Study Product Return
Re-Supply and Re-Issue
MTN-003 Study-Specific Training
Overview of Presentation
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Some Definitions
Review of Visit Flow
Study Product Return
Study Product Hold/Discontinuation
Study Product Re-Supply
Study Product Re-Issue
Some Examples for Discussion
Definitions

Study Product Return

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Refers to participants bringing their unused
study product to follow-up visits for counting
at the site pharmacy
Returned product may either be retained in
the pharmacy or re-issued to the participant
Definitions

Study Product Re-Supply

Refers to dispensing new supplies of study
product

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Tablets re-supplied in
quantities of 30
Gel usually re-supplied in
quantities of 30 but may
be re-supplied in quantities
of 10 or 20
Definitions
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Study Product Re-Issue

Refers to providing participants with their
own previously returned study product
Visit Flow
Participant
presents to the site
clinic and registers.
Clinic staff complete
clinic procedures with
participant, including
adherence counseling and
scheduling of next visit.
CLINIC
PHARMACY
Clinic staff order
additional study
product for participant
and communicate the
participant's next
scheduled visit date to
pharmacy staff.
Participant delivers
unused study product to
the pharmacy.
Participant obtains
study product at the
pharmacy.
Pharmacy staff perform
unused product count and
provide count details to
clinic staff. If needed,
pharmacy staff query
participant about product
condition and product use
since the last visit.
Pharmacy staff
provide counseling as
needed.
Participant returns
to clinic for
check-out and
reimbursement,
then departs.
Study Product Return
Participants instructed to bring all
unused product to all visits
 Pharmacy staff count returned
product and determine quantity:
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Expected to be returned
Actually returned
Available for re-issue
Product Eligible for Re-Issue
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Pharmacy staff will determine based on
factors such as:
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Physical condition
Expiry Dates
 Oral: 30 days after bottle is opened
 Gel: 60 days after dispensed
 Indicated by “do not use after” date
Key counseling message:
Use re-issued product first
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4
4
6
6
4
4
Comments:
Only four of each tablet are available for re-issue
before the “do not use after” date (2 APR 2010).
Remind participant to take re-issued product
first, then open new bottles.
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3
3
2
3
2
2
Comments:
All of the tablets returned are in good condition.
However, an unequal number of TDF/placebo and
FTC/TDF or placebo were returned, therefore the most
available for re-issue is 2 of each tablet.
4
0
0
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Comments:
Four gels were expected to be returned, but none were
actually returned. Participant stated she did not
accidentally leave at home, but suspects that her sister
may have used some of her gels.
1
4
2
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Comments:
Of 4 gels returned, 2 were damaged.
Therefore only 2 applicators are available
for re-issue
Study Product Return
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Clinic staff use information recorded on
the Study Product Returns Form to
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Guide adherence counseling
Guide the ordering of study product to be
re-supplied and re-issued
Study Product Re-Supply
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At each follow-up visit, authorized clinic staff
must assess participant eligibility to continue
product use
For those NOT eligible, product use is
temporarily held or permanently discontinued
Document fully in participant’s clinic records
Inform pharmacy
Study Product Retrieval
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For participants NOT eligible to continue
product use, product retrieval may be
required, if participant did not bring all
unused product to her visit
Retrieval may be done by
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Participant returning product
Study staff conducting outreach to retrieve
product from participant
Study Product Retrieval
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See protocol Section 6.6 for retrieval
requirements
24 hours for HIV (oral & vaginal)
24 hours for Grade 3+ liver or renal toxicity (oral)
otherwise 5-7 days working days (oral & vaginal)

Inform Protocol Safety Review Team if
product not retrieved within timeframe
Study Product Re-Supply
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For participants eligible to continue product use,
authorized clinic staff determine quantity of
product needed until next visit
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Usually 30-day supply
Up to 60-day supply permitted at IoR discretion
More than 60-day supply requires approval of
DAIDS Medical Officer (see SSP Section 9)
Study Product Request Slip
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For signatures, follow local regulations on:
 Staff authorized to “prescribe” vs “re-supply”
 How often an authorized prescriber must sign
 NB: Authorized prescriber must sign for all
resumptions
Document authorizations on staff roster and
maintain current listings of staff in each category
Study Product Re-Issue
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For participants eligible to continue product use,
authorized clinic staff determine quantity of
product needed until next visit
Total amount = re-supply + re-issue
To determine total amount, consider
 Number of days until next visit
 Standard re-supply quantities (30
tablets/bottle; 10 gels/carton)
 Quantity available for re-issue
Ideal Quantity

Unless specific concerns are identified by
the IoR or designee, aim to provide the
larger of these two quantities
Quantity needed for daily use through
the next scheduled visit date, plus 7
days
or
 Quantity needed for daily use through
the next target visit date, plus 7 days
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Minimum Quantity
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At a minimum, participants must be
provided with enough study product for
daily use until their next scheduled study
visit
Ideal is ideal,
minimum is required
Study Product Re-Supply
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For example, if next visit is targeted to take place
in 28 days, but is scheduled to take place in 29
days, aim to provide a 36-day supply (29+7=36)
That is, ideally re-supply 30 and re-issue 6 if
available from the participant’s returns
At a minimum, a 29-day supply is required
Remember Expiry: Instruct and counsel
participant to use re-issued product first
Example #1
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Today’s visit date = 1 SEP 09
Unused Product Returns slip indicates 2 TDF and
2 TDF/FTC tablets available for re-issue
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Target date for next visit is Sunday, 27 SEP 09
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Scheduled date for next visit is Friday, 25 SEP 09
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What is the ideal quantity of product to provide to
the participant at today’s visit?
How much would you re-supply and how much
would you re-issue?
Example #1
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Today’s visit date = 1 SEP 09

