EXECUTIVE SUMMARY INNOVATION IS THE KEY TO CHANGING THE PARADIGM FOR THE TREATMENT OF PAIN AND ADDICTION TO CREATE AN AMERICA FREE OF OPIOID ADDICTION
|
|
- Leon Hicks
- 5 years ago
- Views:
Transcription
1 EXECUTIVE SUMMARY INNOVATION IS THE KEY TO CHANGING THE PARADIGM FOR THE TREATMENT OF PAIN AND ADDICTION TO CREATE AN AMERICA FREE OF OPIOID ADDICTION The Bitechnlgy Innvatin Organizatin (BIO) and ur member cmpanies are cmmitted t unleashing the pwer f scientific innvatin t develp slutins that will allw fr an America free f prescriptin piid addictin. BIO believes this plan shuld rest n three legs. 1. ADVANCE OUR UNDERSTANDING OF THE BIOLOGY OF PAIN AND ADDICTION TO ENABLE THE DEVELOPMENT OF INNOVATIVE TREATMENTS FOR PAIN AND ADDICTION AND ENSURE APPROPRIATE AND OPTIMAL USE OF EXISTING THERAPIES Supprt a mre cmprehensive understanding f the preclinical pain and addictin envirnment Supprt investment in research at Natinal Institutes f Health (NIH)and ther majr centers fcused n the bilgy f pain and addictin 2. ENSURE PATIENTS SUFFERING FROM PAIN OR ADDICTION ARE ABLE TO RECEIVE THE RIGHT TREATMENT AT THE RIGHT TIME WITH THE RIGHT SUPPORT, WITHOUT STIGMA Remve cverage and reimbursement barriers that are preventing patient-centric decisins abut and access t the mst effective treatments fr pain and addictin Advance implementatin f and adherence t laws and regulatins prtecting and prmting access t resurces fr cmprehensive pain and addictin treatment 3. STIMULATE RESEARCH & DEVELOPMENT (R&D) OF INNOVATIVE TREATMENTS THAT EFFECTIVELY TREAT PAIN AND OPIOID ADDICTION AND PREVENT ABUSE Increase leadership engagement, expertise, and resurces within the Fd and Drug Administratin (FDA) and the Drug Enfrcement Agency (DEA) t prmte effective and efficient review f innvative treatments fr pain and addictin Mdernize and streamline drug develpment and review prcesses t enable effective and efficient drug develpment and review, and stimulate investment in innvatin Establish and utilize expedited apprval pathways and ther incentives t stimulate innvatin
2 Nvember 1, 2017 Page 2 f 6 ADVANCE OUR UNDERSTANDING OF THE BIOLOGY OF PAIN AND ADDICTION TO ENABLE THE DEVELOPMENT OF INNOVATIVE TREATMENTS FOR PAIN AND ADDICTION AND ENSURE APPROPRIATE AND OPTIMAL USE OF EXISTING THERAPIES Understanding the bilgy underlying pain and addictin are critical t supprting the discvery f nvel and safer treatments fr bth pain and addictin as well as fr ensuring that patients receive the right treatment at the right time, with the right supprt, and withut stigma. Unfrtunately, ur current understanding f pain and addictin bilgy is lacking. Supprt a mre cmprehensive understanding f the preclinical pain and addictin envirnment A mre cmprehensive understanding f mechanisms underlying different types f pain as well as bimarkers that allw fr the differentiatin f pain subsets, and identificatin f preclinical mdels that better translate t therapeutic utcmes fr peple are needed t infrm the develpment f nvel and safer treatments. Supprt research investigating ptential therapeutic targets with increased receptr/intracellular signaling selectivity Supprt research investigating nvel mechanisms fr preventing and/r treating piid addictin and verdse Supprt the identificatin and validatin f bimarkers that identify subsets f pain and mre accurately predict treatment respnse fr bth pain and addictin Supprt the identificatin and utilizatin f mre effective drug screening mdels and assays that better translate t therapeutic utcmes fr patients Supprt research fcused n elucidating the underlying bilgical mechanisms f different types f pain and addictin, as well as differences in pain perceptin Supprt a mre cmprehensive understanding f the clinical pain and addictin envirnment Cmprehensive methds fr evaluating pain in the patient, tls that allw fr better diagnsis f pain, as well as the establishment f clinical trial registries, clinical trial netwrks, and data sharing and analytics will be critical fr ensuring that patients are able t receive the mst apprpriate treatment. Encurage the develpment and use, in bth the clinic and clinical trial setting, f mre cmprehensive and bjective tls fr assessing pain that take int accunt acute versus chrnic pain, the pssible neurbilgical and psychscial mechanisms underlying pain, individual differences in pain perceptin, and distinctins between smatic and psychic pain Supprt research int the develpment f diagnstic tls that enable the identificatin f specific causes f pain
3 Nvember 1, 2017 Page 3 f 6 Prmte multi-disciplinary appraches t treating pain and addictin by enabling appraches fr determining risk r susceptibility fr individual patients, and assciate utcmes with the basic neurbilgy and/r pharmaclgical alteratins Establish clinical trial registries and clinical trial netwrks fr pain and addictin t help develp, validate, refine, and deliver new treatment ptins t patients Encurage public and private payers, academic researchers, and industry spnsrs t apply data analytic methdlgies t answer imprtant questins abut pain and addictin treatment, including but nt limited t: Which treatments wrk best fr whm? What is the ptimal duratin f specific treatments? When shuld a patient s treatment regimen be changed, and hw? Given the critical rle that treatment must play in ending the piid epidemic, every effrt shuld be made t maximize the use f data t guide plicy-making decisins that supprt the mst effective appraches. INNOVATION IS THE KEY TO CHANGING THE PARADIGM FOR THE TREATMENT OF PAIN AND ADDICTION TO CREATE AN AMERICA FREE OF OPIOID ADDICTION The Bitechnlgy Innvatin Organizatin (BIO) and ur member cmpanies are cmmitted t unleashing the pwer f scientific innvatin t develp slutins that will allw fr an America free f prescriptin piid addictin. ENSURE PATIENTS SUFFERING FROM PAIN OR ADDICTION ARE ABLE TO RECEIVE THE RIGHT TREATMENT AT THE RIGHT TIME WITH THE RIGHT SUPPORT, WITHOUT