Addiction, Author Interviews, Columbia, Opiods / 03.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28490" align="alignleft" width="165"]Silvia S. Martins, MD, PHD Associate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University New York, NY 10032 Dr. Silvia Martins[/caption] Silvia S. Martins, MD, PHD Associate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University New York, NY 10032 MedicalResearch.com: What is the background for this study? Response: Given the high probability of nonmedical use among adolescents and young adults, the potential development of prescription opioid use disorder secondary to nonmedical use among youth represents an important and growing public health concern. Still, no study had investigated time trends, specifically if prescription opioid use disorder has increased in the past decade among adolescents, emerging adults and young adults who are nonmedical users of prescription opioids.
Author Interviews, Cost of Health Care, Opiods, Pain Research / 26.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28168" align="alignleft" width="200"]Jaren Howard, PharmD, BCPS Associate Director, Medical Affairs Strategic Research Purdue Pharma L.P. Dr. Jared Howard[/caption] Jaren Howard, PharmD, BCPS Associate Director Medical Affairs Strategic Research Purdue Pharma L.P. MedicalResearch.com: What is the background for this study? Response: The existing scientific literature estimating the healthcare burden of opioid misuse disorders often combines all patients within the broad category of “opioid abuse,” defined as opioid abuse, dependence, or overdose/poisoning. Collectively, these three conditions can significantly increase healthcare costs among commercially insured patients. • Real world medical coding practices present challenges to researchers aiming to separately analyze excess costs by diagnosis, though combining these diagnoses may mask some variation in excess costs. • Furthermore, little is known about the specific drivers of excess costs in terms of medical conditions driving excess costs or places of service at the diagnosis-level.
Author Interviews, JAMA, Opiods / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28220" align="alignleft" width="130"]Bradley D. Stein, MD, MPH, PhD RAND Corporation University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania Dr. Bradley Stein[/caption] Bradley D. Stein, MD, MPH, PhD RAND Corporation University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: The United States is in the midst of a serious opioid abuse epidemic and we know that medically assisted treatment is one of the best ways to help people with addiction to opioids. The drug buprenorphine has advantages over methadone, the historic medical treatment, because it can be prescribed by physicians in the community who receive a waiver allowing them to prescribe it after undergoing eight hours of training.. Methadone is dispensed at special clinics that many people with opioid addition may be unable to get to with the frequency required by effective treatment. To better understand patterns of the use of buprenorphine, we examined treatment patterns in the states with the most buprenorphine-waivered physicians (California, Florida, Massachusetts, Michigan, New York, Pennsylvania and Texas). Our data came from a prescription records that account for over 80 percent of the retail pharmacies in the nation. We examined use patterns among 3,200 physicians who treated 250,000 patients. We had two surprising findings:  First, the median length of treatment with buprenorphine was 53 days, which is much shorter than the duration that most individuals are likely to need for optimal results. Second, despite concerns that federal limits on the number of patients and waivered physician can treat being a significant barrier for many individuals obtaining treatment, we found that most physicians were treating far fewer patients than would be allowed by the patient limits. In fact, 22 percent of the physicians treated an average of 3 patients per month and just 9 percent treated 75 or more patients per month.
Addiction, Author Interviews, Opiods, Pain Research / 21.09.2016

MedicalResearch.com Interview with: Thomas Alfieri, PhD Director, Medical Affairs Strategic Research Purdue Pharma L.P. MedicalResearch.com: What is the background for this study? Response: When researchers assess the abuse potential of opioids, they follow current FDA guidance, which stipulates that questions such as “Do you like this drug?” and “How much would you like to take this drug again?” be asked of recreational drug users. We think that assessing abuse potential among recreational users provides useful information, however, we believe that the questions designed to be asked of recreational users are not appropriate for use with pain patients. These items can confuse the liking of a drug for pain relief with the liking of a drug to get high – two very different reasons that a pain patient might want to take a drug again. In theory, abuse potential could be overestimated among pain patients because of the somewhat general nature of the items used in the survey instrument.
Author Interviews, Cost of Health Care, Opiods, Pain Research / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28168" align="alignleft" width="200"]Jaren Howard, PharmD, BCPS Associate Director, Medical Affairs Strategic Research Purdue Pharma L.P. Dr. Jared Howard[/caption] Jaren Howard, PharmD, BCPS Associate Director, Medical Affairs Strategic Research Purdue Pharma L.P. MedicalResearch.com: What is the background for this study? Response: Opioid abuse, dependence, overdose, and poisoning (referred to collectively for the purposes of this study as “abuse”) represent a costly public health concern to payers. Excess annual costs for a diagnosed opioid abuser range from $10,000-$20,000 per patient. Current literature does not sufficiently address the drivers of excess costs in terms of medical conditions driving costs or places of service.
Author Interviews, Opiods, Pain Research / 21.09.2016

