00012_am.ppt 1 An Assessment of the Accutane (Isotretinoin) Pregnancy Prevention Program Allen A....

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An Assessment of theAn Assessment of theAccutane (Isotretinoin)Accutane (Isotretinoin)

Pregnancy Prevention ProgramPregnancy Prevention Program

Allen A. Mitchell, M.D.

Carla Van Bennekom, R.N., M.P.H.

Carol Louik, Sc.D.

Slone Epidemiology Unit

Boston University School of Public Health

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Pregnancy Prevention Program (PPP):Pregnancy Prevention Program (PPP):

– Introduced in fall, 1988

– Multi-component program

– Aimed at female patients and their physicians

– Unprecedented and novel approach

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Does the PPP work?Does the PPP work?

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Survey of Accutane Use in WomenSurvey of Accutane Use in Women

Sponsored by: Hoffmann-La Roche, Inc.

SEU Responsible for: - Design/Protocol

- Data Collection

- Data Processing

- Data Analysis

Guidance provided by: Independent Advisory Committee

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Slone Epidemiology UnitSlone Epidemiology UnitAccutane Survey Advisory CommitteeAccutane Survey Advisory Committee

1988 - 20001988 - 2000

Paul D. Stolley, M.D., Chair*University of Maryland School of MedicineBaltimore, MD

Edward L. Decker, Pharm.D.New England Medical CenterBoston, MA

Karen McKoy, M.D.Lahey ClinicBurlington, MA

Observers:

Charlotte Catz, M.D., NICHD

John Melski, M.D.Marshfield ClinicMarshfield, WI

Peter Pochi, M.D.Boston University School of MedicineBoston, MA

Robert S. Stern, M.D.Harvard Medical SchoolBoston, MA

José F. Corderó, M.D., CDC

*Dr. Stolley resigned as Committee Chair on July 19, 2000 because he has joined the FDA as a Senior Consultant.

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ObjectivesObjectives

To assess compliance with the Pregnancy Prevention Program

• Awareness of the teratogenic risk

• Patient and physician behaviors

• Pregnancy rate

• Pregnancy outcome

• Risk factors for pregnancy

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LimitationsLimitations

• No pilot testing

• No pre/post comparison

• What is “success”?

• Survey itself is an intervention

• Voluntary enrollment/? representativeness

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Accutane SurveyAccutane Survey

Design

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TIME PERIOD OF INTERESTTIME PERIOD OF INTEREST

(Duration of Follow-up)(Duration of Follow-up)

Accutane Treatment Potential Pregnancy (2 Trimesters)

0 1 2 3 4 5 6 7 8 9 10 11MONTHS

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To Encourage EnrollmentTo Encourage Enrollment

• Multiple/different opportunities

• Keep it simple

• Provide payment

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Enrollment OpportunitiesEnrollment Opportunities

1) Physician-generated

• All prescriptions originate with physician

• Logistically feasible

• Strong incentive

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2) Toll-free telephone call

• Simple

• Quick

• Familiar

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3) Package-generated

• Unique

• Direct to patient

• Bypasses physician

• May preferentially target women who

– were not encouraged by their physician

– may be relatively noncompliant

– are attracted by payment

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Follow-Up ApproachesFollow-Up Approaches

Frequent: During and After Treatment (DAT)

Advantage - Avoid recall bias

Disadvantage - ? Affect outcome beyond PPP

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Follow-Up ApproachesFollow-Up Approaches

Infrequent: After Treatment only (AT)

Advantage - Avoids intervention beyond PPP

Disadvantage - Potential recall bias

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Information Obtained at Follow-UpInformation Obtained at Follow-Up

DAT AT

Patient characteristics

Education + -

Doctor specialty + -

Pregnancy risk + -

Patient knowledge

Risk of birth defects + +

Avoid pregnancy + -

Compliance

Pregnancy testing + +

Contraception + +

Wait for next menstrual period + -

Pregnancy occurrence + +

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Results

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Accutane SurveyAccutane SurveyEnrollments: 1989-1999Enrollments: 1989-1999

0

10000

20000

30000

40000

50000

60000

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

Cumulative enrollmentsthrough 6/30/00: >494,000

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Method of EnrollmentMethod of Enrollment

21%

76%

3%

Doctor-generated

Package-generated

Toll-free phone no.