STIGMA Patients suffering frm pain r addictin shuld have knwledge f, access t, and cverage fr all available medicines in rder t make infrmed decisins abut their treatment. A patient-centric apprach t the treatment f pain and addictin will help prevent piid addictin and prvide better care fr thse wh are diagnsed with addictin. Remve cverage and reimbursement barriers that are preventing patientcentric decisins abut and access t the mst effective treatments fr pain and addictin The healthcare cverage and reimbursement system includes barriers t current treatment ptins fr pain and addictin, and presents ptential barriers fr access t advances in treatment. Addressing these cverage issues is imperative t delivery f the right treatment at the right time fr each patient suffering frm pain and addictin. Establish apprpriate payer cverage pathways fr current pain and addictin treatments and innvative treatment ptins (sme examples include but are nt limited t nn-piid treatments, practitiner-administered (r nn-ral), and abuse deterrent frmulatins) including:
4 Nvember 1, 2017 Page 4 f 6 Ensure that the rute r lcatin f administratin f specific pain r addictin treatments des nt hinder patient access t treatment Secure timely designatin f specific healthcare payment cdes fr each apprved therapy fr pain and addictin fr adequate reimbursement f therapies Eliminate insurance cverage barriers that impact patient access t the mst apprpriate r mst timely curse f treatment fr their given cnditin (i.e., step-therapy, fail first, cst sharing requirements, care limits n substance use disrder treatment) Prvide cverage fr medicatin assisted treatment (MAT) fr substance use disrders and fr all Fd and Drug Administratin (FDA) apprved substance abuse disrder treatments acrss health insurance access pints Withdrawal f cverage fr nn-abuse deterrent frmulatins when abuse deterrent frmulatins with identical patient utcmes are available Advance implementatin f and adherence t laws and regulatins prtecting and prmting access t resurces fr cmprehensive pain and addictin treatment Recent and future legislative and regulatry activities include critical refrms t ensure patient access t cmprehensive treatment fr pain and addictin and activities t cmbat the piid crisis. Ensure equitable cverage fr treatment f substance use disrders as mandated under the Mental Health Parity and Addictin Equity Act (MHPAEA) Supprt prper implementatin f the aligned directives and activities f the Cmprehensive Addictin and Recvery Act (CARA) Supprt future legislative and regulatry effrts t revlutinize the treatment f and respnse t pain and addictin STIMULATE RESEARCH & DEVELOPMENT (R&D) OF INNOVATIVE TREATMENTS THAT EFFECTIVELY TREAT PAIN AND OPIOID ADDICTION AND PREVENT ABUSE Steady investments in drug discvery are critical fr drug develpment and fr bringing treatments t patients that need them. Over the past ten years investments in treatments fr pain have been incnsistent. Several factrs influence the lack f investments int treatments fr pain and addictin including uncertainty in bth cverage and access f treatments and drug develpment and regulatry review requirements. Mdernizatin f drug develpment and apprval prcesses, increased engagement between the FDA and industry spnsrs, and incentives fr the develpment f new therapies will help mitigate sme f these issues. Increase leadership engagement, expertise, and resurces within the Fd and Drug Administratin (FDA) and the Drug Enfrcement Agency (DEA) t
5 Nvember 1, 2017 Page 5 f 6 prmte effective and efficient review f innvative treatments fr pain and addictin Currently, limited resurces within the FDA and a lack f cmmunicatin between the FDA, the DEA, and industry spnsrs has led t inefficient review f nvel and safer treatments fr bth pain and addictin and have prevented individuals frm receiving apprpriate access t medicines that treat pain and addictin. Increased resurces within the FDA and imprved cmmunicatin between the FDA and industry spnsrs will help clarify the Agency s expectatins and speed apprval and access t nvel and safer treatments. Increase engagement f senir FDA leadership t supprt transparency, cnsistency, and effective cmmunicatin between FDA and industry spnsrs, thrughut the drug apprval prcess Increase engagement f senir FDA and DEA leadership t supprt transparency, cnsistency, and effective cmmunicatin with spnsrs t enable effective and efficient apprval prcesses and apprpriate access t medicines that treat pain and addictin Increase resurces and expertise within the FDA t ensure efficient and effective review f abuse deterrent frmulatins f cnventinal piids, nvel and safer treatments, and innvative treatments that have, in general, lwer r n abuse liability Advance the develpment f FDA draft guidance and encurage clarity in existing guidance t address issues related t abuse deterrent frmulatins and analgesic indicatins in a way that supprts innvatin Ensure that best practices are adpted by FDA divisins respnsible fr reviewing treatments fr pain and addictin Ensure cnsistent applicatin f warnings and ther safety infrmatin regardless f diagnsis fr all piid medicatins apprved fr the treatment f pain and addictin Encurage glbal harmnizatin f regulatry requirements fr treatments fr pain and addictin Mdernize and streamline drug develpment and review prcesses t enable effective and efficient drug develpment and review, and stimulate investment in innvatin Current apprval requirements fr nvel and safer treatments fr pain and addictin are ften inefficient, redundant, and unsafe. Nt nly des this slw apprval but it is als prhibitive fr investments in pain and addictin treatments. The utilizatin f innvative clinical trial designs, and new data surces, as well as the validatin and quantificatin f bimarkers fr pain and addictin will allw fr mre effective, efficient, and safer drug develpment and review. Mdernize and streamline clinical trial requirements by streamlining the number f clinical trials required fr each type f pain and utilizatin f mdern appraches fr the cllectin f safety data. Encurage the utilizatin f innvative clinical trials designs and new data surces that allw fr the use f cmmn cntrl data t evaluate efficacy in multiple therapies and reduce the number f individuals expsed t cntrl interventins
