Educating Groups Influencing Generic Drug Use

Focus Group Protocols – Patients/Caregivers

Educating Groups Influencing Generic Drug Use
Focus Group Guide- Patients/Caregivers
Date:
Moderator:
Note taker:
Overview of Purpose of the Study and Introductions
Hello [Name]. My name is [Name]. I am joined by my colleague [Name]. Thank you for agreeing to
participate in our study to better educate groups influencing generic drug use, based on their unique
educational needs. The study is being conducted by Auburn University and IMPAQ International and is
funded by the U.S. Food and Drug Administration (FDA). Each of you were selected to participate in this
study because you are age 19 or older and a patient or caregiver.
The discussion is expected to take approximately 60 minutes. I and the research team aim to learn and
discuss your thoughts on the content, format, channel, and satisfaction of one example of educational
materials developed specifically for your stakeholder group. To thank you for your time spent
participating in this study, you will be offered an honorarium of a $25 mailed check after completion of
the focus group.
If you change your mind about participating, you can 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 If you choose to withdraw, your data can be withdrawn as long as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, IMPAQ International, or the FDA.
Personal information collected in connection to your honorarium will be saved in password protected
folders on a password and firewall protected server at Auburn University. This information is being
collected in order to withhold necessary tax payments on your behalf and will remain private.
Having heard this information, you must decide if you would like to participate in this study. If you
decide to participate, your signature will indicate your willingness to participate. (Give participants time
to sign the consent form and incentive information collection form)
Before we begin I would like to ask you if we may audio record our discussion. The recordings will be
kept confidential and are intended to assist us in our notetaking and analysis of the information. If you
agree to allow the discussion to be 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 deidentifying the data, including assigning false names after our discussion and removing any identifiable
information from transcripts of the audio file. Electronic notes and transcripts from the study will be
saved in password-protected folders on a password- and firewall-protected server at Auburn University.
Audio recordings will be destroyed immediately upon completion of the records.

Focus Group Protocols – Patients/Caregivers
Do you have any questions about the recording or how it will be used? May I record?
If permission is verbally granted by all participants, START RECORDING! If not granted by ALL
participants, DO NOT RECORD! Note taker will record responses.

Demonstration of the example of educational material for patient/caregiver group:
First, I would like to show you an example of an educational material regarding generic drugs we
designed for the patients and caregivers. Here is a printed handout summarizing the safety and efficacy
of generic drugs and similarities and differences between brand and generic drugs. (Give participants
about 3 minutes to read the handout and lead discussion with the following questions):
Content questions
1. Does this handout provide adequate information for you about the safety and efficacy of
generic drugs?
a. If yes, which part of the information do you think is most important for
patients/caregivers like yourself?
b. If no, what additional information would you like to see provided that would increase
your understanding/knowledge of the safety and efficacy of generic drugs?
2. Does this handout provide adequate information for you to know about the differences and
similarities between brand and generic drugs?
a. If yes, which part of the information do you think most explains the similarities and
differences between brand and generic drugs?
b. If no, what additional information would you like to see provided that would increase
your understanding/knowledge of the differences and similarities between brand and
generic drugs? How can the content be improved to fit your knowledge needs regarding
generic drugs?
3. Was there any new information regarding generic drugs that you learned upon your review of
the handout?
a. If yes, which part of the information?
b. If no, where did you get the information regarding generic drugs before?
Format questions
4. Do you think the information in this handout is presented in a simple, easily understood
format?
a. If no, do you have any suggestions on how to make the materials easier to follow for
patients/caregivers like yourself?
5. How satisfied are you with the format (i.e., printed handout, layout, design, organization of
the content, etc.) used to present the information in this handout?
a. Do you have any suggestions on how to improve it?

Focus Group Protocols – Patients/Caregivers
Channel questions
6. Where do you prefer to receive a handout with information regarding generic drugs like this?
(such as a clinic, pharmacy, hospital, mailed from doctor’s office, online, email, etc.) Why?
7. With whom do you prefer to discuss the information regarding generic drugs using a handout
like this? Why?
Satisfaction questions
8. Can you please share whether you find the information regarding generic drugs in this
handout to be useful for patients/caregivers like yourself?
9. Can you please describe your overall satisfaction with the information regarding generic drugs
in this handout?
10. Can you please describe how you would change the handout to improve your satisfaction with
it?
11. How will you apply the information regarding generic drugs in this handout in your future
generic drug use?
12. Would you recommend this handout to other patients/caregivers if they are interested in
information regarding generic drugs?

