Addiction, Author Interviews, Opiods, Pediatrics / 30.10.2016
Rapid Rise in Opioid Poisonings and Hospitalizations Among Children and Adolescents
MedicalResearch.com Interview with:
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Dr. Julie R Gaither[/caption]
Julie R Gaither, PhD, MPH, RN
Postdoctoral Fellow in Biostatistics
Yale School of Medicine
MedicalResearch.com: What is the background for this study?
Response: In light of the prescription opioid epidemic that has affected the adult US population in recent years, our objective with this study was to examine how hospitalization rates for prescription opioid poisonings have changed over time in the pediatric population.
In addition, because prescription opioids are thought to be a precursor to illicit opioid use, we examined in older adolescents hospitalization rates for heroin overdose.
In all children, we determined whether the poisoning was of an accidental nature or could be attributed to suicidal intent.
To address these questions, we used the Kids’ Inpatient Database, a nationally representatives sample of pediatric hospital records released every three years, starting in 1997.
Dr. Julie R Gaither[/caption]
Julie R Gaither, PhD, MPH, RN
Postdoctoral Fellow in Biostatistics
Yale School of Medicine
MedicalResearch.com: What is the background for this study?
Response: In light of the prescription opioid epidemic that has affected the adult US population in recent years, our objective with this study was to examine how hospitalization rates for prescription opioid poisonings have changed over time in the pediatric population.
In addition, because prescription opioids are thought to be a precursor to illicit opioid use, we examined in older adolescents hospitalization rates for heroin overdose.
In all children, we determined whether the poisoning was of an accidental nature or could be attributed to suicidal intent.
To address these questions, we used the Kids’ Inpatient Database, a nationally representatives sample of pediatric hospital records released every three years, starting in 1997.













Dr. Phillip Coffin[/caption]
Phillip O. Coffin, MD, MIA
Director of Substance Use Research
San Francisco Department of Public Health
Assistant Professor, Division of HIV, ID & Global Health
University of California, San Francisco
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: San Francisco has a longstanding naloxone distribution program that primarily works out of syringe exchange programs and is temporally associated with a substantial decline in opioid overdose death due to heroin or involving injection drug use. Over 90% of opioid overdose deaths from 2010-2012 were due to prescription opioids in the absence of heroin, and most of those decedents were prescribed opioids in primary care settings. Based on these data, as well as anecdotal reports from sites such as U.S. Army Fort Bragg in North Carolina - where providing naloxone to pain patients appeared to be associated with a radical decline in opioid overdose admissions to the emergency department - we implemented a naloxone prescribing program in the safety net primary care clinics.
We recommended that providers offer naloxone to all patients who used opioids on a regular basis, or were otherwise at risk for experiencing or witnessing an opioid overdose, although we only measured outcomes related to patients who were prescribed opioids for chronic pain. We also recommended that providers avoid the term "overdose" as that term does not properly reflect the epidemiology of opioid poisoning and is interpreted by many to mean intentionally consuming a large amount of opioids; instead we recommended saying things like: "Opioids can cause bad reactions where you stop breathing or can't be woken up." Providers prescribed mostly the jerry-rigged nasal device, with the atomizer and a brochure dispensed at clinic and the naloxone picked up at the patients' usual pharmacies, to approximate real-world medical practice.

Dr. Hsien-Yen Chang[/caption]
Hsien-Yen Chang PhD
Assistant Scientist
Johns Hopkins Bloomberg School of Public Health
Department of Health Policy & Management
Center for Drug Safety & Effectiveness
MedicalResearch.com: What is the background for this study?
Dr. Chang: Prescription opioid addiction and non-medical use are significant public health problems, responsible for about 44 daily overdose deaths in the United States. Although there are no magic bullets to address these issues, policy makers play an important role in shaping regulatory, payment and public health policies to reduce opioid-related injuries and deaths. For example, state policy-makers in the United States have used prescription drug monitoring programs (PDMPs) and “pill mill” laws to address the prescription opioid epidemic. While there is growing evidence regarding the effect of these approaches on opioid sales, little is known about how they affect specific groups of prescribers. This is important, as approximately 20% of U.S. physicians are responsible for prescribing 80% of all opioid analgesics. Therefore, in this study we evaluated the impact of PDMPs and pill mill laws on the clinical practices of high-risk prescribers in Florida, such as their total number of prescription-filling patients with an opioid prescription. Furthermore, we also characterized the concentration of opioid volume and prescriptions among this group of prescribers as well as how the policies of interest impacted these measures.
