Device Usability and Compliance: The Implications, Opportunities and Requirements

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Andy Fry and Julian Dixon presented during the Parenteral Drug Association's (PDA) Prefilled Syringes SIG in March 2011 on the hot topic of device usability and compliance.

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  • It has been generally acknowledged for years that non-adherence rates for chronic illness regimens and for lifestyle changes are ∼ 50% Haynes et al (1979) Compliance in health care . Johns Hopkins University Press, 1979 Adherence to oral medications (e.g. sulfonylurea) in patients with type 2 diabetes = 53% - 67% when measured by electronic monitoring Paes et al (1997) Impact of dosage frequency on patient compliance.  Diabetes Care  20:1512 -1517 Factors affecting adherence Demographic factors; poor education = reduced adherence Psychological factors; patients adhere well when treatment makes sense to them, when it seems effective Social factors; robust social support (family, HCP) = better compliance Disease- and treatment-related factors; lower regimen adherence can be expected when a health condition is chronic Rheumatoid arthritis 30% - 35% complete compliance at 3 years [predominantly] on weekly oral methotrexate treatment Factors : “good compliance” factors: older age > female sex > decreased disability > +ve rel’ship with HCP > patient understanding of disease Viller et al (1999) Compliance to drug treatment of patients with rheumatoid arthritis: a 3 year longitudinal study. J Rheumatol 10: 2114-22 !!! “Unadjusted” (?) 4 year drug adherence rates for Humira adalimumab (i.e. autoinjector) = 52%; for infliximab (i.e infusion) = 41% … NICE DATA …showing improvement in compliance arguably due to delivery technology Hetland et (2010) ARTHRITIS & RHEUMATISM 62: 22–32 Osteoporosis 25%-35% complete compliance at 1 year on daily oral bisphosphonate therapy; rising to has 35% and 45% for weekly dosing Cramer et al (2007) A systematic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporos Int 18:1023–103 Factors: “ Wilful non-compliance”: adverse effects (e.g. gastric upset from an oral bisphosphonate) > psychological (low perceived risk of fracture / sceptical of effectiveness of medication) > treatment cost “ Unintentional non-compliance”: Lack of perceived ability to take the medication as prescribed > complex dosing schedules > lack of social support / aid their medication use activities > forgetting to take the medication Silvermann et al (2010) Oral bisphosphonate compliance and persistence: a matter of choice? Osteoporos Intenrational 22: 21-26
  • Device Usability and Compliance: The Implications, Opportunities and Requirements

    1. 1. Device Usability and Compliance: The Implications, Opportunities and Requirements Andy Fry, Founder Julian Dixon, Head of User Research 24 th March 2011 www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide
    2. 2. Compliance – some research data www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide 1 - Haynes et al (1979) Compliance in health care . Johns Hopkins University Press, 1979 2 - Paes et al (1997) Impact of dosage frequency on patient compliance.  Diabetes Care  20:1512 -1517 3 - Viller et al (1999) Compliance to drug treatment of patients with rheumatoid arthritis: a 3 year longitudinal study. J Rheumatol 10: 2114-22 4 - Hetland et (2010) Arthritis & Rheumatism 62: 22–32 5 - Cramer et al (2007) A systematic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporos Int 18:1023–103 50% estimated compliance across chronic illnesses & lifestyle changes 1 measured compliance with oral medications for Type 2 diabetes 2 53% to 67% 30% to 35% compliance with oral methotrexate for RA 3 compliance with inflximab infusion for RA 4 41% 52% compliance with adalimumab autoinjector for RA 4 25% to 35% compliance with daily oral bisphosphonate for osteoporosis 5 35% to 45% compliance with weekly oral bisphosphonate for osteoporosis 5 change delivery route reduce dose freq side effects
