Challenges in Conducting Postmarketing Abuse Investigations
|
|
- Irene Gibbs
- 5 years ago
- Views:
Transcription
1 Challenges in Conducting Postmarketing Abuse Investigations Paul Coplan, ScD, MBA Risk Management & Epidemiology Purdue Pharma, L.P. ADF Guidance Meeting Washington DC, October 1,
2 That which we do not bring into consciousness appears in our lives as fate Carl Gustav Jung Disclaimer: Views expressed are those of the speaker and not those of any organization he is affiliated with. 2
3 Key Challenges 1. New molecular entity or product 2. Clinical endpoints 3. Time to see event 4. Novel surveillance measures 5. Public Health Impact 3
4 1. New Product or New Molecular Entity: The Challenge ADF Guidance (page 13): The goal of postmarketingstudies, Category 4, is to determine whether the marketing of the potentially abuse-deterrent formulation results in a significant decrease in population-based and use-based estimates of abuse compared to estimates of abuse if only formulations without abuse-deterrent properties are marketed Challenge Low (initial) uptake No baseline Possible Approach Assess relative rate of abuse Eg, IR Tapentadol (new molecular entity), buprenorphine patch (new formulation of established molecular entity) 4
5 Example: Relative Rates of Nonmedical Use of IR Tapentadol vs. other opioids in RADARS System College Survey Population-adjusted rates Prescription-adjusted rates (URDDS) Source: Dart et al. ClinJ Pain
6 Example: Relative Rates of Abuse Exposures in RADARS System Poison Center Program for Buprenorphine Products Rates per 1,000 Individuals Dispensed Drug from Jan 2011 to Sep 2012 Source: The RADARS System Poison Center Program and IMS LRx 6
7 Example: Relative Rates of Abuse Exposures in RADARS System Poison Center Program for ER Opioids by Opioid Substance Rates per 1,000 Individuals Dispensed Drug from Jan 2011 to Sep 2012 Source: The RADARS System Poison Center Program, IMS LRx 7
8 New Product of Molecular Entity: Summary Can identify relative rates of abuse over time as compared to other comparator opioid groups What level constitutes sufficiently lower level to be considered abuse-deterrent? Need to account for underlying differences between opioid active substances and types of formulations in abuse-related outcomes Cannot compare to pre-reformulation baseline 8
9 2. Clinical Endpoints/Outcomes ADF Guidance: Clinical outcomes should include: Prevalence or rates of overdoses, poisonings, addiction, and death Severity of overdoses, poisonings, and addiction Duration of addiction 9
10 Example: Decrease in Number of Causal Drug-Related Deaths in Florida for Oxycodone after 2010: ADF or Legislation/Policing? Oxycodone Methadone Other prescription opioids Heroin # of occurences in drug related deaths Introduction of ORF Oxycodone Other RX opioids Methadone Heroin State legislation to control pill mills (IR SE oxycodone) +20% -22%* -7% +10% Time period * Statistically significant change (p<.0001) from (2H2009 1H2010) to (1H2011-1H2012) Change in oxycodone deaths per 6 month period increased by 69, then decreased by 88 (p<0.001) Data source: Florida medical Examiner data 10
11 Endpoints that are feasible to measure are not direct clinical outcomes Reported abuse among individuals at substance abuse treatment centers Calls to poison centers reporting abuse or misuse Surveys of reported abuse in general population or students Trends in number/type of prescriptions Street price Number of drug diversion events reported by law officers Doctor shopping By # of doctors/pharmacists and overlapping prescriptions Adverse events reported to manufacturer and AERS, including fatalities, fatal overdoses, tablet manipulation or medication error 11
12 Endpoints for Epidemiology Study Program Physicochemical barriers to crushing and dissolving Intentional Abuse Unintentional errors Rates of abuse Routes of abuse Diversion Patients Non-patients Abuse exposures reported to poison centers Substance abuse treatment patients Cohort of OxyContin abusers Overdose death spontaneous reports National surveys of abuse Substance abuse treatment patients Cohort of OxyContin abusers Internet chat room monitoring National drug diversion surveillance Therapeutic error exposures reported to poison centers Overdose and poisoning events among people prescribed opioids Spontaneous adverse event reports Unintentional general exposures reported to poison centers Spontaneous adverse event reports
13 Example: Fatalities reported to manufacturer are product-specific but rely on spontaneous reports: Example -fatalities associated with OxyContin 366 cases with date of death specified, 3Q2009-2Q2012 Note: Reports received after 2Q2012 with a date of death before 2Q2012 not yet included. Source: Sessler et al., PAINWeek 2013; Purdue Adverse Event Reporting Database (ARGUS) 13
