This document summarizes presentations from a clinical track on decreasing opioid risks and exploring non-opioid options for pain management. It discusses the FDA and VA's responses to the opioid epidemic through decreasing opioid prescribing and exploring alternatives. Robert Bianchi discusses the FDA's guidance for developing abuse-deterrent opioids and evaluating claims about abuse-deterrence through laboratory studies. Michael Saenger discusses applying a biopsychosocial model to chronic pain diagnosis and treatment rather than a biomedical model, using a coaching approach to self-management, and applying neuroplasticity principles. The document emphasizes considering the whole person and moving away from a focus on prescription opioids for chronic pain.
The document discusses generic drugs, including their regulatory approval process. Generic drugs must demonstrate bioequivalence to the branded version to gain approval. They are approved through an abbreviated new drug application that shows they deliver the same amount of active ingredients as the branded drug. India has a large and growing generic drug industry that supplies over 30% of the global generic market. Recent FDA rules now require generic drug makers to pay user fees for product approvals.
Good Laboratory Practice (GLP) is a quality system for managing research laboratories to ensure uniformity, consistency, reliability, reproducibility, quality, and integrity of non-clinical safety tests. GLP was first introduced in the 1970s in New Zealand and Denmark, and was adopted in the US in 1978 and internationally via OECD guidelines in 1981. GLP requires documentation and procedures to ensure traceability and monitoring of study data to authenticate published results.
The document discusses the regulatory requirements for approval of biologics. It defines biologics as complex molecules produced through biotechnology from biological sources. The regulatory authority for biologics is the Center for Biologics Evaluation and Research (CBER) within the FDA. The approval process involves an Investigational New Drug Application, Biologics License Application, and approval or refusal. Key differences between biologics and chemical drugs are outlined regarding size, structure, stability and manufacturing. Regulatory guidelines in the US and EU are compared.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
This document summarizes a presentation given by Robert Lionberger on novel methods for demonstrating pharmaceutical equivalence and bioequivalence for complex drug products. It discusses the new Office of Research and Standards within the Office of Generic Drugs at FDA, which facilitates pre-ANDA development and conducts regulatory science research. It also describes challenges with evaluating generic versions of complex drugs like liposomes, inhalation products, and topical dermatological products. The presentation outlines FDA's research on evaluating these complex generics and developing new guidance through regulatory science approaches.
Regulatory guidance and guidelines for filing and approval for biologicsNimmiRoy
This document provides an overview of the regulatory guidance and guidelines for filing a Biologics License Application (BLA) with the FDA for approval of a biological product. It discusses the requirements for a BLA, including the contents that must be submitted. A BLA generally includes 20 sections that provide information on chemistry and manufacturing, nonclinical and clinical data, labeling, facilities and more. The document reviews the content required in each section and the review process by the FDA.
Regulation of biosimilars in India is overseen by the Central Drugs Standard Control Organization (CDSCO). Biosimilars must demonstrate similarity to an approved reference biologic in terms of quality, safety and efficacy through comparative clinical and preclinical studies. The guidelines allow for waiving late-stage clinical trials if early studies show high similarity. Three approval protocols exist based on whether the product is indigenous or imported and if the final product contains genetically modified organisms. Biosimilars offer to increase access to biologic treatments in India at a lower cost than originator biologics.
This document provides an overview of bioequivalence and drug product assessment. It defines key terms like bioequivalence and pharmaceutical equivalence. It discusses the need for and types of bioequivalence studies. The document outlines the objectives and statistical evaluation of bioequivalence data. It also describes different study designs like randomized crossover designs and factors to consider like food effects. Furthermore, it discusses the types of evidence required to establish bioequivalence and conditions for biowaivers.
The document discusses generic drugs, including their regulatory approval process. Generic drugs must demonstrate bioequivalence to the branded version to gain approval. They are approved through an abbreviated new drug application that shows they deliver the same amount of active ingredients as the branded drug. India has a large and growing generic drug industry that supplies over 30% of the global generic market. Recent FDA rules now require generic drug makers to pay user fees for product approvals.
Good Laboratory Practice (GLP) is a quality system for managing research laboratories to ensure uniformity, consistency, reliability, reproducibility, quality, and integrity of non-clinical safety tests. GLP was first introduced in the 1970s in New Zealand and Denmark, and was adopted in the US in 1978 and internationally via OECD guidelines in 1981. GLP requires documentation and procedures to ensure traceability and monitoring of study data to authenticate published results.
The document discusses the regulatory requirements for approval of biologics. It defines biologics as complex molecules produced through biotechnology from biological sources. The regulatory authority for biologics is the Center for Biologics Evaluation and Research (CBER) within the FDA. The approval process involves an Investigational New Drug Application, Biologics License Application, and approval or refusal. Key differences between biologics and chemical drugs are outlined regarding size, structure, stability and manufacturing. Regulatory guidelines in the US and EU are compared.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
This document summarizes a presentation given by Robert Lionberger on novel methods for demonstrating pharmaceutical equivalence and bioequivalence for complex drug products. It discusses the new Office of Research and Standards within the Office of Generic Drugs at FDA, which facilitates pre-ANDA development and conducts regulatory science research. It also describes challenges with evaluating generic versions of complex drugs like liposomes, inhalation products, and topical dermatological products. The presentation outlines FDA's research on evaluating these complex generics and developing new guidance through regulatory science approaches.
Regulatory guidance and guidelines for filing and approval for biologicsNimmiRoy
This document provides an overview of the regulatory guidance and guidelines for filing a Biologics License Application (BLA) with the FDA for approval of a biological product. It discusses the requirements for a BLA, including the contents that must be submitted. A BLA generally includes 20 sections that provide information on chemistry and manufacturing, nonclinical and clinical data, labeling, facilities and more. The document reviews the content required in each section and the review process by the FDA.
Regulation of biosimilars in India is overseen by the Central Drugs Standard Control Organization (CDSCO). Biosimilars must demonstrate similarity to an approved reference biologic in terms of quality, safety and efficacy through comparative clinical and preclinical studies. The guidelines allow for waiving late-stage clinical trials if early studies show high similarity. Three approval protocols exist based on whether the product is indigenous or imported and if the final product contains genetically modified organisms. Biosimilars offer to increase access to biologic treatments in India at a lower cost than originator biologics.
This document provides an overview of bioequivalence and drug product assessment. It defines key terms like bioequivalence and pharmaceutical equivalence. It discusses the need for and types of bioequivalence studies. The document outlines the objectives and statistical evaluation of bioequivalence data. It also describes different study designs like randomized crossover designs and factors to consider like food effects. Furthermore, it discusses the types of evidence required to establish bioequivalence and conditions for biowaivers.
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...JAYA PRAKASH VELUCHURI
This document summarizes a review of clinical trial evidence for metformin fixed-dose combinations (FDCs) used to treat type 2 diabetes in India. The review found:
- Only 25 relevant clinical trials were identified, with most comparing metformin FDCs to monotherapy rather than the individual components.
- None of the trials met all of the WHO's criteria for size, duration, design, and assessing adverse reactions.
- Only 3 trials were conducted in India, with one including just 101 patients over 2 months.
