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DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Pregnancy Registry andPregnancy Registry and Root Cause Analysis Root Cause Analysis
Pregnancy Registry andPregnancy Registry and Root Cause Analysis Root Cause Analysis
Cynthia Kornegay, Ph.D.Cynthia Kornegay, Ph.D.
Division of Drug Risk EvaluationDivision of Drug Risk EvaluationOffice of Surveillance and EpidemiologyOffice of Surveillance and Epidemiology
Center for Drug Evaluation and Research Center for Drug Evaluation and Research
Food and Drug AdministrationFood and Drug Administration
Cynthia Kornegay, Ph.D.Cynthia Kornegay, Ph.D.
Division of Drug Risk EvaluationDivision of Drug Risk EvaluationOffice of Surveillance and EpidemiologyOffice of Surveillance and Epidemiology
Center for Drug Evaluation and Research Center for Drug Evaluation and Research
Food and Drug AdministrationFood and Drug Administration
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2DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
OutlineOutlineOutlineOutline
• Challenges– Pregnancy Registry and Root Cause Analysis
• Background• Possible Barriers• Considerations
– Knowledge and Behavior Assessment• Background• Possible Barriers• Considerations
• Comparison Group• Preliminary Observations
• Challenges– Pregnancy Registry and Root Cause Analysis
• Background• Possible Barriers• Considerations
– Knowledge and Behavior Assessment• Background• Possible Barriers• Considerations
• Comparison Group• Preliminary Observations
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DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Pregnancy Registry and Root Pregnancy Registry and Root Cause Analysis (RCA)Cause Analysis (RCA)
Pregnancy Registry and Root Pregnancy Registry and Root Cause Analysis (RCA)Cause Analysis (RCA)
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4DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Background – Background – Pregnancy Registry and RCAPregnancy Registry and RCA
Background – Background – Pregnancy Registry and RCAPregnancy Registry and RCA
• Root Cause Analysis (RCA) proposed by 2004 AC committee– Purpose is to gather detailed information on all
reported isotretinoin-exposed pregnancies and use aggregate data to improve iPLEDGE program
• Root Cause Analysis (RCA) proposed by 2004 AC committee– Purpose is to gather detailed information on all
reported isotretinoin-exposed pregnancies and use aggregate data to improve iPLEDGE program
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5DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Background – Background – Pregnancy Registry and RCAPregnancy Registry and RCA
Background – Background – Pregnancy Registry and RCAPregnancy Registry and RCA
• All women who become pregnant are asked to participate in the Registry– Initial data collected at time pregnancy
reported with quarterly follow-up until infant is up to 1 year old
• The RCA is administered as part of the Registry
• All women who become pregnant are asked to participate in the Registry– Initial data collected at time pregnancy
reported with quarterly follow-up until infant is up to 1 year old
• The RCA is administered as part of the Registry
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6DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Background – Background – Pregnancy Registry and RCA Pregnancy Registry and RCA
Background – Background – Pregnancy Registry and RCA Pregnancy Registry and RCA
• For the first year of iPLEDGE, the RCA participation rate was approximately 10% the total number of eligible pregnancies*– Insufficient enrollment to use data for
improving iPLEDGE
• For the first year of iPLEDGE, the RCA participation rate was approximately 10% the total number of eligible pregnancies*– Insufficient enrollment to use data for
improving iPLEDGE
*Data derived from iPLEDGE Quarterly Reports from January 1, 2006 through March 31, 2007.
