This is the first in a series of articles on treating pregnant patients in MAT, clinical considerations related to their care, and outcomes for their babies.
Check back in the coming days for part two, or follow us on Twitter @MeridianNetwork to get a live feed from our blog.
Holly is a 35-year-old tenth-grade dropout who has been addicted to both heroin and cocaine for 15 years. She put her first two children up for adoption because she lacked the financial and emotional resources to care for them. But when Holly learned she was pregnant again, she vowed to change her life and keep her baby. She enrolled in a comprehensive drug-treatment program near her home.
Some women, like Holly, seek treatment in an opioid treatment program (OTP) when they learn they are pregnant. Others, already receiving MAT, are leading active, productive lives, and decide to have babies. These women count on their OTP for support and prenatal care.
Holly delivered her baby, and thanks to counseling, medical care and methadone treatment, she is keeping her baby.
Addiction Treatment Forum discussed the needs of pregnant women in MAT with two leading experts, Karol A. Kaltenbach, PhD, clinical associate professor of pediatrics and psychiatry and human behavior, Thomas Jefferson Medical College, Philadelphia, PA; and Hendree E. Jones, PhD, associate professor, Department of Psychiatry and Behavioral Sciences, Department of Obstetrics and Gynecology, Johns Hopkins University School of Medicine, Baltimore, MD. Dr. Kaltenbach and Dr. Jones direct comprehensive programs for opioid-dependent pregnant women.
Methadone Recommended as Standard of Care
Methadone has been used in the treatment of opioid-dependent pregnant patients since the 1960s. In 1998, a National Institutes of Health (NIH) consensus panel recommended methadone maintenance as the standard of care for treating pregnant women with opioid dependence. Methadone also is recommended as the standard of care by the Center for Substance Abuse Treatment (CSAT). The CSAT publication TIP 43 states that effective methadone-maintenance treatment and prenatal care improve obstetrical and fetal outcomes.
Buprenorphine as an Alternative to Methadone
CSAT TIP 43 recommends using buprenorphine in treating pregnant patients only when the prescribing physician believes the potential benefits outweigh the risks.
“Buprenorphine is an alternative to methadone for some women,” Dr. Kaltenbach told AT Forum, “especially those who are already being maintained successfully, become pregnant, and either refuse transition to methadone, or live in areas without access to an OTP. Physicians whose patients become pregnant while taking buprenorphine should counsel these patients about the use of buprenorphine during pregnancy. Physicians should also have the patients sign an informed consent if they wish to continue receiving buprenorphine.”
Clinical Trial in Progress
Both the NIH and CSAT support methadone as the standard of care for opioid-dependent pregnant women. due to the 40 years of clinical experience and numerous published reports documenting its safety and efficacy. Pregnant women have been allowed to participate in clinical trials examining any medication only since 1993; therefore, methadone, like most other medications, has remained in the U.S. Food and Drug Administration (FDA) Pregnancy Category C (meaning there is a lack of controlled clinical study data in pregnant humans).
An international clinical trial being conducted at eight sites is the first large randomized controlled trial to prospectively evaluate the maternal and neonatal safety and efficacy of buprenorphine versus methadone in opioid-dependent pregnant women. The trial, the Maternal Opioid Treatment Human Experimental Research (MOTHER) project, began in 2005, and includes 175 randomized participants. Dr. Jones is lead principal investigator of the project at the Baltimore site, and Dr. Kaltenbach is the principal investigator at the Jefferson site. Preliminary data are expected by the end of this year. Dr. Jones told AT Forum, “Our hope is that we’ll have both medications approved for use in pregnant women, so patients will have a choice.”
Challenges of Diagnosing Pregnancy
The TIP 43 consensus panel acknowledged that some opioid-dependent women may misinterpret early signs of pregnancy—nausea and vomiting, headaches, fatigue—as symptoms of opioid withdrawal. Consequently, they may increase their use of illicit opioids. If an opioid-dependent woman becomes pregnant, early enrollment in an OTP is recommended for the health of the mother and child.
For patients already in treatment, OTP staff members should discuss contraception regularly. Because methadone normalizes endocrine functions, women in the early stages of MAT may become pregnant unintentionally. Dr. Kaltenbach strongly urged that OTPs run periodic pregnancy tests on patients of child-bearing age, because the earlier pregnancy is diagnosed, the earlier medical care for mother and child can begin.
Federal Regulations for Treating Pregnant Patients
Federal regulations require OTPs to:
- Give priority to pregnant women who seek treatment, documenting any reasons for denying admission. For pregnant patients, OTP physicians may waive the usual requirement of a 1-year history of opioid addiction.
- Maintain policies and procedures that reflect the special needs of pregnant patients.