MedicalResearch.com Interview with: Angela DeVeaugh-Geiss, PhD Director, Epidemiology, Purdue Pharma L.P. MedicalResearch.com: What is the background for this study? Response: Due to widespread abuse, including abuse via non-oral routes (eg, snorting, injecting), OxyContin was reformulated with abuse deterrent properties in August 2010. In this study we explored changes in nonmedical use of OxyContin after the reformulation using public use data files from the National Survey on Drug Use and Health (NSDUH). NSDUH has included questions about nonmedical use of OxyContin (including pill images) since 2004. Nonmedical use is defined as use without a prescription or use that occurred simply for the experience or feeling the drug caused.
Accidents & Violence, Author Interviews, Cannabis, Columbia, Opiods / 17.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28045" align="alignleft" width="163"]June H. Kim Doctoral candidate,Department of Epidemiology Mailman School Public Health Columbia University June Kim[/caption] June H. Kim Doctoral candidate,Department of Epidemiology Mailman School Public Health Columbia University MedicalResearch.com: What is the background for this study? What are the main findings? Response: A previous study indicated that states with medical marijuana laws had a reduced rate of opioid overdoses. If this is true, we'd expect to see similar reductions in opioid use associated with these laws. For this study, we used data from the FARS, a national surveillance system that records any crash events on US public roads that result in a fatality. Some states provide uniform testing of the majority of their deceased drivers, year to year. Among these states, we found that there was a lower prevalence of positive opioid toxicology tests among drivers crashing in states with an operational medical marijuana versus drivers crashing in states before a future medical marijuana law is implemented, particularly among drivers aged 21-40.
Author Interviews, CDC, Emory, Opiods / 15.09.2016

MedicalResearch.com Interview with: [caption id="attachment_27960" align="alignleft" width="180"]Curtis Florence, PhD National Center for Injury Prevention and Control and Assistant professor, Department of Health Policy Management Rollins School of Public Health at Emory Curtis Florence, PhD[/caption] Curtis Florence, PhD National Center for Injury Prevention and Control and Assistant professor, Department of Health Policy Management Rollins School of Public Health Emory MedicalResearch.com: What is the background for this study? Response:
  • This study presents most recent CDC estimates of the economic burden of prescription opioid abuse, dependence and overdose in the United States.
  • In 2013, over 16,000 persons died of prescription opioid overdoses, and almost 2 million people met the diagnostic criteria for abuse and/or dependence.
Addiction, Anesthesiology, Author Interviews, Opiods / 02.09.2016