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7DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Possible Participation Barriers –Possible Participation Barriers –Pregnancy Registry and RCAPregnancy Registry and RCA
Possible Participation Barriers –Possible Participation Barriers –Pregnancy Registry and RCAPregnancy Registry and RCA
• Reasons for low participation are not known, but several possible barriers may exist– Significant time element involved in
participation– Additional informed consent and
lengthy questionnaires– Intrusive nature of RCA
• Reasons for low participation are not known, but several possible barriers may exist– Significant time element involved in
participation– Additional informed consent and
lengthy questionnaires– Intrusive nature of RCA
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8DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Possible Participation Barriers –Possible Participation Barriers –Pregnancy Registry and RCAPregnancy Registry and RCA
Possible Participation Barriers –Possible Participation Barriers –Pregnancy Registry and RCAPregnancy Registry and RCA
• Possible barriers (cont.)– iPLEDGE prescriber may not have
further contact with participant– Registry is not widely promoted– RCA is administered only after
introductory reporting forms have been completed
• Possible barriers (cont.)– iPLEDGE prescriber may not have
further contact with participant– Registry is not widely promoted– RCA is administered only after
introductory reporting forms have been completed
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9DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Considerations – Considerations – Pregnancy Registry and RCAPregnancy Registry and RCA
Considerations – Considerations – Pregnancy Registry and RCAPregnancy Registry and RCA
• To help increase participation:– Streamline informed consent process
and questionnaires– Continue to ensure interviewers present
questionnaire in non-judgmental manner
– Increase awareness– Collect RCA information as soon as
possible after pregnancy is reported
• To help increase participation:– Streamline informed consent process
and questionnaires– Continue to ensure interviewers present
questionnaire in non-judgmental manner
– Increase awareness– Collect RCA information as soon as
possible after pregnancy is reported
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DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Knowledge and Behavior Knowledge and Behavior AssessmentAssessment
Knowledge and Behavior Knowledge and Behavior AssessmentAssessment
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11DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Background – Background – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Background – Background – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• Patient education is primary method of risk communication in iPLEDGE– Brochures, workbooks, and videos are
available for patients and prescribers– All patients receive basic materials, but
females of childbearing potential also get additional brochures targeted specifically for them
• Patient education is primary method of risk communication in iPLEDGE– Brochures, workbooks, and videos are
available for patients and prescribers– All patients receive basic materials, but
females of childbearing potential also get additional brochures targeted specifically for them
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12DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Background – Background – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Background – Background – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• iPLEDGE makes effort to provide adequate contraceptive counseling– iPLEDGE prescribers are required to
provide contraceptive counseling as part of the program
– Health care providers can refer patients to contraceptive counselors
– Initial contraceptive counseling is provided free of charge if requested
• iPLEDGE makes effort to provide adequate contraceptive counseling– iPLEDGE prescribers are required to
provide contraceptive counseling as part of the program
– Health care providers can refer patients to contraceptive counselors
– Initial contraceptive counseling is provided free of charge if requested
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13DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Background – Background – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Background – Background – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• Females of childbearing potential must answer a series of questions every month of therapy to assess knowledge of iPLEDGE– At start, questions focus on receipt of
iPLEDGE materials– During therapy, questions assess
contraceptive practices – Must be answered prior to receiving each
prescription
• Females of childbearing potential must answer a series of questions every month of therapy to assess knowledge of iPLEDGE– At start, questions focus on receipt of
iPLEDGE materials– During therapy, questions assess
contraceptive practices – Must be answered prior to receiving each
prescription
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14DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Possible Barriers – Possible Barriers – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Possible Barriers – Possible Barriers – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• Possible information overload– Females of childbearing potential
receive over 50 pages of materials at the start of therapy
– Research suggests that even when more information is available, patients may still not understand the risks associated with isotretinoin*
• Possible information overload– Females of childbearing potential
receive over 50 pages of materials at the start of therapy
– Research suggests that even when more information is available, patients may still not understand the risks associated with isotretinoin*
*Allen LaPointe et al. Patient receipt and understanding of written information provided with isotretinoin and estrogen prescriptions. J Gen Intern Med 2007 Jan;22(1):98-101
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15DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Possible Barriers – Possible Barriers – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Possible Barriers – Possible Barriers – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• Inconsistencies regarding initial counseling by females of childbearing potential– Patient informed consent states that
they have received counseling from their iPLEDGE prescriber
– About 13% of patients reported not receiving contraceptive counseling when starting isotretinoin therapy*
• Inconsistencies regarding initial counseling by females of childbearing potential– Patient informed consent states that
they have received counseling from their iPLEDGE prescriber
– About 13% of patients reported not receiving contraceptive counseling when starting isotretinoin therapy*
*iPLEDGE Year 1 Report, Table 7, March 30, 2007