6 Nvember 1, 2017 Page 6 f 6 Enable validatin and qualificatin f bimarkers that help identify subsets f pain r risk fr addictin Establish and utilize expedited apprval pathways and ther incentives t stimulate innvatin While there is a clear need t develp and apprve nvel and safer treatments fr pain and addictin, drug develpment is risky, and time and resurce intensive. Several accelerated apprval pathways and incentives have been successfully implemented t encurage innvatin and investment in ther areas that are in urgent need f treatments, including rare diseases (Orphan Drug Act) and antibitics that are effective against drug resistant bacteria (Generating Antibitic Incentives Nw (GAIN) Act). Similar appraches shuld be implemented in rder t encurage investments fr the develpment f nvel and safer treatments fr pain and addictin. Supprt the utilizatin f expedited apprval pathways fr nvel and safer treatments fr pain and addictin Supprt the utilizatin f additinal incentives fr nvel and safer treatments fr pain and addictin
2017 Optum, Inc. All rights reserved BH1124_112017
1) What are the benefits t clients f encuraging the use f MAT? Withut MAT, 90% f individuals with Opiid Use Disrder (OUD) will relapse within ne year. With MAT, the relapse rate fr thse with OUD decreases
More informationA. Catalonia World Health Organization Demonstration Project
A. Catalnia Wrld Health Organizatin Demnstratin Prject In 1989, the Health Department f Catalnia (Spain) and the Cancer Unit at the WHO (Geneva) designed and planned a demnstratin prject fr implementatin
More informationVCCC Research and Education Lead for Breast Cancer
VCCC Research & Educatin Lead VCCC Research and Educatin Lead fr VCCC Visin The Victrian Cmprehensive Cancer Centre (VCCC) will save lives thrugh the integratin f cancer research, educatin and clinical
More informationIndependent Charitable Patient Assistance Program (IPAP) Code of Ethics
Independent Charitable Patient Assistance Prgram (IPAP) Cde f Ethics Independent charitable patient assistance prgrams (IPAPs) fcus n the needs f patients wh are insured, meet certain financial limitatin
More informationState Health Improvement Plan Choosing Priorities, Creating a Plan. DHHS DPH - SHIP Priorities (Sept2016) 1
State Health Imprvement Plan 2017-2021 Chsing Pririties, Creating a Plan DHHS DPH - SHIP Pririties (Sept2016) 1 Creating a Plan: 2017-2021 SHIP Welcme! Wh s here? What is the State Health Imprvement Plan
More informationIll Health. Unit reference number: L/616/7295 Level: 3. Credit value: 3 Guided learning hours: 16. Unit summary
Unit 11: Understand Mental Ill Health Unit reference number: L/616/7295 Level: 3 Unit type: Optinal Credit value: 3 Guided learning hurs: 16 Unit summary Mental ill health culd be ne f the mst serius health
More informationOrange County Heroin Task Force: A targeted approach to improving outcomes
Orange Cunty Herin Task Frce: A targeted apprach t imprving utcmes Christpher Hunter, M.D., Ph.D. Directr, Orange Cunty Health Services Department Assciate Medical Directr, Orange Cunty EMS System Cntents
More informationMeeting the Nutritional Requirements of Individuals with Dementia
Unit 15: Understanding and Meeting the Nutritinal Requirements f Individuals with Dementia Unit reference number: D/616/7124 Level: 3 Unit type: Optinal Credit value: 3 Guided learning hurs: 26 Unit summary
More informationOntario s Approach to Federal Cannabis Legalization
Ontari s Apprach t Federal Cannabis Legalizatin Ontari s Key Areas f Fcus Ontari s regulatry apprach will align with the federal gvernment s legislative framewrk (see Appendix fr further detail n federal
More informationLEVEL OF CARE GUIDELINES: INTENSIVE BEHAVIORAL THERAPY/APPLIED BEHAVIOR ANALYSIS FOR AUTISM SPECTRUM DISORDER HAWAII MEDICAID QUEST
OPTUM LEVEL OF CARE GUIDELINES: INTENSIVE BEHAVIORAL THERAPY / APPLIED BEHAVIOR ANALYSIS FOR AUTISM SPECTRUM DISORDER HAWAII MEDICAID QUEST LEVEL OF CARE GUIDELINES: INTENSIVE BEHAVIORAL THERAPY/APPLIED
More informationNational Imaging Associates, Inc. (NIA) Frequently Asked Questions (FAQs) For Managed Health Services (MHS)
Questin GENERAL Why did MHS implement a Medical Specialty Slutins Prgram? Natinal Imaging Assciates, Inc. (NIA) Frequently Asked Questins (FAQs) Fr Managed Health Services (MHS) Answer Effective Nvember
More informationNational Imaging Associates, Inc. (NIA) Frequently Asked Questions (FAQs) For Louisiana Healthcare Connections Providers
Natinal Imaging Assciates, Inc. (NIA) Frequently Asked Questins (FAQs) Fr Luisiana Healthcare Cnnectins Prviders Questin GENERAL Why did Luisiana Healthcare Cnnectins implement a Medical Prgram? Answer
More informationNIA Magellan 1 Spine Care Program Interventional Pain Management Frequently Asked Questions (FAQs) For Medicare Advantage HMO and PPO
NIA Magellan 1 Spine Care Prgram Interventinal Pain Management Frequently Asked Questins (FAQs) Fr Medicare Advantage HMO and PPO Questin GENERAL Why is Flrida Blue implementing a Spine Management prgram
More informationStrategic Plan Publication No: EO-SP
Strategic Plan 2017-2019 Publicatin N: EO-SP-170223 +61 2 9036 5002 www.pcg.rg.au pcg.ffice@sydney.edu.au This dcument was prepared by the PCG Executive Office PCG Publicatin number: EO-SP-170223 Psych-nclgy
More informationMedication Assisted Treatment for Opioid Use Disorder in Rural Colorado
Medicatin Assisted Treatment fr Opiid Use Disrder in Rural Clrad Why is piid use disrder getting s much attentin? Opiid Use Disrder (OUD) has seen an epidemic rise in the United States ver the past decade.
