Summary/Journal Review: Buprenorphine for Treatment of Neonatal Abstinence Syndrome (NAS) 1

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1 THE 2017 AUTISM SPECTRUM DISORDER & INTELLECTUAL DEVELOPMENTAL DISORDER: FLORIDA BEST PRACTICE PSYCHOTHERAPEUTIC MEDICATION RECOMMENDATIONS FOR TARGET SYMPTOMS IN CHILDREN AND ADOLESCENTS ARE NOW AVAILABLE! The 2017 Autism Spectrum Disorder and Intellectual Developmental Disorder: Florida Best Practice Psychotherapeutic Medication Recommendations for Target Symptoms in Children and Adolescents were updated to provide broad treatment recommendations for common behavioral symptoms, such as hyperactivity, impulsivity, and inattention, seen in children with Autism Spectrum Disorder and/or Intellectual Disability who may present in the primary care setting. Visit our website medicaidmentalhealth.org to view these guidelines. Please contact Sabrina Singh at if you would like hardcopies of the guidelines. THE PHARMACIST S CORNER The Pharmacist s Corner of our newsletter is devoted to providing prescribers with the most current information on psychotherapeutic drugs and mental health treatment. The Pharmacist s Corner is written by Thea Moore, PharmD, BCPP. Dr. Moore is an Associate Professor in the Department of Pharmacotherapeutics and Clinical Research at the University of South Florida College of Pharmacy. Summary/Journal Review: Buprenorphine for Treatment of Neonatal Abstinence Syndrome (NAS) 1 Thea Moore, PharmD, BCPP Current standard of pharmacological treatment for neonatal abstinence syndrome is an opioid, with morphine being the most commonly used. Yet, there is insufficient data to guide the selection of an opioid. Pregnant women with opioid use disorder are commonly treated with either methadone or buprenorphine. While methadone is the current standard treatment, there is growing clinical evidence for buprenorphine leading to less neonatal abstinence syndrome in infants born to these mothers. 2 There is increasing interest in treating pregnant women with opioid use disorder with buprenorphine, as well as the neonates born to this population of women with buprenorphine to treat symptoms of NAS. (Continued on next page)

2 THE PHARMACIST S CORNER Summary/Journal Review: Buprenorphine for Treatment of Neonatal Abstinence Syndrome (NAS) 1 continued On May 4, 2017 New England Journal of Medicine published a study comparing outcomes for buprenorphine versus morphine treatment in neonates with neonatal abstinence syndrome (NAS). This was a single-site, randomized, double-blind, double-dummy clinical trial. Included in the clinical trial were 63 term infants ( 37 weeks of gestation) who had been exposed to opioids in-utero and who had signs of the neonatal abstinence syndrome. Infants with in utero exposure to benzodiazepines were excluded from the trial. Mothers were predominantly enrolled in an outpatient methadone treatment program. Infants were stratified based on maternal self-declaration of feeding plans based on breast-feeding versus bottle-feeding. Infants were randomly assigned to receive either sublingual buprenorphine or oral morphine. Those infants who were not controlled with the maximum dose of opioid were treated adjunctively with phenobarbital. The primary endpoint of the study was duration of treatment for symptoms of neonatal opioid withdrawal. Secondary clinical endpoints included length of hospital stay, percentage of infants who required adjunctive phenobarbital treatment, and safety. The study found that the median treatment duration was significantly shorter with buprenorphine as compared to morphine (15 days versus 33 days) as well as a shorter median length of hospital stay (21 days versus 33 days) (P<0.001 for both comparisons). Adjunctive phenobarbital was administered to 15% of infants in the buprenorphine group as compared to 23% in the morphine group (P=0.36). The rates of adverse effects were similar in the two groups. Study limitations include a small sample size, most infants having mothers in methadone treatment programs, and exclusion of infants with in-utero exposure to benzodiazepines. It would also be helpful to have comparison to other opioids such as long-acting opiates like methadone. The authors concluded that sublingually administered buprenorphine was significantly more effective than oral morphine in reducing duration of treatment for neonatal abstinence syndrome, which in turn led to a decreased length of stay in the hospital. It was also concluded that the two drugs had similar safety profiles. References: 1. Kraft WK, Adeniyi-Jones SC, Chervoneva I, et al. Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome. The New England journal of medicine. May Jones HE, Kaltenbach K, Heil SH, et al. Neonatal abstinence syndrome after methadone or buprenorphine exposure. The New England journal of medicine. Dec ;363(24): page 2

