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Seneca Falls, N. Timothy R. Brown, 28, Amy M. Weeman, 42, Andrea A. Osterhout, 22 and Mary E. Brown, 64 lived there together, deputies said. Deputies found Brown with 30 baggies of heroin and Weeman with three baggies. They charged both with felony sale and possession of heroin and criminally using drug paraphernalia, a misdemeanor. Weeman was also charged with selling prescription medication, deputies said. Seneca County Child Protective Services took emergency custody of Osterhout's child, who was living in the residence and present during the drug activity, deputies said. Deputies also charged Osterhout with possession of a stolen iPod, and released her on a Dec. Brown had maintained the residence and allowed the drug activity to take place, deputies said. They charged her with felony criminal nuisance and released her on a Dec. All four were charged with unlawfully dealing with a child, a misdemeanor. If you purchase a product or register for an account through a link on our site, we may receive compensation. Your source for local, state and national voting. Central NY News. By Meera Jagannathan Contributing writer.

Neurotoxicity in Psychostimulant and Opiate Addiction

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Liberatore , Kathleen L. The opioid epidemic, driven in part by increased prescribing, is a public health emergency. This study examines dispensed prescription patterns and approvals of new opioid analgesic products to investigate whether the introduction of these new drugs increases prescribing. Prescribing patterns based on dispensed prescription claims from the U. From through , the U. Food and Drug Administration Silver Spring, Maryland approved opioid analgesic products, including 33 brand products. Morphine milligram equivalents dispensed per prescription increased from in to a peak of in , before decreasing to in The remaining prescriptions were dispensed for brand products, of which nearly half were dispensed for one brand product OxyContin, Purdue, USA. There has been a dramatic increase in prescriptions dispensed for opioid analgesics since and an increasing number of opioid analgesic approvals; however, the number of prescriptions dispensed has declined since despite an increasing number of approvals. Examination of dispensed prescriptions shows a shifting and complex market where multiple factors likely influence prescribing; the approval of new products alone may not be sufficient to be a primary driver of increased prescribing. Since there has been an increasing number of opioid analgesics approved by the U. Food and Drug Administration, and an increase in prescriptions dispensed for opioid analgesics. There are concerns that new opioid products are driving prescribing, but the relationship between prescribing patterns and product approvals is not well understood. Data on new brand and generic opioid analgesic product approvals, and on retail dispensed prescription claims, were used to evaluate the opioid product space. Opioid prescriptions dispensed and amount per prescription nearly doubled, and total morphine milligram equivalents more than tripled, from to the peak in , and partially declined thereafter. Approval of new branded opioid products alone does not appear to be a primary driver of increased opioid prescribing. DURING the past two decades, there has been a marked increase in outpatient utilization of opioid analgesics in the United States, paralleled by increases in abuse, misuse, and adverse outcomes, including addiction, overdose, and death. While the increased prescribing of opioids is widely considered to have contributed to this public health emergency, the specific factors leading to increased prescribing are the subject of debate. During the last 20 yr, the U. Food and Drug Administration Silver Spring, Maryland has approved numerous new opioid analgesic products. However, most of these new products contain active moieties that have been used for decades in older products. In fact, only one new molecular entity opioid analgesic was approved during this period: tapentadol New product development of opioid analgesics has focused on new formulations of existing products, including, in some cases, the development of abuse-deterrent formulations. In recent years, lawmakers, advocacy groups, and others have voiced concern that approvals of new opioid products are driving prescribing. Using nationally estimated prescription claims data and U. Food and Drug Administration resources, we examine patterns in prescriptions dispensed in the outpatient setting relative to new opioid product approvals to shed light on the relationship between prescribing patterns and product approvals. We obtained data on all new drug applications and abbreviated new drug applications approved for opioid analgesic products between and National estimates of the number of prescriptions dispensed for opioid analgesics were obtained from a proprietary database available to the U. The National Prescription Audit captures approximately 3. Changes