More informationTASKFORCE REPORT AIMS TO BOOST CANCER SURVIVAL AND TRANSFORM PATIENT EXPERIENCE
Sunday 19 July, 2015 TASKFORCE REPORT AIMS TO BOOST CANCER SURVIVAL AND TRANSFORM PATIENT EXPERIENCE SIX STRATEGIC pririties have tday (Sunday) been recmmended by the Independent Cancer Taskfrce t help
More informationThe Integration of Oral Health with Primary Care Services and the Use of Innovative Oral Health Workforce in Federally Qualified Health Centers
The Integratin f Oral Health with Primary Care Services and the Use f Innvative Oral Health Wrkfrce in Federally Qualified Health Centers Presented by: Margaret Langelier, MSHSA Center fr Health Wrkfrce
More informationGuidance for Applicants to the Global fund to Fight AIDS, TB and Malaria Round 8 Call for proposals 28 February 2008
Guidance fr Applicants t the Glbal fund t Fight AIDS, TB and Malaria Rund 8 Call fr prpsals 28 February 2008 Sexual Minrities Backgrund: The bard f the Glbal Fund t Fight AIDS, TB and Malaria at its 16
More informationImpacts of State Level Dental Hygienist Scope of Practice on Oral Health Outcomes in the U.S. Population
Impacts f State Level Dental Hygienist Scpe f Practice n Oral Health Outcmes in the U.S. Ppulatin Building Trust in Peple and Places C-spnsred by: Prfessinal Standards Authrity Centre fr Trust, Peace and
More informationMEASURE #10: PLAN OF CARE FOR MIGRAINE OR CERVICOGENIC HEADACHE DEVELOPED OR REVIEWED Headache
MEASURE #10: PLAN OF CARE FOR MIGRAINE OR CERVICOGENIC HEADACHE DEVELOPED OR REVIEWED Headache Measure Descriptin All patients diagnsed with migraine headache r cervicgenic headache wh had a headache management
More informationFOR RESTRICTED AOs DIPLOMA IN POLICING ASSESSMENT UNITS Banked. D/507/3718 Interview suspects in relation to priority and volume investigations
Title: D/507/3718 Interview suspects in relatin t pririty and vlume investigatins Level: 4 Credit Value: 6 GLH: 20 Learning Outcmes The learner will: 1. understand the principles f interviewing suspects
More informationMINISTRY OF HEALTH INFORMATION BRIEFING NOTE
Cliff # 980489 MINISTRY OF HEALTH INFORMATION BRIEFING NOTE. PREPARED FOR: Graham Whitmarsh, Deputy Minister, Ministry f Health Heather Davidsn, ADM, Planning and Innvatin Divisin FOR INFORMATION TITLE:
More informationIntroduction to Psychological Disorders (Myers for AP 2 nd Edition, Module 65)
Intrductin t Psychlgical Disrders (Myers fr AP 2 nd Editin, Mdule 65) Why are we s interested in learning abut psychlgical disrders? The Wrld Health Organizatin reprts that peple suffer frm mental r behavir
More informationAssessment criteria for Primary Health Disciplines Eligibility for Recognition as Credentialled Diabetes Educator. December 2015 ADEA
Assessment criteria fr Primary Health Disciplines Eligibility fr Recgnitin as Credentialled Diabetes Educatr December 2015 ADEA ASSESSMENT CRITERIA FOR PRIMARY HEALTH DICIPLINES ELIGIBILITY FOR RECOGNITION
More informationRelated Policies None
Medical Plicy MP 3.01.501 Guidelines fr Cverage f Mental and Behaviral Health Services Last Review: 8/30/2017 Effective Date: 8/30/2017 Sectin: Mental Health End Date: 08/19/2018 Related Plicies Nne DISCLAIMER
More informationHealth Consumers Queensland submission
Health Cnsumers Queensland submissin Inquiry int Public Health (Medicinal Cannabis) Bill 2016 Queensland Parliament Health, Cmmunities, Disability Services and Family Vilence Preventin Cmmittee Cntact:
More informationContinuous Quality Improvement: Treatment Record Reviews. Third Thursday Provider Call (August 20, 2015) Wendy Bowlin, QM Administrator
Cntinuus Quality Imprvement: Treatment Recrd Reviews Third Thursday Prvider Call (August 20, 2015) Wendy Bwlin, QM Administratr Gals f the Presentatin Review the findings f Treatment Recrd Review results
More informationPennsylvania Guidelines on the Use of Opioids to Treat Chronic Noncancer Pain
Pennsylvania Guidelines n the Use f Opiids t Treat Chrnic Nncancer Pain Chrnic pain is a majr health prblem in the United States, ccurring with a pintprevalence f abut ne-third f the US ppulatin.(1) Mre
More informationNational Imaging Associates, Inc. (NIA) Frequently Asked Questions (FAQ s) For PA Health & Wellness Providers
Natinal Imaging Assciates, Inc. (NIA) Frequently Asked Questins (FAQ s) Fr PA Health & Wellness Prviders Questin GENERAL Why is PA Health & Wellness implementing a Medical Specialty Slutins Prgram? Answer
More informationCancer Association of South Africa (CANSA)
Cancer Assciatin f Suth Africa (CANSA) Fact Sheet and Psitin Statement n Cannabis in Suth Africa Intrductin Cannabis is a drug that cmes frm Indian hemp plants such as Cannabis sativa and Cannabis indica.
