able to keep up with the technological
development and evolving stakeholder needs, an open solution with
respect to suppliers is pivotal in securing flexibility and fast response to
the changing market environment.

29. All proposals:
Unique life cycle management
through recycling
A deposit is included in the purchase price. After use
the blistercard deposit can be refunded on return to th
PCY. This provides the opportunity of:
✜ reinforcing patient motivation to continue treatment
✜ reinforcing repeat purchase/prescription
✜ download of intake frequency stored in chip –
datagathering from bulk collection to on un-premise via
industri standard 13.56 MHz Frequency Readers
✜ insurer/public payer can be provided with proof of
concept
✜ endorsement from GP
✜ brand differentiation
✜ goodwill from recycling of used blistercards

30. Functionality
(Unique life cycle management through recycling)
New cycle
commenses
PCY deduct deposit
from renewed
prescription (or
refund it)
Return of user
Blistercard
When time for
reneval of
prescription is
expired, green light is
constantly on.
Payment of
deposit to the
PCY
Purchase of drug
in Electronic
Compliance
Blistercard
Optionally download of intake
frequency stored in chip - from
bulk collection to on premise via
Industri standard 13.56 MHz
Frequency Readers.
+ -

31. Conclusion, Packaging
The integrated compliance optimizing solution ensures:
✜ unique value added brand differentation
✜ simple and convenient all-in-one concept
✜ method of action is understood across cultures
✜ instructions for use printed on device in local language
✜ some protection by EU marketing legislation
✜ fulfilment of stakeholder requirements
✜ use of known technology
✜ no child resistance issue
✜ no potential separation of tablets and timer
✜ quality assurance expectations are met
✜ proactive treatment
✜ value for money/cost efficient
✜ reliability due to replacement with every drug purchase
✜ batterylifetime exceeds shelflife of drug
Proposal A
All proposals
Proposal C
Proposal B

32. References
References:
1. Hochner-Celnikier, D. First World Congress On: Controversies in Obstetrics, Gynecology & Infertility,
Prague 1999. Compliance: Raloxifene versus Hormone Replacement Terapy.
2. Chen K. et al. A Clinical and Economic Evaluation of Osteoporosis Medications Use Patterns in a
Managed Care Organization: A Focus on Alendronate, Raloxifene, and Nasal Calcitonin.www. Rx
Solitions.com
3. Schnitzer T. et al: Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg
daily in the treatment of osteoporosis. Aging Clin. Exp. Res. 12:1-12,2000.
4. Danish Medicine Agency. Quarterly Statistics, Q1 2002.
Comments:
• Schnitzer T. et al does not provide any numbers, but states in the discussion and conclusion that
compliance with alendronate once weekly is improved. The paper however also states that the intention
was not to measure compliance and that further studies are needed.
• The Danish Medicine Agency was contacted. In the quarterly statistics it is shown for bisphosphonates
that app. 20% of new patients drop out - and among the existing patients app. 22% drop out. Based on
this a drop out rate = lack of compliance of 70-75% is a reasonable estimate.

33. Medicompliance
ProjektGruppen A/S
Denmark
Phone +45 70 20 30 44
Birger Jan Olsen, CEO
birgerjan@gmail.com