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Follow-Up RatesFollow-Up Rates

During and After Treatment (“DAT”)

Number to date (6/00): 61,659

1/89 - 12/94 (telephone) 32,301

Completed Follow-Up: Tx start 98%

Tx middle 98%

6 mos.p Tx 93%

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During and After Treatment (“DAT”)

1/95 - 6/00 (mail) 29,358

Completed Follow-Up: Tx start 98%

Tx middle 98%

6 mos.p Tx 97%

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After Treatment (“AT”)

Number to date (6/00): 433,256

Completed Follow-Up: 6 mos.p Tx 80-86%

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Results:

Demographics

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AgeAge

1/89 – 6/00(n=494,915)

Mean (years) 25.6

Median (years) 24

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Age of Enrollees by Enrollment YearAge of Enrollees by Enrollment Year

24

24.5

25

25.5

26

26.5

27

Mea

n a

ge

(yea

rs)

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000

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Highest Level of EducationHighest Level of Education

0

5

10

15

20

25

30

35

%

<12 years High schoolgraduate

Some college ortechnical school

Collegegraduate

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Type of PrescriberType of Prescriber

010

2030

4050

6070

8090

% Y

es

Dermatologist GeneralPractice

Family Practice Other

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Past Treatment for AcnePast Treatment for Acne

0102030405060708090

100

% Y

es

Any antibiotics Oral vitamin A Retin-A BenzoylPeroxide

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Pregnancy Risk CategoriesPregnancy Risk Categories

(at DAT 1)1/95 – 6/00(n=28,016)

3% Hysterectomy/postmenopausal

57% Not sexually active

40% Sexually active

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Pregnancy Risk CategoriesPregnancy Risk Categories

(at DAT 1)1/95 – 6/00(n=28,016)

57% Not sexually active: Using birth control 44%

Not using birth control 56%

100%

40% Sexually active: Using birth control 98%

Not using birth control 2%

100%

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Results:

Women’s Knowledge

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Receipt of PPP InformationReceipt of PPP Information

1/95 – 6/00(n=28,386)

Patient brochure 92%

True/false test 42%

Birth Control brochure 53%

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Knowledge of Accutane RiskKnowledge of Accutane Risk

1/95 – 6/00(n=28,386)

May cause miscarriage 43%

May cause birth defects 99%

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Results:

Compliance

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Compliance with PPP – ICompliance with PPP – I

1/95 – 6/00(n=28,386)

Told to avoid pregnancy 99%

Signed consent form77%

Postpone Accutane until pregnancy test 67%

Postpone Accutane until next menstrual period 57%

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Compliance with Selected Measures of the PPPCompliance with Selected Measures of the PPP

0

10

20

30

40

50

60

70

80

90

100

% Y

es

1995 1996 1997 1998 1999 2000

Told to avoid pregnancy

Signed consent form

Postponed Accutane untilresults of pregnancy test known

Postponed Accutane until nextmentrual period

n=5,108 n=5,157 n=5,206 n=5,047 n=5,283 n=2,585

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Compliance with PPP – IICompliance with PPP – II

Pregnancy Testing1/95 – 6/00(n=27,073)

Serum 56%

Urine 9%

Both serum and urine 8%

Any 76%

None 24%

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Pregnancy Testing Before Starting Accutane by Pregnancy Testing Before Starting Accutane by Enrollment YearEnrollment Year

0

10

20

30

40

50

60

70

80

%

1995 1996 1997 1998 1999 2000

Any pregnancy test

No pregnancy test

n=5,108 n=5,157 n=5,206 n=5,047 n=5,283 n=2,585

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Knowledge and Compliance at Onset of TherapyKnowledge and Compliance at Onset of Therapy

1989 -1990(n=9,365)

% Yes Instructions from physicians Wait until pregnancy test results 78% Wait until next menstrual period 63% Behavior Any pregnancy test before therapy 60%

