Addiction, Anesthesiology, Author Interviews, Opiods / 02.09.2016 Interview with: 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 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. (more…)
Addiction, Author Interviews, CDC, Opiods / 30.08.2016 Interview with: Alexis B. Peterson, PhD (Epidemic Intelligence Service Officer) R. Matthew Gladden, PhD (Behavioral Scientist) 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. (more…)
Addiction, Author Interviews, CDC, Opiods / 29.08.2016 Interview with: R. Matthew Gladden, PhD Surveillance and Epidemiology Team, Division of Unintentional Injury Prevention, Centers for Disease Control and Prevention 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). (more…)
Addiction, Author Interviews, CDC, Opiods, Pain Research / 27.08.2016 Interview with: John Halpin, MD, MPH, Medical officer Prescription Drug Overdose Epidemiology and Surveillance Team CDC Injury Center 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. 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. (more…)
Addiction, Author Interviews, Compliance, Opiods, Pharmacology / 23.08.2016 Interview with: F. Leland McClure III, MSci, PhD, F-ABFT Medical science liaison director Quest Diagnostics 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. (more…)
Author Interviews, JAMA, Opiods, Toxin Research / 10.08.2016 Interview with: Ann M. Arens, MD California Poison Control Center San Francisco, CA 94110 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. (more…)
Addiction, Author Interviews, Opiods, Primary Care / 04.08.2016 Interview with: 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 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. (more…)
Author Interviews, Genetic Research, Opiods, Pain Research, Thromboembolism / 14.07.2016 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. 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. (more…)
Addiction, Annals Internal Medicine, Author Interviews, Opiods, UCSF / 28.06.2016 Interview with: 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 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. (more…)
Author Interviews, NEJM, Occupational Health, Opiods / 24.06.2016 Interview with: Professor Ellen Meara, PhD Professor The Dartmouth Institute for Health Policy and Clinical Practice 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.” (more…)
Anesthesiology, Author Interviews, Breast Cancer, Opiods, Pain Research / 04.06.2016 Interview with: Dr. Sarah Saxena Université Libre de Bruxelles 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. (more…)
Author Interviews, Opiods / 03.06.2016 Interview with: Hsien-Yen Chang PhD Assistant Scientist Johns Hopkins Bloomberg School of Public Health Department of Health Policy & Management Center for Drug Safety & Effectiveness 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. (more…)
Author Interviews, Opiods, Pain Research / 11.05.2016 Interview with: 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. 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. (more…)
Author Interviews, Emergency Care, Heart Disease, Opiods / 05.05.2016 Interview with: William Eggleston, PharmD Fellow in Clinical Toxicology/Emergency Medicine Upstate Medical University Upstate New York Poison Center 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. 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. (more…)
Author Interviews, CMAJ, Opiods, Pain Research / 04.04.2016 Interview with: Shawn Bugden B.Sc. (Pharm), M.Sc., Pharm.D. Associate Professor College of Pharmacy, Faculty of Health Sciences University of Manitoba Winnipeg, Manitoba, Canada 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. (more…)
Author Interviews, Depression, Opiods, Pain Research / 19.02.2016 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. (more…)
Author Interviews, NEJM, NIH, Opiods / 14.01.2016

For more on Opioids on please click here. 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. (more…)
Author Interviews, CMAJ, Opiods / 04.01.2016

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. (more…)
Annals Internal Medicine, Author Interviews, Emergency Care, Opiods, Pain Research / 29.12.2015 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. (more…)
Author Interviews, CDC, Opiods / 22.12.2015 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%. (more…)
Author Interviews, Opiods, Pain Research / 28.10.2015 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%). (more…)
Author Interviews, CDC, JAMA, Opiods, Pharmacology / 16.10.2015 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.
Author Interviews, Opiods, Pediatrics, Pharmacology / 29.09.2015