14 3. Time to see change in poison centers: Number of Abuse Exposures continue to decrease after 2 Years Number of Calls to Poison Centers for Abuse Total OxyContin Original OxyContin Reformulated OxyContin Canadian OxyContin Unknown OxyContin Reformulation introduced 0 3Q Q Q Q Q Q Q Q Q Q Q Q Q Q 2012 Source: RADARS System Poison Center Program 14
15 Canadian OxyContin exposures are found in all 50 states (N = 6,061), 1Q 2007 to 2Q 2010 Metropolitan county Micropolitan county Non-core county 1 With identifiable ZIP, of 653 total cases SOURCE: National Poison Data System; McKinsey 15
16 Opana ER Abuse Exposures in RADARS Poison Center Program: Changes after Reformulated OxyContin and ER Opana introduced Rate per 1,000 URDD Introduction of Reformulated OxyContin Introduction of reformulated Opana ER Year/Quarter 16 16
17 Example: Time to see change in NSDUH: Significant reductions in nonmedical use of OxyContin occur only 2 years after reformulation 700 Number of non-medical users in past month (1000s) Source: National Survey on Drug Use and Health, SAMHSA 2012 report; Gfroerer
18 Reduction in Accidental Exposures in National Poison Data System 66% of accidental exposures among children months of age (Baseline is 12 months prior to ORF introduction; number of exposures) Source: Coplan et al. Pharmacoepidemiology Drug Safety, 2013; National Poison Data System. 95% CI shown 18
19 4. Internet Monitoring of Web Fora used by Drug Abusers: Posts reporting Tampering resulting in Injecting or Snorting 3,500 3,000 2, Total Posts about OxyContin Posts about Tampering Methods for Reformulated OxyContin - --Posts about Tampering Methods for ReformulatedOxyContin That Reported Injecting or Snorting OxyContin Post Count 2,000 1,500 1,000 Reformulation of OxyContin Q3* Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q Source: Coplan P. International Conference on Opioids, 2013 NAVIPRRO Web Informed Services 19
20 5. Broader Use of ADFs needed to have Public Health Impact Unique patients in 2012 Opioid Overdose Diagnoses (%) Size of ADF reduction Impact of ADF on All Overdoses Type of Opioid % of Users IR Hydrocodone- Acetaminophen 43,400, % 23.3% 0% 0.00% IR Oxycodone- Acetaminophen 14,800, % 10.7% 0% 0.00% IR Oxycodone single entity 3,600, % 6.8% 0% 0.00% IR hydromorphone 1,100, % 2.9% 0% 0.00% ER Morphine 1,100, % 4.0% 0% 0.00% ER Oxycodone 1,000, % 4.3% 50% 2.15% Fentanyl patches 876, % 4.2% 0% 0.00% IR morphine & Fentanyl 593, % 1.6% Methadone 542, % 2.5% 0% 0.00% ER Oxymorphone 200, % 1.2% 40% 0.48% Buprenorphine patches 127, % 0.3% 0% 0.00% ER tapentadol 80, % 0.0%? 0.00% ER Hydromorphone 40, % 0.1% 0% 0.00% None %?? Total 67,458, % 20 Source: Patient numbers from IMS Health NPA; % of opioid overdoses from MarketScan Commercial database in 2011
21 Summary New formulations or molecular entities: baseline comparators missing, but can be compared to other products Clinical endpoints: Mismatch between feasible-tomeasure endpoints and clinical endpoints defined in Guidance Time to see majority of change in existing surveillance systems: approximately 2 years ADFs will need to be widely used to have a significant public health impact 21
22 Thank You 22
23 BACK-UP SLIDES FOR Q&A 23
24 Evaluating Abuse Deterrence of Low Use Product Calls to Poison Centers related to Abuse of ER Opioid Products Rates per 100,000 Population from January 2011 to September 2012 Source: The RADARS System Poison Center Program 24
25 Calls to Poison Centers related to Abuse of Buprenorphine Products Rates per 100,000 Population from January 2011 to September 2012 Source: The RADARS System Poison Center Program 25
26 Trends for Intentional abuse exposures in Florida for SE ER Oxycodone(OxyContin), other SE oxycodone and Heroin in National Poison data System ( )
Opioid Analgesics with Abuse- Deterrent Properties: Current Data and Future Opportunities
1 National Academy of Medicine Session 4 Opioid Analgesics with Abuse- Deterrent Properties: Current Data and Future Opportunities Richard C. Dart, MD, PhD Director, Rocky Mountain Poison and Drug Center
More informationA National Perspective on the Abuse and Diversion of Prescription Drugs
A National Perspective on the Abuse and Diversion of Prescription Drugs Hilary L. Surratt, Ph.D Steven P. Kurtz, Ph.D. ARSH: Center for Applied Research on Substance Use and Health Disparities Faculty
More informationPrescription Opioid Dependence and Addiction: Experience in the United States
Prescription Opioid Dependence and Addiction: Experience in the United States September 27, 2013 Richard C. Dart, MD, PhD Director, Rocky Mountain Poison and Drug Center Professor, University of Colorado
More informationCategory 4 Can we prove that ADF opioids really are?