MedicalResearch.com Interview with: [caption id="attachment_27601" align="alignleft" width="125"]N. Nick Knezevic, MD, PhD Vice Chair for Research and Education Associate Professor of Anesthesiology and Surgery at University of Illinois Advocate Illinois Masonic Medical Center Department of Anesthesiology Chicago, IL 60657 Dr. N. Nick Knezevic[/caption] N. Nick Knezevic, MD, PhD Vice Chair for Research and Education Associate Professor of Anesthesiology and Surgery at University of Illinois Advocate Illinois Masonic Medical Center Department of Anesthesiology Chicago, IL 60657 MedicalResearch.com: What is the background for this study? Response: Even though serious efforts have been undertaken by different medical societies to reduce opioid use for treating chronic non-cancer pain, still many Americans seek pain relief through opioid consumption. The purpose of this study was to accurately assess compliance of chronic opioid consuming patients in an outpatient setting and evaluate if utilizing repeated urine drug testing could improve compliance.
Addiction, Author Interviews, CDC, Opiods / 30.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27499" align="alignleft" width="125"]Alexis B. Peterson, PhD Alexis B. Peterson, PhD[/caption] Alexis B. Peterson, PhD (Epidemic Intelligence Service Officer) [caption id="attachment_27435" align="alignleft" width="125"]R. Matthew Gladden, PhD Surveillance and Epidemiology Team Division of Unintentional Injury Prevention Centers for Disease Control and Prevention Dr. R. Mathew Gladden[/caption] R. Matthew Gladden, PhD (Behavioral Scientist) MedicalResearch.com What is the background for this study? Response: In March and October 2015, the Drug Enforcement Administration and the Centers for Disease Control and Prevention (CDC) issued nationwide alerts identifying fentanyl, particularly illicitly manufactured fentanyl, as a threat to public health and safety. During 2013-2014, Ohio and Florida reported significant increases in fentanyl-involved overdose deaths (fentanyl deaths) and fentanyl submissions (drug products obtained by law enforcement that tested positive for fentanyl). Fentanyl is a synthetic opioid 50-100 times more potent than morphine. The University of Florida and the Ohio Department of Public Health with CDC assistance compared trends in fentanyl deaths, fentanyl submissions, and fentanyl prescribing during January 2013–June 2015. In-depth review of medical examiner and coroner reports of fentanyl deaths occurring in Ohio’s 14 high-burden counties were performed to identify circumstances surrounding fentanyl overdose death.
Addiction, Author Interviews, CDC, Opiods / 29.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27435" align="alignleft" width="153"]R. Matthew Gladden, PhD Surveillance and Epidemiology Team Division of Unintentional Injury Prevention Centers for Disease Control and Prevention Dr. R. Mathew Gladden[/caption] R. Matthew Gladden, PhD Surveillance and Epidemiology Team, Division of Unintentional Injury Prevention, Centers for Disease Control and Prevention MedicalResearch.com: What is the background for this study? Response: In March and October 2015, the Drug Enforcement Administration (DEA) and CDC, respectively, issued nationwide alerts identifying illicitly manufactured fentanyl (IMF) as a threat to public health and safety.IMF is unlawfully produced fentanyl, obtained through illicit drug markets, includes fentanyl analogs, and is commonly mixed with or sold as heroin. Starting in 2013, the production and distribution of IMF increased to unprecedented levels, fueled by increases in the global supply, processing, and distribution of fentanyl and fentanyl-precursor chemicals by criminal organizations. Fentanyl is a synthetic opioid 50?100 times more potent than morphine. Multiple states have reported increases in fentanyl-involved overdose (poisoning) deaths (fentanyl deaths). This report examined the number of drug products obtained by law enforcement that tested positive for fentanyl (fentanyl submissions) and synthetic opioid-involved deaths other than methadone (synthetic opioid deaths), which include fentanyl deaths and deaths involving other synthetic opioids (e.g., tramadol).
Addiction, Author Interviews, CDC, Opiods, Pain Research / 27.08.2016