Dr. Richard Mangano[/caption]
Richard M. Mangano, PhD
Chief Scientific Officer at Relmada Therapeutics
Dr. Mangano has extensive experience leading global R&D programs in both large and small pharmaceutical companies including positions in discovery and clinical research at Hoffmann-La Roche, Lederle Laboratories, Wyeth Research and Adolor Corporation. He served as acting Therapeutic Area Director for Neuroscience at Wyeth before joining Adolor as Vice President of Clinical Research and Development. Dr. Mangano’s expertise includes multiple IND/CTC submissions and NDA/MAA approvals in psychiatry, neurology and gastrointestinal therapeutic areas. Dr. Mangano is also an adjunct professor in the Department of Pharmacology and Physiology at the Drexel University School of Medicine. He lectures in the Drug Discovery and Development Program and in the Psychiatry Department’s Resident Training Program. He has authored 30 peer reviewed publications and over 120 abstracts and presentations. Dr. Mangano holds a B.S degree in Chemistry from Iona College and a PhD degree in Biochemistry from Fordham University. Prior to joining the pharmaceutical industry, he was a research faculty member of the Maryland Psychiatric Research Institute at the University of Maryland School of Medicine.
Dr. Mangano discusses the opioid addiction and the development of abuse-resistant medications.
MedicalResearch.com: What is the background for the development of abuse-resistant medications? How extensive is the problem of opioid addiction?
Dr. Mangano: Recognizing the growing incidence of opioid abuse, misuse, and overdose in the United States, pharmaceutical companies, with the guidance of the FDA, are developing products that can mitigate abuse, while recognizing the importance of maintaining the availability of opioid analgesics for the millions of patients in this country who suffer from pain.
Approximately two million people in the U.S. are addicted to opioids. The market for products that treat opioid dependence has grown significantly due to the rapidly escalating problem of prescription opioid misuse and abuse, a recent resurgence of heroin use, and the growing number of physicians treating opioid dependence.
One of our product candidates, REL-1028 (BuTab), is a proprietary formulation of buprenorphine designed to treat both opioid addiction and moderate to severe chronic pain. Although there is the potential for addiction to buprenorphine, the risk is lower because it is a “partial agonist” of the mu opioid receptor compared with “full agonist” opioids like heroin, morphine, oxycodone, and hydrocodone. As a result, products containing buprenorphine, such as BuTab, should have reduced risk of abuse and physical dependence and would be controlled in Schedule III of the Controlled Substances Act (as opposed to the more restrictive Schedule II). We are also considering a formulation that would include an opioid antagonist that would not interfere with analgesia when taken orally as prescribed but would block the action of buprenorphine if it were to be inhaled or injected.
Dr. William Eggleston[/caption]
William Eggleston, PharmD
Fellow in Clinical Toxicology/Emergency Medicine
Upstate Medical University
Upstate New York Poison Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Eggleston: The case series describes two deaths associated with loperamide abuse with supportive post-mortem findings. It adds to the growing body of literature reporting cardiac toxicity after loperamide abuse and demonstrates the deadly consequences. It also highlights the growing trend of loperamide abuse amongst opioid addicted patients looking to get high or stave off withdrawal symptoms.
MedicalResearch.com: What should readers take away from your report?
Dr. Eggleston: Readers should recognize that loperamide is an OTC opioid medication that acts similarly to morphine or heroin in the body after high doses. The drug is easily abused due to its low cost, ease of accessibility, legal status, and lack of social stigma associated with its possession. Most importantly, loperamide is a cardiac toxin that causes conduction disturbances in high doses and can produce deadly dysrhythmias.




