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Horton C, Jawish R, Nynas J. Medication for addiction treatment for opioid use disorder in pregnancy by primary care obsetricians. HPHR. 2024. 85. https://doi.org/10.54111/0001/GGGG3
Opioid overdose is a major cause of pregnancy-associated morbidity and mortality in the United States. The opioid related mortality ratio more than tripled from 2018 to 2021 and the vast majority of these overdose related deaths occur in women who are not engaged in the healthcare system. Medication for Addiction Treatment with methadone and buprenorphine is the most effective treatment modality and has been proven safe and effective for use during pregnancy. Medication for Addiction Treatment is associated with decreased maternal and perinatal morbidity and mortality associated with preterm delivery and overdose. The American College of Obstetrics and Gynecologists recommends the use of opioid agonist therapy for the treatment of opioid use disorder in pregnancy. The elimination of the DEA waiver was intended to eliminate barriers to prescribing opioid agonist therapy in a primary care setting, thus primary OBGYN providers have a responsibility to familiarize themselves with these clinical recommendations to provide medication for addiction treatment for their patients as soon as possible after initial presentation.
Opioid overdose is a major cause of pregnancy-associated morbidity and mortality in the United States.1 Antepartum opioid use increased nearly fivefold from 2000 to 2009.2 From 2010 to 2017, opioid-related deaths increased by 220% and antepartum maternal opioid-related diagnoses in pregnancy increased in nearly all states throughout the nation.1 The opioid related mortality ratio more than tripled among pregnant individuals from 2018 to 2021.3 All providers caring for pregnant persons have a responsibility to provide evidence-based care for these patients as soon as possible to reduce the risks associated with substance use during pregnancy.
Addiction is a complex chronic disorder that results in physiological changes in the brain neurocircuitry.4 Chronic opioid use can cause physical dependence as a result of these anatomical changes leading to withdrawal symptoms upon discontinuation which can be detrimental for pregnant women and the fetus.1 Opioid use disorder (OUD) is a chronic medical condition that can be treated using evidence-based medications. These treatment modalities are safe and effective for use in pregnant patients.1
Pregnancy is frequently a time when individuals re-engage in healthcare or seek care for the first time; thus, OBGYNs are often the first point of contact for these patients with substance use disorder. Most pregnancy-associated overdose deaths occur outside a healthcare setting among those not engaged in the medical system.3 OBGYNs have a responsibility to their patients with opioid use disorder to connect them with the appropriate services immediately on presentation.
The current opioid epidemic has particularly affected pregnant persons and women of reproductive age living in rural areas.5 Rural communities are particularly susceptible because healthcare access is limited, poverty levels are higher, and resources are scarce. Access to hospital-based obstetric care is declining in rural America with fewer than half of rural counties with a hospital that provides these services.5 Rural communities face a shortage in access to comprehensive treatment for opioid use disorder.6 Additional challenges for rural individuals in seeking treatment for substance use disorder is long distance traveled, unreliable transportation, financial burdens of travel, childcare, work leave, socioeconomic stressors, and demands of frequent dosing. Rural communities also face disparities related to structural determinants of health including but not limited to lack of insurance, health literacy and understanding of health infrastructure, language barriers, and mistrust of the healthcare system.
Medication for Addiction Treatment (MAT) is the evidence-based treatment that is recommended for OUD during pregnancy versus detoxification therapy.7 MAT has historically been known as medication-assisted treatment when referring to FDA-approved medications used to treat substance use disorder (SUD); to reduce stigma it is now recommended to use the verbiage medication for addiction treatment when referring to MAT.8 MAT refers to the evidence-based treatment for substance use disorder, specifically medications that have been proven effective for opioid use disorder and alcohol use disorder.9 These medications ameliorate withdrawal symptoms, decrease cravings, and reduce return to use.10
MAT is preferred in pregnancy given that it is associated with a lower risk of adverse outcomes such as overdose and preterm delivery.1 Each additional week that a mother receives MAT during pregnancy increases the odds of continued recovery, decreasing the risk of overdose mortality in the postpartum period. MAT is the only intervention proven to decrease the risk of overdose.1 MAT can reduce the risk of death from substance use by more than 50%.11 MAT has been shown to improve birth outcomes, improve patient survival, increases recovery rates, decrease illicit opiate use and other criminal activity, increase patients’ ability to gain and maintain employment.11 Although specific statistical data on perinatal outcomes and long-term treatment success is limited,12 underscoring the need for ongoing research on this topic, it is known that MAT for OUD improves outcomes when compared to abstinence-based treatments. Abstinence-based treatment modalities are associated with high rates of continued substance use, increasing the risk of adverse maternal and neonatal outcomes including fetal growth restriction, abruption, preterm labor and delivery, infection morbidity, and overdose.1 Due to the significant benefits with MAT during pregnancy, clinical guidelines from the American College of Obstetricians and Gynecologists (ACOG) recommend MAT treatment versus other abstinence-based treatment modalities.13 A recent study showed 73.2% of pregnant people who received MAT during pregnancy remained in recovery at 12 months postpartum. There was a significant association between increased time receiving treatment and reduction in opioid use,14 further underscoring the need for timely treatment initiation.