MedicalResearch.com Interview with: John Halpin, MD, MPH, Medical officer Prescription Drug Overdose Epidemiology and Surveillance Team CDC Injury Center MedicalReseach.com editor’s note: Dr. Halpern discusses the CDC alert of August 25, 2016 regarding the increase in fentanyl-related unintentional overdose fatalities in multiple states. MedicalResearch.com: What is the background for this alert? Response: The current health alert is an update to a previous alert in October, 2015 from CDC which described the geographic spread of states in which forensic labs were increasingly detecting fentanyl in the drug submissions that they receive from law enforcement, and how many of these same states were beginning to report fentanyl-related overdose deaths by their departments of public health. Further investigation by CDC and DEA have revealed that the great majority of fentanyl now present in the illicit drugs market is clandestinely-produced, and most commonly mixed with and sold as heroin, and is responsible for the great majority of fentanyl-related overdose deaths. Indications at the time of that alert pointed to a likely continuous rise in the supply of illicitly-manufactured fentanyl, and the potential for increasing numbers of fentanyl-related overdose deaths, particularly among those who use heroin.
Addiction, Author Interviews, Compliance, Opiods, Pharmacology / 23.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27243" align="alignleft" width="190"]F. Leland McClure III, MSci, PhD, F-ABFT Medical science liaison director Quest Diagnostics Dr. F. Leland McClure[/caption] F. Leland McClure III, MSci, PhD, F-ABFT Medical science liaison director Quest Diagnostics MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many physicians associate Quest Diagnostics with their lab service needs because of our leadership in laboratory testing. But Quest is more than a lab, which is why we refer to ourselves as a diagnostic information services provider. This means that we help providers, health plans and even patients use the insights we derive from our lab testing data to deliver better care, quality and outcomes, both for the patient and the managed population. Our 2016 Quest Diagnostics Health Trends(TM) Prescription Drug Monitoring Report is an example of how we provide important health insights from Quest's laboratory data. Prescription drug misuse is a major epidemic in the United States. Laboratory testing can help identify if a patient is using or misusing prescribed medications. For instance, lab tests can show evidence of additional medications and other drugs in a patient’s urine specimen, suggesting potentially dangerous drug combinations. Earlier this year, the CDC issued guidelines that call for laboratory testing for patients prescribed certain medications, such as opioids, that carry a risk of abuse. Quest's prescription drug monitoring services help the physician identify if a patient is taking or not taking up to about four dozen drugs, such as oxycodone, Adderall XR® and Percocet®. For the Quest analysis, we analyzed more than 3 million de-identified lab test results. In this report, we found that 54 percent of patients’ results tested in 2015 showed evidence of drug misuse, slightly above the 53 percent misuse rate in 2014. That is certainly unacceptably high, but it’s a significant decline from the high of 63 percent we observed in 2011. We also found that an increasing proportion of patients who misuse medications combine their prescription medication with non-prescribed drugs. Among patients with inconsistent test results, forty-five percent of these patients showed evidence of one or more other drug(s) in addition to their prescribed drug regimen. That’s much higher than our findings of 35 percent in 2014 and 2013, 33 percent in 2012, and 32 percent in 2011. Finally, we were alarmed by the data showing the connection between heroin and benzodiazepines misuse. Our data showed one in three heroin users combine their drug use with benzodiazepines, the vast majority of which were unprescribed. This is an extremely dangerous practice given that benzodiazepines can have strong respiratory depressant effects when combined with other substances. Drug combinations, but particularly of heroin with benzodiazepines, can be potentially very dangerous, leading to coma and even death in some cases.
Author Interviews, JAMA, Opiods, Toxin Research / 10.08.2016

MedicalResearch.com Interview with: Ann M. Arens, MD California Poison Control Center San Francisco, CA 94110 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prescription opioid abuse is a significant public health threat that has garnered the attention of health care providers throughout medicine. With efforts to curb the number of prescriptions for opioid pain medications, users may begin to purchase prescription medications from illegal sources. Our study reports a series of patients in the San Francisco Bay Area who were exposed to counterfeit alprazolam (Xanax®) tablets found to contain large amounts of fentanyl, an opioid 100 times more potent than morphine, and in some cases etizolam, a benzodiazepine. The California Poison Control System – San Francisco division identified eight patients with unexpected serious health effects after exposure to the tablets including respiratory depression requiring mechanical ventilation, pulmonary edema, cardiac arrest, and one fatality. Patients reportedly purchased the tablets from drug dealers, and were unaware of their true contents. In one case, a 7 month-old infant accidentally ingested a counterfeit tablet dropped on the floor by a family member.
Addiction, Author Interviews, Opiods, Primary Care / 04.08.2016

