Prescription Compliance Survey
Transcript of Prescription Compliance Survey
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Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Isotretinoin Pregnancy Prevention Isotretinoin Pregnancy Prevention Program EvaluationProgram Evaluation
Prescription Compliance Surveyand
Patient Surveys
Allen Brinker, MD, MSFebruary 26, 2004
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Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Isotretinoin Pregnancy Prevention Isotretinoin Pregnancy Prevention Program EvaluationProgram Evaluation
Collaborators -Cynthia Kornegay, Ph.D.
Primary reviewer for prescription compliance survey
Parivash Nourjah, Ph.D.Primary analyst for a patient survey dataset supplied by Hoffmann-LaRoche
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Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Isotretinoin Pregnancy Prevention Isotretinoin Pregnancy Prevention Program EvaluationProgram Evaluation
Order of topics:
Prescription Compliance Program (PCS)
Patient Survey
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4Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Prescription Compliance Survey (PCS)Prescription Compliance Survey (PCS)OverviewOverview
• Survey Design• Survey Results• Methodological Issues
– Response Rate– Number of Prescriptions Captured– Participation by Stores
• Survey Audit– Recruiting Strategy/Response Rate
• Conclusions
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5Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
PCS GoalsPCS Goals
• Primary Outcome: Compliance with
Qualification sticker use
• Secondary Outcomes: Completeness
and correctness of Qualification stickers
• Inference
– presence of a Qualification sticker
does not imply adherence to all parts
of the current RMP
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6Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
PCS DesignPCS Design
• Retrospective, repeated-measures survey
• 6,000 selected U.S. pharmacies
• Stratified, random sample
• Data collected in March, June, September,
and December for 2 years
• 750 Stores selected for each collection period
• Stores can only be included once
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7Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
PCS ResultsPCS Results
• High rate of compliance (>90%) across all survey waves for both PCS and audit
• Results consistent across age, gender, and payer type
• Some differences across prescription volume and population density– both high volume and rural pharmacies
more likely to receive prescriptions with incomplete stickers
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8Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Methodological IssuesMethodological Issues
• Minimum necessary response rate for each wave
was 60% of the sample, or 450 stores
– response rates ranged from 25% to 59%
• In December 2002, CVS, Eckerd, Rite Aid,
Walgreens and Wal-Mart asked and were removed
from the survey pool
– 33% of stores, or 15,200
– probably represented more than 33% of Rxs
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9Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Methodological IssuesMethodological IssuesPCS Prescriptions CapturedPCS Prescriptions Captured
Number of Prescriptions: Estimated Actual
Average no. per QTR 2.55 0.84
Total per QTR 1,150 268
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10Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
PCS AuditPCS AuditRecruitingRecruiting
• Proposed strategy: random sample of
15% of PCS respondents– does not appear to have been
implemented as proposed
– consistently high response rates (>20%)• recruiting strategy may not be random
– utility and/or applicability of audit results is
questionable
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11Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
PCS Overall ConclusionsPCS Overall Conclusions
• High rate of compliance with
Qualification stickers
– not the same as high rate of compliance
with SMART program in total
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12Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
PCS Overall ConclusionsPCS Overall Conclusions
• Insufficient pharmacy sample size
• Generalizability compromised
– low pharmacy response rate
– 23% of expected prescriptions captured
– five largest U.S. chains dropped out
• Alternate study designs should be considered
for future studies with similar goals
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13Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Patient Surveys Patient Surveys OverviewOverview
• Purpose of Patient Survey
• Methods
– Limitations
• Survey Population
– Representativeness / Generalizability
• Results
• Summary Conclusions
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14Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Patient Survey - PurposePatient Survey - Purpose
• Isotretinoin Patient Surveys
– Implemented in 1989 to “assess the
compliance of physicians and patients with
the Accutane Pregnancy Prevention
Program and to identify the rate of
pregnancy during treatment with
isotretinoin.”
