Renaldo P. DeFrank, Jr. presented at the ATI Physical Therapy seminar on September 23, 2015, discussing Opioids and the impact on Michigan workers' compensation claims.
The Michigan Workers' Compensation Agency enacted new Rules governing the use of Opioids involving workers' compensation claims. This presentation provides background information concerning the purpose of the new Rules and how to handle them as part of a given workers' compensation claim.
iHT² Health IT Summit San Francisco “Connecting the Data: Improving Outcomes and Quality with Clinical and Claims Data”
There is a fundamental need in today’s healthcare system for the two largest constituents—payers and providers—to work together in alignment. Changing the thinking and actions to shift the dynamic of how payors and providers work and interact with each other is no small task. This session will address the challenges and opportunities for payors and providers to work together. Panelists will discuss examples of collaboration and lessons learned.
Learning Objectives:
∙ Assess the structure of provider-payor collaborations reducing cost and improving outcomes
∙ Identify methods to combine clinical and claims data to glean insight
∙ Define clinical, economic and administrative opportunities for alignment
Moderator: Jay Srini, Chief Strategist, SCS Ventures, Adjunct Faculty Assistant Professor, University of Pittsburgh, Senior Fellow and Innovation Chair, iHT² Advisory Board Member
Betsy Thompson, MD, DrPH, Chief Medical Officer, Region IX, Centers for Medicare and Medicaid Services
Brett Johnson, Associate Director, Medical and Regulatory Policy, California Medical Association (CMA)
Clinical edvidence and access for medicinal cannabis productsTGA Australia
This document summarizes the Australian government's approach to medicinal cannabis, which includes treating it as a medicine available by prescription. It outlines reviews finding evidence that cannabis is effective for chronic pain, spasticity, nausea from chemotherapy, and some other conditions. Clinical guidance documents are being developed for conditions like epilepsy, multiple sclerosis, pain, and palliative care. The TGA regulates cultivation, manufacturing, and patient access through schemes like Special Access that require authorization from a prescriber and state health department. Over 170 approvals have been issued under these schemes since 2016.
This document discusses challenges in managing cancer pain and strategies to promote safe and effective pain management. It outlines Joint Commission standards on comprehensive pain assessment, treatment, and reassessment. Barriers to pain management include inadequate processes and education. Effective strategies include standardized policies, electronic tools to support safe opioid prescribing and administration, education and training programs for providers, and monitoring programs to improve patient safety.
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
Pharmacovigilance Activity at NRS Medical College in 2017 and 3 Years of Comp...Anindya Banerjee
Pharmacovigilance Activity at NRS Medical College in 2017 AND 3 Years of Comparative Study under NCC-PvPI, IPC by Patient Safety-Pharmacovigilance Associate Mr. Anindya Banerjee
Expert review of medicines and medical devices regulation: Prescription medic...TGA Australia
This presentation outlines proposals for implementation of several recommendations from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, and the use of overseas assessment reports.
The Michigan Workers' Compensation Agency enacted new Rules governing the use of Opioids involving workers' compensation claims. This presentation provides background information concerning the purpose of the new Rules and how to handle them as part of a given workers' compensation claim.
iHT² Health IT Summit San Francisco “Connecting the Data: Improving Outcomes and Quality with Clinical and Claims Data”
There is a fundamental need in today’s healthcare system for the two largest constituents—payers and providers—to work together in alignment. Changing the thinking and actions to shift the dynamic of how payors and providers work and interact with each other is no small task. This session will address the challenges and opportunities for payors and providers to work together. Panelists will discuss examples of collaboration and lessons learned.
Learning Objectives:
∙ Assess the structure of provider-payor collaborations reducing cost and improving outcomes
∙ Identify methods to combine clinical and claims data to glean insight
∙ Define clinical, economic and administrative opportunities for alignment
Moderator: Jay Srini, Chief Strategist, SCS Ventures, Adjunct Faculty Assistant Professor, University of Pittsburgh, Senior Fellow and Innovation Chair, iHT² Advisory Board Member
Betsy Thompson, MD, DrPH, Chief Medical Officer, Region IX, Centers for Medicare and Medicaid Services
Brett Johnson, Associate Director, Medical and Regulatory Policy, California Medical Association (CMA)
Clinical edvidence and access for medicinal cannabis productsTGA Australia
This document summarizes the Australian government's approach to medicinal cannabis, which includes treating it as a medicine available by prescription. It outlines reviews finding evidence that cannabis is effective for chronic pain, spasticity, nausea from chemotherapy, and some other conditions. Clinical guidance documents are being developed for conditions like epilepsy, multiple sclerosis, pain, and palliative care. The TGA regulates cultivation, manufacturing, and patient access through schemes like Special Access that require authorization from a prescriber and state health department. Over 170 approvals have been issued under these schemes since 2016.
