Author Interviews, JAMA, Opiods, Pharmacology / 13.03.2015

Theodore J. Cicero, PhD Professor, Vice Chairman for Research Department of Psychiatry, Washington University St Louis, MissouriMedicalResearch.com Interview with: Theodore J. Cicero, PhD Professor, Vice Chairman for Research Department of Psychiatry, Washington University St Louis, Missouri MedicalResearch: What is the background for this study? What are the main findings? Dr. Cicero: Prescription opiate abuse (eg Vicodin, Percocet, OxyContin) has reached epidemic proportions in this country over the past decade. Although most people swallow the drugs whole, a relatively large number either chew the drugs to produce an immediate delivery of large quantities of drugs or they crush them and/or dissolve them in some solvent which makes them useful for intranasal (eg snorting) or intravenous administration. Non-oral routes, particularly injection, represent the most serious public health risk due to a high incidence of infection, including Hepatitis C and HIV, and the much greater severity of abuse. In an effort to reduce these practices, drug companies are introducing so-called abuse deterrent formulations (ADF) which are resistant to crushing or dissolving in an aqueous solution. In one such important effort, the company responsible for distributing one of the most widely abused prescription opiates, OxyContin, introduced an ADF in 2010. Although the abuse deterrent formulations was highly successful in reducing abuse of OxyContin by either chewing, crushing, or dissolving in water, there was none-the-less a clear limit to how effective it was. For example, some people simply switched to the oral route of administration or never did snort or inject the drug, whereas a small number found ways to defeat the abuse deterrent formulations and persisted in harmful patterns of abuse. Unfortunately, there was also an unintended result. ADF-OxyContin caused many individuals to abandon the use of OxyContin - a good thing - in favor of other opiates (a bad thing). Most serious, however, was that 70% of those who switched drugs moved from OxyContin to heroin abuse. Although by no means the only factor, the abuse deterrent formulations has contributed to the wide-spread reports of heroin abuse in suburban and rural Caucasian male and females, a group here-to-fore not the typical heroin users (i.e. poor minorities, living in large urban centers). (more…)
Addiction, Author Interviews, CDC, OBGYNE, Pediatrics / 11.03.2015

Dr. Jennifer Lind PharmD, MPH Division of Birth Defects and Developmental Disabilities, National Center on Birth Defects and Developmental Disabilities, CDCMedicalResearch.com Interview with: Dr. Jennifer Lind PharmD, MPH Division of Birth Defects and Developmental Disabilities, CDC Medical Research: What is the background for this study? Dr. Lind: CDC and Florida investigators published a new report describing the characteristics of infants with neonatal abstinence syndrome (NAS) and their mothers.  NAS is a group of signs exhibited by newborns exposed to addictive drugs taken by a mother during pregnancy. Infants with neonatal abstinence syndrome have prolonged hospital stays, experience serious medical complications, and are very costly to treat. Medical Research: What are the main findings? Dr. Lind: In this investigation, 242 infants with neonatal abstinence syndrome were identified in three Florida hospitals during a 2-year period (2010–2011). Nearly all of the infants with NAS were exposed to opioid painkillers during pregnancy (99.6%) and experienced serious medical complications, with more than 97% being admitted to an intensive care unit, where the average length of stay was 26 days. Despite a high prevalence of positive urine toxicology tests during the birth hospitalization, only a small proportion of mothers had documentation of referrals for drug counseling or rehabilitation. (more…)
Author Interviews, CDC, Opiods, Pharmacology / 21.02.2015

Dr. Zhou Yang Office of the Associate Director for Policy Centers for Disease Control and Prevention, Atlanta, GAMedicalResearch.com Interview with: Dr. Zhou Yang Office of the Associate Director for Policy Centers for Disease Control and Prevention, Atlanta, GA Medical Research: What is the background for this study? Response: Prescription drug misuse and abuse, largely those involving opioid painkillers, have been characterized as an epidemic. According to a CDC report, drug-related overdose has surpassed traffic crashes to become the leading cause of injury death in the U.S. in 2009. Medicaid programs in most states implement Patient Review and Restriction (PRR) programs, also called ‘lock-in’ program. The PRR programs use a set of behavioral indicators to identify patients at higher risk of opioid drug misuse and abuse, and ‘locks’ them in to a designated provider, pharmacy, or both. Pharmacy shopping is one of the key indicators employed by the PRR program. However, definition of pharmacy shopper varies widely across states. In addition, the PRR programs have not paid attention to the indicators of prescribing overlapped drugs, which we see as a missed opportunity to help the PRR program to better target users at high risk of overdose. Medical Research: What are the main findings? Response: Among a number of currently used definitions of pharmacy shopping, we found that the definition of ‘four or more pharmacies visited within any 90-day period’ is the most effective one. We also found that having overlapping opioid prescriptions is associated with an elevated risk of overdose. In fact, patients who exhibited both pharmacy shopping and having overlapping prescription had more than twice the risk of overdose than those who only exhibited pharmacy shopping. (more…)
Author Interviews, NEJM, Opiods, Pharmacology / 29.01.2015