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Original Medication PackageOriginal Medication Package

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Revised Medication PackageRevised Medication Package

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Knowledge and Compliance at Onset of TherapyKnowledge and Compliance at Onset of Therapy

1989-1990 1991-1993 (n=9,365) (n=11,809) Instructions from physicians Wait until pregnancy test results 78% 85% Wait until next menstrual period 63% 75% Behavior Any pregnancy test before therapy 60% 67%

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Compliance with PPP - IIICompliance with PPP - III

Contraceptive Status, By Age

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Contraceptive StatusContraceptive StatusNoncontraceptors by Age GroupNoncontraceptors by Age Group

0

10

20

30

40

50

60

70

80

%

<15years

15-24years

25-34years

35-44years

45+years

Sexually active

Not sexually active

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Contraceptive StatusContraceptive StatusSurgical Sterility by Age GroupSurgical Sterility by Age Group

0

10

20

30

40

50

60

70

%

<15 years 15-24 years 25-34 years 35-44 years 45+ years

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Contraceptive StatusContraceptive StatusNonsurgical Contraception by Age GroupNonsurgical Contraception by Age Group

0

10

20

30

40

50

60

70

%


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Contraceptive StatusContraceptive StatusNonsurgical Contraception by Enrollment YearNonsurgical Contraception by Enrollment Year

0

10

20

30

40

50

60

%

1995 1996 1997 1998 1999 2000

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Among Nonsurgical Contraceptors, % Reporting Among Nonsurgical Contraceptors, % Reporting Oral Contraceptive Use by Enrollment YearOral Contraceptive Use by Enrollment Year

0

10

20

30

40

50

60

70

80

%

1995 1996 1997 1998 1999 2000

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Among ContraceptorsAmong Contraceptors% Reporting Use of 2+ Methods by Age Group% Reporting Use of 2+ Methods by Age Group

0

5

10

15

20

25

30

35

40

45

%


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Among ContraceptorsAmong Contraceptors% Reporting Use of 2+ Methods by Enrollment Year% Reporting Use of 2+ Methods by Enrollment Year

5

10

15

20

25

30

35

40

%

1995 1996 1997 1998 1999 2000

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Among the 27,439 women in DAT1,

6,549 (24%) reported no pregnancy test before starting Accutane

Of those, 3,958 (60%) did not wait until their next menstrual period

Of those,

1,554 (39%) were sexually active

and 39 (1%) were sexually active, not using birth control

Thus, among 27,439 women, 39 (0.1%) were sexually active, not using birth control, had no pregnancy test, and did not wait until their menstrual period before starting Accutane.

Proportion of the Most “At Risk” Women Who Are Proportion of the Most “At Risk” Women Who Are Noncompliant with Pregnancy Testing and Noncompliant with Pregnancy Testing and

Waiting to Start AccutaneWaiting to Start Accutane

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Results:

Pregnancies

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Pregnancies During Accutane TreatmentPregnancies During Accutane Treatment

1989 – 1999 Cohorts

Number of women completing follow-up 347,857

Number of pregnancies reported 1,019

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Number of Pregnancies ReportedNumber of Pregnancies Reportedby Enrollment Yearby Enrollment Year

0

20

40

60

80

100

120

Nu

mb

er o

f P

reg

nan

cies

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

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Characteristics of Pregnancies(n=1,019)

Pregnant at start of treatment 10%

No contraceptive use 23%

Contraceptive failure 66%

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Outcomes of Accutane Exposed PregnanciesOutcomes of Accutane Exposed Pregnancies

1989 – 1999 cohorts(n=1,019)

No. %

Therapeutic abortion 681 67

Spontaneous abortion 177 17

Liveborn 117 11

Ectopic 29 3

Unknown 15 1

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Pregnancy Rate During Accutane TreatmentPregnancy Rate During Accutane Treatment

1989 – 1999 Cohorts(Duration of Use <1 Year)

