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http:\/\/taylorandfrancis.com\/iada
ISSN: 0095-2990 (print), 1097-9891 (electronic)
Am J Drug Alcohol Abuse, 2015; 41(5): 367\u2013370
! 2015 Taylor & Francis Group, LLC. DOI: 10.3109\/00952990.2015.1047502
PERSPECTIVE
Opioid use disorder during pregnancy in Tennessee: expediency vs.
science
Peter R. Martin, MD and A. J. Reid Finlayson, MD
Department of Psychiatry, Vanderbilt University, Nashville, TN, USA
Abstract
Methadone and buprenorphine are highly effective and commonly prescribed for the
treatment of opioid use disorder. Both medications are also efficacious for the treatment of
pregnant women with this disorder. In one third of states, however, Medicaid reimbursement
will cover the cost of buprenorphine, but not methadone, to treat opioid use disorder in
pregnant women. This commentary will explore the clinical and policy rational and
consequences of this policy, with the opinion that this approach is guided by political
expediency rather than sound clinical research. The commentary will focus on the pharmacological management of prescription opioid dependence during pregnancy in Tennessee, one
of the states that restrict Medicaid coverage of pregnant women to buprenorphine. Tennessee
is also relevant in that this state ranks second nationally in the rate of prescriptions written for
opioid pain relievers; in contrast to injection opioid use in urban populations, opioid addiction
in rural and southeastern regions of the US is characterized by use of non-injection prescription
opioids. Until recently, most research-based recommendations for the management of opioid
use disorder during pregnancy have derived from studies of women using opioids
intravenously. The lack of research in non-injection opioid-using pregnant women may
partially explain why policy rather than scientific evidence guides Medicaid reimbursement. It is
hoped that future research in pregnant women addicted to prescription opioids will clarify
which opioid addicted pregnant women have better outcomes with buprenorphine or
methadone treatment and these findings, in turn, will inform Medicaid reimbursement.
Keywords
Buprenorphine, methadone, opioid use
disorder, pregnancy, policy
History
Received 12 January 2015
Revised 20 April 2015
Accepted 21 April 2015
Published online 15 July 2015
A growing public health concern
Opioid use disorder in pregnancy is of mounting public health
concern in our country, complicating an estimated 54 000
pregnancies annually (1). A wide range of consequences of
opioid exposure during pregnancy for mother, fetus, and the
neonate have been described and questions persist as to
whether adverse effects continue into infant development and
beyond (2). Neonatal abstinence syndrome (NAS) is a
postnatal withdrawal syndrome, first described in heroinexposed newborns; more recently, other factors than opioid
exposure have also been implicated in this clinical syndrome
(3). NAS presents with an array of clinical signs, including
feeding difficulty, autonomic dysfunction, and behavioral
distress. NAS has become widely recognized as a major
healthcare expenditure associated with opioid use disorder
during pregnancy and accordingly has been identified as an
important focus for prevention efforts (4). The incidence of
NAS increased substantially in the United States between
2000 and 2009 (3). This increase has been striking in
Tennessee, where 29% of pregnant women enrolled in
Medicaid (TennCare) filled opioid prescriptions during<\/p>\n\n\n\n

  1. From 1995\u20132009, pregnancy-related use of opioid
    analgesics nearly doubled among TennCare participants (5).
    From 2009\u20132011, the rate of NAS among infants in TennCare
    increased from 6.0\u201310.7 per 1000 births (6) and to 11.6 in
    2013 (4) \u2013 representing a 16-fold increase since 2000. This
    commentary focuses on opioid agonist treatment as a
    significant component of the management of prescription
    opioid use disorder during pregnancy in Tennessee, of
    particular interest, as this state ranked second nationally in
    the rate of prescriptions written for opioid pain relievers, at
    1.4 per person in 2012 (7). In rural and southeastern regions
    of the United States, such as Tennessee, where opioid
    addiction is predominantly characterized by non-injection
    use of prescription opioids, available therapeutic choices for
    opioid use disorder have become limited to buprenorphine
    instead of methadone, seemingly a policy decision, not one
    guided by the available scientific evidence which supports the
    efficacy of both medications.
