Educating Groups Influencing Generic Drug Use

IMPROVE 4-D MODEL FOCUS GROUP SCRIPT

INTRODUCTION

• Greeting – “Thank you for participation” and “Welcome”

• Explain format and purpose – “60 minute conversation”

  • We are interested in your “opinion” as an “expert” on the issues concerning generic prescribing

• Confidentiality – Your opinions and comments are confidential and will be aggregated in the analysis. Your personal information will not be included in any reports.

• Note-taking/Recording: “We will audio record this session for analysis purposes. We will also take notes of your comments.”

  • Please sign consent forms so we can start the recording.

• Any questions before we start?

DEFINITION & DISCOVERY (30 minutes):

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

1. How do you receive information about generic drugs?

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

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

2. What are your general perceptions of generic drugs as a substitution for branded drugs?

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

   2. What is your understanding of how the decision is made about whether to approve a generic drug?

Prompt: We are interested in discussing your prescribing strategy for oral contraceptives.

3. How many types of drugs in the oral contraceptive category do you usually prescribe?

   1. How do you select from the number of oral contraceptive options available to you?

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

4. What factors influence your prescribing strategy for oral contraceptives?

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

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

5. Have you ever considered substituting a generic oral contraceptive for a patient but ended up prescribing the brand drug instead? If so, what kinds of things 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?

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

6. What barriers exist for providers prescribing generic oral contraceptives?

   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 oral contraceptives.”

1. How do you think the prescribing rates of generic oral contraceptives can be improved?

   1. Probe: IT, individual, patient, institutional, pharmacy, policy level

2. What messages do you think would help you learn best about and increase the rate of generic oral contraceptive prescribing among your peers?

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

   2. Who should deliver these messages?

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

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

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

3. What solutions would make it easier for you to personally prescribe more generic oral contraceptive alternatives?

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

4. What information could FDA provide to improve your perception of generic oral contraceptives?

5. 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 because no one else can tell us what issues are on your minds regarding generic drugs.