- Despite a lack of robust evidence, over 50 metformin FDCs have been approved in India. The document calls for Indian regulators to make their review and approval evidence public, and to strengthen clinical trial requirements
This document provides an overview of new biosimilar regulations including definitions of biologics and biosimilars. It discusses FDA guidance on pharmacological and scientific testing, labeling, and naming of biosimilars. It also covers the clinical development process for biosimilars including required pre-clinical and clinical studies as well as pharmacovigilance after approval.
The document discusses the International Council for Harmonisation (ICH), its aims, objectives, and guidelines. ICH aims to harmonize technical requirements for pharmaceuticals internationally to ensure safety and efficacy and reduce duplicative testing. It discusses ICH's structure and role of various groups. The four main ICH guidelines categories are also summarized: quality (Q), safety (S), efficacy (E), and multidisciplinary (M). Key points covered include ICH's goal of protecting public health, preventing duplicative clinical trials, and facilitating drug development and registration processes.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
1)spontanious reporting schemes for biodrug adverse reactionsNeha Suresh
This document discusses sources of reports on adverse reactions to herbal drugs, herbal products targeted for safety monitoring, and reporting of suspected adverse drug reactions. The main sources of reports are healthcare professionals, consumers, and manufacturers. Herbal products can be categorized based on their regulatory status and marketing status. Only certain professionals can report adverse reactions, and reports should include identification information, herbal product details, adverse reaction data, other medication use, and the reporter's contact information. A single reporting form should be used to submit reports via various methods.
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
The first generation of biological drugs, which
have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars.
Bioequivalence – Still a Quality Achilles’ Heel? 16 October 2014Ajaz Hussain
This document summarizes a presentation on bioequivalence and pharmaceutical equivalence given by Dr. Ajaz Hussain. Some key points included:
- Pharmaceutical equivalence can be a vulnerable point and Achilles' heel if not properly ensured between generic and reference listed drugs.
- Quality by Design requires early investment in analytics to characterize reference listed drug variability and identify critical quality attributes.
- Lessons learned are that complex generic and biosimilar development share common challenges in demonstrating equivalence, and asking the right questions with the appropriate tools is important.
The document outlines the organization of the Common Technical Document (CTD), which harmonizes the electronic submission of information for drug registration. The CTD includes five modules: Module 1 contains region-specific administrative information; Module 2 provides overviews and summaries of Modules 3-5; Module 3 covers quality topics; Module 4 addresses nonclinical safety studies; and Module 5 concerns clinical efficacy studies. The document describes the content and order recommended for each module to ensure a standardized presentation and review of information.
1) Fixed-dose combinations (FDCs) containing multiple active pharmaceutical ingredients are increasingly common in India but have faced regulatory issues.
2) A parliamentary report found that many FDCs were approved by state authorities without clearance from the central drug regulator and recommended banning FDCs that could not prove safety and efficacy.
3) In 2016 and 2018, the central government banned over 300 FDCs citing lack of therapeutic justification after expert reviews, though the decisions were appealed by pharmaceutical companies.
This document provides guidelines for monitoring the safety of herbal medicines. It discusses the importance of including herbal medicines in pharmacovigilance systems to understand adverse effects from combined herbal and conventional medicine use. Sources of safety reports include healthcare professionals, consumers, hospitals, and manufacturers. National regulatory agencies are responsible for communicating safety information through various channels to facilitate safe and effective herbal medicine use.
Bioequivalence study Exemptions- and Waivers:Ashok Kumar Batham.ashokpharmaco...DrAshok Batham
BIOEQUIVALENCE STUDY: EXEMPTIONS AND WAIVERS
This presentation is based on:
1. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Guidance for Industry
U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER).December 2017. Biopharmaceutics.
2. ICH guideline Q3D M9 on biopharmaceutics classification system based biowaivers
EMA/CHMP/ICH/493213/2018
3. Guidelines For Bioavailability & Bioequivalence Studies
Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi.
(March 2005)
Objectives of this presentation:
Understand the drug regulatory requirements for:
Conducting Bioequivalence Study or
Not Conducting Bioequivalence Study for obtaining regulatory marketing authorization for pharmaceutical formulations,
Bioequivalence studies are required or mandatory for certain formulations,
Exemptions are available for Bioequivalence Studies on certain formulations,
Waivers are granted by drugs regulatory authorities in certain cases, like Biopharmaceutical Classification System (BCS) Class-I and Class-III, Pharmaceutical Drugs, and some drug products with high safety margin,
Propose a clinical classification system-Biotherapeutics Classification System (BTCS) based upon:
Bioavailability of pharmaceutical drug, and
Clinical Safety Margin of pharmaceutical drug
Based on this Biotherapeutics Classification System (BTCS) Waivers may be requested for some pharmaceutical drug formulations, such as those with High Bioavailability and High safety Margin.
Globalization Of Clinical Trials 2010 Josep M. Badenasjosepmariabadenas
Globalization of clinical trials can help bring drugs to market more quickly. While the majority of research and development spending still occurs in developed countries like the US and Western Europe, emerging markets are playing a larger role in global drug development. Countries like India and China provide opportunities for cost-effective clinical trials due to their large patient populations and improving healthcare infrastructures and regulations. However, conducting trials globally also presents challenges around cultural and medical practice differences that need to be addressed.
This document summarizes U.S. drinking water standards. It discusses the difference between primary and secondary standards, how standards are set, and provides tables listing the current contaminant standards. Primary standards are enforced by the EPA and are based on health considerations to limit pathogens, radioactive elements, and toxic chemicals. Secondary standards regulate contaminants that affect aesthetic water qualities like taste and odor. Standards are set by considering toxicology data, calculating acceptable risk levels, and feasibility of water treatment. States enforce EPA standards and can set additional guidelines.
This document provides an introduction to bioequivalence studies, including definitions of key terms, the need for and importance of bioequivalence studies, criteria for establishing a bioequivalence requirement, types of bioequivalence studies, design of bioequivalence studies, evaluation of bioequivalence study results, and clinical significance. It discusses in vivo and in vitro bioequivalence study types and designs, including factors such as single dose, multiple dose, fasting, food effect, and crossover designs. Statistical evaluation methods including ANOVA, confidence intervals, and bioequivalence limits of 80-125% are also summarized.
The document provides an overview of the Orange Book, which is a publication by the FDA that lists approved drug products with therapeutic equivalence evaluations. It discusses the history, contents, and purpose of the Orange Book. The key points covered include a description of the drug approval process, how generic drugs are evaluated for therapeutic equivalence, and how the Orange Book is organized to list brand and generic drug products along with their therapeutic equivalence ratings.
This document discusses biosimilar drugs. It begins by defining biological products and biosimilars. Biosimilars are biologics that are similar but not identical to an already approved biologic reference product. They are developed to be similar in safety, purity and potency. Key differences between biosimilars and generics are discussed. For approval, biosimilars require clinical trials and other testing to show similarity rather than equivalence. Switching a patient from a reference biologic to a biosimilar requires physician approval due to unknown effects on immunogenicity. Naming of biosimilars and increasing competition in the biologics market are also covered.
- Comparative studies demonstrated that PF-05280586, a potential biosimilar to rituximab, has similar structural, functional, and toxicity profiles as rituximab from the EU and US.
- A clinical study in patients with rheumatoid arthritis found similar pharmacokinetics between PF-05280586 and both EU- and US-sourced rituximab, as well as similar safety profiles.
- The data support continued development of PF-05280586 as a potential biosimilar to rituximab that could improve access to treatment.
