Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Derek Martinig Suzanne Lane Julia Barnscher REGULATIONS AND PET TECHNOLOGY POSITRON EMISSION TOMOGRAPHY FDG (18-fluoro-2-deoxyglucose) – Radioactive F in place of O in glucose Fluoride decays back to Oxygen and emits positrons Cellular consumption of glucose molecules can be observed using a PET scanner Used for research, cancer, blood clots, Alzheimers BACKGROUND 1952 – First positron imaging device Mid 70s – First PET scanners using Fluoride Late 70s – first PET scanners using in clinical settings 1980s – Research showing clinical utility 1988- U.S.A – Medicare funded first PET Scan 1992 – Australia’s first PET Facility BARRIERS Lack of Personnel High Costs Accessibility of FDG Lack of Standardized Protocols Government Regulations FDG Radiopharmaceutical drug - Investigation drug - Biologics and Genetic Therapies Directorate (BGTD) branch of Health Canada Over 5,000 studies demonstrating safety and benefits of FDG Support from: Canadian Association of Radiologists Canadian Society of Nuclear Medicine European Association of Nuclear Medicine American Society of Nuclear Medicine The power of PET over traditional imaging modalities CASE STUDIES CASE STUDY #1 72 year old Male Diagnosed with Esophageal Tumor CT scan revealed abnormality in distal esophagus Treatment Plan: radiation & chemo. then Surgery PET/CT Imaging revealed two undiagnosed lymph nodes Staging and treatment volume were both altered. Studies found that up to 62% of treatments were adjusted as a result of a PET Scan CASE STUDY #2 •82 year old female with Rectal Bleed •Mass found in Right transverse colon during colonscopy •CT performed and revealed mass in presacral area •Liver was unremarkable on CT Scan •Patient underwent colectomy and 8 out of 9 nodes tested were positive for metastases •Follow up PET Scan was completed after surgery •The presacral mass was localized once again •Two additional liver metastases were identified •Findings would have resulted in patient not undergoing surgery REGULATION OF FDG IN CANADA REGULATION OF FDG Regulations changed in 2003 Approval for production and use of FDG by BGTD New drug submission 4 manufacturers approved for limited uses Non approved uses must be carried out under clinical trial applications PET SCANNING IN CANADA Limited number of funded scans per province Not related to size of population or availability of scanning facilities Not available in all provinces Public and private not equivalent Up to 6 week waiting period PET SCANNING IN CANADA Canada approves scans for fewer conditions than other countries US, European Union, Australia Lung, breast, colorectal cancers Revisions suggested as of March 2009 Will not have any rapid effect to increase availability of FDG Those impacted by the Current Regulations on PET in Canada WINNERS AND LOSERS Pros: Still Pending.... Cons: -”Brain Drain” still exists as a result of limitations on research (6 months in US, 3 years in Canada) -Costly and time consuming clinical trials -Redundancy of research -Lack of motivation to continue with research in the field. RESEARCHERS PROVINCIAL GOVERNMENT Pros: -Limit initial healthcare spending -Capital Investments -Exam Reimbursement Cons: -Less cost-effective -Reduction in Surgeries -More effective treatment regiments -Perception of not providing best possible care. Pros: Monopoly Power....really? Cons: Expensive licensing costs & Low demand lead to Inability to control pricing MANUFACTURERS PATIENTS DOESN’T MATTER HOW YOU SPIN IT... .... EVERYONE’S STILL A LOSER What needs to be done to fix this problem... REGULATION REFORM THREE STEP PROCESS STEP ONE Remove the Clinical Trial Label Eliminate Redundancy of NDS Provide Guidelines for Production of FDG _____________________ Result in Increased Provision! STEP TWO Collaboration of College of Physicians and Government Set Fee Structure Cover cost of PET under provincial health plans _____________________ Resulting in Increased Utilization and Provision STEP THREE Advertising and Promotion of PET Increase Physician Awareness Increase Patient Awareness Increase Research _____________________ Optimal Utilization of PET QUESTIONS??