to the underlying source data and projection methodologies were conducted by IQVIA over time for greater accuracy. Prescriptions covered by commercial third-party payers, Medicaid, or Medicare, and cash payments are included. Prescription data were analyzed by active moiety appendix 1 , by formulation e. Because authorized generics are products marketed under existing new drug applications without separate U. All formulations of opioid analgesics were included, except for injectable formulations, which are not commonly dispensed in the outpatient setting. Thus, methadone dispensed as medication-assisted treatment from methadone clinics was not captured in the database, but all other methadone prescriptions dispensed from retail pharmacies were included in the analysis. We also quantified the total amount of morphine milligram equivalents dispensed based on standardization of total dispensed opioid prescriptions across the different active moieties, quantity, and strength of doses. To calculate overall morphine milligram equivalents dispensed per year, we calculated the milligrams of opioids dispensed annually by a morphine milligram equivalents conversion factor for each opioid analgesic using conversion factors outlined in a recent publication by the Centers for Disease Control and Prevention Atlanta, Georgia. We first reported new opioid analgesic product approvals in the United States from through by year of approval for new drug applications and abbreviated new drug applications. Next, we show the total opioid analgesic market for brand and generic products by both the nationally estimated number of total prescriptions and morphine milligram equivalents dispensed and prescriptions dispensed adjusted for the total U. Census data. OxyContin was originally approved in before our study period; subsequently another new drug application was approved in as a reformulation of the original OxyContin, at which time the marketing of the original product ceased. We recorded the approval of the reformulated product as a new brand approval, although we did not distinguish between the original formulation and the new formulation in our calculations of total OxyContin prescriptions dispensed. Additional supplemental analyses were performed to assess generic opioid analgesic approvals and prescription patterns for the years through First, we conducted an analysis of new and additional generic products approved after for the six most frequently dispensed opioid analgesics in Next, we analyzed opioid analgesics for which the first generic was initially dispensed between and , as these represent the clearest cases for interpretation in the current opioid market. Descriptive statistics and calculation of morphine milligram equivalents were conducted using Excel Microsoft, USA ; no statistical hypothesis testing was performed. From through , new opioid analgesic applications were approved, including abbreviated new drug applications and 41 new drug applications fig. Thirty-three 33 of the 41 new drug applications approvals were for brand products. Number of U. Adjusted for the total U. Census population, the overall trends were similar, but the peak in population-adjusted utilization during the study period was in years to fig. Morphine milligram equivalents per prescription dispensed nearly doubled from in to a peak of in before decreasing to morphine milligram equivalents per prescription in Outpatient Retail Pharmacies. Nationally estimated annual number of opioid analgesics dispensed in number of morphine milligram equivalents MME, right axis, line graph and in number of prescriptions left axis, bar graph , by brand brand and branded generics and generic product, adjusted for the U. Estimates were derived from the following sources: Total U. Brand: All trade name products including Brand and Branded Generic products. Of the 33 brand products approved as new drug application between and , 23 brand products were dispensed in Nationally estimated annual number of prescriptions dispensed for the top 10 newly approved opioid analgesic brand products left axis, bar graph and the combined market share of all newly approved opioid analgesic brand products right axis, line graph in the U. Individual brand products represent the brand opioid analgesics dispensed in that were introduced into the market from to Only brand utilization is shown—does not include generic utilization. Solid line represents the combined market share for all brand products approved between and , out of the total opioid analgesic market. Opana ER includes original formulation approved and reformulation approved OxyContin includes original formulation approved and reformulation approved Figure 4 shows prescriptions dispensed for OxyContin and generic extended-release oxycodone increased from nearly 1 million prescriptions dispensed in to about 7 to 7. Nationally estimated annual number of dispensed prescriptions and morphine milligram equivalents MME dispensed for extended-release oxycodone brand and generic products, left axis, bar graph and their market share of