This document discusses the importance of using patient registries alongside claims data and electronic health records for comparative effectiveness research. Sequencing of therapies and use of combination therapies can introduce biases if not properly accounted for. An example study on type 2 diabetes medications found some limitations in fully adjusting for severity factors. The document recommends that registries can help address gaps by collecting additional clinical data not found in other sources, and by assessing outcomes at standardized time points. Registries complement but cannot replace large claims/EHR data sources due to their more limited size and scope.
This document discusses the field of pharmacoeconomics. It begins by defining pharmacoeconomics as the scientific discipline concerned with comparing the costs and benefits of drug therapies. It describes how pharmacoeconomics helps optimize health care resource allocation by comparing drug costs and outcomes. The document then outlines several key aspects of pharmacoeconomics including its need, challenges, evaluation methods, and applications. In conclusion, it states that pharmacoeconomics provides a means to quantify pharmaceutical value by balancing costs and outcomes to help inform better healthcare decisions.
Pharmacoeconomics tools will not make a decision, but are useful as an aid to decision makers regarding the appropriate use of a product. These tools can assist in selecting an area of preclinical exploration, choosing which drugs should move forward to man, and weather to progress in the phases of clinical trials.
Drug use evaluation (DUE) is a quality improvement process that reviews prescribing patterns to promote appropriate drug use. It involves identifying a drug or therapeutic area, developing criteria and standards, collecting data, evaluating results, providing feedback, and implementing interventions. The process then reevaluates drug use and revises the DUE program as needed. The presented document outlines the 11 steps of a DUE process focusing on monitoring renal function during aminoglycoside therapy.
This document outlines the process of drug utilization evaluation (DUE), which involves ongoing review of drug use and prescribing patterns to promote optimal drug therapy. It describes the aims of DUE as improving health outcomes, safety and costs. The DUE process involves planning studies, collecting data, evaluating results against criteria, providing feedback, developing interventions, and re-evaluating drug use. Key roles of the DUE committee and pharmacists in conducting this quality improvement process are also summarized.
Drug utilization evaluation(DUE) & Drug utilization review)Pooja Anothra
Drug utilization evaluation (DUE) is a systematic, ongoing evaluation of drug therapy that ensures medications are used appropriately and meet current standards of care. The goals of DUE include promoting optimal medication therapy, creating guidelines for appropriate drug use, and controlling costs. The DUE process involves establishing responsibility, developing review criteria, collecting and analyzing data, providing feedback to prescribers, and conducting follow-up evaluations. Drug utilization review (DUR) similarly involves ongoing review of prescribing, dispensing, and drug use, and can be prospective, concurrent, or retrospective to identify problems and improve medication therapy.
1. Drug Use Evaluation (DUE) is a performance improvement method that focuses on evaluating and improving medication use processes to optimize patient outcomes.
2. Clinical pharmacists can positively impact mortality rates through services like DUE, patient education, adverse drug reaction management, and participating on patient rounds.
3. The DUE process involves establishing criteria to evaluate medication use, collecting and analyzing data, developing and implementing improvement plans, and repeating the cycle for ongoing enhancements.
This document discusses the field of pharmacoeconomics. It begins by defining pharmacoeconomics as the scientific discipline concerned with comparing the costs and benefits of drug therapies. It describes how pharmacoeconomics helps optimize health care resource allocation by comparing drug costs and outcomes. The document then outlines several key aspects of pharmacoeconomics including its need, challenges, evaluation methods, and applications. In conclusion, it states that pharmacoeconomics provides a means to quantify pharmaceutical value by balancing costs and outcomes to help inform better healthcare decisions.
Pharmacoeconomics tools will not make a decision, but are useful as an aid to decision makers regarding the appropriate use of a product. These tools can assist in selecting an area of preclinical exploration, choosing which drugs should move forward to man, and weather to progress in the phases of clinical trials.
Drug use evaluation (DUE) is a quality improvement process that reviews prescribing patterns to promote appropriate drug use. It involves identifying a drug or therapeutic area, developing criteria and standards, collecting data, evaluating results, providing feedback, and implementing interventions. The process then reevaluates drug use and revises the DUE program as needed. The presented document outlines the 11 steps of a DUE process focusing on monitoring renal function during aminoglycoside therapy.
This document outlines the process of drug utilization evaluation (DUE), which involves ongoing review of drug use and prescribing patterns to promote optimal drug therapy. It describes the aims of DUE as improving health outcomes, safety and costs. The DUE process involves planning studies, collecting data, evaluating results against criteria, providing feedback, developing interventions, and re-evaluating drug use. Key roles of the DUE committee and pharmacists in conducting this quality improvement process are also summarized.
Drug utilization evaluation(DUE) & Drug utilization review)Pooja Anothra
Drug utilization evaluation (DUE) is a systematic, ongoing evaluation of drug therapy that ensures medications are used appropriately and meet current standards of care. The goals of DUE include promoting optimal medication therapy, creating guidelines for appropriate drug use, and controlling costs. The DUE process involves establishing responsibility, developing review criteria, collecting and analyzing data, providing feedback to prescribers, and conducting follow-up evaluations. Drug utilization review (DUR) similarly involves ongoing review of prescribing, dispensing, and drug use, and can be prospective, concurrent, or retrospective to identify problems and improve medication therapy.
1. Drug Use Evaluation (DUE) is a performance improvement method that focuses on evaluating and improving medication use processes to optimize patient outcomes.