Number of women completing follow-up 339,994

Number of pregnancies reported 992

Rate per 1000 Accutane courses 2.8

Rate per 1000 person years 7.4

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Pregnancy Rates During Accutane Treatment Pregnancy Rates During Accutane Treatment by Ageby Age

1989 – 1999 Cohorts

Age (years) No. of women Pregnancy rate/1000 courses

<15 12,290 1.0

15-24 138,497 2.8

25-34 89,040 3.7

35-44 44,574 1.7

45+ 7,970 0.5

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Pregnancy Rate/1000 Person CoursesPregnancy Rate/1000 Person Coursesby Enrollment Yearby Enrollment Year

0

0.5

1

1.5

2

2.5

3

3.5

4

Rat

e/10

00 c

ou

rses

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

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Pregnancy Rate During Accutane Treatment Pregnancy Rate During Accutane Treatment by Contraceptive Methodby Contraceptive Method

1989 – 1999 Cohorts

Method No. of Women Pregnancy rate/1000 courses

None 113,247 1.7

Oral contraceptive 97,895 2.5

Tubal ligation 23,194 0.5

Condom 17,475 10.6

Vasectomy 15,965 0.3

Other 12,318 3.1

Unknown 4,622 2.5

Diaphragm 4,519 5.9

IUD 2,212 3.6

Rhythm 855 15.2

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Validity

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Validity

• Follow-up rates are high

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Validity

• Follow-up rates are high• Responses consistent (AT vs. DAT)

– Knowledge– Behaviors– Pregnancy rates

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Accutane Survey vs. U.S. Female PopulationAccutane Survey vs. U.S. Female Population

Pregnancy Rates(per 1,000 women/years)

Accutane Survey U.S. Population*

7.4 105

*NCHS, 2000; women ages 15-44

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Proportion Sexually Activeand

Not Using Contraception(n=26,074)

Accutane

Survey

U.S.

Population* Age: 15-24

25-34

35-44

<1

1

1

7

5

5

*National Survey of Family Growth, NCHS, 1995.

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Among Contraceptors:Proportions using birth control pill

Accutane

Survey %

U.S. Population*

% Age: 15-24 73 49

25-34 53 33

35-44 20 8

*National Survey of Family Growth, NCHS (1995 Data).

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Major Factors Associated withMajor Factors Associated withSuccessful Contraception*Successful Contraception*

– Age (coital frequency, fecundity)

– Education

– Duration of method use

– Motivation

*Trussell J and Kost K: Studies in Family Planning 1987;18:237-183

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% of Pregnancies by Contraceptive Method% of Pregnancies by Contraceptive Method

27%

25%

33%

2%13%

No method

Condom

Oral contraceptive

Unknown method

Other

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Validity

• Follow-up rates are high• Responses consistent

– Knowledge– Behaviors– Pregnancy rates

• Pregnancy rates “rebound” after stopping Accutane

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Pregnancy Rates and Outcomes During and After Pregnancy Rates and Outcomes During and After Therapy with Isotretinoin in 122,582 Women,Therapy with Isotretinoin in 122,582 Women,

1989-19931989-1993

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Representativeness

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1) What proportion of eligible women enroll in the Survey?

2) Do women in the Survey represent the larger population of Accutane users?


Representativeness

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Roche Consumer SurveyRoche Consumer Survey

Female Accutane Users1990 – 1991

(n=400)

Proportion reporting enrollment in survey:

239/400; 60%

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Consumer SurveyConsumer Survey

Accutane Survey

Enrolled Not enrolled

Age (mean) 29 31

Education (median) 14 14

Dermatologist prescribed 91% 88%

Sexually active 64% 54%

- Using contraception (96%) (92%)

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Consumer SurveyConsumer Survey

Contraceptive Methods(among 205 contraceptors; in %)

Accutane Survey

Enrolled Not enrolled

Birth control pill 40 16

Condom 10 12

Other barrier methods 9 8

Surgical sterilization 44 65

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United Health CareUnited Health Care

Population: 1.2 million women ages 12-59

1/90 – 6/96

5,095 women ages 12-59, who filled Accutane prescription between 1/90 and 6/96

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Population: 1.2 million women ages 12-59

1/90 – 6/96

5,095 women ages 12-59, who filled Accutane prescription between 1/90 and 6/96

Proportion enrolled in Accutane Survey

Definite: 38.4%

Possible: 7.5%

Total: 45.9%

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Accutane Survey: Enrolled vs. Not Enrolled

Accutane Survey

Enrolled* Not enrolled

Age (mean) 26.4 28.2

*“Definite” matches only.