    Address correspondence to Peter R. Martin, Department of Psychiatry,
    Vanderbilt University, School of Medicine, 1601 23rd Avenue South,
    Suite 3068, Nashville, TN 37212, USA. E-mail: peter.martin@
    vanderbilt.edu
    The Tennessee approach: criminalization to
    \u2018\u2018encourage\u2019\u2019 treatment but no Medicaid access
    to methadone
    Even these very high rates of NAS in Tennessee likely
    underestimate the use of opioids during pregnancy because of
    significant underreporting due to stigma associated with drug
    use disorders. This stigma is greatly exacerbated by recent
    Tennessee legislation which \u2018\u2018allows prosecution of a woman
    for assault for the illegal use of a narcotic drug while
    pregnant, if her child is born addicted to or harmed by the
    narcotic drug and the addiction or harm is a result of
    her illegal use of a narcotic drug taken while pregnant\u2019\u2019
    (http:\/\/state.tn.us\/sos\/acts\/108\/pub\/pc0820.pdf). This legislation clearly may deter pregnant women from seeking prenatal
    care for fear of being reported. However, the law should also
    be viewed as offering incentive for addiction treatment and
    recovery as it next states that, \u2018\u2018It is an affirmative defense to
    a prosecution \u2026 that the woman actively enrolled in an
    addiction recovery program before the child is born, remained
    in the program after delivery, and successfully completed the
    program, regardless of whether the child was born addicted to
    or harmed by the narcotic drug.\u2019\u2019 Interpretation of this
    legislation is challenging based on recent findings that opioid
    type, including methadone and buprenorphine maintenance,
    and tobacco and SSRI antidepressant use all significantly
    increase risk of NAS (6).
    In order to attempt to contain the prescription opioid
    epidemic in the state, the Tennessee Department of Health has
    implemented a Controlled Substance Monitoring Database
    (CSMD) program and mandatory education for prescribers
    (http:\/\/health.state.tn.us\/boards\/ControlledSubstance\/index.
    shtml). This program mandates that pharmacies record all
    controlled drug prescriptions in a centralized database that
    physicians must search in real-time prior to providing a
    prescription for a controlled drug to any patient. However, the
    high incidence of NAS has not diminished, so much so that
    the first statewide surveillance system for NAS was recently
    implemented by the Tennessee Department of Health to allow
    study of prevention of this serious complication of prescription opioid dependence (4).
    Options for management of opioid use disorder during
    pregnancy include maintenance on an opioid agonist approved
    for addiction treatment or detoxification (1). With careful
    monitoring, the prescribed opioid analgesic may also be
    continued or discontinued slowly by tapering. Detoxification
    from opioids during pregnancy has not been the recommended
    course for more than 40 years, particularly not for women with
    the most severe form of opioid use disorder, namely those who
    use intravenous opioids; such pregnant women are very unlikely
    to be able to avoid relapse without pharmacological support (8).
    Methadone maintenance treatment, as currently widely
    employed throughout the United States, remains the standard
    of care for agonist treatment of opioid use disorder in pregnancy
    (1). Although consensus holds methadone maintenance as the
    standard against which other treatments of pregnant women
    with opioid use disorder must be compared, TennCare does not
    cover the cost of methadone maintenance. Tennessee is not
    alone: approximately a third of states do not provide for
    methadone maintenance treatment of pregnant women (9).
    Policy rather than evidence-guided clinical practice?
