Educating Groups Influencing Generic Drug Use

Data to Support Drug Product Communications

Appendix F - Protocol for Policymakers

Educating Groups Influencing Generic Drug Use

OMB: 0910-0695

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Appendix F: Interview Protocol - Policymakers

OMB No. 0910-0695
Expiration Date: 02-28-2021

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FDA Educating Groups Influencing Generic Drug Use
Telephone Key Informant Interview Guide- Policymakers
Date:
Participant Number:
Interviewer:
Overview of Purpose of Call and Introductions

Hello [Name]. My name is [Name]. Thank you for agreeing to participate in our study to better
educate groups influencing generic drug use, based on their unique educational needs,
sponsored by the US Food and Drug Administration (FDA). The study is being conducted by
Auburn University and IMPAQ International. You were selected as a possible participant
because you were identified as having a role in the policymaking process for prescription drugs
within the previous six months and are age 19 or older.
The interview is expected to take approximately 45 minutes. What I and the research team
learn from this study may better inform how information is provided related to generic
medications. You will receive $75 as a token of our appreciation for your participation
after completion of the interview.
If you change your mind about participating, you can request to stop at any time during the
study. Your participation is completely voluntary. If you choose to withdraw, your data can be
withdrawn as long as it is identifiable. Your decision about whether or not to participate or to
stop participating will not jeopardize your future relations with Auburn University, the
Department of Health Outcomes Research and Policy, or IMPAQ International.
Do you have any questions about the study or your role in the study? Do you wish to continue
with the interview?
Before we begin I would like to ask you if we may audio record the interview. The recordings
will be kept private to the extent permitted by law and are intended to assist us in our
notetaking and analysis of the information. If you agree to allow the interview to be audio
recorded, any data obtained in connection with this study will be made anonymous as soon
as possible. We will protect your privacy and the data you provide by de-identifying the
data, including assigning pseudonyms and removing any identifiable information from
transcripts of the audio file. Notes and transcripts from the study will be saved in password
protected folders on a password and firewall protected server at IMPAQ International. Audio
recordings will be destroyed immediately upon completion of the project.
Do you have any questions about the recording or how it will be used? May I record?

Appendix F: Interview Protocol - Policymakers
If permission is granted, START RECORDING!
Information Questions
First, I would like to know your thoughts on the information provided in the educational materials.
Why don’t we begin with…
1. How informative did you find the information in the educational materials on the differences
between brand and generic drugs?
a. Did you find the information to be innovative with regards to generic drug use?
2. Was there any new information regarding generic drug use that you learned upon your review
of the materials?
a. If so, what?
b. If not, how can the materials be improved for educating policymakers on generic drug
use?
c. What would you have changed about any of the information provided in the materials,
if anything?
3. What information in particular stood out to you after reviewing the materials?
4. How helpful do you find the information in these materials for policymakers like yourself?
a. How will you apply this information to your role in the process of getting generic drugs
from manufacturers to patients in the future?
5. Do you think these materials may be helpful for other groups involved in the generic drug
process, such as large purchasers of drugs or formulary managers?
a. If helpful, how?
b. If not helpful, do you have any suggestions on how these materials may be better
geared towards educating these groups?
Channel questions
6. What would be the best way to provide this type of information in a timely manner to
policymakers like yourself?
7. From whom do you prefer to receive an email or newsletter with information regarding generic
drugs like this? (such as FDA, professional associations, insurance companies, etc.) Why?
Format Questions
Next, I would like to ask you about your thoughts on the format of the educational materials.
8. What are your thoughts about the format used to present the information in the educational
materials?
a. What did you like about the presentation of the information?
b. Do you have any suggestions on how to make the materials easier to follow for
policymakers like yourself?
Satisfaction questions

Appendix F: Interview Protocol - Policymakers
9.
Can you please describe if you find the information regarding generic drugs in this
email/newsletter to be useful for policymakers like yourself?
10.
Can you please describe if you find the information regarding generic drugs in this
email/newsletter to be interesting for policymakers like yourself?
11.
Can you please describe your overall satisfaction with the information regarding generic
drugs in this email/newsletter?
12.
How would an email or newsletter with information regarding generic drugs like this
help you with your work related to generic drugs (for example, health policies)?
13.
Would you recommend this email/newsletter to other policymakers if they are
interested in information regarding generic drugs?


File Typeapplication/pdf
AuthorJennifer Howard
File Modified2018-02-22
File Created2018-02-21

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