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Background: In 2021, approximately 60 million individuals worldwide and 9 million individuals in the United States (US) reported opioid misuse. In the US, 2.5 million have OUD, of which only about a third receive any substance abuse treatment. OUD is often regarded as a monolithic disorder but different opioid problem subtypes may exist beyond DSM-IV/5 criteria. Understanding the characteristics of these subtypes could be useful for informing treatment and intervention strategies. Methods: Latent class analysis was used to identify OUD symptom subtypes among persons in the US who reported misusing prescription opioids or heroin in the 2015-2018 National Survey on Drug Use and Health (n=10,928). Regression analyses were utilized to determine associations between class membership and treatment receipt, as well as demographic characteristics and other comorbid conditions. Results: Five classes were identified with unique OUD symptom patterns: Class 1: Asymptomatic (71.6%), Class 2: Tolerance/Time (14.5%), Class 3: Loss of Control/Pharmacological (LOC/Pharmacol) (5.7%), Class 4: Social Impairment (2.6%), and Class 5: Pervasive (5.6%). Nearly all persons in the LOC/Pharmacol, Social Impairment, and Pervasive classes met criteria for OUD (98-100%); however, they differed in receipt of past-year treatment for substance use (28%, 28%, 49%, respectively). Age, race, education, insurance status, and criminal activity were also associated with treatment receipt. Conclusions: There were considerable differences in OUD symptom patterns and substance use treatment among individuals who misused opioids. The findings indicate a substantial unmet need for OUD treatment and point to patterns of heterogeneity within OUD that can inform development of treatment programs.
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OBJECTIVES: Individuals in recovery from opioid use disorder (OUD) are vulnerable to the impacts of the COVID-19 pandemic. Recent findings suggest increased relapse risk and overdose linked to COVID-19-related stressors. We aimed to identify individual-level factors associated with COVID-19-related impacts on recovery. METHODS: This observational study (NCT04577144) enrolled 216 participants who previously partook in long-acting buprenorphine subcutaneous injection clinical trials (2015-2017) for OUD. Participants indicated how COVID-19 affected their recovery from substance use. A machine learning approach Classification and Regression Tree analysis examined the association of 28 variables with the impact of COVID-19 on recovery, including demographics, substance use, and psychosocial factors. Ten-fold cross-validation was used to minimize overfitting. RESULTS: Twenty-six percent of the sample reported that COVID-19 had made recovery somewhat or much harder. Past-month opioid use was higher among those who reported that recovery was harder compared with those who did not (51% vs 24%, respectively; P < 0.001). The final classification tree (overall accuracy, 80%) identified the Beck Depression Inventory (BDI-II) as the strongest independent risk factor associated with reporting COVID-19 impact. Individuals with a BDI-II score ≥10 had 6.45 times greater odds of negative impact (95% confidence interval, 3.29-13.30) relative to those who scored <10. Among individuals with higher BDI-II scores, less progress in managing substance use and treatment of OUD within the past 2 to 3 years were also associated with negative impacts. CONCLUSIONS: These findings underscore the importance of monitoring depressive symptoms and perceived progress in managing substance use among those in recovery from OUD, particularly during large-magnitude crises.
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Buprenorfina , COVID-19 , Trastornos Relacionados con Opioides , Humanos , Analgésicos Opioides/efectos adversos , Pandemias , Buprenorfina/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/psicología , Tratamiento de Sustitución de OpiáceosRESUMEN
INTRODUCTION: This study describes utilization patterns of oral buprenorphine products indicated for the treatment of opioid use disorder with a focus on patterns consistent with prescribing guidelines and the safe use conditions during induction and maintenance treatment outlined by the Risk Evaluation and Mitigation Strategy (REMS) Program, including trends over time. METHODS: Using an anonymized longitudinal patient-level dataset that captures information on medical and pharmacy claims in the United States (October 1, 2014 through March 31, 2020), buprenorphine prescriptions, days' supply, and daily dose were described overall and stratified by induction (month 1) vs. maintenance (month 2-6) treatment, along with duration of concomitant benzodiazepines or opioid analgesics. RESULTS: Overall, there were 1.5 million buprenorphine treatment episodes initiated between January 1, 2015 to September 30, 2019 (2015: 258,899; 2019: 351,378). Treatment episodes included an average of 6.8 buprenorphine prescriptions (standard deviation [SD] = 6.7), 16.8 days' supply per prescription (SD = 10.5), 94.2 total days' supply per treatment episode (SD = 71.4), and a mean daily dose of 13.6 mg (SD = 6.3), with the number of prescriptions and total days' supply per treatment episode declining over the study period. There was a lower mean number of days' supply per prescription in the first month of treatment compared to months 2-6 (month 1: 15.8 [SD = 11.0]; month 2-6: 19.0 [SD = 10.1]) and daily dose per prescription (month 1: 13.3 mg [SD = 6.4]; months 2-6: 14.3 mg [SD = 6.2]), and a higher mean number of prescriptions per month (month 1: 2.5 per month [SD = 1.7]; months 2-6: 1.8 per month [SD = 1.2]). From 2015 to 2019, there appeared to be a shift in payer mix, with increases in Medicaid/Medicare and declines in cash and commercial insurance. Concomitant benzodiazepine and opioid analgesic use declined over time; in 2019, 16.6 % and 14.3 % of treatment episodes had any concomitant benzodiazepine or opioid analgesic, respectively, and <5 % had chronic (>90 overlapping days) concomitant use (3.0 % and 0.4 %, respectively). CONCLUSIONS: The number of oral buprenorphine treatment episodes increased over the study period, and prescribing was generally consistent with the REMS and other treatment guidelines. There was a decline in concomitant buprenorphine and benzodiazepine or opioid analgesics, and chronic concomitant use was rare.