Human Abuse Liability & Abuse-Deterrent Formulations Category 4 Can we prove that ADF opioids really are? March 7, 2016 Richard C. Dart, MD, PhD Director, Rocky Mountain Poison and Drug Center Executive
More informationThe Evolution of Abuse Deterrent Drug Formulations: Testing Effectiveness from the Benchtop to the Real World
The Evolution of Abuse Deterrent Drug Formulations: Testing Effectiveness from the Benchtop to the Real World Richard C. Dart, MD, PhD Director, Rocky Mountain Poison and Drug Center Executive Director,
More informationKey points. o Potential for nonmedical use, abuse, and diversion of new products
RADARS System Technical Report # 2012Q2-1 Use of unique recipients of dispensed drug (URDD) in assessing the burden of abuse, misuse, and diversion of prescription opioid products Key points Considering
More informationDiversion, misuse and trafficking of methadone and buprenorphine
Diversion, misuse and trafficking of methadone and buprenorphine Global Addiction Conference Richard C. Dart, MD, PhD Professor, University of Colorado Prescription Opioid Deaths are Rising Internationally
More informationAbuse, Misuse, and Diversion of Prescription Opioids: Evaluating the Problem and Proposed Solutions
Abuse, Misuse, and Diversion of Prescription Opioids: Evaluating the Problem and Proposed Solutions Eric Lavonas, MD, FACEP, FACMT, FAACT Associate Director, Rocky Mountain Poison & Drug Center Denver
More informationSetting the Stage: Are Abuse-Deterrent Opioids Formulations Ready for Prime Time?
Setting the Stage: Are Abuse-Deterrent Opioids Formulations Ready for Prime Time? Lewis S. Nelson, MD New York University School of Medicine New York City Poison Control Center Opioid Abuse Liability
More informationA LOOK AT ABUSE-DETERRENT OPIOIDS
JULY 2017 Drugs Under Review ICER s report reviewed evidence on ten abuse-deterrent formulations (ADF) of opioids. Nine of the drugs were extended release (ER) opioids, and one was immediate release (IR).
More informationEffect of Abuse-Deterrent Formulations and IR Opioids on Abuse, Overdose and Death from Rx Opioids
Effect of Abuse-Deterrent Formulations and IR Opioids on Abuse, Overdose and Death from Rx Opioids Richard C. Dart, MD, PhD Executive Director, RADARS System Professor, University of Colorado Competing
More informationDo Pre Marketing Studies Anticipate Post Market Consequences? A Case Study of Reformulated Oxycontin
Do Pre Marketing Studies Anticipate Post Market Consequences? A Case Study of Reformulated Oxycontin Edward M. Sellers MD, PhD, FRCPC, FACP Professor Emeritus, University of Toronto Principal, DL Global
More informationValue of Abuse-Deterrent Opioids. For your personal use. Not for further distribution.
Value of Abuse-Deterrent Opioids HHS Data Show that Prescription Opioid Abuse Continues To Be a Serious Public Health Issue At least half of all opioid overdose deaths in the United States (US) involve
More informationDiversion, Misuse and Trafficking of Methadone and Buprenorphine in the US and Europ
Diversion, Misuse and Trafficking of Methadone and Buprenorphine in the US and Europ Richard C. Dart, MD, PhD Director, Rocky Mountain Poison and Drug Center Professor, University of Colorado Prescription
More informationEvaluating the Impact of Abuse Deterrent Formulations: Methodological Challenges in Postmarketing Data
Evaluating the Impact of Abuse Deterrent Formulations: Methodological Challenges in Postmarketing Data Judy A. Staffa, Ph.D., R.Ph. Associate Director for Public Health Initiatives Office of Surveillance
More informationOXYCONTIN Diversion & Abuse Drug Enforcement Administration Office of Diversion Control October 2003
OXYCONTIN Diversion & Abuse Office of Diversion Control October 2003 OXYCONTIN OxyContin is a controlled release form of Schedule II oxycodone Manufactured in tablet form and intended for oral ingestion
More informationDan Cohen Forum Chair - Abuse DeterrentCoalition. Abuse Deterrent Formulations of Opioids and the Abuse Deterrent Coalition
Dan Cohen Forum Chair - Abuse DeterrentCoalition Abuse Deterrent Formulations of Opioids and the Abuse Deterrent Coalition Prescription Drug Abuse and Diversion Partnering with Law Enforcement, Anti-Drug
More informationPostmarketing Surveillance of Prescription Drug Abuse
Postmarketing Surveillance of Prescription Drug Abuse August 13, 2013 Richard C. Dart, MD, PhD Director, Rocky Mountain Poison and Drug Center, Denver, Colorado Professor, University of Colorado School
More informationInterventions in Prescription Opioid Abuse Do (or can) Prescription Monitoring Programs Make a Difference?
