10 Apr The Impact Of The National Opioid Epidemic On Obstetric, Maternal-Fetal, Neonatal & Pediatric Medicine
Written by: Ryan Donihue, Esq.
Beginning in 2016 and continuing to date, mainstream media has brought the ever present and alarming increasing rate of dependence on opioids to the forefront of our daily lives. Surprisingly, the media’s attention toward the nation’s “Opioid Epidemic” has been largely silent and unreported as to three of the most medically complicated and challenging groups of patients’ whom healthcare providers examine, diagnose and treat on a daily basis, those being pregnant woman, neonates and infants.
Out of this media spotlight has developed a national awareness to opioid addiction which has caught the attention of the Plaintiffs’ Bar. In fact, we are just now starting to see attorneys across the country commence litigation against the pharmaceutical companies who manufacture opioids as it is alleged that there was “concerted effort” to “mislead doctors and the public” concerning the need to prescribe these drugs to patients which caused and/or furthered the addition. Due to the fact that some of the largest reported jury verdicts arise out of medical malpractice actions involving the management of obstetrical, maternal-fetal, neonatal and pediatric patients, it is only a matter of time before the Plaintiffs’ Bar shifts its attention away from the pharmaceutical companies and toward healthcare providers who render care to opioid addicted pregnant women, neonates and infants.
By the Numbers: A National Epidemic
According to the National Institute on Drug Abuse, parallel to the large increase in opioid use, use disorders and overdose across the nation, the incidence of babies born dependent on opioids as a result of a mother’s opioid use during pregnancy has also increased.1) The National Institute on Drug Abuse found that the incidence of Neonatal Abstinence Syndrome (“NAS”) “rose nearly fivefold between 2000 and 2012 and this increase was associated with increases in the prescription of opioids to pregnant women for pain, which doubled between 1995 and 2009.”2) More specifically, the National Institute on Drug Abuse commented that an estimated 21,732 babies were born with NAS in 2012, which reflected a five-fold increase since 2000. Of these babies born with NAS in 2012, the average hospital stay averaged 16.9 days compared to 2.1 days for other newborns.3) It should be noted, these numbers were reflective of approximately four years ago and included only 28 states, well before opioid epidemic was reported in the media as spreading throughout the United States.
Based on a recent analysis by the Centers for Disease Control (“CDC”), it is estimated that nearly 6 out of every 1,000 births in the United States are now diagnosed with NAS.4) It is believed that this number of NAS births cited by the CDC was actually under represented as not all states are required or regularly collect such data. While this epidemic is spreading and impacting the entire nation, some of the states which have experienced significant increases in NAS births include Tennessee, Alabama, Kentucky, Mississippi, West Virginia, Maine, Vermont, New Hampshire, Rhone Island and Massachusetts. In just one of many examples, Sullivan County, located in East Tennessee, reported a rate of 50.5 neonates diagnosed with NAS per 1,000 births. Similarly, it has been reported that 15 out of every 1,000 neonates born in Kentucky are opioid dependent.5) The trend is alarming and healthcare providers must be aware of the growing number of opioid dependent pregnant women and their offspring.
The Epidemic & Obstetric Medicine
In response to this growing trend of opioid addicted pregnant women and neonates diagnosed with NAS, The American College of Obstetricians and Gynecologists (“ACOG”) issued Committee Opinion Number 711 in August 2017. According to this guideline, the Committee confirmed that “Opioid use in pregnancy has escalated dramatically in recent years, paralleling the epidemic observed in the general population. To combat the opioid epidemic, all healthcare providers need to take an active role.”6) Having also identified this epidemic as affecting women across all racial, ethnic and socioeconomic groups, ACOG proceeded to outline a series of recommendations for obstetricians and maternal-fetal medicine specialists to consider in the evaluation, diagnosis and treatment of opioid addictive pregnant women.
At the very first prenatal appointment, it has been recommended by ACOG that the obstetrician perform a “universal” screen for substance abuse (which would specifically include inquiring about prescription opioids and other medications used for non-medical reasons). This screen should be accomplished “in partnership with the pregnant woman” in order to give the impression of a collaborative effort, rather than a unilateral inquiry making the patient feeling uncomfortable and possibly withholding information. 7)The screen will consist of the obstetrician engaging in a conversation with the patient; allow feedback and advise; and provide a referral for opioid use and opioid use disorder to improve maternal and infant outcomes. It should be noted that ACOG has recognized that a screen performed by an obstetrician based “only on poor adherence to prenatal care or a prior adverse pregnancy outcome can lead to a missed diagnosis and may only further stereotyping and stigma.”8)
In addition to the universal screen, ACOG has recommended that the obstetrician and maternal-fetal medicine specialist obtain a through history of substance use and review the Prescription Drug Monitoring Program, which is operational in 49 states and the District of Columbia.9) According to the CDC, the Prescription Drug Monitoring Program is an electronic database that tracks controlled substance prescriptions in a state.10) The Prescription Drug Monitoring Program allows the obstetrician or maternal-fetal medicine specialist to timely obtain information about opioid prescriptions and patient behaviors that may contribute to facilitate a targeted response from a patient concerning opioid use. The Prescription Drug Monitoring Program would be extremely valuable to the obstetrician or maternal-fetal medicine specialist as it permits her/him to determine whether the patient has received prior/current opioid medications and other high risk medications that would impact the pregnancy, fetus, neonate, and infant outcome. By arming themselves with this additional and critical information, the obstetrician or maternal-fetal medicine specialist will be able to better prescribe an appropriate and safe medication course for the patient. Additionally, this information will assist with identifying those individuals who have drug seeking behavior; were not identified during the universal screen; or self-disclosed the opioid use on the medical history forms.