total opioid analgesic prescriptions or MME dispensed right axis, line graph from U. The majority of these prescriptions were dispensed as generics throughout the examined time fig. Cumulative number of new U. Food and Drug Administration generic product approvals right axis, line graph and the nationally estimated annual number of prescriptions dispensed left axis, bar graph from U. Generic versions of six opioid analgesics, which were dispensed for the first time during years through , are shown in figure 6. In some cases, the decrease in prescriptions began before the introduction of generics. Cumulative number of U. Food and Drug Administration generic approvals right axis, line graph and the nationally estimated annual number of prescriptions dispensed left axis, bar graph from U. Brand product of hydromorphone ER includes Exalgo. Our examination of brand and generic opioid analgesics product approvals and outpatient dispensing patterns shows that dispensing of opioid analgesics dramatically increased since , both in the number of prescriptions dispensed and in the quantity of opioid per dispensed prescription, as measured by morphine milligram equivalents per dispensed prescription. The annual number of approvals, which generally increased over time, was higher in the second half of the study period through than in the first half through Our data do not suggest a clear relationship between new product approvals and utilization; rather, several observations suggest a shifting and complex market in which multiple factors are at work. First, while the introduction of new products could increase prescribing if additional new molecular entities were brought to market, this had not occurred to any significant extent. Tapentadol, the only new molecular entity approved during the study period, was minimally prescribed, accounting for only 0. Third, among the six most commonly prescribed opioid analgesics, the relationship of cumulative generic drug approvals to the number of dispensed prescriptions was variable. Fourth, the number of dispensed prescriptions for opioid analgesics whose initial generic version was introduced after was either stable or declined. The introduction of lower-priced generics has the potential to increase patient accessibility and utilization, with lower prices making medicines more accessible to patients, 20 but the data suggest that the introduction of generics in recent years may not increase total dispensing. For example, we observed that the initial introduction of generic extended-release oxycodone did not appear to increase overall prescribing; rather, the increase in use of extended-release oxycodone occurred before the approval of generics. The pattern of stable or declining prescribing observed after introduction of new generic opioid products supports previous research that the approval of generic products may not drive increased utilization. Fifth, despite an increased number of approvals in the most recent quarter of the study period through relative to previous years, the number of prescriptions dispensed and morphine milligram equivalents decreased since This finding, along with the observed increase, a near doubling, in the quantity of opioids dispensed per prescription during the study period, further suggests that factors other than product approvals drove prescribing decisions. The declines in total opioid analgesic dispensing observed in the later years of the study period may be driven in part by interventions implemented by federal, state, and local governments, regulatory agencies, medical associations, healthcare systems, and prescribers. Such efforts may include changes in prescribing guidelines, requirements for prescriber education, recommended limitations on opioid dosages, increased law enforcement activities, payer-based dispensing restrictions, prescription drug monitoring programs, and risk evaluation mitigation strategies. One study suggests this may have caused a shift from hydrocodone-combination products to other products, but this effect appears to be smaller than the reduction in hydrocodone-combination product dispensing. Our study also found that morphine milligram equivalents per prescription dispensed nearly doubled since to a peak of morphine milligram equivalents per prescription in , before decreasing to morphine milligram equivalents per prescription in Changes in the annual total of average morphine milligram equivalent dispensed per prescription may be due to changes in drug product prescribed, dosage, strength, or quantity; further investigation is warranted to fully understand the complex factors contributing to the differences in prescribing pattern changes. Although this study provides a broad overview of opioid analgesic utilization, we were not able to specifically address the impact of our findings on opioid abuse, misuse, addiction, and deaths. The opioid epidemic is a complex and multifactorial phenomenon associated with both legal and illicit sources e. For example, the opioid data in our analyses relate to prescriptions obtained legally