Rapid Message Testing with Consumer Panel - Transmucosal Immediate Release Fentanyl Patient Presriber Agreement Form

OMB Control No. 0910-0695

Expiration date: 2/28/2021

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0695 and the expiration date is 2/28/2021. The time required to complete this information collection is estimated to average 3 minutes per response, including the time for reviewing instructions and completing and reviewing the collection of information.

FDA RAPID – MESSAGE #13

Transmucosal Immediate Release Fentanyl (TIRF) Patient Prescriber Agreement Form (PPAF)

Introduction

The U.S. Food and Drug Administration, or FDA, hired Westat to help them get opinions about health information. Rare Patient Voice is helping Westat and FDA find people who may be interested in being interviewed about health information. To make sure you are a good fit for the interview, please take about 3 minutes to answer the questions below.

1. Do you currently take any prescription medicines around-the-clock to treat pain?

YES GO TO Q2

NO GO TO Q4

Don’t Know  INELIGIBLE

2. Is your pain due to any type of cancer?

YES

NO

Don’t Know

3. Which, if any, of these prescription medicines do you use around-the-clock to treat your pain? Select all that apply.

1. Hydrocodone acetaminophen, also known as Vicodin,
   Lortab, Lorcet, Norco, or Zydone GO TO Q8

2. Hydrocodone extended-release, also known as Zohydro
   or Hysingla GO TO Q8

3. Hydromorphone extended-release also known as Exalgo
   or Dilaudid GO TO Q8

4. Oxycodone acetaminophen, also known as Percocet,
   Endocet, or Primlev GO TO Q8

5. Oxycodone, also known as Oxycontin, Oxy IR, or Oxyfast GO TO Q8

6. Tramadol, also known as Ultram GO TO Q8

7. Codeine acetaminophen, also known as Tylenol #3, Tylenol #4,
   or Vopac GO TO Q8

8. Morphine, also known as MS Contin, Morphine Sulfate ER,
   Morphine Sulfate IR, or Kadian GO TO Q8

9. Methadone, also known as Dolophine GO TO Q8

10. Oxymorphone, also known as Opana GO TO Q8

11. Buprenorphine skin patch or film, also known as Butrans
    or Belbuca GO TO Q8

12. Tapentadol, also known as Nucynta or Nucynta ER GO TO Q8

13. Fentanyl skin patch, also known as Duragesic GO TO Q8

14. Immediate Release Fentanyl tablets, lozenges, films or sprays,
    also known as Abstral, Actiq, Fentora, Lazanda, Onsolis,
    or Subsys INELIGIBLE

15. None of the above INELIGIBLE

16. Don’t know  INELIGIBLE

4. Do you currently help manage medications for an adult who has cancer? Managing medications includes talking with this person’s healthcare provider about medications, picking up prescriptions from the pharmacy, or giving medications to the person.

1. Yes

2. No  INELIGIBLE

5. What is the relationship of this person with cancer to you? If you help more than one person with cancer, select the person who experiences the most pain.

1. Child 18 years or older

2. Spouse

3. Partner

4. Parent

5. Mother-in-law or father-in-law

6. Grandparent

7. Brother or sister

8. Friend

9. Other (please specify this person’s relationship to you)  INELIGIBLE IF PROFESSIONAL CAREGIVER

6. Does this person with cancer currently take any prescription medicines around-the-clock to treat pain?

YES GO TO Q7

NO  INELIGIBLE

Don’t Know  INELIGIBLE

7. Which, if any, of these prescription medicines does this person with cancer use around-the-clock to treat pain? Select all that apply.

1. Hydrocodone acetaminophen, also known as Vicodin, Lortab, Lorcet, Norco, or Zydone

2. Hydrocodone extended-release, also known as Zohydro or Hysingla

3. Hydromorphone extended-release also known as Exalgo or Dilaudid

4. Oxycodone acetaminophen, also known as Percocet, Endocet, or Primlev

5. Oxycodone, also known as Oxycontin, Oxy IR, or Oxyfast

6. Tramadol, also known as Ultram

7. Codeine acetaminophen, also known as Tylenol #3, Tylenol #4, or Vopac

8. Morphine, also known as MS Contin, Morphine Sulfate ER, Morphine Sulfate IR, or Kadian

9. Methadone, also known as Dolophine

10. Oxymorphone, also known as Opana

11. Buprenorphine skin patch or film, also known as Butrans or Belbuca

12. Tapentadol, also known as Nucynta or Nucynta ER

13. Fentanyl skin patch, also known as Duragesic

14. Immediate Release Fentanyl tablets, lozenges, films or sprays, also known as Abstral, Actiq, Fentora, Lazanda, Onsolis, or Subsys INELIGIBLE

15. None of the above INELIGIBLE

16. Don’t know  INELIGIBLE

8. What is your gender?

1. Female

2. Male

9. What is your age?

1. Under 18  INELIGIBLE

2. 18 to 29

3. 30 to 49

4. 50 to 64

5. 65 or older  INELIGIBLE

10. What is the highest grade or level of education you have completed?

1. Less than High School

2. High School Diploma or GED

3. Some College, including Associate’s Degree

4. Bachelor’s Degree (for example: BA, BS)

5. Graduate or Professional Degree  INELIGIBLE

11. Do you currently work for pay?

YES

NO  GO TO Q13

12. What kind of work do you do?

OPEN-ENDED TEXT BOX  INELIGIBLE IF PROFESSIONAL CAREGIVER

13. Are you of Hispanic, Latino, or Spanish origin?

YES

NO

14. What is your race? Please select one or more.

White

Black or African-American

American Indian or Alaska Native

Asian

Native Hawaiian or other Pacific Islander

15. What state do you live in? [DROP DOWN LIST OF US STATES, INCLUDING “OUTSIDE OF THE US”] [“OUTSIDE OF THE US”  INELIGIBLE]

Request for Contact Information

C1. Thank you for answering the questions. Based on your answers, you may be chosen for the interview. If you are chosen for the interview and you finish it, you will get $50. At the start of the interview, the interviewer will ask if it’s okay to audio record it. This helps Westat to make sure they hear everything you say correctly. If you are chosen for an interview, you will get a package in the mail. Make sure to have the package with you during the interview. Is it okay with you for Rare Patient Voice to share your contact information with Westat?

YES

NO  INELIGIBLE

Thank and Terminate

Thank you for taking our survey. Unfortunately, based on your responses, you are not eligible for this study. However, we appreciate you taking the time to answer our questions today.

Contact Information

C2. In the space below, please give us the best information to contact you by phone, email, and regular mail. Please know that Westat will not share your information with anyone else. Your personal information will be deleted upon completion of the research project.

Contact Information

Name ______________________________________________________________________

Address 1 ___________________________________________________________________

Address 2 ___________________________________________________________________

City, State, ZIP _______________________________________________________________

Phone Number _______________________________________________________________

Email Address________________________________________________________________

Technology Preferences

C3. The Westat interviewer would like to be able to show you information on her computer screen during the interview. Westat will send directions for how to view the interviewer’s screen. Which app do you prefer for screen sharing? [SINGLE SELECT]

1. Skype

2. Google Hangouts

3. WebEx

4. I am not able to use any of these, please just call me

Closing

Thank you for your answers to these questions. If you are chosen for an interview, someone will contact you within the next 1-2 days.