Accuracy of Opioid Product Ascertainment (CDER)

OMB Control No. 0910-0847

Expirations Date: 12/31/2022

Accuracy of Opioid Product Ascertainment
Part 2: Online Videoconference Interview Guide

This document is the guide to the videoconference interview that follows the online questionnaire that is provided to the interviewer who is interacting with the participant.

INTRODUCTION (~2 Minutes)

Thank you for completing the survey and rejoining the call. The conversation we are about to have is the last part of this study. It will take about 15 minutes.

I’m going to ask you to think about the survey you just completed and how you identified opioid pain medications. When I refer to opioid pain medications, I’m referring to a class of drugs that doctors use to treat moderate to severe pain in some patients. This class of drugs includes oxycodone, hydrocodone, morphine, and many others. Pain medications that you can buy over the counter without a prescription from a doctor, like Tylenol, Advil, or aspirin, are NOT opioid pain medications.

At the end of the survey you just completed, you should have been directed to a screen with a question that looks like one you saw in the survey. We are going to come back to that screen and talk about how you would choose an answer to a couple of questions that are similar to the ones you saw in the survey. Finally, I’ll ask you some questions about your understanding of some terms used to refer to opioid pain medications.

There are no right or wrong answers to the questions I’m going to ask. We want to learn about how you identify opioid pain medications in order to improve surveys and tools that ask people about their use of these medications.

Before we begin, I want to draw your attention to a few items that were described in the consent document you read at the beginning of this study:

• Audio Recording. We’re planning to audio record this interview. At the end of all our interviews, we want to summarize our findings. I want to give you my full attention and not take a lot of notes, so I will refer to the recordings, when writing the summary.

• Confidentiality. Your identity and anything you say will remain secure to the extent permitted by law. Your name, address, and contact information will not be given to anyone, and no one will contact you after this interview is over. When we write a summary of the interviews, we will not refer to you or anyone in this study by name.

Do you have any questions before we begin?

[BEGIN AUDIO RECORDING BEFORE CONTINUING TO NEXT PAGE]

DECISION MAKING PROCESS FOR IDENTIFYING OPIOID PRODUCTS (~7 Minutes)

First, I’d like to ask you to think back to the questions you answered in the survey you just completed that asked you to match names and pictures of opioid pain medications.

1. Thinking back to the survey, when you were shown a picture and asked to identify the opioid pain medication in the picture, what did you look for first?

   1. PROBE: What did you look for in the picture to help you figure out what medication it was?

   2. PROBE: Was it the shape, color, or some other characteristic of the medication that helped you to identify it? What was it about this characteristic/these characteristics that helped you identify the medication?

2. How did you decide which name went with the medication in the picture?

   1. PROBE: What difficulties did you have in selecting a name from the list of names?

3. Thinking about the opioid pain medications you’ve used or know about, are you more likely to be able to identify them by name or from a picture?

   1. PROBE: Would having both a name and picture make you feel more confident that you know which medication it is? Why or why not?

   2. PROBE: How do you typically refer to these medications? By the brand name, a slang name, or something else?

NOTE: Examples 1 and 2 will be drawn from the products that the individual participant reported using in response to the opioid misuse question in the computerized online questionnaire. If the participant reports misusing only one opioid product, we will use a commonly misused opioid product, such as Percocet or Vicodin. In this follow-up interview, they are asked specifically about 2 products that they have identified as using for nonmedical use (if they only report 1 product, then another common product will be used).

Example 1

Next, we’re going to talk about a question that looks like one of the questions you saw in the survey, and I’ll ask you how you would choose an answer.

[REFER PARTICIPANT TO THE SCREEN AT THE END OF THE SURVEY TO SHOW EXAMPLE 1. WALK PARTICIPANT THROUGH INSTRUCTIONS ON HOW TO SHARE THEIR SCREEN.]

Please select the name of the medication shown in the image below. If you do not know the answer, please select “I don’t know.”