2. Clinical pharmacists can positively impact mortality rates through services like DUE, patient education, adverse drug reaction management, and participating on patient rounds.
3. The DUE process involves establishing criteria to evaluate medication use, collecting and analyzing data, developing and implementing improvement plans, and repeating the cycle for ongoing enhancements.
Pharmacoepidemiology is the study of effects of drugs in large numbers of people.
Epidemiologic Study Designs, Reasons to perform Pharmacoepidemiology studies, Users of pharmacoepidemiology and Role of Pharmacists & other Public Health Practitioners in Pharmacoepidemiology are discussed in this presentation.
Drug Utilization in a regulated EnviormentAlok Anand
Tracking drugs across the supply chain in a regulated environment. This white paper brief on would be drug utilization approach of Life Science Industry. This white paper is just a step forward to show future life science industry process automation
This document discusses drug utilization review (DUR), which is a systematic process to ensure appropriate medication use. DUR involves reviewing patient medication and health histories before, during, and after dispensing. It can help prevent unnecessary drug use, adverse reactions, and improve effectiveness. The document outlines the classification, goals, and steps to establish a basic hospital DUR program, including forming a committee, developing policies/procedures, identifying drugs for review, establishing criteria, collecting/evaluating data, implementing interventions if needed, and re-evaluating the program annually.
A concise overview of pharmacoeconomics, health economics, various costs, various pharmacoeconomic study designs and its application in the field of medicine and drug development
This document discusses the pharmacoeconomic program and analysis conducted by the General Administration of Pharmaceutical Care in Saudi Arabia. It provides details on:
1) A pharmacoeconomic analysis of drug-related problems identified through the Drug Information Center, assigning costs to different levels of harm or intervention required.
2) Examples of pharmacists' interventions through the program and the estimated total cost savings of 139,155 Saudi Riyals per month.
3) The goals, policies, procedures and principles of the pharmacoeconomic manual developed for the Saudi Ministry of Health, including supporting formulary and resource allocation decisions with pharmacoeconomic evidence.
Following topics are covered in this slide deck:
Role and use of Pharmacoeconomics and health outcomes research | Impact of price regulation in India | Factors affecting drug pricing | Need, challenges and components of pharmacoeconomics | Aims, Objectives and principle of Pharmacoeconomic Evaluation | Different types of cost measurement | The Methods of Pharmacoeconomic Evaluation | Cost Analysis (CUA)
It is a sub-discipline of health economics , Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another.
Pharmacoeconomics deals with identifying, measuring, and comparing the costs and consequences of pharmaceutical products and services.
This document provides an overview of a presentation on pharmacoeconomics given by Dr. Salim Sheikh at VMMC & Safdarjung Hospital. It discusses the history and introduction of pharmacoeconomics, which evaluates the costs and benefits of pharmaceutical products and services. The presentation covers challenges in pharmacoeconomic evaluation, common methodologies like cost-effectiveness analysis, and limitations of economic evaluations.
This document discusses drug utilization reviews (DUR), also known as drug utilization evaluations (DUE) or medication utilization evaluations (MUE). DURs involve comprehensive review of patient prescription and medication data before, during, and after dispensing to ensure appropriate medication decisions and positive outcomes. DURs aim to promote optimal medication therapy, prevent medication-related problems, evaluate medication effectiveness, improve patient safety, and stimulate improvements in medication use processes. The document also outlines the value of DUR programs in helping health systems understand and improve prescribing, administration, and medication use.
The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
b) A cost analysis of a single intervention
c) A comparison of costs per life-year gained for two interventions
d) An estimation of the total costs of a disease to the society
12/10/2018
DEPARTMENT OF PHARMACOLOGY
KMCH COLLEGE OF PHARMACY
42
Which one of the following is an example of a partial
pharmaco-economic evaluation
This document discusses pharmacoeconomics, drug compliance, and therapeutic failure. It begins by defining pharmacoeconomics as the analysis of costs and consequences of pharmaceutical products and services. It then discusses various pharmacoeconomic methods like cost-benefit analysis and cost-effectiveness analysis. The document also explains drug compliance, adherence, and the consequences of non-compliance. It notes that non-compliance can result in therapeutic drug failure and increased costs. It concludes by discussing common interventions to improve compliance like patient education and simplifying drug regimens.
This presentation give detail overview of pharmacoepidemiology, epidemiological study design, case report, case series, analysis of secular trends, case control studies, cohort studies, statistical interpretation, randomised clinical trials, field trials, community trials, drug utilisation studies.
For all five YouTube Live video lecture series of this topic click:
https://youtube.com/playlist?list=PLBVbJ9HCa1BbqIaLoMmuF0Bf66SMFZtnb
For More Such Learning You Can Subscribe to
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Facebook Page: https://www.facebook.com/asacademylearningforever
Website Blog: https://itasacademy.blogspot.com/
This document discusses pharmacoeconomics and its importance in balancing the interests of stakeholders in the healthcare industry. It begins by defining health economics and pharmacoeconomics, and explaining their relationship. It then discusses the shift in focus of healthcare consumers towards disease prevention. The document outlines various challenges faced by the healthcare industry and how pharmacoeconomic solutions can address the perspectives of patients, physicians, insurers, manufacturers, researchers and policymakers. It provides a case study on drug selection for osteoarthritis using pharmacoeconomic analysis. Finally, it discusses the global presence and potential for establishing pharmacoeconomics in India.
