Form #4 Form #4 Focus group guide for Adults

Form Approved
OMB No. 0935-XXXX
Exp. Date XX/XX/20XX

Attachment D
Adult Focus Group Questions
Theme I: Knowledge
Share with me what you call this {Facilitator holds up a bottle of Tylenol®}. Different
people call this by different names. Are there other names that you call this medicine?
Describe what it is it used for. Tell us the story of how you or a family member has used
it. [Probe: Where do you get this medicine? What was it for?] What do you know about
different strengths of this medicine? What is the best way to tell the strength of the
medicine? Share with us how you know how much to take and how often. Can you
describe any side effects from this medicine? [Probe: Can it harm your kidneys or your
liver?] Let’s talk about medicine prescribed by the doctor. Tell how you know if a
prescription has acetaminophen or Tylenol® in it. [Use a prescription bottle with APAP
on the label] What do you know about taking Tylenol® or acetaminophen over-thecounter and a prescription medicine at the same time? What about something like this
[hold up package with NON-ASPIRIN on it] that says non-aspirin. What does that mean?
Theme II: Beliefs about Benefits and Risks
What I would like to hear about is does this medicine work when you use it? Explain to
me how you know if it works. [Probes: How long do you think it takes to work?]
I would like for you to talk to each other about how strong you think this medicine is.
[Probe: Do you think this medicine is safe to use?] If you took too much, could it make
you sick or hurt you? How important is that concern? How much of this medicine would
someone have to take to cause harm? Why do you think that amount would cause harm?
[Probe: is that more than the recommended dose]
Theme III: Patterns and Frequency of Use
Think about the times you use this medication. Tell me about that. [Probes: How much
do you take? How often? Do you take it with other medicines? What about with alcohol?]
I’m wondering if you keep this at your home? [Probes: How do you store it? Do you
carry it with you? Do you share it with other people?] Do you know anyone who has used
this drug recreationally or taken more than the recommended dose? Tell me about that
situation. Have you heard of anyone taking acetaminophen either accidentally or on
purpose with alcohol? Describe that to me.
Theme IV: Sources of Information
Tell me how did you learn about this medicine. Have you seen any advertisements for
acetaminophen-free drugs? If so, how has this changed the way you view and/or use
acetaminophen-containing drugs?" "Have you heard about the new FDA labeling rule? If
so, how (friends, newspapers, etc.)? Do you know what the rule says? How has this
changed your views and/or use of acetaminophen?" Let’s talk about ads on TV. Can
anyone think of other places they heard about this medicine? Think of a situation when
you ever talked to your doctor about this medicine. Describe that to me.{Probe: a
pharmacist; any other healthcare worker, nurse, case worker}
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Theme V: Related Experiences
Have you ever heard about someone taking too much or having a problem from taking
this medicine? Tell us that story. [Probe if not offered by group: Have you ever heard
about someone taking too much on purpose?] Has hearing or knowing that changed the
way you take or use acetaminophen?
Theme VI: Labeling and Packaging
{Facilitator to distribute a wide variety of over-the-counter acetaminophen packaging and
bottles to include Tylenol®, store brands, Vicks, Dayquil etc.. and packages with NONASPIRIN}
Now, I would like for you to look at these bottles and packages and labels.
First, tell me about the packages. Do you use the package to get information about the
medicine? Can you see it? What would you change about that?
If you could tell from this package that the product contained Tylenol [or other acetaminophen
containing drug], would this change what you think about this medicine? Describe what you
might do.
{Probe 1-Would you use the medicine any differently? If so, how? (Would you take a
different/lesser dose?)}
{Probe 2 -Would you turn to other drugs for pain relief instead? (If so, which ones?)}
What if this Tylenol [or other acetaminophen containing drug] was labeled where you could
easily see a warning that it causes a risk of liver damage, would this change how you act about
this the medicine? Describe how you might act.
{Probe 1 - Would you use the medicine any differently? If so, how? (Would you take a
different dose?)}
{Probe 2 - Would you turn to other drugs for pain relief instead? (If so, which ones?)}
What would you do if the strength of Tylenol [or other acetaminophen containing drug] was
made weaker? Would you take a greater dose? Would you turn to other drugs for pain relief?
(If so, which ones?)
Do any of you experience chronic pain? If so, do you use acetaminophen containing drugs to
manage the pain? How might it affect how you manage your pain if the acetaminophen was
made weaker? Tell me what you might do. {Probe: take a greater dose; turn to other
medicines, if so, which ones}

Are there any other comments that you would like to share with us today.
Thank you for your participation.