Educating Groups Influencing Generic Drug Use

FDA Educating Groups Influencing Generic Drug Use
Telephone Key Informant Interview Guide- Patients
Date:
Participant Number:
Interviewer:
Overview of Purpose of Call and Introductions
1. Provide a brief description of what you'll be doing today and ask the participant if they have any
questions.
2. Inform the participant that we like to record these calls for transcripts that we use in analysis.
Assure them their individual names won't be reported, although we may highlight quotes or
other information about specific programs in our reports. Ask for their permission to record.
If permission is granted, START RECORDING!
Background
First, I would like to know a bit about your generic drug use.
1. What generic drug(s) have you taken within the last six months?
a. Are you currently taking X? [Fill in drug name based on the name of one of the most
recent generic drug prescriptions taken]
i. If so, how long have you been taking X? [Fill in drug name based on the name
of one of the most recent generic drug prescriptions taken]
ii. If not, how long did you take X? [Fill in drug name based on the name of one of
the most recent generic drug prescriptions taken]
iii. If not, why did you stop taking X? [Fill in drug name based on the name of one
of most recent generic drug prescriptions taken]
iv. Are you currently taking something else instead of X? [Fill in drug name based
on the name of one of the most recent generic drug prescriptions taken]
2. Was X prescribed to you by your physician or did your pharmacist suggest taking X as an
alternative to the drug prescribed to you by your physician? [Fill in drug name based on the
name of one of the most recent generic drug prescriptions taken]
Beliefs
Next, I would like to switch topics and ask you a few questions regarding your views on generic drugs.
1. Do you think generics are as safe and work as well as brand name drugs? Why or why not?
2. What caused you to feel this way about generic drugs?

3. Who or what has the most influence on whether or not you take generic drugs?
a. How do each of the following groups or factors influence which drugs you take, both
brand and generic drugs? [Ask only those key groups or factors that were not
discussed in question 3]?
i. Physician
ii. Pharmacy
iii. Insurance
4. How do you learn if a generic alternative to a brand you have either been prescribed or had
filled is available?
a. Do you ever ask your physician or pharmacist if a generic alternative to the brand is
available?
5. What information or source of information could cause your views on the safety of generic
drugs to change? How about on how well they work?
Information Needs
Now I would like to turn to how you got information about X and how you would have preferred to
receive the information or would like to get information about generic drugs in the future. Why don’t we
start by discussing…
1. What kind of information did your physician/pharmacist provide you when s/he prescribed you
X? [Fill in drug name based on the name of one of the most recent generic drug prescriptions
taken]
a. How did s/he give you that information, for instance was it told to you or were you
given a pamphlet?
2. What information about X would have been helpful when it was being prescribed? [Fill in drug
name based on the name of one of the most recent generic drug prescriptions taken]
3. How would you have preferred to receive the information about X? [Fill in drug name based on
the name of one of the most recent generic drug prescriptions taken] Would you have
preferred it being told to you and in a pamphlet, online, or another way?
4. What are other ways you have gotten information related to X when you needed it?
5. How would additional information or information provided in other ways influence your views
on generic drugs?
6. Do you have any suggestions on how to make information about generic drugs easier to get for
patients like you?
a. How about making the information stand out amongst the large amount of information
you receive about all kinds of generic drugs?

