Generic Drug Substitution in Special Populations

Focus Groups About Drug Products As Used by The Food and Drug Administration

Appendix A - Recruitment mailer_7_7_2017

Generic Drug Substitution in Special Populations

OMB: 0910-0677

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Appendix A

Recruitment Scrips for Focus Groups

2 versions:

Screeners – pharmacists/physicians
Screeners – patients/caregivers

Interview Recruitment
The Auburn University/IMPAQ research team will develop a list of
prescribers, pharmacists, and patients for recruitment. Participants for
these three groups will be identified in collaboration with the FDA and no
formal screeners will be utilized in identifying members for these three
groups. More targeted, informal recruitment will be conducted with these
three groups in order to allow the research team to better identify
participants from various stages of generic drug utilization (i.e. prescribers
and pharmacists) and members of targeted special populations (i.e. older
adults and caregivers of pediatric patients).

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Name __________________________________Phone _____________________ 
Address _______________________________Phone 2 ___________________ 
City/ State/ Zip ______________________Recruiter ___________________ 

INTRODUCTION 
Hello, my name is ____________ and I am calling from Baltimore Research. We are an independent 
marketing research firm located in Towson, Maryland. Today we are inviting a select group of people to 
discuss their experience communicating drug information and administration instructions to special 
patient populations taking generic medications for an FDA funded study. Let me assure you that this is a 
professional research study and not sales related in any way. If you qualify, you will receive financial 
compensation for your time and input. May I ask you a few questions to see if you qualify? 
1. Record Gender (DO NOT ASK)
Male
Female
2. Record age ________
3. What is your role in medication utilization? (SELECT ONE ANSWER)
Prescriber/Physician
Dispenser/Pharmacist

RECRUIT AT LEAST 10 TOTAL, 5 PRESCRIBERS/PHYSICIANS AND 5 DISPENSERS/PHARMACISTS.  

4. What is your level of certification within your specialty? (SELECT ONE)
Board certified
Board eligible
Pharmacy Cert (PHARM ONLY)
None of the above

1
2
3
4

5. How many years have you been in practice post-residency or post-training (for older pharmacists
with only a BS degree)? (DO NOT ACCEPT RANGE)
______ Years
Physic ONLY- Pharm skip to 10
6. What is your specialty?
7. What proportion of your professional time do you spend performing each of the following
activities? (Doctor)

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Direct patient care
Research
Teaching
Administrative duties
Other

%
%
%
%
%

8. Are you primarily based in a (SELECT ONE)
Hospital OR other institutional setting
Community setting
Other

RECRUIT AT LEAST 2 HOSPITAL/INSTITUTITIONAL‐BASED AND 2 COMMUNITY‐BASED Prescribers 

9. Have you prescribed a medication within the last month?
Yes
No

CONTINUE TO 8A
THANK & TERMINATE

9a. Have you prescribed a medication within the last month to an adult over the age of 65 or
younger than 18?
Yes
No

CONTINUE TO 9B
THANK & TERMINATE

9b. What was the last generic drug you prescribed to a patient in each age group (i.e. over the
age of 65 and younger than 22?
__________________________________________________

Pharm Only
10. What proportion of your professional time do you spend performing each of the following
activities? (Pharmacist)
Direct patient care
Research
Teaching
Administrative duties
Other

%
%
%
%
%

11. Are you primarily based in a (SELECT ONE)
Hospital
Clinic

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Large Retail Pharmacy
Independent Pharmacy
Other

RECRUIT AT LEAST 1 HOSPITAL‐BASED AND 1 LARGE RETAILER AND 1 COMMUNITY‐BASED 
12. Have you dispensed a medication within the last month?
Yes
No

CONTINUE
THANK & TERMINATE

12a. Have you dispensed a medication within the last month to an adult over the age of 65 or
younger than 18?
Yes
No

CONTINUE TO 11B
THANK & TERMINATE

12b. What was the last generic drug you dispensed to a patient in each age group (i.e. over the
age of 65 and younger than 22?

INVITATION: Thank you for answering my questions. I’m pleased to inform you that you do qualify to
participate in our study. Researchers from Auburn University and IMPAQ International are conducting 60minute in-person discussion on DATE TBD. You will be speaking with a professional researcher about
your experience communicating drug information and administration instructions to special patient 
populations taking generic medications which we expect would be both fun and interesting. For your
time, we would be able to offer you $___ upon completion of the session. Would you be interested in
participating?




Yes CONTINUE
No THANK & TERMINATE

We will be sending you a letter with additional information related to the study and your role as a 
participant. The letter is yours to keep and if you have any questions you may feel free to reach out to 
one of the researchers listed on the letter. Would you like us to send the letter electronically via email, 
in the mail or both?  
RECRUITER NOTE: TAKE DOWN INFORMATION AND PREFERENCE TO SEND LETTER.  