    Disparities among states in Medicaid support for treatment of
    these pregnant women is not easily understood by examining
    the published evidence alone. Does excluding methadone
    from the therapeutic armamentarium for pregnant opioidaddicted women reflect simply an ill-advised political decision or are these appropriate regional policies because
    relevant evidence supporting methadone maintenance in
    their populations is not readily available? State laws and
    regulations pose significant implications for practitioners in
    that policy might influence clinical practice in a manner that
    is not entirely consistent with recommendations in the
    scientific literature (10).
    Without opioid agonist treatment, which reduces drug
    craving and use, those who are addicted to intravenous
    opioids are recognized to be at a particularly high risk of
    relapse and consequently opioid overdose, premature labor
    triggered by repeated episodes of withdrawal, exposure to
    intravenously transmitted infections, and consequences of
    involvement with the criminal justice system. Evidence-based
    treatment includes administration of a therapeutic daily dose
    of methadone provided within the context of a comprehensive
    treatment program comprising psychiatric and obstetrical
    prenatal care, counseling and group therapy, and social work
    services (11). Methadone maintenance in comparison with
    active intravenous opioid addiction has been shown to result
    in improved adherence to prenatal care, increased fetal
    growth, and decreased risk of HIV infection, preeclampsia,
    and foster care placement of the neonate. Nevertheless, NAS
    of significant severity to require treatment with morphine is
    still observed in well over 50% of pregnancies on methadone
    maintenance (12). Hence, if absence of NAS is one criterion
    for treatment efficacy, as inferred from the above-mentioned
    Tennessee law, methadone maintenance, while it is evidencebased practice, may not be the best we can do. Also, focusing
    solely on NAS, as the Tennessee law does, misses the
    possibility that women who relapse during pregnancy may
    never even reach delivery because of complications of
    accelerated opioid use disorder (13,14).
    Changing face of opioid addiction
    By not covering methadone costs, TennCare, like Medicaid in
    the other non-methadone states, limits access to methadone,
    but it does ensure that opioid-dependent Tennesseans can
    receive buprenorphine during pregnancy at a limited daily
    dose, with prior authorization (http:\/\/www.tn.gov\/tenncare\/
    forms\/ben11001.pdf). This policy may be a reflection of the
    changing face of opioid addiction among pregnant women
    due to an ever-expanding prescription opioid epidemic (1).
    From a problem affecting predominantly disenfranchised
    inner city women using intravenous heroin, a much larger,
    demographically diverse population addicted to prescription
    opioid analgesics has become widely distributed throughout
    smaller urban and rural regions of the United States. This
    increase in prescription opioid use disorder is characteristic of
    southeastern states, including Tennessee. Not only is the
    pattern of opioid use different in the Southeast and in rural
    regions, but this pattern of opioid addiction represents a
    considerably larger challenge in absolute numbers than do
    368 P. R. Martin & A. J. Reid Finlayson Am J Drug Alcohol Abuse, 2015; 41(5): 367\u2013370
    injection opioid users. For example, in 1997, annual quantities
    of opioid pain relievers prescribed were equivalent to 96 mg
    of morphine per individual; by 2007, rates had reached the
    equivalent of 700 mg of morphine per person. In 2010,
    2 004 000 persons aged 12 or older initiated non-medical
    opioid pain reliever use (almost as high as the 2 426 000 for
    marijuana) compared to only 140 000 for heroin (15). These
    trends suggest that management of non-injection prescription
    opioid use during pregnancy will continue as a major clinical
    challenge and that states like Tennessee may be legislating
    care based upon epidemiologic data. However, methadone
    treatment in pregnancy standards were established in large
    urban areas from which most of the NIH-funded research
    guiding practitioners, to date, has been conducted.
    Management of non-injection vs. injection
    opioid addiction
    Although non-injection opioid addiction has fewer severe
    medical complications than injection drug use (16), overdose
    deaths due to opioid analgesics recently surpassed heroin and
    cocaine, rivaling death rates from motor vehicle accidents in
    absolute terms as reported by the CDC (17). So, while
    ingested prescription opioids have been considered a \u2018\u2018safer\u2019\u2019
    dosage form compared to intravenously administered opioids,
    consequences of these drugs are far from benign and cannot
    be ignored. In fact, an increasingly common clinical trajectory
    is to switch to intravenous or smoked heroin from prescription
    opioids (13,14) based upon changing supply and demand,
    unintended consequences of tighter regulation of prescribing.
