To contain costs and improve healthcare outcomes, players across the value chain must apply advanced analytics to measure and understand patients’ failure to follow treatment therapies, and to then determine effective remedial action. This white paper lays out a framework for enabling patient adherence management and some general prescriptions on how to convert lofty concepts to meaningful action.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
The document discusses key aspects of validating solid dosage forms such as tablets. It emphasizes that quality must be built into the product from the beginning, starting with validating the characteristics of the active pharmaceutical ingredients and excipients used. Analytical methods, manufacturing equipment, and the entire production process must also be validated to ensure reproducible quality batches. The validation program involves defining critical material attributes, establishing control parameters, and testing batches to set specification limits to maintain process control.
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
The document discusses the history and importance of pharmacovigilance. It describes how the thalidomide disaster in the 1950s showed that drugs approved for use can still cause undetected harmful effects. Pharmacovigilance aims to improve patient safety by monitoring drugs after approval to identify adverse effects. It outlines key governing bodies like the WHO and methods used like individual case reports and periodic safety update reports. The document emphasizes that pharmacovigilance is needed because clinical trials prior to approval are limited in detecting rare or long-term effects.
This document provides an overview of pharmaceutical validation. It defines validation as proving that processes, methods, or activities will consistently produce a quality product meeting predetermined specifications. The major types of validation discussed are process, cleaning, equipment, and analytical method validation. Process validation aims to demonstrate a process is capable of consistently producing a product meeting its quality standards. Prospective, concurrent, and retrospective validation approaches are described. Equipment validation occurs in pre-purchase, post-purchase, and routine operation phases to ensure equipment functions as intended. Validation helps ensure pharmaceutical products meet quality standards.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
IRT in Clinical Trials (IxRS)_IVRS_IWRS in Clinical TrialsClinosolIndia
This document discusses the use of interactive voice/web response systems (IxRS) in clinical trials. IxRS systems allow users to respond and provide inputs via telephone or web and are used for patient enrollment, randomization, drug dispensation, and other trial activities. The document outlines the advantages of IxRS in making trials more patient-centric and less dependent on site staff. It also discusses how IxRS can support global and adaptive trials as well as clinical outcome assessments. Validation of IxRS systems and their role as a central hub connecting other eClinical systems are also summarized.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
The document discusses key aspects of validating solid dosage forms such as tablets. It emphasizes that quality must be built into the product from the beginning, starting with validating the characteristics of the active pharmaceutical ingredients and excipients used. Analytical methods, manufacturing equipment, and the entire production process must also be validated to ensure reproducible quality batches. The validation program involves defining critical material attributes, establishing control parameters, and testing batches to set specification limits to maintain process control.
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
The document discusses the history and importance of pharmacovigilance. It describes how the thalidomide disaster in the 1950s showed that drugs approved for use can still cause undetected harmful effects. Pharmacovigilance aims to improve patient safety by monitoring drugs after approval to identify adverse effects. It outlines key governing bodies like the WHO and methods used like individual case reports and periodic safety update reports. The document emphasizes that pharmacovigilance is needed because clinical trials prior to approval are limited in detecting rare or long-term effects.
This document provides an overview of pharmaceutical validation. It defines validation as proving that processes, methods, or activities will consistently produce a quality product meeting predetermined specifications. The major types of validation discussed are process, cleaning, equipment, and analytical method validation. Process validation aims to demonstrate a process is capable of consistently producing a product meeting its quality standards. Prospective, concurrent, and retrospective validation approaches are described. Equipment validation occurs in pre-purchase, post-purchase, and routine operation phases to ensure equipment functions as intended. Validation helps ensure pharmaceutical products meet quality standards.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
IRT in Clinical Trials (IxRS)_IVRS_IWRS in Clinical TrialsClinosolIndia
This document discusses the use of interactive voice/web response systems (IxRS) in clinical trials. IxRS systems allow users to respond and provide inputs via telephone or web and are used for patient enrollment, randomization, drug dispensation, and other trial activities. The document outlines the advantages of IxRS in making trials more patient-centric and less dependent on site staff. It also discusses how IxRS can support global and adaptive trials as well as clinical outcome assessments. Validation of IxRS systems and their role as a central hub connecting other eClinical systems are also summarized.
This document provides an overview of a presentation on computer system validation practices. It discusses regulatory requirements, best practices guidance, quality risk management, and life cycles for computer systems and validation. The presentation covers topics such as ICH guidelines, GAMP5, risk-based approaches to validation, and integration of validation life cycles with system development and project management life cycles. It also references sources such as FDA guidance documents and international standards. The document consists of an agenda and slides outlining key concepts and approaches to computer system validation.
This document discusses post-marketing surveillance (PMS), which involves monitoring drugs after they reach the market to detect previously unrecognized effects. PMS is important for safety and improving products. Key goals are identifying adverse effects and characterizing incidence rates. Several methods are used in PMS, including voluntary reporting, controlled trials, cohort studies, and case-control studies. Cohort studies follow groups over time to assess outcomes, while case-control studies compare exposure rates between those with and without a disease. PMS provides real-world evidence on drug performance and benefits patients.
