EMR Referrals for Teratogen and Contraceptive Counseling for Category D or X Medication Users: RCT

Approximately 6% of pregnancies in the United States are exposed to potentially teratogenic
medications. Birth defects due to prenatal exposure to teratogenic medications are among the
only truly preventable types of congenital anomalies. However, despite the risk of
unintended pregnancies exposed to potentially teratogenic medications, women prescribed
category D or X medications do not use more effective contraception then the general
population. These women also are not more compliant with short acting methods such as oral
contraceptives. The electronic medical record provides an unique opportunity to identify
women taking potentially teratogenic medications and offer interdisciplinary teratogen and
contraceptive counseling. These women specifically may benefit from more counseling about
long acting reversible contraception while they are taking a potentially teratogenic
medication.

Previous studies have revealed that women want more counseling regarding a potentially
teratogenic medication when it is prescribed even if they are not planning a pregnancy or
sexually active. In addition to desiring more teratogen counseling, these women may benefit
from more contraceptive counseling. Eisenberg et al. identified that time constraint is one
of the major barriers to providing adequate contraceptive counseling by an internist to
women taking potentially teratogenic medications. Many internists in the Eisenberg study
believed that an EMR alert would be worthwhile. In addition, approximately two-thirds of the
internists in the Eisenberg study agreed that "a referral or telephone consultation service
for assistance in providing appropriate contraception for women on potential teratogens
would be useful." In order to improve the contraceptive counseling among women prescribed
potentially teratogenic medications, the investigators for the proposed project have been
conducting collaborative research for the past two years with the Family Medicine and the
California Teratogen Information Service (CTIS). First, the investigators conducted a
cross-sectional study to assess contraceptive utilization among women prescribed category D
or X medications. Investigators obtained access to the EMR of women seen in an academic
Family Medicine Department between April 2011 to April 2012 who were taking a category D or
X medication. Information was abstracted regarding the specific category D or X medication,
demographics, sexual activity and the contraceptive method. There were a total of 610 women
included in this study. Among the 610 women, 72 (11.8%) of women had documentation in the
EMR that they were not asked about their sexual activity. Sexual activity with men was
documented in 407 of the 610 women. Of the 407 women who were sexually active with men, 132
(32.4%) had no contraceptive method documented in the EMR. Despite the importance of
avoiding an unintended pregnancy in women taking teratogens, the contraceptive utilization
rate is similar to the national average (38% of 15-44 year olds reported not using a
contraceptive method). In addition, among the women using contraception, the most common
contraceptive method was oral contraceptives, which is very user dependent with a typical
failure rate of 9%. In fact, the oral contraceptive compliance rate for women taking
teratogens is the same as the national compliance rate.

Next, we conducted a descriptive pilot study to evaluate the feasibility and patient
satisfaction with an EMR alert and referral system. This intervention was chosen since the
Eisenberg study identified the time constraint issue, the acceptability of EMR alert, and
the acceptability of the telephone consultation service. Women of reproductive age who were
seen by a Family Medicine clinician at a UCSD Medical Center clinic with access to the EMR
were included in the pilot study. If a woman of reproductive age was seen by a Family
Medicine clinician and she was currently taking or was newly prescribed a category D or X
medications, an EMR electronic alert was be generated for the clinician. The alert said
"This patient may benefit from a referral to the CTIS Information Line for counseling,"
click "Accept" or "Decline". The alert was purposefully created so it is easier to accept
the referral. If the Family Medicine clinician clicked "Decline" then a reason must be given
for declining the referral. If the clinician decided a referral is appropriate, he/she
clicked "Accept" and informed the patient that she will be contacted by CTIS. The referral
was also included in the patient instructions.

Within one month of the referral, a CTIS counselor contacted the patient and reviewed the
category D or X medication and potential effects if the patient were to become pregnant as
well as contraceptive options. The counseling included some information about the efficacy
of each contraceptive method. She was instructed that she could return to her Family
Medicine clinician for contraceptive service delivery. She was also offered a referral to
Reproductive Medicine at UCSD for further counseling. The referring Family Medicine
clinician was then informed of the outcome of the referral via an EMR communication.
Following counseling a phone interview was used to assess contraceptive utilization and
motivation. In addition a satisfaction survey completed. Contraceptive utilization was
assessed using a modified version of Module 5 of Behavioral Risk Factor Surveillance System.
Participant satisfaction was assessed using a Likert scale.

Among 25 participants in the pilot study, 11 (44%) women were using oral contraceptives, 7
(28%) women were using condoms, 3 (12%) women were using withdrawal, 2 (8%) women were using
the IUD, 1 (4%) woman was using vaginal contraceptive ring and 1 (4%) woman was not using
contraception. Among the women using oral contraceptive, the majority of the women
underestimated the typical failure rate. Among the women using contraception, only 2 women
stated that they chose their current contraceptive method based on the effectiveness in
preventing pregnancy. After receiving the teratogen and contraceptive counseling, 25% of
women using contraception were considering using a more effective contraceptive method. The
women were also asked about when they would want a child, the most common response was
wanting a child in 2-5 years. Satisfaction with the referral system and counseling was high.
Approximately 96% of participants strongly agreed or agreed that the information they
received on contraceptive options was helpful.

The conclusion from this descriptive pilot study is that an EMR referral system for
teratogen and contraceptive counseling for women prescribed category D or X medications is
feasible and has high patient satisfaction. Women taking category D or X medications are not
currently choosing a contraceptive method based on efficacy of preventing pregnancy,
therefore efficacy should emphasized more in future contraceptive counseling interventions.
Most participants indicated that they wanted a child in 2-5 years. The results of this pilot
study support promoting long-acting reversible contraception in this population. In
addition, the pilot study revealed that the contraceptive counseling can motivate women
taking potentially teratogenic medications to consider using more effective contraception.
Now we need to focus on helping these women go from thinking about using more effective to
actually using more effective contraception.

The proposed project incorporates the findings of this pilot study to facilitate intention
to use more effective contraception into behavior change. It utilizes the EMR to not only
identify and counsel women exposed to high risk medications, but also facilitates behavior
change by incorporating a clinic visit to further discuss and receive more effective
contraception. The primary objective for the study is to determine if an EMR referral to
teratogen counseling, contraceptive counseling and a follow up contraceptive appointment
will increase the utilization of more effective contraception among women prescribed
category D or X medications. The Internal Medicine department and Family Medicine department
have approved the proposed study.

Inclusion Criteria:

- Ethnic Background: No limitation, will include minorities and Spanish speaking
participants

- Health Status: no limitation

- Sexually active with men

- Currently taking the Category D or X medication

Exclusion Criteria:

- Currently Pregnant

- Not currently sexually active with men

- History of hysterectomy, bilateral oophorectomy, history of female sterilization

- Partner with history of vasectomy