Integrating nine prescription opioid analgesics and/or four signal detection systems to summarize statewide prescription drug abuse in the United States in 2007

2009 ◽  
Vol 18 (9) ◽  
pp. 778-790 ◽  
Author(s):  
Michael F. Schneider ◽  
J. Elise Bailey ◽  
Theodore J. Cicero ◽  
Richard C. Dart ◽  
James A. Inciardi ◽  
...  
Author(s):  
John J. Coleman

This chapter discusses how the pharmaceutical industry’s actions affected the accomplishments of the Decade of Pain Control and Research, which began on January 1, 2001, following almost two decades of rising concern over the inadequate treatment of chronic pain in the United States. To tell the story of this decade we must describe the accompanying problem of drug diversion and abuse. The development in 1995 of a new opioid product called OxyContin, its aggressive marketing, the morbidity and mortality associated with its misuse, and the eventual felony conviction in 2007 of the drug’s sponsor for fraudulent claims and marketing practices, affected the Decade in unexpected ways. The response by Congress and the regulatory community to what they termed an “epidemic” of prescription drug abuse produced long-lasting policy changes. The chapter also touches on the peculiar and sometimes troubling relationship between the regulators and the regulated.


2017 ◽  
Author(s):  
Sanford M Silverman

Prescription drug abuse is the fastest growing problem in the United States. According to the Centers for Disease Control and Prevention (CDC), enough opioid pain relievers were sold in 2010 to provide every adult in the United States with the equivalent of a typical dose of 5 mg of hydrocodone every 4 hours for 1 month. Many solutions have been proposed to address this problem, including treatment guidelines, political solutions (statutory changes), Risk Evaluation and Mitigation Strategy (REMS), and technological innovations. Many opioid products are manipulated (crushed, snorted, injected, etc.) to facilitate abuse. Since extended-release/long-acting (ER/LA) opioids contain a large amount of opioid contained in a single delivery system, they are a favorite target of abusers. In short, the goal of an abuser is to convert an ER/LA opioid into an immediate-release one. Abuse-deterrent formulations (ADFs) are intended to make manipulation more difficult or to make abuse of the manipulated product less attractive or less rewarding. One such technological solution is the development of ADFs for opioid pain medications. The Food and Drug Administration's (FDA) guidelines for industry released in 2015 establish the rationale and methodology for the development of ER/LA opioids that contain abuse-deterrent properties. The goal is to deter abuse, realizing that it is impossible to prevent abuse. Key words: abuse-deterrent formulations, abuse-deterrent opioids, CDC guidelines, FDA opioid guidelines, opioid abuse, opioid deaths, opioid diversion, opioid overdose, prescription drug abuse, REMS 


2014 ◽  
Vol 40 (1) ◽  
pp. 85-112 ◽  
Author(s):  
Joanna Shepherd

Prescription painkiller abuse is the fastest growing drug problem in the United States. In the past year, approximately one out of twenty Americans reported misuse or abuse of prescription painkillers. Several factors contribute to the prescription painkiller epidemic. Drug abusers use various methods—such as doctor shopping, paying with cash, and filling prescriptions in different states—to avoid detection and obtain prescription painkillers for illegitimate uses. A few rogue physicians and pharmacists, lured by substantial profits, enable drug abusers by illegally prescribing or supplying controlled substances. Even ethical physicians rarely have adequate training to recognize and address prescription drug abuse, and as a result, prescribe painkillers to patients who are not using them for legitimate medical purposes. Similarly, although the majority of pharmacies have taken steps to combat drug abuse and reduce prescription painkiller dispensing, under current reporting systems, pharmacists lack visibility into several important indicators of drug abuse. As a result, even the most vigilant pharmacists find it extremely difficult to identify and detect drug abuse with certainty.While state governments have established prescription drug monitoring programs (PDMPs) to crack down on prescription drug abuse, these programs have proven to be inadequate. The programs currently suffer from inadequate data collection, ineffective utilization of data, insufficient interstate data sharing, and constraints on sharing data with law enforcement and state agencies. By contrast, third-party prescription payment systems run by pharmacy benefit managers (PBMs) or health insurers have been effective in detecting prescription drug abuse. This paper suggests that a national prescription drug reporting program building on existing PBM networks could be significantly more effective than existing state PDMPs in detecting prescription drug abuse.