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
The document discusses the Common Technical Document (CTD) and electronic CTD (eCTD) formats used for submitting registration documents to international regulatory agencies. The CTD format organizes documents into 5 modules: Module 1 contains administrative information specific to each region; Module 2 contains summaries of quality, non-clinical, and clinical information; Module 3 contains quality/manufacturing data; Module 4 contains non-clinical study reports; and Module 5 contains clinical study reports. The eCTD format is the electronic version of CTD, with documents in PDF format linked together via an XML backbone for easier navigation and review compared to the paper CTD format.
The document provides an overview of the New Drug Application (NDA) process used in the United States to gain approval for new drugs. It discusses how the NDA process has evolved since 1938 to require evidence of both safety and efficacy. It also describes the various sections required in an NDA, including summaries of clinical data, chemistry and manufacturing, labeling, and safety information. The review process for an NDA by the FDA is also summarized, including timeframes for filing and reviewing an application.
PharmaReady ECTD is a fully integrated web-based electronic common technical document publishing system designed for intuitive content assembly and management of regulatory submissions. It supports submissions to major global health authorities and features automated processes, drag-and-drop functionality, simultaneous multi-agency submissions, and comprehensive validation documentation. Services include implementation support, training, and validation documentation to ensure a smooth rollout. PharmaReady is used by over 110 clients worldwide.
The document discusses the electronic Common Technical Document (eCTD), which is a standardized format for submitting regulatory information electronically to health authorities. It provides details on the objectives, format, structure, modules, and technical requirements of an eCTD. The key points are:
1. eCTD standardizes electronic submissions and reduces burden on reviewers.
2. It has 5 modules covering administrative information, product summaries, quality, non-clinical studies, and clinical studies.
3. PDF files, hyperlinks, MD5 checksums, and virus checks are required.
4. Validation ensures the submission meets technical requirements before authority review.
The document discusses developing a validation master plan (VMP) for a new pharmaceutical facility. Key points:
- A VMP comprehensively describes validation requirements and plans for meeting them. It covers production, storage, utilities, and staff areas.
- The VMP sets goals and limits for validation projects. It defines the scope and systems included.
- Developing the VMP involves determining standards, qualifications for design, installation, operation, and performance, documentation requirements, and change control procedures.
- User requirement specifications (URS) are critical documents that validation is dependent on. Developing clear, testable URS in multiple levels is important, especially for software.
This document provides guidance on handling and retention of reserve samples from bioavailability and bioequivalence studies. It outlines that testing facilities should randomly select samples for testing and reserve samples from batches sent by sponsors. Reserve samples should be retained in original packaging and in sufficient quantity (usually 5 times the release tests) to allow FDA retesting. Responsibilities depend on the study setting, but testing facilities are generally responsible for retaining reserve samples, and can transfer them to independent third parties if needed. The guidance aims to prevent sample substitution or alteration.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
The document provides information about useful materials for QA interviews, including two free ebooks on QA interview questions and answers and secrets to winning job interviews. It then lists the top 25 QA interview questions and provides sample answers for each, covering topics like testing types, quality assurance processes, audits, customer interactions, and weaknesses. The document aims to help candidates prepare for QA interview questions and feel confident in their responses.
Regulatory requirements for api registrationSiddu K M
This document discusses regulatory requirements for API registration with the US FDA. It explains that a Drug Master File (DMF), also called an Active Substance Master File (ASMF), is submitted by API manufacturers to the FDA with confidential details about the API. There are different types of DMFs. Type II DMFs cover drug substances, intermediates, and materials used in their preparation. Recently, the FDA has begun assessing Type II API DMFs submitted under GDUFA. DMFs can now be submitted electronically using eCTD format. A DMF includes administrative information and quality modules providing details about the API's manufacture, characterization, controls, and stability. Filing fees for a new API DMF
Virtual clinical trials utilize emerging technologies like mobile apps, remote monitoring devices, and online platforms to conduct clinical trials remotely with participants in their homes. This allows trials to have more convenient participation, potentially improving enrollment, retention, and compliance. However, virtual trials also face challenges like developing patient trust in internet-based data collection and ensuring appropriate populations are selected. Early case studies provided lessons about balancing technology with human support. Overall, virtual trials may become a more important model as patients expect remote participation options and for certain study types and populations.
This document provides an overview of marketing authorization procedures and premarketing requirements for drug product registration in Southeast Asian countries. It discusses the regulatory framework in the ASEAN region and details the marketing authorization processes in major Southeast Asian countries like Singapore, Malaysia, Thailand, Indonesia, and the Philippines. The key steps involved are application submission, evaluation, and the regulatory decision. Requirements like dossier format, samples, certificates, and administrative documents are also summarized. Finally, some regulatory challenges around GMP compliance, labeling requirements, authorization timelines, and country-specific rules are highlighted.
Distribution records document the transfer of drug products from manufacturers to distributors and must include information such as product name and strength, manufacturer, lot number, quantity shipped, and recipient. They allow defective products to be recalled and ensure accountability. Records should contain sections for product information, transaction details, distribution information, and recipient information according to WHO guidelines. An example distribution record format was also presented.
Leveraging Anonymized Patient Level Data to Detect Hidden Market PotentialCognizant
Longitudinal analysis of anonymized patient level data (APLD) is a powerful tool for assessing patient experience on a granular level that will lead to better treatment outcomes and increased life sciences market penetration.
