IMPROVE FG ADP Script Final

IMPROVE FG Script ADP Final.docx

Focus Groups About Drug Products As Used by The Food and Drug Administration

IMPROVE FG ADP Script Final

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IMPROVE 4-D MODEL FOCUS GROUP SCRIPT - ADP

INTRODUCTION

Welcome and thank you for participating in this focus group. My name is X, co-investigator and this is Y, co-investigator. The objective of the focus group is to gather your opinions and perspectives on generic prescribing. I will be asking you several open-ended questions and you are encouraged to provide your opinions and perspectives in response to the questions. We expect that you will have different points of view and we are interested in hearing from each of you. To ensure we are able to accurately capture your responses for analysis, this session will be audio recorded. In addition, we may also take notes of your comments. Your opinions and comments are confidential and will be aggregated in the analysis. Your personal information will not be included in any reports. This focus group is expected to last about one hour. Are there any questions before we start?

DEFINITION & DISCOVERY:

Prompt: The purpose of this focus group is to understand when and why you prescribe certain drugs. (10 minutes)

  1. What is your understanding of the FDA’s approval process of a generic drug?

    1. Are you aware of the FDA standards (for example bioequivalence standards) a generic drug is required to meet before it can get approved by the FDA?

  2. How do you receive information about generic drugs?

    1. Particularly, Where do you get information about the differences between generic and non-generic drugs?

      1. Probe: journals, senior colleagues, pharmaceutical industry, marketing, FDA, institutions

      2. Which of the ones you list have influenced you the most? Why?

  3. What are your general perceptions of generic drug quality?

    1. What has your experience been with substituting generic for branded drugs? Be specific.

      1. In your practice, do you dispense as written? Do you review the formulary that you can check off or auto-populates with generic options?

Prompt: We are interested in discussing your prescribing practice for anti-depressants. (20 minutes)

  1. What factors influence your prescribing strategy for anti-depressants?

    1. Probe: IT workflows, institutions, insurance, mobile apps, social media, patient preferences, cost, efficacy profile, side effect profile, marketing, awareness & availability of generics, dispense as written, review the formulary

    2. (Time permitting) How does this compare to how you prescribe cholesterol-lowering agents?

  2. How do you select from the number of anti-depressant options available to you?

    1. Probe: How often do you do this?

    2. (Time permitting) How does this compare to how you prescribe cholesterol-lowering agents?

  3. Have you ever considered substituting a generic anti-depressant for a patient but decided to prescribe the brand drug instead? If so, what kinds of factors did you consider and what finally influenced you to prescribe the brand drug?

    1. Probe: Cost, patient’s drug benefit design, therapeutic efficacy, side effects, dosing differences, patient preference, availability of samples, word of mouth/colleague perceptions,

    2. (Time permitting) How does this compare to how you would prescribe cholesterol-lowering agents?

  4. What barriers exist for providers prescribing generic anti-depressants?

    1. (Time permitting) How do these barriers compare to barriers for cholesterol-lowering agents?



DREAM & DESIGN (30 minutes):

Prompt: “Despite potential benefits to patients, payers and the healthcare system, providers have been slow to adopt the use of generic anti-depressants.”

  1. How do you think the prescribing rates of generic anti-depressants can be improved?

    1. Probe: On a(n)… IT, individual, patient, institutional, pharmacy, policy level, payer… level*

  2. What messages do you think would help motivate your peers to increase the rate of generic anti-depressant prescribing among your peers?

    1. What do you find compelling/influential about brand drug advertising that could be replicated for generic anti-depressants?

    2. Who should deliver these messages?

      1. Prompt: FDA, colleagues, professional societies, institutions, pharmaceutical companies

    3. What method of communication is the best way to get this information to you?

    1. Probe: journals, professional societies, FDA, social media, phone alerts, decision-support

    1. (Time permitting) Would your answers change if the aim was to improve generic prescribing of cholesterol-lowering agents

  1. What solutions would make it easier for you to personally prescribe more generic anti-depressant alternatives?

    1. Probe: IT systems, payer, samples, patient education

(Time permitting) Would your answers change if the aim was to improve generic prescribing of cholesterol-lowering agents

  1. What information could FDA provide to improve your perception of generic anti-depressants?

  2. Thinking back to our discussion, is there anything else that you would like to comment on now?



Thank you again for your participation. Your input is invaluable.

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