18 December 2013 Patient / Carer Revision Human Medicines Research and Development Support Division Geriatric Needs Survey to the Quality Working Party (QWP) on appropriate packaging and formulations for older people. This questionnaire is intended to be sent to older patients and their carers to help the European Medicines Agency (EMA) clarify the clinical needs and practical suggestions on packaging and formulations for older people. This will help us to understand if the medicines you are taking could be improved. Please email the completed questionnaire to Geriatrics@ema.europa.eu by February 3rd 2014. Note, for questionnaires completed in paper format, please scan and email to the provided email address. Patient Carer (Please answer according to your experience) Gender Male Female What age are you? 65-69 70-74 80-85 85+ 75-79 How many medications are you taking? 0-3 4-6 6+ Country __________ 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. List of questions 1. Patient Needs 1.1. Have you experienced difficulty in opening medicine packages? (E.g. opening child resistant containers, peel back or push though foil packages) YES NO If YES, please explain: 1.2. Have you experienced difficulties in swallowing medicines? YES NO 1.3. If so, which types of medicines do you have the most difficulties with? (E.g. tablet with unpleasant taste / smell, large capsule) 1.4. Which types of medicines do you find the easiest to use? (E.g. capsules, granules to mix into food, liquids, medicated patches) 1.5. Have you experienced confusion when taking your medicines? E.g. the colour, shape, size of the tablets look similar YES NO 1.6. If so, have you any ideas on how to help avoid confusion? 1.7. When taking your medication, do you need to crush or split tablets? YES NO 1.8. Do you check if you are allowed to do so by: Reading the patient information leaflet Asking your doctor / pharmacist I do not check 1.9. Do you think that combination medicines (e.g. two medicines combined into one tablet) would be helpful? YES NO If YES, please explain: Geriatric Needs Survey to the Quality Working Party (QWP) on appropriate packaging and formulations for older people. EMA/CHMP/SAWP/794669/2013 Page 2/4 2. Packaging and design 2.1. Do you have any suggestions on how to improve packaging design (E.g. adaptations to caps for creams, eye drops, syringe plungers etc) Please provide suggestions: 2.2. Do you have any specific comments about child resistant caps? 2.3. Do you or your pharmacist often repackage medicines? (E.g. remove from the original package and store in a weekly pill box) YES NO If YES, please explain: 2.4. Weekkly pill boxes / blister medication packs are used by many older people. Have you experienced any problems in using these? For example the appearance of tablets in the box changes over time 2.5. Have you experienced difficulties in reading the instruction label? YES NO If YES, please explain: 2.6. Any other comments or suggestions? 3. Compliance and adherence 3.1. Do you think that imprinting symbols on medicines, such as a heart symbol for heart medicines makes it easier to know what the tablet is for? YES NO If YES, please explain: 3.2. Any other comments or suggestions? Geriatric Needs Survey to the Quality Working Party (QWP) on appropriate packaging and formulations for older people. EMA/CHMP/SAWP/794669/2013 Page 3/4 4. Information about your medicine(s) 4.1. Every medicine pack includes a Patient Information Leaflet (PIL), which provides the patient with information on how to use their medicine safely. Did you know that you can ask for a large print information leaflet from your pharmacist and / or the manufacturer? YES NO 4.2. Do you think that the Patient Information Leaflet (PIL) includes adequate information on: How to take the medicine What the medicine looks like When not to use the medicine What to do if a dose is missed What happens if you are taking other medicines 4.3. Is there any other information that you would like to see included in the Patient Information Leaflet? 4.4. Do you think that more visual images would be helpful? (E.g. images of how to apply a medicated patch etc.) YES NO 4.5. Do you have any suggestions on improving and adapting the PIL to the needs of the older population? (e.g. information regarding missed dose, interactions with other medicines) YES NO If YES, please provide suggestions: 4.6. Any other comments or suggestions? 5. Conclusion 5.1. Besides packaging and formulation, what do you think are the major needs of older patients? Geriatric Needs Survey to the Quality Working Party (QWP) on appropriate packaging and formulations for older people. EMA/CHMP/SAWP/794669/2013 Page 4/4