3 THE PHARMACIST S CORNER Substance Use Disorder: The Pharmacist s Perspective Summary Thea Moore, PharmD, BCPP, Vanita Sahasranaman, MD Recent statistics regarding substance use in Florida, and particularly opioid use, has been staggering. Florida was one of the few states that showed a statistically significant increase in the drug overdose death rate from 2014 to 2015 ( Drug Overdose Death Data, CDC, 2016). 1 In 2013, the National Institute on Drug Abuse (NIDA) identified South Florida as the location of a heroin epidemic with a 120% increase in heroin deaths from 2011 to 2012 (NIDA, 2014). 2 There has been some success with measures implemented such as the Prescription Drug Monitoring Program started in 2011, increased naloxone access by allowing pharmacist dispensing according to standing order, and decrease of prescription drug abuse due to decrease in pill mills. Yet, setbacks have included the increased use of alternatives to prescription opioids such as heroin and illicitly manufactured fentanyl derivatives. As further evidence, on May 3, 2017, following the Centers for Disease Control and Prevention (CDC) declaring a national opioid epidemic, Governor Rick Scott signed Executive Order declaring a public health emergency across the state of Florida. The Florida Medicaid Drug Therapy Management Program for Behavioral Health convened a meeting on Saturday, April 29, 2017 in Tampa, FL to highlight current issues with substance use disorder (SUD) and more specifically opioid use disorder (OUD) and the role of pharmacists in management of these issues in severe mental illness (SMI). Furthermore, potential collaboration areas for policy implementation and research were discussed. The first presentation by Anna Kostric, PharmD, BCPS, entitled Opioid Use and Abuse: A Balancing Act addressed key issues such as identifying populations at high-risk for opioid misuse, abuse, and overdose; opioids used in the treatment of chronic pain with focus on Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain; and naloxone. The second presentation by Jill Hanson, PharmD, MBA, BCPP, entitled Opioid Summit Recap, outlined a summit convened by Sunshine Health in Tampa on January 19, 2017 to address issues and concerns around the current opioid epidemic in the United States and how the epidemic is particularly impacting Florida. Stated goals of the summit and key issues addressed included improving prescribing practices (decreasing high dosages of opioids), using the Electronic-Florida Online Reporting of Controlled Substances Evaluation (E-FORCSE), and distributing an electronic toolkit with summary guidelines, assessment tools, and miscellaneous prescriber resources. The third presentation by Joe Spillane, PharmD, DABAT, entitled Opioid & Benzodiazepine Toxicity in the Emergency Department addressed the historical perspective and current status of opioid use and abuse and benzodiazepine use and abuse in Florida, and the management and treatment of substance use in the emergency department setting. Dr. Spillane also discussed the advantages and disadvantages of naloxone at home and newer policies for obtaining naloxone without a prescription. The fourth presentation by Antionette Moore, PharmD, entitled Retail Pharmacy: The Pharmacist s Role in Substance Use Disorder and Serious Mental Illness Therapy Management focused on characteristics that make retail pharmacy the ideal setting for therapy management, barriers to drug therapy management in patients with SUD and/or SMI, and tools that may be utilized to optimize drug therapy management. (Continued on next page) page 3

4 THE PHARMACIST S CORNER Substance Use Disorder: The Pharmacist s Perspective Summary continued Following the presentations, attendees were asked to vote on the top two quality improvement ideas that they would most like to collaborate on with the Florida Medicaid Drug Therapy Management Program for Behavioral Health. The top two areas receiving a significant number of votes (greater than half of those voting) were: 1. Promoting the use of E-FORCSE: a. Providing educational seminars on registering with the prescription drug management program (PDMP), advantages and disadvantages of the current system, E-FORCSE. b. Providing feedback to clinicians regarding the impact of utilizing the PDMP on healthcare metrics. c. Determining the number of clinicians and pharmacists accessing E-FORCSE. Potentially providing incentives for clinicians showing how their utilization of the program has positively impacted care. d. Working with state agencies to have E-FORCSE integrated into the EMHR. Several participants indicated that they would be much more likely to use the PDMP if it were integrated into the EMHR that they currently use. 2. Developing ways to collaborate with prescribers: a. Implementing systems where pharmacists are contacting clinicians regarding management of patients with OUD. b. Documenting the number of contacts/interventions, and c. Documenting the outcome of these communications. d. Subsequent or follow-up opioid summits with increased involvement of various healthcare professionals to develop policies on managing patients with OUD. References: 1. Centers for Disease Control and Prevention (CDC). Drug Overdose Death Data [Internet] Dec [cited 12 May 2017]. Available from: 2. National Institute on Drug Abuse (NIDA). Miami-Dade and Broward Counties, South Florida [Internet] Feb [cited 12 May 2017]. Available from: community-epidemiology-work-group-cewg/meeting-reports/highlights-summaries-january-2014/miami. 3. State of Florida Office of the Governor. Executive Order Number [Internet]. 3 May 2017 [cited 12 May 2017]. Available from: page 4

