Prenatal care

Pregnant women who use opioids should receive all elements of routine prenatal care ( Tables 1 and 2 ). Because they often are judged by family and friends, feel guilt, and experience stigma for their substance use during pregnancy, they may expect to be similarly judged and poorly treated by healthcare providers. Providers who project a caring and nonjudgmental attitude can build strong rapport with these patients, engender trust, and facilitate effective communication. This approach decreases patient anxiety, improves effective coping abilities, yields more productive patient-provider interactions, improves prenatal care attendance, and leads to better clinical outcomes. Techniques to build empathy with even the most difficult patients include establishing and maintaining eye contact, allowing the patient to speak without interruption, using nonverbal cues (eg, nodding) to indicate active listening, using the patient’s own words to summarize what was heard, and asking for any needed clarification. The use of simple language to convey instructions and the reason for and the nature of any anticipated medical procedures helps to build trust and may improve adherence to treatment and care.

Importantly, excellent patient-provider rapport increases the likelihood that the patient will disclose an accurate history of licit and illicit substance use. Verbal, written, or computer-assisted questioning about patient history and current drug use is the gold standard for substance-use screening. Urine drug testing can also identify women who use drugs, but it should never replace written or verbal screening because biologic tests cannot diagnose a drug-use disorder or its severity, nor can it determine use quantity, frequency, or route of administration of a given drug. Before urine drug testing, providers should obtain the patient’s consent and explain the reasons for and limitations of any such test. Because false-positive rates for these tests can be as high as 5%, a confirmatory gas chromatography–mass spectrometry test may be needed. An “opiates” test typically detects only morphine, codeine, and heroin metabolites; detection of semisynthetic or synthetic opioids (such as oxycodone, oxymorphone, buprenorphine, and fentanyl) may require more specific testing. Once opioid use is identified, the obstetric provider should educate the patient so that she understands the potential effects of the opioid on her, her fetus, and her newborn infant. The underlying reasons for opioid use (ie, illicit use or prescribed therapy for acute or chronic pain or an opioid use disorder) have critical treatment implications. Although patients with opioid-use disorders or patients who misuse opioids may benefit from more frequent prenatal visits, in the absence of other indications, they do not necessarily require more intense medical care than other pregnant patients.

As noted in Table 2 , all pregnant patients who use or are suspected of using illicit substances should be questioned about tobacco, alcohol, and other substance use, comorbid mental health conditions, and social service needs. Indications that a patient might benefit from further assessment and/or treatment by an addiction specialist include self-reported illicit substance use, clinical suspicion of illicit substance use based on substance use before and/or during pregnancy, a report of an illicit drug-using significant other, homelessness, and/or initiation of prenatal care after the first trimester of pregnancy. Similarly, the presence of a mental health disorder requires referral for appropriate specialized care. In general, the threshold for referral to specialized care is lower for pregnant women than for other patients, given concerns for both the mother and the fetus. However, a woman should not be referred to specialized addiction treatment on the basis of a positive opioid urine test if she is being treated with opioids in a legitimate pain management program or is adhering to an opioid maintenance program.

Management of opioid use in pregnant patients should be coordinated with a practitioner who is knowledgeable about pain or addiction medicine. Ideally, a staff person within each obstetrics practice can address potential issues of substance use by screening, assessment and brief intervention and has knowledge about community resources and drug treatment programs that provide care to pregnant women. It is important to ensure that referral agencies are accessible and accept the patient’s insurance. As with referrals to any other specialist, referral to addiction medicine specialists is not a “hand-off of care” on the part of the obstetrician but rather should be integrated into the obstetrics management plan. Such referral may be complicated, given that methadone pharmacotherapy can be offered only through licensed treatment programs, and many such programs nationwide face waiting lists for treatment entry. Clinical experience suggests patient benefit if the obstetric provider validates the need for specialized addiction treatment and personally communicates with the drug addiction clinic director or specialist; this approach may also lead to a more timely patient appointment. It can be beneficial if the provider helps the patient develop strategies to overcome any barriers that may be encountered with specialized addiction treatment access or attendance. Opioid use, on its own, does not necessarily require referral to a maternal-fetal medicine specialist. Community standards, physician experience, and coexisting medical conditions should all play a role in the determination of referral decisions. An obstetrics provider who lacks the knowledge necessary to treat a patient who uses opioids may consider transferring her to a provider more skilled in this area. For patients who use opioids who meet criteria for an opioid-use disorder with current opioid dependence, opioid-agonist pharmacotherapy is strongly recommended. Considerable guidance is available about the treatment of the opioid-dependent pregnant patient with methadone or buprenorphine, both of which are classified as pregnancy category C medications by the Food and Drug Administration. Prescribing these medications during pregnancy is not considered “off-label” because labeling for both products specifically includes information for pregnant women. Table 3 presents provider information on screening, licensure, and provision of these medications. Methadone binds to and activates the μ-opioid receptors and antagonizes N -methyl-d-aspartate receptors. Buprenorphine is a μ-opioid receptor partial agonist with primarily antagonistic actions on κ-opioid and δ-opioid receptors. Published studies suggest that buprenorphine has similar effectiveness to methadone for the treatment of opioid-use disorders during pregnancy and may reduce the likelihood and severity of NAS. Some women express dissatisfaction with buprenorphine, possibly because of its partial agonist properties. Both research and clinical practice suggest that induction is easier with methadone than buprenorphine, although buprenorphine induction methods that are used in research protocols have not been optimal. Patients who use opioids can experience precipitated withdrawal if the initial buprenorphine dose is taken too soon after their last μ-opioid-agonist administration. The most commonly prescribed formulation of buprenorphine in pregnancy is the single-agent sublingual tablet. Although most published data and clinical use of buprenorphine in pregnancy has been with this formulation, there has been no evidence that prenatal exposure to the combination buprenorphine-plus-naloxone product that was developed to reduce buprenorphine misuse leads to worse outcomes for the mother, fetus, or neonate than either methadone or buprenorphine monotherapy.