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Accutane Survey Enrollment Rates by Age

Age Enrolled

<20 38%

20-29 44%

30-39 41%

40-49 26%

50-59 14%

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SEU Accutane SurveySEU Accutane Survey

Is there selection bias favoring women at low risk?

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Characteristics of Survey ParticipantsCharacteristics of Survey ParticipantsAccording to Enrollment MethodAccording to Enrollment Method

Doctor-generated

Package-generated

Age (mean) 24.3 25.9

Prescriber –dermatologist 98% 88%

Signed consent 98% 71%

Pregnancy test before starting 84% 69%

Pregnancy rate (per 1000 courses) 2.5 2.8

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Among women who enrolled via the Medication Package, only 13% reported that they did so because of their doctor’s encouragement.

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Doctor Encouraged to Enroll in SurveyDoctor Encouraged to Enroll in Surveyby Age Groupby Age Group

0

10

20

30

40

50

60

% Y

es


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SummarySummary

Since 1989, 494,915 women have enrolled in the Accutane survey.

Follow-up rates are high.

Except for a slight decline in age, demographic characteristics have remained stable.

Awareness of teratogenic risk is high.

Compliance with pregnancy testing and contraceptive guidelines is variable but not decreasing.

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SummarySummary(cont’d)(cont’d)

Pregnancy rates are appreciably lower than U.S. population and have declined over time.

Data appear to be valid.

No evidence that Survey results are not representative.

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Future DirectionsFuture Directions

Increase enrollments– Increase payment at enrollment– Add payment upon completion– Modify doctor-patient enrollment procedures

Enroll women on multiple courses

Increase power and value of DAT follow-up5000/yr 25,000/yr

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Future DirectionsFuture Directions(cont’d)(cont’d)

Modify Survey questions– Oral contraceptive type– Refine pregnancy risk questions

Initiate regular feedback to prescribers to encourage them to value the Survey and enroll patients.

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Method of Enrollment by Enrollment YearMethod of Enrollment by Enrollment Year

0102030405060708090

%

Doctor-generated

Package-generated

Toll-free phone no.

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Age of Enrollees by Enrollment YearAge of Enrollees by Enrollment Year

05

1015202530354045

%

<20 years

20-29 years

30-39 years

40+ years

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Region of Residence by Enrollment YearRegion of Residence by Enrollment Year

0

5

10

15

20

25

%

New EnglandMid AtlanticSouth AtlanticEast South CentralWest South CentralMountainPacificWest North CentralEast North CentralOther

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Highest Level of Education by Enrollment YearHighest Level of Education by Enrollment Year

0

5

10

15

20

25

30

35

40

1995 1996 1997 1998 1999 2000

%

<12 years

High school graduate

Some college ortechnical school

College graduate+

n=5,108 n=5,157 n=5,206 n=5,047 n=5,283 n=2,585

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Past Treatment for Acne by Enrollment YearPast Treatment for Acne by Enrollment Year

0

10

20

30

40

50

60

70

80

90

100

% Y

es

1995 1996 1997 1998 1999 2000

Any antibiotics

Oral vitamin A

Retin-A

Benzoyl Peroxide

n=5,108 n=5,157 n=5,206 n=5,047 n=5,283 n=2,585

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Pregnancy Risk Category by Enrollment YearPregnancy Risk Category by Enrollment Year

0

5

10

15

20

25

30

35

40

% Y

es

1995 1996 1997 1998 1999 2000

Hysterectomy orpostmenopausal

Not sexually active,using birth control

Not sexually active, notusing birth control

Sexually active, usingbirth control

Sexually active, notusing birth control

n=5,023 n=5,087 n=5,144 n=4,987 n=5,220 n=2,555

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Oral Contraceptive Users by Sexual Activity StatusOral Contraceptive Users by Sexual Activity StatusAge 15-24 yearsAge 15-24 years