This document discusses challenges in managing cancer pain and strategies to promote safe and effective pain management. It outlines Joint Commission standards on comprehensive pain assessment, treatment, and reassessment. Barriers to pain management include inadequate processes and education. Effective strategies include standardized policies, electronic tools to support safe opioid prescribing and administration, education and training programs for providers, and monitoring programs to improve patient safety.
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
Pharmacovigilance Activity at NRS Medical College in 2017 and 3 Years of Comp...Anindya Banerjee
Pharmacovigilance Activity at NRS Medical College in 2017 AND 3 Years of Comparative Study under NCC-PvPI, IPC by Patient Safety-Pharmacovigilance Associate Mr. Anindya Banerjee
Expert review of medicines and medical devices regulation: Prescription medic...TGA Australia
This presentation outlines proposals for implementation of several recommendations from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, and the use of overseas assessment reports.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
Pharmacovigilance a general overview most updatedpeter donik
The document provides an overview of the Pharmacovigilance Programme of India (PvPI) and adverse drug reaction (ADR) reporting. It defines key pharmacovigilance terminology and introduces PvPI, which aims to improve patient safety through ADR monitoring. PvPI has established 220 ADR Monitoring Centers to collect reports from healthcare professionals and consumers via forms or a mobile app. Reported ADRs are assessed for causality and signals to support regulatory decision making. The goal is rational medicine use and reducing health risks.
International society of pharmacovigilance (IsOP) training course: Early acce...TGA Australia
The document discusses expedited pathways in Australia for earlier patient access to important new medicines. It describes:
1) Two new pathways - Priority Review and Provisional Approval - which allow faster review/approval of medicines that address unmet needs, while maintaining safety standards.
2) The determination process required to assess eligibility for these pathways before submission. Most determinations received so far are for cancer drugs and meet eligibility criteria.
3) Considerations for implementing these pathways, including managing safety, requiring confirmatory trials, enhancing post-market vigilance, and clearly communicating provisional status and risks to patients and doctors.
4) Other options for early access like compassionate use programs that provide treatment
This document provides an overview of pharmacovigilance and the Pharmacovigilance Program of India (PvPI). It defines pharmacovigilance as the science of detecting, assessing, understanding, and preventing adverse effects of medicines. The document outlines the historical events that led to the development of pharmacovigilance, including the sulfanilamide and thalidomide disasters. It describes the vision, mission, aims, and objectives of PvPI in India to improve patient safety related to medicine use. Key aspects of PvPI covered include adverse drug reaction reporting processes and the expansion of PvPI to include additional medical areas over time.
1) The presentation summarizes the pharmacovigilance activity at Nilratan Sircar Medical College and Hospital from December 2015 to November 2016 and compares it to the previous year.
2) General medicine reported the most adverse drug reactions at 21.27% and the skin was the most commonly involved system at 31.85%.
3) The number of adverse drug reaction reports sent to the national pharmacovigilance program increased from 160 in 2014-2015 to 221 in 2015-2016.
The Pharmacovigilance Program in India (PvPI) was initiated in July 2010 by the Central Drugs Standard Control Organization (CDSCO) in New Delhi to monitor adverse drug reactions. The program aims to ensure the benefits of medicine use outweigh the risks by monitoring adverse reactions. It operates through a network of ADR monitoring centers across India which report adverse reactions using the Vigiflow reporting system. The program is coordinated by the Indian Pharmacopoeia Commission and overseen by steering and advisory committees with technical support from review panels. The program has expanded over the years to include more monitoring centers and now also includes haemovigilance and biovigilance programs.
This document provides an overview of risk management plans (RMPs) and how they are evaluated by the Therapeutic Goods Administration (TGA) in Australia. RMPs outline how risks associated with a medicine will be identified, characterized and minimized once the medicine is available for use. They include a pharmacovigilance plan for monitoring safety and risk minimization activities. The TGA evaluates RMPs to ensure all risks related to a medicine have been considered. Guidance documents are available to assist companies in developing RMPs that meet the TGA's requirements.
ROLE OF PHARMACOVIGILANCE AGAINST ADVERSE DRUG REACTIONAnindya Banerjee
The document discusses the role of pharmacovigilance in monitoring adverse drug reactions (ADRs). It summarizes that pharmacovigilance aims to improve drug safety by identifying ADRs from reported cases and analyzing benefit-risk ratios of medications. Historical drug disasters like thalidomide and sulfanilamide poisonings demonstrated the importance of post-market drug safety monitoring. The document outlines the objectives, reporting process, and future of pharmacovigilance in India including expanding stakeholder reporting and standardizing methodology.
TGA Presentation: TGA Approval PathwaysTGA Australia
This document discusses the TGA approval pathways for medicinal cannabis in Australia. It covers the rescheduling of cannabis and THC to allow access through special access schemes like SAS Category B or authorized prescribers. It provides details on the current scheduling of cannabis and requirements for approval, including information needed about the patient, product, and prescriber. It also discusses implications of the scheduling and amendments made to regulations to tighten access and align with the narcotic drugs act.
