This case study examined the role of pharmacists in outpatient chemotherapy in Japan. It found that pharmacists at the study hospital played key roles in standardizing regimens, improving workflow using concepts from manufacturing like modularization and kanban systems, and providing medication information to strengthen safety. The pharmacist's combination of manufacturing and service perspectives helped optimize the medication use process and quality of team-based care while potentially reducing costs from medication-related problems.
Hướng dẫn xác nhận và xác minh các phương pháp thử định lượng và định tính. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Pharmaceutical development report (pdr)Atul Bhombe
The document discusses the key sections and guidelines for an effective Pharmaceutical Development Report (PDR) as outlined in ICH Q8 and Q8(R1). The six critical sections of a PDR are: 1) active and inactive ingredients, 2) formulation development and properties, 3) manufacturing process development, 4) container closure system, 5) microbiological attributes, and 6) compatibility with diluents. The PDR provides a comprehensive understanding of the product and manufacturing process for regulatory review and should be updated throughout the product lifecycle.
The document provides guidelines on pharmaceutical development as described in ICH Q8(R2). It discusses the objective to design a quality product and manufacturing process. Key points covered include critical quality attributes, design space, control strategies, flexibility opportunities, and examples of QbD application. The annex to ICH Q8(R1) further explains quality by design principles and their application in practice.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
This document provides guidance for pharmaceutical manufacturers to gradually incorporate Quality by Design (QbD) systems into the manufacturing of drugs. It outlines a methodology for evaluating manufacturing processes, identifying deficiencies, proposing improvements, and calculating the return on investment of QbD projects. The document is structured to first assess current process control and understanding, then evaluate potential design and knowledge gaps, and finally demonstrate the methodology through a case study applying QbD to a tablet manufacturing process. The overall aim is to move from a compliance-based model to one based on continuous improvement and scientific understanding of processes.
The document discusses the International Council for Harmonization (ICH) and its goal of improving efficiency in drug development and registration. It provides an overview of the ICH's phases and agreement to continue harmonization efforts. The rest of the document focuses on Quality by Design (QbD), including defining the pharmaceutical development process, quality systems, quality risk management, and moving from empirical to systematic and knowledge-driven approaches. It provides details on the contents and topics that should be included in pharmaceutical development submissions to regulatory agencies.
Computational modeling of drug dispositionPV. Viji
Computational modeling of drug disposition , Modeling techniques , Drug absorption , solubility , intestinal permeation , Drug distribution , Drug excretion , Active Transport , P-gp , BCRP , Nucleoside transporters , hPEPT1 , ASBT , OCT , OATP , BBB-choline transporter
Hướng dẫn xác nhận và xác minh các phương pháp thử định lượng và định tính. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Pharmaceutical development report (pdr)Atul Bhombe
The document discusses the key sections and guidelines for an effective Pharmaceutical Development Report (PDR) as outlined in ICH Q8 and Q8(R1). The six critical sections of a PDR are: 1) active and inactive ingredients, 2) formulation development and properties, 3) manufacturing process development, 4) container closure system, 5) microbiological attributes, and 6) compatibility with diluents. The PDR provides a comprehensive understanding of the product and manufacturing process for regulatory review and should be updated throughout the product lifecycle.
The document provides guidelines on pharmaceutical development as described in ICH Q8(R2). It discusses the objective to design a quality product and manufacturing process. Key points covered include critical quality attributes, design space, control strategies, flexibility opportunities, and examples of QbD application. The annex to ICH Q8(R1) further explains quality by design principles and their application in practice.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
This document provides guidance for pharmaceutical manufacturers to gradually incorporate Quality by Design (QbD) systems into the manufacturing of drugs. It outlines a methodology for evaluating manufacturing processes, identifying deficiencies, proposing improvements, and calculating the return on investment of QbD projects. The document is structured to first assess current process control and understanding, then evaluate potential design and knowledge gaps, and finally demonstrate the methodology through a case study applying QbD to a tablet manufacturing process. The overall aim is to move from a compliance-based model to one based on continuous improvement and scientific understanding of processes.
