Buprenorphine Maintenance, a Form of Medication-Assisted Treatment, Has Become a Major

ABSTRACT

In the last decade, the prevalence of opioid dependency in the United States has dramatically increased. Opioid dependency is a form of substance abuse and is characterized by an individual’s inability to stop using opioids. It is a medical disease that, while treatable, is chronic and relapsing. Because dependency creates difficulties in one’s physical, psychological, social, and economic functioning, treatment must be designed to address all of those areas. Research suggests that opioid dependency is best treated in a comprehensive, individualized tailored program of medication therapy integrated with psychosocial and support services. The Pregnancy Recovery Center (PRC) provides the aforementioned services to opioid-dependent pregnant women in the Pittsburgh area and its surrounding communities.

Buprenorphine maintenance, a form of Medication-Assisted Treatment, has become a major public health initiative to treat opioid dependency. All studies have found buprenorphine to be well accepted by mothers and infants, and to be useful in treating opioid dependent pregnant women. Patients have reported improved social functioning, in addition to elimination of illicit-opioid use. Other outcomes include improvements in employment, education, productivity, homemaking, parenting, physical and mental health, and overall quality of life.

The purpose of this case study is to examine and evaluate the development of the Pregnancy Recovery Center - an integrated Medical Home Care Model that provides Medication-Assisted Treatment (MAT) and prenatal care & delivery for opioid dependent mothers in a single program. The Pregnancy Recovery Center is the only comprehensive buprenorphine clinic dedicated to serving pregnant women in Pittsburgh and the surrounding communities of Western Pennsylvania. This local public health initiative provides consistent, collaborative care throughout the patient’s pregnancy and is a movement toward better health for women and infants. In this case study, the PRC is evaluated based on outcome measures in its first 3 months of operations and compared to scholarly literature. Outcome measures support literature findings that suggest buprenorphine maintenance is an effective method in reducing infant length of stay (LOS) and severity of Neonatal Abstinence Syndrome (NAS). Finally, recommendations are made as the Pregnancy Recovery Center continues to expand and provide services.

TABLE OF CONTENTS

Acknowledgement x

1.0 Introduction 1

1.1 background 2

1.2 Literature review 4

1.2.1 Methadone versus Buprenorphine 4

1.2.2 Barriers to Treatment 6

1.2.3 Management of Opioid Dependence in Pregnancy 7

2.0 the pregnancy recovery center 9

2.1 goals & objectives 10

2.2 Program design 11

2.2.1 Medication-Assisted Treatment 11

2.2.2 Prenatal Care & Delivery 12

2.3 Program Procedure 13

2.3.1 Eligibility 13

2.3.2 Assessment 15

2.3.3 Consultation 15

2.3.4 Induction 16

2.3.5 Follow-Up 18

2.3.6 Postpartum 18

2.4 Treatment outcome measures 19

2.4.1 Infant Outcomes 20

2.4.2 Maternal Outcomes 23

3.0 Analysis & Discussion 25

3.1 Recommendations 27

4.0 Conclusion 30

bibliography 31

List of tables

Table 1. Maternal and Infant Characteristics and Outcomes 20

Table 2. Finnegan Score (NAS Score) 22

List of figures

Figure 1. Medical Home Model 9

Figure 2. Clinical Opiate Withdrawal Score (COWS) 16

Figure 3. Profile of Enrolled Patients 24

Figure 4. Gestation Age upon Admission 24

Figure 5. Patient Navigator Relationship 28

Figure 6. Health System Maze 29

Acknowledgement

I would like to express my deepest appreciation to everyone that supported me throughout the course of my graduate studies. I am truly grateful for every aspiring guidance, invaluably constructive criticism, and friendly advice. Thank you for taking an active interest in my academics as I embark on my career as a health care professional.

I express my warmest thanks to Mrs. Stephanie Bobby for allowing me to actively participate in the Pregnancy Recovery Center. Your dedication to the PRC and its patients is truly remarkable and one that should be modeled.

I would also like to sincerely thank my professor, Dr. Julie Donohue, and my mentor, Dr. Jeannette South-Paul, for their involvement in the development and completion of my MPH Master’s Essay.

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1.0 Introduction

In recent years, the abuse, dependence, and misuse of opioids has become a growing public health concern in the United States. Substance abuse is a major public health problem that impacts society on multiple levels. This includes health care expenditures, lost earnings, and costs associated with crimes and accidents. It destroys families, damages the economy, victimizes communities, and places extraordinary demands on the educational, judicial, and social service systems[1]. Many of America’s top medical problems can be directly linked to drug abuse, including cancer, heart disease, and HIV/AIDS[2]. Societal issues, such as violence and child abuse, are also related to drug abuse. Substance abuse places an enormous financial and social burden on many communities, including Pittsburgh, Pennsylvania.