Real-World Evidence: A Better Life Journey for Pharmas, Payers and PatientsCognizant
Driven partly by regulatory pressure, stakeholders in the healthcare ecosystem—including payers and patients—now want real-world evidence (RWE) about wellness to supplement and expand randomized control trial (RCT) input from pharmas about pharmaceuticals' efficacy and effectiveness.
This document provides an overview of a presentation on computer system validation practices. It discusses regulatory requirements, best practices guidance, quality risk management, and life cycles for computer systems and validation. The presentation covers topics such as ICH guidelines, GAMP5, risk-based approaches to validation, and integration of validation life cycles with system development and project management life cycles. It also references sources such as FDA guidance documents and international standards. The document consists of an agenda and slides outlining key concepts and approaches to computer system validation.
This document discusses post-marketing surveillance (PMS), which involves monitoring drugs after they reach the market to detect previously unrecognized effects. PMS is important for safety and improving products. Key goals are identifying adverse effects and characterizing incidence rates. Several methods are used in PMS, including voluntary reporting, controlled trials, cohort studies, and case-control studies. Cohort studies follow groups over time to assess outcomes, while case-control studies compare exposure rates between those with and without a disease. PMS provides real-world evidence on drug performance and benefits patients.
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
The document discusses the Common Technical Document (CTD) and electronic CTD (eCTD) formats used for submitting registration documents to international regulatory agencies. The CTD format organizes documents into 5 modules: Module 1 contains administrative information specific to each region; Module 2 contains summaries of quality, non-clinical, and clinical information; Module 3 contains quality/manufacturing data; Module 4 contains non-clinical study reports; and Module 5 contains clinical study reports. The eCTD format is the electronic version of CTD, with documents in PDF format linked together via an XML backbone for easier navigation and review compared to the paper CTD format.
The document provides an overview of the New Drug Application (NDA) process used in the United States to gain approval for new drugs. It discusses how the NDA process has evolved since 1938 to require evidence of both safety and efficacy. It also describes the various sections required in an NDA, including summaries of clinical data, chemistry and manufacturing, labeling, and safety information. The review process for an NDA by the FDA is also summarized, including timeframes for filing and reviewing an application.
PharmaReady ECTD is a fully integrated web-based electronic common technical document publishing system designed for intuitive content assembly and management of regulatory submissions. It supports submissions to major global health authorities and features automated processes, drag-and-drop functionality, simultaneous multi-agency submissions, and comprehensive validation documentation. Services include implementation support, training, and validation documentation to ensure a smooth rollout. PharmaReady is used by over 110 clients worldwide.
The document discusses the electronic Common Technical Document (eCTD), which is a standardized format for submitting regulatory information electronically to health authorities. It provides details on the objectives, format, structure, modules, and technical requirements of an eCTD. The key points are:
1. eCTD standardizes electronic submissions and reduces burden on reviewers.
2. It has 5 modules covering administrative information, product summaries, quality, non-clinical studies, and clinical studies.
3. PDF files, hyperlinks, MD5 checksums, and virus checks are required.
4. Validation ensures the submission meets technical requirements before authority review.
The document discusses developing a validation master plan (VMP) for a new pharmaceutical facility. Key points:
- A VMP comprehensively describes validation requirements and plans for meeting them. It covers production, storage, utilities, and staff areas.
- The VMP sets goals and limits for validation projects. It defines the scope and systems included.
- Developing the VMP involves determining standards, qualifications for design, installation, operation, and performance, documentation requirements, and change control procedures.
- User requirement specifications (URS) are critical documents that validation is dependent on. Developing clear, testable URS in multiple levels is important, especially for software.
This document provides guidance on handling and retention of reserve samples from bioavailability and bioequivalence studies. It outlines that testing facilities should randomly select samples for testing and reserve samples from batches sent by sponsors. Reserve samples should be retained in original packaging and in sufficient quantity (usually 5 times the release tests) to allow FDA retesting. Responsibilities depend on the study setting, but testing facilities are generally responsible for retaining reserve samples, and can transfer them to independent third parties if needed. The guidance aims to prevent sample substitution or alteration.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
The document provides information about useful materials for QA interviews, including two free ebooks on QA interview questions and answers and secrets to winning job interviews. It then lists the top 25 QA interview questions and provides sample answers for each, covering topics like testing types, quality assurance processes, audits, customer interactions, and weaknesses. The document aims to help candidates prepare for QA interview questions and feel confident in their responses.
Regulatory requirements for api registrationSiddu K M
This document discusses regulatory requirements for API registration with the US FDA. It explains that a Drug Master File (DMF), also called an Active Substance Master File (ASMF), is submitted by API manufacturers to the FDA with confidential details about the API. There are different types of DMFs. Type II DMFs cover drug substances, intermediates, and materials used in their preparation. Recently, the FDA has begun assessing Type II API DMFs submitted under GDUFA. DMFs can now be submitted electronically using eCTD format. A DMF includes administrative information and quality modules providing details about the API's manufacture, characterization, controls, and stability. Filing fees for a new API DMF
Virtual clinical trials utilize emerging technologies like mobile apps, remote monitoring devices, and online platforms to conduct clinical trials remotely with participants in their homes. This allows trials to have more convenient participation, potentially improving enrollment, retention, and compliance. However, virtual trials also face challenges like developing patient trust in internet-based data collection and ensuring appropriate populations are selected. Early case studies provided lessons about balancing technology with human support. Overall, virtual trials may become a more important model as patients expect remote participation options and for certain study types and populations.