    Despite the fact that we do not really know which patients
    (injection or non-injection) do better on methadone or on
    buprenorphine, TennCare and the Medicaid formularies of
    many demographically similar states provide buprenorphine
    rather than methadone for opioid use disorder treatment.
    While it would be ideal to determine for each individual
    whether a partial (buprenorphine) or full (methadone) mu
    opioid agonist combined with structured psychosocial care of
    the mother during gestation can result in a healthier neonate at
    the point when opioid exposure stops at delivery (1), the other
    extreme, a public health approach, attempts to reach
    the greatest number of patients with an evidence-based
    approach (18).
    The risk-benefit analysis supporting methadone maintenance for intravenous opioid addicted pregnant women is very
    compelling (8,19,20), but comparable studies in non-injection
    opioid use disorder patients, who obtain these drugs from the
    street or by prescription from their doctors for pain control,
    are only now emerging from other rural states like Vermont.
    The findings suggest that buprenorphine is equal to, or may
    be even better, for prescription opioid addicted pregnant
    women (21). The situation is somewhat more complicated by
    the fact that the route of heroin administration has change
    dramatically in the past 10 years due to the purity of the drug
    that allows for smoking or snorting (22). It may be argued that
    some of these women addicted to prescription opioids may
    well be detoxified or tapered off the opioid, thus avoiding
    NAS for their child. However, the likelihood of continued
    abstinence without maintenance treatment is not very high in
    oral prescription opioid use disorder either (23); hence, the
    risks of repeated cycles of intoxication and withdrawal, albeit
    less severe, do exist with prescription opioids as well. A case
    can thus be made for maintenance with an opioid agonist to
    reduce craving and risky use, but these women may not
    require the intensive (expensive and time-consuming) daily
    monitoring mandated by law for methadone maintenance.
    Buprenorphine maintenance: the practical choice
    for pregnant prescription opioid addicts
    Buprenorphine appears to be a particularly appropriate choice
    for management of the pregnant prescription opioid addict
    because it has been approved for office-based maintenance of
    opioid addiction, thus eliminating barriers associated with
    daily visits to a methadone clinic. Buprenorphine can be used
    during pregnancy with little risk to the fetus, and pregnancy
    outcomes are not significantly different from those obtained
    with methadone (24). Buprenorphine, a partial mu opioid
    agonist and kappa opioid antagonist, causes less activation of,
    and has greater affinity for the mu-opioid receptor than
    methadone. Additionally, there is less placental transfer of
    buprenorphine than methadone. These considerations, in
    theory, should lead to decreased physical dependence of the
    fetus with buprenorphine and less severe associated NAS
    upon delivery. The MOTHER study, a randomized controlled
    trial comparing buprenorphine and methadone exposure
    during pregnancy, provided some support for these predictions (12). Infants exposed to buprenorphine during gestation
    were found to spend fewer days in the hospital and required
    lower morphine doses over a shorter treatment period for
    NAS than those exposed to methadone, while both opioid
    agonists were equally well tolerated and effective in
    decreasing illicit drug use.
    Further research is needed to determine the appropriate
    clinical threshold for opioid prescribing in pregnancy,
    including opioid agonist maintenance in women who are
    addicted to prescription opioids and use them only via noninjection routes. This is possibly a different population than
    that from which most of the existing research guiding
    treatment is currently available.
    Declaration of interest
    The authors report no conflicts of interest. The authors alone
    are responsible for the content and writing of this paper.
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    370 P. R. Martin & A. J. Reid Finlayson Am J Drug Alcohol Abuse, 2015; 41(5): 367\u2013370
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