The document summarizes the key considerations and process for drug synthesis. It discusses the need for a drug to be absorbed, distributed to the right target, metabolized and excreted properly, while also considering toxicities. It then outlines the basic process of drug synthesis including organic synthesis, conversion of molecules, and common methods like formation of carbon-carbon bonds and functional group interconversions. Examples of drug syntheses including aspirin and paracetamol are provided at a high level.
Tackling the Opioid Problem - Analgesic Prescribing in the Emergency DepartmentSCGH ED CME
This document discusses the opioid crisis and approaches to pain management. It describes how Purdue Pharma aggressively marketed OxyContin in the 1990s, leading to widespread overprescription and misuse. This contributed significantly to the rise in opioid overdoses and deaths in the US. In response, pharmaceutical companies developed abuse-deterrent formulations of opioids like OxyContin and Targin to discourage tampering and injection. However, these formulations did not prove abuse-proof. The document advocates for careful opioid prescribing practices to limit diversion and abuse, including assessing risks, limiting durations, and involving specialist services. Non-opioid options like paracetamol, NSAIDs, and tramadol should be prioritized for mild-moderate pain
This document provides an overview of Schedule Y, which establishes requirements and guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India. Schedule Y aims to frame guidelines for clinical research in line with global standards. It outlines application procedures, ethics committee requirements, pre-clinical and clinical data to be submitted, protocol elements, and other rules to ensure safety and efficacy of investigational products. The objectives of Schedule Y are to regulate clinical trials and new drugs in India according to current scenarios and integrate the country into global drug development while improving clinical trial quality.
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...JAYA PRAKASH VELUCHURI
This document summarizes a review of clinical trial evidence for metformin fixed-dose combinations (FDCs) used to treat type 2 diabetes in India. The review found:
- Only 25 relevant clinical trials were identified, with most comparing metformin FDCs to monotherapy rather than the individual components.
- None of the trials met all of the WHO's criteria for size, duration, design, and assessing adverse reactions.
- Only 3 trials were conducted in India, with one including just 101 patients over 2 months.
- Despite a lack of robust evidence, over 50 metformin FDCs have been approved in India. The document calls for Indian regulators to make their review and approval evidence public, and to strengthen clinical trial requirements
This document provides an overview of new biosimilar regulations including definitions of biologics and biosimilars. It discusses FDA guidance on pharmacological and scientific testing, labeling, and naming of biosimilars. It also covers the clinical development process for biosimilars including required pre-clinical and clinical studies as well as pharmacovigilance after approval.
The document discusses the International Council for Harmonisation (ICH), its aims, objectives, and guidelines. ICH aims to harmonize technical requirements for pharmaceuticals internationally to ensure safety and efficacy and reduce duplicative testing. It discusses ICH's structure and role of various groups. The four main ICH guidelines categories are also summarized: quality (Q), safety (S), efficacy (E), and multidisciplinary (M). Key points covered include ICH's goal of protecting public health, preventing duplicative clinical trials, and facilitating drug development and registration processes.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
1)spontanious reporting schemes for biodrug adverse reactionsNeha Suresh
This document discusses sources of reports on adverse reactions to herbal drugs, herbal products targeted for safety monitoring, and reporting of suspected adverse drug reactions. The main sources of reports are healthcare professionals, consumers, and manufacturers. Herbal products can be categorized based on their regulatory status and marketing status. Only certain professionals can report adverse reactions, and reports should include identification information, herbal product details, adverse reaction data, other medication use, and the reporter's contact information. A single reporting form should be used to submit reports via various methods.
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
The first generation of biological drugs, which
have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars.
Bioequivalence – Still a Quality Achilles’ Heel? 16 October 2014Ajaz Hussain
This document summarizes a presentation on bioequivalence and pharmaceutical equivalence given by Dr. Ajaz Hussain. Some key points included:
- Pharmaceutical equivalence can be a vulnerable point and Achilles' heel if not properly ensured between generic and reference listed drugs.
- Quality by Design requires early investment in analytics to characterize reference listed drug variability and identify critical quality attributes.
- Lessons learned are that complex generic and biosimilar development share common challenges in demonstrating equivalence, and asking the right questions with the appropriate tools is important.
The document outlines the organization of the Common Technical Document (CTD), which harmonizes the electronic submission of information for drug registration. The CTD includes five modules: Module 1 contains region-specific administrative information; Module 2 provides overviews and summaries of Modules 3-5; Module 3 covers quality topics; Module 4 addresses nonclinical safety studies; and Module 5 concerns clinical efficacy studies. The document describes the content and order recommended for each module to ensure a standardized presentation and review of information.
1) Fixed-dose combinations (FDCs) containing multiple active pharmaceutical ingredients are increasingly common in India but have faced regulatory issues.
2) A parliamentary report found that many FDCs were approved by state authorities without clearance from the central drug regulator and recommended banning FDCs that could not prove safety and efficacy.
3) In 2016 and 2018, the central government banned over 300 FDCs citing lack of therapeutic justification after expert reviews, though the decisions were appealed by pharmaceutical companies.
This document provides guidelines for monitoring the safety of herbal medicines. It discusses the importance of including herbal medicines in pharmacovigilance systems to understand adverse effects from combined herbal and conventional medicine use. Sources of safety reports include healthcare professionals, consumers, hospitals, and manufacturers. National regulatory agencies are responsible for communicating safety information through various channels to facilitate safe and effective herbal medicine use.
Bioequivalence study Exemptions- and Waivers:Ashok Kumar Batham.ashokpharmaco...DrAshok Batham
BIOEQUIVALENCE STUDY: EXEMPTIONS AND WAIVERS
This presentation is based on:
1. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Guidance for Industry
U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER).December 2017. Biopharmaceutics.
2. ICH guideline Q3D M9 on biopharmaceutics classification system based biowaivers
EMA/CHMP/ICH/493213/2018
3. Guidelines For Bioavailability & Bioequivalence Studies
Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi.
(March 2005)
Objectives of this presentation:
Understand the drug regulatory requirements for:
Conducting Bioequivalence Study or
Not Conducting Bioequivalence Study for obtaining regulatory marketing authorization for pharmaceutical formulations,
Bioequivalence studies are required or mandatory for certain formulations,
Exemptions are available for Bioequivalence Studies on certain formulations,
Waivers are granted by drugs regulatory authorities in certain cases, like Biopharmaceutical Classification System (BCS) Class-I and Class-III, Pharmaceutical Drugs, and some drug products with high safety margin,
Propose a clinical classification system-Biotherapeutics Classification System (BTCS) based upon:
Bioavailability of pharmaceutical drug, and
Clinical Safety Margin of pharmaceutical drug
Based on this Biotherapeutics Classification System (BTCS) Waivers may be requested for some pharmaceutical drug formulations, such as those with High Bioavailability and High safety Margin.
Globalization Of Clinical Trials 2010 Josep M. Badenasjosepmariabadenas
Globalization of clinical trials can help bring drugs to market more quickly. While the majority of research and development spending still occurs in developed countries like the US and Western Europe, emerging markets are playing a larger role in global drug development. Countries like India and China provide opportunities for cost-effective clinical trials due to their large patient populations and improving healthcare infrastructures and regulations. However, conducting trials globally also presents challenges around cultural and medical practice differences that need to be addressed.