Methadone and buprenorphine are the preferred medications for use during pregnancy.2 There is a known risk of neonatal opioid withdrawal syndrome (NOWS), but this risk is outweighed by the benefits of MAT and can be effectively managed in the postnatal period. There is no known association with increased risk of fetal birth defects or long-term developmental impacts on the fetus with these medications.1 Maternal MAT can reduce NOWS-related morbidity, prevent prolonged hospitalization, shorten duration of pharmacotherapy, decrease severity of NOWS symptoms, and improve neonatal outcomes.15 NOWS can be effectively managed with close neonatal observation during the postnatal period and assessment using a validated screening tool such as Eat, Sleep, Console (ESC),16 which can be used to monitor neonatal withdrawal symptoms. In cases of severe NOWS, pharmacological treatment can be used; morphine is the recommended first-line treatment.16
There is no identified relationship between the dose of these medications and the incidence or severity of NOWS, but buprenorphine is associated with a shorter duration of treatment needed for NOWS than methadone.17, 18 Given this finding, buprenorphine is the preferred first-line agent for many pregnant patients with OUD. Buprenorphine is easier to access, has a very low risk of overdose, and is available in many formulations, making it the preferred agent for most patients. Regardless of the chosen agent, administration should be initiated early, continued throughout the pregnancy and into the postpartum period.
The X-waiver, also known as the DATA-waiver, was a certification previously required by the Drug Enforcement Administration (DEA) in order to prescribe MAT. Section 1262 of the Consolidated Appropriations Act of 2023 removed the federal requirement for practitioners to apply for a waiver to prescribe FDA approved medications for the treatment of OUD.19 Elimination of this policy means that any practitioner with a current DEA registration is able to prescribe medications for treatment of OUD. This policy amendment also removes other federal requirements previously associated with waiver requirements including discipline restrictions, patient limits, and certification related to provision of counseling. The elimination of the waiver requirement was intended to remove many of the barriers to prescribing MAT in a primary care setting, yet only a small subset of practitioners have started to incorporate this care into their routine practice.6
The X-waiver, also known as the DATA-waiver, was a certification previously required by the Drug Enforcement Administration (DEA) in order to prescribe MAT. Section 1262 of the Consolidated Appropriations Act of 2023 removed the federal requirement for practitioners to apply for a waiver to prescribe FDA approved medications for the treatment of OUD.19 Elimination of this policy means that any practitioner with a current DEA registration is able to prescribe medications for treatment of OUD. This policy amendment also removes other federal requirements previously associated with waiver requirements including discipline restrictions, patient limits, and certification related to provision of counseling. The elimination of the waiver requirement was intended to remove many of the barriers to prescribing MAT in a primary care setting, yet only a small subset of practitioners have started to incorporate this care into their routine practice.6
The following case depicts the timely MAT induction in a pregnant patient after presentation to a rural prenatal clinic. This case provides an example of a protocol for implementation of evidence-based MAT initiation for pregnant patients who present in a primary care setting in rural and low resource communities.