- Provide prenatal care, on site or through linkage agreements, and refer pregnant patients to appropriate health care providers.
Accreditation agencies usually review how OTPs provide care to pregnant patients.
Special Needs of Pregnant Patients in MAT
Pregnant patients in MAT can have complex medical and obstetric issues, as well as co-occurring mental health issues that require careful management.
Stigma affects all opioid-dependent patients to some degree, but prejudice toward those who become pregnant is especially high. Staff must provide patient care in a nonjudgmental way, conveying an understanding of the patient’s fears and cultural or ethnic beliefs.
Staff-Patient Relationships
Staff members can build rapport and mutual trust with the patient during the assessment. It’s essential to answer the patient’s questions openly and thoroughly. A patient should understand that if she follows the OTP staff’s recommendations about issues related to her health, the baby’s health, and her family or personal situation, she will help to achieve a positive pregnancy outcome.
The benefits of methadone maintenance during pregnancy need to be clearly outlined for patients entering treatment, and those already on MAT. Methadone:
- Eliminates risks associated with repeated fluctuations in blood levels of short- acting opioids
- Helps prevent the mother’s use of needles and illicit drugs, thus reducing the risk to mother and fetus of bloodborne pathogens
- Improves adherence to medical care
- Reduces the risk of problems during pregnancy and delivery
- Provides better outcomes for the newborn (higher birth weight, lower risk of complications)
Patients need to be aware that some babies born to OTP patients develop withdrawal symptoms, known as neonatal abstinence syndrome (NAS). There is no conclusive evidence that higher methadone doses lead to more severe abstinence. Teamwork between obstetrician, mother, and OTP staff can improve outcomes for mother and child. There are known and effective treatments for NAS. Appropriately treated NAS has not been associated with long-term developmental problems for the child.
Managing Comprehensive Services of Pregnant Patients
Dr. Kaltenbach’s and Dr. Jones’ programs routinely treat opioid-dependent pregnant patients with methadone. Both programs offer comprehensive services that include obstetrical care, pediatric care, preparation for child care, psychological therapy, and individual, family, group, and couples counseling. Very few such specialized programs exist. Most OTPs will need to link with outside medical professionals, or community-based agencies, or both.
Coordinating Prenatal Care
“A major challenge for OTPs is to coordinate prenatal care,” Dr. Kaltenbach told AT Forum. “OTPs need to establish a relationship with an obstetrician willing to work with them, so they can obtain consent and communicate with each other. Then the OTP physician and the obstetrician can exchange clinical information and work cooperatively to achieve the best outcome for mother and child.”
Dr. Jones added, “Communication, training, and working with everyone involved throughout the pregnancy is the key. Hospital staff members need to have a clear understanding of OTPs. Ongoing training is necessary, due to high staff turnover, particularly in large public medical centers.”
Coordinating Other Services
The list of recommended services is long, but opioid-dependent pregnant women are among the most vulnerable groups in our society. There are special needs of the unborn child as well.
- Patients need services aimed at eliminating substance use, developing personal resources, improving family and interpersonal relationships, and eliminating socially destructive behavior.
- Domestic violence and destructive behavior must be addressed in some families; preventing HIV/AIDS and other communicable diseases are important in others.
- Patients should receive screening for co-occurring psychiatric disorders, including mood disorders (eg, depression), anxiety (eg, post-traumatic stress disorder), and other drug use disorders (eg, alcohol, nicotine, benzodiazepines, cocaine, marijuana). Patients with positive test results for co-occurring disorders should receive assessment and treatment.
- Patients should have an assessment of their nutritional status, weight, and eating habits, and should receive dietary education when necessary.
Opportunities for OTPs
Some OTPs have very few pregnant patients, and say they haven’t any place to send them, and don’t have the linkages that lead to effective care. Dr. Kaltenbach told AT Forum, “There is a wealth of guidance available to OTPs. TIP 43 has a lot of information on managing opioid dependence during pregnancy. So do many journal articles.” (see resources below.)
A few years ago only three methadone programs in Baltimore actively admitted pregnant patients; now about 25 do. “We have been successful in communicating the message that it’s okay to be maintained on methadone during pregnancy,” Dr. Jones told AT Forum.
OTPs that promote services to attract pregnant patients can gain a competitive edge, while providing a valuable service to pregnant women and their babies.
Reference:
Jones, Martin. “Medication-Assisted Treatment (MAT) During Pregnancy – Part I.” Center for Substance Abuse Treatment. U.S. Department of Health and Human Services, 19 July 2009. Web. 5 Nov. 2009. <http://csat.samhsa.gov/>.
Again, check back for part 2 in this series in the coming days. You can also follow us on Twitter at @MeridianNetwork for a live feed of our blog.
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