The document discusses proposed expedited pathways for prescription medicines in Australia, including a Priority Review pathway. It outlines proposed eligibility criteria focusing on serious conditions with unmet needs where the medicine provides a major therapeutic advantage.
A draft designation process is presented involving assessment of eligibility criteria within 6-8 weeks. Designations would lapse if no registration submission is made within 3 months. Appeals of designation decisions are proposed.
Priority Review is aimed to complete assessments in 150 working days through flexible business processes and expert advice. Provisional Approval could grant earlier conditional registration based on early safety and efficacy data, with enhanced post-market monitoring required. Public consultation on
The document summarizes pharmacovigilance in Australia. It describes Australia's health care system and spending, the leading causes of illness and death, and key events that led to the establishment of pharmacovigilance guidelines and committees. It provides details on guidelines adopted from the EU and ICH, adverse drug reaction reporting procedures to the TGA and ADRAC, and statistics on reported adverse events.
Pharmacovigilance aims to detect, assess, monitor, understand, and prevent adverse drug reactions. It has evolved over time in response to drug safety issues. Key events include the Thalidomide disaster in the 1960s which led to clinical trials, and the establishment of reporting systems in the UK, US, and Europe. India launched its national pharmacovigilance program in 2010 to monitor adverse drug reactions, but progress in expanding monitoring centers has been slow. Increased funding and commitment are needed to fully establish nationwide pharmacovigilance in India.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
Current Pharmacovigilance Practice And Improving Methodsavinashkhairnar
1. The document discusses the history and current state of pharmacovigilance in India, including the establishment of the National Pharmacovigilance Programme in 2004 and challenges faced.
2. Methods to improve pharmacovigilance are proposed, including intensive event monitoring, consumer reporting, use of triggers to identify adverse drug reactions, and monitoring laboratory values for early detection of adverse reactions.
3. A proposed structure is described to strengthen pharmacovigilance in India through collaboration between various stakeholders like consumers, healthcare professionals, and the regulatory authority.
Presentation: Prescription Medicines ReformsTGA Australia
The document summarizes recent and upcoming reforms to Australia's prescription medicine regulations. It discusses the following key points:
1) The launch of the MedSearch app, which allows consumers to access medicine information directly from the Australian Register of Therapeutic Goods.
2) Changes to the format of Product Information documents to highlight important safety and usage details upfront.
3) The introduction of expedited pathways called Priority Review and Provisional Approval to facilitate earlier access to important new medicines.
4) Reforms to the orphan drug program criteria and pathways to incentivize medicines for rare diseases.
5) The upcoming Black Triangle Scheme to more easily identify new medicines and encourage adverse event reporting.
TGA presentation: MMDR Consultation - Strengthening monitoring of medicines i...TGA Australia
The document outlines new and enhanced pharmacovigilance activities being implemented by the TGA to strengthen post-market monitoring of medicines in Australia. Key changes include establishing a Pharmacovigilance Inspections Program, implementing a Black Triangle Scheme, monitoring compliance with Risk Management Plans, developing a new Adverse Events Management System, reformatting Product Information, and increasing collaboration with overseas regulators and use of advanced data analytics. The changes aim to ensure the ongoing safety of medicines on the Australian market through improved monitoring and risk mitigation strategies.
Signifcance of pharmacovigilance & risk management planAnsuman Parida
Pharmacovigilance is concerned with monitoring the safety of pharmaceutical drugs. It involves collecting, detecting, and assessing adverse drug reactions and preventing harm to patients. A risk management plan describes the known safety risks of a drug and outlines activities to further characterize risks, minimize risks to patients, and evaluate the effectiveness of risk minimization measures. Key parties in a risk management plan include patients, healthcare professionals, regulators, payers, pharmaceutical companies, and politicians. Risk management plans help ensure medications are reasonably safe and effective for their intended uses.
This document discusses focussed pharmacovigilance, which involves intensified adverse drug reaction (ADR) reporting within a defined cohort. It provides examples of focussed pharmacovigilance projects in Uganda and Kenya. The Uganda project monitored renal toxicities related to tenofovir use and ADRs related to zidovudine use in adults with HIV infection at specific regional pharmacovigilance clinics. The Kenya project at AMPATH focused on treatment-threatening ADRs to antiretrovirals (ARVs) across multiple HIV treatment sites. The benefits of focussed pharmacovigilance include utilizing existing reporting infrastructure and targeting specific medicines or patient groups, while limitations include potential under-
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
This presentation discusses the opioid epidemic, guidelines for prescribing opioids, and strategies for managing postoperative pain with reduced opioid use. It provides objectives about understanding the societal costs of the opioid epidemic, complying with state prescribing laws, and following guidelines for different types of pain. The presentation reviews CDC guidelines for prescribing opioids, the Arizona prescription drug monitoring program, factors influencing opioid use, and results from a study showing most patients use fewer opioids than prescribed after surgery. It emphasizes multimodal analgesia, patient education, and tapering or discontinuing certain medications before surgery to reduce postoperative opioid needs.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
Pharmacovigilance a general overview most updatedpeter donik
The document provides an overview of the Pharmacovigilance Programme of India (PvPI) and adverse drug reaction (ADR) reporting. It defines key pharmacovigilance terminology and introduces PvPI, which aims to improve patient safety through ADR monitoring. PvPI has established 220 ADR Monitoring Centers to collect reports from healthcare professionals and consumers via forms or a mobile app. Reported ADRs are assessed for causality and signals to support regulatory decision making. The goal is rational medicine use and reducing health risks.