This document discusses principles of pharmacoeconomics and their impact on pharmaceutical research and development. It describes how pharmacoeconomic evaluations measure health gains and costs to compare medical procedures. Randomized controlled trials are required to prove efficacy and safety, but real-world studies are also needed to evaluate long-term health benefits and costs. Economic modeling can be used alongside clinical trials to estimate benefits like quality-adjusted life years to determine appropriate pricing and reimbursement strategies for new drugs. Understanding pharmacoeconomics principles is important for pharmaceutical R&D decision making.
This document provides an overview of drug utilization studies. It defines drug utilization research as the study of how drugs are used in populations with the goal of promoting rational and cost-effective drug use. The document outlines the objectives of drug utilization studies as describing drug use patterns, identifying irrational use, evaluating interventions to improve use, and quality control of drug use. It also discusses the types of information collected in these studies including drug-based, problem-based, patient-based, prescriber-based, and cost-based data. Finally, the document reviews the steps involved in conducting a drug utilization study from identifying the drugs and therapeutic areas to study design, data collection sources and methods, and establishing criteria to evaluate appropriate drug use.
This presentation describes the objectives, approach and application of Drug Utilization studies in Pharmacotherapeutics. This emphasizes on how to conduct a drug utilization studies.
Introduction to Premarketing Phase
Limitation of Premarketing Phase and Importance of Phase IV period
Definition of DUS
History of DUS
Objectives of DUS
Types of Drug Use Information
Drug Utilization Cycle
This document discusses pharmacoeconomics and provides definitions, principles, perspectives, types of costs and consequences, and methods of pharmacoeconomic evaluation. Pharmacoeconomics analyzes the costs and benefits of drug therapies to health systems and society. It considers costs from multiple perspectives including patients, providers, payers, and society. Costs include direct medical, direct non-medical, and indirect costs. Consequences include clinical, economic, and humanistic outcomes. Common methods of pharmacoeconomic evaluation are cost-of-illness analysis, cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. These methods are used to inform healthcare decisions at both the individual patient
The document discusses new paradigms in pharmacoeconomics, healthcare, and electronic medical records. It introduces the 3-Dimensional Outcome Assessment model of economic, clinical, and humanistic outcomes. It examines areas of collaboration between economists, physicians, and policy-makers. The new paradigms include changing patient roles, empowerment, continuity of care, team-based care, and computer applications. Electronic medical records are discussed as having modules for different areas like outpatient, inpatient, investigations, pharmacy, and more. Finally, it reflects on the changing digital healthcare ecosystem.
Therapeutic drug monitoring (TDM) involves measuring drug concentrations in body fluids to aid in drug prescribing and management. TDM enables assessment of drug efficacy and safety in different clinical settings and individualizes treatment regimens for optimal patient outcomes. Key aspects of TDM include understanding the relationship between drug concentrations and effects, defining therapeutic ranges, selecting target concentrations, and interpreting test results based on pharmacokinetic and patient factors. Proper sample collection and timing are important for accurate TDM interpretation and dosage adjustments.
Еженедельный отчет Центра мониторинга общественного мнения при Правительстве ...ICMOSRU
Отчет ЦМОМ с 2 по 8 сентября 2015 года
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Pharmacoepidemiology is the study of effects of drugs in large numbers of people.
Epidemiologic Study Designs, Reasons to perform Pharmacoepidemiology studies, Users of pharmacoepidemiology and Role of Pharmacists & other Public Health Practitioners in Pharmacoepidemiology are discussed in this presentation.
Drug Utilization in a regulated EnviormentAlok Anand
Tracking drugs across the supply chain in a regulated environment. This white paper brief on would be drug utilization approach of Life Science Industry. This white paper is just a step forward to show future life science industry process automation
This document discusses drug utilization review (DUR), which is a systematic process to ensure appropriate medication use. DUR involves reviewing patient medication and health histories before, during, and after dispensing. It can help prevent unnecessary drug use, adverse reactions, and improve effectiveness. The document outlines the classification, goals, and steps to establish a basic hospital DUR program, including forming a committee, developing policies/procedures, identifying drugs for review, establishing criteria, collecting/evaluating data, implementing interventions if needed, and re-evaluating the program annually.
A concise overview of pharmacoeconomics, health economics, various costs, various pharmacoeconomic study designs and its application in the field of medicine and drug development
This document discusses the pharmacoeconomic program and analysis conducted by the General Administration of Pharmaceutical Care in Saudi Arabia. It provides details on:
1) A pharmacoeconomic analysis of drug-related problems identified through the Drug Information Center, assigning costs to different levels of harm or intervention required.
2) Examples of pharmacists' interventions through the program and the estimated total cost savings of 139,155 Saudi Riyals per month.
3) The goals, policies, procedures and principles of the pharmacoeconomic manual developed for the Saudi Ministry of Health, including supporting formulary and resource allocation decisions with pharmacoeconomic evidence.
Following topics are covered in this slide deck:
Role and use of Pharmacoeconomics and health outcomes research | Impact of price regulation in India | Factors affecting drug pricing | Need, challenges and components of pharmacoeconomics | Aims, Objectives and principle of Pharmacoeconomic Evaluation | Different types of cost measurement | The Methods of Pharmacoeconomic Evaluation | Cost Analysis (CUA)
It is a sub-discipline of health economics , Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another.
Pharmacoeconomics deals with identifying, measuring, and comparing the costs and consequences of pharmaceutical products and services.