FDA Educating Groups Influencing Generic Drug Use
Telephone Key Informant Interview Guide- Caregivers
Date:
Participant Number:
Interviewer:
Overview of Purpose of Call and Introductions
1. Provide a brief description of what you'll be doing today and ask the participant if they have any
questions.
2. Inform the participant that we like to record these calls for transcripts that we use in analysis.
Assure them their individual names won't be reported, although we may highlight quotes or
other information about specific programs in our reports. Ask for their permission to record.
If permission is granted, START RECORDING!
Background
First, I would like to know a bit about your role as a caregiver…
1. Are you providing care for a friend or family member?
2. How long have you been providing care on her/his behalf?
3. Have you helped her/him in making medical decisions, such as getting or filling prescriptions?
Now, I would like to ask a few questions about her/his medications…
4. What generic drug(s) has s/he taken within the last six months?
a. Is s/he currently taking X? [Fill in drug name based on the name of one of the most
recent generic drug prescriptions taken]
i. If so, how long have s/he been taking X? [Fill in drug name based on the name
of one of the most recent generic drug prescriptions taken]
ii. If not, how long did s/he take X? [Fill in drug name based on the name of one
of the most recent generic drug prescriptions taken]
iii. If not, why did s/he stop taking X? [Fill in drug name based on the name of one
of the most recent generic drug prescriptions taken]
iv. Is s/he currently taking something else instead of X? [Fill in drug name based on
the name of one of the most recent generic drug prescriptions taken]
5. Was X prescribed to her/him by her/his physician or did her/his pharmacist suggest taking X as
an alternative to the brand drug prescribed to her/him by her/his physician? [Fill in drug name
based on the name of one of the most recent generic drug prescriptions taken]
6. Were you present when the prescription was being made or filled?

a. If so, did [name’s] physician or pharmacist discuss the prescription with [name] or with
both of you? [Fill in the care recipient’s name based on the information provided
above]
b. If not, why not?
i. Are you usually present?
ii. Have you been involved in the discussion with [name] regarding a prescription?
[Fill in the care recipient’s name based on the information provided above]
Beliefs
Next, I would like to switch topics and ask you a few questions regarding your views on generic drugs.
1. Do you think generics are as safe and work as well as brand name drugs? Why or why not?
2. What caused you to feel this way about generic drugs?
3. Who or what has the most influence on whether or not [name] takes a generic drug?
a. How do each of the following groups or factors influence which drugs [name] takes,
both brand and generic drugs? [Ask only those key groups or factors that were not
discussed in question 3]?
i. Physician
ii. Pharmacy
iii. Insurance
4. How do you or [name] learn if a generic alternative to a brand you have either been prescribed
or had filled is available? [Fill in the care recipient’s name based on the information provided
above]
a. Do you ever ask [name’s] physician or pharmacist if a generic alternative to the brand is
available? [Fill in the care recipient’s name based on the information provided above]
5. What information or source of information could cause your views on the safety of generic
drugs to change? How about on how well they work?
Information Needs
Now I would like to turn to how you got information about X [Fill in drug name based on the name of
one of the most recent generic drug prescriptions taken]and how you would have preferred to receive
the information or would like to get information about generic drugs in the future for [name]. Why don’t
we start by discussing…
1. What kind of information did [name] physician/pharmacist provide you when s/he prescribed
her/him X? [Fill in the care recipient’s name and recent prescription drug based on the
information provided above]
a. How did the physician or pharmacist give you that information, for instance was it told
to you or were you given a pamphlet?
2. What information about X would have been helpful when [name] was prescribed X? [Fill in drug
name based on the name of one of the most recent generic drug prescriptions taken]

3. How would you have preferred to receive the information about X? [Fill in drug name based on
the name of one of the most recent generic drug prescriptions taken] Would you have
preferred it being told to you and in a pamphlet, online, or another way?
4. What are other ways you have gotten information related to X when you needed it? [Fill in drug
name based on the name of one of the most recent generic drug prescriptions taken]
5. How would additional information or information provided in other ways influence your views
on generic drugs?
6. Do you have any suggestions on how to make information about generic drugs easier to get for
patients like [name] and caregivers like yourself?
a. How about making the information stand out amongst the large amount of information
you receive about all kinds of generic drugs?

