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Post-market review comparing clinical guidelines and PBS restrictions for smoking cessation therapies.
Year:
2023
Region / City:
Australia
Subject:
Smoking cessation, pharmaceutical benefits
Document Type:
Report
Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Unknown
Target Audience:
Healthcare providers, policymakers
Period of Effect:
Ongoing
Approval Date:
Unknown
Date of Changes:
Unknown
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
XXXX
Region / city:
XXXX
Topic:
Medical Device Safety and Performance Evaluation
Document Type:
Evaluation Report
Organization / Institution:
XXXX
Author:
XXXX
Target Audience:
Regulatory Bodies, Medical Device Manufacturers
Period of Effectiveness:
XXXX
Approval Date:
XXXX
Date of Changes:
XXXX
Year:
YYYY
Region / City:
[City/Region]
Topic:
Medical Device Safety and Performance Monitoring
Document Type:
PMCF Plan
Organization:
[Manufacturer Name]
Author:
[Author Name]
Target Audience:
Regulatory Authorities, Medical Device Manufacturers
Validity Period:
YYYY/MM/DD to YYYY/MM/DD
Approval Date:
DD/MM/YYYY
Revision Date:
XXXX
Date of Changes:
YYYY/MM/DD
Year:
2015
Region / city:
International
Topic:
Medical Device Regulation
Document Type:
Official Report
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
National Competent Authority Report Working Group
Target Audience:
Medical Device Regulators, Public Health Authorities
Period of validity:
Ongoing
Approval Date:
26 March 2015
Date of amendments:
None
Year:
2016-2017
Region / city:
Australia
Topic:
Life Saving Drugs Program, Rare Diseases, Health Policy
Document type:
Government Report
Organization / institution:
Australian Government
Author:
Australian Government
Target audience:
Health policymakers, healthcare professionals, stakeholders in rare disease treatment
Period of validity:
Ongoing
Date of approval:
2014-04-09
Date of amendments:
None
Year:
2021
Region / City:
Australia
Topic:
Smoking cessation, medicines cost-effectiveness, Pharmaceutical Benefits Scheme
Document type:
Report
Organization:
Pharmaceutical Benefits Advisory Committee
Author:
Centre for Health Economics, Monash University
Target audience:
Health professionals, policy makers, Pharmaceutical Benefits Advisory Committee members
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Purpose:
Post-market review, cost-effectiveness evaluation
Clinical issue:
Smoking cessation treatment
Proposed changes to PBS restrictions:
Yes
Market size:
Pharmacological assisted quit attempts
Treatment costs and co-payments:
Yes
Market growth:
Change in quit attempts
Health outcomes:
Quit rates, relapse rates, smoking-related diseases
References:
Yes
Note:
Contextual description
Year:
2023
Region / City:
Australia
Topic:
Opioid Dependence Treatment, Pharmaceutical Benefits Scheme
Document Type:
Government Report
Organization:
Australian Government Department of Health and Aged Care
Author:
Australian Government Department of Health and Aged Care
Target Audience:
Stakeholders, policymakers, healthcare providers, public
Effective Period:
2023-07-01 and onwards
Approval Date:
2023-03-01
Modification Date:
N/A
Interim Review Outcomes Date:
2023-03-01
Note:
Contextual Description
Year:
2019
Region / Country:
Australia
Subject:
Pulmonary arterial hypertension medicines and subsidy policy
Document Type:
Policy review agenda item and briefing
Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Program:
Pharmaceutical Benefits Scheme (PBS)
Topic:
Post-Market Review (PMR) of PAH medicines
Medicines Mentioned:
bosentan, ambrisentan, macitentan, sildenafil, tadalafil, iloprost, riociguat, epoprostenol
Medical Classification Referenced:
WHO Functional Class II–IV pulmonary arterial hypertension
Guidelines Referenced:
2015 European Society of Cardiology / European Respiratory Society Guidelines for the diagnosis and treatment of pulmonary hypertension
Stakeholders:
PAH Reference Group, medicine sponsors including Actelion, GlaxoSmithKline, and Pfizer
Regulatory Focus:
Revision of PBS prescribing restrictions and subsidy conditions
Key Policy Changes Considered:
Extension of subsidised monotherapy to WHO Functional Class II patients, updated PAH definition, inclusion of additional WHO Group 1 PAH subtypes, removal of calcium channel blocker trial requirement, strengthened diagnostic role of right heart catheterisation
Consultation Process:
Pre-PBAC consultation with sponsors and reference group
Associated Meetings:
PBAC meetings in November 2018, March 2019, and planned July 2019 review discussion
Related Policy Activity:
Planned stakeholder meeting on PAH combination therapy scheduled for May 2019
Year:
2016
Region / city:
Boston, MA
Topic:
Smoking cessation, public health
Document type:
Research article
Organization:
Boston University School of Public Health, Harvard T.H. Chan School of Public Health, Boston Housing Authority
Author:
Daniel R. Brooks, Joanna Burtner, Belinda Borrelli, Timothy C. Heeren, Tegan Evans, Jessica Davine, Jonathan Greenbaum, Matthew Scarpaci, John Kane, Vaughan W. Rees, Alan C. Geller
Target audience:
Public health professionals, researchers, policymakers
Period of validity:
2012-2016
Approval date:
2016
Date of changes:
None
Year:
2025
Region / city:
United States
Subject:
Nuclear reactor inspection
Document type:
Manual
Organization / institution:
Nuclear Regulatory Commission (NRC)
Author:
NRC
Target audience:
NRC staff, reactor facility operators, regulatory bodies
Period of validity:
From April 24, 2025
Approval date:
April 24, 2025
Date of amendments:
Not provided
Year:
20____
Region / City:
Labuan, Malaysia
Topic:
Cessation of leasing business
Document Type:
Application Form
Organization / Institution:
Labuan FSA
Author:
[Name of Labuan Company / Head Office / Shareholder]
Target Audience:
Labuan FSA, legal and financial officers
Period of Action:
After approval for the cessation of leasing business
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2024
Region / City:
North America
Subject:
Theology, Spiritual Gifts, Church History
Document Type:
Research Study
Organization / Institution:
Defend the Word Ministries, NorthPointe Church
Author:
D. Gene Williams Jr., PhD
Target Audience:
Theologians, Clergy, Seminary Students, Christian Scholars
Period Covered:
Early Church to Contemporary Charismatic Movements
Date of Publication:
2024
Primary Sources Referenced:
1 Corinthians 12-14, Acts 2, Writings of Origen, Jerome, Ephrem the Syrian, John Chrysostom
Theological Perspective:
Continuationist, Scriptural Exegesis, Historical Analysis
Languages Discussed:
Hebrew (Primordial Language)
Contextual Focus:
Proper use of spiritual gifts, comparison between cessationism and continuationism
Summary:
Scholarly study analyzing early church perspectives on spiritual gifts, the metaphorical significance of Hebrew as the primordial language, and implications for contemporary Christian practice.
Year:
2021
Region / City:
Australia
Topic:
Smoking cessation, medicines cost-effectiveness, Pharmaceutical Benefits Scheme
Document type:
Report
Organization:
Pharmaceutical Benefits Advisory Committee
Author:
Centre for Health Economics, Monash University
Target audience:
Health professionals, policy makers, Pharmaceutical Benefits Advisory Committee members
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Purpose:
Post-market review, cost-effectiveness evaluation
Clinical issue:
Smoking cessation treatment
Proposed changes to PBS restrictions:
Yes
Market size:
Pharmacological assisted quit attempts
Treatment costs and co-payments:
Yes
Market growth:
Change in quit attempts
Health outcomes:
Quit rates, relapse rates, smoking-related diseases
References:
Yes
Note:
Contextual description
Year:
2026
Region / State:
West Virginia, USA
Subject:
Tobacco cessation funding
Document type:
Legislative fiscal note
Legislative body:
West Virginia Legislature
Authors:
Delegates Rohrbach and Amos
Introduced date:
February 3, 2026
Referred committee:
Committee on Finance
Effective period:
Fiscal year ending June 30, 2026
