Focus Groups to assess the post-marketing safety of authorized generic drug products

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

Appendix B - Screening_guides_3_30_2016

Focus Groups to assess the post-marketing safety of authorized generic drug products

OMB: 0910-0677

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Focus Group Telephone Screening Guide

Date Completed: ___________
Initials: ___________

Hello, my name is Nazleen Khan. I’m part of the research team at Brigham and Women’s
Hospital leading this project in which we seek to better understand how authorized generic
drugs can be used to improve safety surveillance for generic drug products. We were excited to
hear about your interest in participating in the [Physician/Pharmacist] Workshop. The
workshop is a 1.5-to-2-hour in-person meeting of [physicians who practice in primary
care/pharmacists who practice in retail pharmacy settings]. During this workshop, which will
be conducted as a focus group, topics of discussion will include issues related to authorized
generics, including knowledge of and experience with authorized generics; opinions about
whether, when, and why authorized generics should be preferred over brand-name or other
generic products; and the price premium that should be placed on authorized generics relative to
other products. Participants will be offers a [$250/$150] honorarium.
I’d like to take a few minutes to learn a little bit more about you. The following questions will
help us determine whether you qualify and help ensure a diversity of participants for this
workshop.
1.) Are you a physician who spends at least 50% of your time practicing primary care [or
pharmacist who practices in a retail pharmacy setting]?
___________________________________________________________________________
___________________________________________________________________________
If yes: continue to question 2.
If no: “Thank you for your interest in participating. However, we are seeking physicians who
spend at least 50% of their time practicing primary care [We are seeking pharmacist who
practice in a retail pharmacy setting]. Thank you for your time. Good bye.
2.) The in-person focus groups will be held in Boston. Do you practice in the Boston area?
______________________________________________________________________________
______________________________________________________________________________
If yes: continue to question 3.
If no: “Thank you for your interest in participating. However, we are seeking physicians who
practice in the Boston area [We are seeking pharmacist who practice the Boston area]. Thank
you for your time. Good bye.
3.) The focus group will be held at our offices, which are located at 1620 Tremont Street in
Boston. Will you be able to travel to our facility to participate in the focus group?
______________________________________________________________________________
______________________________________________________________________________
If yes: continue to question 4.

If no: “Thank you for your interest in participating. However, individuals will need to be able to
travel to our facility for the in-person focus group. Thank you for your time. Good bye.
4.) We anticipate that the workshop will be held in [Month]. Can you tell me which days you are
available? Or, can you provide me with the contact information for the person who manages
your schedule so that we can begin the process of finding a mutually convenient time for all of
the participants?
______________________________________________________________________________
______________________________________________________________________________
Thank you. You are eligible for the focus group. We will contact you by email within the next
two weeks to finalize the date and time of the focus group. If you have any questions in the
interim, please do not hesitate to contact me.
If individual is not available in [month]: “Thank you for your interest in participating. Please
let us know if your availability changes. May we contact you if we plan for a different month?
______________________________________________________________________________
______________________________________________________________________________
Thank you for your time. Good bye.

Focus Group Email Screening Guide

Subject: Authorized Generics [Physician/Pharmacist] focus group screening
Dear [Mr./Ms./Dr. X],
On behalf of our research team at Brigham and Women’s Hospital and Harvard Medical School,
thank you for your interest in participating in our focus group in which we seek to better
understand how authorized generic drugs can be used to improve safety surveillance for generic
drug products. The focus group is a 1.5-to-2-hour in-person meeting of [physicians who practice
in primary care/pharmacists who practice in retail pharmacy settings]. During focus group,
topics of discussion will include issues related to authorized generics, including knowledge of
and experience with authorized generics; opinions about whether, when, and why authorized
generics should be preferred over brand-name or other generic products; and the price premium
that should be placed on authorized generics relative to other products. Participants will be
offered a [$250/$150] honorarium.
Please complete the following questions, which will help us determine whether you qualify for
the focus group.
1.) Are you a [physician who spends at least 50% of your time practicing primary care/
pharmacist who practices in a retail pharmacy setting]? (Yes or No)
2.) The in-person focus groups will be held in Boston. Do you practice in the Boston area? (Yes
or No)
3.) The focus group will be held at our offices, which are located at 1620 Tremont Street in
Boston. Will you be able to travel to our facility to participate in the focus group? (Yes or No)
4.) We anticipate that the workshop will be held in [Month]. Please indicate which days you are
available. Or, please provide the contact information for the person who manages your schedule
so that we can begin the process of finding a mutually convenient time for all of the participants.
We will respond within two business days to confirm your eligibility.
Sincerely,
Nazleen Khan

Follow-up Email
Subject: CONFIRMATION: Authorized Generics [Physician/Pharmacist] focus group
Dear [Mr./Ms./Dr. X],
If eligible: I wanted to confirm your eligibility at the [Physician/Pharmacist] focus group at
Brigham and Women’s Hospital in [month]. We will be back in touch with you within the next
two weeks to finalize the date and time of the focus group.
If not eligible: Thank you for your interest in our project. [provide appropriate response below]
•

Unfortunately, you are not eligible to participate in the focus group. [We are seeking
physicians who spend at least 50% of their time practicing primary care./We are seeking
pharmacist who practice in a retail pharmacy setting.]

•

Unfortunately, you are not eligible to participate in the focus group. [We are seeking
physicians who practice in the Boston area./We are seeking pharmacist who practice the
Boston area.]

•

Unfortunately, you are not eligible to participate in the focus group. Individuals will need to
be able to travel to our facility for the in-person focus group.

•

We are sorry that [month] will not work for you. Please let us know if your availability
changes. We will get back in touch with you if we plan for a different month.

For any additional questions, please feel free to contact me at (617) 278-0930 or by e-mail at
[email].
Sincerely,
Nazleen Khan

Focus group Confirmation E-mail (to be sent to all eligible participants)
Subject: CONFIRMATION: Authorized Generics [Physician/Pharmacist] focus group
Dear [Mr./Ms./Dr. X],
On behalf of the US Food and Drug Administration and my research team at Brigham and
Women’s Hospital and Harvard Medical School, I want to thank you for assisting us in our focus
group on authorized generic drugs. We wanted to confirm that the focus group will be held:
[Date: XX
Time: XX
Location: XX]
For any additional questions, please feel free to contact me at (617) 278-0930 or by e-mail at
[email].
We look forward to seeing you at the focus group!
Sincerely,
Nazleen Khan

Focus group Reminder E-mail (to be sent to all eligible participants)
Subject: FINAL REMINDER: Authorized Generics [Physician/Pharmacist] focus group
Message Send Date: [Three business days prior to meeting]
Dear [Mr./Ms./Dr. X],
The Authorized Generics focus group is just around the corner! As a reminder, the meeting
details are:
[Date: XX
Time: XX
Location: XX]
For any additional questions, please feel free to contact me at (617) 278-0930 or by e-mail at
[email].
We look forward to seeing you at the focus group!
Sincerely,
Nazleen Khan


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