The document discusses the International Council for Harmonization (ICH) and its goal of improving efficiency in drug development and registration. It provides an overview of the ICH's phases and agreement to continue harmonization efforts. The rest of the document focuses on Quality by Design (QbD), including defining the pharmaceutical development process, quality systems, quality risk management, and moving from empirical to systematic and knowledge-driven approaches. It provides details on the contents and topics that should be included in pharmaceutical development submissions to regulatory agencies.
Computational modeling of drug dispositionPV. Viji
Computational modeling of drug disposition , Modeling techniques , Drug absorption , solubility , intestinal permeation , Drug distribution , Drug excretion , Active Transport , P-gp , BCRP , Nucleoside transporters , hPEPT1 , ASBT , OCT , OATP , BBB-choline transporter
The document discusses the International Council for Harmonization (ICH) and its goal of improving efficiency in drug development and registration. It provides an overview of the ICH's phases and agreement to continue harmonization efforts. The rest of the document focuses on Quality by Design (QbD), including defining the pharmaceutical development process, quality systems, quality risk management, and moving from empirical to systematic and knowledge-driven approaches. It provides details on the contents and topics that should be included in pharmaceutical development submissions to regulatory agencies.
This document summarizes ICH Q8 guidelines on pharmaceutical development. It outlines the key components of drug development, including drug substances, excipients, formulation development, manufacturing process development, container closure systems, and compatibility studies. The objectives of Q8 are to design a quality product and manufacturing process using scientific approaches and quality risk management. It advocates moving from quality by testing to quality by design to build quality in from the beginning and continuously improve through the product lifecycle.
- The document discusses a research project analyzing the use and effectiveness of Total Quality Management (TQM) approaches in the German food industry.
- A survey of 442 food industry companies in Germany was conducted to assess the current status of TQM implementation based on the EFQM Excellence Model, which defines nine key areas.
- The results showed that companies have successfully implemented some TQM requirements like reducing environmental impacts and ensuring organizational structures. However, other areas like collecting employee feedback and communicating societal impacts need improvement.
- Statistical analysis found a positive correlation between TQM implementation and long-term business success, though companies ranked the impact of different TQM areas differently than the statistical results.
This document provides an overview of Quality by Design (QbD) in pharmaceutical development based on ICH Q8 guidelines. It discusses key QbD concepts like critical quality attributes, risk assessment, design space and control strategy. It also presents two case studies applying QbD approaches - one on developing controlled-release felodipine tablets using polymeric surfactants and another on starch-based nanocapsules for topical drug delivery. The document outlines the various elements of pharmaceutical development as defined in ICH Q8 like quality target product profile, critical quality attributes, risk assessment, design space and product lifecycle management.
Layout of pharmaceutical building and servicesHimal Barakoti
The document discusses the layout of pharmaceutical buildings and services. It begins with an introduction to good manufacturing practices (GMP) and their importance. It then covers the basic requirements for building layout, including material and personnel flows, equipment layout, and ensuring proper process flow. Specific areas of the building are also addressed, including ancillary, storage, weighing, production, and quality control areas. Proper lighting, electricity, and environmental controls are emphasized throughout.
This document summarizes a study that evaluated the supply chain management performance of Amhara Pipe Factory. The study aimed to measure the factory's supply chain system, identify hindrances to performance, and analyze strengths and weaknesses. Through questionnaires, the study found that while the factory's supply chain management performance was generally good, there were some weaknesses in sourcing and training. The researchers recommended that the factory provide short-term training to existing employees and hire new skilled workers to improve performance.
Application of Statistical Quality Control Techniques for Improving the Servi...inventionjournals
This document discusses applying statistical quality control techniques to improve the quality of paramedical services. It analyzes the time taken to provide different paramedical services to patients at a hospital in Bhubaneswar, India. Control charts are created for the mean and range of time taken for seven common services (blood sugar, creatinine, etc.). The charts identify samples where the process went out of control, indicating room for improvement. Suggestions are made to reduce variations and delays in service delivery times.