Interventions in Prescription Opioid Abuse Do (or can) Prescription Monitoring Programs Make a Difference? Richard C. Dart, MD, PhD Executive Director of RADARS System, Denver, Colorado Professor, University
More informationKey points. Background
RADARS System Technical Report # 2012Q3-1 Prescription Opioid Abuse and Misuse rates from RADARS System are Highly Correlated with Rates from The Drug Abuse Warning Network (DAWN) Key points The RADARS
More informationVirtual Mentor American Medical Association Journal of Ethics April 2014, Volume 16, Number 4:
Virtual Mentor American Medical Association Journal of Ethics April 2014, Volume 16, Number 4: 279-283. POLICY FORUM OxyContin, the FDA, and Drug Control Gary M. Reisfield, MD One percent of people will
More informationPrescription Drug Abuse: Colorado and Nationwide
Prescription Drug Abuse: Colorado and Nationwide Eric Lavonas, MD Associate Director, Rocky Mountain Poison and Drug Center Associate Professor, University of Colorado School of Medicine 1 What s the Problem?
More information25/03/2014. Workshop Overview. Hot Topics in FDA Regulations and Pharmacotherapy Research that Impact Patient Care:
Hot Topics in FDA Regulations and Pharmacotherapy Research that Impact Patient Care: Sharon L. Walsh, Ph.D. Shanna Babalonis, Ph.D. Michelle Lofwall, M.D. Center on Drug and Alcohol Research Department
More informationHydrocodone 10mg vs oxycodone 10 mg. What is the difference between oxycontin and oxycodone hcl 1 acetaminophen with oxycodone and roxicodone 5mg
TE Te Hydrocodone 10mg vs oxycodone 10 mg What is the difference between oxycontin and oxycodone hcl 1 acetaminophen with oxycodone and roxicodone 5mg Manufacturer of oxycodone hcl 15 mg tablet side effects
More informationPrescription Opioid Abuse: Abuse-Deterrent Opioids as Part of a Multipronged Approach. For Pfizer Use Only
Prescription Opioid Abuse: Abuse-Deterrent Opioids as Part of a Multipronged Approach Table of Contents Chronic Pain and Prescription Opioids Source of Prescription Opioids and Patient Risk Assessment
More informationIdentification of Specific Drugs and Drug Diversion in Drug Overdose Fatalities
Identification of Specific Drugs and Drug Diversion in Drug Overdose Fatalities Svetla Slavova, PhD Sara LaMantia, MS Terry Bunn, PhD Tracey Corey, MD 2016 Safe States Annual Meeting April 13, 2016, Albuquerque,
More informationRADARS System International Pre-Symposium 11 May Global Insights in Prescription Drug Misuse
RADARS System International Pre-Symposium 11 May 2017 Global Insights in Prescription Drug Misuse WELCOME 2 The Global Mosaic: RADARS System International Program Updates Jody L. Green, PhD, CCRP Director
More informationPolicy and Political Dynamics of the Opioid Addiction Crisis in the United States
Policy and Political Dynamics of the Opioid Addiction Crisis in the United States Mark W. Parrino, M.P.A. July 21, 2018 15 th Annual Midwest Conference on Problem Gambling and Substance Abuse Hilton Kansas
More informationUnderstanding the US Opioid Analgesic Market
Understanding the US Opioid Analgesic Market Key Trends & Market Snapshot December 2017 Purdue Pharma L.P. provided funding and content review for this report. Avalere Health maintained full editorial
More informationMayors Opioid Summit PATTERNS AND TRENDS OF THE OPIOID EPIDEMIC IN BROWARD COUNTY TYPES OF OPIOIDS DEFINITION OF OPIOID. Pill Press from China
The Opioid Epidemic In Broward County 8/24/217 Mayors Opioid Summit PATTERNS AND TRENDS OF THE OPIOID EPIDEMIC IN BROWARD COUNTY Jim Hall Senior Epidemiologist Center for Applied Research on Substance
More informationIn Vitro Considerations for Development Abuse Deterrent Dosage Forms
In Vitro Considerations for Development Abuse Deterrent Dosage Forms Presentation to AAPS Annual Meeting Nov 3, 2014 Nagesh Bandi, Ph.D. Global CMC New Products Pfizer Inc. 1 Disclaimer The thoughts and
More informationAbuse-Deterrent Formulations of Opioids: Effectiveness and Value
Abuse-Deterrent Formulations of Opioids: Effectiveness and Value Evidence Report June 28, 2017 Prepared for: Institute for Clinical and Economic Review, 2017 ICER Staff/Consultants Reiner Banken, MD, MSc
More informationEvolution of the Opioid Epidemic
Clinical Directors Network, Inc. (CDN) Evolution of the Opioid Epidemic February 5, 2018 2:30 PM-4:00 PM EST Richard C. Dart, MD, PhD Director, Rocky Mountain Poison and Drug Center, Denver Health Professor,
More informationEvolution of the Opioid Epidemic
NYSAM - Intersection of Science, Policy and Treatment Evolution of the Opioid Epidemic Richard C. Dart, MD, PhD Director, Rocky Mountain Poison and Drug Center, Denver Health Professor, University of Colorado
More informationThe Epidemiology of Fatal Drug Overdoses: Potential for Prevention
The Epidemiology of Fatal Drug Overdoses: Potential for Prevention Len Paulozzi, MD, MPH National Center for Injury Prevention and Control Centers for Disease Control and Prevention Presented at Promising
More informationPrescription Drug Abuse: Prevention and Treatment Across the Continuum of Care
Prescription Drug Abuse: Prevention and Treatment Across the Continuum of Care Scott P. Novak, Ph.D. Senior Research Scientist RTI International RTI International is a trade name of Research Triangle Institute.