More informationFull-time or part-time to a minimum of 0.8FTE (30 hours per week) Job Reference: CLS00161
Jb Title: Medical Statistician Grade: 8 Salary: 42,418 t 47,722 per annum Department: Research Design Service (RDS) and Leicester Clinical Trials Unit (LCTU) Cntract: Open ended cntract subject t fixed
More informationSwindon Joint Strategic Needs Assessment Bulletin
Swindn Jint Strategic Needs Assessment Bulletin Swindn Diabetes 2017 Key Pints: This JSNA gives health facts abut peple with diabetes r peple wh might get diabetes in Swindn. This helps us t plan fr medical
More informationLaw Fellowships in Legal Empowerment
Law Fellwships in Legal Empwerment Abut Namati Namati is dedicated t putting the law in peple s hands. We strive t build a just wrld, in which every ne f us can take part in the decisins and demand accuntability
More informationFOUNDATIONS OF DECISION-MAKING...
Table f Cntents FOUNDATIONS OF DECISION-MAKING... Errr! Bkmark nt Describe the decisin-making prcess pp.62-66... Errr! Bkmark nt Explain the three appraches managers can use t make decisins pp.67-70 Errr!
More informationCommissioning Policy: South Warwickshire CCG (SWCCG)
Cmmissining Plicy: Suth Warwickshire CCG (SWCCG) Treatment Indicatin Criteria FreeStyle Libre Flash Cntinuus Glucse Mnitring System Type I Diabetes Prir apprval must be requested frm the Individual Funding
More informationImproving Surveillance and Monitoring of Self-harm in Irish Prisons
HSE Mental Health Divisin Stewart s Hspital, Palmerstwn, Dublin 20 Tel: 01 6201670 Email: inf@nsp.ie www.nsp.ie Imprving Surveillance and Mnitring f Self-harm in Irish Prisns Prject Scpe Dcument 8 th June
More informationMethadone Maintenance Treatment for Opioid Dependence
POLICY STATEMENT Methadne Maintenance Treatment fr Opiid Dependence APPROVED BY COUNCIL: May 2010 PUBLICATION DATE: Dialgue, Issue 2, 2010 Disclaimer: As f May 19, 2018 physicians n lnger require an exemptin
More informationFDA Dietary Supplement cgmp
FDA Dietary Supplement cgmp FEBRUARY 2009 OVERVIEW Summary The Fd and Drug Administratin (FDA) has issued a final rule regarding current gd manufacturing practices (cgmp) fr dietary supplements that establishes
More informationCode of employment practice on infant feeding
Cde f emplyment practice n infant feeding An Emplyer s guide t: Sectin 69Y f the Emplyment Relatins Act 2000 Frewrd As Minister f Labur, I am pleased t publish the Cde f Emplyment Practice n Infant Feeding.
More informationA Phase I Study of CEP-701 in Patients with Refractory Neuroblastoma NANT (01-03) A New Approaches to Neuroblastoma Therapy (NANT) treatment protocol.
SAMPLE INFORMED CONSENT A Phase I Study f CEP-701 in Patients with Refractry Neurblastma NANT (01-03) A New Appraches t Neurblastma Therapy (NANT) treatment prtcl. The wrd yu used thrughut this dcument
More informationCode of Conduct for Employees
Crprate Human Resurces Plicy Cntent Updated: 2016-06-22 Wrk Envirnment Plicy N: HR-01-09 Page 1 f 5 Apprval: 2014-09-24 Cde f Cnduct fr Emplyees POLICY STATEMENT The residents and businesses f the City
More informationNovel methods and approaches for sensing, evaluating, modulating and regulating mood and emotional states.
Nvel methds and appraches fr sensing, evaluating, mdulating and regulating md and emtinal states. 2018 Jy Academic Grant Call fr Prpsals Intrductin The Annual Jy grant initiative aims t prmte and cntribute
More informationAssessment Field Activity Collaborative Assessment, Planning, and Support: Safety and Risk in Teams
Assessment Field Activity Cllabrative Assessment, Planning, and Supprt: Safety and Risk in Teams OBSERVATION Identify a case fr which a team meeting t discuss safety and/r safety planning is needed r scheduled.
More informationPain Management Learning Plan
Pain Management Learning Plan Overriding Gal T imprve the quality f patient care available fr patients living with chrnic pain. Learning Outcmes By the end f the implementatin, participants will be able
More informationUS Public Health Service Clinical Practice Guidelines for PrEP
Webcast 1.3 US Public Health Service Clinical Practice Guidelines fr PrEP P R E S ENTED BY: M A R K T H R U N, M D A S S O C I AT E P R O F E S S O R, U N I V E R S I T Y O F C O L O R A D O, D I V I S
More informationSTAKEHOLDER IN-DEPTH INTERVIEW GUIDE
STAKEHOLDER IN-DEPTH INTERVIEW GUIDE PURPOSE The Stakehlder In-Depth Interview Guide cntributes t understanding the scale-up prcess by asking key stakehlders t evaluate what has been achieved in scaleup,
More informationGUIDANCE DOCUMENT FOR ENROLLING SUBJECTS WHO DO NOT SPEAK ENGLISH
GUIDANCE DOCUMENT FOR ENROLLING SUBJECTS WHO DO NOT SPEAK ENGLISH Aurra Health Care s Research Subject Prtectin Prgram (RSPP) This guidance dcument will utline the prper prcedures fr btaining and dcumenting
More informationPreventing and Responding to Emerging IDs the role of WHO
Preventing and Respnding t Emerging IDs the rle f WHO Mark Jacbs Directr, Divisin f Cmmunicable Diseases WHO Respnding t Emerging Infectius Diseases Sympsium 21st Public Health Summer Schl University f
More informationACSQHC National Consensus Statement: Essential Elements for High Quality End-oflife Care in Acute Hospitals.