FDA Educating Groups Influencing Generic Drug Use
Telephone Key Informant Interview Guide- Physicians
Date:
Participant Number:
Interviewer:
Overview of Purpose of Call and Introductions
1. Provide a brief description of what you'll be doing today and ask the participant if they have any
questions.
2. Inform the participant that we like to record these calls for transcripts that we use in analysis.
Assure them their individual names won't be reported, although we may highlight quotes or
other information about specific programs in our reports. Ask for their permission to record.
If permission is granted, START RECORDING!
Background
First, I would like to know a bit about your generic drug prescribing patterns.
1. Have you ever prescribed a patient a generic drug(s)?
a. If so, have you prescribed a patient a generic drug(s) in the last month?
i. What were the last three generic drugs you’ve prescribed?
1. How long have you been prescribing X [pick one of the three to focus on
for this question]?
2. How often do you prescribe X [the name of the drug selected for
question 1 above]?
b. If not, why not? [Skip to beliefs section]
Beliefs
Next, I would like to switch topics and ask you a few questions regarding your views on generic drugs.
1. Do you think generics are as effective and safe as brand name drugs? Why or why not?
a. If not, what could be done to make generics as effective as brand name drugs? What
about as safe?
2. Who or what has the most influence on whether or not you prescribe generic drugs?
a. How about what types or categories of generic drugs you prescribe, who or what has
the most influence on what type or category of generic drug you prescribe?
i. Can you describe how each of these factors or groups influence they type or
category of generic drug you prescribe?

b. How do each of the following groups or factors influence which drugs you prescribe,
both brand and generic drugs [ask only those key groups that were not discussed in
question a above]?
i. Policy/policymakers
ii. Patients and/or caregivers
iii. Pharmaceutical companies
iv. Insurance providers including Medicare and Medicaid
v. Colleagues/other physicians
vi. Wholesalers or corporate distributers
3. Have you ever prescribed generic drugs as per a patient’s suggestion/preference? Please
describe.
4. What information or source of information could cause your views on the effectiveness and
safety of generic drugs to change?
Information Needs
Now I would like to turn to how you got information about X drug and how you would have preferred to
receive the information or would like to get information about other generic drugs in the future. Why
don’t we start by discussing…
1. Where do you receive information regarding the generic drugs you recently prescribed?
a. How did you receive that information, for instance was the information shared with you
verbally or did you receive written material on the drug’s effectiveness and safety?
i. By/from whom?
b. How would you have preferred to receive the information about these generic drugs?
Would you have preferred it being shared with you in a presentation, pamphlet, online,
publication, or another way?
c. What information about these drugs was helpful when you prescribed it?
d. What are other ways have you gotten information related to other generic drugs when
you needed it?
e. How would additional information or information provided in other ways influence your
views on which drugs to prescribe?
f. Do you have any suggestions on how to make information about generic drugs easier to
get for physicians like you?
i. How about making the information stand out amongst the large amount of
information you receive about various generic drugs available?
2. How about brand name drugs? Where do you receive information regarding the brand name
drugs you recently prescribed?
a. Is there a method you would have preferred receiving the information in, such as in a
presentation, pamphlet, online, publication, or another way?
b. What information about brand name drugs is the most helpful in your decision to
prescribe them?

c. How would additional information or information provided in other ways about generic
alternatives influence your views on which drugs to prescribe?

FDA Educating Groups Influencing Generic Drug Use
Telephone Key Informant Interview Guide- Pharmacists
Date:
Participant Number:
Interviewer:
Overview of Purpose of Call and Introductions
1. Provide a brief description of what you'll be doing today and ask the partipant if they have any
questions.
2. Inform the participant that we like to record these calls for transcripts that we use in analysis.
Assure them their individual names won't be reported, although we may highlight quotes or
other information about specific programs in our reports. Ask for their permission to record.
If permission is granted, START RECORDING!
Background
First, I would like to know a bit about your generic drug advising patterns.
1. Approximately how many prescriptions does your pharmacy dispense each day?
a. Approximately what proportion of the prescriptions dispensed is generic?
2. Have you ever advised a patient to take a generic drug(s) alternative upon receiving a
prescription for the brand-name equivalent?
a. If so, please describe
b. If not, why not?
Beliefs
Next, I would like to switch topics and ask you a few questions regarding your views on generic drugs.
1. Do you think generics are as effective and safe as brand name drugs? Why or why not?
a. If not, what could be done to make generics as effective as brand name drugs? What
about as safe?
2. Who or what has the most influence on whether or not you dispense generic drugs?
a. How about what types or categories of generic drugs you advise, who or what has the
most influence on what type or category of generic drug you advise?
i. Can you describe how each of these factors or groups influence they type or
category of generic drug you prescribe?
b. How do each of the following groups or factors influence which drugs you prescribe,
both brand and generic drugs [ask only those key groups that were not discussed in
question a above]?