0

5

10

15

20

25

30

1995 1996 1997 1998 1999 2000

%

Sexually activeNot sexually active

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Doctor Encouraged to Enroll in SurveyDoctor Encouraged to Enroll in Surveyby Enrollment Methodby Enrollment Method

010

20304050

60708090

% Y

es

Doctor-generated Medicationpackage-genrated

Toll-free telephonenumber

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Number of Liveborns by Enrollment YearNumber of Liveborns by Enrollment Year

0

2

4

6

8

10

12

14

16

18

Nu

mb

er o

f L

iveb

orn

s

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

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% of Pregnancies by Contraceptive Method% of Pregnancies by Contraceptive Method

27%

2%

25%4%

1%

32%

1%

1%5% 2%

No methodRhythymCondomDiaphragmIUDOral contraceptiveVasectomyTubal ligationOther methodUnknown method

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Pregnancy Rate During Accutane Treatment by Pregnancy Rate During Accutane Treatment by Contraceptive Method by Enrollment YearContraceptive Method by Enrollment Year

0

5

10

15

20

25

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

No method

Oral contraceptive

Condom

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Pregnancy Rates According to Follow-UpPregnancy Rates According to Follow-Upby Enrollment Yearby Enrollment Year

1

1.5

2

2.5

3

3.5

4

4.5

5

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

DAT

AT

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Contraceptive Failure RatesContraceptive Failure Rates

Typical Use* Perfect Use* Accutane Survey†

Method (%) (%) (%)

Diaphragm 18 6 1.5

Condom (male) 12 3 2.8

IUD 0.1-2.0 0.1-1.5 0.9

Oral contraceptive pill

0.1-0.5 0.6

Female sterilization 0.4 0.4 0.1

Male sterilization 0.15 0.10 0.08*Percent pregnant in first year of use; Hatcher RA et al.: Contraceptive Technology, 17th Edition, 1994, p113.

†Rate per 100 woman-years.

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Compliance According to PregnancyCompliance According to PregnancyRisk CategoryRisk Category

(DAT1, 1995 – 2000)

Hyst.

Not sexually active, using birth control

Not sexually active, not using

birth control

Sexually active, using birth

control

Sexually active, not using birth

control Unk.

N 943 6,970 8,821 10,811 195 276

% % % % % %

Told to avoid pregnancy 95 99 99 99 99 99

Signed consent 51 81 78 76 69 79

Had pregnancy test N/A 82 70 76 70 64

Waited for test after starting N/A 74 58 70 63 53

Waited for next month after starting N/A 63 48 60 53 47

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Does the more intensive DAT follow-up Does the more intensive DAT follow-up itselfitself result in enhanced compliance?result in enhanced compliance?

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Pregnancy Rates According to Follow-Up

Follow-Up N Pregnancies Rate/1000 Courses

AT 292,955 848 2.8

DAT 46,989 144 3.0

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Pregnancy Rate in 30 Days Following AccutanePregnancy Rate in 30 Days Following Accutaneby Enrollment Yearby Enrollment Year

(n=338/338,959; Rate=1.0/1000 enrollees)

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

%

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Pregnancy Rate During TreatmentPregnancy Rate During TreatmentAmong Women on Accutane for 1-2 YearsAmong Women on Accutane for 1-2 Years

N=27/7,862, or 27/9,641 person-years of treatment

Rate=2.8/1000 person-years of treatment

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Accutane Survey Enrollment Rates by Age

0

5

10

15

20

25

30

35

40

45

<20 years 20-29 years 30-39 years 40-49 years 50-59 years

00012_am.ppt 1 An Assessment of the Accutane (Isotretinoin) Pregnancy Prevention Program Allen A....

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Transcript of 00012_am.ppt 1 An Assessment of the Accutane (Isotretinoin) Pregnancy Prevention Program Allen A....