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Buprenorfina , Trastornos Relacionados con Opioides , Anciano , Humanos , Estados Unidos/epidemiología , Analgésicos Opioides/uso terapéutico , Buprenorfina/uso terapéutico , Benzodiazepinas/uso terapéutico , Medicare , Trastornos Relacionados con Opioides/tratamiento farmacológico , Prescripciones de MedicamentosRESUMEN
BACKGROUND AND AIMS: Limited information exists regarding individual subgroups of recovery from opioid use disorder (OUD) following treatment and how these subgroups may relate to recovery trajectories. We used multi-dimensional criteria to identify OUD recovery subgroups and longitudinal transitions across subgroups. DESIGN, SETTING AND PARTICIPANTS: In a national longitudinal observational study in the United States, individuals who previously participated in a clinical trial for subcutaneous buprenorphine injections for treatment of OUD were enrolled and followed for an average of 4.2 years after participation in the clinical trial. MEASUREMENTS: We identified recovery subgroups based on psychosocial outcomes including depression, opioid withdrawal and pain. We compared opioid use, treatment utilization and quality of life among these subgroups. FINDINGS: Three dimensions of the recovery process were identified: depression, opioid withdrawal and pain. Using these three dimensions, participants were classified into four recovery subgroups: high-functioning (minimal depression, mild withdrawal and no/mild pain), pain/physical health (minimal depression, mild withdrawal and moderate pain), depression (moderate depression, mild withdrawal and mild/moderate pain) and low-functioning (moderate/severe withdrawal, moderate depression and moderate/severe pain). Significant differences among subgroups were observed for DSM-5 criteria (P < 0.001) and remission status (P < 0.001), as well as with opioid use (P < 0.001), treatment utilization (P < 0.001) and quality of life domains (physical health, psychological, environment and social relationships; Ps < 0.001, Cohen's fs ≥ 0.62). Recovery subgroup assignments were dynamic, with individuals transitioning across subgroups during the observational period. Moreover, the initial recovery subgroup assignment was minimally predictive of long-term outcomes. CONCLUSIONS: There appear to be four distinct subgroups among individuals in recovery from OUD. Recovery subgroup assignments are dynamic and predictive of contemporaneous, but not long-term, substance use, substance use treatment utilization or quality of life outcomes.
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Buprenorfina , Trastornos Relacionados con Opioides , Síndrome de Abstinencia a Sustancias , Humanos , Estados Unidos , Analgésicos Opioides/uso terapéutico , Calidad de Vida , Trastornos Relacionados con Opioides/tratamiento farmacológico , Buprenorfina/uso terapéutico , Tratamiento de Sustitución de Opiáceos/métodos , Síndrome de Abstinencia a Sustancias/tratamiento farmacológico , Dolor/tratamiento farmacológicoRESUMEN
OBJECTIVE: Buprenorphine (Suboxone) is an effective treatment for opioid use disorder (OUD). However, there have been widespread reports of diversion and misuse. This study examined motivations for nonprescribed buprenorphine use among rural residents. METHODS: Eligible participants (N = 200) were at least 18 years old, had used any illegal or prescription drugs to get high, and had ever used nonprescribed buprenorphine. A questionnaire administered by a trained interviewer assessed demographic characteristics, substance use, and motivations for use. RESULTS: Primary motivations for first nonprescribed buprenorphine use included avoiding withdrawal and getting high, while at most recent nonprescribed use, motivations shifted toward maintaining abstinence from other drugs. In adjusted logistic regression analyses, past month use of stimulants decreased odds of nonprescribed buprenorphine use for the purposes of self-treatment by 68% (adjusted odds ratio, 0.26; 95% confidence interval, 0.11-0.61), whereas history of treatment for OUD more than doubled odds of use for self-treatment (adjusted odds ratio, 2.71; 95% confidence interval, 1.11-6.63). CONCLUSIONS: Results indicate that many individuals used buprenorphine without a prescription, motivated largely by behaviors consistent with self-treatment, and diversion of buprenorphine may be driven by these motivations more than desire to get high. While many participants attempted to access treatment, many were still using nonprescribed buprenorphine for self-treatment, and many were dissatisfied with care they had received as part of a treatment program. Thus, increasing quantity of providers may not be adequate to address the opioid epidemic, but particular attention should be paid to providing care targeted to the needs of those with OUD in rural areas.