MedicalResearch.com Interview with: [caption id="attachment_26700" align="alignleft" width="133"]Richard A. Deyo MD, MPH Kaiser Permanente Professor of Evidence-Based Family Medicine Department of Family Medicine Department of Medicine Department of Public Health and Preventive Medicine Oregon Institute of Occupational Health Sciences Oregon Health and Science University Portland, OR 97239 Dr. Richard Deyo[/caption] Richard A. Deyo MD, MPH Kaiser Permanente Professor of Evidence-Based Family Medicine Department of Family Medicine Department of Medicine Department of Public Health and Preventive Medicine Oregon Institute of Occupational Health Sciences Oregon Health and Science University Portland, OR 97239 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Doctors and other prescribers often wonder how much and for how long they can prescribe opioids before inadvertently promoting long-term use. Unfortunately, few data are available to guide initial prescribing. Long-term opioid use is problematic because of substantial rates of dependence and misuse, and because the efficacy of long-term therapy remains unproven. Development of drug tolerance and increasing sensitivity to pain may limit long-term efficacy. Several factors may explain the emergence of inadvertent long-term use, including opioid dependence, recreational use, addiction, and illicit diversion to other users. We studied the risk of long-term use (defined as filling 6 or more opioid prescriptions in the subsequent year) with data from Oregon's Prescription Drug Monitoring Program, which captures all opioid prescriptions filled in Oregon pharmacies, regardless of who wrote the prescription or who paid for the prescription. We identified patients who had not received opioid medication in the previous year, but now received an initial prescription. There were over half a million such patients during the one-year study. Our most informative analysis was among people under age 45, which excluded most patients with a diagnosis of cancer, who were near the end of life, or who had chronic painful conditions such as arthritis. In this group, a patient who received just a three day supply of a moderate dose of opioids (For example, 10 mg. of hydrocodone plus acetaminophen 4 times daily for 3 days) had about a 2% risk of becoming a long term user. Someone who filled two prescriptions jumped to a 7% risk. Patients receiving a long-acting opioid as the first prescription had a higher risk of becoming long term users than those receiving short-acting opioids. Patients receiving a single prescription for such medications had almost a 16% likelihood of becoming long-term users compared to just 2% for those receiving short-term opioids. In some cases, long-term use may have been intended, but our exclusion of patients with cancer and end-of-life care made this less likely.
Author Interviews, Genetic Research, Opiods, Pain Research, Thromboembolism / 14.07.2016

[caption id="attachment_26111" align="alignleft" width="125"]Brian Meshkin Founder and CEO of Proove Biosciences Brian Meshkin[/caption] MedicalResearch.com Interview with: Brian Meshkin Founder and CEO of Proove Biosciences Editor’s note: Proove Biosciences, Inc introduced three new evidence-based tests to support better clinical decision-making for difficult-to-treat conditions that are influenced by genetics. These conditions include substance abuse, fibromyalgia and venous thromboembolism. The tests are especially relevant in light of the House of Representatives passing the Comprehensive Addiction Recovery Act (CARA) bill on July 8, 2016 to combat the opioid epidemic. MedicalResearch.com: Would you update our readers on the significance and implications of the CARA Act? What is the role of genetics in addiction? What is the background for the Proove Addiction™ Profile? How does it aid in addiction management? Response: CARA is a national piece of legislation to expand access to treatment for drug overdoses and addiction. It also includes some other provisions meant to help address the opioid epidemic. However, there are some serious implications. First, it does not contain any funding, so it is a bit of a “Potemkin Village”. It is also a bit of a façade because it does not address 50% of the equation. According to the definition of addiction from the American Society of Addiction Medicine (ASAM) and the National Institutes of Drug Abuse (NIDA), about half of substance abuse is due to genetic factors. If you are studying for a test and ignoring half of the material, chances are you are not going to do well on the test. As doctors are confronted with the challenges of objectively assessing pain and knowing which patients are at risk for abuse, they must consider genetics. The Proove Opioid Risk test combines genetic markers and phenotypic variables into an algorithm to effectively identify patients at low, moderate and high risk for opioid abuse. By knowing this information, a physician can make better decisions about opioids. For low risk patients, a physician can safely prescribe and a patient does not need to fear the opioid prescription they are given – as this is about 50% of the population. For those at moderate risk, a physician can use a greater level of vigilance to monitor those patients with abuse-deterrent formulations, regular urine drug screens, opioid contracts, and other tools to monitor their use. For the small number of patients – less than 10% - that are at high risk, a physician can use alternative forms of pain relief such as interventional procedures or non-opioid analgesics to provide the needed relief to patients. The Proove Addiction Profile builds on this commitment, by providing genetic data points related to other disorders, such as addictions to alcohol, heroin, cocaine and others. Unfortunately, many patients who screen positive for aberrant behavior, such as having an illicit drug in their urine, are often discharged from care by their doctor. This just gets them lost in the system. By running the Proove Addiction Profile in addition to a urine drug screen, a doctor can better understand the genetic factors associated with the aberrant behavior and refer the troubled patient to an addiction specialist for treatment.
Addiction, Annals Internal Medicine, Author Interviews, Opiods, UCSF / 28.06.2016