International society of pharmacovigilance (IsOP) training course: Early acce...TGA Australia
The document discusses expedited pathways in Australia for earlier patient access to important new medicines. It describes:
1) Two new pathways - Priority Review and Provisional Approval - which allow faster review/approval of medicines that address unmet needs, while maintaining safety standards.
2) The determination process required to assess eligibility for these pathways before submission. Most determinations received so far are for cancer drugs and meet eligibility criteria.
3) Considerations for implementing these pathways, including managing safety, requiring confirmatory trials, enhancing post-market vigilance, and clearly communicating provisional status and risks to patients and doctors.
4) Other options for early access like compassionate use programs that provide treatment
This document provides an overview of pharmacovigilance and the Pharmacovigilance Program of India (PvPI). It defines pharmacovigilance as the science of detecting, assessing, understanding, and preventing adverse effects of medicines. The document outlines the historical events that led to the development of pharmacovigilance, including the sulfanilamide and thalidomide disasters. It describes the vision, mission, aims, and objectives of PvPI in India to improve patient safety related to medicine use. Key aspects of PvPI covered include adverse drug reaction reporting processes and the expansion of PvPI to include additional medical areas over time.
1) The presentation summarizes the pharmacovigilance activity at Nilratan Sircar Medical College and Hospital from December 2015 to November 2016 and compares it to the previous year.
2) General medicine reported the most adverse drug reactions at 21.27% and the skin was the most commonly involved system at 31.85%.
3) The number of adverse drug reaction reports sent to the national pharmacovigilance program increased from 160 in 2014-2015 to 221 in 2015-2016.
The Pharmacovigilance Program in India (PvPI) was initiated in July 2010 by the Central Drugs Standard Control Organization (CDSCO) in New Delhi to monitor adverse drug reactions. The program aims to ensure the benefits of medicine use outweigh the risks by monitoring adverse reactions. It operates through a network of ADR monitoring centers across India which report adverse reactions using the Vigiflow reporting system. The program is coordinated by the Indian Pharmacopoeia Commission and overseen by steering and advisory committees with technical support from review panels. The program has expanded over the years to include more monitoring centers and now also includes haemovigilance and biovigilance programs.
This document provides an overview of risk management plans (RMPs) and how they are evaluated by the Therapeutic Goods Administration (TGA) in Australia. RMPs outline how risks associated with a medicine will be identified, characterized and minimized once the medicine is available for use. They include a pharmacovigilance plan for monitoring safety and risk minimization activities. The TGA evaluates RMPs to ensure all risks related to a medicine have been considered. Guidance documents are available to assist companies in developing RMPs that meet the TGA's requirements.
ROLE OF PHARMACOVIGILANCE AGAINST ADVERSE DRUG REACTIONAnindya Banerjee
The document discusses the role of pharmacovigilance in monitoring adverse drug reactions (ADRs). It summarizes that pharmacovigilance aims to improve drug safety by identifying ADRs from reported cases and analyzing benefit-risk ratios of medications. Historical drug disasters like thalidomide and sulfanilamide poisonings demonstrated the importance of post-market drug safety monitoring. The document outlines the objectives, reporting process, and future of pharmacovigilance in India including expanding stakeholder reporting and standardizing methodology.
TGA Presentation: TGA Approval PathwaysTGA Australia
This document discusses the TGA approval pathways for medicinal cannabis in Australia. It covers the rescheduling of cannabis and THC to allow access through special access schemes like SAS Category B or authorized prescribers. It provides details on the current scheduling of cannabis and requirements for approval, including information needed about the patient, product, and prescriber. It also discusses implications of the scheduling and amendments made to regulations to tighten access and align with the narcotic drugs act.
The document discusses proposed expedited pathways for prescription medicines in Australia, including a Priority Review pathway. It outlines proposed eligibility criteria focusing on serious conditions with unmet needs where the medicine provides a major therapeutic advantage.
A draft designation process is presented involving assessment of eligibility criteria within 6-8 weeks. Designations would lapse if no registration submission is made within 3 months. Appeals of designation decisions are proposed.