The next visit’s Target Date is 27 SEP 09
What is the number of days from today to the target date?
1.
2.
3.
4.
24
25
26
28
SUN
MON
Example #1
TUE
1
WED
2
THU
FRI
SAT
3
4
5
Start
Count
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Target
Date
Example #1
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Today’s visit date = 1 SEP 09
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The next visit’s Scheduled Date is 25 SEP 09
What is the number of days from today to the scheduled
date?
1.
2.
3.
4.
23
24
26
27
SUN
MON
Example #1
TUE
1
WED
2
THU
FRI
SAT
3
4
5
Start
Count
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Scheduled
Date
27
28
29
30
Example #1
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Today’s visit date = 1 SEP 09
The next visit’s Target Date is 27 SEP 09
(26 days from today)
The next visit’s Scheduled Date is 25 SEP 09
(24 days from today)
What is the ideal quantity of product to provide to the
participant at today’s visit?
1.
2.
3.
4.
31
33
37
30
SUN
MON
Example #1
TUE
1
WED
2
THU
FRI
SAT
3
4
5
Start
Count
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Target
Date
Correct answer
26+7=33
Example #1
Today’s visit date = 1 SEP 09
 Unused Product Returns Form indicates 2 TDF and
2 TDF/FTC tablets available for re-issue
 The next visit’s Target Date is 27 SEP 09
 The next visit’s Scheduled Date is 25 SEP 09
 The ideal quantity of product to provide is 33
How much would you re-supply and how much would you
re-issue?
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1.
2.
3.
4.
Re-supply
Re-supply
Re-supply
Re-supply
2, Re-issue 30
3, Re-issue 30
31, Re-issue 2
30, Re-issue 2
Example #2
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Today’s visit date = 1 SEP 09
Unused Product Returns Form indicates 8 applicators
available for re-issue
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The next visit’s Target Date is Saturday, 26 SEP 09
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The next visit’s Scheduled Date is Monday, 28 SEP 09

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What is the ideal quantity of product to provide to
the participant at today’s visit?
How much would you re-supply and how much
would you re-issue?
Example #2

Today’s visit date = 1 SEP 09

The next visit’s Target Date is 26 SEP 09
What is the number of days from today?
1.
2.
3.
4.
24
25
26
28
SUN
MON
Example #2
TUE
1
WED
2
THU
FRI
SAT
3
4
5
Start
Count
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Target
Date
27
28
29
30
Example #2
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Today’s visit date = 1 SEP 09

The next visit’s Scheduled Date is 28 SEP 09
What is the number of days from today?
1.
2.
3.
4.
23
24
26
27
SUN
MON
Example #2
TUE
1
WED
2
THU
FRI
SAT
3
4
5
Start
Count
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Scheduled
Date
Example #2
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Today’s visit date = 1 SEP 09

The next visit’s Target Date is 26 SEP 09

The next visit’s Scheduled Date is 28 SEP 09
What is the ideal quantity of product to provide to the
participant at today’s visit?
1.
2.
3.
4.
31
34
37
30
SUN
MON
Example #2
TUE
1
WED
2
THU
FRI
SAT
3
4
5
Start
Count
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Scheduled
Date
Correct answer
27+7=34
Example #2
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Today’s visit date = 1 SEP 09
Unused Product Returns Form indicates 8 applicators
available for re-issue

The next visit’s Target Date is 26 SEP 09

The next visit’s Scheduled Date is 28 SEP 09
How much would you re-supply and how much would you
re-issue?
1.
2.
3.
4.
Re-supply
Re-supply
Re-supply
Re-supply
26, Re-issue 8
4, Re-issue 30
30, Re-issue 4
30, Re-issue 8
Example #3
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Today’s visit date = 1 SEP 09
Participant does not return any unused applicators but
reports that she has an unopened carton of gel at
home that she forgot to bring with her to the visit
Target date for next visit is Saturday, 26 SEP 09
25 )
(number of days from today = ___
Scheduled date for next visit is Monday, 28 SEP 09
27 )
(number of days from today = ___
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How will you handle this situation?
Example #4
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Unused Product Returns slip indicates 4 TDF and 4
TDF/FTC tablets available for re-issue

Target Date is in 28 days

Scheduled Date is in 37 days
What is the ideal and minimum quantity to supply?
1.
2.
3.
4.
Ideal
Ideal
Ideal
Ideal
35,
35,
44,
44,
Minimum
Minimum
Minimum
Minimum
37
30
37
30
Example #4
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Ideal 44, Minimum 37
Four of each tablet available for re-issue
How might you handle this situation?
 Consider re-scheduling participant
 Up to 60-day supply permitted at IoR discretion


More than 60-day supply requires approval of DAIDS Medical
Officer
Can always consult the PSRT
Print 2 copies:
- File one in participant binder
- Send one to pharmacy with
study product request slip
Scheduled
Minimum
Ideal
What Are Your Questions?