(Close the focus group by asking if participants have any questions or additional thoughts and thanking
them for their time and contribution to the study).

Focus Group Protocols – Formulary Managers, Large Purchasers, and Policymakers

Educating Groups Influencing Generic Drug Use
Focus Group Guide- Formulary Managers, Large Purchasers, and Policymakers
Date:
Moderator:
Note taker:
Overview of Purpose of the Study and Introductions
Hello [Name]. My name is [Name]. I am joined by my colleague [Name]. Thank you for agreeing to
participate in our study to better educate groups influencing generic drug use, based on their unique
educational needs. The study is being conducted by Auburn University and IMPAQ International and is
funded by the U.S. Food and Drug Administration (FDA). Each of you were selected to participate in this
study because you are age 19 or older and among the formulary manager, large purchaser of drugs, and
policymaker stakeholder group that has an important role in generic drug use.
The discussion is expected to take approximately 60 minutes. I and the research team aim to learn and
discuss your thoughts on the content, format, channel, and satisfaction of one example of an
educational material developed specifically for your stakeholder group. To thank you for your time spent
participating in this study, you will be offered an honorarium of a $25 mailed check after completion of
the focus group.
If you change your mind about participating, you can 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, IMPAQ International, or the FDA.
Personal information collected in connection to your honorarium will be saved in password protected
folders on a password and firewall protected server at Auburn University. This information is being
collected in order to withhold necessary tax payments on your behalf and will remain private.
Having heard this information, you must decide if you would like to participate in this study. If you
decide to participate, your signature will indicate your willingness to participate. (Give participants time
to sign the consent form and incentive information collection form)
Before we begin I would like to ask you if we may audio record our discussion. The recordings will be
kept confidential and are intended to assist us in our notetaking and analysis of the information. If you
agree to allow the discussion to be 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 deidentifying the data, including assigning false name 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 Auburn University. Audio recordings will be
destroyed immediately upon completion of the records.

Focus Group Protocols – Formulary Managers, Large Purchasers, and Policymakers
Do you have any questions about the recording or how it will be used? May I record?
If permission is verbally granted by all participants, START RECORDING! If not granted by ALL
participants, DO NOT RECORD! Note taker will record responses.

Demonstration of the example of educational material for formulary manager/large
purchaser/policymaker group:
First, I would like to show you an example of educational material regarding generic drugs we designed
for the formulary manager/large purchaser/policymaker group. Here is a printed handout presenting an
email/newsletter for formulary manager/large purchaser/policymaker about FDA generic drug approval
process, generic drug bioequivalence profile, and generic drug market availability and access. (Give
participants about 3 minutes to read the handout and lead discussion with the following questions):
Content questions
1. Does this email/newsletter provide adequate information for you to understand the FDA
generic drug approval process? What about bioequivalence profile, market availability, and
access?
a. If yes, which part of the information do you think is most important for formulary
managers/large purchasers/policymakers like yourself?
b. If no, what additional information would you like to see provided that would increase
your knowledge regarding generic drugs? How can the content be improved to address
your knowledge needs regarding generic drugs?
2. Was there any new information regarding generic drugs that you learned upon your review of
the email/newsletter?
a. If yes, which part of the information?
b. If no, where did you get the information regarding generic drugs before?
Format questions
3. Do you think the information in this email/newsletter is presented in a simple, easy access
format?
a. If no, do you have any suggestions on how to make the materials easier to follow or
access for formulary managers/large purchasers/policymakers like yourself?
4. How satisfied are you with the format (i.e., print vs. email, layout, design, organization of the
content, etc.) used to present the information in this email/newsletter?
a. Do you have any suggestions on how to improve it?

Focus Group Protocols – Formulary Managers, Large Purchasers, and Policymakers
Channel questions
5. 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,
pharmaceutical companies, etc.) Why?
Satisfaction questions

6. Can you please share whether you find the information regarding generic drugs in this
email/newsletter to be useful for formulary managers/large purchasers/policymakers like
yourself?
7. Can you please describe your overall satisfaction with the information regarding generic drugs
in this email/newsletter?
8. How would an email or newsletter with information regarding generic drugs like this help you
with your work related to generic drugs (can be purchasing, revising prescription formularies
or health policies, etc.)?
9. Would you recommend this email/newsletter to other formulary managers/large
purchasers/policymakers if they are interested in information regarding generic drugs?