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Buprenorfina , Trastornos Relacionados con Opioides , Síndrome de Abstinencia a Sustancias , Humanos , Adolescente , Buprenorfina/uso terapéutico , Motivación , Analgésicos Opioides/uso terapéutico , Combinación Buprenorfina y Naloxona/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/epidemiología , Tratamiento de Sustitución de Opiáceos , Síndrome de Abstinencia a Sustancias/tratamiento farmacológicoRESUMEN
BACKGROUND: Opioid use disorder (OUD) seriously impacts public health in the United States. However, few investigations of long-term outcomes following treatment with medication for OUD exist. Additionally, these studies have prioritized opioid use and treatment utilization outcomes, and a gap in knowledge regarding long-term, multidimensional trajectories of OUD recovery exists. This study investigated a diverse array of outcomes for individuals with OUD at an average of 4.2 years post clinical trial participation. METHODS: Individuals who previously participated in long-acting buprenorphine subcutaneous injection clinical trials (NCT023579011; NCT025100142; NCT02896296) and enrolled in The Remission from Chronic Opioid Use-Studying Environmental and SocioEconomic Factors on Recovery (RECOVER; NCT03604861) Study participated in a follow up assessment (n = 216). Substance use, psychosocial, opioid dependence, and delay discounting outcomes were assessed. Regression analyses were conducted to determine significant associations between psychosocial/opioid dependence variables and both recent opioid use and delay discounting. RESULTS: The majority of participants reported abstinence from opioids since the last RECOVER study assessment (mean 2.26 years; 55%) and in the past 30 days (69%). Participants reported low levels of depression and psychological distress. Positive associations between depression and opioid craving with past 30-day opioid misuse and delay discounting, and negative associations between quality of life and treatment effectiveness with these outcomes were observed. CONCLUSIONS: This study examined longer term OUD recovery outcomes. Participants reported high levels of abstinence from opioids and psychosocial functioning. These encouraging results highlight the multidimensional nature of recovery from OUD, and further support the effectiveness of buprenorphine as an OUD treatment.
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Buprenorfina , Trastornos Relacionados con Opioides , Analgésicos Opioides/uso terapéutico , Buprenorfina/uso terapéutico , Ensayos Clínicos como Asunto , Humanos , Tratamiento de Sustitución de Opiáceos , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/psicología , Calidad de Vida , Factores Socioeconómicos , Estados UnidosRESUMEN
Buprenorphine, an effective treatment for opioid use disorder (OUD), remains underutilized in many U.S. jails and prisons. However, use of non-prescribed (i.e., diverted) buprenorphine has been reported in these settings. The current study examined non-prescribed buprenorphine use experiences in correctional and community contexts. The study conducted face-to-face interviews with 300 adults with OUD/opioid misuse and recent incarceration, recruited in Baltimore, MD, and New York, NY (n = 150 each). Illicit/non-prescribed opioid use during incarceration was reported by 63% of participants; 39% reported non-prescribed buprenorphine. Non-prescribed buprenorphine was considered the most widely available opioid in jails/prisons in both states (81% reported "very" or "somewhat" easy to get). The average price of non-prescribed buprenorphine in jail/prison was ~10× higher than in the community (p < 0.001). Participants were more likely to endorse getting high/mood alteration as reasons for using non-prescribed buprenorphine during incarceration, but tended to ascribe therapeutic motives to use in the community (e.g., self-treatment; p < 0.001). Multivariable logistic regression analyses showed that different individual-level characteristics were associated with history of non-prescribed buprenorphine use during incarceration and in the community. Use of non-prescribed buprenorphine during incarceration was associated with younger age (p = 0.006) and longer incarceration history (p < 0.001), while use of non-prescribed buprenorphine in the community was associated with MD recruitment site (p = 0.001), not being married (p < 0.001), prior buprenorphine treatment experience (p < 0.001), and housing situation (p = 0.01). These findings suggest that different dynamics and demand characteristics underlie the use of non-prescribed buprenorphine in community and incarceration contexts, with implications for efforts to expand OUD treatment in correctional settings.