The document provides an overview of the structure and content requirements for drug substance and drug product documentation as outlined by ICH guidelines. It discusses topics such as stability testing, manufacturing processes, characterization of drug substance and drug product, specifications, control of materials, validation, and stability data that must be included. The documentation requirements cover general information, manufacturing, characterization, specifications, reference standards, packaging, and stability for both drug substance and drug product.
Quality by design in pharmaceutical developmentSHUBHAMGWAGH
This document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses the benefits of QbD including eliminating batch failures and ensuring a better designed product. The key aspects of QbD include establishing a quality target product profile, identifying critical quality attributes, performing a risk assessment, defining a design space, describing a control strategy, and enabling continuous improvement through life cycle management. QbD aims to build quality into the product design and manufacturing process through a systematic and scientific approach.
The document discusses Quality by Design (QbD) principles for pharmaceutical product development. It defines key QbD concepts like quality target product profile, critical quality attributes, critical material attributes, critical process parameters, risk assessment, design space, and control strategy. It provides examples of applying these concepts for developing different dosage forms like tablets, capsules, solutions, and creams. The document aims to guide systematic development of pharmaceutical products using a QbD approach with a focus on understanding and controlling critical factors influencing quality.
This document describes a pharmaceutical documentation project submitted by Rahul Sharma for the degree of Bachelor of Pharmacy. It includes a certificate signed by his supervisor, Mr. Shailesh Kumar Singh, confirming Rahul conducted the project work. Rahul also includes a declaration that the work presented in the project entitled "Pharmaceutical Documentation" was carried out by him. The project acknowledges various individuals who helped Rahul complete the work. It then provides an abstract stating the project specifies GMP requirements for documentation within the pharmaceutical industry and describes key documents concerning manufacturing, testing, packaging and other aspects.
This document outlines standards of practice for clinical pharmacy in Australia. It defines clinical pharmacy practice as optimizing patient outcomes through quality use of medicines as part of a multidisciplinary healthcare team. The standards describe the objective and definition of clinical pharmacy, the extent and operation of clinical pharmacy services including individual patient care and broader services. Procedures for clinical pharmacy services for individual patients are outlined, including the medication action plan and specific clinical activities. Training and education requirements for clinical pharmacists are also discussed.
HOSPITAL_PHARMACY ROLE OF AND DUTIES OF PHARMACIST.docxDrVivekChauhan1
This document summarizes the key aspects of hospital pharmacy services and standards. It defines hospital pharmacy as the department responsible for supplying medications to patients and providing other pharmaceutical services. The goals of hospital pharmacy are outlined, such as providing qualified pharmacists, ensuring high quality practice, promoting research, and advancing drug therapy. Minimum standards are established for the administration, facilities, drug distribution/control, information services, and role of the pharmacy director in setting goals and supervising personnel. The roles of pharmacy technicians are also mentioned. Overall, the document provides a framework for developing and evaluating pharmaceutical services in hospitals.
Regulatory affairs cmc , post approval regulatory affairsArjunDhawale
The document summarizes CMC (chemistry, manufacturing and controls) regulatory affairs for pharmaceutical products. It discusses the CMC section of regulatory filings which contains information on drug substance and product characteristics, manufacturing and quality. It describes the chemistry, manufacturing process, specifications and controls for ensuring consistent quality batches. It also covers CMC regulatory compliance after approval and post-approval regulatory requirements to ensure continued safety and effectiveness. The goal of CMC regulatory affairs is to provide the necessary CMC information and strategy to obtain and maintain regulatory approvals.
The document compares regulatory standards for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). It finds that GMP places more emphasis on maintaining quality during product manufacturing, while GDP guidance for distribution is less extensive. Both are important quality systems, but GMP requirements for manufacturing processes are more rigorous. Pharmaceutical companies should design quality systems that ensure product quality is maintained during both manufacturing and distribution operations.
