Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations

OMB No: 0910-0695 Expiration Date: 02/28/2021

Appendix G

Pre-Focus Group Worksheet: Autoinjector (Epi-Pen) – Caregiver

1. Which family member of yours uses an autoinjector?

______________________________________

2. When was this family member first diagnosed and prescribed an autoinjector to treat their condition? (Enter year)

______________________________________

3. How long have they been using an autoinjector? (Enter in months or years)

______________________________________

4. About how many times have you had to use the autoinjector on your family member?

_____________________________________

5. How satisfied or dissatisfied are you with their current autoinjector? (Circle one only)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

6. Did you get training on administering the medication when your family member was first prescribed an autoinjector, even if it is different than the one they have now? (Circle one only)

   1. Yes

   2. No

   3. I don’t remember

7. If you got training, who gave it to you? (Circle all that apply. If you did not receive training, please skip this question)

   1. Doctor

   2. Nurse

   3. Someone in the doctor’s office

   4. Pharmacist

   5. Someone else ______________________

8. If you got training, how satisfied or dissatisfied are you with the training you received? (Circle one only. If you did not receive training, please skip this question)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

Pre-Focus Group Worksheet: Autoinjector-Adults (Epi-Pen users)

1. When were you first diagnosed and prescribed an autoinjector to treat your condition? (Enter year)

______________________________________

2. How long have you been using an autoinjector? (Enter in months or years)

______________________________________

3. About how often do you use your autoinjector?

______________________________________

4. How satisfied or dissatisfied are you with your current autoinjector? (Circle one only)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

5. Did you get training when you were first prescribed an autoinjector, even if it is different than the one you have now? (Circle one only)

   1. Yes

   2. No

   3. I don’t remember

6. If you got training, who gave it to you? (Circle all that apply. If you did not receive training, please skip this question)

   1. Doctor

   2. Nurse

   3. Someone in the doctor’s office

   4. Pharmacist

   5. Someone else ______________________

7. If you got training, how satisfied or dissatisfied are you with the training you received? (Circle one only. If you did not receive training, please skip this question.)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

Pre-Focus Group Worksheet: Autoinjector (Epi-Pen)-Adolescents

1. When were you first diagnosed and prescribed an autoinjector to treat your condition? (Enter year)

______________________________________

2. How long have you been using an autoinjector? (Enter in months or years)

______________________________________

3. About how often do you use your autoinjector?

______________________________________

4. If you needed the autoinjector, would you administer it yourself, or would someone else do it for you?

   1. I would do it myself

   2. Someone else would have to do it for me

   3. It depends on the situation

   4. I don’t know

5. How satisfied or dissatisfied are you with your current autoinjector? (Circle one only)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

6. Have you (not your parent or caregiver) received training on how to use your autoinjector? (Circle one only)

   1. Yes

   2. No

   3. I don’t remember

7. If you got training, who gave it to you? (Circle all that apply. If you did not receive training, please skip this question)

   1. Doctor

   2. Nurse

   3. Someone in the doctor’s office

   4. Pharmacist

   5. A parent or caregiver

   6. Someone else ______________________

8. If you got training, how satisfied or dissatisfied are you with the training you received? If you did not receive training, please skip this question. (Circle one only. If you did not receive training, please skip this question)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

Pre-Focus Group Worksheet: Autoinjector-Adults (Other AI users)

1. Why do you need the autoinjector device (what is your diagnoses)?

_____________________________________

2. When were you first diagnosed and prescribed an autoinjector to treat your condition? (Enter year)

______________________________________

3. How long have you been using an autoinjector? (Enter in months or years)

______________________________________

4. About how often do you use your autoinjector?

______________________________________

5. How satisfied or dissatisfied are you with your current autoinjector? (Circle one only)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

6. Did you get training when you were first prescribed an autoinjector, even if it is different than the one you have now? (Circle one only)

   1. Yes

   2. No

   3. I don’t remember

7. If you got training, who gave it to you? (Circle all that apply. If you did not receive training, please skip this question)

   1. Doctor

   2. Nurse

   3. Someone in the doctor’s office

   4. Pharmacist

   5. Someone else ______________________

8. If you got training, how satisfied or dissatisfied are you with the training you received? (Circle one only. If you did not receive training, please skip this question.)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

Pre-Focus Group Worksheet: DPI - Adolescents

1. When were you first diagnosed and prescribed a dry powder inhaler to treat your condition? (Enter year)

______________________________________

2. How long have you been using an inhaler device? (Enter in months or years)

______________________________________

3. About how often do you use your inhaler?

______________________________________

4. How satisfied or dissatisfied are you with your current inhaler device? (Circle one only)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

5. Did you get training when you were first prescribed an inhaler device? (Circle one only)

   1. Yes

   2. No

   3. I don’t remember

6. If you got training, who gave it to you? (Circle all that apply. If you did not receive training, please skip this question)

   1. Doctor

   2. Nurse

   3. Someone in the doctor’s office

   4. Pharmacist

   5. Parent or caregiver

   6. Someone else ______________________

7. If you got training, how satisfied or dissatisfied are you with the training you received? (Circle one only. If you did not receive training, please skip this question)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

Pre-Focus Group Worksheet: DPI – Adults (Naïve DPI User Group and Experienced DPI User Group)

1. When were you first diagnosed and prescribed a dry powder inhaler to treat your condition? (Enter year)

______________________________________

2. How long have you been using an inhaler device? (Enter in months or years)

______________________________________

3. About how often do you use your inhaler?

______________________________________

4. How satisfied or dissatisfied are you with your current inhaler device? (Circle one only)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied

5. Did you get training when you were first prescribed an inhaler device? (Circle one only)

   1. Yes

   2. No

   3. I don’t remember

6. If you got training, who gave it to you? (Circle all that apply. If you did not receive training, please skip this question)

   1. Doctor

   2. Nurse

   3. Someone in the doctor’s office

   4. Pharmacist

   5. Someone else ______________________

7. If you got training, how satisfied or dissatisfied are you with the training you received? (Circle one only. If you did not receive training, please skip this question)

   1. Very dissatisfied

   2. Somewhat dissatisfied

   3. Somewhat satisfied

   4. Very satisfied