MedicalResearch.com Interview with: [caption id="attachment_25429" align="alignleft" width="170"]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 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.
Author Interviews, NEJM, Occupational Health, Opiods / 24.06.2016

MedicalResearch.com Interview with: [caption id="attachment_25503" align="alignleft" width="125"]Professor Ellen Meara, PhD Professor The Dartmouth Institute for Health Policy and Clinical Practice Prof. Ellen Meara[/caption] Professor Ellen Meara, PhD Professor The Dartmouth Institute for Health Policy and Clinical Practice MedicalResearch.com: What is the background for this study? Response: Responding to a fourfold rise in death rates, between 2006 and 2012, states collectively enacted 81 laws restricting prescribing and dispensing of prescription opioids. Jill Horwitz, PhD, JD, said “states hoped passing a range of laws might help. So they are enacting small fixes — forbidding patients from “doctor-shopping,” and requiring doctors to use tamper-resistant prescription forms. They are also implementing major efforts such as prescription drug monitoring programs (PDMPs) — online databases that allow law enforcement and clinicians to monitor prescriptions.”
Anesthesiology, Author Interviews, Breast Cancer, Opiods, Pain Research / 04.06.2016

MedicalResearch.com Interview with: Dr. Sarah Saxena Université Libre de Bruxelles MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Saxena: Opioids are well known analgesics, but like every drug, they do not come without side-effects. Recently, certain studies have been published about an opioid-free approach in bariatric patients. An opioid free approach is possible combining ketamine, lidocaine and clonidine. We studied this type of approach in breast cancer patients and looked at several factors such as patient comfort pain quality after an opioid free approach vs after an opioid approach. The study showed patients requiring less analgesics after an opioid free approach.
Author Interviews, Opiods / 03.06.2016

MedicalResearch.com Interview with: [caption id="attachment_24896" align="alignleft" width="176"]Hsien-Yen Chang PhD Assistant Scientist Johns Hopkins Bloomberg School of Public Health Department of Health Policy & Management Center for Drug Safety & Effectiveness 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.
Author Interviews, Opiods, Pain Research / 11.05.2016

MedicalResearch.com Interview with: [caption id="attachment_24269" align="alignleft" width="133"]Richard M. Mangano, PhD Chief Scientific Officer at Relmada Therapeutics 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.
Author Interviews, Emergency Care, Heart Disease, Opiods / 05.05.2016

MedicalResearch.com Interview with: [caption id="attachment_24067" align="alignleft" width="200"]William Eggleston, PharmD Fellow in Clinical Toxicology/Emergency Medicine Upstate Medical University Upstate New York Poison Center 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.
Author Interviews, CMAJ, Opiods, Pain Research / 04.04.2016

MedicalResearch.com Interview with: [caption id="attachment_23135" align="alignleft" width="130"]Shawn Bugden B.Sc. (Pharm), M.Sc., Pharm.D. Associate Professor College of Pharmacy, Faculty of Health Sciences University of Manitoba Winnipeg, Manitoba, Canada R3E 0T5 Dr. Bugden[/caption] Shawn Bugden B.Sc. (Pharm), M.Sc., Pharm.D. Associate Professor College of Pharmacy, Faculty of Health Sciences University of Manitoba Winnipeg, Manitoba, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Bugden: Fentanyl is 100 times more potent than morphine.  While there has been a great deal of attention to fentanyl deaths associated with substance abuse, our study focused on the safety of fentanyl use in standard medical practice.   Fentanyl is most commonly prescribed as a transdermal (skin) patch that delivers the medication over 3 days. The product monograph and numerous safety warnings (FDA, Health Canada…) make it clear that fentanyl patches should not be used unless the patient has had considerable previous opioid exposure (more than 60mg morphine per day for more than 1 week).  Failure to heed these warnings may result in opioid overdose, respiratory depression and death. This study examined over 11 000 first prescriptions for fentanyl patches over a 12-year period to determine if patients had received adequate exposure to opioids.  Overall 74.1% of first prescriptions were filled by patients who had not received adequate prior opioid exposure. An improvement was seen over the study period but even at the end of the study, 50% of prescriptions would be classed as unsafe.  More than a quarter (26.3%) of fentanyl prescriptions were given to patients who were completely opioid naïve and had no exposure to opioids of any kind in the previous 60 days.  Older adults, who may be more sensitive to the effects of fentanyl overdose, were more likely to receive unsafe prescriptions than younger adults.
Author Interviews, Depression, Opiods, Pain Research / 19.02.2016