This document summarizes U.S. drinking water standards. It discusses the difference between primary and secondary standards, how standards are set, and provides tables listing the current contaminant standards. Primary standards are enforced by the EPA and are based on health considerations to limit pathogens, radioactive elements, and toxic chemicals. Secondary standards regulate contaminants that affect aesthetic water qualities like taste and odor. Standards are set by considering toxicology data, calculating acceptable risk levels, and feasibility of water treatment. States enforce EPA standards and can set additional guidelines.
This document provides an introduction to bioequivalence studies, including definitions of key terms, the need for and importance of bioequivalence studies, criteria for establishing a bioequivalence requirement, types of bioequivalence studies, design of bioequivalence studies, evaluation of bioequivalence study results, and clinical significance. It discusses in vivo and in vitro bioequivalence study types and designs, including factors such as single dose, multiple dose, fasting, food effect, and crossover designs. Statistical evaluation methods including ANOVA, confidence intervals, and bioequivalence limits of 80-125% are also summarized.
The document provides an overview of the Orange Book, which is a publication by the FDA that lists approved drug products with therapeutic equivalence evaluations. It discusses the history, contents, and purpose of the Orange Book. The key points covered include a description of the drug approval process, how generic drugs are evaluated for therapeutic equivalence, and how the Orange Book is organized to list brand and generic drug products along with their therapeutic equivalence ratings.
This document discusses biosimilar drugs. It begins by defining biological products and biosimilars. Biosimilars are biologics that are similar but not identical to an already approved biologic reference product. They are developed to be similar in safety, purity and potency. Key differences between biosimilars and generics are discussed. For approval, biosimilars require clinical trials and other testing to show similarity rather than equivalence. Switching a patient from a reference biologic to a biosimilar requires physician approval due to unknown effects on immunogenicity. Naming of biosimilars and increasing competition in the biologics market are also covered.
- Comparative studies demonstrated that PF-05280586, a potential biosimilar to rituximab, has similar structural, functional, and toxicity profiles as rituximab from the EU and US.
- A clinical study in patients with rheumatoid arthritis found similar pharmacokinetics between PF-05280586 and both EU- and US-sourced rituximab, as well as similar safety profiles.
- The data support continued development of PF-05280586 as a potential biosimilar to rituximab that could improve access to treatment.
The document summarizes the key considerations and process for drug synthesis. It discusses the need for a drug to be absorbed, distributed to the right target, metabolized and excreted properly, while also considering toxicities. It then outlines the basic process of drug synthesis including organic synthesis, conversion of molecules, and common methods like formation of carbon-carbon bonds and functional group interconversions. Examples of drug syntheses including aspirin and paracetamol are provided at a high level.
Tackling the Opioid Problem - Analgesic Prescribing in the Emergency DepartmentSCGH ED CME
This document discusses the opioid crisis and approaches to pain management. It describes how Purdue Pharma aggressively marketed OxyContin in the 1990s, leading to widespread overprescription and misuse. This contributed significantly to the rise in opioid overdoses and deaths in the US. In response, pharmaceutical companies developed abuse-deterrent formulations of opioids like OxyContin and Targin to discourage tampering and injection. However, these formulations did not prove abuse-proof. The document advocates for careful opioid prescribing practices to limit diversion and abuse, including assessing risks, limiting durations, and involving specialist services. Non-opioid options like paracetamol, NSAIDs, and tramadol should be prioritized for mild-moderate pain
This document provides an overview of Schedule Y, which establishes requirements and guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India. Schedule Y aims to frame guidelines for clinical research in line with global standards. It outlines application procedures, ethics committee requirements, pre-clinical and clinical data to be submitted, protocol elements, and other rules to ensure safety and efficacy of investigational products. The objectives of Schedule Y are to regulate clinical trials and new drugs in India according to current scenarios and integrate the country into global drug development while improving clinical trial quality.
FDA Guidelines for Drug Development & Approvalrahimbrave
The document discusses the drug development and approval process in the United States. It describes the roles and responsibilities of the Food and Drug Administration (FDA) in regulating drugs, medical devices, and other products. It then outlines the various phases of clinical trials (Phases I-IV) that drugs must go through to test for safety and efficacy before FDA approval. It also discusses the processes for approving generic drugs, biological products, and modifications to approved drugs.
The FDA regulates food, drugs, medical devices and other products. It oversees the drug approval process which involves preclinical testing in animals, followed by Phase I-III clinical trials in humans to test safety, efficacy and side effects. If approved, the drug can be marketed and is monitored for side effects. The document outlines the drug approval process and regulations around generic drugs, biologics, manufacturing and product changes.
This document provides an overview of biologics, their regulatory approval process in the United States and Europe, and differences between the two regions. It defines biologics as products derived from living organisms used to treat and prevent disease. The US Food and Drug Administration's Center for Biologics Evaluation and Research and the European Medicines Evaluation Agency regulate biologics. Companies must submit a Biological License Application in the US and a Marketing Authorization Application in Europe for product approval, which involves preclinical and clinical testing according to each region's guidelines. The main goal of regulations in both the US and Europe is to safeguard public health.
This module is intended to introduce the students of biotechnology to obtain an overview of the pharmaceutical industry. The concept of clinical trials is discussed in brief.
Hospital Pharmacy Isolator Solutions for USP <797> Compliance from EscoEsco Group
The document discusses guidelines and regulations for handling hazardous drugs in hospitals, including USP <797>. It outlines the risks of exposure to hazardous drugs, such as cancer risks. Engineering controls are important for compounding sterile preparations to reduce contamination, including biological safety cabinets and compounding isolators. Personal protective equipment and proper work practices are also needed to safely handle hazardous drugs.
This document provides an overview of the scope of pharmacology. It discusses the history and evolution of pharmacology from materia medica and early pharmacy to its modern academic, industrial and research applications. Key areas of pharmacology discussed include drug development process, clinical pharmacology, special domains like pharmacovigilance, pharmacoeconomics and emerging areas like pharmacogenomics. The document outlines the past, present and future scope of pharmacology and how it aims to advance human health through rational and safe use of medicines.
The document provides an overview of the drug development and approval process at the US Food and Drug Administration (FDA). It describes the FDA's structure and responsibilities in regulating drugs, medical devices, food, cosmetics, and other products. The key stages of drug development include drug discovery, pre-clinical testing, clinical trials (Phase I-III), and new drug application. FDA approval is required through this rigorous process to ensure safety and effectiveness before a new drug can reach consumers.
This document provides information about the Food and Drug Administration (FDA). It discusses that the FDA is a federal agency that regulates food, drugs, medical devices, and other products to protect public health. The FDA has approximately 9,000 employees including scientists, inspectors, and medical doctors. It is organized into several program centers responsible for approving products and ensuring safety. The document outlines the FDA's role in regulating key areas like food, drugs, medical devices, vaccines, and more.
Pharmacovigilance & Adverse drug reactionRahul Bhati
This document discusses pharmacovigilance and adverse drug reactions (ADRs). It begins by defining pharmacovigilance as the monitoring of drug safety, and describes how the thalidomide disaster in the 1960s prompted significant changes to drug safety systems worldwide. It then discusses various reasons for the need of pharmacovigilance like limited preclinical safety data and changing drug use patterns. The aims and methods of pharmacovigilance including spontaneous reporting, case studies, and periodic safety reports are summarized. It also provides an overview of the Pharmacovigilance Program of India and its goals of monitoring ADRs and ensuring drug benefits outweigh risks. Finally, it defines different types of ADRs and their
The document summarizes a presentation on abuse-deterrent formulations of opioids given by Douglas Throckmorton of the FDA and Richard Dart. It discusses the FDA's efforts to encourage development of abuse-deterrent opioids through guidance and regulatory decisions. While progress has been made, challenges remain in developing, testing, and assessing the real-world impact of abuse-deterrent technologies. The FDA aims to improve treatment of pain while reducing risks of prescription drug abuse and overdose through multiple strategies.