Opioid addiction is a chronic, relapsing disease. Like all chronic diseases, it cannot be cured, but it can be managed. A person with addiction can regain a healthy, productive lifestyle with proper treatment. Research shows that Medication-Assisted Treatment (MAT) is an effective treatment option for opioid addiction[3]. The Pregnancy Recovery Center provides an interdisciplinary, comprehensive treatment approach for opioid dependency. It specifically targets pregnant women, as there has been a noticeable increase on opioid-dependent pregnant women locally and across the nation. Pregnant women with Substance Use Disorders (SUDs) are often stigmatized within their communities. As a result, they are commonly reluctant to disclose their problems to providers, to seek timely prenatal care, and to adhere to treatment plans. The Pregnancy Recovery Center is an innovative initiative that aims to break down the barriers between opioid-dependent mothers and access to prenatal care. Consequently, these mothers can begin their journey to recovery and toward better health for themselves and their infants.

1.1 background

Opiates are among the world’s oldest known drugs. They are naturally derived from the opium poppy and are highly addictive. The term “opioids” is used to define the entire family of opiates including natural, synthetic, and semi-synthetic[4]. To date, opioid refers to any painkilling narcotic with opium-like effects. Opioids bind to receptors in the brain causing anesthetic effects by decreasing perception of pain, decreasing reaction to pain, and increasing pain tolerance1. They are well known for their ability to produce a feeling of euphoria, which is a mental and emotional state of intense well-being. Tolerance is a neurological adaptation in which sensitivity of opioid receptors decreases, requiring increasingly larger doses for the same drug effects. Continuous and unregulated use of opioids can lead to opioid dependence, which is defined as a biopsychosocial disorder[5]. Other examples of biopsychosocial disorders include diabetes type II and cancer because of the intertwining biological, psychological, and social influences over the course of the disease.

Opioid abuse in pregnancy includes the misuse of prescription opioid medications and the use of heroin4. Since the 1990s through to today, there has been a noticeable increase in opioid abuse in North America coinciding with the enormous increase in opioid prescriptions. Shockingly, Americans consume approximately 80% of the world’s opioid supply although Americans only constitute roughly 4.6% of the world’s population[6]. Statistics from the 2010 National Survey on Drug Use and Health report that the number of persons aged 12 years and older illicitly using prescription pain relievers doubled from 2.6 to 5.2 million between 1999 and 2006[7]. Additionally, the CDC estimates that in 2012, providers wrote over 259 million prescriptions for opioids. From 2007 to 2012, the number of past users of heroin had increased from 373,000 to 669,000 respectively. In 2012, 156,000 people reported using heroin for the first time, which was an increase from the 90,000 people who were first-time users in 2007. Sustained remission from opioid dependence is difficult to achieve, as most users will continue to struggle with dependency for their whole lives.

Opioid use during pregnancy is not uncommon. According to the 2010 National Survey of Drug Use, roughly 4.4% of pregnant women reported using illicit drugs in the past 30 days8. A second study showed that while 0.1% of pregnant women were estimated to have used heroin in the past 30 days, 1% of pregnant women reported nonmedical use of opioid-containing pain medication[8]. A retrospective study observed an increased risk of birth defects with the use of opioids by women in the month before and during the first trimester of pregnancy4. Not surprisingly, the use of illicit opioids during pregnancy is associated with an increased risk of adverse outcomes. These outcomes are related to the repeated exposure of the fetus to opioid withdrawal and include increased risk for Neonatal Abstinence Syndrome (NAS), premature births, low birth weight, and perinatal death[9]. According to the findings of Winhusen et al, approximately 55-94% of infants exposed to opioids in-utero developed withdrawal signs of NAS[10]. Signs of NAS often began within 24-72 hours for methadone-exposed infants and 24-96 hours for buprenorphine-exposed infants.

Not only is NAS associated with adverse health effects for infants, but it is also linked to costly hospitalizations. In 2009, the average length of stay (LOS) for NAS was 16 days and the average cost of treatment was $53,400, equaling over $3,300 per day per infant[11]. Infants with NAS require specialized care, as the presentation of the syndrome is unpredictable, with individual neonates displaying different symptoms and severity over time[12]. The current standard of care for pregnant women with opioid dependence is a Medication-Assisted Treatment (MAT) in an opioid treatment program1. It is widely accepted that tapering doses of opioid during pregnancy is not effective and often results in relapse of use. Additionally, abrupt discontinuation of opioid during pregnancy is not advised and can result in preterm labor, fetal distress, or fetal demise4.