This document provides an overview of a presentation on pharmacoeconomics given by Dr. Salim Sheikh at VMMC & Safdarjung Hospital. It discusses the history and introduction of pharmacoeconomics, which evaluates the costs and benefits of pharmaceutical products and services. The presentation covers challenges in pharmacoeconomic evaluation, common methodologies like cost-effectiveness analysis, and limitations of economic evaluations.
This document discusses drug utilization reviews (DUR), also known as drug utilization evaluations (DUE) or medication utilization evaluations (MUE). DURs involve comprehensive review of patient prescription and medication data before, during, and after dispensing to ensure appropriate medication decisions and positive outcomes. DURs aim to promote optimal medication therapy, prevent medication-related problems, evaluate medication effectiveness, improve patient safety, and stimulate improvements in medication use processes. The document also outlines the value of DUR programs in helping health systems understand and improve prescribing, administration, and medication use.
The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
b) A cost analysis of a single intervention
c) A comparison of costs per life-year gained for two interventions
d) An estimation of the total costs of a disease to the society
12/10/2018
DEPARTMENT OF PHARMACOLOGY
KMCH COLLEGE OF PHARMACY
42
Which one of the following is an example of a partial
pharmaco-economic evaluation
This document discusses pharmacoeconomics, drug compliance, and therapeutic failure. It begins by defining pharmacoeconomics as the analysis of costs and consequences of pharmaceutical products and services. It then discusses various pharmacoeconomic methods like cost-benefit analysis and cost-effectiveness analysis. The document also explains drug compliance, adherence, and the consequences of non-compliance. It notes that non-compliance can result in therapeutic drug failure and increased costs. It concludes by discussing common interventions to improve compliance like patient education and simplifying drug regimens.
This presentation give detail overview of pharmacoepidemiology, epidemiological study design, case report, case series, analysis of secular trends, case control studies, cohort studies, statistical interpretation, randomised clinical trials, field trials, community trials, drug utilisation studies.
For all five YouTube Live video lecture series of this topic click:
https://youtube.com/playlist?list=PLBVbJ9HCa1BbqIaLoMmuF0Bf66SMFZtnb
For More Such Learning You Can Subscribe to
My YouTube Channel:
https://www.youtube.com/channel/UC5o-WkzmDJaF7udyAP2jtgw/featured?sub_confirmation=1
Facebook Page: https://www.facebook.com/asacademylearningforever
Website Blog: https://itasacademy.blogspot.com/
This document discusses pharmacoeconomics and its importance in balancing the interests of stakeholders in the healthcare industry. It begins by defining health economics and pharmacoeconomics, and explaining their relationship. It then discusses the shift in focus of healthcare consumers towards disease prevention. The document outlines various challenges faced by the healthcare industry and how pharmacoeconomic solutions can address the perspectives of patients, physicians, insurers, manufacturers, researchers and policymakers. It provides a case study on drug selection for osteoarthritis using pharmacoeconomic analysis. Finally, it discusses the global presence and potential for establishing pharmacoeconomics in India.
This document discusses principles of pharmacoeconomics and their impact on pharmaceutical research and development. It describes how pharmacoeconomic evaluations measure health gains and costs to compare medical procedures. Randomized controlled trials are required to prove efficacy and safety, but real-world studies are also needed to evaluate long-term health benefits and costs. Economic modeling can be used alongside clinical trials to estimate benefits like quality-adjusted life years to determine appropriate pricing and reimbursement strategies for new drugs. Understanding pharmacoeconomics principles is important for pharmaceutical R&D decision making.
This document provides an overview of drug utilization studies. It defines drug utilization research as the study of how drugs are used in populations with the goal of promoting rational and cost-effective drug use. The document outlines the objectives of drug utilization studies as describing drug use patterns, identifying irrational use, evaluating interventions to improve use, and quality control of drug use. It also discusses the types of information collected in these studies including drug-based, problem-based, patient-based, prescriber-based, and cost-based data. Finally, the document reviews the steps involved in conducting a drug utilization study from identifying the drugs and therapeutic areas to study design, data collection sources and methods, and establishing criteria to evaluate appropriate drug use.
This presentation describes the objectives, approach and application of Drug Utilization studies in Pharmacotherapeutics. This emphasizes on how to conduct a drug utilization studies.
Introduction to Premarketing Phase
Limitation of Premarketing Phase and Importance of Phase IV period
Definition of DUS
History of DUS
Objectives of DUS
Types of Drug Use Information
Drug Utilization Cycle
This document discusses pharmacoeconomics and provides definitions, principles, perspectives, types of costs and consequences, and methods of pharmacoeconomic evaluation. Pharmacoeconomics analyzes the costs and benefits of drug therapies to health systems and society. It considers costs from multiple perspectives including patients, providers, payers, and society. Costs include direct medical, direct non-medical, and indirect costs. Consequences include clinical, economic, and humanistic outcomes. Common methods of pharmacoeconomic evaluation are cost-of-illness analysis, cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. These methods are used to inform healthcare decisions at both the individual patient
The document discusses new paradigms in pharmacoeconomics, healthcare, and electronic medical records. It introduces the 3-Dimensional Outcome Assessment model of economic, clinical, and humanistic outcomes. It examines areas of collaboration between economists, physicians, and policy-makers. The new paradigms include changing patient roles, empowerment, continuity of care, team-based care, and computer applications. Electronic medical records are discussed as having modules for different areas like outpatient, inpatient, investigations, pharmacy, and more. Finally, it reflects on the changing digital healthcare ecosystem.