    3. 3. Compliance – influencing factors www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide 1 - Paes et al (1997) Impact of dosage frequency on patient compliance.  Diabetes Care  20:1512 -1517 3 - Viller et al (1999) Compliance to drug treatment of patients with rheumatoid arthritis: a 3 year longitudinal study. J Rheumatol 10: 2114-22 6 - Silvermann et al (2010) Oral bisphosphonate compliance and persistence: a matter of choice? Osteoporosis International 22: 21-26 compliance chronic conditions younger age / male gender poor education disability <ul><li>driving wilful non-compliance </li></ul>treatment cost side effects poor perceived treatment effectiveness/ understanding of disease lack of social / professional support relationships lack of confidence/ perceived ability to take medication dosing regime complexity forgetting <ul><li>driving unintentional non-compliance </li></ul>
    4. 4. Compliance – what can we device developers influence? <ul><li>what can’t we change? </li></ul><ul><ul><li>the disease condition </li></ul></ul><ul><ul><li>the drug: side effects, symptomatic relief </li></ul></ul><ul><ul><li>the patient’s age / gender / disabilities / socioeconomic status </li></ul></ul><ul><li>what can we influence? </li></ul><ul><ul><li>the formulation: e.g. dosing frequency </li></ul></ul><ul><ul><li>the delivery route: e.g. from IV to SC, depot implants, wearable devices/patches </li></ul></ul><ul><ul><li>the demands on the user associated with dose delivery </li></ul></ul><ul><ul><li>the support provided to the patient to help them adhere to dosing regime </li></ul></ul><ul><ul><li>the patient’s perceptions of and attitudes to their treatment </li></ul></ul>www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide demands on user support of user
    5. 5. Improving Compliance through Usability - Reducing Demands on our Users <ul><li>what do we need to do to minimise the core physical and cognitive burden of delivering a dose ? </li></ul><ul><li>target - eliminate the negatives </li></ul><ul><ul><li>perfect device reliability / consistency of performance in hands of users </li></ul></ul><ul><ul><li>no significant use-related risks </li></ul></ul><ul><ul><li>accommodate to full range of user input (e.g. grip styles, operation styles) & maximise ease of use </li></ul></ul><ul><ul><li>minimise delivery pain / anxiety </li></ul></ul><ul><li>but there are some conflicts </li></ul><ul><ul><li>e.g. clarity of feedback vs. discretion/privacy </li></ul></ul><ul><ul><li>e.g. some users want to be in ‘control’, others want ‘distance’ </li></ul></ul><ul><li>excellent usability = zero “delivery task” burden … </li></ul><ul><li>… . but cannot address the “self-management task” burden </li></ul>www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide
    6. 6. Improving Compliance through Additional Functionality – Supporting Users <ul><li>what can we do to reduce the cognitive and emotional burden of managing their treatment ? </li></ul><ul><li>on-board electronic features: </li></ul><ul><ul><li>reminders </li></ul></ul><ul><ul><li>dose logging / memory </li></ul></ul><ul><li>wearable / implantable devices </li></ul><ul><li>links to other devices: </li></ul><ul><ul><li>smartphone self-management apps </li></ul></ul><ul><ul><li>diagnostic devices – theranostics – improved patient awareness of therapeutic effectiveness </li></ul></ul><ul><ul><li>integration – physical and communications – of these devices </li></ul></ul><ul><li>links to social networks </li></ul><ul><ul><li>e.g. www.patientslikeme.com/ </li></ul></ul>www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide
    7. 7. Health Economics and Related Issues <ul><li>compliance = improved clinical outcome </li></ul><ul><ul><li>improved clinical outcome means </li></ul></ul><ul><ul><ul><li>improved patient wellbeing </li></ul></ul></ul><ul><ul><ul><li>improved ability for gainful employment </li></ul></ul></ul><ul><ul><ul><li>better return on cost of treatment </li></ul></ul></ul><ul><ul><li>i.e. better health economics overall </li></ul></ul><ul><li>a compliance-enhanced delivery device </li></ul><ul><ul><li>offers health economics benefits </li></ul></ul><ul><ul><li>becomes the device of choice by patients, prescribers and payers </li></ul></ul><ul><ul><li>hence increases product loyalty </li></ul></ul><ul><ul><li>this is further enhanced for a retained device which </li></ul></ul><ul><ul><ul><li>offers desirable additional features (alarms, aids to use etc) which may not be possible with a disposable device </li></ul></ul></ul><ul><ul><ul><li>the retained device can be designed to accept only the ‘official’ refills, thus ensuring product loyalty and hence continued revenue </li></ul></ul></ul>www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide
    8. 8. Discussion Point 1 – Delivering Excellent Usability <ul><li>follow usability engineering / human factors process with passion and creativity </li></ul><ul><ul><li>FDA guidance </li></ul></ul><ul><ul><li>ISO/IEC 62366 (incl. ANSI/AAMI HE74) </li></ul></ul><ul><ul><li>ANSI/AAMI HE75:2009 </li></ul></ul><ul><li>regulatory necessity … </li></ul><ul><li>… and improve compliance </li></ul>www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide
    9. 9. Discussion Point 2 – Realising the Potential of Reusable Injectors (1/2) <ul><li>Electronically Enabled Delivery Devices (EEDDs) </li></ul><ul><li>don’t spoil the opportunity! </li></ul><ul><li>there is a perception that re-usable devices are clunky, awkward to use and undesirable…. </li></ul><ul><li>IT DOESN’T NEED TO BE LIKE THIS! </li></ul><ul><li>well designed devices should be easy to use and can support additional functionality … </li></ul><ul><li>… remember that different patient groups have different needs/viewpoints; </li></ul><ul><ul><li>seniors with a regular, but infrequent dosing regimen need reminders </li></ul></ul><ul><ul><li>children may respond well to simple compliance “rewards” </li></ul></ul><ul><ul><li>…… ..different strokes for different folks </li></ul></ul>www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide
    10. 10. Discussion Point 2 – Realising the Potential of Reusable Injectors (2/2) <ul><li>Electronically Enabled Delivery Devices – Cost Comparison </li></ul><ul><li>for prolonged/chronic treatment, cost per shot with an EEDD can be very competitive compared to a single use mechanical device; </li></ul><ul><ul><li>mechanical single-use device ~ $3 </li></ul></ul><ul><ul><li>‘ limited’ functionality </li></ul></ul><ul><ul><li>if weekly therapy, device cost per shot (excluding drug and primary pack) = $3 </li></ul></ul><ul><ul><li>electro-mechanical multi-use reloadable device ~ $40 </li></ul></ul><ul><ul><li>‘ unlimited’ functionality </li></ul></ul><ul><ul><li>if weekly therapy and device replaced after 3 years (156 shots), hence device cost per shot (excluding drug and primary pack) = $0.25 </li></ul></ul><ul><li>so maybe it’s not the expensive option after all… </li></ul><ul><li>… .especially if repeat prescriptions are unlikely to be filled with a substitute product! </li></ul>www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide
    11. 11. Discussion Point 3 – Changing Perceptions of Injection <ul><li>what do we expect the injection experience to be like? </li></ul><ul><li>what might a new generation of patients expect? </li></ul><ul><li>why not see how we can improve the experience for the patient (and for us as well!)? </li></ul>www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide
    12. 12. www.team-consulting.com © Team Consulting 2011 PDA Europe IGM PFS – Team Presentation, slide www.team-consulting.com © Team Consulting 2010 For further information, please contact Andy Fry Tel: +44 (0)1799 532739 e-mail: [email_address] Julian Dixon Tel: +44 (0)1799 532746 e-mail: [email_address] Team Consulting Ltd Abbey Barns, Duxford Road Ickleton, Cambridge CB10 1SX, UK Tel:+44 (0)1799 532 700 Fax:+44 (0)1799 532 701 Email: info@team-consulting.com

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