2021 ◽  
Vol 12 ◽  
Author(s):  
Thomas Soeiro ◽  
Clémence Lacroix ◽  
Vincent Pradel ◽  
Maryse Lapeyre-Mestre ◽  
Joëlle Micallef

Opioid analgesics and maintenance treatments, benzodiazepines and z-drugs, and other sedatives and stimulants are increasingly being abused to induce psychoactive effects or alter the effects of other drugs, eventually leading to dependence. Awareness of prescription drug abuse has been increasing in the last two decades, and organizations such as the International Narcotics Control Board has predicted that, worldwide, prescription drug abuse may exceed the use of illicit drugs. Assessment of prescription drug abuse tackles an issue that is hidden by nature, which therefore requires a specific monitoring. The current best practice is to use multiple detection systems to assess prescription drug abuse by various populations in a timely, sensitive, and specific manner. In the early 2000's, we designed a method to detect and quantify doctor shopping for prescription drugs from the French National Health Data System, which is one of the world's largest claims database, and a first-class data source for pharmacoepidemiological studies. Doctor shopping is a well-known behavior that involves overlapping prescriptions from multiple prescribers for the same drug, to obtain higher doses than those prescribed by each prescriber on an individual basis. In addition, doctor shopping may play an important role in supplying the black market. The paper aims to review how doctor shopping monitoring can improve the early detection of prescription drug abuse within a multidimensional monitoring. The paper provides an in-depth overview of two decades of development and validation of the method as a complementary component of the multidimensional monitoring conducted by the French Addictovigilance Network. The process accounted for the relevant determinants of prescription drug abuse, such as pharmacological data (e.g., formulations and doses), chronological and geographical data (e.g., impact of measures and comparison between regions), and epidemiological and outcome data (e.g., profiles of patients and trajectories of care) for several pharmacological classes (e.g., opioids, benzodiazepines, antidepressants, and methylphenidate).


2014 ◽  
Vol 100 (3) ◽  
pp. 7-18
Author(s):  
Sindy M. Paul ◽  
Virginia Allread

ABSTRACT Prescription drug abuse is considered the fastest growing drug problem in the United States. The major increase is in unintentional drug overdose from opioid analgesics, which has caused more overdose-related deaths since 2003 than cocaine and heroin combined. The misuse of prescription pills is becoming particularly prevalent among suburban and rural youth in the United States, sometimes leading to heroin addiction and putting this population at a higher risk of blood-borne pathogens where heroin is injected. New Jersey has spearheaded initiatives to address misuse of opioid analgesics. These initiatives, which are part of an overall strategy and include medical regulatory response, are consistent with the newly (2013) updated Federation of State Medical Boards (FSMB) guidelines to better educate physicians and aid in the proper diagnosis and treatment of pain. They address physician prescribing practices, consumer need for safe disposal and treatment, and educational campaigns that target providers and the general public.


2017 ◽  
Vol 13 (6) ◽  
pp. 397 ◽  
Author(s):  
J. David Haddox, DDS, MD

Three concurrent public health problems coexist in the United States: endemic nonmedical use/misuse of opioid analgesics, epidemic overdose fatalities involving opioid analgesics, and endemic chronic pain in adults. These intertwined issues comprise an opioid crisis that has spurred the development of formulations of opioids with abuse-deterrent properties and label claims (OADP). To reduce abuse and misuse of prescription opioids, the federal Food and Drug Administration (FDA) has issued a formal Guidance to drug developers that delineates four categories of testing to generate data sufficient for a description of a product's abuse-deterrent properties, along with associated claims, in its Full Prescribing Information (FPI). This article reviews the epidemiology of the crisis as background for the development of OADP, summarizes the FDA Guidance for Industry regarding abuse-deterrent technologies, and provides an overview of some technologies that are currently employed or are under study for incorporation into OADP. Such technologies include physical and chemical barriers to abuse, combined formulations of opioid agonists and antagonists, inclusion of aversive agents, use of delivery systems that deter abuse, development of new molecular entities and prodrugs, and formulation of products that include some combination of these approaches. Opioids employing these novel technologies are one part of a comprehensive intervention strategy that can deter abuse of prescription opioid analgesics without creating barriers to the safe use of prescription opioids. The maximal public health contribution of OADP will probably occur only when all opioids have FDA-recognized abuse-deterrent properties and label claims.


