Generic Drug Substitution in Special Populations

1

FDA Generic Drug Substitution in Special Populations
Focus Group Guide- Older Adult Patients
Date:
Interviewer:
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 understand the alignment between clinical practice, drug
labeling, and patient safety, sponsored by the US Food and Drug Administration (FDA). The
study is being conducted by Auburn University and IMPAQ International. Each of you were
selected to participate in this study because you have taken a generic medication within the
last month, and are age 65 or older.
The discussion is expected to take approximately 60 minutes. What I and the research team
learn from this study may better inform patient safety of generics in special populations. As a
thank you for participating in this study, you will be offered an honorarium of $75 for your time
and travel expenditures.
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withdrawn as long as it is identifiable.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, IMPAQ
International, or the FDA.
Before we begin I would like to ask you if we may 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 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?
If permission is verbally granted by all participants, START RECORDING! If not granted by ALL
participants, DO NOT RECORD! Note taker will record responses.

2

Drug Labeling (Insert and Bottle Label)
First, I would like to ask you to describe what drug labeling information you discuss with your physician
and pharmacist
1.
2.
3.

4.
5.

6.

7.
8.

Do you know the differences and similarities between brand and generic medications?
REQUIRED QUESTION
Do you believe there are differences between brand and generic medications that your doctor
or pharmacist should discuss with you? REQUIRED QUESTION
Do you read the information on your drug bottle labels? How about the paper inserts inside
the box or that came with the medication, do you read that? REQUIRED QUESTION
a. If so, did it have any special instructions for someone of your age or health condition?
i. What were the special instructions?
ii. Did you find the special instructions easy to understand?
iii. Are there any other resources you used or information you received to find out
any special instructions for someone of your age or health condition?
What information from the generic or brand drug label from your current generic or brand
drug did your doctor or pharmacist discuss with you? REQUIRED QUESTION
What administration instructions or information about the safety and effectiveness about
your generic or brand medications did your doctor or pharmacist provide you? REQUIRED
QUESTION
a. Were you provided special instructions on the administration or the safety and
effectiveness of your generic or brand medication based on your age or health
condition from your doctor or pharmacist? REQUIRED QUESTION
i. If yes, how did those instructions regarding administration of drugs vary to what
other patients get? In other words, how did your doctor tell you that these
instructions were different from how other patients get instructions?
ii. If not, were there any other resources you used or information you received to
find out any special instructions for someone of your age or health condition
after speaking to your doctor?
Did your doctor make you aware of any differences in instructions between generic and brand
medications? How about your pharmacist? REQUIRED QUESTION
a. If yes, what were they?
Did your doctor make sure that you understood the special instructions provided? How about
your pharmacist?
Was there information about your generic drugs would you have liked to have received or did
you need that was not provided? REQUIRED QUESTION
a. If so, what information would you have liked or did you need that was not provided?
i. Who should have provided that information?
ii. How should it have been provided?
iii. How will the information about generic drugs impact your willingness to take a
generic alternative over a brand name drug?

3

b. If not, were you satisfied with the information you received about the administration or
safety and effectiveness of your generic drugs? How did the information about generic
drugs you received impact your willingness for generic substitution?
9. Did you search for additional information about your generic drugs or special instructions for
older patients?
a. If so, what additional information were you able to find?
b. Where did you find the additional information?
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.

4

FDA Generic Drug Substitution in Special Populations
Focus Group Guide- Caregivers of Pediatric Patients
Date:
Interviewer:
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 understand the alignment between clinical practice, drug
labeling, and patient safety, sponsored by the US Food and Drug Administration (FDA). The
study is being conducted by Auburn University and IMPAQ International. Each of you were
selected to participate in this study because your child has taken a generic medication within
the last month, and you are age 19 or older.
The discussion is expected to take approximately 60 minutes. What I and the research team
learn from this study may better inform patient safety of generics in special populations. As a
thank you for participating in this study, you will be offered an honorarium of $75 for your time
and travel expenditures.
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, IMPAQ
International, or the FDA.
Before we begin I would like to ask you if we may 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 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?
If permission is verbally granted by all participants, START RECORDING! If not granted by ALL
participants, DO NOT RECORD! Note taker will record responses.

5

Drug Labeling (Insert and Bottle Label)
First, I would like to ask you to describe what drug labeling information you discuss with your physician
and pharmacist
1.
2.
3.

4.
5.

6.

7.
8.