This document provides an overview of marketing authorization procedures and premarketing requirements for drug product registration in Southeast Asian countries. It discusses the regulatory framework in the ASEAN region and details the marketing authorization processes in major Southeast Asian countries like Singapore, Malaysia, Thailand, Indonesia, and the Philippines. The key steps involved are application submission, evaluation, and the regulatory decision. Requirements like dossier format, samples, certificates, and administrative documents are also summarized. Finally, some regulatory challenges around GMP compliance, labeling requirements, authorization timelines, and country-specific rules are highlighted.
Distribution records document the transfer of drug products from manufacturers to distributors and must include information such as product name and strength, manufacturer, lot number, quantity shipped, and recipient. They allow defective products to be recalled and ensure accountability. Records should contain sections for product information, transaction details, distribution information, and recipient information according to WHO guidelines. An example distribution record format was also presented.
Leveraging Anonymized Patient Level Data to Detect Hidden Market PotentialCognizant
Longitudinal analysis of anonymized patient level data (APLD) is a powerful tool for assessing patient experience on a granular level that will lead to better treatment outcomes and increased life sciences market penetration.
Real-World Evidence: A Better Life Journey for Pharmas, Payers and PatientsCognizant
Driven partly by regulatory pressure, stakeholders in the healthcare ecosystem—including payers and patients—now want real-world evidence (RWE) about wellness to supplement and expand randomized control trial (RCT) input from pharmas about pharmaceuticals' efficacy and effectiveness.
Post-Market Research to Create Treatment Guidelines Oriented to Patient Cente...David Selkirk
The document discusses the need for post-market research focused on patient-centered outcomes to develop treatment guidelines. Specifically, it proposes two methodologies: 1) defining treatment algorithms based on symptomatology to determine optimal drug combinations and doses for symptom control, and 2) defining predictors of disease relapse to determine which patients can safely reduce doses. The goal is to provide clinicians and other stakeholders with real-world data on therapies to improve quality of life and inform decision-making.
Top seven healthcare outcome measures of healthJosephMtonga1
The seven healthcare outcome measures are meant to understand the quality of health systems and how they could be measured and how quality care could be provided to clients.
How to Define Effective and Efficient Real World TrialsTodd Berner MD
This document discusses strategies for designing effective and efficient real-world clinical trials. It covers topics such as using real-world evidence to inform clinical trial design, the differences between efficacy and effectiveness, challenges around representativeness in trial populations, and the value of pragmatic clinical trials. It also discusses leveraging electronic health records for condition-specific prompts and clinical decision support to improve performance and quality of care.
How to design effective and efficient real world trials TB Evidence 2014 10.2...Todd Berner MD
This document discusses strategies for designing effective and efficient real-world clinical trials. It covers topics such as using real-world evidence to inform clinical trial design, the differences between efficacy and effectiveness, challenges in defining quality metrics, and strategies for improving performance within healthcare systems. The document provides information on pragmatic clinical trials and how real-world evidence could reduce costs compared to traditional clinical trials.
EDM ForumEDM Forum CommunityeGEMs (Generating Evidence & M.docxgreg1eden90113
EDM Forum
EDM Forum Community
eGEMs (Generating Evidence & Methods to
improve patient outcomes) Publish
4-20-2017
Reducing Healthcare Costs Through Patient
Targeting: Risk Adjustment Modeling to Predict
Patients Remaining High-Cost
Jonathan A. Wrathall
Intermountain Healthcare, [email protected]
Tom Belnap
Intermountain Healthcare, [email protected]
Follow this and additional works at: http://repository.edm-forum.org/egems
Part of the Other Medicine and Health Sciences Commons, and the Social Statistics Commons
This Methods Case Study is brought to you for free and open access by the the Publish at EDM Forum Community. It has been peer-reviewed and
accepted for publication in eGEMs (Generating Evidence & Methods to improve patient outcomes).
The Electronic Data Methods (EDM) Forum is supported by the Agency for Healthcare Research and Quality (AHRQ), Grant 1U18HS022789-01.
eGEMs publications do not reflect the official views of AHRQ or the United States Department of Health and Human Services.
Recommended Citation
Wrathall, Jonathan A. and Belnap, Tom (2017) "Reducing Healthcare Costs Through Patient Targeting: Risk Adjustment Modeling to
Predict Patients Remaining High-Cost," eGEMs (Generating Evidence & Methods to improve patient outcomes): Vol. 5: Iss. 2, Article 4.
DOI: https://doi.org/10.13063/2327-9214.1279
Available at: http://repository.edm-forum.org/egems/vol5/iss2/4
Reducing Healthcare Costs Through Patient Targeting: Risk Adjustment
Modeling to Predict Patients Remaining High-Cost
Abstract
Context: The transition to population health management has changed the healthcare landscape to identify
high risk, high cost patients. Various measures of patient risk have attempted to identify likely candidates for
care management programs. Pre-screening patients for outreach has often required several years of data.