2006 ◽  
Vol 2 (5) ◽  
pp. 283 ◽  
Author(s):  
Hilary L. Surratt, PhD ◽  
James A. Inciardi, PhD ◽  
Steven P.q Kurtz, PhD

National population surveys and individual studies over the past decade have documented the escalating abuse of a variety of prescription medications, particularly prescription opioids. Although surveillance data provide important information for estimating the prevalence of prescription opioid abuse in the general population, studies documenting the patterns of prescription drug abuse among chronic street-drug-using populations are extremely rare. This paper examines the abuse of prescription opioids among drug-involved street-based sex workers in Miami, Florida. The data for this study were drawn from an ongoing HIV intervention trial initiated in 2001, designed to test the relative effectiveness of two alternative HIV prevention protocols for this population. Participants in the study were recruited through traditional targeted sampling strategies, and complete data are available on 588 street-based sex workers. In terms of prescription drug abuse, 12.2 percent of the sample reported using at least one opioid analgesic in the past 90 days without having a legitimate prescription. Logistic regression analyses were conducted to examine the associations between prescription opioid abuse and its predictors. In the multivariate model, factors positively associated with prescription opioid abuse included: Caucasian race (OR = 2.53; 95 percent CI 1.30 to 4.91), current powder cocaine use (OR = 2.28; 95 percent CI 1.28 to 4.08), current heroin use (OR = 2.08; 95 percent CI 1.10 to 3.92), 90-day physical abuse/victimization (OR = 2.07; 95 percent CI 1.18 to 3.61), and shorter sex-work involvement (OR = 1.98; 95 percent CI 1.13 to 3.48). In contrast, daily crack smoking was negatively associated with prescription opioid abuse (OR = 0.61; 95 percent CI 0.33 to 1.10). This study provides some of the first empirical evidence to indicate that prescription opioid abuse is emerging in a heretofore unstudied community of marginalized drug-using sex workers. In addition, data on this population’s mechanisms of access to prescription opioids clearly suggest that there is an active black market for these drugs. These findings warrant intensive study to determine the relative contribution of each mechanism of diversion to the illicit market.


Author(s):  
Victor Puac-Polanco ◽  
Stanford Chihuri ◽  
David S Fink ◽  
Magdalena Cerdá ◽  
Katherine M Keyes ◽  
...  

Abstract Prescription drug monitoring programs (PDMPs) are a crucial component of federal and state governments’ response to the opioid epidemic. Evidence about the effectiveness of PDMPs in reducing prescription opioid–related adverse outcomes is mixed. We conducted a systematic review to examine whether PDMP implementation within the United States is associated with changes in 4 prescription opioid–related outcome domains: opioid prescribing behaviors, opioid diversion and supply, opioid-related morbidity and substance-use disorders, and opioid-related deaths. We searched for eligible publications in Embase, Google Scholar, MEDLINE, and Web of Science. A total of 29 studies, published between 2009 and 2019, met the inclusion criteria. Of the 16 studies examining PDMPs and prescribing behaviors, 11 found that implementing PDMPs reduced prescribing behaviors. All 3 studies on opioid diversion and supply reported reductions in the examined outcomes. In the opioid-related morbidity and substance-use disorders domain, 7 of 8 studies found associations with prescription opioid–related outcomes. Four of 8 studies in the opioid-related deaths domain reported reduced mortality rates. Despite the mixed findings, emerging evidence supports that the implementation of state PDMPs reduces opioid prescriptions, opioid diversion and supply, and opioid-related morbidity and substance-use disorder outcomes. When PDMP characteristics were examined, mandatory access provisions were associated with reductions in prescribing behaviors, diversion outcomes, hospital admissions, substance-use disorders, and mortality rates. Inconsistencies in the evidence base across outcome domains are due to analytical approaches across studies and, to some extent, heterogeneities in PDMP policies implemented across states and over time.


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