Priority Review is aimed to complete assessments in 150 working days through flexible business processes and expert advice. Provisional Approval could grant earlier conditional registration based on early safety and efficacy data, with enhanced post-market monitoring required. Public consultation on
The document summarizes pharmacovigilance in Australia. It describes Australia's health care system and spending, the leading causes of illness and death, and key events that led to the establishment of pharmacovigilance guidelines and committees. It provides details on guidelines adopted from the EU and ICH, adverse drug reaction reporting procedures to the TGA and ADRAC, and statistics on reported adverse events.
Pharmacovigilance aims to detect, assess, monitor, understand, and prevent adverse drug reactions. It has evolved over time in response to drug safety issues. Key events include the Thalidomide disaster in the 1960s which led to clinical trials, and the establishment of reporting systems in the UK, US, and Europe. India launched its national pharmacovigilance program in 2010 to monitor adverse drug reactions, but progress in expanding monitoring centers has been slow. Increased funding and commitment are needed to fully establish nationwide pharmacovigilance in India.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
Current Pharmacovigilance Practice And Improving Methodsavinashkhairnar
1. The document discusses the history and current state of pharmacovigilance in India, including the establishment of the National Pharmacovigilance Programme in 2004 and challenges faced.
2. Methods to improve pharmacovigilance are proposed, including intensive event monitoring, consumer reporting, use of triggers to identify adverse drug reactions, and monitoring laboratory values for early detection of adverse reactions.
3. A proposed structure is described to strengthen pharmacovigilance in India through collaboration between various stakeholders like consumers, healthcare professionals, and the regulatory authority.
Presentation: Prescription Medicines ReformsTGA Australia
The document summarizes recent and upcoming reforms to Australia's prescription medicine regulations. It discusses the following key points:
1) The launch of the MedSearch app, which allows consumers to access medicine information directly from the Australian Register of Therapeutic Goods.
2) Changes to the format of Product Information documents to highlight important safety and usage details upfront.
3) The introduction of expedited pathways called Priority Review and Provisional Approval to facilitate earlier access to important new medicines.
4) Reforms to the orphan drug program criteria and pathways to incentivize medicines for rare diseases.
5) The upcoming Black Triangle Scheme to more easily identify new medicines and encourage adverse event reporting.
TGA presentation: MMDR Consultation - Strengthening monitoring of medicines i...TGA Australia
The document outlines new and enhanced pharmacovigilance activities being implemented by the TGA to strengthen post-market monitoring of medicines in Australia. Key changes include establishing a Pharmacovigilance Inspections Program, implementing a Black Triangle Scheme, monitoring compliance with Risk Management Plans, developing a new Adverse Events Management System, reformatting Product Information, and increasing collaboration with overseas regulators and use of advanced data analytics. The changes aim to ensure the ongoing safety of medicines on the Australian market through improved monitoring and risk mitigation strategies.
Signifcance of pharmacovigilance & risk management planAnsuman Parida
Pharmacovigilance is concerned with monitoring the safety of pharmaceutical drugs. It involves collecting, detecting, and assessing adverse drug reactions and preventing harm to patients. A risk management plan describes the known safety risks of a drug and outlines activities to further characterize risks, minimize risks to patients, and evaluate the effectiveness of risk minimization measures. Key parties in a risk management plan include patients, healthcare professionals, regulators, payers, pharmaceutical companies, and politicians. Risk management plans help ensure medications are reasonably safe and effective for their intended uses.
This document discusses focussed pharmacovigilance, which involves intensified adverse drug reaction (ADR) reporting within a defined cohort. It provides examples of focussed pharmacovigilance projects in Uganda and Kenya. The Uganda project monitored renal toxicities related to tenofovir use and ADRs related to zidovudine use in adults with HIV infection at specific regional pharmacovigilance clinics. The Kenya project at AMPATH focused on treatment-threatening ADRs to antiretrovirals (ARVs) across multiple HIV treatment sites. The benefits of focussed pharmacovigilance include utilizing existing reporting infrastructure and targeting specific medicines or patient groups, while limitations include potential under-
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
This presentation discusses the opioid epidemic, guidelines for prescribing opioids, and strategies for managing postoperative pain with reduced opioid use. It provides objectives about understanding the societal costs of the opioid epidemic, complying with state prescribing laws, and following guidelines for different types of pain. The presentation reviews CDC guidelines for prescribing opioids, the Arizona prescription drug monitoring program, factors influencing opioid use, and results from a study showing most patients use fewer opioids than prescribed after surgery. It emphasizes multimodal analgesia, patient education, and tapering or discontinuing certain medications before surgery to reduce postoperative opioid needs.
This presentation describes regulations around the Texas Prescription Monitoring Program and rules for physicians to comply with pain management legislation passed in 2019.
1) This case discusses the challenges of managing acute pain in a hospitalized patient on chronic opioids who underwent foot amputation surgery.
2) The patient was prescribed escalating doses of opioids, including extended-release morphine up to 165mg 3 times daily as well as IV and oral hydromorphone. He developed somnolence and hypoxemia.