5 MAY IS NATIONAL MENTAL HEALTH AWARENESS MONTH The Florida Medicaid Drug Therapy Management Program would like to celebrate National Mental Health Awareness month by honoring two important contributors to our Program: Dr. Daniel Castellanos and Dr. Tanya Murphy. Daniel Castellanos, MD is a child and adolescent psychiatrist who has spent his career in academic medicine dedicated to the teaching and training of students, residents, and fellows in Psychiatry. He has given numerous presentations and published on topics related to suicide and Hispanic youth, the use of novel psychoactive drugs, and education and policy development focusing on the appropriate use of psychotropic medications in children and adolescents. Dr. Castellanos is the Founding Chair of the Department of Psychiatry & Behavioral Health and Professor of Psychiatry and Behavioral Health and Pediatrics at the Florida International University Herbert Wertheim College of Medicine. Over the past nine years he has led the expansion of his Department s clinical, educational, and research programs. Today, the Department of Psychiatry & Behavioral Health is the second largest clinical department in the College of Medicine. Education and training have been an integral part of Dr. Castellanos vision and the department s mission. He has prioritized the goal of increasing medical student selection of psychiatry as a specialty. Over the past four years the department s efforts have resulted in the College of Medicine s medical students matching into psychiatry residency programs at nearly double the national rate. In partnership with Citrus Health Network, Dr. Castellanos and his faculty helped develop and obtain accreditation for a new psychiatry residency program. The novel training program is the first ACGME accredited psychiatry residency program in the country based out of a Federally Qualified Health Center and a Community Mental Health Center. Since 2015, he has also served as the College of Medicine s Assistant Dean for Graduate Medicate Education (GME) working to develop and expand GME programs in different specialties throughout the region. Dr. Castellanos is committed to developing programs that offer excellence in education, training, research, and clinical services. Dr. Castellanos was asked what he enjoyed the most about being a child and adolescent psychiatrist: Working with children & adolescents is a challenging and rewarding experience. As I have obtained more experience and wisdom, I am still aware of how much more I have to learn ( know what you don t know ). I embrace the idea of lifelong learning. I am also fortunate to be able to work with different levels of learners. I find it rewarding when I am able to help a youngster and his or her family. Children and adolescents are in the early phases of their proverbial life journey. It is personally and professionally fulfilling to be able to facilitate healthy development and help with behavioral health problems. He was also asked what he felt is most important in training future psychiatrists: Future psychiatrists face the challenge of learning the multiplicity of factors involved in understanding normal development and clinical issues. Trainees should heed caution in categorically adopting biological or psychosocial perspectives. Emerging technologies, pharmacological and biological developments should continue to be balanced with understanding the social determinants of health. Future psychiatrists are best served with figuring out how to keep up with new scientific developments, critically appraise research and how to incorporate evidence based changes into their clinical practices. (Continued on next page) page 5

6 MAY IS NATIONAL MENTAL HEALTH AWARENESS MONTH continued... The Florida Medicaid Drug Therapy Management Program would like to celebrate National Mental Health Awareness month by honoring two important contributors to our Program: Dr. Daniel Castellanos and Dr. Tanya Murphy. Dr. Tanya Murphy is the Director of the Rothman Center for Pediatric Neuropsychiatry, and holds the Maurice A. and Thelma P. Rothman Endowed Chair in Developmental Pediatrics with a joint appointment in the Department of Psychiatry at the University of South Florida in the Morsani College of Medicine. After graduating from the College of Medicine at the University of Florida (UF), Dr. Murphy stayed at UF to complete her residency in general psychiatry and fellowship in child and adolescent psychiatry. As a member of the Department of Psychiatry faculty, she served as Director of the UF Child & Adolescent Psychiatry Outpatient Program, Director of the UF Child Anxiety & Tic Disorder Clinic, and Medical Director for the UF Autism Unit. From she was Chief of the Division of Child and Adolescent Psychiatry at UF. Dr. Murphy is board-certified in psychiatry and child psychiatry. She also holds a Master of Science in Clinical Investigation. She actively participates in numerous professional organizations including the American Academy of Child and Adolescent Psychiatry (AACAP), the National Tourette Syndrome Association where she served for 13 years on the Medical Advisory Board, the International Obsessive Compulsive Foundation Scientific Advisory Board, and as a fellow in the American Psychiatric Association. With regard to research, Dr. Murphy has received several major grants from the National Institute of Mental Health and has published more than 100 peer-reviewed papers. She has extensive experience in designing and coordinating studies for pediatric clinical trials, including pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS), childhood obsessive-compulsive disorder (OCD), tic disorders, anxiety disorders, and autism spectrum disorders. Her current research focuses on understanding the role of infections and the immune system in the onset of childhood psychiatric disorders and pharmacological and psychological treatments for Tourette's Syndrome and obsessive-compulsive disorder. page 6

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