Richard C. Dart, M.D., Ph.D Denver Health & Hospital Authority Professor, University of Colorado School of MedicineMedicalResearch.com Interview with: Richard C. Dart, M.D., Ph.D Denver Health & Hospital Authority Professor, University of Colorado School of Medicine   Medical Research: What is the background for this study? What are the main findings? Dr. Dart: For the past two decades, prescription opioid medication abuse has increased significantly in the US. An estimated 25 million people initiated nonmedical use of pain relievers between 2002 and 2011.  In 2010 the number of death attributed to prescription opioid medications reached 16,651. The  RADARS® System (Researched Abuse, Diversion and Addiction Related Surveillance) has been monitoring prescription drug abuse and diversion for over 13 years. We use a “mosaic” approach, measuring abuse and diversion from multiple perspectives, to describe this hidden phenomenon as comprehensively as possible. For the current publication we used 5 separate RADARS® System programs to collect data and the study period was from January 2002 through December 2013. We noticed a substantial increase  of prescription drug abuse from 2002 through 2010, followed by a flattening or decrease in 2010 and, lastly, a decline in 2011 through 2013. We also noticed a similar pattern in opioid-related deaths. Nonmedical use did not change significantly among college students. (more…)
Author Interviews, CDC, OBGYNE, Opiods / 25.01.2015

Dr. Jennifer Lind PharmD, MPH Division of Birth Defects and Developmental Disabilities, National Center on Birth Defects and Developmental Disabilities, CDCMedicalResearch.com Interview with: Dr. Jennifer Lind PharmD, MPH Division of Birth Defects and Developmental Disabilities, National Center on Birth Defects and Developmental Disabilities, CDC Medical Research: What is the background for this study? Dr. Lind:  CDC researchers published a new study estimating the proportion of women aged 15-44 years who filled a prescription for opioid pain medications.  Opioids are prescribed by healthcare providers to treat moderate to severe pain. They are also found in some prescription cough medications. Opioids include medications like codeine, oxycodone, hydrocodone, or morphine. For this study, researchers used data from two large insurance claims datasets—one on Medicaid and one on private insurance—and looked at data from 2008-2012. Medical Research: What are the main findings? Dr. Lind: Opioid medications are widely used among women of reproductive age in the United States, regardless of insurance type. On average, more than a third (39 percent) of women aged 15-44 years enrolled in Medicaid, and more than one fourth (28 percent) of those with private insurance filled a prescription for an opioid pain medication each year during 2008-2012. Taking these medications early in pregnancy, often before women know they are pregnant, can increase the risk for some birth defects (such as spina bifida) and other poor pregnancy outcomes (such as preterm birth or low birth weight). (more…)
Author Interviews, Opiods, Pharmacology, University Texas / 11.12.2014

Barbara J Turner MD, MSEd, MA, MACP James D and Ona I Dye Professor of Medicine Director, Center for Research to Advance Community Health (ReACH) University of Texas Health Science Center San AntonioMedicalResearch.com Interview with: Barbara J Turner MD, MSEd, MA, MACP James D and Ona I Dye Professor of Medicine Director, Center for Research to Advance Community Health (ReACH) University of Texas Health Science Center San Antonio Medical Research: What is the background for this study? What are the main findings? Dr. Turner: Daily dose of opioid analgesics has been widely used to assess the risk of overdose death and this risk has been reported to be greatest for a morphine equivalent dose at least 100 to 120 mg per day. However, the total dose of filled opioid prescriptions over a period of time may offer a complementary measure of the risk to that provided by the daily dose. In fact, the total dose is not necessarily a simple linear transformation of the daily dose because not all patients use opioids every day, instead it reflects the total amount of opioids available to a patient. Among 206,869 national HMO patients aged 18-64 with non-cancer pain filling at least 2 schedule II or III opioid analgesic prescriptions, the rate of overdose was 471 per 100,000 person-years. Over the study period of 3.5 years, risk of drug overdose was two to three times greater for patients with a daily dose >100 mg regardless of the total dose filled or a daily dose of 50-99 mg with a high total dose (>1830 mg) filled a six month interval (versus no opioids). The overdose risk was increased slightly for 50-99 mg per day with a lower total dose and not increased at all for daily doses under 20 mg regardless of the total dose. (more…)
Author Interviews, Opiods / 02.12.2014