THE PRESENTATIONS DESCRIBES THE ICH GUIDELINE FOR RESIDUAL SOLVENTS i.e Q3C.
IT contains the basic of ICH and the complete description about the ICH guideline Q3C and its classification,limits,acceptance criteria in Pharma industries and the standards.
#Pharmaceuticalguideline
#medicine
#healthandmedicine
The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, cosmetics and radiation-emitting products. It aims to protect public health by ensuring safety and efficacy. The FDA employs scientists, physicians and other staff across various centers to review products, conduct inspections, set standards and provide information to consumers. Key responsibilities include approving new drugs, ensuring food safety, regulating medical devices and regulating veterinary products.
Pharmacovigilance is the science of monitoring the safety of medicines. It aims to detect adverse effects from drugs, understand their causes, and prevent patient harm. Pharmacovigilance programs collect reports of adverse drug reactions and analyze the data to identify safety issues, quantify risks, and communicate safety information to patients and healthcare professionals. The ultimate goals are to protect patients and promote the safe use of medicines.
The document discusses the process of developing new drug products in the pharmaceutical industry. It describes the key stages of development including preclinical testing in animals, followed by clinical trials in three phases with humans to test safety and efficacy. During these phases, the drug formulation is also developed. If clinical trials are successful, a New Drug Application is submitted to the FDA for review and potential approval. After approval, further development may continue through product line extensions, formulation improvements, or additional clinical studies. The development process aims to produce drug products that are safe, effective and stable.
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The document discusses various stages of drug discovery and development. It begins with an introduction to traditional methods of drug discovery and advances in understanding disease at the molecular level. It then covers key stages like drug discovery, preclinical studies, clinical trials, and regulatory approvals required by agencies like the FDA and India's CDSCO. Different types of applications submitted during development and regulatory processes are explained, including IND, NDA, ANDA, SNDA, and supplements for post-approval changes. Challenges and methods in each stage are also summarized.
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organization, structure, function of FDA, FR, CFR, FFDCA, Approval process of IND, NDA, ANDA, orphan drug, combination product, changes to approved NDA, ANDA, packaging labelling of pharmaceutical.
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Dr. Tom Frieden, Director of the Centers for Disease Control and Prevention, keynote presentation at the National Rx Drug Abuse & Heroin Summit on March 30, 2016.
Kana Enomoto, Acting Administrator, Substance Abuse and Mental Health Services Administration, keynote presentation at the National Rx Drug Abuse & Heroin Summit March 29, 2016
This document summarizes a presentation on managing morphine equivalent dose (MED) and identifying high-risk opioid use through "red flagging." It discusses how calculating MED at the point of sale can help identify unsafe dosages and decrease opioid prescriptions. It also evaluates different methods to screen for overdose risk, finding that simple opioid use thresholds to flag patients may not accurately target those most likely to experience preventable overdoses. The presentation aims to explain MED management, describe payer solutions that reduced opioid use, and identify more precise ways to intervene with highest-risk patients.
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Rx15 clinical tues_200_1_bianchi_2saenger
1. Clinical Track:
FDA on Decreasing Opioid Risks and
VA on Exploring Non-Opioid Options
Presenters:
• Robert P. Bianchi, Vice President and Chief of Scientific
and Technical Affairs, Prescription Drug Research
Center
• Michael Saenger, MD, FACP, Lead Physician, Pain
Management, VISN 7, and Director, Empower Veterans
Programs, and Leader, Task Force for Opioid Safety,
Atlanta VA Medical Center
Moderator: Kelly J. Clark, MD, MBA, FASAM, DFAPA,
President-elect, American Society of Addiction Medicine
(ASAM), and Member, Rx Summit National Advisory Board
2. Disclosures
• Robert Bianchi and Michael Saenger, MD, FACP, have
disclosed no relevant, real or apparent personal or
professional financial relationships with proprietary
entities that produce health care goods and services.
• Kelly J. Clark, MD, MBA, FASAM, DFAPA –
Employment: Publicis Touchpoint Solutions;
Consultant: Grunenthal US
3. Disclosures
• All planners/managers hereby state that they or their
spouse/life partner do not have any financial
relationships or relationships to products or devices
with any commercial interest related to the content of
this activity of any amount during the past 12 months.
• The following planners/managers have the following to
disclose:
– Kelly Clark – Employment: Publicis Touchpoint Solutions;
Consultant: Grunenthal US
– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center
– Carla Saunders – Speaker’s bureau: Abbott Nutrition
4. Learning Objectives
1. Explain a top-down and a bottom-up federal
response to the Rx drug abuse epidemic.
2. Evaluate abuse-deterrent opioids.
3. Advocate a framework for diagnosing and
treating chronic pain that de-emphasizes
opioids.
5. Government and Industry
Response to Rx Abuse
Robert Bianchi
Prescription Drug Research Center -
Chicago, IL
Atlanta GA - April 7, 2015
6. DISCLAIMER
• Robert Bianchi has disclosed no relevant,
real or apparent personal or professional
financial relationships with proprietary
entities that produce health care goods
and services.
7. Learning Objectives
• Government response to the Rx drug abuse
epidemic
• Industry Response to the Rx drug abuse
epidemic
• FDA Guidance to Industry
• In vitro testing to evaluate abuse-deterrent
opioids
8. Current Situation
• CDC has declared Rx abuse as an epidemic. More
americans abuse Rx than cocaine, heroin, inhalants
& hallucinogens COMBINED
• In 2013 approximately 43,982 overdose deaths
occurred, one death every 12 min*
• Of these deaths, 22,767 (51.7%) were attributed to
Rx drug abuse – 16,235 were attributed to opioids
– 6,973 were attributed to benzodiazepines*
*CDC Centers for Disease Control and Prevention. National Vital Statistics System
mortality data. (2015)
9. Insatiable Appetite - 2010
Rx abuse is the fastest growing drug problem in
the United States (5% of world population)
• 65% of the worlds supply of hydromorphone
(Dilaudid)
• 80% of the worlds supply of oxycodone
(OxyContin)
• US consumed 99% of the worlds supply of
hydrocodone (Vicodin)
10. What caused this phenomenon?
• Prescription drugs do not fall under the
clandestine cloud of illegal drugs such as heroin,
ecstasy or methamphetamine
• Prescription drugs are more available due to the
development of new products and increased
prescriptions
• Rx drugs are safe - FDA approved & Dr. prescribed
• Friends and family use them
• Drugs are frequently obtained free of cost
14. Industry Response
• Develop consortium to explore options and
advise FDA
• Develop formulations that deter abuse
• Educate prescribers and patients
• Conduct research to develop new pain
medications
15. Government Response
• Increased monitoring of
– Manufactures
– Distributors
– Pharmacies
– Doctors
• Prescription Drug Monitoring Programs
• DEA “Take Back Program” 309 tons of Rx
medications from nine collection events
• Increased criminal investigations
16. Government Response
• Educational programs and publications for prescribers and
patients
• Requires sponsors to develop REMS
• FDA issued draft guidance to industry in Jan 2013,
describing how to demonstrate if an opioid formulation
contains abuse deterrent properties.