More informationStrategies to Manage The Opioid Crisis
Strategies to Manage The Opioid Crisis Matt Feehery, LCDC Senior Vice President & CEO PaRC (Prevention & Recovery Center) Behavioral Health Services February 1, 2018 A Pill for Your Pain But my doctor
More informationOpioid Analgesics. Recommended starting dose for opioid-naïve patients
Opioid Analgesics Goals: Restrict use of opioid analgesics to OHP-funded conditions with documented sustained improvement in pain and function and with routine monitoring for opioid misuse and abuse. Promote
More informationOpioid Prescribing Guidelines for Patients in the Emergency Department
Opioid Prescribing Guidelines for Patients in the Emergency Department and Immediate Care Centers These guidelines are meant to assist clinicians in treating patients with acute and chronic pain in the
More informationAbuse-Deterrent Formulations
Abuse-Deterrent Balancing Evidence with Value Tyson Thompson, PharmD Clinical Consultant Pharmacist University of Massachusetts Medical School Clinical Pharmacy Services Disclosure Statement I have no
More informationCAN YOU INJECT A G77 OPANA
CAN YOU INJECT A G77 OPANA Can You Inject A G77 Opana Opana taper after using for 3 weeks Can you cut opana er in half safely Opana sirloin tip roast recipe oven recipes easy recipes easy What is comparable
More informationHOW TO PREPARE OXYCONTIN FOR INJECTION
HOW TO PREPARE OXYCONTIN FOR INJECTION How To Prepare Oxycontin For Injection Oxycontin epidemic article 15 clothing Oxycontin express report card 50 mg oxycontin identification card How much is 75 mg
More information9/5/2011. Outline. 1. Past and Current Trends re: RX Abuse 2. Diversion Methods 3. Regulatory Reporting Requirements 4. Q/A
Prescription Drug Abuse Crises Outline 1. Past and Current Trends re: RX Abuse 2. Diversion Methods 3. Regulatory Reporting Requirements 4. Q/A 1 1970s 1980s 2 The 1990s OXYCODONE Oxycodone/APAP OxyContin
More informationRAPID Analysis of Routes of Administration: Oral to Non-Oral Transitions
RAPID Analysis of Routes of Administration: Oral to Non-Oral Transitions Dr. Theodore J. Cicero, PhD John P. Feighner Professor of Psychiatry Washington University in St. Louis, MO RAPID Program Overview
More informationArticle #2 Prescription Drug Overdose CDC: Centers for Disease Control and Prevention. Understanding the Epidemic
Article #2 Prescription Drug Overdose CDC: Centers for Disease Control and Prevention Understanding the Epidemic When the Prescription Becomes the Problem In a period of nine months, a tiny Kentucky county
More informationBlueprint for Prescriber Continuing Education Program
CDER Final 10/25/11 Blueprint for Prescriber Continuing Education Program I. Introduction: Why Prescriber Education is Important Health care professionals who prescribe extended-release (ER) and long-acting
More informationNumber of Drug-related ER Visits by Day, January - December 2017
D - E R V, J D, D B : A, From January, through December,, emergency rooms (ERs) in Cuyahoga County treated an estimated, patients presenting with drug-related injuries (inclusive of prescription and illicit
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Reference Number: CP.CPA.259 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory
More informationThe Challenge of Treating Pain
FDA Charge to the Committee: FDA Opioid Action Plan and Incorporating the Broader Public Health Impact into the Formal Risk-Benefit Assessment for Opioids Robert M. Califf, MD Commissioner of Food and
More informationReference ID: NDA was approved on December 12, The product was not formulated with properties to deter abuse,
tablets (NDA 020553). 1 According to Purdue, the reformulated OxyContin (OCR) had controlled-release features that would be less easily compromised by tampering than the original OxyContin (OC), and thereby
More informationTrends in Opioid Analgesic Abuse and Mortality in Europe
Current Challenges of Opioids EAPCCT Annual Congress 26 May 2016 Trends in Opioid Analgesic Abuse and Mortality in Europe Jody L. Green, PhD, CCRP Denver Health Rocky Mountain Poison & Drug Center Disclosure