Silvia S. Martins, MD, PHD Associate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University New York, NY 10032MedicalResearch.com Interview with: Silvia S. Martins, MD, PHD Associate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University New York, NY 10032 MedicalResearch: What is the background for this study? What are the main findings? Dr. Martins: While a large proportion of young adults, ages 18 to 22, are prescribed opiates, non-medical use of opioids is second only to marijuana as the most prevalent form of illegal drug use among young adults. Until this study, little was known about nonmedical use of prescription drugs among non-college-attending young adults in the United States. Approximately 70 percent of all U.S. young adults enroll in some form of college education, but around 30% do not. We analyzed public data for 36,781 young adults between the ages of 18 and 22 over a 12-month period in 2008 through 2010 from the National Survey on Drug Use and Health, an annual cross-sectional survey of the Substance Abuse and Mental Health Administration. Using the Kessler 6 screening instrument, we also measured past-year serious psychological distress as self-reported by the respondents. Among non-college-attending young adults with at least a high school degree, 13.1 percent reported using prescription opioids for non-medical reasons. The figure rose slightly to 13.2 percent for those who did not graduate from high school, and declined to 11.3 percent among college attendees. (more…)
Author Interviews, Gastrointestinal Disease, NEJM, Pain Research, University of Michigan / 11.06.2014

William D. Chey, MD, AGAF, FACG, FACP, RFF Professor of Medicine Director, GI Physiology Laboratory Co-director, Michigan Bowel Control Program University of Michigan Health SystemMedicalResearch.com Interview with: William D. Chey, MD, AGAF, FACG, FACP, RFF Professor of Medicine Director, GI Physiology Laboratory Co-director, Michigan Bowel Control Program University of Michigan Health System MedicalResearch: What are the main findings of the study? Dr. Chey: Opiate analgesics are the most commonly prescribed medications in the US. GI side effects are common in patients who opiates. Constipation is the most common and most bothersome GI side effect of opiates. Peripherally acting mu opioid antagonists have been shown to benefit a subset of patients with opiate induced constipation. In 2 large, randomized, placebo controlled phase III trials, the peripherally acting, mu-opioid antagonist naloxegol was found to improve constipation in patients taking opioid analgesics for noncancer pain. Response rates were significantly higher with 25 mg of naloxegol than with placebo (intention-to-treat population: study 04, 44.4% vs. 29.4%, P = 0.001; study 05, 39.7% vs. 29.3%, P = 0.02) in both studies. Benefits were seen with the lower 12.5 mg dose in one of the studies (intention-to-treat population, 40.8% vs. 29.4%, P = 0.02). An interesting aspect of this study was the a priori inclusion of patients who had tried and failed to respond to other laxatives prior to enrollment. Response rates in this population were similar to the overall population (patients with an inadequate response to laxatives: study 04, 48.7% vs. 28.8%, P = 0.002; study 05, 46.8% vs. 31.4%, P = 0.01). Pain scores and daily opioid dosing were similar among the three groups before and after treatment. (more…)
Addiction, Author Interviews, Emergency Care, Pain Research, Pharmacology / 16.03.2014

Maryann Mazer-Amirshahi PharmD, MD1MedicalResearch.com Interview with: Maryann Mazer-Amirshahi PharmD, MD The Department of Emergency Medicine, The George Washington University The Department of Clinical Pharmacology, Children's National Medical Center, Washington, DC MedicalResearch.com: What are the main findings of the study? Answer: We found a significant increase in the prescribing of opioid pain medications in the emergency department. At the same time, this was not accounted for by a similar increase in pain-related visits and prescribing patterns of non-opioid analgesics did not change. (more…)