• April 2013 FDA allows labeling concession to Purdue for
reformulated OxyContin (physical or chemical properties
that deter IV and nasal abuse). Original formulation
available 1995-2010
• Encouragement to develop abuse resistant formulations
(ADF)
17. ABUSE DETERRENT OPTIONS
1. Physical/Chemical barriers – Physical barriers can
prevent chewing, crushing, cutting, grating, or
grinding. Chemical barriers can resist extraction of
the opioid using common solvents like water, alcohol,
or other organic solvents. Physical and chemical
barriers can change the physical form of an oral drug
rendering it less amenable to abuse (e.g., reformulated
OxyContin®)
18. ABUSE DETERRENT OPTIONS
2. Agonist/Antagonist combinations – An opioid
antagonist can be added to interfere with, reduce,
or defeat the euphoria associated with abuse. The
antagonist can be sequestered and released only
upon manipulation of the product. For example, a
drug product may be formulated such that the
substance that acts as an antagonist is not clinically
active when the product is swallowed but becomes
active if the product is crushed and injected or
snorted. (e.g., Talwin Nx®, Suboxone, Embeda®)
19. ABUSE DETERRENT OPTIONS
3. Aversion – Substances can be combined to produce
an unpleasant effect if the dosage form is
manipulated prior to ingestion or a higher dosage
than directed is used. (Oxecta oxycodone/niacin)
4. Prodrug – A prodrug that lacks opioid activity until
transformed in the gastrointestinal tract. Can be
unattractive for intravenous injection or intranasal
routes of abuse (e.g. Vyvanse amphetamine).
20. ABUSE DETERRENT OPTIONS
5. Delivery System (including depot injectable formulations
and implants) – Certain drug release designs or the
method of drug delivery can offer resistance to abuse. For
example, a sustained-release depot injectable formulation
that is administered intramuscularly or a subcutaneous
implant can be more difficult to manipulate.
6. Combination – Two or more of the above methods can
be combined to deter abuse.
21. FDA GUIDANCE
The Guidance describes four categories of
recommended studies for supporting and
evaluating claims of abuse-deterrence:
–Premarket studies:
•Laboratory Manipulation and Extraction
Studies (Category 1)
•Pharmacokinetic Studies (Category 2)
•Clinical Abuse Potential Studies (Category
3)
-Post marketing Studies (Category 4)
22. Laboratory Manipulation and
Extraction Studies
Evaluate various simple and sophisticated
mechanical and chemical ways a drug can be
manipulated.
(1) defeating or compromising the controlled release of
an opioid from extended-release formulations
(2) preparing an IR or ER formulation for alternative
routes of administration
(3) separating the opioid antagonist, if present, from the opioid
agonist, thus compromising the product’s abuse-deterrent
properties.
23. Laboratory Manipulation and
Extraction Studies
Evaluate resistance to manipulation
1. Ease of particle size reduction using commonly
available manual tools (spoons, hammer, mortar &
pestle) & electrical appliances (coffee grinder,
blender)
• 2. Effects of heat & cold on manipulation efficiency
24. Coffee mills used to grind tablets
• Shown lids have been used for approx 15 runs each
• Examples on broken blades from two mills
Photos by permission, Egalet, Copenhagen DK, 2010.
25. Laboratory Manipulation and
Extraction Studies
• For a product with potential for snorting, the
particle size distribution should be
established.
• For a product with potential for snorting, the
particle size distribution should be
established, using various tools.
Photo by permission, National Medical Services Laboratories (NMS) 2014
26. Laboratory Manipulation and
Extraction Studies
Evaluate extractability of intact &
manipulated product
1.Commonly available aqueous solvents that have potentially
relevant solvent characteristics (pH, polarity such as water,
alcohol, cola, vinegar, acetone, mineral spirits)
2.Conduct at elevated temperature & room temperature.
3.Conduct on stirred & soaked comparator & ADF
4.Conduct on in tact and ground material
28. SMOKING ABUSE
• For a product with potential for smoking, the
vaporization temperature and degradation
temperature of the opioid in salt and base
form should be determined.
30. INTRAVENOUS ABUSE
• For a product with potential for intravenous
injection, the opioid concentration in a small
injection volume and the viscosity
(syringeability and injectability) of the
injection fluid should be determined.
33. DOSE DUMPING
• The ingestion of alcoholic beverages with
extended release opioids poses serious safety
concerns i.e. uncontrolled immediate release of
drug.
• The FDA now recommends in vitro drug release
studies to determine if alcohol causes enhanced
release of opioid using varying concentrations of
alcohol
35. IN-VITRO EXPERIMENTS
• Develop written protocols that produce statistically valid,
reproducible results.
– Include related comparator product
– Include controls
– Include quality assurance procedures
– All experiments must be conducted at least in triplicate
– Use graphs and charts to illustrate data
– Experiments should be conducted by an independent
laboratory that is blinded to the fullest extent possible in
addition to in house laboratory experiments
– Take photographs to illustrate results
36. IN-VITRO EXPERIMENTS
aka KITCHEN CHEMISTRY
• Every product is different; therefore each requires a unique
set of experiments developed under the standardized tests to
assess tamperability.
• Sponsor knows product’s vulnerabilities and should develop
experiments in concert with abuse experts based on product
knowledge and current abuse methods of similar products
using commonly available chemicals and equipment.
• Standardized laboratory extractions must be developed for
each dosage form, e.g. tablets, capsules, patches, liquids, IR,
SR using solvents & equipment commonly available.
• Consider testing all dosage strengths
37. Summary
• No objective measure exists to measure
tamperability/extractability
• Each product/system requires unique experiments designed
to address vulnerabilities
• Use independent laboratory (NMS) & abuse experts
• Consider all modes of abuse & all strengths
• Include photographs, graphs & charts where appropriate
• No product has addressed multiple pill abuse
• No product has been proven to be tamper proof
38. Thank you
Robert P. Bianchi
Vice-President and Chief
of Scientific and Technical affairs
Prescription Drug Research Center
134 N. LaSalle Street
Chicago, IL 60602
312-726-8620 - Office
571-233-4780 – Cell
RBianchi@pdrcllc.com
RBConsulting700@AOL.com
40. Conflicts of Interest
• Michael Saenger, MD, FACP, has disclosed no
relevant, real or apparent personal or
professional financial relationships with
proprietary entities that produce health care
goods and services.
• Biases toward:
– Bio-psycho-social-spiritual framework of Health
– Self-empowered care
– Evidence Based Practice (EBP)
– Systems of care / Team-based care
• Patient Centered Medical Home
– Model for Improvement
• Changing, and testing to see if it is improvement
41. Learning Objectives
• Discuss how to apply a “Whole Health”
Framework i.e. Bio-Psycho-Social-Spiritual Model
of Chronic Pain rather than Bio-Medical one
• Review how to become a “Coach” for
Collaborative Self-Management and draw out the
Client’s Internal Motivation for Change
• Review how to apply “Retraining the Brain” /
“Neuroplasticity” Model to chronic pain
management.
