With proper informed consent, the prescription of progesterone to prevent preterm birth in appropriate patients should not put physicians at increased risk of liability, according to several experts.
In fact, physicians may face a lawsuit if they fail to offer it when indicated, suggested Steve Caritis, M.D.
“You can envision a woman who has had two previous preterm births and her physician doesn't raise this option. If she has another preterm birth there could be liability for not informing her that the therapy exists,” he said in an interview.
Dr. Caritis, professor and chief of maternal-fetal medicine at the University of Pittsburgh, was one of the investigators in the key study that led to the endorsement of progesterone therapy by the American College of Obstetricians and Gynecologists as a means of preventing preterm birth (ACOG Committee Opinion #291 [Obstet. Gynecol. 2003;102:1115–6]).
The randomized, placebo-controlled trial, conducted for the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, found that weekly intramuscular injections of 250 mg of 17 α-hydroxyprogesterone caproate (17-OHPC) decreased the risk of preterm birth by 34% in women with at least one spontaneous preterm birth (N. Engl. J. Med. 2003;348:2379–85).
ACOG's endorsement of the therapy stresses the importance of restricting it to this very select group of high-risk patients. The opinion notes that the drug “has been studied only as a prophylactic measure in asymptomatic women, not as a tocolytic agent,” and that further studies are needed to evaluate its use in women with multiple gestations, short cervical length, or positive test results for cervicovaginal fetal fibronectin. It also says that both the optimal route of drug delivery and its long-term safety remain unknown.
Given such issues, it is reasonable for physicians to have concerns about liability, but this should not deter them from prescribing the therapy where appropriate, said Larry Veltman, M.D., chair of ACOG's Committee on Professional Liability and chair of obstetrics and gynecology at Providence St. Vincent Medical Center in Portland, Ore.
“It is good medicine to have concerns about risks to the baby—this is a relatively new development and the risks and benefits still need to be thoroughly investigated. But to date, there have been no specific fetal or maternal risks identified,” he told this newspaper. The main point of the committee opinion was not to caution physicians about risks, but rather to inform them about the treatment, explained Laura Riley, M.D., who, as past chair of ACOG's Committee on Obstetric Practice, was involved in preparing the opinion on progesterone therapy.
“It brought this treatment to the attention of people who don't necessarily read the [New England Journal of Medicine], so that people would know this is one option—the only preventive option for preterm birth,” said Dr. Riley, medical director of labor and delivery at Massachusetts General Hospital in Boston.
Physicians at Northwest Perinatal Center, a subdivision of Women's Healthcare Associates in Portland, Ore., have been prescribing progesterone therapy for more than 2 years and until now have asked patients to sign a consent form stating that the treatment is not considered standard of care and that it does not ensure a term delivery, said Thomas Lee, M.D., a perinatologist who works at the center. “We are now questioning whether this is still necessary. The more experience we have with this therapy, the less concerned we are with liability issues,” he said, adding that more than 80% of the 20 patients they have treated with it have delivered after 35 weeks.
At the University of Illinois at Chicago, Sarah J. Kilpatrick, M.D., said she feels very comfortable about offering the treatment without any specific informed consent. “Personally, I don't think there's a risk of liability,” said the professor and head of obstetrics at the university.
“When you review the literature on risk of progesterone to the fetus you really can't come up with anything, but because there are no long-term data it is important to limit its use to only those women who can benefit from it. To me, the risk with progesterone is that people are going to use it inappropriately and therefore expose women to whom it may be not helpful,” Dr. Kilpatrick said.
Dr. Caritis agreed that long-term safety issues are probably not high on the list of concerns for most physicians prescribing this therapy, but quality control and standardization issues may be. Currently, a commercial preparation of 17-OHPC is not available, and the drug can be obtained only through compounding pharmacies.
“Compounding pharmacies do not have anybody regulating them, and what regulations they do have are kind of loose. Therefore, I think there's a concern from physicians about the quality of the compound that comes from these pharmacies. You don't know how they're making the product and whether they're doing the proper testing,” said Dr. Caritis.