27 March 2014 Prfessr Debra Picne Chief Executive Officer Australian Cmmissin n Safety and Quality in Health Care c/ Ms Jennifer Hill, Senir Prject Officer Level 5, 255 Elizabeth Street SYDNEY NSW 2000
More informationPublic consultation on the NHMRC s draft revised Australian alcohol guidelines for low-risk drinking
Public cnsultatin n the NHMRC s draft revised Australian alchl guidelines fr lw-risk drinking Recmmendatins frm The Cancer Cuncil Australia The Cancer Cuncil Australia is Australia s peak nn-gvernment
More informationMedicare Advantage 2019 Advance Notice Part 1 21 st Century Cures Act Methodological Changes
Medicare Advantage 2019 Advance Ntice Part 1 21 st Century Cures Act Methdlgical Changes Review f Relevant Prvisins with Expert Insight January 2018 PULSE8 is privileged t bring yu a summary f key Medicare
More informationUsing discussion and case examples, and specific approaches that attendees can immediately use the presenters will extend and enhance skill with:
This seminar is based n: published material Drs. Curtis and Frd their jint wrk as c-chairs f the Internatinal Sciety fr Traumatic Stress Studies Cmplex Trauma Task Frce and its recently published treatment
More informationA fake medicine that passes itself off as a real, authorised medicine. (1)
Falsified medicines Index 1 Intrductin 2 Types f falsified medicines 3 Eurpean regulatin n falsified medicines 4 Risks f falsified medicines 5 Buying medicine nline safely 6 References 7 Further resurces
More informationExclusion of Key Populations and People Living with HIV from implementation of programmes 10 June To: CC:
Exclusin f Key Ppulatins and Peple Living with HIV frm implementatin f prgrammes 10 June 2016 T: CC: Mr. Nrbert Hauser, Chair f the Bard f the Glbal Fund t fight AIDS, TB and Malaria Ms. Aida Kurtvic,
More informationAlcohol & Substance Misuse Policy. St Mary s CE Academy Trading Company. Date: Spring 2017 Date of Next Review: Summer 2018
St Mary s CE Academy Trading Cmpany Alchl & Substance Misuse Plicy Date: Spring 2017 Date f Next Review: Summer 2018 Signed by: Family Supprt Crdinatr Signed by: Grup Manager Alchl and Substance Misuse
More informationWorld Confederation for Physical Therapy Congress , May Singapore
Wrld Cnfederatin fr Physical Therapy Cngress 2015 1-4, May Singapre Call fr applicatins fr Chair f the Internatinal Scientific Cmmittee The Executive Cmmittee f WCPT invites applicatins and suggestins
More informationFIGHT DEMENTIA ACTION PLAN
FIGHT DEMENTIA ACTION PLAN DEMENTIA IS A HEALTH PRIORITY Dementia will be the majr health prblem f this century. Over ne millin Australians are already affected by the disease themselves r are caring fr
More informationAccess to Heme Treatment in Canada - Survey 2018
Access t Heme Treatment in Canada - Survey 2018 The Canadian Assciatin fr Prphyria/Assciatin Canadienne de Prphyrie (CAP/ACP) asserts that patients with acute prphyria shuld have access t Hemin treatment,
More informationBuilding Code 101 OWMC November 20, Ministry of Municipal Affairs and Housing
Building Cde 101 OWMC Nvember 20, 2015 Ministry f Municipal Affairs and Husing Disclaimer These slides are prvided by the Ministry f Municipal Affairs and Husing fr cnvenience nly The slides shuld nt be
More informationSpecifically, on page 12 of the current evicore draft, we find the statement:
Octber 23, 2016 evicre Healthcare Attn: Dr Greg Allen 400 Buckwalter Place Bulevard Blufftn, SC 29910 RE: evicre Draft Onclgy Imaging Guidelines, v 19.0 Gentlepersns: Prstate Cancer Internatinal is a nt-fr-prfit
More informationBritish Sign Language (BSL) Plan October 2018 Scottish Charity Regulator
British Sign Language (BSL) Plan 2018-2024 Octber 2018 Scttish Charity Regulatr Cntents Sectin 1: Intrductin and cntext 1.1 Intrductin 1.2 Our wrk and what we d Sectin 2: Our BSL Plan 2.1 Scttish Public
More informationOrganizational Capacity for Change and Patient Safety
Organizatinal Capacity fr Change and Patient Safety Debrah M. Nadzam, PhD, FAAN - Jint Cmmissin Resurces Lrrie Jnes-Hartley, MSN, CRRN-A - Durham Reginal Hspital Presentatin Objectives Briefly describe
More informationLaw Fellowships in Legal Empowerment
Law Fellwships in Legal Empwerment Abut Namati Namati is dedicated t putting the law in peple s hands. We strive t build a just wrld, in which every ne f us can take part in the decisins and demand accuntability
More informationOTHER AND UNSPECIFIED DISORDERS
OPTUM COVERAGE DETERMINATION GUIDELINE OTHER AND UNSPECIFIED DISORDERS Guideline Number: BH727OUD_102017 Effective Date: Octber, 2017 Table f Cntents Page INSTRUCTIONS FOR USE... 1 BENEFIT CONSIDERATIONS...