Intermountain Healthcare relied on cost-ranking algorithms which had limited predictive ability. A new risk-
adjusted algorithm shows improvements in predicting patients’ future cost status to facilitate identifying
patient eligibility for care management.
Case Description: A retrospective cohort study design was used to evaluate high-cost patient status for two
of the next three years. Modeling was developed using logistic regression and tested against other decision tree
methods. Key variables included those readily available in electronic health records supplemented by
additional clinical data and estimates of socio-economic status.
Findings: The risk-adjusted modeling correctly identified 79.0% of patients ranking among the top 15% of
costs in one of the next three years. In addition, it correctly estimated 48.1% of the patients in the top 15% cost
group in two of the next three years. This method identified patients with higher medical costs and more
comorbid conditions than previous cost-ranking methods.
Major Themes: This approach improves the predictive accuracy of identifying high cost patients in the future
.
A few months ago I wrote an article entitled Unplanned Readmissions: Are They Quality Measures or Utilization Measures? It explained the Hospital Readmissions Reduction Program (HRRP) that began in October 2012 as part of the Affordable Care Act (ACA). That article explained the program and its results over the past 5 years. However, more and more healthcare leaders and organizations are beginning to question whether HRRP is a valuable program or whether it is time to move on to something that focuses on quality of care and clinical outcomes, rather than cost savings. This article will address those issues. (In this article “readmissions” mean unplanned or preventable readmissions).
FINAL MSmith_ Medn Measures that Matter_ AJPB_Jan-Feb 2015Marie Smith, PharmD
This document discusses the need for new quality measures that assess medication management across care settings and providers. It notes that while current measures address prescribing and adherence, they do not address optimization, coordination of medications prescribed by multiple providers, or medication management during care transitions. The document advocates developing measures that close these gaps, such as those assessing comprehensive medication reviews, reconciliation of medication lists during care transitions, and development of patient medication action plans. It provides examples of how measures could be organized into families and sets that cut across conditions and specialties to promote coordination and alignment of quality measurement.
This document discusses scenario-building methods to define the future of clinical evidence requirements in the US drug development and healthcare systems. It identifies key factors like integration of health systems, use of big data, and patient roles that could impact clinical evidence requirements. Three potential scenarios are described ranging from a status quo system to a fully integrated system. The "moderate integration" scenario is deemed most likely, featuring some increased system integration, standardized electronic health records, growing big data opportunities, and more organized patient groups. Accountable care organizations are also examined, finding they may evaluate drug effectiveness and cost-effectiveness as risk-based payments increase and care pathways are established.
To lower health costs, physician networks and medical homes must employ a closed loop population management program that focus on patient SOH stratification, chronic disease management, care coordination and incentive management. This approach will enable them to consistently reduce ER and inpatient admissions, which are the greatest expenditures in health care today.
What quality measures does the MCO have in placeSolutionManag.pdfformicreation
What quality measures does the MCO have in place?
Solution
Managed care organizations (MCOs) are responsible for ensuring that persons enrolled in their
plans receive quality health care. In addition, MCOs publicly funded through the Medicare and
Medicaid programs are required by State and Federal governments to meet certain quality
standards.
To fulfill their responsibilities, MCOs need ready access to a comprehensive array of evidence-
based clinical information and other clinical performance measures to enable them to evaluate
their providers\' performance and identify areas where improvement is needed. They also need to
know how their members feel about the care they receive and the way they are treated. Finally,
they need to ensure that both their providers and members are aware of the most recent
preventive care recommendations.
Valid, reliable, and cost-effective measurement tools must be available to make such
determinations, but these tools have not always been available. Furthermore, because the science
of performance measurement is relatively new, additional measures need to be developed and
those that have been developed can be improved. Therefore, to ensure that their enrollees in
MCOs receive high-quality care, MCOs need a reliable source to provide the most current and
scientifically sound tools.
In response to this need, the Agency for Healthcare Research and Quality (AHRQ) has funded
research to compile a database of evidence-based clinical guidelines and to develop clinical
performance measures, member satisfaction surveys, and preventive care recommendations that
can help MCOs meet their responsibilities. Additionally, AHRQ funds research and develops
performance measures and guidelines that MCOs, insurers, providers, and consumers can trust.
This report describes these tools and how they have been used and provides information on
where to learn more about them.
Background
Around one-half of insured Americans are enrolled in some form of managed care. However, as
the number of persons enrolled in MCOs increased in the 1990s, health care purchasers,
policymakers, and other stakeholders became concerned about the potential for health care
quality to diminish. In their view, the policies and practices imposed by MCOs to reduce what
MCOs define as unnecessary care might result in patients not receiving needed care. Therefore,
MCOs faced accreditation systems and other requirements to ensure that patients were receiving
the most appropriate care.
More recently, MCOs have had to address other emerging concerns such as: Rapid introduction
of new technologies, Data showing unexplained variations in the provision of care, Severe cost
pressures.
These factors have provided additional motivation to MCOs to develop systematic ways of
preserving and enhancing health care quality and cost-effectiveness.
Evidence-based practice guidelines and performance measures were developed to help ensure
that patients always receive the most appropri.