When a pregnant patient has been identified as having a history of, or has been, diagnosed with chronic pain, ACOG recommends that the obstetrician or maternal-fetal medicine specialist implement a plan to avoid and minimize the use of opioids for pain management. Specifically, the obstetrician or maternal-fetal medicine specialist should emphasize non-opioid pharmacologic treatments in order to relieve chronic pain.11) By avoiding initial or refilling opioid prescriptions (e.g., codeine, fentanyl, morphine, oxycodone, meperidine, hydromorphone, hydrocodone and propoxyphene) for chronic pain, the healthcare provider would be limiting the effect of euphoria, which could lead to potential misuse or abuse by the pregnant patient and have an adverse impact on the fetus.
With regard to pregnant patients who have been diagnosed with an opioid use disorder,12) ACOG suggests that the obstetrician or maternal-fetal medicine specialist proceed with opioid agonist pharmacotherapy, rather than the traditional medically supervised withdrawal due to the fact that withdrawal is associated with high relapse rates, which lead to worse fetal and maternal outcomes.13) Opioid agonist pharmacotherapy (also known as medication-assisted treatment) utilizes methadone or buprenorphine to treat an opioid use disorder in pregnant women as it prevents withdrawal symptoms; reduces relapse risk and its associated consequences; and has demonstrated reduced risk in obstetrical complications when combined with appropriate prenatal care.14) It should be noted that when opioid agonist pharmacotherapy treatment is prescribed by the obstetrician or maternal-fetal specialist, further steps should be taken by the provider. Specifically, maternal fetal counseling, family therapy, nutritional education and medical-psychological services should be prescribed in order for there to be comprehensive obstetrical and postpartum treatment.15)
In light of the dramatic increase in opioid dependent population, the obstetrician and maternal-fetal medicine specialist should be extremely conscious to the patient’s potential for past, present and future opioid use and the impact it has on the pregnancy. From the outset, the healthcare provider should perform a universal screen for substance abuse on every patient; obtain a detailed history of past, recent and current substance use; and review the Prescription Drug Monitoring Program. Additionally, there needs to be an open conversation with the patient concerning a history of chronic pain and alternative methods to treat that pain. The information obtained from these inquiries will permit the healthcare provider to gain an invaluable insight into the pregnancy; identify and recommend a course of multidiscipline care for fetal and maternal well-being; and establish appropriate preparation and management of potential complications associated with the expecting mother’s opioid dependence and use. By taking these affirmative action, the obstetrician and maternal-fetal medicine specialist have accomplished an important step toward the patient’s comprehensive obstetrical and postpartum care which are necessary in the face of a growing opioid epidemic.
The Epidemic & Neonatal and Pediatric Medicine
Similar to the obstacles faced in the field of obstetric and maternal-fetal medicine, the nation’s Opioid Epidemic has had a substantial impact on neonatologists and pediatricians. As early as 1998, the American Academy of Pediatrics published a paper entitled “Neonatal Drug Withdrawal” which continues to have relevance and applicability to neonatologists and pediatricians today.16)
According to the American Academy of Pediatrics, 55% to 94% of fetuses exposed to opioids or heroin in-utero will develop withdrawal signs.17) With the tide of opioid use in pregnant patients now reaching epidemic levels, it can be expected that these percentages are significantly higher than were published twenty years ago. In fact, the CDC has reported that the overall incident rate of NAS has increased almost 300% during the timeframe of 1999-2013, from 1.5 to 6.0 per 1,000 births.18) This increase necessitates the neonatologist and pediatrician to be even more diligent in the identification, diagnosis and treatment of opioid dependent neonates or infants as outlined by the American Academy of Pediatrics years earlier.
In addition to the fact that neonates born to opioid addicted mothers have the potential for developing significant multifaceted medical conditions requiring prolonged hospital stays in the Neonatal Intensive Care Unit, the neonatologist and pediatrician are faced with the compounding problem of a NAS diagnosis. NAS can develop in a neonate as a direct result of opioid exposure and/or the medications used to treat a pregnant woman addicted to opioids (e.g. methadone or buprenorphine). NAS is a post-natal withdrawal syndrome that manifests itself through a series of symptoms, which principally involve the central nervous system irritability, gastrointestinal dysfunction, and temperature instability. Some of the symptoms a neonate or infant may experience are include tremors, increased muscle tone, high-pitched crying, seizures, difficulty feeding and prematurity.