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Buprenorfina , Trastornos Relacionados con Opioides , Prisioneros , Adulto , Baltimore , Buprenorfina/uso terapéutico , Derecho Penal , Humanos , New York , Tratamiento de Sustitución de Opiáceos , Trastornos Relacionados con Opioides/tratamiento farmacológicoRESUMEN
Opioid use disorder (OUD) and its consequences are a major public health concern. The partial agonist buprenorphine is a safe and effective treatment for OUD, but concerns about abuse, misuse, and diversion of buprenorphine have been raised. This narrative review examined the rates and motives for use of illicit buprenorphine in the United States. Findings from the 17 included studies suggest the majority of study participants using illicit buprenorphine do so for reasons related to misuse (to manage opioid withdrawal symptoms or achieve or maintain abstinence from other opioids). A smaller percentage of study respondents reported using buprenorphine for reasons related to abuse (to get high). There appears to be a gap between need for buprenorphine and access to adequate treatment. Attenuation of policy-related barriers and adoption of appropriate buprenorphine use by the treatment community are critical tools in the continued effort to reduce the burdens associated with OUD.
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Analgésicos Opioides/uso terapéutico , Buprenorfina/uso terapéutico , Accesibilidad a los Servicios de Salud , Tratamiento de Sustitución de Opiáceos , Trastornos Relacionados con Opioides/tratamiento farmacológico , Mal Uso de Medicamentos de Venta con Receta , Accesibilidad a los Servicios de Salud/normas , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Humanos , Tratamiento de Sustitución de Opiáceos/normas , Tratamiento de Sustitución de Opiáceos/estadística & datos numéricos , Mal Uso de Medicamentos de Venta con Receta/estadística & datos numéricos , Estados UnidosRESUMEN
BACKGROUND: Buprenorphine is approved in many countries for the treatment of opioid use disorder (OUD), but problems with diversion and abuse exist. There is a need to understand how and why patients use diverted buprenorphine, and whether barriers to access contribute to illicit use. METHODS: Adults >18 years with DSM-IV criteria for substance use disorder and primarily using an opioid completed the online Survey of Key Informants' Patients (SKIP) between August and September 2016. The survey included closed- and open-ended questions regarding reasons for buprenorphine use with and without a prescription, sources of buprenorphine, route of administration, and barriers to treatment. RESULTS: Of 303 respondents, 175 (58%) reported a history of diverted buprenorphine use, 65 (37%) of whom reported never receiving a prescription. The most common reasons for illicit buprenorphine use were consistent with therapeutic use: to prevent withdrawal (79%), maintain abstinence (67%), or self-wean off drugs (53%). Approximately one-half (52%) reported using buprenorphine to get high or alter mood, but few (4%) indicated that it was their drug of choice. Among respondents who had used diverted buprenorphine, 33% reported that they had issues finding a doctor or obtaining buprenorphine on their own. Most (81%) of these participants indicated they would prefer using prescribed buprenorphine, if available. CONCLUSIONS: Although 58% of survey respondents reported a history of using diverted buprenorphine, the most frequently cited reasons for non-prescription use were consistent with therapeutic use. Diversion was partially driven by barriers to access, and an unmet need for OUD treatment persists.
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Analgésicos Opioides/uso terapéutico , Buprenorfina/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Desvío de Medicamentos bajo Prescripción , Adolescente , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Adulto JovenRESUMEN
PURPOSE: The purpose of this study is to assess positive predictive value (PPV), relative to medical chart review, of International Classification of Diseases (ICD)-9/10 diagnostic codes for identifying opioid overdoses and poisonings. METHODS: Data were obtained from Kaiser Permanente Northwest and Northern California. Diagnostic data from electronic health records, submitted claims, and state death records from Oregon, Washington, and California were linked. Individual opioid-related poisoning codes (e.g., 965.xx and X42), and adverse effects of opioids codes (e.g., E935.xx) combined with diagnoses possibly indicative of overdoses (e.g., respiratory depression), were evaluated by comparison with chart audits. RESULTS: Opioid adverse effects codes had low PPV to detect overdoses (13.4%) as assessed in 127 charts and were not pursued. Instead, opioid poisoning codes were assessed in 2100 individuals who had those codes present in electronic health records in the period between the years 2008 and 2012. Of these, 10/2100 had no available information and 241/2100 were excluded potentially as anesthesia-related. Among the 1849 remaining individuals with opioid poisoning codes, 1495 events were accurately identified as opioid overdoses; 69 were miscodes or misidentified, and 285 were opioid adverse effects, not overdoses. Thus, PPV was 81%. Opioid adverse effects or overdoses were accurately identified in 1780 of 1849 events (96.3%). CONCLUSIONS: Opioid poisoning codes have a predictive value of 81% to identify opioid overdoses, suggesting ICD opioid poisoning codes can be used to monitor overdose rates and evaluate interventions to reduce overdose. Further research to assess sensitivity, specificity, and negative predictive value are ongoing. Copyright © 2017 John Wiley & Sons, Ltd.