i. Physicians
ii. Policy/policymakers
iii. Patients and/or caregivers
iv. Pharmaceutical companies
v. Insurance providers including Medicare and Medicaid
vi. Colleagues/other pharmacists
vii. Wholesalers or corporate distributers
3. Have you ever modified a prescription to a generic as per a patient’s suggestion/preference?
Please describe.
4. What information or source of information could cause your views on the effectiveness and
safety of generic drugs you dispense to change?
Information Needs
Now I would like to turn to how you got information about X drug and how you would have preferred to
receive the information or would like to get information about other generic drugs in the future. Why
don’t we start by discussing…
1. Where do you receive information regarding the generic drugs you recently dispensed?
a. How did you receive that information, for instance was the information shared with you
verbally or did you receive written material on the drug’s effectiveness and safety?
i. By whom?
b. How would you have preferred to receive the information about these generic drugs?
Would you have preferred it being shared with you in a presentation, pamphlet, online,
publication, or another way?
c. What information about these drugs was helpful when you dispensed or advised it?
d. What are other ways have you gotten information related to other generic drugs when
you needed it?
e. How would additional information or information provided in other ways influence your
views on which drugs to dispense or advise?
f. Do you have any suggestions on how to make information about generic drugs easier to
get for pharmacists like you?
i. How about making the information stand out amongst the large amount of
information you receive about various generic drugs available?
2. How about brand name drugs? Where do you receive information regarding the brand name
drugs you recently prescribed?
a. Is there a method you would have preferred receiving the information in, such as in a
presentation, pamphlet, online, publication, or another way?
b. What information about brand name drugs is the most helpful in your decision to
dispense or advise them?
c. How would additional information or information provided in other ways about generic
alternatives influence your views on which drugs to dispense or advise patients to
choose?

FDA Educating Groups Influencing Generic Drug Use
Telephone Key Informant Interview Guide- Formulary Managers
Date:
Participant Number:
Interviewer:
Overview of Purpose of Call and Introductions
1. Provide a brief description of what you'll be doing today and ask the participant if they have any
questions.
2. Inform the participant that we like to record these calls for transcripts that we use in analysis.
Assure them their individual names won't be reported, although we may highlight quotes or
other information about specific programs in our reports. Ask for their permission to record.
If permission is granted, START RECORDING!
Background
First, I would like to know a bit about how the process works for getting generic drugs from
manufacturers to patients.
1.
2.
3.
4.

5.
6.
7.
8.
9.

Could you please describe the process?
What is your role in this process?
Which groups do you think your role in this process impacts?
What type of formulary do you manage? [If not answered as part of the response to question 2
above]
a. How did you come to manage this formulary?
b. Have you previously held other positions in which you managed a formulary?
c. Have you held any other positions in which you played an integral role in the utilization
of generic drugs?
What is the role of large purchasers in generic drug utilization?
What is the role of physicians in generic drug utilization?
What is the role of pharmacists in generic drug utilization?
What is the role of patients in generic drug utilization?
What is the role of policymakers in generic drug utilization?

Beliefs
Next, I would like to switch topics and ask you a few questions regarding your views on generic drugs.
1. Do you think generics are as effective and safe as brand name drugs? Why or why not?

2.

3.
4.