(Close the focus group by asking if participants have any questions or additional thoughts and thanking
them for their time and contribution to the study).

Focus Group Protocols – Prescribers/Pharmacists

Educating Groups Influencing Generic Drug Use
Focus Group Guide- Prescribers/Pharmacists
Date:
Moderator:
Note taker:
Overview of Purpose of the Study and Introductions
Hello [Name]. My name is [Name]. I am joined by my colleague [Name]. Thank you for agreeing to
participate in our study to better educate groups influencing generic drug use, based on their unique
educational needs. The study is being conducted by Auburn University and IMPAQ International and is
funded by the U.S. Food and Drug Administration (FDA). Each of you were selected to participate in this
study because you are age 19 or older and among the prescriber/pharmacist stakeholder group that has
an important role in generic drug use.
The discussion is expected to take approximately 60 minutes. I and the research team aim to learn and
discuss your thoughts on the content, format, channel, and satisfaction of one example of educational
materials developed specifically for your stakeholder group. To thank you for your time spent
participating in this study, you will be offered an honorarium of a $25 mailed check after completion of
the focus group.
If you change your mind about participating, you can 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, IMPAQ International, or the FDA.
Personal information collected in connection to your honorarium will be saved in password protected
folders on a password and firewall protected server at Auburn University. This information is being
collected in order to withhold necessary tax payments on your behalf and will remain private.
Having heard this information, you must decide if you would like to participate in this study. If you
decide to participate, your signature will indicate your willingness to participate. (Give participants time
to sign the consent form and incentive information collection form)
Before we begin I would like to ask you if we may audio record our discussion. The recordings will be
kept confidential and are intended to assist us in our notetaking and analysis of the information. If you
agree to allow the discussion to be 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 deidentifying the data, including assigning false name 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 Auburn University. Audio recordings will be
destroyed immediately upon completion of the records.

Focus Group Protocols – Prescribers/Pharmacists
Do you have any questions about the recording or how it will be used? May I record?
If permission is verbally granted by all participants, START RECORDING! If not granted by ALL
participants, DO NOT RECORD! Note taker will record responses.

Demonstration of the example of educational material for prescriber/pharmacist group:
First, I would like to show you an example of educational material regarding generic drugs we designed
for prescribers and pharmacists. Here is a printed handout presenting an email/newsletter for prescribers
and pharmacists about safety and efficacy of generic drugs, as well as information on access and cost of
generic drugs. (Give participants about 3 minutes to read the handout and lead discussion with the
following questions):
Content questions
1. Does this email/newsletter provide adequate information for you to understand the safety
and efficacy about generic drugs? What about access to and cost of generic drugs?
a. If yes, which part of the information do you think is most important for
prescribers/pharmacists like yourself?
b. If no, what additional information would you like to see provided that would increase
your knowledge regarding generic drugs? How can the content be improved to address
your knowledge needs regarding generic drugs?
2. Was there any new information regarding generic drugs that you learned upon your review of
the email/newsletter?
a. If yes, which part of the information?
b. If no, where did you get the information regarding generic drugs before?
Format questions
3. Do you think the information in this email/newsletter is presented in a simple, easy access
format?
a. If no, do you have any suggestions on how to make the materials easier to follow or
access for prescribers/pharmacists like yourself?
4. How satisfied are you with the format (i.e., printed handout, layout, design, organization of
the content, etc.) used to present the information in this email/newsletter?
a. Do you have any suggestions on how to improve it?

Focus Group Protocols – Prescribers/Pharmacists
Channel questions
5. 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,
pharmaceutical companies, etc.) Why?
Satisfaction questions

6. Can you please share whether you find the information regarding generic drugs in this
email/newsletter to be useful for prescribers/pharmacists like yourself?
7. Can you please describe your overall satisfaction with the information regarding generic drugs
in this email/newsletter?
8. How would an email or newsletter with information regarding generic drugs like this help you
discuss generic drugs and treatments options with your patients?
9. How would an email or newsletter with information regarding generic drugs like this help you
prescribe/dispense generic drugs for your patients?
10. Would you recommend this email/newsletter to other prescribers/pharmacists if they are
interested in information regarding generic drugs?

(Close the focus group by asking if participants have any questions or additional thoughts and thanking
them for their time and contribution to the study).