through retail pharmacies. However, drugs such as heroin may be laced with other drugs such as fentanyl; death certificate data do not capture whether the source of the drug attributed as the cause of death due to overdose is legal or illicit. The observational and descriptive design of this study also limits our ability to infer causal relationships between regulatory approvals or other interventions and opioid analgesic dispensing patterns. However, observational trends in the data provide a robust, national-level understanding of prescribing patterns. More granular analyses for specific populations or locations may not be generalizable and may reflect local interventions. Food and Drug Administration definitions based on new drug application or abbreviated new drug application approval, the overall impact of this difference in the analyses of the opioid analgesic product market appears to be minimal. In addition, we did not examine the role that promotional efforts may have played in increased prescribing of opioids, particularly earlier in the study period. The marketing and promotion of prescription opioid analgesics and their effects on increased prescribing have been the subject of investigations and legal actions. There has been a dramatic increase in prescriptions dispensed for opioid analgesics since However, despite an increased number of opioid analgesic approvals in recent years, prescriptions dispensed in the outpatient setting declined since The current opioid analgesic market appears to be an ecosystem in which the introduction of new products, brand or generic, is more likely to lead to substitutions between products than increased dispensing. Our examination of dispensed prescription patterns shows a shifting and complex market where multiple factors likely influence prescribing, and the approval of new products alone may not be sufficient to be a primary driver of increased prescribing. The authors would like to thank Rajdeep Gill, Pharm. The authors would also like to thank Judy Staffa, Ph. Racoosin, M. Throckmorton, M. D, at the U. Food and Drug Administration, and Christopher M. Jones, Pharm. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Food and Drug Administration. Outpatient Retail Pharmacy Setting from through Sign In or Create an Account. Search Dropdown Menu. Advanced Search. Sign In. Skip Nav Destination Close navigation menu Article navigation. Volume , Issue 5. Previous Article Next Article. Materials and Methods. Research Support. Competing Interests. Appendix 1. Appendix 2. Appendix 3. Article Navigation. Pain Medicine May Address correspondence to Dr. Chai: U. This article may be accessed for personal use at no charge through the Journal Web site, www. This Site. Google Scholar. Jing Xu, Ph. James Osterhout, Ph. Mark A. Liberatore, Pharm. Kathleen L. Miller, Ph. Carolyn Wolff, Ph. Marisa Cruz, M. Peter Lurie, M. Gerald Dal Pan, M. Author and Article Information. This is a Frontiers in Opioid Pharmacotherapy Symposium article. Submitted for publication June 29, Accepted for publication February 19, Anesthesiology May , Vol. Get Permissions. View large Download slide. Table 1. View large. View Large. The authors declare no competing interests. Accessed July 15, Centers for Disease Control and Prevention: Trends in deaths involving heroin and synthetic opioids excluding methadone, and law enforcement drug product reports, by census region — United States, — Accessed September 27, Accessed April 4, Trump is taking action on drug addiction and the opioid crisis. The White House. Accessed October 28, Centers for Disease Control and Prevention: Vital signs: overdoses of prescription opioid pain relieversUnited States, Accessed July 11, Accessed August 8, Accessed June 23, Rally Steering Committee. Accessed July 27, Search ADS. Accessed June 10, Food and Drug Administration: Development and approval process drugs. Food and Drug Administration: Generic drugs. Accessed June 11, A compilation of opioid analgesic formulations with morphine milligram equivalent conversion factors, version. Census Bureau, Population Division. December Accessed July 1, Accessed July 10, Pharmaceutical use following generic entry: Paying less and buying less No. National Bureau of Economic Research. Accessed July 12, National Pain Strategy: A comprehensive population health-level strategy for pain. Federal Pain Research Strategy. Drug Enforcement Administration, Department of Justice. Van Zee. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Accessed November 10, Nashville sues opioid manufacturers to recoup costs of fighting epidemic. Accessed December 29, Table A1. Opioid Analgesics by Active Moiety. Table A2. Table A3. Wolters Kluwer Health, Inc. All Rights Reserved. View Metrics. Visual Abstract. Citing articles via Web Of Science 9. Uptake of Halothane by the Human Body. Email alerts Article Activity Alert. Online First Alert. Anesthesiology Featured Articles Alert. Social Media Twitter. Anesthesiology ASA Monitor. Cookie Settings. Close Modal.

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