3) After holding the extended-release morphine, the patient's pain worsened and muscle spasms developed. He was prescribed diazepam which led to respiratory depression and an opioid/benzodiazepine overdose requiring naloxone and ICU admission.
The Center for Medicare and Medicaid Innovation (CMS Innovation Center) hosted an introduction webinar about the Oncology Care Model (OCM) on Thursday, February 19, 2015 from 12:00pm – 1:00pm EST. The webinar focused on introducing core concepts of OCM and application instructions. Advance registration was not required.
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The document outlines an antimicrobial stewardship program that aims to optimize antibiotic use through a multidisciplinary team approach. It discusses how pharmacists monitor antibiotic use daily for appropriateness, look for opportunities to convert IV antibiotics to oral ones when possible, review culture data to de-escalate broad spectrum antibiotics, and perform therapeutic drug monitoring. It also describes how the infection control team tracks emerging resistance, analyzes healthcare-associated infections, and incorporates stewardship into broader infection prevention efforts through annual antibiogram reviews and periodic evaluations of antibiotic use. The overall goal is to improve patient outcomes while containing costs and slowing the development of resistance.
Controlled Substance Prescribing: What to Do?RIAPA
Dr. James MacDonald, Chief Administrative Officer or the RI Board of Medical Licensure and Discipline presents to the RIAPA on controlled substance prescribing in RI.
1. The document discusses pharmacoeconomics in India, including guidelines for conducting pharmacoeconomic evaluations. Some key guidelines covered include identifying relevant perspectives and comparators, choosing appropriate analytical techniques, establishing appropriate time horizons, and properly accounting for costs and effects.
2. Case studies on the cost-effectiveness of treating osteoarthritis pain and deep vein thrombosis are provided. For osteoarthritis, NSAIDs may be more cost-effective than COX-II inhibitors due to lower costs and risks, depending on risk of GI issues. For deep vein thrombosis, low molecular weight heparin enables outpatient treatment due to lower monitoring needs despite higher costs.
3. Pharmacoeconomics can help inform healthcare decisions
This document summarizes a presentation on implementing strategies to reduce prescription drug abuse.
1. It discusses analyzing the scope of payers' role in prescription drug abuse and identifying best practices payers can use, such as member education and prescriber interventions, to reduce fraud and abuse.
2. It describes how the "drug seeker" profile has changed and provides an overview of medical guidelines and current opioid prescribing practices.
3. It outlines solutions payers and providers can implement, such as education, use of drug testing and prescription monitoring programs, to curb inappropriate opioid use and change practices.
This document discusses medication adherence, including its definition, causes of non-adherence, factors influencing adherence, and methods for monitoring and improving adherence. Medication adherence refers to a patient correctly following medical advice regarding medication. Non-adherence can be due to patient-related factors like beliefs, costs, and forgetfulness or provider-related factors like poor education. Adherence is influenced by predisposing, enabling, and reinforcing factors. Methods for monitoring include direct measures like drug levels or indirect ones like patient surveys and prescription refill rates. Improving adherence involves effective provider-patient communication and education.
The CDC published guidelines in 2016 for prescribing opioids for chronic pain that included 12 recommendations. The guidelines aimed to reduce risks of long-term opioid use, including overdose risk. They recommended non-opioid therapies as preferred for chronic pain. If opioids are used, immediate-release are preferred over extended-release/long-acting opioids. The guidelines also recommended starting low doses and slowly increasing if needed, establishing treatment goals, considering risk factors, reviewing prescription drug monitoring programs, using urine drug testing, avoiding concurrent benzodiazepines, and offering treatment for opioid use disorder. However, the guidelines received criticism from medical organizations for being too rigid and not accounting for specialist care of individual patients.
This document provides guidance on conducting audits to assess appropriate use of venous thromboembolism (VTE) prophylaxis in hospitals. It describes snap-shot and detailed audits, resources needed, steps to conduct audits, and how to report and disseminate results to drive quality improvement. The goal is to help close any gaps between evidence-based guidelines and actual clinical practice of VTE prophylaxis prescription and use.
Regulatory procedures for obtaining marketing authorization of medicines in the European Union are described. There are several types of authorization procedures including the centralised procedure, mutual recognition procedure, and decentralized procedure. Conditional approval may be granted if the risk-benefit balance is positive, comprehensive data will likely be provided, and unmet medical needs will be fulfilled. Accelerated assessment can be requested for products that are major therapeutic innovations or of major public health interest. Compassionate use programs make products available for named patients or cohorts when a product has not yet received full authorization.
Balancing post-market monitoring with pre-market requirementsTGA Australia
Dr Jane Cook discusses balancing pre-market requirements with post-market monitoring of new drugs. International trends show increased demand for early access to promising new therapies and different regulatory approaches between Europe and the US. This includes adaptive licensing in Europe and breakthrough therapy designation in the US. Ensuring benefits are realized requires effective post-market monitoring as initial trials may overstate benefits or overlook safety issues. Opportunities exist to learn from other regulators and focus on the drug lifecycle to confirm benefits, inform patients of limitations, and withdraw products if risks outweigh benefits.