RECRUITER NOTE: TERMINATION LANGUAGE “Unfortunately, you do not qualify for this study. Thank

you for taking the time to answer my questions today. We’ll be in contact with future research
opportunities.”

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RECRUITER NOTE: PLEASE ONLY RECRUIT ARTICULATE AND CHATTY RESPONDENTS. DO NOT
HESITATE TO TERMINATE A RESPONDENT WHO YOU DO NOT BELIEVE WILL CONTRIBUTE INSIGHTFUL
INFORMATION TO THE DISCUSSION.

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Name __________________________________Phone _____________________ 
Address _______________________________Phone 2 ___________________ 
City/ State/ Zip ______________________Recruiter ___________________ 
 
INTRODUCTION 
Hello, my name is ____________ and I am calling from Baltimore Research. We are an independent 
marketing research firm located in Towson, Maryland. Today we are inviting a select group of people to 
discuss the information you are provided on your drug labels and the information shared with you by 
your physician and pharmacist about your medications. Let me assure you that this is a professional 
research study and not sales related in any way. If you qualify, you will receive financial compensation 
for your time and input. May I ask you a few questions to see if you qualify? 
1. RECORD GENDER. DO NOT ASK. 
 Male 
 Female 
RECRUIT AT LEAST 5 FEMALES & 5 MALES  
2. Which range does your age fall into? 
 Under 19 THANK & TERMINATE 
 Between 19 and 64 CONTINUE 
 65 or older CONTINUE 
 Refused THANK & TERMINATE 
FOR FOCUS GROUP 1 (OLDER ADULTS) RECRUIT AT LEAST 10 PARTICIPANTS 65 OR OLDER. FOR FOCUS 
GROUP 2 (PEDIATRICS) RECRUIT 10 PARTICIPANTS AT OR OVER THE AGE OF 19.    
3. Have you been prescribed a medication within the last month? 
 Yes SKIP TO Q4 
 No CONTINUE TO Q3a 
 
a. Are you the parent or guardian or currently caring for someone under the age of 18 who has 
been prescribed a medication within the last month? 
 Yes SKIP TO Q4 
 No THANK & TERMINATE 
FOR FOCUS GROUP 2 (PEDIATRICS) RECRUIT AT LEAST 10 CAREGIVERS OF CHILDREN 18 AND YOUNGER 
THE FOLLOWING QUESTIONS ARE FOR CLASSIFICATION PURPOSES ONLY 

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RECRUITER NOTE: PLEASE INFORM POTENTIAL PARTICIPANTS THAT THE FOLLOWING QUESTIONS WILL 
BE USED FOR CLASSIFICATION PURPOSES ONLY.  
4. Which best describes your race?
 White or Caucasian CONTINUE
 Black or African American CONTINUE
 Asian CONTINUE
 American Indian or Alaska Native CONTINUE
 Native Hawaiian or other Pacific Islander CONTINUE
 Some other race CONTINUE
 Two or more races CONTINUE
 Refused THANK & TERMINATE
RECRUIT A REPRESENTATIVE MIX 
5. Which best describes your employment situation?
 Employed Full‐Time  CONTINUE
 Employed Part‐Time CONTINUE
 Do not work outside the home CONTINUE
 Retired CONTINUE
 Laid off or unemployed CONTINUE
 Refused THANK & TERMINATE
RECRUIT A MIX 
6. Which best describes your education level?
 Some high school CONTINUE
 High school diploma/GED CONTINUE
 Some college CONTINUE
 Bachelor’s degree CONTINUE
 Graduate degree CONTINUE
 Refused THANK & TERMINATE
RECRUIT A MIX 

INVITATION: Thank you for answering my questions. I’m pleased to inform you that you do qualify to 
participate in our study. Researchers from Auburn University and IMPAQ International are conducting 
60‐minute in‐person discussion on DATE TBD. If you participate, you will be speaking with a professional 
researcher about your opinions about the information you are provided about your medications which 
we expect would be both fun and interesting. For your time, we would be able to offer you $75 upon 
completion of the session. Would you be interested in participating? 

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


Yes CONTINUE
No THANK & TERMINATE

We will be sending you a letter with additional information related to the study and your rights and role 
as a participant. The letter is yours to keep and if you have any questions you may feel free to reach out 
to one of the researchers listed on the letter. Would you like us to send the letter electronically via 
email, in the mail or both?  
RECRUITER NOTE: TAKE DOWN INFORMATION AND PREFERENCE TO SEND LETTER.  
RECRUITER NOTE: TERMINATION LANGUAGE “Unfortunately, you do not qualify for this study. Thank

you for taking the time to answer my questions today. We’ll be in contact with future research
opportunities.”

RECRUITER NOTE: PLEASE ONLY RECRUIT ARTICULATE AND CHATTY RESPONDENTS. DO NOT HESITATE 
TO TERMINATE A RESPONDENT WHO YOU DO NOT BELIEVE WILL CONTRIBUTE INSIGHTFUL 
INFORMATION TO THE DISCUSSION. 


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