The patient is a 24-year-old G1P0 at 10 weeks and 2 days, who presents for her initial prenatal visit. The abbreviation G1P0 indicates that this patient is pregnant for the first time and has not yet given birth to any children; the G stands for gravida and is the number of pregnancies this patient has had; the P stands for para and correlates to the number times the patient has given birth. The current pregnancy is complicated by a history of polysubstance use disorders including alcohol, heroin, and nicotine. The pregnancy was unintended but desired. The patient is excited to become a mother, giving her motivation to pursue treatment for her substance use disorder (SUD). The patient has stopped consuming alcohol since finding out she was pregnant, she reports her last drink was four weeks ago, making it around 6 weeks gestational age. The patient is still smoking tobacco, mostly vaping, equivalent to about a half pack per day. The patient tried to stop using heroin after learning she was pregnant but was unable to tolerate withdrawal symptoms. Her last reported heroin use was yesterday, on presentation she reported cravings, anxiety, restlessness, nausea, tremulousness, and diaphoresis. She reported no known use of fentanyl. Prior to pregnancy she was using heroin and drinking daily for at least the last 6 months. She is motivated to stop substance use now that she is going to going to be a mother and she is interested in pursuing MAT.
The decision was made to initiate MAT immediately with buprenorphine. To align with current clinical recommendations from the American Society of Addiction Medicine (ASAM), the patient was transferred to the inpatient service for close monitoring during induction.20, 21 At presentation, her Clinical Opioid Withdrawal Scale (COWS) was 15, consistent with mild withdrawal.22 Given her last reported use, daily habitual use, the onset of withdrawal symptoms, and COWS score of 15, the patient was started on sublingual buprenorphine at a dose of 8 mg. After observation, the patient reported persistent withdrawal symptoms with a COWS score of 13 so she was administered an additional dose of 4 mg. She did not require any additional dosing on day 1, having received a total dose of 12 mg. On day 2 of treatment, the patient was administered 12 mg of buprenorphine sublingually, based on her total dose from day 1. She later reported a COWS score of 13 so she was given an additional 4 mg sublingually, after which her symptoms resolved, making her total daily dose of 16 mg on day 2 of treatment. On day 3, the patient was given a dose of 16 mg. With this dosing she remained symptom free throughout the day and overnight with a maximum COWS score of 4, indicating an appropriate starting maintenance dose of 16 mg per day. On day 4, the patient was discharged with a maintenance dose of 16 mg per day. Upon discharge, the patient was scheduled with the local MAT clinic daily for the next week to ensure her discharge dose appropriately managed her withdrawal symptoms. After this initial week of outpatient monitoring, the patient was scheduled to follow up with the MAT clinic on a weekly basis to monitor for recurrent symptoms. She was also followed by her OBGYN who initiated her on buprenorphine, at which time this provider could make any necessary dose adjustments as the pregnancy progressed. This patient remained stable throughout the pregnancy with 16 mg of buprenorphine daily, she carried to term and eventually delivered a healthy baby via normal spontaneous vaginal delivery. This patient was able to maintain recovery after delivery; she was able to secure employment with healthcare benefits allowing her to continue following up with the MAT clinic with which she established during her pregnancy. She has since returned to school to become a social worker and is currently working as a patient care coordinator to help fellow pregnant patients battling substance use disorder.
Although this case represents a relatively straightforward case of initiation and maintenance of MAT in a pregnant individual, it also provides an excellent example for hospitals in rural and low resource areas to incorporate a protocol for prompt induction and close follow up for individuals who present through primary care departments (prenatal care clinic, urgent care, emergency department, etc.). In the rural hospital system where this case occurred, once a pregnant patient with OUD was identified, a protocol was initiated to consult the OBGYN on service to admit the patient to labor and delivery, determine appropriate timing of induction, monitor treatment initiation, and coordination of close follow-up.
