PITTSBURGH, Feb. 4, 2014 – Providing women who take a powerful acne drug with a fact sheet about contraception while visiting the dermatologist can significantly improve their awareness of the most effective birth control options and may prevent unintended pregnancies and birth defects that can be caused by the drug, according to a University of Pittsburgh School of Medicine study published Feb. 4 in the journal JAMA Dermatology.
Isotretinoin, formerly marketed as Accutane, is an effective drug for the treatment of acne, but is also considered a teratogen, or a drug that can cause birth defects. Because of this, the Food and Drug Administration (FDA) strictly regulates the distribution of the drug to women of childbearing age. Through the FDA’s iPLEDGE program, woman who are prescribed the drug must pledge to use two forms of contraception, in addition to taking regular pregnancy tests while on the drug and online tests to make sure they understand the dangers of getting pregnant while taking the drug.
Despite the regulations, 122 pregnancies affected by isotretinoin were reported in the U.S. during the first year of the iPLEDGE program. Pitt researchers have been studying this and found gaps in patients’ knowledge about the most effective forms of contraception.
“While contraceptive counseling isn’t something a dermatologist has to do on a daily basis – like an obstetrician or gynecologist would – it does matter for young women using these drugs. Our goal was to show that a simple intervention like our handout could be added to dermatology office visits to enhance contraceptive counseling and decrease the number of exposed fetuses through more effective means of contraception,” said Carly A. Werner, M.D., a UPMC resident in the Department of Obstetrics, Gynecology and Reproductive Sciences and lead author on the study.
In the study, researchers surveyed 100 women from a single dermatology clinic between April and May 2014. Prior to viewing the contraceptive fact sheet, 75 percent overestimated the effectiveness of condoms, while 51 percent did the same for oral contraceptives. Thirty-four percent of women said they had never heard of contraceptive implants, and 16 percent had never heard of IUDs, or intrauterine contraceptive devices, despite their effectiveness being much higher than that of condoms and oral options.
Researchers surveyed those women again after they had reviewed the fact sheet and found significant improvement in knowing about contraceptives.
“This shows us that dermatologists can make a difference by providing women who take this drug more education regarding effective forms of contraception,” said Laura Ferris, M.D., Ph.D., director of clinical trials for UPMC’s Department of Dermatology, who was a co-author on the study.
The researchers recommended that future study is needed to determine how much the information provided on the fact sheet was retained and if it does reduce the risk of medication-induced birth defects.
Other collaborators were Melissa J. Papic, B.S., and Eleanor Bimla Schwarz, M.D., both with the University of Pittsburgh.
The study was funded in part by FDA grant U01FD004253-01.