More informationPrescription Opioids
What are prescription opioids? Prescription Opioids Opioids are a class of drugs naturally found in the opium poppy plant. Some prescription opioids are made from the plant directly, and others are made
More informationAppearance before House of Commons Standing Committee on Health as part of its Study on the Government s Role in Addressing Prescription Drug Abuse
Opening Statement Appearance before House of Commons Standing Committee on Health as part of its Study on the Government s Role in Addressing Prescription Drug Abuse Dr. Chris Simpson, President-elect
More informationPrescription Drug Monitoring Program Update. Rebecca R. Poston, BPharm., MHL Program Manager August 26, 2017
Prescription Drug Monitoring Program Update Rebecca R. Poston, BPharm., MHL Program Manager August 26, 2017 Objectives Brief historical overview of opioids Review of PDMP information Discuss ideas from
More informationIncrease in Opioid Related Deaths What the Data Can Tell us. Ontario Methadone Prescriber s Conference November 7, 2014 Tara Gomes
Increase in Opioid Related Deaths What the Data Can Tell us Ontario Methadone Prescriber s Conference November 7, 2014 Tara Gomes Objectives Prescription Opioid Misuse and Abuse: How did we get here? Opioid
More informationRichard C. Dart, MD, PhD Executive Director, RADARS System Denver Health and Hospital Authority
Richard C. Dart, MD, PhD Executive Director, RADARS System Denver Health and Hospital Authority RADARS System 12 th Annual Scientific Meeting 95 Registrants Government 26 Academic 14 Industry/Pharma 28
More informationFentanyl, Opioid Overdose and Naloxone
Fentanyl, Opioid Overdose and Naloxone Opioid Agonist Therapy Conference Saskatoon, SK April, 2016 Declaration No conflict of interest. Consultant in Addiction Medicine, SHR. Chair, College of Physicians
More informationOpioids drive continued increase in drug overdose deaths
CDC: Drug overdose deaths increase for 11th consecutive year Opioids drive continued increase in drug overdose deaths Atlanta, GA, USA (February 20, 2013) - Drug overdose deaths increased for the 11th
More informationTop 10 narcotic pain pills
Top 10 narcotic pain pills Click to go to the item or just scroll down the page. Doctors Respond to FDA Panel Recommendations FDA Considers Banning Popular Prescription Pain Medications and. Top 10 Natural
More informationWhat is an opioid? What do opioids do? Why is there an opioid overdose crisis? What is fentanyl? What about illicit or bootleg fentanyls?
What is an opioid? What do opioids do? Why is there an opioid overdose crisis? What is fentanyl? What about illicit or bootleg fentanyls? What is an opioid? What do opioids do?: The term opioid can be
More informationOHIO S OPIOID DRUG OVERDOSE EPIDEMIC: CONTRIBUTING FACTORS AND ONGOING PREVENTION EFFORTS
OHIO S OPIOID DRUG OVERDOSE EPIDEMIC: CONTRIBUTING FACTORS AND ONGOING PREVENTION EFFORTS DEFINITIONS Opiate- originate from naturally-occurring elements found in the opium poppy plant. These drugs are
More informationTrends in Opioid Analgesic Abuse and Mortality in the United States
The new england journal of medicine special article Trends in Opioid Analgesic Abuse and Mortality in the United States Richard C. Dart, M.D., Ph.D., Hilary L. Surratt, Ph.D., Theodore J. Cicero, Ph.D.,
More informationOpioid Addiction Statistics
May 2017 Opioid Addiction Statistics Definitions Heroin Epidemic - As pill mills close, prescribing is becoming tighter, demand among younger users rise, and dealer s profits rise, addicts are turning
More informationMorphine er to oxycontin conversion
Morphine er to oxycontin conversion The Borg System is 100 % Morphine er to oxycontin conversion 17-4-2011 Conversion dose from Oxycontin 40mg 3x a day to morphine sulfate 15 mg?. Oxycontin vs morphine
More informationPharmacy Medical Necessity Guidelines: Opioid Analgesics
Pharmacy Medical Necessity Guidelines: Effective: January 1, 2019 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX) or Medical (MED) Benefit
More informationGabapentin diversion and misuse in the United States from a law enforcement perspective: Diversion rates and qualitative research findings