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16DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Possible Barriers – Possible Barriers – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Possible Barriers – Possible Barriers – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• Possible disconnect between reading and comprehension of program materials– Although response rates indicate that
over 95% of women had read the materials*:
• 38% of women answered the question “ You can use any forms of birth control for iPLEDGE” incorrectly**
• Possible disconnect between reading and comprehension of program materials– Although response rates indicate that
over 95% of women had read the materials*:
• 38% of women answered the question “ You can use any forms of birth control for iPLEDGE” incorrectly**
*iPLEDGE 4th Quarter 2006 Report, Table B.1, January 31, 2007**iPLEDGE 4th Quarter 2006 Report, Table B.1.5, January 31, 2007
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17DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Possible Barriers – Possible Barriers – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Possible Barriers – Possible Barriers – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• Monthly questions may need to be revised– Depending on the birth control method
chosen, between 21% and 62% of women answered a key birth control question incorrectly*
– Wording has been improved in recent changes proposed by Sponsors
• Monthly questions may need to be revised– Depending on the birth control method
chosen, between 21% and 62% of women answered a key birth control question incorrectly*
– Wording has been improved in recent changes proposed by Sponsors
*iPLEDGE 4th Quarter 2006 Report, Table B.1.5, January 31, 2007
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18DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Considerations – Considerations – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Considerations – Considerations – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• Reduce length of materials• Streamline message on essentials of
iPLEDGE• Review materials to ensure clear,
consistent and patient-friendly language
• Changes to materials should be tested prior to distributing as part of iPLEDGE
• Reduce length of materials• Streamline message on essentials of
iPLEDGE• Review materials to ensure clear,
consistent and patient-friendly language
• Changes to materials should be tested prior to distributing as part of iPLEDGE
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19DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Considerations – Considerations – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Considerations – Considerations – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• Although patients may receive their contraception from other healthcare providers, isotretinoin prescribers still need to review iPLEDGE’s additional contraceptive requirements with females of child-bearing potential– Two forms of birth control must be
emphasized
• Although patients may receive their contraception from other healthcare providers, isotretinoin prescribers still need to review iPLEDGE’s additional contraceptive requirements with females of child-bearing potential– Two forms of birth control must be
emphasized
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20DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Considerations – Considerations – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
Considerations – Considerations – Knowledge and Behavior AssessmentKnowledge and Behavior Assessment
• Ongoing review of questions should continue to ensure that:– They are focused on demonstrating
knowledge of the iPLEDGE program– They are clearly worded– Correct answers pertain to iPLEDGE– They provide an accurate assessment
of knowledge
• Ongoing review of questions should continue to ensure that:– They are focused on demonstrating
knowledge of the iPLEDGE program– They are clearly worded– Correct answers pertain to iPLEDGE– They provide an accurate assessment
of knowledge
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DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Comparison GroupComparison GroupComparison GroupComparison Group
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22DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Comparison GroupComparison GroupComparison GroupComparison Group
• RCA gathers retrospective data on actual contraceptive use
• Comparable information is not available for women who did not get pregnant
• This comparison will help place RCA data in context
• RCA gathers retrospective data on actual contraceptive use
• Comparable information is not available for women who did not get pregnant
• This comparison will help place RCA data in context
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23DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Comparison GroupComparison GroupComparison GroupComparison Group
• The Agency and Sponsors need to – Consider additional studies to provide
data on non-pregnant females’ contraceptive behaviors for comparison
• Random sample of non-pregnant females (age matched)
– Should help make evaluation of iPLEDGE more informative
• The Agency and Sponsors need to – Consider additional studies to provide
data on non-pregnant females’ contraceptive behaviors for comparison
• Random sample of non-pregnant females (age matched)
– Should help make evaluation of iPLEDGE more informative
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DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Preliminary ObservationsPreliminary ObservationsPreliminary ObservationsPreliminary Observations
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25DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Preliminary ObservationsPreliminary ObservationsPreliminary ObservationsPreliminary Observations
• Concerns:– RCA participation rate– Patient understanding of risks
associated with isotretinoin– Evaluation of patient knowledge
• Needs to be valid assessment
• Consideration for minor program adjustments might be helpful– Concerns about program disruption
• Concerns:– RCA participation rate– Patient understanding of risks
associated with isotretinoin– Evaluation of patient knowledge
• Needs to be valid assessment
• Consideration for minor program adjustments might be helpful– Concerns about program disruption
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26DODAC and DSaRM Advisory Committee DODAC and DSaRM Advisory Committee August 1, 2007August 1, 2007
Preliminary ObservationsPreliminary ObservationsPreliminary ObservationsPreliminary Observations
• Evaluation goal is to determine if there are areas of iPLEDGE that can be enhanced to improve the program’s overall effectiveness– Behavior change can be difficult to
achieve – iPLEDGE program effectiveness may be
limited by non-program factors (motivation, perception of risk)
• Evaluation goal is to determine if there are areas of iPLEDGE that can be enhanced to improve the program’s overall effectiveness– Behavior change can be difficult to
achieve – iPLEDGE program effectiveness may be
limited by non-program factors (motivation, perception of risk)