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Analgésicos Opioides/envenenamiento , Codificación Clínica , Sobredosis de Droga/epidemiología , Clasificación Internacional de Enfermedades , Adulto , California/epidemiología , Certificado de Defunción , Registros Electrónicos de Salud , Femenino , Humanos , Masculino , Persona de Mediana Edad , Oregon/epidemiología , Valor Predictivo de las Pruebas , Sensibilidad y Especificidad , Washingtón/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Opioid abuse and misuse are significant public health issues. The CDC estimated 72% of pharmaceutical-related overdose deaths in the US in 2012 involved opioids. While studies of opioid overdoses have identified sociodemographic characteristics, agents used, administration routes, and medication sources associated with overdoses, we know less about the context and life circumstances of the people who experience these events. METHODS: We analyzed interviews (n=87) with survivors of opioid overdoses or family members of decedents. Individuals experiencing overdoses were members of a large integrated health system. Using ICD codes for opioid overdoses and poisonings, we identified participants from five purposefully derived pools of health-plan members who had: 1) prescriptions for OxyContin(®) or single-ingredient sustained-release oxycodone, 2) oxycodone single-ingredient immediate release, 3) other long-acting opioids, 4) other short-acting opioids, or 5) no active opioid prescriptions. RESULTS: Individuals who experienced opioid overdoses abused and misused multiple medications/drugs; experienced dose-related miscommunications or medication-taking errors; had mental health and/or substance use conditions; reported chronic pain; or had unstable resources or family/social support. Many had combinations of these risks. Most events involved polysubstance use, often including benzodiazepines. Accidental overdoses were commonly the result of abuse or misuse, some in response to inadequately treated chronic pain or, less commonly, medication-related mistakes. Suicide attempts were frequently triggered by consecutive negative life events. CONCLUSIONS: To identify people at greater risk of opioid overdose, efforts should focus on screening for prescribed and illicit polysubstance use, impaired cognition, and changes in life circumstances, psychosocial risks/supports, and pain control.
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Analgésicos Opioides/uso terapéutico , Sobredosis de Droga/etiología , Oxicodona/uso terapéutico , Mal Uso de Medicamentos de Venta con Receta/psicología , Prescripciones/estadística & datos numéricos , Adulto , Analgésicos Opioides/envenenamiento , Benzodiazepinas/envenenamiento , Dolor Crónico/tratamiento farmacológico , Dolor Crónico/psicología , Sobredosis de Droga/prevención & control , Femenino , Humanos , Masculino , Oxicodona/envenenamiento , Manejo del Dolor/psicología , Factores de Riesgo , Apoyo Social , Trastornos Relacionados con Sustancias/psicologíaRESUMEN
BACKGROUND: Doctor-shopping (obtaining prescriptions from multiple prescribers/pharmacies) for opioid analgesics produces a supply for diversion and abuse, and represents a major public health issue. METHODS: An open cohort study assessed changes in doctor-shopping in the U.S. for a brand extended release (ER) oxycodone product (OxyContin) and comparator opioids before (July, 2009 to June, 2010) versus after (January, 2011 to June, 2013) introduction of reformulated brand ER oxycodone with abuse-deterrent properties, using IMS LRx longitudinal data covering >150 million patients and 65% of retail U.S. prescriptions. RESULTS: After its reformulation, the rate of doctor-shopping decreased 50% (for 2+ prescribers/3+ pharmacies) for brand ER oxycodone, but not for comparators. The largest decreases in rates occurred among young adults (73%), those paying with cash (61%) and those receiving the highest available dose (62%), with a 90% decrease when stratifying by all three characteristics. The magnitude of doctor-shopping reductions increased with increasing number of prescribers/pharmacies (e.g., 75% reduction for ≥2 prescribers/≥4 pharmacies). CONCLUSIONS: The rate of doctor-shopping for brand ER oxycodone decreased substantially after its reformulation, which did not occur for other prescription opioids. The largest reductions in doctor-shopping occurred with characteristics associated with higher abuse risk such as youth, cash payment and high dose, and with more specific thresholds of doctor-shopping. A higher prescriber and/or pharmacy threshold also increased the magnitude of the decrease, suggesting that it better captured the effect of the reformulation on actual doctor-shoppers.