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical
Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its
manufacturing process. It is first produced for the original marketing application and
can be updated to support new knowledge gained over the lifecycle of a product. The
Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its manufacturing process. It is first produced for the original marketing application andcan be updated to support new knowledge gained over the lifecycle of a product. The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
The Common Technical Document (CTD) provides a standardized format for new drug applications across Europe, Japan, and the US. It is organized into 5 modules: Module 1 contains regional information; Modules 2-5 are common. Module 2 provides overviews and summaries of quality, nonclinical, and clinical data in Modules 3-5. The CTD standardizes the presentation of information on pharmaceutical quality, nonclinical safety and efficacy, and clinical data to facilitate simultaneous new drug applications in multiple regions.
Six sigma dmaic methodology as a support tool for health technology assessmen...Murilo Souza, MBA, MBB
This document describes a study that uses a Six Sigma DMAIC methodology to support a health technology assessment of two antibiotics - Ceftriaxone and Cefazolin plus Clindamycin. The goal is to assess the clinical and organizational impact of each antibiotic in terms of postoperative length of stay for patients undergoing tongue cancer surgery. The DMAIC cycle is applied to analyze the process and compare the antibiotics, with length of stay used as the performance measure. Multiple linear regression analysis is also used within the DMAIC cycle to add additional information and confirm results. The findings show the methodology is effective for determining the impact of each antibiotic and guiding decision making.
The document discusses the International Council for Harmonization (ICH) and its goal of improving efficiency in drug development and registration. It provides an overview of the ICH's phases and agreement to continue harmonization efforts. The rest of the document focuses on Quality by Design (QbD), including defining the pharmaceutical development process, quality systems, quality risk management, and moving from empirical to systematic and knowledge-driven approaches. It provides details on the contents and topics that should be included in pharmaceutical development submissions to regulatory agencies.
This document summarizes ICH Q8 guidelines on pharmaceutical development. It outlines the key components of drug development, including drug substances, excipients, formulation development, manufacturing process development, container closure systems, and compatibility studies. The objectives of Q8 are to design a quality product and manufacturing process using scientific approaches and quality risk management. It advocates moving from quality by testing to quality by design to build quality in from the beginning and continuously improve through the product lifecycle.
- The document discusses a research project analyzing the use and effectiveness of Total Quality Management (TQM) approaches in the German food industry.
- A survey of 442 food industry companies in Germany was conducted to assess the current status of TQM implementation based on the EFQM Excellence Model, which defines nine key areas.
- The results showed that companies have successfully implemented some TQM requirements like reducing environmental impacts and ensuring organizational structures. However, other areas like collecting employee feedback and communicating societal impacts need improvement.
- Statistical analysis found a positive correlation between TQM implementation and long-term business success, though companies ranked the impact of different TQM areas differently than the statistical results.
This document provides an overview of Quality by Design (QbD) in pharmaceutical development based on ICH Q8 guidelines. It discusses key QbD concepts like critical quality attributes, risk assessment, design space and control strategy. It also presents two case studies applying QbD approaches - one on developing controlled-release felodipine tablets using polymeric surfactants and another on starch-based nanocapsules for topical drug delivery. The document outlines the various elements of pharmaceutical development as defined in ICH Q8 like quality target product profile, critical quality attributes, risk assessment, design space and product lifecycle management.
Layout of pharmaceutical building and servicesHimal Barakoti
The document discusses the layout of pharmaceutical buildings and services. It begins with an introduction to good manufacturing practices (GMP) and their importance. It then covers the basic requirements for building layout, including material and personnel flows, equipment layout, and ensuring proper process flow. Specific areas of the building are also addressed, including ancillary, storage, weighing, production, and quality control areas. Proper lighting, electricity, and environmental controls are emphasized throughout.
This document summarizes a study that evaluated the supply chain management performance of Amhara Pipe Factory. The study aimed to measure the factory's supply chain system, identify hindrances to performance, and analyze strengths and weaknesses. Through questionnaires, the study found that while the factory's supply chain management performance was generally good, there were some weaknesses in sourcing and training. The researchers recommended that the factory provide short-term training to existing employees and hire new skilled workers to improve performance.
Application of Statistical Quality Control Techniques for Improving the Servi...inventionjournals
This document discusses applying statistical quality control techniques to improve the quality of paramedical services. It analyzes the time taken to provide different paramedical services to patients at a hospital in Bhubaneswar, India. Control charts are created for the mean and range of time taken for seven common services (blood sugar, creatinine, etc.). The charts identify samples where the process went out of control, indicating room for improvement. Suggestions are made to reduce variations and delays in service delivery times.