Shannon M. Monnat, PhD Assistant Professor of Rural Sociology, Demography, and Sociology Department of Agricultural Economics, Sociology, and Education The Pennsylvania State University University Park, PA Interview with: Shannon M. Monnat, PhD Assistant Professor of Rural Sociology, Demography, and Sociology Department of Agricultural Economics, Sociology, and Education The Pennsylvania State University University Park, PA 16802  Medical Research: What is the background for this study? What are the main findings? Dr. Monnat: Given concurrent rapid increases in opioid prescribing and adolescent prescription opioid misuse since the 1990s and historical problems with opioid abuse in rural areas, we were interested in whether adolescents in rural areas were more likely to abuse prescription opioids than their peers in urban areas. Adolescence is a really crucial time to study substance abuse disorders because most abuse begins during adolescence, and individuals who begin use before age 18 are more likely to develop a long-term disorder as an adult compared to those who first try a substance later in life. The active ingredient in prescription opioids and heroin is the same. Prescription opioids are highly addictive and can be dangerous if utilized incorrectly. Prescription opioid abuse is currently responsible for over 16,000 deaths in the US annually and has an estimated annual cost of nearly $56 billion dollars. Therefore, it is correctly viewed as a major public health problem. We found that teens living in rural areas are more likely to abuse prescription opioids compared to teens living in large urban areas. Several important factors increased rural teens’ risk of abusing prescription opioids, including that they are more likely to rely on emergency department treatment than their urban peers, they have less risky attitudes and perceptions about substance abuse than their urban peers, and they are less likely to be exposed to drug/alcohol prevention messages outside of the school environment than their urban peers. Rural teens are also buffered by several factors that help to reduce opioid abuse, including stronger religious beliefs, less depression, less peer substance abuse, and less access to illicit drugs. If not for these protective factors, the current epidemic we see in rural areas could be even worse. We also found that both rural and urban adolescents were most likely to report obtaining the prescriptions they abused from friends or family. However, rural adolescents were less likely than urban adolescents to obtain the pills this way. Rural adolescents were more likely than urban adolescents to report getting the pills they abuse directly from physicians.  (more…)
Author Interviews, Opiods, Pain Research / 10.09.2015

Lynn Webster, M.D. Vice President of Scientific Affairs PRA Health Sciences (lead study investigator, and former President of the American Academy of Pain Medicine) photo: Interview with: Lynn Webster, M.D. Vice President of Scientific Affairs PRA Health Sciences (lead study investigator, and former President of the American Academy of Pain Medicine) Medical Research: What is the background for this study? What are the main advantages of the buccal film? Dr. Webster: Because of its partial agonist activity and high affinity for mu-opioid receptors, buprenorphine has the potential to precipitate withdrawal in patients who are already on mu-opioid full agonists.  As a result, the current practice is to taper patients who are on around-the-clock (ATC) opioid therapy to a morphine sulfate equivalent (MSE) dose before switching to buprenorphine.  But tapering can result in a loss of pain control for patients.  For this study, we wanted to determine if patients on around-the-clock opioid full agonist therapy could be safely transitioned to buprenorphine HCl buccal film – an opioid partial agonist administered through the buccal mucosa – without the need for an opioid taper, and without inducing opioid withdrawal or sacrificing pain control.  Buprenorphine HCl buccal film is the first pain product in development to combine the efficacy of buprenorphine with this unique delivery system, which allows for efficient and convenient delivery of buprenorphine into the bloodstream. (more…)
Author Interviews, JAMA, Opiods, Pharmacology / 21.08.2015