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Trastornos Relacionados con Opioides/epidemiología , Oxicodona/administración & dosificación , Oxicodona/química , Médicos/tendencias , Desvío de Medicamentos bajo Prescripción/tendencias , Mal Uso de Medicamentos de Venta con Receta/tendencias , Adolescente , Adulto , Anciano , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/química , Estudios de Cohortes , Preparaciones de Acción Retardada/administración & dosificación , Preparaciones de Acción Retardada/química , Composición de Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Trastornos Relacionados con Opioides/diagnóstico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Farmacias/tendencias , Mal Uso de Medicamentos de Venta con Receta/prevención & control , Prescripciones , Adulto JovenRESUMEN
BACKGROUND: Addiction, overdoses and deaths resulting from prescription opioids have increased dramatically over the last decade. In response, several manufacturers have developed formulations of opioids with abuse-deterrent properties. For many of these products, the Food and Drug Administration (FDA) recognized the formulation with labeling claims and mandated post-marketing studies to assess the abuse-deterrent effects. In response, we assess differences in rates of opioid-related overdoses and poisonings prior to and following the introduction of a formulation of OxyContin® with abuse-deterrent properties. METHODS/DESIGN: To assess effects of this formulation, electronic medical record (EMR) data from Kaiser Permanente Northwest (KPNW) and Kaiser Permanente Northern California (KPNC) are linked to state death data and compared to chart audits. Overdose and poisoning events will be categorized by intentionality and number of agents involved, including illicit drugs and alcohol. Using 6-month intervals over a 10-year period, trends will be compared in rates of opioid-related overdoses and poisoning events associated with OxyContin® to rates of events associated with other oxycodone and opioid formulations. Qualitative interviews with patients and relatives of deceased patients will be conducted to capture circumstances surrounding events. DISCUSSION: This study assesses and tracks changes in opioid-related overdoses and poisoning events prior to and following the introduction of OxyContin® with abuse-deterrent properties. Public health significance is high because these medications are designed to reduce abuse-related behaviors that lead to important adverse outcomes, including overdoses and deaths.
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Analgésicos Opioides/envenenamiento , Prestación Integrada de Atención de Salud/tendencias , Composición de Medicamentos/tendencias , Sobredosis de Droga/epidemiología , Oxicodona/uso terapéutico , Vigilancia de Productos Comercializados/tendencias , Prestación Integrada de Atención de Salud/métodos , Sobredosis de Droga/diagnóstico , Sobredosis de Droga/prevención & control , Registros Electrónicos de Salud/tendencias , Humanos , Trastornos Relacionados con Opioides/diagnóstico , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/prevención & control , Oxicodona/química , Vigilancia de Productos Comercializados/métodosRESUMEN
PURPOSE: Abuse of opioid analgesics for their psychoactive effects is associated with a large number of fatalities. The effect of making opioid tablets harder to crush/dissolve on opioid-related fatalities has not been assessed. The objective of this study was to assess the impact of introducing extended-release oxycodone (ERO [OxyContin(®) ]) tablets containing physicochemical barriers to crushing/dissolving (reformulated ERO) on deaths reported to the manufacturer. METHODS: All spontaneous adverse event reports of death in the US reported to the manufacturer between 3Q2009 and 3Q2013 involving ERO were used. The mean numbers of deaths/quarter in the 3 years after reformulated ERO introduction were compared with the year before. Changes in the slope of trends in deaths were assessed using spline regression. Comparison groups consisted of non-fatal reports involving ERO and fatality reports involving ER morphine. RESULTS: Reports of death decreased 82% (95% CI: -89, -73) from the year before to the third year after (131 to 23 deaths per year) reformulation; overdose death reports decreased 87% (95% CI: -93, -78) and overdose deaths with mention of abuse-related behavior decreased 86% (95% CI:-92, -75). In contrast, non-fatal ERO reports did not decrease post-reformulation, and reported ER morphine fatalities remained unchanged. The ratio of ERO fatalities to all oxycodone fatalities decreased from 21% to 8% in the year pre-reformulation to the second year post-reformulation. CONCLUSIONS: These findings, when considered in the context of previously published studies using other surveillance systems, suggest that the abuse-deterrent characteristics of reformulated ERO have decreased the fatalities associated with its misuse/abuse. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
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Química Farmacéutica/normas , Mortalidad/tendencias , Oxicodona/química , Adolescente , Adulto , Anciano , Química Farmacéutica/tendencias , Niño , Sistemas de Administración de Bases de Datos , Preparaciones de Acción Retardada , Formas de Dosificación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Oxicodona/administración & dosificación , Estados UnidosRESUMEN
