Investigation of Consumer and Physician Beliefs about Direct-to-Consumer (DTC) Advertising

DRAFT

Moderator’s Guide

Role of DTC Advertising in the Doctor-Patient Interaction

Total Time: 1:30

I. Introduction to Group (5 min)

A. Introduction of Moderator

1. Independent consultant hired to moderate these discussions

2. No vested interest in any particular point of view

B. Ground Rules

You have been asked here to offer your views and opinions; everyone’s participation is important

1. Audio and videotaping/observer(s)

2. Speak one at a time

3. No side conversations

4. No right or wrong answers

5. It’s OK to be critical. If you dislike something or disagree with something that is said, I want to hear about it

6. All answers will be kept private to the extent provided by law, so feel free to speak your mind

C. Brief Explanation of the Focus Group Purpose/ Introduction of Topic

Today we are going to be talking about you and your patients, how you interact with them, and what influences your experiences in your daily practice. We may touch on a number of topics that relate to your interactions with your patients. Feel free to bring up ideas and issues as you see fit.

II. Participant Introductions and Warm-Up

A. Please go around table and introduce selves

1. First name

2. Specialty

3. Type of practice you are in

B. Warm-Up Questions

What kind of patients do you see typically?

Please describe a typical patient appointment. Walk us through the interaction.

How satisfied are you with your patient interactions? Why?

Now, describe the ideal patient appointment (for something other than a healthy check-up visit). Pretend that managed care and other factors were not in play: how would it differ from the typical patient interaction you’ve just described?

III. DTC Advertising

I’d like to talk about consumer-directed medical product advertising for a moment.

A. And Patient Interaction

How does DTC affect your patient interactions? (follow up with probes).

How often do patients mention prescription drug ads they’ve seen on TV/radio/internet/in magazines/?

How do you react when a patient mentions an ad or a drug they’ve seen advertised?

What do you think these ads encourage your patients to do? For instance, how often do you see these ads influencing patients’ to:

-seek treatment for a condition that needs treatment

-request to switch medications or

-seek treatment for a condition they don’t have?

Do DTC ads add to time pressures? In what way?

B. The Ads Themselves

What do you see as some of the benefits created by the ads? (If asked for clarification: quality, content, impact)

What do you see as some of the drawbacks created by the ads? (If asked for clarification: quality, content, impact)

Are there any drugs or classes of drugs that you believe should never be advertised directly to the public? What are they and why or why not?

Are there any drugs or classes of drugs that do not currently run direct-to-consumer ads, also called D-T-C ads, that you believe would be useful? Why or why not?

What kind of information would be most useful to your patients in these ads that is not there now?

What kind of information would be most useful to you in these ads that is not there now?

C. Your personal viewing of the ads

How often do you see the ads that are directed to consumers outside of the office?

What is your personal reaction to the ads? How much do you pay attention to them?

IV. Miscellaneous

How do you feel about various changes that the pharmaceutical industry has instituted in the last several years (e.g., reduction in gifts, guidelines)?

What do you think FDA’s role is related to prescription drug advertising in general? What about DTC advertising?

What do you think FDA’s role should be related to DTC advertising?

IV. Wrap Up Questions

How have you changed the way you practice medicine since you began your medical career?

How has your relationship with your patients changed since you began practicing medicine?

If you could change one thing about your patients or your practice, what would it be?

V. False Close (5 minutes)

Moderator will go back to observation room to see if there are any additional questions that should be asked

VI. Thank you/Closure

Also, in last five minutes:

• What role do incentives play in your decision to participate in focus groups or not?

• Was the incentive you received today similar to incentives you have received in the past year or two?