Painsolver is a clinical decision support tool designed to improve healthcare outcomes for low back pain. It addresses limitations in how patient care is currently managed by providing evidence-based guidance, integrating recommendations into workflows, and promoting shared decision making between providers and patients. The tool aims to help organizations and providers succeed under emerging pay-for-performance models by enhancing outcomes and reducing costs over a patient's lifetime. Vertelogics believes Painsolver can help providers and organizations not just survive but thrive as the healthcare system shifts its focus to outcomes-based reimbursement.
Case Study "Using Real Time Clinical Data To Support Patient Risk Stratification in The Clinical Care Setting"
HealthInfoNet operates the statewide health information exchange in Maine. The exchange currently manages clinical and patient care encounter information on 97 percent of the residents of the State of Maine. The information is gathered in real time, standardized, and aggregated at a patient specific level to support treatment. For the past three years, HealthInfoNet has worked with HBI Solutions, Inc of Palo Alto, CA to utilize this real time clinical and encounter data to support the development of predictive analytic tools that risk stratify patient populations and individual patients for future incidence of disease, cost, and both inpatient and ambulatory care encounters. These real time predictive models have now been used in clinical care settings for a year. The presentation will cover both lessons learned to date from implementing and optimizing real time predictive analytic tools and the early finding of the impact that the use of these tools is having on patient care management, utilization and outcome.
Devore Culver
Executive Director & CEO
HealthInfoNet
Great article on how to integrate machine learning and optimization technique.
One group of researchers was able to reduce heart failure readmissions by 35% by combining machine learning and decision science technique, see "Data-driven decisions for reducing readmissions for heart failure: general methodology and case study" (Bayati, et. al., 2014).
HCC Coding and Risk Adjustment Tool model is specially designed to estimate future health care costs for patients. its main objective is to consider the well-being of the executives alongside exact repayments from medicare Advantage Plans.
Community Pharmacists and Medication Therapy ManagementDownlLynellBull52
Community Pharmacists and Medication Therapy Management
Download the strategy pdf icon[PDF - 775 KB].
Medication therapy management (MTM) is a distinct service or group of services provided by health care providers, including pharmacists, to ensure the best therapeutic outcomes for patients. MTM includes five core elements: medication therapy review, a personal medication record, a medication-related action plan, intervention or referral, and documentation and follow-up.
Within the context of cardiovascular disease (CVD) prevention, MTM can include a broad range of services, often centering on the following:
· Identifying uncontrolled hypertension
· Educating patients on CVD and medication therapies
· Advising patients on health behaviors and lifestyle modifications for better health outcomes
MTM is especially effective for patients with multiple chronic conditions, complex medication therapies, high prescription costs, and multiple prescribers. MTM can be performed by pharmacists with or without a collaborative practice agreement (CPA), and it is a strategy that can be considered to straddle Domain 3 (health care system interventions) and Domain 4 (community-clinical links).
· Evidence of Effectiveness
· Evidence of Impact
· Implementation Considerations
Strong evidence exists that the use of MTM by pharmacists is effective. Although the exact combination of MTM activities tends to vary between settings, studies examining MTM have generally found it to be effective and to have strong internal and external validity. MTM trials have been replicated in many different contexts with positive results. Implementation guidance on MTM is available from several sources, including the guidance provided under Medicare Part D.
MTM at Ohio Department of Health
In 2014, the Ohio Department of Health (ODH) teamed up with three Federally Qualified Health Center (FQHC) sites to assess the effect of MTM counseling sessions on patients with hypertension. This effort involved collaboration among the Ohio State University College of Pharmacy, Ohio Pharmacists Association, Ohio Association of Community Health Centers, and the Health Services Advisory Group. These partners helped plan and develop the assessment. Pharmacists administered MTM to 500 patients with hypertension who were receiving care at one of the three FQHC sites. After 6 months, assessments found that hypertension control had increased to 68.6% among these patients. There were key components related to the project’s achievement, which included maintaining relevant partnerships, implementing the pilot in one type of pharmacy setting, allowing FQHC sites to develop their own protocols for patient enrollment, using effective dissemination processes, and selecting data points that align with current pharmacy practices. Challenges included finding champions for the MTM model.
For more information:
Jen Rodis, Assistant Dean for Outreach and Engagement
Ohio State University College of Pharma ...
The document discusses medication non-adherence and strategies for improving adherence and ensuring safe hospital discharges. It notes that 50% of prescribed medications are not taken correctly and identifies barriers to adherence like cost, side effects, and health literacy. It introduces the Case Management Adherence Guidelines (CMAG) which assess patient knowledge, motivation, and skills to improve adherence using tools like health literacy tests. CMAG provides an algorithm to improve understanding and motivate patients to take medications as prescribed. The document emphasizes the importance of educating patients before discharge to maintain treatment and ensure a safe transition to outpatient care.
The Design of Accountable Care OrganizationsCJ Fulton
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Pioneer ACO burn and learn lessons
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1. • Cognizant 20-20 Insights
Predicting Patient Adherence:
Why and How
To contain costs and improve healthcare outcomes, players across
the value chain must apply advanced analytics to measure and
understand patients’ failure to follow treatment therapies, and to
then determine effective remedial action.
Executive Summary
The new healthcare regime — both in the U.S.
and across the world — can be boiled down to
reducing costs and enhancing the quality of
patient care. Improving patient adherence to a
treatment regimen can be a crucial factor. And
as with many other areas of modern healthcare
and life sciences, the role of data analytics is of
paramount importance.