Do you know the differences and similarities between brand and generic medications?
REQUIRED QUESTION
Do you believe there are differences between brand and generic medications that your doctor
or pharmacist should discuss with you? REQUIRED QUESTION
Do you read the information on your child’s drug bottle labels? How about the paper inserts
inside the box or that came with the medication, do you read that? REQUIRED QUESTION
a. If so, did it have any special instructions for someone of your child’s age or health
condition?
i. What were the special instructions?
ii. Did you find the special instructions easy to understand?
iii. Are there any other resources you used or information you received to find out
any special instructions for someone of your child’s age or health condition?
What information from the generic or brand drug label from your current generic or brand
drug did your child’s doctor or pharmacist discuss with you? REQUIRED QUESTION
What administration instructions or information about the safety and effectiveness about
your child’s generic or brand medications did your child’s doctor or pharmacist provide you?
REQUIRED QUESTION
a. Were you provided special instructions on the administration or the safety and
effectiveness of your child’s generic or brand medication based on your child’s age or
health condition from your child’s doctor or pharmacist? REQUIRED QUESTION
i. If yes, how did those instructions regarding administration of drugs vary to what
other patients get? In other words, how did your child’s doctor tell you that
these instructions were different from how adult patients get instructions?
ii. If not, were there any other resources you used or information you received to
find out any special instructions for someone of your child’s age or health
condition after speaking to your child’s doctor?
Did your child’s doctor make you aware of any differences in instructions between your child’s
generic and brand medications? How about your child’s pharmacist? REQUIRED QUESTION
a. If yes, what were they?
Did your child’s doctor make sure that you understood the special instructions provided? How
about your child’s pharmacist?
Was there information about your child’s generic drugs would you have liked to have received
or did you need that was not provided? REQUIRED QUESTION
a. If so, what information would you have liked or did you need that was not provided?
i. Who should have provided that information?
ii. How should it have been provided?

6

iii. How will the information about generic drugs impact your willingness for
generic substitution for your child’s prescription?
b. If not, were you satisfied with the information you received about the administration or
safety and effectiveness of your child’s generic drugs? How did the received information
about your child’s generic drugs impact your willingness for generic substitution for your
child’s prescription?
9. Did you search for additional information about your child’s generic drugs or special instructions
for younger patients?
a. If so, what additional information were you able to find?
b. Where did you find the additional information?
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.

7

FDA Generic Drug Substitution in Special Populations
Focus Group Guide- Prescribers and Dispensers
Date:
Interviewer:
Note taker:
Overview of Purpose of 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 understand the alignment between clinical practice, drug
labeling, and patient safety in generic drug utilization, 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 participant because you have prescribed or dispensed a
medication within the last month, and you are age 19 or older.
The discussion is expected to take approximately 60 minutes. What I and the research team
learn from this study may better inform patient safety of generics in special populations. As a
thank you for participating in this study, you will be offered an honorarium of $275 for your
time and travel expenditures.
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, IMPAQ
International, or the FDA.
Before we begin I would like to ask you if we may record the 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 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?
If permission is verbally granted by all participants, START RECORDING! If not granted by ALL
participants, DO NOT RECORD! Note taker will record responses.

8

Background
First, I would like to know a bit about your generic drug prescribing and dispensing patterns.
1. Have you recently prescribed or dispensed a generic drug to a special patient population, such
as a patient over the age 65 or younger than 18, a patient who is black, Latino, or other racial
or ethnic minority, a patient who is pregnant, or a patient who has a disability? REQUIRED
QUESTION
a. If so, what is an example of a recently prescribed or dispensed generic drug to X?
2. Do you believe generic drugs may be more or less appropriate for special populations than
others? REQUIRED QUESTION
Drug Labeling (Insert and Bottle Label)
Next, I would like to switch topics a bit and ask you to describe what information you discuss with
patients.
1. Do you believe generic drugs are as safe and efficacious as brand drugs?
2. Do you discuss why you are prescribing or dispensing a brand or generic drug when
communicating with patients? REQUIRED QUESTION
3. What information from the generic drug label do you discuss with patients?
a. How about brand drug label information?
b. How does this information impact patients use or your dispensing of generic drugs?
4. What administration instructions or information on efficacy and safety did you provide to the
patient? REQUIRED QUESTION
a. Do you believe that special populations should receive additional information about
brand or generic drugs that may be relevant to them?
b. Do you/Have you provide/provided special instructions on the administration or
information on efficacy and safety of generic drugs based on a patient’s background
(e.g. race, age, or disability status)?
c. How have your instructions regarding administration or information on efficacy and
safety of brand and generic drugs varied by patient population?
5. Do you ensure that the patient has understood the special instructions provided? How?
Administration Instructions
Now I would like to turn to how you would prefer to communicate administration instructions to
patients. Why don’t we start by discussing current administration instructions?
1. How do you remain current with clinical practice on generic safety and efficacy information?
REQUIRED QUESTION
2. Do you receive information and updates related to current clinical practice updates for special
patient populations? REQUIRED QUESTION
a. Where do you receive information related to current clinical practice updates?

9

b. How do you receive the information?
c. How often do you receive the information?
3. Do you seek out additional information and updates related to current clinical practice for
special patient populations?
a. Where do you seek out information related to current clinical practice updates?
b. How often do you seek out the information?
4. What additional information or information provided in other ways better enable you to
remain current on generic administration instructions or information on efficacy and safety
for special patient populations? How about provide special instructions for these patients?
REQUIRED QUESTION
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.