Lainie Rutkow, JD, PhD, MPH Associate Professor Department of Health Policy and Management Johns Hopkins Bloomberg School of Public Interview with: Lainie Rutkow, JD, PhD, MPH Associate Professor Department of Health Policy and Management Johns Hopkins Bloomberg School of Public Health  Medical Research: What is the background for this study? What are the main findings? Dr. Rutkow: Rates of prescription drug diversion and misuse, as well as overdose deaths, have increased throughout the United States. CDC estimates that each day, 44 people die from a prescription drug overdose. In the mid-2000s, Florida was viewed as the epicenter of this epidemic, with prescription drug overdose deaths increasing more than 80% from 2003 to 2009. In response, Florida enacted several laws to mitigate prescription drug abuse and diversion. Its pill mill law required pain management clinics to register with the state and prohibited physician dispensing of certain drugs. Florida’s Prescription Drug Monitoring Program (PDMP) collects data about dispensing of prescription drugs and can be accessed by physicians and pharmacists. Little is known about how these laws have affected prescribing of opioids. We applied comparative interrupted time series analyses to pharmacy claims data to examine four outcomes related to opioid prescribing in Florida, with Georgia as a comparison state. We found that in the first year of implementation, Florida’s Prescription Drug Monitoring Program and pill mill law were associated with modest reductions in prescription opioid volume, prescriptions written, and the dose per prescription. These declines were statistically significant among the highest volume prescribers and patients at baseline. (more…)
Addiction, Author Interviews, HIV, Lancet / 10.08.2015 Interview with: Dr. Keith Ahamad, a clinician scientist at the BC Centre for Excellence in HIV/AIDS and a Family Doctor trained and certified in Addiction Medicine.  He is Division Lead for Addiction Medicine in the department of Family and Community Medicine at Providence Health Care, and is also an addiction physician at the St. Paul’s Addiction Medicine Consult Service, the Immunodeficiency Clinic and Vancouver Detox. He is also Lead Study Clinician for CHOICES, a US National Institutes of Drug Abuse (NIDA) funded clinical trial looking at an opioid receptor blocker (Vivitrol) to treat opioid or alcohol addiction in HIV positive patients.Dr. Keith Ahamad, a clinician scientist at the BC Centre for Excellence in HIV/AIDS and a Family Doctor trained and certified in Addiction Medicine. He is Division Lead for Addiction Medicine in the department of Family and Community Medicine at Providence Health Care, and is also an addiction physician at the St. Paul’s Addiction Medicine Consult Service, the Immunodeficiency Clinic and Vancouver Detox. He is also Lead Study Clinician for CHOICES, a US National Institutes of Drug Abuse (NIDA) funded clinical trial looking at an opioid receptor blocker (Vivitrol) to treat opioid or alcohol addiction in HIV positive patients. MedicalResearch: What is the background for this study? Dr. Ahamad: Previous methadone research has mostly been done in restrictive settings, such as the USA, where methadone can only be dispensed through restrictive methadone programs and cannot be prescribed through primary care physician’s offices. Since a systematic review in 2012, randomised controlled trials have compared methadone treatment provided at restrictive specialty clinics with primary care clinics, which have shown the benefits of primary care models of methadone delivery on heroin treatment outcomes, but not on HIV incidence. MedicalResearch: What are the main findings? Dr. Ahamad: After adjusting for factors commonly associated with HIV, methadone remained independently associated in protecting against HIV in this group of injection drug users. Those study participants who were not prescribed methadone at baseline were almost four times more likely to contract HIV during study follow up. MedicalResearch: What should clinicians and patients take away from your report? Dr. Ahamad: Methadone is an effective medication in treating opioid addiction. Through international randomized control trials, we already know that when prescribed though primary care offices, access to this life-saving medication is increased, effective, and increases patient satisfaction. Now, through our study, we have evidence that when delivered in this manner, it also decreases the spread of HIV. (more…)
Author Interviews, Emergency Care, FDA, Opiods, Pharmacology / 15.07.2015 Interview with: Christopher M. Jones, Pharm D., M.P.H Senior advisor, Office of Public Health Strategy and Analysis Office of the Commissioner, Food and Drug Administration Medical Research: What is the background for this study? Dr. Jones: Opioid analgesics and benzodiazepines are the two most common drug classes involved in prescription drug overdose deaths. In 2010, 75% of prescription drug overdose deaths involved opioid analgesics and 29% involved benzodiazepines. Opioid analgesics and benzodiazepines are also the most common drugs associated with emergency department visits due to nonmedical use of prescription drugs. Combined opioid and benzodiazepine use has been suggested as a risk factor for overdose death. Opioids and benzodiazepines have complex drug interactions and in combination can result in synergistic respiratory depression, but the exact mechanisms by which benzodiazepines worsen opioid-related respiratory depression are not fully understood. Widespread co-use of benzodiazepines and opioids has been documented in both chronic pain and addiction treatment settings. Studies suggest that among patients who receive long-term opioids for chronic non-cancer pain, 40% or more also use benzodiazepines. Among patients who abuse opioids, benzodiazepine abuse also is prevalent, and co-users report using benzodiazepines to enhance opioid intoxication. This study builds on the prior literature by analyzing trends on how the combined use of opioids and benzodiazepines in the U.S. contributes to the serious adverse outcomes of nonmedical use–related ED visits and drug overdose deaths. A better understanding of the consequences of co-use of these medications will help identify at-risk populations, inform prevention efforts, and improve the risk–benefit balance of these medications. Medical Research: What are the main findings? Dr. Jones: From 2004 to 2011, the rate of nonmedical use–related Emergency Department visits involving both opioid analgesics and benzodiazepines increased from 11.0 to 34.2 per 100,000 population. During the same period, drug overdose deaths involving both drugs increased from 0.6 to 1.7 per 100,000. Statistically significant increases in Emergency Department visits occurred among males and females, non-Hispanic whites, non-Hispanic blacks, and Hispanics, and all age groups except 12–17-year-olds. For overdose deaths, statistically significant increases were seen in males and female, all three race/ethnicity groups, and all age groups except 12–17-year-olds. Benzodiazepine involvement in opioid analgesic overdose deaths increased each year, increasing from 18% of opioid analgesic overdose deaths in 2004 to 31% in 2011. (more…)
Author Interviews, Mayo Clinic, Opiods, Tobacco Research / 10.07.2015