Therapeutic drug monitoring (TDM) involves measuring drug concentrations in body fluids to aid in drug prescribing and management. TDM enables assessment of drug efficacy and safety in different clinical settings and individualizes treatment regimens for optimal patient outcomes. Key aspects of TDM include understanding the relationship between drug concentrations and effects, defining therapeutic ranges, selecting target concentrations, and interpreting test results based on pharmacokinetic and patient factors. Proper sample collection and timing are important for accurate TDM interpretation and dosage adjustments.
Еженедельный отчет Центра мониторинга общественного мнения при Правительстве ...ICMOSRU
Отчет ЦМОМ с 2 по 8 сентября 2015 года
Следите за новостями:
Сайт: http://icmos.ru
Facebook https://www.facebook.com/icmosru
Вконтакте http://vk.com/icmosru
Twitter https://twitter.com/icmosru
Youtube: http://www.youtube.com/user/icmosru
Market segmentation involves dividing customers into groups based on demographics, geography, psychographics, or behaviors to better understand customer needs. A SWOT analysis evaluates a company's strengths, weaknesses, opportunities, and threats to develop strategies - for example, a company may have a strong brand but outdated technology posing opportunities and threats.
Evolution of concurrent programming models - from monitors to actorsArkadiusz Burdach
This talk is about how concurrent models evolved during last decades. It shows why Actor model is worth to use and what benefits it gives. It also presents most common mistakes when using Akka actors.
The document provides instructions for computing profit and return on investment (ROI) per item using a sample spreadsheet. It explains how to calculate profit/item as selling price minus cost and fees, and ROI/item as profit divided by cost and fees. The steps include adding columns to the spreadsheet for the formulas, applying the formulas across rows, and formatting the spreadsheet to highlight the top three ROI results.
Afonso de Albuquerque adalah seorang pelaut dan admiral Portugis yang berperan besar dalam pembentukan pemerintahan kolonial Portugis di Asia pada abad ke-16. Ia membawa armada Portugis untuk menjajah kawasan Nusantara dengan motivasi perdagangan, dominasi militer, dan penyebaran agama Katolik. Periode 1511-1526 menjadi masa kejayaan pengaruh Portugis di berbagai pulau Nusantara sebelum akhirnya mengalami perlawanan
Creativity and innovation by manish dubey.Manish Dubey
Creativity refers to generating new ideas or concepts, while innovation is the process of applying creative ideas to create new products, services, or business practices. Creativity is a starting point for innovation but not sufficient on its own. Distinguishing between them, creativity is the generation of novel ideas by individuals while innovation is the entire process an organization undertakes to convert creative ideas into viable commercial offerings. Obstacles to creativity in organizations can include internal politics, harsh criticism of new ideas, and an overemphasis on maintaining the status quo, while workload pressures and distractions from outside sources can also impede creativity.
Megan Bunck is a detail-oriented sales and marketing professional seeking a new role. She has over 15 years of experience managing clients, budgets, and large-scale events. Most recently, she worked as the Association/Government Sales & Catering Manager for Biltmore Farms Hotels, where she increased sales by $600,000 over 8 years and averaged $1.3 million in annual group revenues. Prior to that, she was the Food & Beverage Director at Biltmore Forest Country Club, managing a staff of 50 and a $1.6 million business. She is proficient in various software programs and is an articulate communicator skilled at establishing long-lasting professional relationships.
The document provides a summary of Tarek Ahmed's career objective, personal details, qualifications, work experience, and skills. His objective is to establish a recognizable career through continuous self-improvement and high quality service. He has over 5 years of experience as a Project Manager for banking implementation projects. His educational background includes an MBA and Bachelor's degree in Pharmacy. He is proficient in project management, customer service, and Microsoft Office applications.
ich guidelines for clinical trials, scientific approach ppt.pptxJyotshnaDevi4
The document outlines the ICH guidelines for conducting clinical trials. It describes the objectives to promote common understanding and evaluation of foreign clinical trial data. Clinical trials should follow scientific principles and protect subjects. Trials generally proceed through four phases, starting with small healthy volunteer studies (Phase I) to evaluate safety, followed by exploratory efficacy studies (Phase II), then confirmatory efficacy and dosing studies (Phase III), and finally post-marketing studies (Phase IV). Special populations like children, pregnant women, and those with organ impairment require unique consideration. Proper study design, conduct, analysis and reporting are emphasized.
1. The document discusses pharmaceutical care and developing a patient care plan. It defines pharmaceutical care and its basic elements which include being patient-oriented and focusing on prevention of drug-related problems.
2. Developing a care plan involves establishing goals of therapy for each medical condition, determining interventions to resolve issues and achieve goals, and scheduling follow-up evaluations. Goals should be measurable and include timeframes.
3. The care plan documentation includes the patient's medical conditions, drug therapy problems, goals of therapy, interventions, and follow-up dates. This ensures a systematic approach to managing a patient's pharmacotherapy needs.
This document summarizes guidelines on obtaining dose-response information to support drug registration. The guidelines aim to identify an appropriate starting dose and dosage adjustments for patients based on the relationship between dose, drug concentration, and clinical response. Specific trial designs are discussed for assessing dose-response curves, including parallel dose-response studies, cross-over studies, forced titration, and optional titration designs. The guidelines provide recommendations on integrating dose-response assessment into drug development and evaluating existing clinical trial data to identify dose-response effects.
The document summarizes three medication management programs:
1. The London Older Peoples Service Development Programme uses a specialist pharmacist assessment and care plan coordinated by a case manager to address older patients' medication access, compliance, and clinical issues.