The World Health Organization (WHO) defines
patient adherence as “the extent to which a
person’s behavior — taking medication, following
a diet and/or executing lifestyle changes — corresponds with agreed recommendations from a
healthcare provider.”
Adherence is a combination of compliance
(correct use of medication as prescribed) and persistence (continued effort in taking medication).
Adherence is what is expected of the patient.
There are multiple estimates of non-adherence
and its associated impact on cost reduction, all
of which are quite alarming. As per the Annals
of Internal Medicine, non-adherence impacts
the U.S. healthcare system between $100 billion
cognizant 20-20 insights | september 2013
and $289 billion annually, 20% to 30% of which
equates to medication prescriptions that are
never filled and 50%for medications that are not
taken as prescribed to treat chronic diseases.1 In
Europe, the situation is no better as non-adherence is said to cause 200,000 deaths per annum
and cost the economy €125 billion each year.2 And
if the increase in age of the global population is
factored in, the cost will likely spike manyfold in
coming years. So it is in the interest of payers,
drug manufacturers and policy makers to contain
this cost by applying advanced analytics.
On average, it costs six times more to attract
new patients than it does to retain existing ones.
Increasing patient adherence can boost profitability in the following ways:
• Payers: Reduction in healthcare expenses.
• Patients: Better health.
• Pharma: Enhanced patient loyalty and
retention.
This white paper lays out a framework for
enabling patient adherence management and
some general prescriptions on how to convert
lofty concepts to meaningful action.
2. 2020: When Computers Outnumber Humans 10 to 1
• Historical Trend analysis by segment, therapy areas.
• ROI measurement of marketing and
educational activities.
Measure
and Track
Predict
Action
• Adherence prediction score.
• Designing segment-level targeting strategy.
• Multichannel optimization for
adherence strategies.
Figure 1
Analytics Framework for
Adherence Management
Players across the healthcare value chain need
to understand the patient journey. Patient
adherence is a complex issue, and requires a
thorough understanding of the root causes of
discontinuing treatment. Measuring and tracking
adherence may help to illuminate specific
strategies, but such tactics needs to be integrated
with prediction and action for the organization to
succeed.
Measure and Track
This phase primarily consists of:
• Developing a patient adherence index.
• Tracking the adherence progress
across
different therapeutic areas, by geography,
patients and physician segments.
• Assessing
the ROI of various marketing
channels
(through
advanced
analytics
techniques such as multivariate regression and
test and control analysis).
The most critical of all these, however, is
developing an adherence index. Multiple measures
exist for this:
• Direct or clinical methods such as the level
of medicine or biological marker in the blood,
etc. However, on a regular basis, measuring
and keeping track of non-adherence by direct
methods is not very practical since patients
require diagnostic procedures to obtain these
measures.
• Indirect
methods, based on prescription
refills or pill counts, are much more popular.
cognizant 20-20 insights
Depending on data availability, these two
measures can be interchangeably used. For
example, if the pharmacy refill data is available,
pill count is probably the best measure; however,
if the analysis is based on patient claims or longitudinal patient data, frequency of claims or
refills is probably the most dependable metric.
Two common measurements that can define an
adherence index are: (1) Medication possession
ratio (MPR) — i.e., the number of days of medicine
supplied within a time interval/total number of
days in the period; and (2) period of days covered
(PDC) — i.e., the number of days of medication
covered over a time period. For a single drug
medication, these measurements are actually
the same, but for a multidrug therapy they might
differ considerably.
In the case of multidrug therapy, MPR would be
calculated as (total days of supply) x (number of
days in the interval). For PDC, it is the proportion
of days when all the medications were available.
Let’s consider a hypothetical example of a
three-drug medication and 10-day interval time
period to understand the difference between MPR
and PDC. The first drug was available for all 10
days, drug two for the last seven days, and drug
three only for the last three days.
MPR = 67% ((10+7+3)/(3)/10 = 6.6) while
PDC (a more accurate measure)
= 33% (10/3 = 3.3).
Apart from the objective measures as described
above there are quite a few self-reported, and
hence subjective, measures that are based on
questions answered by patients. These include
2
3. the Morisky scale, medication adherence report
scale (MARS), beliefs about medication questionnaire (BaMQ), etc.
Prediction
The measure and track stage is a completely retrospective analysis. It’s a good first step for any
company starting patient adherence analysis,
but is not enough. That is simply because once
a patient becomes non-adherent, bringing him
or her into the adherence zone is much more
costly. Hence, predicting the
The sole objective of probable non-adherence and
taking proactive actions is
the predict phase is to required to stay ahead of the
discover the factor/s curve. Given huge healthcare
influencing adherence data sets, and ever-escalating computing speeds, this is
and understanding actually not such a big deal.
why the patient is However, analysis should
entering the non- follow a systematic approach
and companies are likely to
adherence zone. encounter several challenges
along the way:
Generally, the data set is divided into two
components — development and validation
(a 50:50 or 60:40 split). While the model is
estimated on the development sample, validation
data is checked to see whether the model
equation works equally efficiently. Metrics for
efficiency include KS statistic, ROC, etc.
However, the challenges typically entail finding
the proper set of explanatory variables rather
than the techniques used to model them.