W. Michael Hooten, M.D Professor of Anesthesiology Mayo Interview with: W. Michael Hooten, M.D Professor of Anesthesiology Mayo Clinic Medical Research: What is the background for this study? Dr. Hooten: The purpose of the study was to investigate a gap in knowledge related to the progression of short-term opioid use to longer-term use. Medical Research: What are the main findings? Dr. Hooten: The main findings are that a history of substance abuse or tobacco use is associated with the progression from short-term to a longer-term pattern of opioid prescribing. (more…)
Author Interviews, Neurological Disorders, NYU, Opiods, Pain Research, Pharmacology / 25.06.2015

Dr. Mia T. Minen, MD, MPH Director, Headache Services at NYU Langone Medical Center Assistant professor, Department of Neurology Interview with: Dr. Mia T. Minen, MD, MPH Director, Headache Services NYU Langone Medical Center Assistant professor, Department of Neurology   Medical Research: What is the background for this study? What are the main findings? Dr. Minen: We conducted a survey on opioid and barbiturate use among patients visiting a headache center to find out which medications they were receiving for treatment. There’s limited evidence that long-term use of these medications can help treat headaches or migraines, and even short-term use in small quantities can cause medication overuse headache. It is important to determine which providers start these medications so that educational interventions can be tailored to these physician specialties to try to prevent situations such as incorrect prescribing practices and medication overuse. In this sample of patients from a specialty headache center, approximately 20 percent of patients -- or 1 in 5 -- were using opioids or barbiturates, and about half had been prescribed these medications at some point in the past for their headaches. These findings show that opioids and barbiturates are commonly prescribed to patients with headaches. While two-thirds of patients found opioids or barbiturates helpful, many did not like them, were limited by side effects or did not find them to be helpful. Emergency department physicians were reported to be the most frequent first prescribers of opioids and general neurologists were the most frequent prescribers of barbiturate-containing medications. Primary care physicians were also identified as frequent first prescribers of these medications. (more…)
Author Interviews, Opiods, Orthopedics, Pain Research, Surgical Research / 02.06.2015 Interview with: Winfried Meissner, M.D. Dep. of Anesthesiology and Intensive Care Jena University Hospital University Hospital Jena, Germany Medical Research: What is the background for this study? Dr. Meissner: Post-operative pain is managed inadequately worldwide. There are probably many reasons for this, one of which may be lack of evidence about outcomes of treatment in the clinical routine. PAIN OUT was established  as a  multi-national research network and quality improvement project offering healthcare providers  validated tools to collect data about pain-related patient reported outcomes and management after surgery. Patients fill in a questionnaire asking for pain intensity, pain interference and side effects of pain management. The questionnaire has now been translated into 20 languages. Data are collected electronically and clinicians are provided with feedback about management of their own patients, compared to similar patients in other hospitals.  Furthermore, the findings are used for outcomes and comparative effectiveness research. PAIN OUT is unique in that  outcomes of postoperative pain management can be examined internationally. PAIN OUT was created in 2009 with funds from the European Commission, within the FP7 framework and  has now been implemented in hospitals in Europe, USA, Africa and SE Asia. The findings allow us to gain insights as to how pain in managed in different settings and countries. For this particular study, we compared management of pain in the US to other countries. We assessed a large group of patients who underwent different types of orthopedic surgery and compared their patient reported outcomes and management regimens. We included 1011 patients from 4 hospitals in the USA  and 28,510 patients from  45  hospitals in 14 countries (“INTERNATIONAL”). Medical Research: What are the main findings? Dr. Meissner: Postoperative pain intensity of US patients was higher than in INTERNATIONAL patients; they felt more often negatively affected by pain-associated anxiety and helplessness, and more US patients stated they wished to have received more pain treatment. However, other patient-reported outcomes like time in severe pain or the level of pain relief did not differ. We found that treatment regiments of American patients differed compared to INTERNATIONAL patients. More US patients received opioids, and their opioid doses were higher compared to INTERNATIONAL patients. In contrast, INTERNATIONAL countries use more nonopioid medications intraoperatively and postoperatively. Thus, under-supply with opioids cannot explain our findings. Mean BMI of US patients was 30.3 while for INTERNATIONAL it was 27.4. However, insufficient evidence exists that this finding might account for differences in pain intensity. Routine pain assessment was performed in almost all US patients, in contrast to about 75% in the INTERNATIONAL group. Obviously, routine pain assessment, as practiced in the United States, fails to result in lower postoperative pain. Perhaps it has the opposite effect by directing patients’ attention to the pain. (more…)