MedicalResearch.com Interview with: Dr-Jeffrey-ScherrerJeffrey F. Scherrer, PhD Associate Professor Research Director Department of Family and Community Medicine Saint Louis University School of Medicine St. Louis, MO 63104  Medical Research: What is the background for this study? What are the main findings? Dr. Scherrer: We initiated a series of studies on chronic opioid use and risk of depression about 3 years ago and obtained an NIH R21 to study prescription opioid use and risk of new onset depression, depression recurrence and transition to treatment resistant depression.  The rationale comes partly from clinical observations of the research team (I am not a clinician, just a epidemiologist).  We also observed the large field demonstrating patients with depression are more likely to get opioids for pain, take them longer and develop abuse.  We wanted to switch the direction of effect to determine if the reverse exists.  After publishing two papers demonstrating longer use of opioid was associated with increasing risk of depression, our next step was to look at recurrence among patients with a recent history of depression. Medical Research: What should clinicians and patients take away from your report? Dr. Scherrer: Our main recommendation is clinicians should repeatedly screen patients for depression.  While screening at time of starting opioids is common, repeated screening is worth consideration.  Patients with depression who may experience temporary euphoria should not expect opioids to cure depression and they may increase risk for worsening mood and or recurrence after long term use.
Author Interviews, NEJM, NIH, Opiods / 14.01.2016

[caption id="attachment_20558" align="alignleft" width="200"]Dr. Wilson Compton Dr. Wilson Compton[/caption] For more on Opioids on MedicalResearch.com please click here. MedicalResearch.com Interview with: Wilson M. Compton, M.D., M.P.E. Deputy Director National Institute on Drug Abuse Medical Research: What is the background for this study? What are the main findings? Dr. Compton: Deaths related to opioids (from both prescription pain killers and street drugs, like heroin) have dramatically increased in the past 15 years.  How these different types of opioids are related to each other is important because the pain killers ultimately are derived from prescriptions written by health care providers and street drugs, like heroin, are from illegal sources.  The different types of opioids vary in there source but are quite similar in their effects in the brain.  Given the different sources, interventions to reduce availability vary across the two categories. There is also a concern that interventions to reduce the availability of prescription opioids may be encouraging people to switch to heroin.  That’s the main question addressed in this review.
Author Interviews, CMAJ, Opiods / 04.01.2016

[caption id="attachment_20406" align="alignleft" width="231"]Tara Gomes MHSc Tara Gomes[/caption] Medical Research: What is the background for this study? What are the main findings? Response: Surveillance of the harms associated with chronic opioid use is imperative for clinicians and policy-makers to rapidly identify emerging issues related to this class of medications.  However, data regarding opioid-related deaths is difficult to obtain in Canada as it is collected by local coroners and is not widely available to researchers.  We conducted a validation study to evaluate whether regularly collected vital statistics data collected by Statistics Canada can be used to accurately identify opioid-related deaths in Canada. We compared deaths identified from charts abstracted from the Office of the Chief Coroner of Ontario to those identified using several coding algorithms in the Statistics Canada Vital Statistics database.  We found that the optimal algorithm had a sensitivity of 75% and a positive predictive value of 90%. When using this algorithm, the death data obtained from the Vital Statistics database slightly underestimated the number of opioid-related deaths in Ontario, however the trends over time were similar to the data obtained from the coroner’s office.
Annals Internal Medicine, Author Interviews, Emergency Care, Opiods, Pain Research / 29.12.2015