Induction of buprenorphine should be done with inpatient hospitalization, at least 12 hours after last reported opioid use, once mild to moderate withdrawal symptoms begin. COWS assessment of 12 or greater is considered mild withdrawal and is a quantitative assessment that can be used to help guide medication initiation.23 The Substance Abuse and Mental Health Services Administration (SAMHSA) recommends a starting does of 2-4 mg after onset of mild withdrawal. After 1-2 hours, reassess withdrawal symptoms using COWS.24 COWS over 12 is consistent with persistent withdrawal and would warrant a subsequent dose of 2-4 mg. Continue to reassess for persistent symptoms every 1-2 hours until no symptoms are reported. The total dose from day 1 is the starting dose for day 2 of treatment. Monitor every 2 hours for persistent withdrawal, COWS score of 12 or above would warrant a subsequent dose of 2-4 mg. Continue this protocol for medication adjustments until a stable dose is established for daily dosing.24 One thing to consider for dosing and maintenance therapy is that these medications are metabolized and cleared faster in pregnant individuals, which may precipitate more severe withdrawal symptoms, requiring higher doses or more frequent dosing in these patients.25
Upon identification of a pregnant patient with OUD it is also important to screen for any other substance use and mental health disorders to ensure the patient gets established with all necessary services for comprehensive care.26 If additional substance use disorders are identified they should be treated as recommended by ASAM, ACOG, and SAMHSA. Shared decision making should be used to guide treatment and carefully way the risks and benefits of the aforementioned pharmacological treatments. Through comprehensive MAT management these patients should be established with the appropriate support services to help them address their polysubstance use disorder. Additionally, for many of these patients, SUD is identified on their first prenatal visit or first interaction with healthcare during that pregnancy, thus it is integral to determine a reliable estimated gestational age and do a basic fetal assessment for viability.26
It is important that patients initiated on MAT in the hospital are connected with appropriate services and have close follow up with a multidisciplinary team prior to discharge to engage in MAT management and care coordination and allow for close monitoring of progression. The protocol for this particular hospital system was to have the patient follow up with the local MAT clinic daily for at least one week after discharge. After the initial week of outpatient dosing and monitoring, the patient can transition to more spaced-out monitoring as deemed fit by the MAT providers, such follow up schedule may be weekly, biweekly, or monthly, individualized to each patient’s case. As mentioned above, these medications may be metabolized faster as the pregnancy progresses, so it is important to monitor for withdrawal and make appropriate dose adjustments.25 The patient should be set up with mental health services, including individual and group therapy, social support, as well as appropriate maternal health services, including maternal-fetal-medicine partners, high risk obstetrics coordinator, and any other available maternal support services. As part of a collaborative care model, it is important to consult psychiatry to help manage concurrent psychiatric diagnoses.
Unique challenges with prescribing MAT in rural communities are discussed above in the introduction. A major consideration with incorporating these services in rural communities is the shortage of physicians providing this care and limited workforce for the various aspects of care incorporated into comprehensive MAT therapy. One way to ameliorate this resource shortage is increasing education and training on this evidence-based care. One commonly perceived challenge is lack of understanding of the requirements and protocols for this management.6 Increasing resources and educating rural primary care providers could help mitigate this challenge. Another potential is to advocate for incorporating this education during residency training for primary care programs, including but not limited to family medicine, internal medicine, emergency medicine, and OBGYN. Future advocacy and public health initiatives could aim to implement reform in graduate medical education to include this topic during residency education, and not just during didactics but also providing opportunities for clinical exposure to prescribing medication for addiction treatment. Implementing such change would require stakeholder buy-in across multiple sectors including but not limited to National and State medical associations, the American Medical Association, Residency Administrators, and teaching institutions willing to take on this training. Engaging resident physicians would be an efficient way to increase access to MAT by increasing the number of physicians providing these services and training the next generation of physicians to continue providing this care as part of their ongoing practice. Additional policy efforts should be focused on increasing resources and investing in MAT programs in rural communities to help increase access to these services.
Another challenge for widespread implementation of MAT care is that state regulations may not align with federal policy updates. Recent studies show that most state boards align with federal guidelines, however, several were more restrictive, such as Kentucky, where opioid overdose mortality rates continue to increase.27 Notably, five states with some of the most restrictive laws include Kentucky, Louisiana, Maine, Ohio, and West Virginia, are among the 10 states with the highest drug overdose mortality rates.28 Furthermore, a recent study found that three of these five states imposed additional regulatory hurdles for office-based opioid treatment, such as state laws dictating the frequency of counseling and office visits with providers, increased urine drug monitoring, and buprenorphine dosing limits.27 State-level barriers to buprenorphine access are worrisome for public health as these restrictive regulations negatively impact information dissemination, destigmatization, and widespread implementation of these services to increase access to evidence-based care.