43. Mindful Moment,
IF You Feel Safe AND Choose To, Then:
• Practice of self-care
– Release tension in your muscles… through
Gently rolling your shoulders…
– Activate “Relaxation Response” through
Slowing and deepening your breathing
44. Client Scenario 1
35 year old woman with chronic pelvic pain is crying
in the exam room. She has already been told by a
Gynecologist and a Gastroenterologist that her
ultrasounds and scopes are normal.
Healthcare Team recommends:
A. Converting oxycodone IR to fentanyl patch
B. Adding alprazolam prn
C. Ordering MRI of pelvis
D. Understanding her goals and
more about her as a whole person
45. Client Scenario 2
30 year old man with phantom limb pain
“cannot sleep because of the pain”.
Healthcare Team recommends adding:
A. Zolpidem
B. Pregabalin
C. Topiramate
D. Mirror Therapy
46. Historical Swing
• From: “Not much we can do”, besides:
– TLC
– Grandma’s chicken soup
– Prayer
• To: Many new choices of:
– Pharmaceuticals and
– Procedures
47. “Find it and Fix it”
• “Reductionistic Science” Model
– Produces many advances in
• Diagnosis
• Therapy
– May miss complexity of Whole
48. Story of Pelvic Pain
• “Usual Care” = “Bio-Medical Model”
– Chief Complaint drives
• Subspecialty referral
(for “Diseased Part”) and
• Differential Diagnosis with
– Life threatening illnesses excluded with
» Advanced testing…
• Symptom management with
» Poly-pharmacy
53. Chronic Pain ≠ Acute Pain
Acute Pain, usually:
• Transient
• Simple
• Bio-Medical cause
• Curable
Complex Chronic Pain, usually
• Long lasting
• Complicated
• Bio-Psycho-Social-Spiritual
• Manageable, not curable
54. Chronic Pain often Driven by:
• Stress and Poor Coping Skills
• Deconditioning
• Central Sensitization
• Anxiety
• Depression
• Substance Use Disorder
– including Opioid Use Disorder
• Note that Sleep may be disrupted
by any of these
55. Whole Person Perspective
Explains Gap between
Objective Evidence and Subjective Pain
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
56. What is “REAL” Pain?
• “Pain” is what the Client says it is
• “Psycho-social pain” is “Real” pain
– But enabling “Chemical Coping”
worsens whole person problems
57. Break the Cycle of Frustration
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
58. Bio-Psycho-Social-Spiritual Model
Affects How to Diagnose Chronic Pain
• Initial thorough H&P and a few tests
• Assessments for
– Anxiety
– Depression
– Substance Use Disorders,
• including Opioid Use Disorder
• NOT additional CT/MRI… until
“real” “pain-generator” image captured
60. Complex Chronic Pain
Diagnostic Clues:
• “Enigmatic” presentations to multiple PCPs
• Declining function over time
• Severe emotional distress and disability
not responding to conventional treatments
• Significant dissatisfaction with medical care
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
62. Collaborative Self-Management
• Chronic Care Model
• Primary Goal:
– NOT urgent nor complete pain relief
– Reduce suffering and disability
• Role of Healthcare Team
– Enhancing adaptive choices
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
63. Collaborative Self-Management
• Values Clients as people
– Identifies Functional Goals
– Supports addressing other life problems
• Challenges dysfunctional beliefs
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
64. Reframing Pain
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
65. “What do you want your Health for?”
• Re-centering
– Rather than: “On a scale of 0-10…?”;
• Moving from passive to active role
– Quarterback
• Drawing out intrinsic motivation for change
Tracy Gaudet, MD; VHA Office of Patient Centered Care and Cultural Transformation
66. Model of
Proactive Health and
Well-being
VHA Office of
Patient Centered Care and
Cultural Transformation;
Tracy Gaudet, MD, Director;
Used with permission
Circle of Health; What is:
- In balance?
- Out of balance?
67. VEMA Process
• Validation
– “We believe you have real pain”
• Education
– Shared model
• Motivation
– Enhanced: “Motivational Interviewing”
• Activation
– Offering new way to react to pain
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
68. “What you do
is more powerful
than any pill”
[or what is done to you]
Tracy Gaudet, MD; VHA Office of Patient Centered Care and Cultural Transformation
69. Facilitating Motivation
• Pre-contemplation
• Contemplation
• Preparation
• Action
• Maintenance
• Relapse
• Challenge false beliefs
• Explore change
• Assist in “Action Plan”
• Reinforce adaptive action
• Reinforce gains; adjust goals
• Explore reasons;
reassess readiness to change
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
70. Roll with Resistance
• Avoid arguments
• “Yes… and…”
– Reflect back Client’s concerns
– Reframe the problem, avoiding false “dualism”
– Acknowledge difficulty
– Emphasize autonomy and responsibility
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
72. Making Health Plan
• Responsibility for change is theirs
• Begin with small goals
• Start with social/recreational reactivation first
• Physical reactivation ≠ PT which “didn’t work”
– Encourage, “Think like an athlete”
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
74. Setting a Goal
SMART Examples:
• Walk in place for 5 minutes
before each meal
• Practice 3 minutes of slow
deep “belly” breathing at 10
and 2 each day
Not so smart examples:
• Get more exercise
• Relax more
75. Follow-up
• Inquire about progress towards goals
• Identify barriers
• Minimize focus on urgent pain relief
• Help establish new goals
• “You know you’re providing high quality pain care when
you spend very little time talking about pain”
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
76. Prepare for “Bad Days”
• Exacerbations are “predictable ebb and flow”
of chronic pain
• Stress may precipitate Bad Day
– “Be prepared”
– “Be proactive”
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
77. We all can be Good “Therapists”,
Using “3 P’s”
• Pause: Relaxation Response
– When “Foaming in” or…
• Be Present: Attentive
– When “Crossing Threshold”
• Then Proceed
– With Whole Health Care
– Including those skills of our particular profession
http://www.fammed.wisc.edu/mindfulness/pip/pause
78. Roles for Primary Care Team:
• Affirming Client’s
– Worth (their story; their significance)
– Innate strengths to move toward Health
• Side-stepping non-value added care, which is:
– No better than standard care (or harmful or …)
– Passive
• Offering
– Motivational Enhancement
– Safe and effective options which promote Health
79. Using Re- Education in
Neuropsychology: “Re-Train the Brain”
The Hunter Group; used with Permission: http://www.youtube.com/watch?v=4b8oB757DKc
80. That to which we give
attention, grows!
“Neurons that fire together, wire together”
Donald Hebbs; “The Theory of Hebbian Learning”
81. From Where is Pain Coming?
Walter Reed Medical Center; http://www.youtube.com/watch?v=YL_6OMPywnQ
82. Re-Training the Nervous SystemStrainonBody
Tissue Damage
Graphic thanks to Neil Pearson, Jennifer Gansen and others
Sensitized
Nervous System
Alarm
Desensitized
Nervous System
Alarm
Deconditioned
Exercise Capacity
Reconditioned
Exercise Capacity
83. Neil Pearson’s “Exercise Guidelines”
for Stretching or Exercising
1. Go to “the Edge” for particular exercise;
2. Ask 2 questions
a. Am I safe? (if “yes”, then)
b. Will I pay for this later? (if “no”, then)
3. While at “the Edge”, keep
a. Body calm
b. Breathing calm
c. In touch with pain (not too much nor too little)
http://www.youtube.com/watch?v=gN-WwxfPIZo Modified; Used with Permission
84. Mindfully Aware
• I (We) cannot do:
– Everything
– Everything today
• I (We) can:
– Play significant role as Coach
– Educate re: range of safe and effective options
85. Collaborating with Other Coaches
Who Excel in:
• Motivational Enhancement
• Assessment and therapies for:
– Psychological care
– Movement needs
– Existential/Spiritual care
– “Biological” and other needs
86. Re-Framing our Care
FROM: TOWARDS:
Bio-Medical Model Bio-Psycho-Social-Spiritual Model
Symptom-driven Seeking Deeper Meaning / Values
Provider-driven Coaching / Motivational Enhancement
“Pharmaceuticals & Procedures” Activating Innate Healing
"Done to you" "You do"
Reactive Proactive / Reflective and Aware
1:1 Appointments Group Education and Support
88. Client Scenario 1
35 year old woman with chronic pelvic pain is crying
in the exam room. She has already been told by a
Gynecologist and a Gastroenterologist that her
ultrasounds and scopes are normal.
