Patient-focussed device design - the clinician s perspective. Prof. Mark L. Everard

Transcription

1 Patient-focussed device design - the clinician s perspective Prof. Mark L. Everard

2 User-focussed device design?

3 Patient-focussed device design If it ain t broke don t fix it Effective treatment to control asthma Transformed peoples lives Provided them with small convenient portable inhalers Can treat pulmonary infection with inhaled antibiotics and other agents Very lucrative market

4 Patient-focussed device design Q for small player This is a lucrative market if we want a share we need to have a USP, what is it? A An improved device [more of the same] Q for big player This is a lucrative market - how do we defend our pitch? A an improved molecule & encourage regulators

5 Sadly it is broke 5.4 million people in the UK are currently receiving treatment for asthma: 1.1 million children and 4.3 million adults. There were 1,204 deaths from asthma in the UK in 2008, 29 were children aged 14 years or under There were over 79,794 emergency hospital 30,740 were children aged 14 years or under An estimated 75% of admissions are preventable. Majority of deaths are preventable

6 Inhaled Steroids and Asthma Reduce:- Bother, Poor lung function, Exacerbations, Death Reddel H Lancet 1999 Haahtela K NEJM 1991

7 Time Course of ICS Action Phillips K et al Thorax 2004

8 Disconnect between ICS therapy and response β-agonist Steroids systemic or inhaled

9 Requires Delivering drug to the lungs Patient-focussed device design a device that generates particles that may deposit in the lungs the patient using the device effectively and regularly

10 Inhaled Therapy Device / Formulation Drug Therapeutic effect Availability Cost Target poly/monodispersed

11 Inhaled Therapy Disease Drug Device Anatomy Physiology Therapeutic effect Formulation issues Availability Cost Target Inter-subject variation Age dependent How controlled? Progressive Variable Adverse Effects

12 Sources of Variability in Lung Dose Disease Compliance Drug Device Anatomy Physiology Competence Contrivance Therapeutic effect Formulation issues Availability Cost Target Inter-subject variation Age dependent How controlled? Fixed Progressive Variable Adverse Effects

13 Patient Behaviour The most expensive device is the device that is not used effectively Regimen Compliance /Adherence Device compliance Competence Contrivance True compliance = regimen compliance x device compliance

14 Poor regimen compliance is common and associated with increased morbidity Milgrom et al 1996 J All Clin Immunol

15 Regimen Compliance Not associated with:- Age Sex Disease (Acute, or chronic) Socio-economic status Risk of Death Education Liking a device associated with:- Complexity of regimen Depression Anxiety Trusting Dr.! Clinic visit

16 Factors Influencing Regimen Compliance Burgess S

17 Why?

18 Exacerbations 298 pts 12 56yrs Prescription records 1yr USA 24 children 3 months - Data logger All Poor control Milgrom H et al JACI 1996 Good control Williams LK et al JACI adults yrs Prescription records for 3 yrs Each 25% increase in time without ICS resulted in doubling of risk of hospitalisation Williams LK et al JACI 2004

19 Effective Interventions? Regimen compliance Liking a device/ Making it fun? Pilot parental reporting Large datalogger study X

20 Effective Interventions? Regimen compliance Education Day Compliance Baseline (n = 77) Control (n = 31) Intervention (n = 35) 0-19% 30% 23% 37% 20-39% 14% 16% 9% 40-59% 17% 6% 14% 60-79% 10% 26% 2% % 29% 29% 20% Over 100% 0% 0% 0%

21 Regimen Compliance - Effective Interventions? Feedback in asthma 1 Nides Datalogger N=19 Feedback N=20 Everard et al Regimen Compliance Shaking device 490ml inhaled True compliance 47% 77% 75% 30% 65% 96% 89% 58% 3 median 39yrs [12 65] 25 wks smartinhaler +/- AV reminders Median [interquartile range] 93% [88 97%] vs 74% [ 49-88%] Charles et al JACI Smartinhaler in children Devadason 2010

22 Accurate Regimen Compliance Data Prob improved clinical outcomes Improved communication Reduced health care resources Possible problems Impaired patient doctor relationship Patient choice Overdose

23 Healthy adherer effect? Device s dose counter VESTBO J ET AL THORAX 2009

24 Device Compliance Competence [The ability to use a device effectively] Not intuitive to use Health professionals cannot use effectively Levels of functional illiteracy approx. 20% Particularly problem in the elderly Easy to use is not the same as easy to use effectively

25 Device Compliance Competence This device should not be used unless you have received effective information regarding its use

26 Device Compliance Contrivance Knowing what to do but contriving to use device ineffectively Spacer disuse >66% in all age groups Brennan et al Respir Med 2005

27 Contrivance is normal behaviour

28 Variable and progressive pulmonary disease B Laube ARRD 1986;133:740-3

29 User-focussed device design?

30 User-focussed device design? The iphone moment there is a need is for a device that The user can and will use effectively and regularly [this does not mean more of the same] +/- dose titration [the lowest dose that works] ICS we do not know what dos we are aiming to achieve and do not know what we can achieve +/- ability to deal with progressive lung disease

31 Will it happen? Driven by clinicians? Little chance Driven by pharma? Not unless someone in pharma has an uncharacteristic level of vision, risk taking and determination Driven by regulators? Likely to remain culpable unless forced to act