Establishing a Baseline for Consumer Knowledge about Medical Product Benefits and Risks

Confidential – Draft – Internal Deliberative

Moderator’s Guide

Consumer Perceptions of the Benefits and Risks of Medicines

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Opening Remarks – Introductions and Rules

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Ice Breaker (5 min.)

Moderator: Let’s go around the room and introduce ourselves. Please tell me your first name, how long you have lived in the area, and just a little bit about your household.

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1. Thinking about medicines in general (10 min.)

Tonight we’re going to talk about prescription drugs or medicines. What does the term prescription drug mean to you? What are some examples of these types of drugs? How are prescription medicines different from other medicines? [IF THEY HAVEN’T ALREADY MENTIONED IT, let them know that a prescription medicine is one that you can’t get from a pharmacy without a prescription from a doctor or other prescribing healthcare provider.]

FOR REMAINDER OF SESSION, use the term (drugs or medicines) they seem to use most, or explain that you’ll be using the terms interchangeably.]

• Is there anything you like about having to take a prescription medicine? What?

• Regardless of whether you think a prescription medicine will help the problem for which you’re taking it, how do you feel when you find out you should be taking medicine? (IF EXAMPLE NEEDED: For example, do you like knowing at least you now have a reason for the symptoms you’ve been experiencing? Do you like the idea that you can pay less attention to what you eat? )

• What do you not like about having to take a prescription medicine?

2. Beliefs about medicine’s benefits (20 min)

• What’s your general sense about how well prescription medicines work? How effective do you think prescription drugs are?

  • Can you tell about a time you (or your child) took a prescription medicine and it really worked well? What made you know it was working?

  • What about a time you took one and it did not seem to help? How did you know it was not working?

  • PROBE if there are any examples of the medicine not working: What did you do when you thought the medicine was not working?

• Does how well prescription drugs work depend on what they’re used for? (For example, they could be used to treat cancer or a stroke or to treat fingernail fungus or acne or to prevent heart disease.) In what way?

  • PROBES: Does it depend on the brand? The strength? How long it’s been available for use? Anything else?

• Does how well prescription medicines work depend on the person who is using them? (For example, men versus women, or as a function of age, or other differences.) Tell me more about how you reached this conclusion.

• What else can you tell me about the way you think about how well prescription medicines work?

3. Beliefs about medicine’s risks (20 min)

• Have you heard of risks associated with prescription drugs? What comes to mind when I ask about that? What about side effects associated with prescription drugs? Do “risks” and “side effects” refer to the same thing or are they different? [IF YES] How do they differ?

• What type of risks or side effects have you heard of? IF NOT ALL OF THESE RISKS ARE MENTIONED ASK, “ What about XXX? Have you heard of XXX as being a drug risk or side effect? LIST: Seizure or a stroke, or a life-threatening rash, fever, dizziness, really bad indigestion, liver problems, severe inability to sleep, headaches, and drowsiness.

• Have you ever heard the term “adverse reaction” in relation to taking prescription drugs? What does that term mean to you? Do you see any differences between the 3 terms: “risks,” “side effects,” and “adverse reactions”?

• When your doctor or another respected source says that a drug is safe to use, what does that meant to you? Does “safe” mean something different when you hear it in an advertisement?

• Can a drug be considered safe for use if some people experience side effects when taking it? [PROBE] Does it depend on the type of side effect? Does it depend on the number of people who experience the side effect? Is it possible for a drug to be considered safe if almost everyone who takes it experiences a side effect (such as sleepiness with antihistamines, or stomach upset with the antibiotic erythromycin)?

• Now, let’s discuss what makes someone more or less likely to experience a side effect when taking a drug.

  • Does the chance of having a side effect from taking a prescription drug depend at all on what problem the drug is treating? [PROBE, IF NEEDED] For example, is someone more likely to have a side effect from a drug that treats a serious problem like cancer or a stroke than one that treats a less serious problem like acne or muscle pain? Or a drug that is used to prevent a problem from occurring – like treating high cholesterol for preventing heart disease? Why is that?

  • What about the type of side effect a person may have? Does this depend on the problem the drug is being used to treat?

• Does the chance and type of side effect a person may experience depend on characteristics of the person using the medicine? [PROBE IF NEEDED] For example, men versus women, or as a function of age, or other differences. Tell me more about why you feel that way.

• What more can you tell me about the way you think about risks (side effects) related to prescription drugs? [PROBE IF NEEDED] For example, do you think the chance of having a side effect or the type of side effect a person is likely to have depends on

  • how long it’s been on the market?

  • how many people take it?

  • how long you have to take it (whether you need to take it short-term or long-term)?

  • past experiences of family members or friends?

  • Anything else?

4. Most recent time taking prescription (20 min.)

Think about the last time your doctor or other healthcare provider gave you (or your child) a prescription for a drug.

• When thinking about whether you should get the prescription filled and take the drug, what kinds of things did you consider? [PROBE] Did you think about:

  • how likely it was to work?

  • the seriousness of the problem the drug was being prescribed for?

  • how long you would need to take the drug?

  • the quality of the drug?

  • drug interactions?

  • side effects?

  • costs?

  • treating the problem differently in some way?

  • Anything else?

• Did you discuss any of this with your provider or with your pharmacist? What specifically did you talk about?

• What did you decide to do about the prescription? Tell me about how you made that decision.

  • PROBES: Did you go right away to a pharmacy to get it filled? Did you put it in your pocket, wallet, or purse for filling later? Did you want to think about whether you were even going to fill it at all?

• Did you think about what would happen if you decided not to take the drug? Did this influence your decision?

• Did you get any additional information about the drug before you started taking it? Where did you look for additional information? Was it helpful?

• Did the drug help? How did you determine that?

• Have you ever cut pills to extend the life of the refill or to reduce side effects? Was there any impact? What was that?

5. Reactions to new risks of existing medicines (20 min.)

Moderator: Sometimes, even after prescription medicines have been available for years, the public will hear about newly discovered risks of using the drug. Can you think of particular instances of this happening in the last few years? [IF NOT, PROBE FOR recollection of hormone replacement therapy (Premarin – PRE-mah-rin), arthritis medicine (Vioxx – VEYE-ox or Celebrex – SELL-a-brehx), medicines to treat depression, diabetes treatment (Rezulin – REH-za-lin).] Why do you think this kind of thing happens?

• Why do you think it is that these risks were not known about when the prescription drug was first approved for use?

PROBE: What’s your understanding of how the decision is made about whether to approve a prescription medicine? Do you think it’s possible to know about all the risks associated with a prescription drug before people are allowed to use it?

• How do you generally hear about a new risk with a prescription drug?

• What makes you pay attention to these type of reports?

• I’d like you to think about how you would react if you heard about a newly uncovered risk associated with taking a prescription drug that you’re using or have used in the past, or that your child or another family member is using or has used for a recurring problem. What would you think about? What would you do?

PROBE: Would you think about the good things that the drug does for you? Would you think about the risks of not using the drug? Why/why not?

ENDING:

Those are all the questions I have for you tonight. Are there any final thoughts about this topic that you want to share before we leave?

Thank you again for your help with these focus groups. Good night.

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