Patient Consent and Release Form for Buprenorphine Treatment During Pregnancy / Neonatal Syndrome
Medication selection during pregnancy
I understand that opioid use disorder during pregnancy is associated with increased risks to both the pregnant woman and fetus, including preterm birth, low birth weight, fetal growth restriction, and other pregnancy complications if untreated. Continued illicit opioid use may increase these risks.
I understand that treatment with medication for opioid use disorder during pregnancy is considered the standard of care. Methadone and buprenorphine are both evidence-based treatment options during pregnancy. Medication treatment is recommended over withdrawal management alone. Untreated opioid use disorder during pregnancy is associated with significant risks, including relapse, overdose, infectious disease, inadequate prenatal care, fetal growth restriction, and pregnancy loss.
I understand that medication selection, including formulation (buprenorphine with naloxone and buprenorphine without naloxone), is determined solely by the treating provider after clinical evaluation and review of my medical records. Current clinical evidence indicates that both buprenorphine with naloxone and buprenorphine without naloxone may be used during pregnancy when clinically appropriate. The choice of formulation will be determined by the treating provider based on individual clinical circumstances in keeping with evidence-based practices. Educational materials and intake documents do not constitute a guarantee of a specific prescription or a prescription in general.
I will meet with a physician, nurse practitioner, or physician assistant at the clinic to discuss the risks and benefits of taking medication containing buprenorphine during my pregnancy.
FDA Status
I understand that methadone is approved by the U.S. Food and Drug Administration (FDA) for the treatment of opioid use disorder. Buprenorphine products are FDA-approved for the treatment of opioid use disorder; however, medication labeling may not specifically reference pregnancy. Use of medications during pregnancy is based on available clinical evidence, expert guidelines, and individualized medical decision-making.
Neonatal Abstinence Syndrome (NAS)
I understand that babies exposed to opioids during pregnancy, including methadone or buprenorphine, may experience withdrawal symptoms after birth. This condition is called Neonatal Abstinence Syndrome (NAS).
I understand that NAS is an expected and treatable condition. Symptoms may include irritability, feeding difficulties, tremors, sleep disturbances, vomiting, diarrhea, or seizures. Some infants may require monitoring and, in some cases, medication treatment in the hospital. Not all infants exposed to medication treatment will develop NAS, and when it occurs it can be effectively treated by pediatric specialists.
I understand that coordination with my obstetric and pediatric providers is important to optimize outcomes for both my baby and me.
Breastfeeding
I understand that, in general, breastfeeding is encouraged for women who are stable on medication treatment for opioid use disorder, are not using illicit substances, and do not have other medical contraindications such as HIV infection.
I understand that breastfeeding and skin-to-skin contact may help reduce the severity of NAS symptoms.
I understand that breastfeeding decisions should be made in consultation with my obstetric and pediatric providers.
Postpartum Relapse Risk
I understand that the postpartum period is associated with increased risk of relapse and overdose, and continued treatment and follow-up care are important after delivery.
Pediatric Notification
I understand that the hospital pediatric team should be informed of medication treatment during pregnancy so that my newborn can be appropriately monitored.
Ongoing Care and Coordination
I understand the importance of:
- Attending regular prenatal care visits
- Informing my obstetric provider of my medication-assisted treatment
- Continuing medication treatment as recommended
- Participating in behavioral health services as clinically indicated
I understand that discontinuing medication without medical supervision may increase risks to both me and my pregnancy.
Acknowledgement and Consent
By signing below, I acknowledge that:
- I have received information regarding medication treatment for opioid use disorder during pregnancy.
- I understand the potential risks and benefits of treatment, as well as the risks of untreated opioid use disorder.
- I understand that medication selection will be determined by my treating provider based on clinical evaluation.
- During the intake appointment with my treating provider, I have/will have/had the opportunity to ask questions, and before the appointment is concluded, have/will have/had all of my questions answered to my satisfaction.
- I voluntarily consent to receive medication treatment for opioid use disorder during pregnancy as determined appropriate by my treating provider.