BACKGROUND: Reformulating opioid analgesics to deter abuse is one approach toward improving their benefit-risk balance. To assess sentiment and attempts to defeat these products among difficult-to-reach populations of prescription drug abusers, evaluation of posts on Internet forums regarding reformulated products may be useful. A reformulated version of OxyContin (extended-release oxycodone) with physicochemical properties to deter abuse presented an opportunity to evaluate posts about the reformulation in online discussions. OBJECTIVE: The objective of this study was to use messages on Internet forums to evaluate reactions to the introduction of reformulated OxyContin and to identify methods aimed to defeat the abuse-deterrent properties of the product. METHODS: Posts collected from 7 forums between January 1, 2008 and September 30, 2013 were evaluated before and after the introduction of reformulated OxyContin on August 9, 2010. A quantitative evaluation of discussion levels across the study period and a qualitative coding of post content for OxyContin and 2 comparators for the 26 month period before and after OxyContin reformulation were conducted. Product endorsement was estimated for each product before and after reformulation as the ratio of endorsing-to-discouraging posts (ERo). Post-to-preintroduction period changes in ERos (ie, ratio of ERos) for each product were also calculated. Additionally, post content related to recipes for defeating reformulated OxyContin were evaluated from August 9, 2010 through September 2013. RESULTS: Over the study period, 45,936 posts related to OxyContin, 18,685 to Vicodin (hydrocodone), and 23,863 to Dilaudid (hydromorphone) were identified. The proportion of OxyContin-related posts fluctuated between 6.35 and 8.25 posts per 1000 posts before the reformulation, increased to 10.76 in Q3 2010 when reformulated OxyContin was introduced, and decreased from 9.14 in Q4 2010 to 3.46 in Q3 2013 in the period following the reformulation. The sentiment profile for OxyContin changed following reformulation; the post-to-preintroduction change in the ERo indicated reformulated OxyContin was discouraged significantly more than the original formulation (ratio of ERos=0.43, P<.001). A total of 37 recipes for circumventing the abuse-deterrent characteristics of reformulated OxyContin were observed; 32 were deemed feasible (ie, able to abuse). The frequency of posts reporting abuse of reformulated OxyContin via these recipes was low and decreased over time. Among the 5677 posts mentioning reformulated OxyContin, 825 posts discussed recipes and 498 reported abuse of reformulated OxyContin by such recipes (41 reported injecting and 128 reported snorting). CONCLUSIONS: After introduction of physicochemical properties to deter abuse, changes in discussion of OxyContin on forums occurred reflected by a reduction in discussion levels and endorsing content. Despite discussion of recipes, there is a relatively small proportion of reported abuse of reformulated OxyContin via recipes, particularly by injecting or snorting routes. Analysis of Internet discussion is a valuable tool for monitoring the impact of abuse-deterrent formulations.
Asunto(s)
Analgésicos Opioides/administración & dosificación , Internet , Trastornos Relacionados con Opioides/prevención & control , Oxicodona/administración & dosificación , Acetaminofén , Química Farmacéutica , Combinación de Medicamentos , Humanos , Hidrocodona , Hidromorfona , Oxicodona/química , Medios de Comunicación SocialesRESUMEN
BACKGROUND: Prescription opioid abuse is a significant public health concern that requires strategies to reduce its impact, including development of abuse deterrent formulations. OxyContin, an extended-release oxycodone (ERO) formulation, has been widely abused. This study assessed the effects of reformulated ERO, designed to be more difficult to manipulate for purposes of intranasal and intravenous abuse, on patterns of opioid abuse among a sample of individuals from rural Appalachia with a history of ERO abuse. METHODS: Structured interviews assessing opioid abuse (past 30-day abuse and retrospectively reported abuse prior to the reformulation in August 2010) were completed by 189 individuals between December 2010 and September 2011. RESULTS: The past 30-day prevalence and frequency of reformulated ERO abuse through any route (33%, 1.9 days/month), snorting (5%, 0.2 days/month), and injecting (0.5%, <0.1 days/month) were low and infrequent compared to that of IR oxycodone (any route: 96%, 19.5 days/month; snorting: 70%, 10.3 days/month; injecting: 51%, 10.5 days/month) and retrospectively reported abuse of original ERO in August 2010 (any route: 74%, 13.4 days/month; snorting: 39%, 6.0 days/month; injecting: 41%, 8.6 days/month). After the reformulation, the prevalence of original ERO abuse significantly declined while abuse of reformulated ERO remained steadily low. Heroin abuse was rare in this sample. CONCLUSIONS: In this sample, abuse of reformulated ERO was low, and lower than abuse of original ERO retrospectively and IR oxycodone concurrently, particularly through injecting and snorting routes of administration. There was no evidence to suggest that reformulated ERO became a substitute for original ERO.
Asunto(s)
Trastornos Relacionados con Opioides/prevención & control , Oxicodona/administración & dosificación , Mal Uso de Medicamentos de Venta con Receta/prevención & control , Adulto , Preparaciones de Acción Retardada , Femenino , Humanos , Entrevistas como Asunto , Masculino , Trastornos Relacionados con Opioides/epidemiología , Mal Uso de Medicamentos de Venta con Receta/estadística & datos numéricos , PrevalenciaRESUMEN
BACKGROUND: There is a growing need to understand trends in nonmedical use of prescription pain relievers as a class, as well as specific opioid products. Surveys such as monitoring the future (MTF) and the National Survey on Drug Use and Health (NSDUH) are important tools for understanding trends in abuse of prescription and illegal drugs. This report compares discrepancies in prevalence between these surveys for a specific opioid product (oxycodone) relative to other drugs. METHODS: Trends in past-year use of marijuana, cocaine, and nonmedical use of oxycodone and any prescription pain reliever were estimated for each survey for a five year period (2005-2010) for adolescents in 12th grade. The proportion of nonmedical pain reliever users who abused oxycodone was estimated for each survey. RESULTS: Prevalence of past-year oxycodone nonmedical use was steady over time for both surveys, but 2.5-3 times higher in the MTF compared to the NSDUH. Trends in prevalence of marijuana and cocaine use were similar across surveys, although prevalence estimates for each were on average 18% higher in the MTF. In contrast, prevalence estimates for any nonmedical prescription pain reliever use were on average 15% lower in MTF. The proportion of nonmedical prescription pain reliever users who used oxycodone was 42% in the MTF versus 19% in the NSDUH. CONCLUSION: The discrepancy between surveys in prevalence estimates for nonmedical use of oxycodone exceed those for other drugs, pointing to the importance of visual aids and items used to measure the nonmedical use of specific products.