Gabapentin diversion and misuse in the United States from a law enforcement perspective: Diversion rates 2002-2015 and qualitative research findings Mance E. Buttram, PhD Steven P. Kurtz, PhD 2 nd European
More informationPreventing Opioid Misuse and Use: The Lucky Preventionist s Guide to Strategic Planning
Preventing Opioid Misuse and Use: The Lucky Preventionist s Guide to Strategic Planning 1 2 LUCK Where Preparation Meets Opportunity Opioids: Understanding how we got here How History Repeats Some Opiate
More informationUnderstanding and Combating the Heroin Epidemic
Understanding and Combating the Heroin Epidemic Kelly Dunn, Ph.D. Assistant Professor; Johns Hopkins School of Medicine Department of Psychiatry and Behavioral Sciences 1 Talk Outline What is causing the
More informationWashington State PMP Data Mapping Project
Washington State PMP Data Mapping Project 2014 Category 3 Grant Harold Rogers Category 3 Grantee Meeting February 25, 2015 Washington State BACKGROUND: OPIOID ISSUES AND PLANNING 2 WA Unintentional Opioid
More information10 mg hydrocodone equals how much oxycodone
Cari untuk: Cari Cari 10 mg hydrocodone equals how much oxycodone Posts about dilaudid 8 vs oxycodone 30 written by buyprescriptionmedication. Can you help me with the conversion of Oxycodone IR (5mg tab)
More information2004-L SEPTEMBER
BULLETIN INTELLIGENCE Buprenorphine: Potential for Abuse Product No. 2004-L0424-013 SEPTEMBER 2004 U. S. D E P A R T M E N T O F J U S T I C E NDIC Within the past 2 years buprenorphine a Schedule III
More informationReductions in reported deaths following the introduction of extendedrelease oxycodone (OxyContin) with an abuse-deterrent formulation
pharmacoepidemiology and drug safety 2014; 23: 1238 1246 Published online 11 June 2014 in Wiley Online Library (wileyonlinelibrary.com).3658 ORIGINAL REPORT Reductions in reported deaths following the
More informationRole of PMPs in Preventing Substance Abuse National Conference of State Legislatures December 6, 2006 San Antonio, Tx
Role of PMPs in Preventing Substance Abuse National Conference of State Legislatures December 6, 2006 San Antonio, Tx Nick Reuter Division of Pharmacologic Therapy Substance Abuse and Mental Health Services
More informationOpana 15 mg street price new formulation
Opana 15 mg street price new formulation Search 28-11-2017 Our Word of the Year choice serves as a symbol of each year s most meaningful events and lookup trends. It is an opportunity for us to reflect
More informationLong-Acting Opioid Analgesics
Market DC Long-Acting Opioid Analgesics Override(s) Prior Authorization Step Therapy Quantity Limit Approval Duration Initial request: 3 months Maintenance Therapy: Additional prior authorization required
More informationIdentifying Key Characteristics and Habits of the Recreational Drug User
Identifying Key Characteristics and Habits of the Recreational Drug User Beatrice Setnik, PhD VP Scientific & Medical Affairs, Early Phase CBI Abuse Deterrent Formulations Summit Alexandria, VA March 7,
More informationBree Collaborative AMDG Opioid Prescribing Guidelines Workgroup. Opioid Prescribing Metrics - DRAFT
Bree Collaborative AMDG Opioid Prescribing Guidelines Workgroup Opioid Prescribing Metrics - DRAFT Definitions: Days Supply: The total of all opioid prescriptions dispensed during the calendar quarter
More informationLong-Acting Opioid Analgesics
Market DC Long-Acting Opioid Analgesics Override(s) Prior Authorization Step Therapy Quantity Limit Approval Duration Initial request: 3 months Maintenance Therapy: Additional prior authorization required
More informationLong-term use of opioid prescriptions and prospects for innovation in prevention, treatment and pain management
Long-term use of opioid prescriptions and prospects for innovation in prevention, treatment and pain management Enterprise Research and Development Clinical Innovation Report Table of Contents Executive
More informationAttitudes Toward Medication-Assisted Treatment Within a Drug Court Program. Caroline Allison. Dr. Kathleen Moore, Ph.D.