More informationAUTHORISED BY: CEO. Introduction. Whistle Blowing
GUIDELINE NAME: Field Cmplaints Disclsure Guidelines SECTION : Refer t Excel Guidelines list Dcument N: DISTRIBUTION: All Emplyees FIRST ISSUED: April 2013 DATE UPDATED: Dec 2014 ISSUED/UPDATED BY: Peple
More informationAnnual Assembly Abstract Review Process
Annual Assembly Abstract Review Prcess AAHPM and HPNA cllabrate t review and select abstracts fr Annual Assembly. The cmmittees meet prir t the calls t review and update the Assembly bjectives (Planning
More informationApproaches to the Care and Support of Individuals with Dementia
Unit 14: Persn-centred Appraches t the Care and Supprt f Individuals with Dementia Unit reference number: H/601/2879 Level: 2 Unit type: Optinal Credit value: 2 Guided learning hurs: 17 Unit summary Understanding
More informationGSB of EDA Meeting Minutes
Hell Everyne! We held a General Service Bard meeting n 04/10/2013. Attendees: Alita, British Clumbia, CAN Annette H, Phenix, AZ Fran, IL Rachel F, Tempe, AZ Rger, MA Vanessa S, Lngwd, FL Ntes: Rger asked
More informationFrontier School of Innovation District Wellness Policy
Frntier Schl f Innvatin 6700 Crprate dr. Suite 150 Phne: 816-363-1907 http://www.kcfsi.rg/ Frntier Schl f Innvatin District Wellness Plicy The Bard prmtes healthy schls, by supprting wellness, gd nutritin,
More informationWilliam Paterson University College of Science and Health DEPARTMENT OF PUBLIC HEALTH HealthyU Syllabus
William Patersn University Cllege f Science and Health DEPARTMENT OF PUBLIC HEALTH HealthyU Syllabus 1. Title & Number f Curse: PBHL 1100-81 HealthyU (3 Credits) 2. Department f Public Health: Department
More informationPROVIDER ALERT. Comprehensive Diagnostic Evaluation (CDE) Guidelines to Access the Applied Behavior Analysis (ABA) Benefit.
Cmprehensive Diagnstic Evaluatin (CDE) Guidelines t Access the Applied Behavir Analysis (ABA) Benefit May 5, 2017 Clinical infrmatin that utlines medical necessity is required t supprt the need fr initial
More informationEDPS 475: Instructional Objectives for Midterm Exam Behaviorism
EDPS 475: Instructinal Objectives fr Midterm Exam Behavirism 1. Given a nvel example t chse frm, identify the characteristics f classical cnditining. General mdel: Stimulus (S) elicits >Respnse (R) Based
More informationCampus Climate Survey
Campus Climate Survey Executive Summary www.ecu.edu/ecyu 2016 A prject spnsred by the Office fr Equity and Diversity Executive Summary Prject Backgrund In FY 2013-2014, the Campus Climate Cmmissin prpsed
More informationFrequently Asked Questions: IS RT-Q-PCR Testing
Questins 1. What is chrnic myelid leukemia (CML)? 2. Hw des smene knw if they have CML? 3. Hw is smene diagnsed with CML? Frequently Asked Questins: IS RT-Q-PCR Testing Answers CML is a cancer f the bld
More informationUsing Causal Inference To Make Sense of Messy Data
Using Causal Inference T Make Sense f Messy Data Ilya Shpitser Jhn C. Malne Assistant Prfessr f Cmputer Science Malne Center fr Engineering in Healthcare The Jhns Hpkins University Health Care: Csts Abslute
More informationStructured Assessment using Multiple Patient. Scenarios (StAMPS) Exam Information
Structured Assessment using Multiple Patient Scenaris (StAMPS) Exam Infrmatin 1. Preparing fr the StAMPS assessment prcess StAMPS is an assessment mdality that is designed t test higher rder functins in
More informationo Procedures performed o Diagnoses Identified o Certain devices/equipment/supplies acquired for patient
Image Surce: https://s-media-cache-ak0.pinimg.cm/736x/7c/29/91/7c2991805f004e1ca05e42a79883f4a7.jpg 6/30/2017 Curse Objectives A Practical Guide t Cding fr Audilgists in 2017 Megan Keirans, AuD University
More informationNon-assurance Services
IFAC Bard Rundtable Briefing Nte May 2018 Internatinal Ethics Standards Bard fr Accuntants Nn-assurance Services Explring Issues t Determine a Way Frward This dcument has been prepared by the IESBA Nn-assurance
More informationAwareness of Autistic Spectrum Conditions
Unit 21: Awareness f Autistic Spectrum Cnditins Unit reference number: H/616/7304 Level: 2 Unit type: Optinal Credit value: 2 Guided learning hurs: 17 Unit summary This unit intrduces yu t autistic spectrum
More information2018 Medical Association Poster Symposium Guidelines
2018 Medical Assciatin Pster Sympsium Guidelines Overview The 3 rd Annual student-run Medical Assciatin f the State f Alabama Research Sympsium will take place n Friday and Saturday, April 13-14 at the
More informationInternational Experts Meeting on Severe Accident Management in the Light of the Accident at the Fukushima Daiichi Nuclear Power Plant
IAEA-CN-233 Internatinal Experts Meeting n Severe Accident Management in the Light f the Accident at the Fukushima Daiichi Nuclear Pwer Plant Organized in cnnectin with the implementatin f the IAEA Actin
More informationduring Last Days of Life
Unit 36: Supprting Individuals during Last Days f Life Unit reference number: F/616/7374 Level: 3 Unit type: Optinal Credit value: 4 Guided learning hurs: 32 Unit summary Prmting respnsive care in the
More informationNon-assurance Services