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15Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Patient Survey - Reports and Analysis Patient Survey - Reports and Analysis OverviewOverview
• FDA data include:
– Slone Epidemiology Group Quarterly
Reports
• year prior and continuing in year following
– Primary FDA analysis of an Accutane-
brand patient survey• started in 3rd QTR following implementation of
the current RMP
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16Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Patient Survey - MethodsPatient Survey - Methods
Two versions of survey instrument:
–Old survey instrument–no questions on Qualification sticker
–no questions related to MedGuide
–pregnancy test question limited to
whether a pregnancy test was
performed
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17Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Patient Survey - MethodsPatient Survey - MethodsNew survey instrument
• Current RMP-specific questions–Qualification sticker present on Rx ?–date and number of pregnancy tests
performed
• Not introduced until 3rd QTR following implementation of the current RMP
–enrolled ~6,000 participants through the end of first year
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18Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Patient Survey - MethodsPatient Survey - MethodsSelected LimitationsSelected Limitations
•Mailed survey–some are surveyed by telephone
•Follow-up survey–cannot be anonymous
•Generalizability limited due to–low enrollment rate–voluntary survey participation
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19Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Patient Survey - MethodsPatient Survey - MethodsSelected LimitationsSelected Limitations
•Important issues - continued
•Measurement errors• Recall bias
• Social desirability bias
• Poor questionnaire design– complex questions and question skip
patterns to be followed
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20Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
ResultsResultsSurvey PopulationSurvey Population
• Absolute participation in Isotretinoin Patient
Surveys based on FDA models:
–16% to 19% in year before current RMP
–22% to 26% in the first year current RMP
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Trends in Enrollment in Isotretinoin Trends in Enrollment in Isotretinoin Patient SurveysPatient Surveys
15.5 17.3 15.418.6 21.4 22.6
26 23.4
0
20
40
60
80
100
QTR1 QTR2 QTR3 QTR4 QTR5 QTR6 QTR7 QTR8
pe
rce
nt e
nro
llme
nt
Arrow separates the 4 QTR’s before implementation of the current RMP and the 4 QTR's following its implementation
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22Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
ResultsResultsSurvey PopulationSurvey Population
Age group
(years)
Degge/SI
cohort*
(as submitted)
AdvancePC
S*
(4/02-3/03)
IMS Health
NDTI™***
(4/02-3/03)
Up to age 19 1917 (35%) 43% 45%
20-29 2092 (38%) 28% 30%
30-39 918 (17%) 16% 16%
40+ 536 (10%) 13% 9%
Total 5463 100% 100%
*excludes 6 records where age was missing + 432 records on generic isotretinoin **Advance PCS™ Dimension Rx, accessed 11 December 2003 ***IMS Health, IMS National Disease and Therapeutic IndexTM, 4/2002-3/2003, accessed 15 December 2003; FDA custom calculations were based on IMS Health data
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23Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
ResultsResultsSurvey PopulationSurvey Population
• Prescriber
–94% of isotretinoin recipients within Degge/SI
cohort indicated prescriber was a dermatologist
–80% of recent isotretinoin prescriptions*
associated with a dermatologist
*Source: IMS Health National Prescription Audit PlusTM (3 Dec 2003)
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24Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - Initiation of TherapyResults - Initiation of TherapyConsent formConsent form
• Analyses of Degge/SI cohort:
– 76% signed two consent forms (as required)
– 4% signed only one form
– 9% reported signing no consent forms
– 11% were uncertain / did not answer
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25Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - Initiation of TherapyResults - Initiation of TherapyQualification stickerQualification sticker
• Analyses of Degge/SI cohort:
– 92% reported Rx with Qualification Sticker
• Consistent with findings from the PCS
– 2.5% reported no sticker
– 5.5% did not know / did not answer
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26Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - Initiation of TherapyResults - Initiation of TherapyPregnancy TestingPregnancy Testing
•Analyses of apparently fertile, 15-45
year-old participants in Degge/SI cohort:•91% reported at least one pregnancy test
•66% reported two tests
•Performance increased only slightly with restriction to sexually active
•Performance decreased only slightly with restriction to sexually INactive
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27Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - Initiation of Therapy Results - Initiation of Therapy Trends in Pregnancy TestingTrends in Pregnancy Testing