Running Head: MEDICATION-ASSISTED TREATMENT ATTITUDES Attitudes Toward Medication-Assisted Treatment Within a Drug Court Program Caroline Allison Dr. Kathleen Moore, Ph.D. Department of Mental Health Law
More informationDrug and Alcohol Dependence
Drug and Alcohol Dependence 149 (2015) 117 121 Contents lists available at ScienceDirect Drug and Alcohol Dependence journal homepage: www.elsevier.com/locate/drugalcdep Trends in abuse and misuse of prescription
More informationEgalet Corporate Presentation
Egalet Corporate Presentation Specialty Pharmaceutical Company Focused on Pain 1 NASDAQ: EGLT Forward-Looking Statements Statements included in this presentation that are not historical in nature are "forward-looking
More informationLessons Learned from the US Prescription Opioid Abuse Epidemic
Lessons Learned from the US Prescription Opioid Abuse Epidemic Michelle Lofwall, M.D. University of KY, Dept. of Psychiatry Center on Drug and Alcohol Research October 3, 2012 Outline for today s talk
More informationSpotlight on Health Policy Beyond the Clinical: The Opioid Epidemic. October 25, 2017
Spotlight on Health Policy Beyond the Clinical: The Opioid Epidemic October 25, 2017 Disclosures and Disclaimer Neither the Institute for Health Policy and Leadership (IHPL) nor I have any relevant financial
More informationOpioid Harm Reduction
Opioid Harm Reduction Lucas G. Hill, PharmD Clinical Assistant Professor, The University of Texas at Austin College of Pharmacy Clinical Pharmacist, CommUnityCare FQHCs Director, Operation Naloxone Mark
More informationWashington State s Overdose Epidemic
Caleb Banta-Green PhD MPH MSW Senior Research Scientist- Alcohol and Drug Abuse Institute Affiliate Associate Professor- School of Public Health Affiliate Faculty- Harborview Injury Prevention & Research
More information3/16/2018. Responding to a crisis. Opioid Overdose Prevention
Opioid Overdose Prevention Responding to a crisis Agenda History of Opiates in the U.S. Understanding Opiates and New Developments Opioid Overdose: Physiology and Risk Factors Opioid Overdose: Signs and
More informationKentucky All Schedule Prescription Electronic Reporting (KASPER)
Kentucky All Schedule Prescription Electronic Reporting (KASPER) Phyllis Millspaugh Manager, Behavioral Health Prevention and Promotion Kentucky Cabinet for Health and Family Services Using PDMP Data to
More informationSession VI. Presenter Disclosure Information. Learning Objectives for Session VI. Prescribing Information. Prescribers Must Be Knowledgeable
SAFE Opioid Prescribing Strategies. Assessment. Fundamentals. Education 4 6pm SPEAKERS Charles Argoff, MD, FABPM Michael Brennan, MD, FACP, FASAM Jeffrey Gudin, MD Presenter Disclosure Information The
More informationRecognizing Narcotic Abuse and Addiction and Helping Those With It
Recognizing Narcotic Abuse and Addiction and Helping Those With It Michael McNett, MD Medical Director for Chronic Pain Member, WI Med Society Opioid Subcommittee Ancient History 1995: OxyContin approved
More informationDisclaimer. New Technologies for Abuse Prevention and Treatment. Sanford M. Silverman, MD
New Technologies for Abuse Prevention and Treatment Sanford M. Silverman, MD Disclaimer Speaker: Purdue, Depomed, DSI, BDSI, AZ Institute of Pain Management, Pompano Beach, Florida Medical Director, Compassionate
More information6/6/2017. The Role of ADFs in Curbing Opioid Abuse Can ADFs Reduce Opioid Abuse? 12-Month Financial Disclosures* Objectives
The Role of ADFs in Curbing Opioid Abuse Can ADFs Reduce Opioid Abuse? Lynn R. Webster, M.D. Vice President of Scientific Affairs PRA Health Sciences Salt Lake City, UT LRWebsterMD@gmail.com (801) 892-5140
More informationOHIO S PRESCRIPTION DRUG OVERDOSE EPIDEMIC:
Cuyahoga County Board of Health OHIO S PRESCRIPTION DRUG OVERDOSE EPIDEMIC: NOVEMBER 5, 2014 CONTRIBUTING FACTORS AND ONGOING PREVENTION EFFORTS DEFINITIONS Opiate- originate from naturally-occurring elements
More informationPK/PD analysis in assessment of abuse deterrence
PK/PD analysis in assessment of abuse deterrence Megan J. Shram, PhD Director and Principal, Altreos Research Partners Inc. Adjunct Professor and Lecturer, Department of Pharmacology, University of Toronto
More informationExpanding hot-melt extrusion based abuse-deterrent formulation technology from extended release (ER) to immediate release (IR) application
Protect the pill, protect the people. Expanding hot-melt extrusion based abuse-deterrent formulation technology from extended release (ER) to immediate release (IR) application Grünenthal 216 www.grunenthal.com
More informationFact Sheet. Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII
Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII Fact Sheet Zohydro ER (hydrocodone bitartrate) Extended-Release Capsule, CII, is a long-acting (extendedrelease) type of pain medication
More informationAbuse of opioid painkillers in the US is a major problem
As appeared in January 2018 Tablets & Capsules www.tabletscapsules.com formulation Abuse-deterrent formulation technologies: Opportunities and limitations Alyn McNaughton Lonza Too many Americans are misusing
More informationAbuse Deterrent Opioid Formulations Claire Saadeh, PharmD, BCOP / August 2017
Opioid Formulations Claire Saadeh, PharmD, BCOP / August 2017 Introduction 1,2 Dilemma: Providing balance between providing appropriate access to opioid products in patients who truly need them AND addressing
More informationPRESCRIPTION DRUG ABUSE: THE NATIONAL PERSPECTIVE
PRESCRIPTION DRUG ABUSE: THE NATIONAL PERSPECTIVE September 20, 2013 Association of State and Territorial Health Officials Annual Meeting R. Gil Kerlikowske Director of National Drug Control Policy National
More informationInjection Drug Use in the United States
Injection Drug Use in the United States M. Fe Caces Office of National Drug Control Policy Executive Office of the President Washington, DC 20503 Presentation at the Treatment Demand Indicators Expert
More information