Instructions for Use neglected opportunity for easy, small wins?

Transcription

1 Instructions for Use neglected opportunity for easy, small wins? Julian Dixon IPAC-RS Science Advisor Human Factors Director of Human Factors, Team Consulting Ltd

2 Disclaimer part of this presentation describes work being conducted by the IPAC-RS device working group IFU workstream sub-group opinions expressed in other parts of this presentation are the author s own and do not necessarily reflect the view of IPAC-RS or IPAC-RS members

3 Non-Adherence & Poor Real World Results adherence to medication regimes is (very) poor this leads to ineffective treatment and poor disease control multiple factors contribute to adherence there are different varieties of non-adherence - many inter-related sub-problems, each requiring different solutions/interventions Acknowledgement: Nicolas Roche, IPAC RS/ISAM Workshop on Inhalation Devices, May 2015

4 Non-Adherence & Poor Real World Results poor technique is an important influence on adherence with inhaled medicine poor technique is very common, across many aspects of inhaler use poor inhalation technique is a particular problem we can t rely on all patients being properly trained training doesn t always result in sustained competence the diversity of inhalers negatively impacts on levels of competence there are some important differences between inhaler types Acknowledgement: Nicolas Roche, IPAC RS/ISAM Workshop on Inhalation Devices, May 2015

5 But is it worth talking about the humble IFU? the IFU is clearly limited in its potential for impact it only deals with competence, not adherence with dosing regime it won t be read, it will be thrown in the bin confirmation bias users are fundamentally motivated to not look! but it is a mandatory part of all inhaled products and it is a part we can readily influence, research and improve and we shouldn t expect intuitive inhalers in the foreseeable future real limitations, for sure, but they should not be excuses are we certain that attention to IFU design won t have a +ve ROI?

6 a low hanging fruit opportunity for easy, small wins

7 Aside: FDA includes IFU under HFE process FDA expects the human factors engineering (HFE) process to optimize all aspects of the user interface to minimise use-related risk profile The user interface also includes the device labeling, which includes package labels, any instructions for use in user manuals, package inserts, instructions on the device itself, and any accompanying informational materials. Ref: FDA Guidance Applying HF and UE to Optimize Medical Device Design, June 2011

8 Regulations Conventions Assumptions

9 9

10 10

11 What can we do? Individually? BEST PRACTICE Collectively? CONSISTENCY within current conventions - work underway by IPAC-RS device working group (IFU workstream) Collectively? Future Steps?

12 IFU Development Best Practice 12

13 13

14 before after Ref: Dickinson et al, Information Design Journal, 18.3,

15 Applying this to inhaler IFU s Identify areas of criticality and potential confusion Communicate key steps through clear illustrations & simple language Use layout and formatting to reinforce information flow Test and iterate with users Manage multiple stakeholders who owns the IFU?

16 Attention to Detail Pictograms & Words

17 Test. Test. Test. standard simulated-use studies inexpensive and quick as recommended by FDA levels of assessment: watch untrained intended users interact without instructions hear their language watch untrained intended users interact with instructions available ask untrained users to first read the IFU and then simulate use ask untrained users to work through IFU step by step and simulate use ask untrained users to do what they think the instruction tells them to plus, always, root cause analysis of errors observed: was the instruction misunderstood or not attended to, not found?

18 Stakeholders Regulatory affairs Risk management Quality Clinical Marketing? Device development Intended User?

19 Mindset: real world results with our audience

20 Example for children? for adults?

21 Example for children? for adults? Nurse: Some medicine comes in a pill form and some comes in an inhaler. Nurse: This part is a small bottle and it s where the medicine goes. The bottle fits into the holder, which is the part that goes into your mouth. Nurse: Squeeze the medicine bottle down into the holder. Push here and here. Boy: Mist shoots out of this part and into your mouth. Coolest thing ever! Nurse: I agree. Its cool. Especially when you know how to use it the right way.

22 Example for children? for adults? Boy: Stick it in your mouth and push down. Right? Nurse: Well, then the medicine would end up in your mouth and not in your lungs. It needs to go to your lungs. Nurse: It s very important to breathe in and squeeze your inhaler at the same time, so that it gets all the way into your body.