This document summarizes changes to CPT codes for 2011, focusing on changes to evaluation and management codes, integumentary system codes, and new codes related to annual wellness visits and H1N1 immunizations. New codes were added for subsequent observation care and annual wellness visits. Codes for debridement were revised and codes for H1N1 immunization administration and pandemic vaccine were added.
NYU Langone Medical Center’s TJA BPCI Experience: Lessons in How to Maximize ...Wellbe
The Bundled Payments for Care Improvement (BPCI) Initiative began generating data in January of 2013. Dr. Iorio will outline the challenges and benefits of implementing BPCI for Total Joint Arthroplasty at an urban, tertiary, academic medical center with a hybrid compensation model. Early results from the implementation of a Medicare BPCI Model 2 primary TJA program demonstrate cost-savings with an improvement in quality of care metrics and continued cost savings through year 3 of our experience. Changes in patient optimization, care coordination, clinical care pathways, and evidence-based protocols are the key to improving the quality metrics and cost effectiveness within the implementation of the Bundled Payment for Care Initiative, thus bringing increased value to our TJA patients.
Maximizing Value in a Bundled Environment – Keys to Success:
• Evidence based, cost effectiveness analysis
• Standardized protocol adoption
• Transparent data
• Perioperative Patient Optimization
• Care management
• Physician-hospital alignment with Gain sharing
• Enhanced pain relief and rehabilitation protocols
• Blood management and rational VTED prophylaxis
About the Speaker:
Richard Iorio, MD, is the William and Susan Jaffe Professor of Orthopaedic Surgery at New York University Langone Medical Center Hospital for Joint Diseases and Chief of Adult Reconstruction at NYU Langone HJD. He co-founded Labrador Healthcare Consulting Services, Responsive Risk Solutions, and the Value Based Healthcare Consortium in 2015. He is a member of the Board of Directors for LIMA, the Lifetime Initiative for the Management of Arthritis. Dr. Iorio is a national expert in physician and hospital quality and safety and a leader in the implementation of alternate payment paradigms in orthopaedic surgery.
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2. WHAT ARE OPIOIDS?
• Opioids are medications
that are prescribed to
relieve acute/chronic
pain
• Most opioids come in pill
or tablet form and can be
taken by mouth, but they
can also be prescribed in
patch form
• Common opioids being
prescribed are
hydrocodone (e.g.
Vicodin), oxycodone (e.g.
Oxycontin, Percocet) and
morphine (e.g. Kadian)
3. INTRODUCTION OF OPIOIDS TO THE
INJURED WORKER
• Treatment is provided to an injured worker
after an injury
• Physician determines that the degree of pain
merits the use of opioids
• The injured worker begins taking the
prescribed medication
• The path of opioid use begins!
4. CHRONIC PAIN
• Chronic pain exists beyond an
expected time for healing. It is
a persistent pain state not
associated with malignancy or
acute pain caused by trauma,
surgery infection or other
factors. However, these and
other pain sources, such as
sprains or twists, may
symptomatically persist to
become chronic benign pain.
The intensity will vary from
mild to severe disabling pain
that may significantly reduce
quality of life
5. OPIOID CONCERNS
• Dependence
• Addiction
• Abuse
– Over medicating
– Overdosing
– Selling the opioids to make $$$
• High medical costs
• Legal exposure
• Medicare!!!
6. THE OPIOID MOVEMENT
• In October 2014, the FDA reclassified combination drugs with
hydrocodone as Schedule II drugs (HIGH POTENTIAL FOR ABUSE!!!)
• Methadone and Oxycodone are also Schedule II drugs
• This requires patients to see their doctors to obtain new
prescriptions, as opposed to obtaining refills without an office visit
• The reclassification limits somewhat the ease of access to opioids
7. AMENDMENTS TO THE WORKERS’
COMPENSATION RULES
• The Michigan Workers’ Compensation Agency (WCA) amended the
Workers’ Compensation Health Care Services rules and fee
schedule, effective December 26, 2014
• The amendments were put in place to address the problem of long-
term use of opioids by injured workers and help reduce medical
costs for the State’s job providers
• Limit potential addiction problems for injured workers, to keep
them healthy and get them back to work
8. • Rule 1008. (1) For purposes of these rules, chronic pain is
pain unrelated to cancer or is incident to surgery and
that persists beyond the period of expected healing after
an acute injury episode. It is pain that persists beyond 90
days following the onset of the pain. The payer shall
reimburse for opioids used in the treatment of chronic
pain resulting from work-related conditions.
• (2) This rule is applicable to opioid treatment of chronic
pain for the following: (a) Injury dates on or after June
26, 2015. (b) Beginning December 26, 2015, all other
injury dates.