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Analgésicos Opioides/administración & dosificación , Recolección de Datos/normas , Trastornos Relacionados con Opioides/diagnóstico , Trastornos Relacionados con Opioides/epidemiología , Mal Uso de Medicamentos de Venta con Receta/tendencias , Adolescente , Recolección de Datos/métodos , Femenino , Humanos , Masculino , Prevalencia , Adulto JovenRESUMEN
PURPOSE: Abuse and misuse of prescription opioids are serious public health problems. Abuse-deterrent formulations are an intervention to balance risk mitigation with appropriate patient access. This study evaluated the effects of physicochemical barriers to crushing and dissolving on safety outcomes associated with extended-release oxycodone (ERO) tablets (OxyContin) using a national surveillance system of poison centers. Other single-entity (SE) oxycodone tablets and heroin were used as comparators and to assess substitution effects. METHODS: The National Poison Data System covering all US poison centers was used to measure changes in exposures in the year before versus the 2 years after introduction of reformulated ERO (7/2009-6/2010 vs 9/2010-9/2012). Outcomes included abuse, therapeutic errors affecting patients, and accidental exposures. RESULTS: After ERO reformulation, abuse exposures decreased 36% for ERO, increased 20% for other SE oxycodone, and increased 42% for heroin. Therapeutic errors affecting patients decreased 20% for ERO and increased 19% for other SE oxycodone. Accidental exposures decreased 39% for ERO, increased 21% for heroin, and remained unchanged for other SE oxycodone. During the study period, other interventions to reduce opioid abuse occurred, for example, educational and prescription monitoring programs. However, these have shown small effects and do not explain a drop for ERO exposures but not for other opioids. CONCLUSIONS: After ERO reformulation, calls to poison centers involving abuse, therapeutic errors affecting patients, and accidental exposures decreased for ERO, but not for comparator opioids. Abuse-deterrent formulations of opioid analgesics can reduce abuse, but switching to other accessible non abuse-deterrent opioids might occur.
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Analgésicos Opioides/administración & dosificación , Heroína/administración & dosificación , Trastornos Relacionados con Opioides , Oxicodona/administración & dosificación , Centros de Control de Intoxicaciones/estadística & datos numéricos , Mal Uso de Medicamentos de Venta con Receta/estadística & datos numéricos , Preparaciones de Acción Retardada , Humanos , Modelos Logísticos , Modelos Estructurales , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/prevención & control , Estados UnidosRESUMEN
Understanding current patterns of population smoking by socioeconomic position (SEP) can be substantially enhanced by research that follows birth cohorts over long periods of time, yet such data in the US are rare. Information from birth cohorts followed during critical time periods when the health consequences of smoking became widely known can inform the ways in which current smoking prevalence has been shaped by the historical processes that preceded it. The present study utilizes data from a substudy of the Child Health and Development Study pregnancy cohort (N = 1612). Women were queried about smoking status in 1959-1962, 1971-1972 and 1977-1980. Women were divided into three cohorts based on date of birth. Offspring represented another birth cohort assessed for smoking in 1977-1980. Results indicated that the overall prevalence of smoking exhibited cohort-specific patterns that persisted across time. Notably, the youngest maternal cohort (born 1937-1946) had high smoking prevalence throughout and showed no appreciable decrease (44.7%, 41.4%, 40.1% for 1959-1962, 1971-1972, and 1977-1980). Results also indicated that the relation of smoking to SEP exhibited cohort-specific patterns over time. Among the oldest birth cohort (born 1914-1930), no inverse relation of SEP to smoking was observed at any time; in contrast, an inverse relation emerged by 1959-1962 among the youngest cohort of mothers. Among the adolescent offspring, there was a strong SEP gradient (OR = 2.0, 95% CI = 1.4-3.0) that was stronger than in any maternal birth cohort at any assessment (ß = 0.40, SE = 0.1, p<0.01). We conclude that SEP gradients in smoking emerge across birth cohorts rather than time alone, with increasingly strong gradients across time especially among younger cohorts.