The document provides an overview of the structure and content requirements for drug substance and drug product documentation as outlined by ICH guidelines. It discusses topics such as stability testing, manufacturing processes, characterization of drug substance and drug product, specifications, control of materials, validation, and stability data that must be included. The documentation requirements cover general information, manufacturing, characterization, specifications, reference standards, packaging, and stability for both drug substance and drug product.
Quality by design in pharmaceutical developmentSHUBHAMGWAGH
This document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses the benefits of QbD including eliminating batch failures and ensuring a better designed product. The key aspects of QbD include establishing a quality target product profile, identifying critical quality attributes, performing a risk assessment, defining a design space, describing a control strategy, and enabling continuous improvement through life cycle management. QbD aims to build quality into the product design and manufacturing process through a systematic and scientific approach.
The document discusses Quality by Design (QbD) principles for pharmaceutical product development. It defines key QbD concepts like quality target product profile, critical quality attributes, critical material attributes, critical process parameters, risk assessment, design space, and control strategy. It provides examples of applying these concepts for developing different dosage forms like tablets, capsules, solutions, and creams. The document aims to guide systematic development of pharmaceutical products using a QbD approach with a focus on understanding and controlling critical factors influencing quality.
This document describes a pharmaceutical documentation project submitted by Rahul Sharma for the degree of Bachelor of Pharmacy. It includes a certificate signed by his supervisor, Mr. Shailesh Kumar Singh, confirming Rahul conducted the project work. Rahul also includes a declaration that the work presented in the project entitled "Pharmaceutical Documentation" was carried out by him. The project acknowledges various individuals who helped Rahul complete the work. It then provides an abstract stating the project specifies GMP requirements for documentation within the pharmaceutical industry and describes key documents concerning manufacturing, testing, packaging and other aspects.
This document outlines standards of practice for clinical pharmacy in Australia. It defines clinical pharmacy practice as optimizing patient outcomes through quality use of medicines as part of a multidisciplinary healthcare team. The standards describe the objective and definition of clinical pharmacy, the extent and operation of clinical pharmacy services including individual patient care and broader services. Procedures for clinical pharmacy services for individual patients are outlined, including the medication action plan and specific clinical activities. Training and education requirements for clinical pharmacists are also discussed.
HOSPITAL_PHARMACY ROLE OF AND DUTIES OF PHARMACIST.docxDrVivekChauhan1
This document summarizes the key aspects of hospital pharmacy services and standards. It defines hospital pharmacy as the department responsible for supplying medications to patients and providing other pharmaceutical services. The goals of hospital pharmacy are outlined, such as providing qualified pharmacists, ensuring high quality practice, promoting research, and advancing drug therapy. Minimum standards are established for the administration, facilities, drug distribution/control, information services, and role of the pharmacy director in setting goals and supervising personnel. The roles of pharmacy technicians are also mentioned. Overall, the document provides a framework for developing and evaluating pharmaceutical services in hospitals.
Regulatory affairs cmc , post approval regulatory affairsArjunDhawale
The document summarizes CMC (chemistry, manufacturing and controls) regulatory affairs for pharmaceutical products. It discusses the CMC section of regulatory filings which contains information on drug substance and product characteristics, manufacturing and quality. It describes the chemistry, manufacturing process, specifications and controls for ensuring consistent quality batches. It also covers CMC regulatory compliance after approval and post-approval regulatory requirements to ensure continued safety and effectiveness. The goal of CMC regulatory affairs is to provide the necessary CMC information and strategy to obtain and maintain regulatory approvals.
The document compares regulatory standards for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). It finds that GMP places more emphasis on maintaining quality during product manufacturing, while GDP guidance for distribution is less extensive. Both are important quality systems, but GMP requirements for manufacturing processes are more rigorous. Pharmaceutical companies should design quality systems that ensure product quality is maintained during both manufacturing and distribution operations.