IFAC Bard IESBA CAG Meeting (September 2018) Ref. Paper t Agenda Item C Rundtable Briefing Nte May 2018 Internatinal Ethics Standards Bard fr Accuntants Nn-assurance Services Explring Issues t Determine
More informationCompleting the NPA online Patient Safety Incident Report form: 2016
Cmpleting the NPA nline Patient Safety Incident Reprt frm: 2016 The infrmatin cntained within this dcument is in line with the current Data Prtectin Act (DPA) requirements. This infrmatin may be subject
More informationBariatric Surgery FAQs for Employees in the GRMC Group Health Plan
Bariatric Surgery FAQs fr Emplyees in the GRMC Grup Health Plan Gergia Regents Medical Center and Gergia Regents Medical Assciates emplyees and eligible dependents wh are in the GRMC Grup Health Plan (Select
More informationSocial Learning Theories
Scial Learning Theries - Careful scientific prcedures and methdlgy that characterize the behaviurist apprach Albert Bandura - Brn in small twn Alberta - Plish decent - Only sn with 5 sisters - Interested
More informationPodcast Transcript Title: Common Miscoding of LARC Services Impacting Revenue Speaker Name: Ann Finn Duration: 00:16:10
Pdcast Transcript Title: Cmmn Miscding f LARC Services Impacting Revenue Speaker Name: Ann Finn Duratin: 00:16:10 NCTCFP: Welcme t this pdcast spnsred by the Natinal Clinical Training Center fr Family
More informationJessica Philpott MD PhD Digestive Diseases Institute Cleveland Clinic
Jessica Philptt MD PhD Digestive Diseases Institute Cleveland Clinic Objectives Review the Crhn s and Clitis Fundatin Challenges t Research Gals 2018 Review data in envirnment and genetics as cntributing
More informationPractice in the Support of Individuals with Autistic Spectrum Conditions
Unit 46: Prmting Gd Practice in the Supprt f Individuals with Autistic Spectrum Cnditins Unit reference number: K/616/7420 Level: 5 Unit type: Optinal Credit value: 7 Guided learning hurs: 53 Unit summary
More informationThank you for committing to engage pharmacists regarding the incredible opportunity for them to prevent opioid overdose deaths by providing naloxone!
Thank yu fr cmmitting t engage pharmacists regarding the incredible pprtunity fr them t prevent piid verdse deaths by prviding nalxne! If yu encunter cmplicated questins that yu are unable t answer, please
More informationMGPR Training Courses Guide
MGPR Training Curses Guide fiscal cde 92107050921 1. Descriptin The training prgram supprted by MGPR is prpsed by a grup f excellent mentrs/educatrs, accmplished in Pesticides Management and Analysis,
More informationQ 5: Is relaxation training better (more effective than/as safe as) than treatment as usual in adults with depressive episode/disorder?
updated 2012 Relaxatin training Q 5: Is relaxatin training better (mre effective than/as safe as) than treatment as usual in adults with depressive episde/disrder? Backgrund The number f general health
More informationPosition Title Diabetes Educator Program / Funding Stream Primary Health Care
P O S I T I O N P R O F I L E POSITION TITLE: Diabetes Educatr Psitin Title Diabetes Educatr Prgram / Funding Stream Primary Health Care Psitin Classificatin RAHP Leve 4 - Level 5 r NUR Level 3 - Level
More informationTrue Patient & Partner Engagement How is it done? How can I do it?
True Patient & Partner Engagement Hw is it dne? Hw can I d it? GROUP TECHNICAL ASSISTANCE JANUARY 18, 2017 COLORADO FOUNDATION FOR PUBLIC HEALTH AND THE ENVIRONMENT Webinar Objectives 1. Describe patient
More informationCommunity Health Worker / Certified Recovery Specialist Training Application
APPLICANTS REQUIRED TO COMPLETE APPLICATION WITHOUT ASSISTANCE FROM OTHERS $35 Applicatin Fee is nn-refundable Applying des NOT guarantee admissin int training Date f Applicatin: First Name: Last Name:
More informationP02-03 CALA Program Description Proficiency Testing Policy for Accreditation Revision 1.9 July 26, 2017
P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin Revisin 1.9 July 26, 2017 P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin TABLE OF CONTENTS TABLE OF CONTENTS...
More informationProposal 101: So, You Want to Change the World AND Receive Funding to do so?
Prpsal 101: S, Yu Want t Change the Wrld AND Receive Funding t d s? Pamela Mitzelfeld Sherry Wynn Perdue Oakland University Writing Center 212 Kresge Library The Nature f Prpsals There is n such thing
More informationSection 6 Students School District No. 71 (Comox Valley)
Sectin 6 Students Schl District N. 71 (Cmx Valley) Administrative Prcedure 6011 MR2 Allergies and Anaphylaxis 1. Intrductin The Bard f Educatin expects schls t reasnably accmmdate students with medically
More informationCOMPARING & CONTRASTING HIE ALTERNATIVES November 9, 2017
COMPARING & CONTRASTING HIE ALTERNATIVES Nvember 9, 2017 WISCONSIN STATEWIDE HEALTH INFORMATION NETWORK WWW.WISHIN.ORG INTRODUCTION There are many effrts and initiatives aimed at making clinical data related
More informationEASTERN ARIZONA COLLEGE Study of Substance Abuse
EASTERN ARIZONA COLLEGE Study f Substance Abuse Curse Design 2011-2012 Curse Infrmatin Divisin Scial Sciences Curse Number SSE 121 Title Study f Substance Abuse Credits 3 Develped by B. Stephen Cullen,
More information