According to ACOG, the symptoms associated with NAS may manifest at any point in time during the first 2 weeks of life, usually appearing within 72 hours of birth, and may last several days to weeks in infants exposed to methadone (which is used to treat opioid addicted women during pregnancy).19) Additionally, neonates exposed to buprenorphine (also prescribed to treat opioid dependent women during pregnancy) generally develop symptoms within 12 to 48 hours of birth; the symptoms peak at 72 to 96 hours; and resolve by 7 days.20) With regard to direct opioid use during pregnancy (excluding methadone or buprenorphine), the American Academy of Pediatrics commented that the clinical presentation of neonatal withdrawal symptoms could be variable, depending on the type of drug; timing and amount of the last maternal use; maternal and neonatal metabolism and excretion; and “other unidentifiable factors.”21) The challenge for any neonatologist or pediatrician when confronted with a neonate or infant who exhibits any of these symptoms would be to identify the underlying cause as NAS and/or the involvement of some other underlying medical condition.
The series of recommendations established in the publication by the American Academy of Pediatrics continue to be applicable to neonatologists and/or pediatricians when there is a suspicion of opioid or drug withdrawal. Some of the principal recommendations include: (1) Screening for maternal substance use (including maternal history, maternal urine testing, and testing of newborn urine and meconium specimens); (2) Drug withdrawal should be considered as a diagnosis in infants who have compatible symptoms, other potential diagnoses should be evaluated and treated if confirmed; (3) Drug withdrawal should be scored using an “appropriate scoring tool”; (4) Pharmacologic therapy of withdrawal-associated seizures would be applicable as indicated, while other causes of neonatal seizures must also be evaluated; (5) Vomiting, diarrhea, or both, associated with hydration and poor weight gain, in the absence of other diagnoses, could be indications for opioid or drug withdrawal treatment; (6) Drug selection should match the type of agent causing the withdrawal (e.g., Tincture is the “preferred drug” for opioid withdrawal); (7) Awareness that the severity of withdrawal signs, including seizures, have not been proven to be associated with differences in long-term outcome after intrauterine drug exposure; and (8) Use of Naxolone in the delivery room is considered to be contraindicated in infants whose mothers are known to be opioid-dependent. However, it was noted that the absence of a specific history of opioid abuse, Naxolone treatment remains a reasonable option in the delivery room management of a depressed infant whose mother recently received a narcotic.22)These recommendations by the American Academy of Pediatrics should be evaluated and applied as indicated by the neonatologist or pediatrician when facing an opioid addicted neonate or infant.
There already is an inherent challenge for neonatologists and pediatricians to manage a neonate or infant who does not have an underlying health issue or condition. By adding in the factor of opioid dependency, it raises the complexity level of managing the care and treatment of a neonate or infant due to the sensitivity of their newly developed systems and ability to rapidly decompensate at any point in time. The healthcare provider should be diligent in identifying and appreciating the neonate/infant’s clinical symptoms of drug withdrawal, without ruling out the potential for a different cause of the underlying symptoms. The neonatologist or pediatrician should also appreciate the fact that the symptoms of NAS or drug withdrawal may not manifest until hours or even days after birth. This means that a neonate or infant may initially present as stable for a period of time before the clinical picture suddenly changes. The healthcare providers should take affirmative action to actively monitor and treat the neonate/infant’s opioid withdrawal, while keeping a continued mindful eye toward the fact that there could be an alternative cause of the symptoms. Finally, it is recommended that a multidisciplinary follow-up approach should be provided to the infant for comprehensive care, which would include medical, developmental and social support.23)
In conclusion, the media and Plaintiffs’ Bar have now squarely fixed upon the Opioid Epidemic and the impact it has upon this nation’s population. It is only a matter of time before the Plaintiffs’ attorneys turn their attention away from the pharmaceutical companies to those healthcare providers who render care to opioid addicted pregnant women, neonates and infants.
Excluding the fact that it is anticipated that litigation on these issues will come in the near future, it cannot be disputed that there is an alarming trend in the number of pregnant women addicted to opioids, which has resulted in a large number of babies born to these same highly addicted opioid drugs. Unfortunately, it appears that the Opioid Epidemic has, and will, continue to only get worse over time; thereby having a significant impact on obstetric, maternal-fetal, neonatal and pediatric medicine. As such, the time is ripe for obstetricians, maternal-fetal medicine specialists, neonatologists and pediatricians to be conscious of this alarming trend and adjust his/her current practice of evaluating, diagnosing, monitoring and treating these three groups of opioid addicted patients.