23 Consistency Within Current Conventions (IPAC-RS IFU workstream)

24 IPAC-RS IFU workstream - stepwise approach our first target is to produce guidelines for future pmdi IFU s guidelines to support greater consistency of messaging through provision of open source design elements

25 Terminology - analysing existing & proposing a guideline

26 Wording - analysing existing & proposing a guideline

27 Pictograms which panels of the cartoon strip are omitted?

28 Diversity of Pictograms

29 Diversity of Architecture

30 Overlap between IFU and other elements of PPI

31 Future Steps?

32 Non-Competitive Basic Work/Research a coherent, cross-industry approach to communication would benefit our intended users objective is higher levels of good enough technique overall not necessarily optimal technique on each inhaler - especially if optimal technique is an unachievable IFU communication goal! - what elements can be standardised (e.g. cleaning where necessary)? - what elements of diversity are dysfunctional? - could we leave any elements out??? or downplay them? - focus on communicating the difficult bits very clearly, very consistently (e.g. orientation of pmdi) researching the basic effectiveness of instructional material is relatively inexpensive and has wide applicability (needs doing once!)

33 Towards Useful Commonality & Important Differences use inhaler to breathe a fine mist/cloud of medication into your lungs exhale before, inhale deeply, hold breath after don t use a wet inhaler don t breathe into an inhaler spray inhaler inhaler releases a fine spray spray release needs to coordinated with breathing in powder inhaler inhaler makes a fine powder cloud as you breathe through it breathe with sufficient effort to empty the dose container breathe in slowly shake before use and always use upright manually loaded load & pierce each dose before inhaling pre-loaded multidose prepare next dose before inhaling co-ordinate release with breathing release into spacer and then inhale mist from spacer auto spray? release is automatically triggered by breathing push buttons fully twist, fully, both ways push lever fully

34 pmdi without spacer Important facts about your inhaler You will use your inhaler to breathe a fine mist of medication into your lungs. This type of inhaler releases a fine spray of medication when you press the top of the canister. With this type of inhaler you must always: shake the inhaler before each dose hold inhaler upright while you take each dose breathe in slowly through the mouthpiece and while continuing to breathe in press the top of the canister to release the spray of medication With all inhalers you should: exhale (blow out) fully before taking your dose - so that you are ready to take a deep breath in inhale (breathe in) deeply through the mouthpiece - to carry the medication into your lungs hold your breath while you count to five after inhaling - so that the dose settles in your lungs never use an inhaler which is wet wait for it to dry fully before using it never breathe into your inhaler this will make it wet inside Read the instructions in full before using your inhaler capsule DPI Important facts about your inhaler You will use your inhaler to breathe a fine cloud of medication into your lungs. This type of inhaler makes a fine cloud of medication powder as you breathe through it. With this type of inhaler you must: not shake the inhaler load and pierce an individual capsule of medication before breathing in through the inhaler breathe in forcefully through the mouthpiece to ensure the capsules are fully emptied With all inhalers you should: exhale (blow out) fully before taking your dose - so that you are ready to take a deep breath in inhale (breathe in) deeply through the mouthpiece - to carry the medication into your lungs hold your breath while you count to five after inhaling - so that the dose settles in your lungs never use an inhaler which is wet wait for it to dry fully before using it never breathe into your inhaler this will make it wet inside Read the instructions in full before using your inhaler

35 Influence Regulations New Evidence-Based Conventions Challenge Assumptions

36 Concluding Remarks the IFU is very limited in its ability to influence our user population, but it does not have zero influence - perhaps a negative one often at present and there are clear actions we can take to improve IFU s and demonstrate that we have done - our evident care alone may have a positive impact cross-industry co-operation through IPAC-RS offers a route to achieve greater consistency the future? - IFU s could play an important role in supporting clear, consistent messaging of similarity and difference between inhaler types - non-competitive basic research into how to communicate inhaler use effectively?

37 Acknowledgements Sincere thanks to: IPAC-RS device working group IPAC-RS device working group IFU workstream Ilse Peterson, IPAC-RS Secretariat Professor Alison Black, University of Reading Rob Fernall and Claire Young, Team Consulting Ltd