# Presentation: 081191

## FCBPs Who Were PregnantPrior to Therapy Start Date

**1 **	Prescriber entered “false” pregnancy test results
**1 **	Designee entered “false” pregnancy test results
**1 **	Patient had access to drug from a previous	program (2003)
**1** 	Patient claimed false negative pregnancy test result
**6** 	Components of pregnancy test:
- Timing relative to first 5 days of menstrual period
- Timing relative to unprotected sexual intercourse
- Inherent test limitations

- (N=10)

## Non-iPLEDGE* Pregnancies(Source of Exposure to Drug)

- (N=19)

| Obtained from outside U.S. | 2 |
| --- | --- |
| Obtained from pharmacy | 2 |
| Accidentally took isotretinoin (instead of ibuprofen) | 1 |
| Took mother’s prescription | 1 |
| Unknown | 13 |

- * Patient not registered in iPLEDGE program

## iPLEDGE Pregnancy Cases –Pregnancies by Month

| iPLEDGE Year 1 |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec | Jan | Feb | Total |
| 4 | 4 | 10 | 10 | 8 | 5 | 11 | 11 | 13 | 10 | 18 | 7 | 111* |

- * 11 cases had no known conception date nor had information to impute a conception date

| iPLEDGE Year 2 |  |  |  |
| --- | --- | --- | --- |
| Mar | Apr | May | Jun |
| 11 | 15 | 8 | 3 |

## iPLEDGE Year 2 Pregnancies 4 Month Data (March-June 2007)

| Description of Conception Date | N
(N=37) | % |
| --- | --- | --- |
| Prior to starting isotretinoin treatment  | 1 | 2.7 |
| During isotretinoin treatment  | 25 | 67.6 |
| Within 30 days after isotretinoin treatment completion | 9 | 24.3 |
| Unknown | 2 | 5.4 |

**Relative Timing to Isotretinoin Exposure**
**Data to June 30, 2007**

-  Number of RCA Forms completed	N=14	37.8%

## SAB Membership

| Paul BeBeau, MD | Roche |
| --- | --- |
| Cathleen M. Boeck, RN, CCRC, DNC  | Dermatology Nurses Association |
| Bruce Bottini | Mylan Labs |
| Laura Saul Edwards | American Academy of Dermatology Association |
| Stephan P. Stone, MD, FAAD | American Academy of Dermatology Association |
| Tom Davis, R.Ph. | CVS Pharmacy, Inc. |
| Anita Ducca, MS | Healthcare Distribution Management Association (HDMA) |
| Joseph P. Lech, R.Ph. | National Community Pharmacists Association |

## SAB Membership (cont.)

| Rufino Santiago, MD | Ranbaxy |
| --- | --- |
| Anthony Oladipo | Barr Labs |
| Katharine O'Connell, MD, MPH | Columbia University Medical Center |
| Ronna B. Hauser, Pharm.D. | National Association of Chain Drug Stores (NACDS) |
| Shelia Weiss Smith, Ph.D. | University of Maryland |
| LaDonna Williams | Inflammatory Skin Disease Institute |

## S.M.A.R.T. - Pregnancy Case Reports (All Manufacturers)

|  | Pre-S.M.A.R.T. | S.M.A.R.T. Year 1 | S.M.A.R.T. Year 2 | S.M.A.R.T. Year 3 | S.M.A.R.T. Year 4* |
| --- | --- | --- | --- | --- | --- |
| Total number | 218 | 224 | 229 | 190 | 123 |

**S.M.A.R.T.**** - Pregnancy Case Reports ****(All Manufacturers)**

- * Data to February 28, 2006

## iPLEDGE – Birth Outcomes(to June 25, 2007)

- Elective termination	54
- Spontaneous abortion	17
- Live birth	1
- Still continuing	15
- Unknown	35
**Total****	****122**

## Females of Child-Bearing Potential

**Definition**
- A non-menopausal female who has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure.  This includes a young woman who has not yet started menstruating.
- A woman who has had a tubal sterilization is considered a female patient of childbearing potential in the iPLEDGE program

## Estimated Patient Exposure to Isotretinoin

| Year | Male (Net) Projected* | Female (Net) Projected* |
| --- | --- | --- |
| 2000 | 260,987 | 234,244 |
| 2001 | 211,371 | 179,333 |
| 2002 | 177,322 | 131,064 |
| 2003 | 174,367 | 130,470 |
| 2004 | 173,732 | 145,042 |
| 2005 | 151,819 | 132,486 |

- * Projected Patient Exposure = Total Prescription / 4
- Source: IMS, NPA, PDDA Data MAT Sep