1.2 Literature review

This section focuses on the current literature involving the Medication-Assisted Treatment of methadone and buprenorphine, barriers to treatment, and the management of opioid dependency among pregnant women.

1.2.1 Methadone versus Buprenorphine

Medication-Assisted Treatment (MAT) is the evidence-based standard of care for opioid dependence[13]. MAT includes the use of medication along with counseling and other support services to provide a comprehensive maintenance treatment program. Research strongly suggests that increased integration and coordination of services improves clinical outcomes and reduces cost during pregnancy9.

Since the late 1960s, methadone has been the recommended medication of treatment for opioid-dependent pregnant women[14]. Methadone is a pure mu opioid-agonist that is associated with improved physical and mental health, and better ability to engage in daily functions. It decreases opioid cravings, which sequentially leads to a decreased risk of relapse of illicit drug use. This medication is administered daily by restricted opioid treatment programs overseen by Federal and State agencies[15]. Known data regarding neonatal outcomes following in-utero exposure to methadone include better prenatal care adherence, higher neonatal birth weights, and lower rates of preterm births, perinatal complications, and neonatal deaths compared to those not seeking treatment[16].

In 2002, the U.S. Food and Drug Administration (FDA) approved buprenorphine for treatment of opioid dependence and classified it as a category C drug (i.e. lacking adequate, well-controlled studies in pregnant women)1. Buprenorphine is a partial mu opioid-agonist, which binds to opioid receptors with higher affinity but lower activity than full agonists like methadone. It works to minimize withdrawal symptoms and blocks the effects of illicit opiate drugs. It is prescribed weekly in medical offices, rather than daily in licensed clinics like methadone8. Brand names for buprenorphine include Suboxone, which is a buprenorphine/naloxone combination, and Subutex, which is buprenorphine alone. While methadone is currently the standard of care for opioid dependence during pregnancy, research suggests that buprenorphine is associated with shorter infant hospital lengths of stay (LOS) due to a reduction in Neonatal Abstinence Syndrome[17]. A study revealed that infant LOS was significantly less for buprenorphine-maintained women (10.0 days) than for methadone-maintained women (17.5 days)1. NAS treatment was required for 57% of methadone-exposed and 47% of buprenorphine-exposed infants. Even though buprenorphine is a category C drug, small cohort studies have found buprenorphine to be safe and effective in the treatment of opioid dependence during pregnancy and has lead to improved pregnancy outcomes8. However, because it is a relatively new medication, long-term outcome data of neonates exposed to buprenorphine in utero are lacking. The literature supports that pregnant women maintained on buprenorphine display improved compliance with prenatal care, improved newborn birth outcomes, and reduced illicit drug use[18]. More importantly, buprenorphine is proven effective in decreasing the risk of relapse in pregnant women. Since preliminary research has found buprenorphine to be successful in the treatment of opioid dependence during pregnancy, it is the chosen medication for use in the Pregnancy Recovery Center.

1.2.2 Barriers to Treatment

Identifying pregnant women with opioid addiction has been a challenge because this population often lacks prenatal care or presents late to care because of fear of stigmatization and pressure to enroll in an addiction treatment program[19]. Research shows that early treatment combined with consistent managed care contributed to the reduction of illicit drug use throughout pregnancy[20]. According to the 2010 National Survey on Drug Use, women reported the following reasons for not receiving treatment for their opioid dependence[21]:

· Not ready to stop using substances (36.1%)

· Lack of insurance or financial barriers to seeking health care (34.4%)

· Social stigma of substance abuse (28.9%)

· Feel they cannot handle the treatment (15.5%)

· Do not know where to go for recovery care (13.2%)

· Feel they do not have time to start (4.7%)

· Do not believe treatment will help with their addiction (2.7%)

1.2.3 Management of Opioid Dependence in Pregnancy

Drug addiction during pregnancy is a complex health and social issue that requires an interdisciplinary health care team providing nonjudgmental, comprehensive care20. The prevalence of opioid abuse during pregnancy requires that providers be aware of the implications of opioid abuse by pregnant women and of the appropriate management strategies. Recent advances in brief screening techniques and improved therapies for Substance Use Disorder (SUD) emphasize that taking a nonjudgmental, empathic stance makes it possible to intervene effectively with SUD[22]. Women addicted to opioids typically face financial, social, and psychological difficulties that create barriers for treatment. Guilt and shame coupled with low self-esteem and self-efficacy can produce behaviors difficult for some staff to manage. Therefore, for a successful treatment program, care should be provided in a gender-specific, nonpunitive, nonjudgmental and nurturing environment.