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Medicompliance: Osteoporosis Compliance

Birger Olsen
Birger Olsen

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.

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Optimized drug administration in treatment of osteoporosis through increased compliance in Packaging Support Programme Developed by: Medicompliance ProjektGruppen A/S Copenhagen, Denmark Copyright 2007
1. Market 2. Stakeholders 3. Packaging
1. Market
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
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
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
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.
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%
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
2. Stakeholders
Patient Woman 50+ with PMO Stakeholders in a compliance programme Pharmacy GP/Hospital Insurer/ public payer Relatives Nursing staff Pharmacy wholesalers Manufacturer
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
Stakeholder requirement/interest Pharmacy wholesaler increased focus on Direct Product Profitability (DPP) through handling and reduced number of Stock Keeping Units (SKUs) 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
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卒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
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
3. Proposal Packaging Support Programme A, B and C
Proposal no. A: 1-press-solution
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
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
Proposal no. B: 2-press-solution
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
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
Proposal no. C: Intelligent device with protective jacket
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
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
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
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
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.
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
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. + -
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
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.
Medicompliance ProjektGruppen A/S Denmark Phone +45 70 20 30 44 Birger Jan Olsen, CEO birgerjan@gmail.com

More Related Content

Medicompliance: Osteoporosis Compliance

  • 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
  • 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
  • 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 (SKUs) 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卒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
  • 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
  • 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