Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions

Nearly half of all pregnancies in the general population in 2006-2010 were unintended. In
addition, data from the National Survey of Family Growth shows that in 2006-2010, only 62.2%
of women aged 15-44 in the United States are using some form of contraception. These
statistics inherently suggest a need for additional education in the general population
regarding contraceptive options. It is unknown how these statistics for the general
population apply to women with psychiatric conditions. In addition, reproductive age women
with psychiatric diagnoses have several unique family planning considerations, some of which
are outlined below:

TERATOGENICITY OF PSYCHIATRIC MEDICATIONS:

Some women with psychiatric conditions may be on medications that are not safe for use in
pregnancy and therefore may require counseling on their highly effective contraceptive
options. These women may also have other environmental exposures to alcohol, tobacco and
illicit drugs, so this may be an additional need for counseling about risk to a potential
pregnancy. Other women in this population may become pregnant and stop using their
psychiatric medications because they are unaware that their medications are safe to use in
pregnancy. The United States Food and Drug Administration uses the following categories to
rate the safety of using various pharmaceutical agents in pregnancy: A, controlled studies
in humans fail to demonstrate a risk to the fetus in pregnancy; B, no evidence of risk to
fetus in animal studies but no controlled studies for use in pregnant women; C, animal
studies demonstrate an adverse effect on the fetus, but no controlled studies in humans; D,
positive evidence of risk to fetus in human studies; and X, agent contraindicated in
pregnancy because risks to fetus clearly outweigh potential benefits. Most psychotropic
drugs used to treat bipolar disorder are category C or D. For example, lithium, a commonly
prescribed mood stabilizer used as a first-line treatment for bipolar disorder, is
associated with an increased risk of congenital cardiac abnormalities and is FDA category D
for use in pregnancy. Also, valproate and carbamazapine, which are commonly used as mood
stabilizers, have been associated with neural tube defects in the fetus and thus are also
FDA category D for use in pregnancy.

CONTRACEPTION:

Women in this population may also wish to delay or avoid pregnancy due to the current state
of their psychiatric condition and thus should be encouraged to use effective contraception.
It has been shown that women with psychiatric diagnoses may interrupt their use of
contraception due a variety of factors including: drug-drug interactions with their
psychiatric medication, psychiatric hospitalization, loss of personal control over their
medication administration, and preconceived notions of how contraception may impact their
psychiatric condition or vice versa. Long-acting reversible contraceptive options, such as
intrauterine devices (IUDs), requiring no patient compliance to achieve maximal efficacy may
therefore be particularly well-suited options for these women. For these reasons, there may
be a role for focused counseling in this population regarding options for safe, effective
and reversible forms of contraception.

DRUG-DRUG INTERACTIONS:

Some women with psychiatric conditions are on medications that interact with combined
hormonal contraceptives and may benefit from specialized counseling regarding which
contraceptive options are safe for them to use. In 2010, the Centers for Disease Control and
Prevention (CDC) published the United States Medical Eligibility Criteria (USMEC) in an
effort to improve contraceptive safety guidance. The USMEC includes guidance on
contraceptive safety for specific medications, including those commonly used to treat
psychiatric illness. For example, carbamazapine, oxcarbazapine, lamictal, and topiramate,
which are commonly prescribed for mood stabilization, increase the clearance rate of oral
contraceptives; thus patients receiving one of these treatments should consider switching to
an alternative form of contraception. The USMEC continues to be updated and will likely
prove to be a valuable resource to optimize contraceptive counseling for these women.

This multidisciplinary research project involves a unique collaboration between the
MotherToBaby Project, Reproductive Medicine at UCSD and Psychiatry at UCSD to deliver
individualized contraceptive and teratogen counseling to women with psychiatric conditions.
MotherToBaby California, formerly known as the CTIS Pregnancy Health Information Line, in
the Department of Pediatrics at UCSD is a community-based organization founded 27 years ago
which has been continuously funded at UCSD to provide direct-to-consumer and
direct-to-health care provider counseling free of charge on the risks or safety of
medications, chemicals, recreational drugs and alcohol, infectious or chronic disease, and
medical conditions in pregnancy. The goal of MotherToBaby is to provide individualized risk
assessments and referrals for further assistance or diagnostic testing to pregnant or
breastfeeding women in order to prevent birth defects that are related to prenatal or
breastfeeding exposures.

The proposed study will serve to investigate the feasibility of a novel type of counseling
service that may uncover and address unmet family planning needs of reproductive age women
with psychiatric diagnoses. The proposed project also promotes the utilization of the
relatively new evidence-based USMEC contraceptive guidance from the CDC which has been
endorsed by the American Congress of Obstetricians & Gynecologists and American Academy of
Family Physicians.

Inclusion Criteria:

- Presenting for follow up psychiatric visit

- Ethnic Background: will include only english speaking participants (MotherToBaby
counselors are only able to speak English)

- Level of Education: No limitation

- Health Status: at least one psychiatric condition for which they are taking
medication

- Sexually active with Men

Exclusion Criteria:

- Planning to become pregnant

- Not sexually active with men

- History of hysterectomy, bilateral oophorectomy, or surgical sterilization

- Decisionally impaired - using post-consent instrument to assess decisional capacity.
If a potential participant does not score 100% on post-consent instrument, then she
will be excluded from participation.