2. Imperial College's My Medication Passport provides patients a consolidated list of their medications, allergies, and contacts to improve information sharing between care settings.
3. Optimize Adherence Service uses accredited community pharmacists to conduct adherence assessments, develop support plans, and provide ongoing reviews to both address unintentional non-compliance barriers and provide cognitive support to improve intentional medication taking.
Clinical Pharmacy Introduction to Clinical Pharmacy, Concept of clinical pptxraviapr7
b) Clinical Pharmacy
Introduction to Clinical Pharmacy, Concept of clinical pharmacy
Functions and responsibilities of clinical pharmacist, Drug therapy monitoring
Medication chart review, clinical review., pharmacist intervention
Ward round participation, Medication history and Pharmaceutical care.
Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern
Agreement between Claims-based and Self-reported Adherence Measures in Patien...dylanturner22
This document summarizes a study that examined the agreement and correlation between claims-based and self-reported adherence measures in patients with type 2 diabetes mellitus. The study found slight agreement between the two measures of adherence. A significant but weak positive correlation was observed between claims-based and self-reported adherence for highly adherent patients. The results suggest that conclusions about adherence based on different measurement approaches may not match, so it is important to consider what specific behavior each approach represents.
This document provides an overview of key concepts in randomized clinical trials. It discusses how randomized clinical trials scientifically assess the safety and efficacy of new drugs or therapies using human subjects. The document outlines different types of blinding in clinical trials, such as single-blind, double-blind, and triple-blind designs. It also describes the different phases of clinical drug trials from Phase I to Phase IV and how each phase contributes to understanding a drug's safety, efficacy, and suitability for specific diseases.
Clinical pharmacy involves optimizing patient medication use and health outcomes. It includes collecting patient data, identifying drug-related problems, monitoring treatment, and educating patients. Clinical pharmacists play an important role in hospitals and communities by reviewing medication orders, participating in ward rounds, conducting medication reconciliation, and providing pharmaceutical care. Dosage adjustment may be needed in renal or hepatic disease based on a drug's pharmacokinetics and a patient's disease state.
The document provides an overview of clinical pharmacy, including its definition, development, scope, and the functions and responsibilities of clinical pharmacists. It discusses key aspects of clinical pharmacy practice such as medication chart review, clinical review, pharmacist intervention, ward round participation, medication history, and pharmaceutical care. The summary is as follows:
Clinical pharmacy deals with the safe and effective use of drugs in patient care. It aims to optimize medication use and promote health. Clinical pharmacists are involved in medication monitoring, patient education, and ensuring rational drug therapy.
Key responsibilities of clinical pharmacists include collecting patient data, identifying drug-related problems, establishing treatment goals, evaluating and modifying drug regimens, and monitoring treatment outcomes.
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and
responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart
review, clinical review
Pharmaceutical care is defined as the responsible provision of drug therapy to achieve definite outcomes that improve a patient's quality of life. It involves identifying potential and actual drug-related issues, resolving problems, and preventing future issues through education and monitoring. The pharmacist works with the patient and other providers to design and implement a care plan with specific therapeutic goals such as curing disease, reducing symptoms, or preventing illness. Key aspects of pharmaceutical care include being patient-oriented, addressing both acute and chronic issues, documenting care in the patient record, and emphasizing health promotion and education.
This document discusses Phase 1 clinical trials. Phase 1 trials involve small studies (20-80 subjects) to determine the safety and tolerability of new drugs in healthy volunteers. They aim to determine the maximum tolerated dose and identify any side effects. The document outlines the objectives, study designs, populations and endpoints of Phase 1 trials. It provides guidance on determining starting doses based on preclinical toxicology studies in animals and safety factors. It also discusses assessments required for special populations and potential drug interactions.
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.
Pharmaceutical care concepts - clinical pharmacy ShaistaSumayya
This document summarizes the concept of pharmaceutical care as presented by Shaista Sumayya, a 4th year PharmD student. It defines pharmaceutical care as the direct provision of medication-related care to improve patient outcomes. The pharmacist's role involves identifying and resolving drug-related problems by designing treatment plans, monitoring outcomes, and preventing potential issues. Key aspects of pharmaceutical care include collecting patient data, evaluating treatment alternatives, individualizing drug regimens, and documenting provided care. The overall goal is to cure diseases, reduce symptoms, and improve a patient's quality of life through optimized medication management.
An introduction to medication therapy managementKabito Kiwanuka
Pharmacists: An Untapped Resource: Pharmacists receive more training on the safe, effective and appropriate use of medications than any other healthcare professional
The document discusses drug use evaluation (DUE), which is a systematic, criteria-based process for evaluating drug use and ensuring medications are used appropriately. It describes the DUE cycle, which involves planning, data collection, evaluation, feedback, interventions, and re-evaluation. The goals are to promote optimal medication therapy and ensure drug use meets standards of care. Key aspects of the DUE process include identifying drugs for study, designing the study, defining criteria, collecting and analyzing data, providing feedback, developing and implementing interventions, and re-evaluating drug use to determine if improvements were made.
Clinical pharmacy is still developing in India. Clinical pharmacists work directly with patients, physicians, and other healthcare professionals to ensure safe and effective medication use. They collect patient medical histories, identify potential drug-related problems, establish treatment goals, evaluate treatment alternatives, monitor outcomes, and individualize drug regimens. In hospitals, clinical pharmacists are involved in prescription monitoring, advising medical staff, monitoring medication errors and adverse reactions, patient education, and participating in ward rounds.