5.
6.

a. If not, what could be done to make generics as effective as brand name drugs? What
about as safe?
Who or what do you believe has the most influence on inclusion of a generic drug on
formularies over their brand alternative? Why?
a. How about what types of generic drugs are included, who or what has the most
influence on policymakers in deciding what type or category of generic drug is
prescribed and ultimately dispensed?
Are there ever circumstances when formulary managers like yourself prefer brand drugs over
their generic alternatives? Please describe.
What role does cost have on generic drug utilization?
a. May you provide a few examples?
b. How about on the decisions regarding formularies?
What information or source of information could cause the views of the effectiveness and safety
of generic drugs to change?
What information or source of information do you feel would have the greatest impact on
generic drug utilization?

Information Needs
Now I would like to turn to how you got information about generic drugs and what you think would have
been a more effective way to receive that information. Why don’t we start by discussing…
1. Where do you receive information regarding safety and effectiveness or cost savings of generic
drug(s)?
a. How did you receive that information, for instance was the information shared with you
verbally or did you receive written material on the drug’s effectiveness and safety or
cost savings?
i. By whom?
b. How would you prefer to receive information about generic drugs?
i. For example, would you have preferred it being shared with you in a
presentation, pamphlet, online, or another way?
2. What are other ways have you gotten information related to other drugs, such as brand name
drugs, when you needed it?
3. How would additional information or information provided in other ways influence your views
on which generic drugs should be utilized more often?
a. How about other groups, such as physicians, pharmacists, patients, large purchasers or
policymakers?
4. Do you have any suggestions on how to make information about generic drugs easier to get for
formulary managers like yourself?
a. How about making the information stand out amongst the large amount of information
you receive about various generic drugs available?

FDA Educating Groups Influencing Generic Drug Use
Telephone Key Informant Interview Guide- Policymakers
Date:
Participant Number:
Interviewer:
Overview of Purpose of Call and Introductions
1. Provide a brief description of what you'll be doing today and ask the participant if they have any
questions.
2. Inform the participant that we like to record these calls for transcripts that we use in analysis.
Assure them their individual names won't be reported, although we may highlight quotes or
other information about specific programs in our reports. Ask for their permission to record.
If permission is granted, START RECORDING!
Background
First, I would like to know a bit about how the process works for getting generic drugs from
manufacturers to patients.
1. Could you please describe the process?
2. Do policies that your organization is responsible for impact access to generic drugs?
a. If so, may you describe how?

3.

4.
5.
6.
7.
8.

b. If not, what policies other organizations are responsible for have the greatest impact on
access to generic drugs? [Skip question 3]
What is your role in this process for getting generic drugs from manufactures to patients?
a. How does your role fit into the policy that influences the utilization of generic drugs?
i. How long have you been in this role?
ii. Have you held any other positions in which you played an integral role in the
utilization of generic drugs?
b. How many people do you think your role in this process impacts?
What is the role of large purchasers in generic drug utilization?
What is the role of physicians in generic drug utilization?
What is the role of pharmacists in generic drug utilization?
What is the role of patients in generic drug utilization?
What is the role of formulary managers in generic drug utilization?

Beliefs
Next, I would like to switch topics and ask you a few questions regarding your views on generic drugs.

1. Do you think generics are as effective and safe as brand name drugs? Why or why not?
a. If not, what could be done to make generics as effective as brand name drugs? What
about as safe?
2. Who or what do you believe has the most influence on generic drug utilization? Why? And how
does that person or factor impact your decision making on generic drug related policy?
a. How about what types of generic drugs are utilized, who or what has the most influence
on what type of generic drug is prescribed and ultimately dispensed?
b. What role does cost have on policy intended to encourage generic drug utilization?
i. May you provide a few examples?
3. What information or source of information could cause your views on the effectiveness and
safety of generic drugs to change?
4. What information or source of information do you feel would have the greatest impact on
generic drug utilization?
Information Needs
Now I would like to turn to how you got information about generic drugs and what you think would have
been a more effective way to receive that information. Why don’t we start by discussing…
1. Where do you receive information regarding safety and effectiveness or cost savings of generic
drug(s)?
a. How did you receive that information, for instance was the information shared with you
verbally or did you receive written material on the drug’s effectiveness and safety or
cost savings?
i. By whom?
b. How would you prefer to receive information about generic drugs?
i. For example, would you have preferred it being shared with you in a
presentation, pamphlet, online, or another way?
2. What are other ways have you gotten information related to other drugs, such as brand name
drugs, when you needed it?
3. How would additional information or information provided in other ways influence your views
on which generic drugs should be utilized more often?
4. Do you have any suggestions on how to make information about generic drugs easier to get for
policymakers like yourself?
a. How about making the information stand out amongst the large amount of information
you receive about various generic drugs available?