Overdoses, primarily caused by opioids, have been increasing in the U.S. at an exponential rate,29 a trend that does not exclude pregnant individuals. Based on the clinical guidelines from ASAM and ACOG, MAT is the recommended, evidence-based treatment for pregnant individuals with OUD and should be initiated as soon as possible. Elimination of the DEA waiver was intended to eliminate barriers to prescribing MAT in a primary care setting and OBGYNs have a responsibility to familiarize themselves with these clinical recommendations to provide MAT for their pregnant patients as early as possible, especially in rural communities where access to these services may be limited. Additionally, for patients who are geographically isolated and those with unreliable transportation, increased frequency of visits for MAT may be a burden to seeking healthcare, and thus the increased monitoring must be balanced with the burden this imposes on a patient’s daily responsibilities. In conclusion, MAT should be initiated for all pregnant patients with OUD, and treatment should be initiated immediately upon presentation.
Public health advocacy and policy amendments are avenues to increase access to MAT for pregnant individuals with OUD and rural communities. State policy makers can advocate to eliminate state regulations that contradict federal policies and create unnecessary barriers to widespread implementation of these services. Medical associations, governing bodies, and graduate medical education organizations can advocate at the federal level and collaborate with Center for Medicare and Medicaid Services (CMS) to include MAT training in the graduation requirements for primary care residency programs to increase physician work force incorporating this care into their practice.
There is a large gap in available literature and large-scale clinical trials that focus on the population of pregnant individuals with SUD. Future research should focus on this high-risk, understudied patient population including psychopharmacological interventions and innovative interventions that are potentially safe in pregnancy and could be instrumental to improving maternal and fetal outcomes. Policies to increase investment in rural MAT programs and residency training could also facilitate avenues to increase research on this vulnerable population.
Pregnancy provides a unique opportunity to engage women with SUD in their healthcare, which they may not have sought otherwise. Once identified, OBGYNs should follow evidence-based recommendations and immediately connect patients with the appropriate services for safe and effective treatments including MAT. This case is particularly relevant as the patient presented to a rural primary care clinic and after transfer to the inpatient hospital unit buprenorphine induction was done immediately by the patient’s OBGYN provider, avoiding any delay of care which resulted in better outcomes.
Consent was not obtained for this case report because it was written retroactively, and the author was unable to contact the patient involved. Extreme care was taken to deidentify patient information and safeguard anonymity.
I want to acknowledge all the authors who contributed to this manuscript and thank them for their time. No funding was sought for this manuscript.
The authors have no relevant financial disclosures or conflicts of interest. All authors listed have contributed to this manuscript and grant HPHR/BCPH permission to review and publish this work. This manuscript is not under consideration by another publication and has not been previously published elsewhere.
Dr. Horton is a recent graduate from the University of Minnesota Medical School interested in obstetrics and gynecology. Her clinical interests include addiction medicine and addressing the maternal health crisis afflicting rural communities and birthing people of color through various public health initiatives. She will be starting her training at Temecula Valley Hospital as a surgery preliminary resident and plans to pursue OBGYN residency in the upcoming match cycle.
Dr. Jawish is an Assistant Professor in the Department of Psychiatry and an Adjunct Assistant Professor in the Division of Epidemiology, Department of Medicine, University of Utah Spencer Fox Eccles School of Medicine. Her clinical interest is in improving women’s mental health and expanding access to mental health care for pregnant women with substance use and mood disorder. She is also interested in identifying existing barriers and factors that are facing this underserved, vulnerable, understudied patient population. Dr. Jawish is board-certified in Psychiatry and board-eligible in Addiction Psychiatry with the American Board of Psychiatry and Neurology. Dr. Jawish has recently been named a member of the VPCAT Scholar program for the 2024-2025 cohort.
Dr. Nynas is a board-certified obstetrician-gynecologist affiliated with Sanford Health of Northern Minnesota in Bemidji, MN. She graduated from the University of Minnesota Medical School and completed her OBGYN residency at St. Joseph Mercy in Ann Arbor, MI. She provides comprehensive obstetric care including the treatment and initiation of medication for addiction treatment. She teaches medical and advanced practice professional students at Sanford Health of Northern Minnesota. Her clinical interests include improving access, quality, and coordination of care for the patients and communities in Northern Minnesota.
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