•Slone Epi Group Quarterly reports
•ANY pregnancy testing
•77%-85% for year prior to the current RMP
•91%-92% in first year of current RMP
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Results - Initiation of TherapyResults - Initiation of TherapyTrends in ANY Pregnancy Testing in Slone SurveyTrends in ANY Pregnancy Testing in Slone Survey
0
20
40
60
80
100
QTR1 QTR2 QTR3 QTR4 QTR5 QTR6 QTR7 QTR8
pe
rce
nt
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29Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - Initiation of TherapyResults - Initiation of TherapyContraception PracticesContraception Practices
• Analyses of apparently fertile and sexually
active women among the Degge/SI cohort:– 95.4% reported use of some form of
birth control– 48.9% reported use of appropriate birth
control per the revised RMP• one primary and one secondary birth
control method
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30Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - Initiation of TherapyResults - Initiation of TherapySexual Activity - Univariate FocusSexual Activity - Univariate Focus
N
Total 4596
Sexually active since starting Accutane therapy
1806
Sexually active before but not during Accutane therapy 993
Not sexually active before or during Accutane therapy 1797
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31Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - Initiation of TherapyResults - Initiation of TherapyBivariate AnalysesBivariate Analyses
• Conducted to address the relationship
between the presence or absence of a
Qualification sticker and
•any pregnancy testing
•any birth control
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32Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - Initiation of TherapyResults - Initiation of TherapyQualification Sticker and Pregnancy TestingQualification Sticker and Pregnancy Testing
n=4400n=4400
NoYesPregnancy
Test
Qualification Sticker
90(90%)
3908(91%) Yes
10(10%)
392(9%)No
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33Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - Initiation of TherapyResults - Initiation of TherapyQualification Sticker and Birth Control (any)Qualification Sticker and Birth Control (any)
n=1788n=1788
NoYesAny Birth Control
Use
Qualification Sticker
70(96%)
1671(97%) Yes
3(4%)
44(3%) No
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34Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
ResultsResultsDuring TherapyDuring Therapy
• Analyses of Degge/SI participants
during therapy:
– 95% report use of a Qualification
sticker
– 81% report monthly pregnancy
testing
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35Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Results - During Therapy Results - During Therapy Trends in Report of Pregnancy TestingTrends in Report of Pregnancy Testing
• Slone Epi Group Quarterly reports
• ANY pregnancy testing during therapy with isotretinoin
• ~70% in year prior to revised RMP
• ~85% in first year of revised RMP
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Results - During TherapyResults - During TherapyTrends in ANY Pregnancy Testing in Slone SurveyTrends in ANY Pregnancy Testing in Slone Survey
0
20
40
60
80
100
QTR1 QTR2 QTR3 QTR4 QTR5 QTR6 QTR7 QTR8
perc
ent
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37Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Pregnancy RatePregnancy Rate
• 15 pregnancies were identified among 4277
first-time users within the Degge/Si cohort
– pregnancy rate: 3.5/1000 women
– the rate is likely an underestimate as it is
censored as of the data lock date
• Similar to that reported for participants in the
Slone Survey of Accutane recipients
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38Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
AddendumAddendumGeneric Isotretinoin DataGeneric Isotretinoin Data
• Any pregnancy testing prior to initiation: ~90%
• Two pregnancy tests prior to initiation: ~65%
• NO birth control among apparently fertile,
sexually active respondents: ~3%
• Any pregnancy testing during therapy: ~82%
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39Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Overall SummaryOverall Summary
• Isotretinoin-exposed pregnancies continue to
occur after implementation of the current RMP
• Enrollment in isotretinoin patient surveys
increased only modestly after implementation of
the current RMP
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40Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Overall SummaryOverall Summary
• Despite their wide utilization,
Qualification stickers have been
issued to patients who have not
undergone pregnancy testing
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41Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Advisory Committee February 26 & 27, 2004February 26 & 27, 2004
Overall SummaryOverall Summary
• The observed pregnancy rate for the
Degge/SI cohort recruited following
implementation of the current RMP
appears similar to that reported for
cohorts recruited before
implementation of the current RMP