FDA Educating Groups Influencing Generic Drug Use
Telephone Key Informant Interview Guide- Large Purchasers
Date:
Participant Number:
Interviewer:
Overview of Purpose of Call and Introductions
1. Provide a brief description of what you'll be doing today and ask the participant if they have any
questions.
2. Inform the participant that we like to record these calls for transcripts that we use in analysis.
Assure them their individual names won't be reported, although we may highlight quotes or
other information about specific programs in our reports. Ask for their permission to record.
If permission is granted, START RECORDING!
Background
First, I would like to know a bit about how the process works for getting generic drugs from
manufacturers to patients.
1. Could you please describe the process?
2. What is your role in this process?
a. How do you/does your company make decisions about which generics to purchase?
i. Are decisions driven by price or data? Please describe. [If not already
answered]
ii. How do these decisions change as new prices or data become available? [If not
already answered]
b. Which groups or types of people do you think your role in the process for getting
generic drugs from manufacturers to patients impacts?
3. Have you previously held any other positions in which you played an integral role in the
utilization of generic drugs?
4. What is the role of policymakers in generic drug utilization?
5. What is the role of physicians in generic drug utilization?
6. What is the role of pharmacists in generic drug utilization?
7. What is the role of patients in generic drug utilization?
8. What is the role of formulary managers in generic drug utilization?
Beliefs
Next, I would like to switch topics and ask you a few questions regarding your views on generic drugs.

1. Do you think generics are as effective and safe as brand name drugs? Why or why not?
a. If not, what could be done to make generics as effective as brand name drugs? What
about as safe?
2. Who or what has the most influence on generic drug utilization?
a. How about what types or categories of generic drugs utilized, who or what has the most
influence on what types or categories of generic drug that are utilized?
i. Can you describe how each of these factors or groups influences the type or
category of generic drug utilized?
b. How do each of the following groups or factors influence which drugs are utilized, both
brand and generic drugs? [Ask only those key groups that were not discussed in
question a above]
i. Policy/policymakers
ii. Patients and/or caregivers
iii. Pharmaceutical companies
iv. Insurance providers including Medicare and Medicaid
v. Colleagues/other physicians
vi. Wholesalers or corporate distributers
c. What role does cost have on generic drug utilization?
i. May you provide a few examples?
ii. How about on the decisions you or your company make regarding which drugs
or types of drugs to purchase?
3. What information or source of information could cause your views on the effectiveness and
safety of generic drugs to change?
4. What information or source of information do you feel would have the greatest impact on
generic drug utilization?
Information Needs
Now I would like to turn to how you got information about generic drugs your company is purchasing
and what you think would have been a more effective way to receive that information. Why don’t we
start by discussing…
1. Where did you receive information regarding the generic drug(s) your company most recently
purchased?
a. How did you receive that information, for instance was the information shared with you
verbally or did you receive written material on the drug’s effectiveness and safety?
i. By whom?
b. How would you have preferred to receive the information about the generic drugs you
were purchasing? Would you have preferred it being shared with you in a presentation,
pamphlet, online, or another way?
c. What information about generic drugs would be most helpful in deciding which to
purchase for your pharmacy?

2. What are other ways have you gotten information related to other drugs, either brand or other
generic drugs available, when you needed it?
3. How would additional information or information provided in other ways influence your views
on which drugs to purchase?
4. Do you have any suggestions on how to make information about generic drugs easier to get for
large purchasers like your company?
a. How about making the information stand out amongst the large amount of information
you receive about various generic drugs available?