Rapid Message Testing with Consumer Panel - Warnings on Opioid Packaging

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 #17

Opioid Packaging

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, or does any member of your household or immediate family work…?

1. For a market research company  INELIGIBLE

2. For an advertising agency or public relations firm  INELIGIBLE

3. In the media (TV, radio, newspapers, magazines)  INELIGIBLE

4. As a healthcare professional (doctor, nurse, pharmacist, dietician, etc.)  INELIGIBLE

5. In the pharmaceutical industry  INELIGIBLE

6. None of the above  GO TO Q2

2. Are you an…?

1. Employee of the U.S. Department of Health and Human Services, or any of its agencies including the Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health INELIGIBLE

2. Employee of a state or local health department INELIGIBLE

3. None of the above  GO TO Q3

3. Have you ever been diagnosed with any type of cancer?

YES  INELIGIBLE

NO  GO TO Q4

Don’t Know  INELIGIBLE

4. Have you ever taken a prescription medicine to treat pain?

YES GO TO Q5

NO  NEVER GROUP CANDIDATE, GO TO Q6

Don’t Know  INELIGIBLE

5. Which of these prescription medicines have you used in the past 6 months to treat pain? Select all that apply.¹

1. Ibuprofen filled as a prescription NEVER GROUP CANDIDATE IF NOT C-Q

2. Diclofenac, Cataflam, Cambia,
   Voltaren or Zorvolex  NEVER GROUP CANDIDATE IF NOT C-Q

3. Hydrocodone acetaminophen, Vicodin, Lortab,
   Lorcet, Norco, or Zydone OPIOID GROUP

4. Hydrocodone extended-release, Zohydro, or Hysingla OPIOID GROUP

5. Hydromorphone extended-release, Exalgo or Dilaudid OPIOID GROUP

6. Oxycodone acetaminophen, Percocet, Endocet,
   or Primlev OPIOID GROUP

7. Oxycodone, Oxycontin, Oxy IR, or Oxyfast OPIOID GROUP

8. Tramadol or Ultram OPIOID GROUP

9. Codeine acetaminophen, Tylenol #3, Tylenol #4,
   or Vopac OPIOID GROUP

10. Morphine, MS Contin, Morphine Sulfate ER,
    Morphine Sulfate IR, or Kadian OPIOID GROUP

11. Methadone or Dolophine OPIOID GROUP

12. Oxymorphone or Opana OPIOID GROUP

13. Buprenorphine skin patch or film, Butrans,
    or Belbuca OPIOID GROUP

14. Tapentadol, Nucynta, or Nucynta ER OPIOID GROUP

15. Fentanyl skin patch or Duragesic OPIOID GROUP

16. Immediate Release Fentanyl tablets, lozenges,
    films or sprays, Abstral, Actiq, Fentora, Lazanda,
    Onsolis, or Subsys OPIOID GROUP

17. Another opioid medicine INELIGIBLE

18. None of the above INELIGIBLE

19. Don’t know  INELIGIBLE

6. Which of the following describe your role? Select all that apply.

1. A parent or guardian of a child or children 17 years old or younger living in your household

2. A grandparent who lives with or watches a grandchild or grandchildren regularly in your own home

3. A paid caregiver who watches a child or children regularly in your own home

4. None of the above  GO TO Q8

7. What age are the children who live or that you watch in your household? Mark all that apply.

1. Under 2 years old

2. 2 to 5 years old

3. 6 to 11 years old

4. 12 to 17 years old

5. 18 years old or older  IF ONLY e, INELIGIBLE

8. What is your sex?

1. Female

2. Male

9. What is your age?

1. Under 18  INELIGIBLE

2. 18 to 24

3. 25 to 34

4. 35 to 44

5. 45 to 54

6. 55 to 64

7. 65 to 74

8. 75 to 80

9. 81 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

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

YES

NO

12. 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

13. What language do you speak most often at home?

English

Spanish

Other (specify)

14. 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 $35. 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 packet in the mail. Make sure to have the packet 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 do this. 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.

1 Loosely based on 2016 NSDUH. See pages 201 and 224. https://www.samhsa.gov/data/sites/default/files/NSDUHmrbCAIquex2016v2.pdf