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical
Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its
manufacturing process. It is first produced for the original marketing application and
can be updated to support new knowledge gained over the lifecycle of a product. The
Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its manufacturing process. It is first produced for the original marketing application andcan be updated to support new knowledge gained over the lifecycle of a product. The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
The Common Technical Document (CTD) provides a standardized format for new drug applications across Europe, Japan, and the US. It is organized into 5 modules: Module 1 contains regional information; Modules 2-5 are common. Module 2 provides overviews and summaries of quality, nonclinical, and clinical data in Modules 3-5. The CTD standardizes the presentation of information on pharmaceutical quality, nonclinical safety and efficacy, and clinical data to facilitate simultaneous new drug applications in multiple regions.
Six sigma dmaic methodology as a support tool for health technology assessmen...Murilo Souza, MBA, MBB
This document describes a study that uses a Six Sigma DMAIC methodology to support a health technology assessment of two antibiotics - Ceftriaxone and Cefazolin plus Clindamycin. The goal is to assess the clinical and organizational impact of each antibiotic in terms of postoperative length of stay for patients undergoing tongue cancer surgery. The DMAIC cycle is applied to analyze the process and compare the antibiotics, with length of stay used as the performance measure. Multiple linear regression analysis is also used within the DMAIC cycle to add additional information and confirm results. The findings show the methodology is effective for determining the impact of each antibiotic and guiding decision making.
This document discusses the concept of quality by design (QbD) in pharmaceutical development and manufacturing. It provides details on key elements of QbD including defining quality target product profiles, identifying critical quality attributes, understanding relationships between raw materials/process parameters and critical quality attributes, developing a design space, implementing a control strategy, and continually improving processes and products. The document compares traditional quality by testing approaches to QbD and outlines benefits of QbD such as increased flexibility, reduced costs, improved quality and predictability, and enabling real-time product release.
02 metodologia estatística em pesquisa clínicagisa_legal
This document provides guidelines on biostatistical methodology for clinical trials. It discusses important considerations for the overall clinical development plan, guidelines for confirmatory and exploratory clinical trial designs, considerations for parallel group designs, crossover designs, factorial designs, and multicenter trials. Statistical principles should be integrated into the design, conduct, analysis, and reporting of clinical trials to ensure the results provide clear evidence to support regulatory decisions.
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.
Community pharmacy management LAHAR PPT 2.pptxLahar Sambana
The document discusses community pharmacy management and provides details about software used in community pharmacies. It covers topics like legal requirements, site selection, layout, accounts and audits, dispensing practices, and different pharmacy management software including Go Frugal, Medicin, Redbook, Rx30, and Liberty. The document appears to be from a seminar presentation providing an overview of key aspects of managing a community pharmacy.
A Process-Centered Approach to the Description of Clinical Pathways Forms and...Lisa Graves
This document summarizes a study that examined the forms of presentation of clinical pathways that physicians require in hospital information systems and electronic medical records. The study found that physicians need the presentation of clinical pathways to change depending on the phase of diagnosis and treatment. It identified some of the main factors that determine the choice of clinical pathway presentation. While not conclusive, the study provides initial directions for further research on optimal interface design in systems that support dynamic management of clinical pathways.
A Process-Centered Approach to the Description of Clinical Pathways Forms and...Jessica Navarro
This document summarizes a study that examined the forms of presentation of clinical pathways that physicians require in hospital information systems and electronic medical records. The study found that physicians need the presentation of clinical pathways to change depending on the phase of diagnosis and treatment. It identified some of the main factors that determine the choice of clinical pathway presentation. While not conclusive, the study provides initial directions for further research on optimal interface design in systems that support dynamic management of clinical pathways.
REGULATORY AND INDUSTRY ASPECT OF QUALITY BY DESIGN.pptxSumant Saini
Quality by Design (QbD) involves a thorough understanding of the manufacturing process, defining goals before starting process development, and establishing a design space and risk assessment strategy. Regulatory agencies like the FDA support QbD and have provided guidelines through ICH Q8, Q9, and Q10. Under QbD, the regulatory burden is reduced because wider process ranges and limits not requiring prior approval can be established through product and process understanding. FDA inspections of QbD processes will evaluate implementation and knowledge transfer from development to manufacturing, as well as the quality system's effectiveness in maintaining consistent quality over the product lifecycle.