Post-marketing surveillance is important to identify adverse drug reactions that were not detected in pre-market clinical trials due to limited sample sizes. There are several methods used for post-marketing surveillance including spontaneous reporting, cohort studies, and case-control studies. These methods help monitor drug safety once a drug is on the market and exposed to a more diverse population and conditions compared to clinical trials. Post-marketing surveillance is especially important for detecting rare or long-term adverse effects.
The document discusses pharmaceutical care, which aims to achieve the best possible outcomes for patients' quality of life through proper medication use. It defines pharmaceutical care as the responsible provision of drug therapy to achieve definite therapeutic outcomes that improve a patient's quality of life. Key aspects of pharmaceutical care include identifying and resolving actual and potential drug-related problems through monitoring medication appropriateness, effectiveness, and safety. The roles of pharmacists include collecting patient data, assessing medications, developing individualized care plans, implementing and monitoring care to evaluate outcomes and modify plans as needed.
Similar to Franks_Know your patients_2Sep14_final (20)
1. Know Your Patients:
Why a registry alongside your observational
claims and Electronic Health Records
research may be crucial
Billy Franks, PhD
Director HECOR Statistics
Astellas Scientific and Medical Affairs, Inc.
September 18, 2014
2. Disclaimer
The presenter is a paid employee of Astellas.
The opinions and positions presented today are
my own and do not necessarily reflect those of
Astellas or any of its affiliate companies or
entities.
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3. Outline
• Apples-to-Apples (sequences & combinations)
• Impact of sequencing or combinations on
claims/EHR comparisons
• Illustrative Example
• Registries should complement your Big Data
strategy
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4. Comparative Effectiveness Research
AHRQ – “[CER] is designed to inform health-care decisions by
providing evidence on the effectiveness, benefits, and harms of
different treatment options.”
Two named sources:
…all of the available evidence about the benefits and harms of
each choice for different groups of people from existing
clinical trials, clinical studies, and other research. These are
called research reviews, because they are systematic reviews
of existing evidence.
…conduct studies that generate new evidence of
effectiveness or comparative effectiveness of a test,
treatment, procedure, or health-care service.
http://effectivehealthcare.ahrq.gov/index.cfm/what-is-comparative-effectiveness-research1/ 4
5. Apples-to-Apples
AHRQ – “The magnitude of potential confounding generally is expected to be
smaller when the comparator (1) has the same indication, (2) has similar
contraindications, (3) shares the same treatment modality (e.g., tablet or
capsule), and (4) has similar adverse effects.”
This guidance fails to warn the user of the implications of bias due to:
• Sequencing of therapies
– Guidelines
– Insurance Step Therapy Programs/Bundles
– Standard of Care
• Combination Therapy vs. Monotherapy Comparisons
(Brief mention on pg. 54 with regards to complexity of inference)
AHRQ - Developing a Protocol for Observational Comparative Effectiveness Research 5
6. Sequencing and Combination Therapy
• What may inform the sequence of therapies?
– Cost – least expensive option first, more expensive alternatives later
– Tolerability – perceived tolerability profile and/or patient characteristics, try alternatives
for lack of tolerability
– Efficacy – perceived efficacy profile and/or patient characteristics, try alternatives for
lack of response
• What may inform the use of combination therapy?
– Lack of efficacy of initial monotherapy regimen
– Severity of disease upon diagnosis or suspected condition
– Uncertainty of diagnosis
Given the above possible rationales for sequencing of therapies/combination
therapies, which would you be able to account for in CER when using data
commonly available in a claims data source? In a robust EHR data source?
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7. Type 2 Diabetes Guidelines (2014)
Pharmacological Therapy for Hyperglycemia in Type 2 Diabetes
• Metformin, if not contraindicated and if tolerated, is the preferred initial
pharmacological agent for type 2 diabetes.
• In newly diagnosed type 2 diabetic patients with markedly symptomatic and/or
elevated blood glucose levels or A1C, consider insulin therapy, with or without
additional agents, from the outset.
• If noninsulin monotherapy at maximum tolerated dose does not achieve or
maintain the A1C target over 3 months, add a second oral agent, a glucagon-like
peptide 1 (GLP-1) receptor agonist, or insulin.
• Patient-centered approach should be used to guide choice of pharmacological
agents. Consider efficacy, cost, side effects, effects on weight, comorbidities,
hypoglycemia risk, and patient preferences.
• Due to the progressive nature of type 2 diabetes, insulin therapy is eventually
indicated for many patients with type 2 diabetes.