R 418.101008 Reimbursement for opioid
treatment for chronic, non-cancer pain
9. R 418.101008a Required documentation for
reimbursement of treatment for chronic, non-cancer
pain with opioids.
• Rule 1008a. (1) In order to receive reimbursement for opioid
treatment beyond 90 days, the physician seeking reimbursement
shall submit a written report to the payer not later than 90 days
after the initial opioid prescription fill for chronic pain and every 90
days thereafter. The written report shall include all of the following:
• (a) A review and analysis of the relevant prior medical history,
including any consultations that have been obtained, and a review
of data received from an automated prescription drug monitoring
program in the treating jurisdiction, such as the Michigan
Automated Prescription System (MAPS), for identification of past
history of narcotic use and any concurrent prescriptions.
• (b) A summary of conservative care rendered to the worker that
focused on increased function and return to work.
• (c) A statement on why prior or alternative conservative measures
were ineffective or contraindicated.
10. • (d) A statement that the attending physician has considered the
results obtained from appropriate industry accepted screening tools
to detect factors that may significantly increase the risk of abuse or
adverse outcomes including a history of alcohol or other substance
abuse.
• (e) A treatment plan which includes all of the following: (i) Overall
treatment goals and functional progress. (ii) Periodic urine drug
screens. (iii) A conscientious effort to reduce pain through the use
of non-opioid medications, alternative non-pharmaceutical
strategies, or both. (iv) Consideration of weaning the injured worker
from opioid use.
• (f) An opioid treatment agreement that has been signed by the
worker and the attending physician. This agreement shall be
reviewed, updated, and renewed every 6 months. The opioid
treatment agreement shall outline the risks and benefits of opioid
use, the conditions under which opioids will be prescribed, and the
responsibilities of the prescribing physician and the worker.
11. • (2) The provider may bill the additional services required for
compliance with these rules utilizing CPT procedure code 99215 for
the initial 90 day report and all subsequent follow-up reports at 90-
day intervals.
• (3) Providers may bill $25.00 utilizing code MPS01 for accessing
MAPS or other automated prescription drug monitoring program in
the treating jurisdiction.
12. R 418.101008b Denial of reimbursement for
prescribing and dispensing opioid medications used to
treat chronic, non-cancer pain.
• Rule 1008b. Reimbursement for prescribing and dispensing opioid
medications may be denied, pursuant to the act. Denial of
reimbursement may occur if the physician reporting and treatment
plan requirements as stated in R 418.101008a are not met. Denial
of reimbursement shall occur only after a reasonable period of
time is provided for the weaning of the injured worker from the
opioid medications, and alternative means of pain management
have been offered.
13. WHAT DOES ALL OF THIS MEAN?
• Limits the ease to which
opioids are prescribed
• Extra hoops for physicians
to jump through in order
to get paid
• Detailed reports to
support the need for
opioid treatment
• Potential to curb the
prescription of opioids in
the first place
15. IMPACT ON WORK COMP CLAIMS
• Opioids are the most common
treatment for chronic pain
– A 2013 study found that 30%
of physician visits for back
and/or neck pain resulted in a
prescription for opioids
– As many as 90% of pain
management patients in the
U.S. receive opioids for
chronic pain
– 50% of patients who take
opioids daily for 90 days are
still taking them daily 5 years
later
17. WHAT DO THESE STATS MEAN?
• The stats show that family physicians, as opposed to pain
management specialists, are prescribing most of the opioids being
used today
• Once an injured worker goes down the opioid route, the odds of
long-term opioid use is significant
• Potential problems are on the horizon
18. WHY SHOULD YOU CARE ABOUT
OPIOID USE?
• Cost of opioids is high
– Future medical treatment costs will be significant
– Need for periodic drug testing
– Potential need for a drug weaning program
– Increases the exposure of a given workers’ compensation claim
– Could lead to a large MSA amount and be an impediment to
settlement
19. HOW TO AVOID OPIOID PROBLEMS
• Be sure to direct medical care for the first 28 days after an injury
occurs
– Could prevent the opioid cycle from starting
• If/when opioids are being discussed as part of a treatment plan,
consider a second opinion (e.g. IME)
• Consider the use of a Nurse Case Manager (NCM) to oversee the
treatment plan, once opioids are prescribed
– Discuss alternatives to opioid treatment
– Monitor the reports from the physicians in support of the
continued use of opioids
– Once opioids are being used, determine the appropriate plan to
wean the injured worker off of the opioids
• Contact an attorney to discuss the claim
20. QUESTIONS?
Renaldo P. DeFrank, Jr.
LeVasseur & DeFrank, P.C.
24725 W. 12 Mile Rd., Ste 230
Southfield, MI 48034
Office: 248-356-8600
Cell: 248-207-6365
www.levasseurlaw.com
rdefrank@levasseurlaw.com