Program:
Tobacco Cessation Initiative Program
Funding mechanism:
Special revenue account in State Treasury
Year:
2017–2019
Country:
Australia
Population:
Aboriginal and Torres Strait Islander pregnant women
Health Focus:
Smoking cessation during pregnancy
Programme Name:
ICAN QUIT in Pregnancy (Indigenous Counselling and Nicotine)
Project Team:
Gillian S. Gould; Yael Bar-Zeev; Michelle Bovill; Billie Bonevski; Maree Gruppetta; ICAN QUIT in Pregnancy Pilot Group
Setting:
Aboriginal Medical Services (AMSs) in New South Wales, Queensland, and South Australia
Study Design:
Step-wedge cluster randomised pilot trial
Sample Size:
22 pregnant women; 50 health providers
Intervention Components:
Webinar-based provider training; culturally tailored educational resources (“Wingadhan Birrang”); free oral Nicotine Replacement Therapy
Theoretical Framework:
Behaviour Change Wheel (BCW); COM-B model; Theoretical Domains Framework (TDF)
Stakeholder Engagement:
Community-based participatory research; Stakeholder and Consumer Aboriginal Advisory Panel (SCAAP)
Primary Outcomes:
Feasibility; acceptability; provider knowledge and attitudes; validated smoking abstinence at 12 weeks (13.6%)
Implementation Sites:
Six Aboriginal Medical Services
Expansion Initiative:
SISTAQUIT™ (Supporting Indigenous Smokers To Assist Quitting) cluster randomised controlled trial
Source Type:
Implementation science case study
Year:
2017
Region / City:
Pennsylvania
Topic:
Tobacco Cessation Services
Document Type:
Instruction Manual
Organization:
PA Department of Health
Author:
PA Department of Health
Target Audience:
Healthcare Providers, Non-Healthcare Professionals
Action Period:
Ongoing
Approval Date:
January 2017
Modification Date:
Not specified
Referral Methods:
Self-referral, Quitlogix online referral, Fax-to-Quit, Bi-Directional e-Referral
Year:
Not specified
Study population:
Patients after cessation of 5-year endocrine therapy
Therapy groups:
Tamoxifen (TMX); Aromatase inhibitor (AI)
Assessment time points:
Baseline; 6 months; 1 year after cessation
Instruments:
QLQ-C30; QLQ-BR45; QLQ-ELD14
Age subgroup:
QLQ-ELD14 assessed only in patients >65 years
Statistical test:
Mann Whitney U test
Outcome measures:
Mean scores and P-values
Score interpretation (functional scales):
0–100 scale, higher score indicates higher functional level
Score interpretation (symptom scales):
0–100 scale, higher score indicates greater degree of symptoms
Domains assessed (QLQ-C30):
Physical; Role; Emotional; Cognitive; Social; Global quality of life; Fatigue; Nausea and vomiting; Pain; Dyspnea; Sleep disturbance; Appetite loss; Constipation; Diarrhea; Financial impact; Summary score
Domains assessed (QLQ-BR45):
Body image; Future perspective; Sexual functioning; Sexual enjoyment; Breast satisfaction; Systemic therapy side effects; Upset by hair loss; Arm symptoms; Breast symptoms; Endocrine therapy symptoms; Skin mucosis symptoms; Endocrine sexual symptoms; Hot flushes; Joint symptoms
Domains assessed (QLQ-ELD14):
Mobility; Worries about others; Future worries; Maintaining purpose; Burden of illness; Joint stiffness; Family support
Note:
Year
Topic:
Smoking cessation, Pregnancy, Qualitative research
Document type:
Research Article
Organization / institution:
University of Nottingham, St George’s University of London, University of Stirling
Author:
Libby Fergie, Tim Coleman, Michael Ussher, Sue Cooper, Katarzyna A Campbell
Target audience:
Researchers, Healthcare professionals, Public health specialists
Year:
2026
Region / State:
United States
Topic:
Workplace health, Tobacco cessation
Document Type:
Fact sheet
Organization:
National Action on Quit Smoking (NAQC)
Author:
NAQC
Target Audience:
Employers and state health departments
Data Sources:
Centers for Disease Control and Prevention, America’s Health Insurance Plans, Kaiser Family Foundation
Purpose:
Assess cost of employee smoking and ROI of cessation programs
Calculation Examples Included:
Yes
Additional Resources:
www.businesscaseroi.org
Note:
, www.naquitline.org