http://care.diabetesjournals.org/content/37/Supplement_1/S5.full.pdf+html 7
8. Type 2 Diabetes Guidelines (2014)
Pharmacological Therapy for Hyperglycemia in Type 2 Diabetes
• Metformin, if not contraindicated and if tolerated, is the preferred initial
pharmacological agent for type 2 diabetes. (Efficacy – Sequence)
• In newly diagnosed type 2 diabetic patients with markedly symptomatic and/or
elevated blood glucose levels or A1C, consider insulin therapy, with or without
additional agents, from the outset. (Efficacy – Combination)
• If noninsulin monotherapy at maximum tolerated dose does not achieve or
maintain the A1C target over 3 months, add a second oral agent, a glucagon-like
peptide 1 (GLP-1) receptor agonist, or insulin. (Efficacy – Sequence to Combination)
• Patient-centered approach should be used to guide choice of pharmacological
agents. Consider efficacy, cost, side effects, effects on weight, comorbidities,
hypoglycemia risk, and patient preferences. (Tolerability + Efficacy + Cost)
• Due to the progressive nature of type 2 diabetes, insulin therapy is eventually
indicated for many patients with type 2 diabetes. (Efficacy – Combination)
http://care.diabetesjournals.org/content/37/Supplement_1/S5.full.pdf+html 8
9. Sample FDA Labeled Indications
• Metformin – “as monotherapy are indicated as an adjunct to diet and
exercise to improve glycemic control in patients with type 2 diabetes…
…Metformin may be used concomitantly with a sulfonylurea to improve
glycemic control in adults”
• Glipizide (sulfonylurea class) – “as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus”
• Repaglinide (Meglitinide class)– “as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus”
• Rosiglitazone Maleate (Thiazolidinediones class) – “as an adjunct to diet
and exercise to improve glycemic control in patients with type 2 diabetes
mellitus… …monotherapy… …combination with sulfonylurea, metformin,
or insulin [due to failure on maximum dose monotherapy with
sulfonylurea or metformin]… …combination with a sulfonylurea plus
metformin”
• Pioglitazone Hydrochloride (Thiazolidinediones class) – “as an adjunct to
diet and exercise to improve glycemic control in adults with type 2
diabetes mellitus in multiple clinical settings”
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10. Big Data Example – Type 2 Diabetes
• DARTNet – “advance observational comparative effectiveness research
(OCER) methods… …by providing a way to account for important clinical
information that is missing from claims databases [LABS and EHR].”
• Type 2 Diabetes medications - “retrospective cohort study that evaluated
patterns of use, comparative effectiveness, and safety”
• “Phase 1 used a commercially available, integrated medical claims
database to examine the comparative effectiveness and safety of oral
diabetes medications.”
• “Phase 2 used DARTNet data for the same purpose… [with] clinically-
relevant data such as body weight, height, self-reported alcohol intake,
and self-reported hypoglycemic events, which were absent in the claims
database [along with H-A1C].”
http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-
reports/?productid=317&pageaction=displayproduct
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11. Results
• 100,000 subjects for utilization and safety and 14,000 subjects for effectiveness
• 80% initiated on monotherapy, 20% initiated on combination therapy
Lack of DM symptoms and glucose
• Persistence differed across specific monotherapy and combination therapy groups.
Biguanides or TZDs had greater persistence than other monotherapies; sulfonylurea
(SU)+biguanides or biguanides+TZDs had greater persistence than other combinations.
No comparisons between monotherapy and combination therapies
• Unadjusted reductions in Hemoglobin A1C (H-A1C) were similar to previous findings: 1%
(single therapy), 2% (two), and 2.6% (three).
Adjusted model showed smaller effect sizes. Was severity really accounted?
• Multivariate modeling showed slight differences across individual ODM drugs or
combinations in comparison to metformin monotherapy
Multivariate models which should account for severity failed to find relevant differences?
• Associated factors with greater H-A1C reduction: propensity score, persistence and
compliance, baseline H-A1C, and number of diabetes-related MD and education visits.
Shouldn’t significant propensity with equal outcomes imply effectiveness?
http://effectivehealthcare.ahrq.gov/ehc/products/53/151/2009_0728DEcIDE_DARTNet.pdf 11
12. Why Registries Can Complement Your
Big Data Strategy
• Registries
– Sponsored/Public
– Assess important questions typically at standardized time
points (PROs, efficacy, safety, exposure, rationale for
treatment choices)
– May collect novel or uncommon data (e.g. labs, genomic
data)
– May allow for prospective queries directly to participants
– Should be designed to capture known confounders
– Possibly improved longitudinality
– Could enrich available data for rare populations/diseases
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14. Public Registry Example:
Diabetes Collaborative Registry
• Announced June 2014
• Seeks to address a multitude of related conditions and
outcomes:
– cardiovascular disease
– kidney disease
– nerve damage
– amputation
– blindness
• Incorporating patients from the PINNACLE Registry®
(American College of Cardiology) ≈ 2.1 million patients
• Will leverage electronic medical records from:
– primary care physicians, endocrinologists, cardiologists and
other diabetes care providers
http://www.cardiosource.org/news-media/publications/cardiology-magazine/2014/06/first-clinical-diabetes-registry-to-
provide-seamless-view-of-diabetes-patients-across-specialties.aspx
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15. Sponsored Example:
Long-Term Non-Interventional Latanoprost
Study (LYNX)
• Dec 2010 – January 2016
• Seeks to collect long-term outcomes in pediatrics treated with Latanoprost
assessed at scheduled time points (baseline, 6, 12, 24, and 36 months):
– Best corrected visual acuity
– Refractive error
– Horizontal corneal diameter
– Intraocular pressure
– Optic nerve changes/structures
– Visual field
– Iris color darkening
– Other
• How many of these endpoints would be found in even the most robust
EHR databases given these would be observed by an optometrist?
Pfizer - http://clinicaltrials.gov/show/NCT01265719 15
16. Conclusion
• Registries should be considered as part of your
RWE strategy to complement Big Data research
• Registries cannot replace claims/EHR due to
limited size, limits on broad applicability, and
frequent lack of economic data
• Consider the implications of sequencing and
combination therapy in defining the scope of or
methodology for therapy comparisons
• Ensure you are ready to address external
research activities which may include your
therapy in a disadvantaged comparison
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