[caption id="attachment_20345" align="alignleft" width="177"]Dr. Marc LaRochelle MD MPH Dr. LaRochelle[/caption] MedicalResearch.com Interview with: Marc R. Larochelle, MD, MPH Assistant Professor of Medicine Boston Medical Center Boston, MA  Medical Research: What is the background for this study? What are the main findings? Dr. Larochelle: More than 16 thousand people in the United States die from prescription opioid overdose each year. However, morbidity extends well beyond fatal overdose - nearly half a million emergency department visits each year are related to prescription opioid-related harms. Emergency department visits for misuse of opioids represent an opportunity to identify and intervene on opioid use disorders, particularly for patients who receive prescriptions for opioids to treat pain. We examined a cohort of nearly 3000 commercially insured individuals prescribed opioids for chronic pain who were treated for a nonfatal opioid overdose in an emergency department or inpatient setting. We were interested in examining rates of continued prescribing after the overdose and the association of that prescribing with risk of repeated overdose. We found that 91% of individuals received another prescription for opioids after the overdose. Those continuing to receive opioids at high dosages were twice as likely as those whose opioids were discontinued to experience repeated overdose.
Author Interviews, CDC, Opiods / 22.12.2015

MedicalResearch.com Interview with: R. Matthew Gladden, PhD Behavioral Scientist Division of Unintentional Injury Prevention CDC Medical Research: What is the background for this study? What are the main findings? Dr. Gladden: The rate for drug overdose deaths has increased approximately 140% since 2000, driven largely by opioid overdose deaths. Nearly every aspect of the opioid overdose death epidemic worsened in 2014. Drug overdose deaths increased significantly from 2013 to 2014. Increases in opioid overdose deaths were the main factor in the increase in drug overdose deaths. The death rate from the most commonly prescribed opioid pain relievers (natural and semisynthetic opioids) increased 9%, the death rate from heroin increased 26%, and the death rate from synthetic opioids (a category that includes illicitly-made fentanyl and synthetic opioid pain relievers other than methadone) increased 80%.
Author Interviews, Opiods, Pain Research / 28.10.2015

[caption id="attachment_18854" align="alignleft" width="133"]Richard L. Rauck, M.D. Director of Carolinas Pain Institute Winston Salem, NC Dr. Richard Rauck[/caption] MedicalResearch.com Interview with: Richard L. Rauck, M.D. Director of Carolinas Pain Institute Winston Salem, NC Medical Research: How large is the problem of chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate? Dr. Rauck: Chronic pain affects more than 100 million Americans - more than diabetes, heart disease and cancer combined. It is the most common cause of long-term disability, costing the U.S. billions of dollars annually in medical costs and lost wages and productivity.   Medical Research: What are the main medical conditions associated with this type of pain?  Dr. Rauck: A National Institute of Health Statistics survey indicated that low back pain is the most common cause of chronic pain (27%), followed by severe headache or migraine pain (15%), neck pain (15%) and facial ache or pain (4%).
Author Interviews, CDC, JAMA, Opiods, Pharmacology / 16.10.2015

MedicalResearch.com Interview with: Beth Han, MD, PhD, MPH Substance Abuse and Mental Health Services Administration U.S. Department of Health and Human Services Rockville, Maryland Medical Research: What is the background for this study? What are the main findings? Dr. Han: Since 1999, the United States has experienced increases in negative consequences and deaths associated with nonmedical use of prescription opioids. During this period, emergency department visits and drug overdose deaths involving these drugs have increased rapidly. To fully understand the current status of this public health crisis and who is currently most affected, we conducted this study based on nationally representative U.S. surveillance data. Our main study findings include:
  • Among adults age 18 through 64 years, the prevalence of nonmedical use of prescription opioids decreased from 5.4 percent in 2003 to 4.9 percent in 2013, but the prevalence of prescription opioid use disorders increased from 0.6 percent in 2003 to 0.9 percent in 2013. The 12-month prevalence of high-frequency use (200 days or more) also increased from 0.3 percent in 2003 to 0.4 percent in 2013.
  • Mortality assessed by drug overdose death rates involving prescription opioids increased from 4.5 per 100,000 in 2003 to 7.8 per 100,000 in 2013. The average number of days of nonmedical use of prescription opioids increased from 2.1 in 2003 to 2.6 in 2013. The prevalence of having prescription opioid use disorders among nonmedical users increased to 15.7 percent in 2010, 16.1 percent in 2011, 17 percent in 2012, and 16.9 percent in 2013, from 12.7 percent in 2003.
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