Primarily, there are five types of variables:
• Demographic variables: Age, sex, race, marital
status, number of people in household, etc.
>> Source: Patient enrollment file with healthcare payers, patient registry, longitudinal patient data and medical claims data.
• Treatment variables: Number of medications
used, duration of treatment, cost of medication
or treatment, frequency of dosing, complexity
of treatment regimen, etc.
>> Source: Medical claims data, EHR/EMR data,
longitudinal patient data, patient registry,
etc.
• Define
“bad” adherence: The sole objective
of the predict phase is to discover the factor/s
influencing adherence and understanding why
the patient is entering the non-adherence
zone. But what level of adherence is nonadherence or bad adherence? Many times this
is guided by past experience; however, a datadriven approach can be more illuminating. An
analysis of the association between non-adherence and the treatment outcome — whether
an adherence rate below a certain level has
significant impact on treatment success rate
— is helpful here. For example, in the case of
diabetes, a benchmark can be decided by the
MPR level below which we see a dramatic rise
in the blood sugar level.
• Disease
factors: State of disease, diagnostic
tests, time, etc.
>> Source:
EHR/EMR, patient registries and
medical claims.
• Patient
factors: Knowledge about disease,
poor communication by healthcare provider,
patient’s own belief in the effectiveness of his
therapy regimen, etc.
>> Source: There is no syndicated data source
to capture patient-related factors. Data is
primarily collected through questionnaires
presented to patients.
• Health insurance variables: Formulary status
of the drug being used, co-pay amount, etc.
• Predictive
modeling: Once bad adherence is
defined, the next order of business is to predict
whether a patient breaches the benchmark.
Typically, a statistical model with a binary
dependent variable is developed, using any of
three techniques: logistic regression, decisiontree analysis or a neural network model. There
are a plethora of statistical measure to judge
the model qualities: C-statistics, coefficient
P-values, Hosmer and Lemshow test, goodness
of fit test, to name a few. However, the final
decision in predictive modeling is based on
whether the result remains “valid outside the
modeling data set.”
cognizant 20-20 insights
>> Source: Medical claims data, IMS PlanTrak,
Source®Payer, etc.
Clearly, data for this analysis can come from
disparate sources. Hence, the challenge is to
integrate and collate relevant information from
all inputs and, in the absence of a primary joining
key, the best technique to utilize is name matching
or text matching.
Action
The actions based on the “prediction” stage are
primarily to design adherence strategies that
3
4. include changing dosage and delivery, education
and communication, such as behavioral coaching/
patient education, program reminders and
financial assistance (i.e., co-pay discounts, etc.).
However, these activities need to be assisted by
additional analysis and modeling exercises.
• Patient
segmentation based on adherence
score and rationale: Targeting strategy
needs to vary according to patient behavior.
For example, if the reason for non-adherence
is frequency of dosages or the method of
delivery, stakeholders need to adopt different
strategies. In the former case, it might be
moving toward longer-lasting medications
and hence less frequency, while in the latter
case it may be moving from injectible to oral
medication.
• Segmentation
of healthcare professionals
(HCPs) based on their patient profile: As the
first patient touch point, HCPs play a critical role
in adherence. An SDI (formerly Verispan) study3
suggests that physicians’ choice of language
can influence adherence. For instance, patients
who were coached by a physician to take their
medication regularly had a 21% greater Rx utilization. They need to be informed and coached
as well. They can be segmented based on their
prescribed population profile (classified as
referenced above) .
• Marketing
budget optimization: A multichannel optimization analysis is needed to
decide where investment should be made to
reinforce adherence. (This is largely influenced
by the ROI analysis undertaken as part of the
“measure and track” stage.)
Looking Forward
industry as a whole. Analytics can help rank the
patient and physician population, and act as an
aid for designing education and other targeting
strategies. However, analytics based on “garbage
in, garbage out” principles will not fly, given the
current immature state of healthcare data, a
situation exacerbated by these factors:
• A
good number of healthcare and pharma
companies do not have a properly functioning
data warehouse.
• Many
players across the value chain cannot
match systems of records with internally
supplied data.
• Quality of third-party-supplied data is generally
poor.
Given these challenges, the approach that
healthcare and life sciences companies should
take is to not force complex analytics when and
where it is not possible. Successful implementation of analytics therefore becomes a function
of data quality and analytical maturity (i.e.,
management push to use a data-driven approach
to inform key decisions). While government initiatives such as “meaningful use” by CMS in the
U.S. will create incentives for better data quality,
pharma companies and healthcare players should
sincerely rethink data strategy — from collection
and storage through retrieval — as well as the ROI
of such strategies.
Hence, both basic data analysis solutions and
complex predictive analytics solutions can be
used to solve patient non-adherence challenges.
The precise approach will depend on the severity
of the problems faced and the ease and pace of
the implementation strategy considered by the
organization.
Improvement in adherence quality is necessary
for the well-being of patients and the healthcare
Footnotes
1
“Interventions to improve adherence to self-administered medications for chronic diseases in the United
States: a systematic review,” Annals of Internal Medicine, Dec 4, 2012.
2
European Federation of Pharmaceutical Industry and Associations.
3
“Understanding and Maximizing Prescriber Impact on Patient Compliance and Persistency,” SDI Case
Study.
cognizant 20-20 insights
4