The image may not be the same as its actual size.

○ Percocet®

○ Roxicodone®

○ Xtampza ER

○ Generic short-acting Vicodin®-type generic

○ Vicodin®

○ Generic extended-release hydromorphone

○ Lorcet®

○ Entrol

○ Opana®

○ None of the above

○ Don’t know

1. Even though it might feel odd, can you talk through your thought process, while answering this question and deciding what medication is in the picture?

2. What did you notice first when you saw the picture?

3. When you looked through the list of medication names, what was the first thing that came to mind?

4. When you chose the name of the medication in the picture, how confident were you that it was correct?

   1. PROBE: What were you unsure about?

Example 2

Now, we’re going to talk about one more question that looks like one of the questions you saw in the survey, and I’ll ask you how you would choose an answer.

NOTE: The chart will show a different medication than the one included in Example 1. There will be a medication screen for each drug product the participant previously identified in the opioid misuse question in the computerized online questionnaire. The order of the screens will be randomized.

[ADVANCE SCREEN AT THE END OF THE SURVEY TO SHOW EXAMPLE 2. PARTICIPANT SHOULD STILL BE SHARING HIS OR HER SCREEN. IF NEEDED, WALK PARTICIPANT THROUGH INSTRUCTIONS ON HOW TO SHARE HIS OR HER SCREEN.]

Please select the name and active ingredient to identify the medication shown in the image below. If you do not know the answer, please select “Don’t know.”

Note that the image may not be the same as its actual size.

○ Percocet® (oxycodone)

○ Roxicodone® (oxycodone)

○ Xtampza ER (oxycodone)

○ Generic short-acting Vicodin®-type generic (hydrocodone)

○ Vicodin® (hydrocodone)

○ Generic extended-release hydromorphone (hydromorphone)

○ Lorcet® (hydrocodone)

○ Enterol (oxyhydrone)

○ Opana® (oxymorphone)

○ None of the above

○ Don’t know

1. Again, even though it might feel odd, can you talk through your thought process, while answering this question and deciding what medication is in the picture?

2. What did you notice first when you saw this picture?

3. What is your understanding of “active ingredient,” as it’s used here?

4. Did including the active ingredient with the name make it easier for you to identify the medication in the picture? Why or why not?

5. When you chose the name of the medication in the picture, how confident were you that it was correct?

   1. PROBE: What were you unsure about?

Real-Life Setting

1. Have you ever bought or been offered opioid pain medication from a dealer, friend, or family member?

IF YES:

1. How did you know it was actually what you were told it was?

2. How confident were you that the drug was what you thought it was?

UNDERSTANDING OF TERMS TO REFER TO OPIOID PRODUCTS (~5 Minutes)

Now, I’d like to ask you some questions about terms used to refer to opioid pain medications.

1. When you hear the term “prescription opioids,” what comes to mind?

   1. PROBE: What are some examples of prescription opioids?

   2. PROBE: If you were explaining what “prescription opioids” are to someone, what would you tell them?

   3. PROBE: What about the term “prescription opioids” do you think other people might find confusing?

   4. PROBE: What would make it less confusing?

2. When you hear the term “opioid pain medications,” what comes to mind?

   1. PROBE: If you were explaining what “opioid pain medications” are to someone, what would you tell them?

   2. PROBE: What about the term “opioid pain medications” do you think other people might find confusing?

   3. PROBE: What would make it less confusing?

3. Do you think the terms “prescription opioids” and “opioid pain medications” refer to different things or the same thing? Why?

Language used in conversation

4. If you were talking to a friend about these types of medications, what would you call them?

5. If you were talking to a dealer about these types of medications, what would you call them?

CLOSING (1 Minute)

That covers all the questions I wanted to ask today. Is there anything else we should know about this topic that we didn’t discuss today?

Closing

Thank you, again, for participating in this study. As I mentioned before, all your comments will remain secure to the extent permitted by law. Your input has been extremely valuable, and we really appreciate your time.

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