Healthcare Team recommends:
A. Converting oxycodone IR to fentanyl patch
B. Adding alprazolam prn
C. Ordering MRI of pelvis
D. Understanding her goals and
more about her as a whole person
89. Client Scenario 2
30 year old man with phantom limb pain
“cannot sleep because of the pain”.
Healthcare Team recommends adding:
A. Zolpidem
B. Pregabalin
C. Topiramate
D. Mirror Therapy
91. Web Resources
Chronic Pain Overview for Clients
• Understanding Pain: What to do about it in Less than Five Minutes
http://www.youtube.com/watch?v=4b8oB757DKc
https://www.youtube.com/watch?v=MI1myFQPdCE
https://www.youtube.com/watch?v=jIwn9rC3rOI
• Low Back Pain – Mike Evans
http://youtu.be/BOjTegn9RuY
• Four Flat Tires – American Chronic Pain Association
http://www.theacpa.org/a-car-with-four-flat-tires
92. Web Resources
Deep Breathing & Exercise for Clients
• Deep Breathing Exercise for Relaxation Response: Breathe2Relax-Demo
http://www.youtube.com/watch?v=YdsipKCACac
• Neil Pearson’s Exercise Guidelines
http://www.youtube.com/watch?v=gN-WwxfPIZo
• Leslie Sansone (first 5 minutes) Starting Walking at Home
http://www.youtube.com/watch?v=ykPr0t2KutY&feature=youtu.be
93. Web Resources
Motivational Story for Clients
• Never, Ever Give Up. Arthur's Inspirational Transformation!
http://www.youtube.com/watch?v=qX9FSZJu448
94. Other Web Resources for Clients
• The American Chronic Pain Association
http://theacpa.org/
• Conditions A to Z
http://theacpa.org/conditions
• Communication Tools (self rating logs…)
http://theacpa.org/Communication-Tools
• Mirror Box Therapy
http://healthskills.wordpress.com/2009/03/05/youtube-mirror-box-
videos/
95. Web Resources for Clinicians
• “Paths to Recovery” / “Retraining the Nervous System”; Neil Pearson
http://www.lifeisnow.ca/
• The American Chronic Pain Association
http://www.theacpa.org/
96. Other References
• The Pain Survival Guide: How to Reclaim Your Life. Turk. American
Psychological Association 2005
• Pain Management for Older Adults – A Self-Help Guide. Hadjistavropoulis.
International Association for the Study of Pain. 2008
97. What CAM to offer?
i.e. Integrative Health Therapy Options
• Complementary Medicine options for cLBP
– “Bridge” – useful short term
• Massage
• Spinal Manipulation
• Acupuncture
– “Active” – Client learns self management tools
• Alexander technique – “retrain the brain”
• Mindfulness – non-judgmental acceptance
• Yoga, Tai Chi ... movement training like Alexander
http://www.psychiatry.org/practice/professional-interests/addiction-psychiatry/learning-the-evidence-behind-alternative-complementary-chronic-pain-management---
emphasis-on-chronic-low-back-pain----part-two
http://www.psychiatry.org/practice/professional-interests/addiction-psychiatry/learning-the-evidence-behind-alternative-complementary-chronic-pain-management-
emphasis-on-chronic-low-back-pain----part-one
99. Transition To
Away from therapies:
Dangerous
Ineffective
Passive
Towards therapies:
Safe
Moderately effective
Self-efficacious
Deep Breathing
Relaxation
Alexander Technique
Yoga / Tai Chi
Mindfulness
100. “Bridging Therapies”
For Those Needing Temporary Help
Away from therapies:
Dangerous
Ineffective
Passive
Towards therapies:
Safe
Moderately effective
Self-efficacious
Saenger, APA PCSS-O Webinars, Evidence for CAM for Chronic LBP,
parts 1&2, 2013;
Saenger, American Chronic Pain Association Chronicle, June 2013;
Heckman, Heckman, Saenger and Marconi, HIV Specialist, Dec 2013
Temporary “Bridging” Therapies
E.g. while tapering opioids; Using
Acupuncture or
Spinal Manipulation or
Massage
101. Goal: Thriving Self-Management
Towards therapies:
Safe
Moderately effective
Self-efficacious
Deep Breathing
Relaxation
Alexander Technique
Yoga / Tai Chi
Mindfulness
103. Building Collaborative Relationship
• Set realistic expectations during initial meeting
• Take their concerns seriously
• Acknowledge their frustration with prior tx
• Listen to their story, not just their symptoms
• Express empathy for urgent pain relief
• Recognize current situation is unacceptable
• Commit to the relationship
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
104. Personal Meaning of Pain
• Disabling beliefs
• Psychosocial factors
• Factors maintaining pain
• Factors influencing medical utilization
• How is person currently managing?
• How ready is the person for self-management?
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
105. Story of Pelvic Pain, Revisited
• “Model of Illness”
• “What do you believe is:
– Causing this _____?
– Going to happen?
– Needed to find this?
– Needed to manage this?
106. “Draw me your story”
• Consider “homework” of one page drawing
“My Life”
Pain (1)
Began
Pain (1)
Worsened
Significant
Life Event 1
Significant
Life Event 2
107. Special Thanks to:
• “Tony” Mariano, PhD;
– VHA VISN 20
• Tracy Gaudet, MD;
– VHA Office of Patient Centered Care and Cultural Transformation
• “Mac” Gallagher, MD;
– VHA National Director for Pain Management
• Neil Pearson, MSc, BScPT, BA-BPHE, Cert MDT;
– Life is Now
• Ilene Robeck, MD;
– VHA VISN 6
• Anne Tomolo, MD, MPH;
– Atlanta VA National Quality Scholars Program
• Nadine Kaslow, PhD;
– American Psychological Association; Grady Health System; and Emory University
108. Clinical Track:
FDA on Decreasing Opioid Risks and
VA on Exploring Non-Opioid Options
Presenters:
• Robert P. Bianchi, Vice President and Chief of Scientific
and Technical Affairs, Prescription Drug Research
Center
• Michael Saenger, MD, FACP, Lead Physician, Pain
Management, VISN 7, and Director, Empower Veterans
Programs, and Leader, Task Force for Opioid Safety,
Atlanta VA Medical Center
Moderator: Kelly J. Clark, MD, MBA, FASAM, DFAPA,
President-elect, American Society of Addiction Medicine
(ASAM), and Member, Rx Summit National Advisory Board