Table 3

Selected management issues for opioid-using patients

Variable	Recommendations	Additional resources
Screening	• Standardized screening tools substantially increase the rate of detection of substance use in pregnant women, yet only 23-50% of obstetricians use such tools for substance use detection. • The T-ACE (tolerance, annoyed by criticism, cut down, eye-opener), TWEAK (tolerance, worry about drinking, eye-opener, amnesia, k/cut down), and 4 P’s Plus (parents, partner, past, pregnancy) are 3 instruments developed to screen for substance use in pregnant women. The commonly used CAGE-AID (cut down, annoyed by criticism, guilty about drinking, eye-opener – adapted to include drugs) instrument was not specifically developed for the pregnant population.	• CSAP Special Report: provides a discussion of self-administered and interview-administered screening tools.
Buprenorphine licensure	• The Drug Addiction Treatment Act of 2000 (DATA 2000) enables qualifying MDs and DOs to treat opioid addiction with Schedule III medications approved by the FDA for this purpose • Buprenorphine derivatives approved by the FDA are buprenorphine hydrochloride (HCl) (Subutex; Reckitt-Benckiser, St. Peters, MO) and the buprenorphine HCl/naloxone HCl combination product (Suboxone; Reckitt-Benckiser) • To be a licensed provider, a qualifying MD or DO must: • Submit a Notification of Intent Form, and • Obtain a waiver from the Center for Substance Abuse Treatment (CSAT) by completing an 8-hour approved buprenorphine training CME program either in person or on-line.	• More details can be found on the SAMHSA website: http://buprenorphine.samhsa.gov/index.html • Webinars on buprenorphine therapy are available at: http://psychiatry.org/pcssbwebinars
Buprenorphine induction	• The optimal induction protocol for pregnant women with opioid use disorder is not known but the process should be similar to that for non-pregnant patients. ▪ The program staff should provide extensive patient support before and during the induction period. ▪ The initial induction dose(s) should be administered under supervision in the office 24 hours after the last use of short acting opioids (eg, heroin or oxycodone) or 2-3 days after the last use of long acting opioids (eg, methadone) ▪ The initial dose is 2 mg sublingual buprenorphine that can be repeated no more frequently than every 2 hours until symptoms are improved. The patient is then sent home with a prescription that will provide enough medication until the next scheduled office evaluation (in 1-3 days). The total daily dose (TDD) can be titrated every 1-3 days based on patient symptoms. The TDD typically ranges from 2 to 16 mg per day, taken either once or twice a day. ▪ The goal is to reach a TDD of buprenorphine that allows a patient to discontinue other opioid use and experience minimal withdrawal symptoms, side effects, and cravings. • Greater attrition has been reported during induction onto buprenorphine therapy relative to methadone in non-pregnant patients. Possible explanations include: ▪ If patients are not in adequate withdrawal, they may experience an increase in withdrawal signs/symptoms for a longer duration. ▪ The partial μ-agonist experience of buprenorphine may be less enjoyable than that of methadone, a “full” μ-agonist. ▪ Mild withdrawal symptoms may encourage early discontinuation. ▪ A recent history of benzodiazepine and/or methadone use or new exposure to buprenorphine has been found to contribute to less successful inductions.	More information on current research and treatment are available at: http://psychiatry.org/practice/professional-interests/addiction-psychiatry/inducting-and-stabilizing-opioid-dependent-pregnant-women-on-methadone-or-buprenorphine-current-research-and-future-treatment-implications and http://psychiatry.org/practice/professional-interests/addiction-psychiatry/Buprenorphine-Treatment-During-Pregnancy and Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40 available at http://www.ncbi.nlm.nih.gov/books/NBK64245/pdf/TOC.pdf
Maintenance dosing	• The longest period of buprenorphine therapy is the maintenance phase, which can last indefinitely • Variability in buprenorphine pharmacokinetics and subjective experience from patient to patient results in a relatively wide range of effective maintenance TDD • Withdrawal and craving symptoms can be easily assessed in less than 5 minutes by measures such as the Clinical Institute Narcotic Assessment (CINA) Scale, the Clinical Opiate Withdrawal Scale (COWS), or the Subjective Opiate Withdrawal Scale (SOWS) • Providers should anticipate the need to increase the maintenance TDD several times during the prenatal period, and then to decrease the TDD several times during the postnatal period	• For more information, see Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40 available at: http://www.ncbi.nlm.nih.gov/books/NBK64245/pdf/TOC.pdf

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