A Review on Step-by-Step Analytical Method Validationiosrphr_editor
When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
This document summarizes a proposed Patient Blood Management (PBM) program at St. Elsewhere Hospital. It identifies issues with current transfusion practices and policies across three pilot areas: post-partum haemorrhage, pre-operative optimization of haemoglobin levels, and deployment of intraoperative cell salvage. The program proposes applying ISO 9001 quality management standards to establish a PBM quality system and governance structure to standardize practices, reduce unnecessary transfusions, and improve outcomes. Key elements include developing a PBM committee, validating all clinical policies, establishing responsibilities and trainings, and deploying alternatives to transfusion like intraoperative cell salvage. The flexibility of ISO 9001 makes it suitable to implement across complex healthcare organizations
Assessment of Good Pharmacy Practice (GPP) in Pharmacies of Community Setting...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
This document discusses quality risk management standard operating procedures (SOPs). It provides links to additional quality management resources and outlines the contents of a quality risk management SOP, including quality risk management principles, tools like check sheets and control charts, and ensuring focus on protecting patients.
Similar to Case Study of Pharmacist Activities in the Multidisciplinary Practice of Outpatient Chemotherapy in Japan (20)
1. What Is “Metaverse”?
2. Use Cases of Metaverse in Healthcare: Robot-Assisted Surgery (RAS) Systems
3. What Is “Web3/NFTs”?
4. Use Cases of Web3/NFTs in Healthcare: Secure Health Information Exchange
5. Conclusion/Q&A
1. 米国立標準技術研究所(NIST) NIST SP 1800-30 遠隔医療の遠隔患者モニタリングエコシステムのセキュア化」草案第2版(2021年5月6日発行)
2. CSA Health Information Management WG 「クラウド上の遠隔医療データ」(2020年6月16日発行)
3. CSA Health Information Management WG 「遠隔医療のリスク管理」(2021年8月10日発行)
4. Q&A/ディスカッション
1. Use Case: Robot-Assisted Surgery (RAS) System on the Cloud
2. Worldwide IT Industry 2023 Predictions
3. Japan IT Spending Forecast by Region: 2021-2026
4. Japan Public Cloud Spending Forecast: 2021-2026
5. Japan Private Cloud Spending Forecast: 2021-2026
6. Japan Information Security Market Forecast: 2020-2026
7. Green Transformation (GX) in Healthcare
8. Conclusion/Q&A
1. Cybersecurity on Telehealth @NIST
2. Cybersecurity on Telehealth x Smart Home @NIST
3. Cloud-Native Privacy/Data Protection on Telehealth @CSA
4. Cloud-Native Security on Telehealth @CSA
5. Conclusions
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
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Case Study of Pharmacist Activities in the Multidisciplinary Practice of Outpatient Chemotherapy in Japan
1. Case Study of Pharmacist Activities in the Multidisciplinary Practice of
Outpatient Chemotherapy in Japan
外来がん化学療法における薬剤師の役割と医療経済に関する研究
2007 年
笹原 英司
5. ABSTRACT
Objective
A case study was undertaken to clarify the qualitative picture of
pharmacist-physician-nurse interactions in medication-use processes for
outpatient chemotherapy operations in a hospital-based setting in Japan.
Methods
An on-site observation and time study was performed at the Blood
Transfusion Unit of St. Luke's International Hospital during the period July
1-31, 2005. For comparison of the results with practices outside Japan, the
observation items of this study were organized in accordance with general
steps of medication-use process identified in the American Society of
Health-System Pharmacist (ASHP) National Surveys of Pharmacy Practice
in Hospital Settings in 2001-2003.
Results
In the case study, adoption trends of pharmacy practice in medication-use
processes seemed to be at relatively the same level as those at hospitals in
the US, when compared to the results of the ASHP National Surveys in
2001-2003 as the key benchmarks. The case study also found that the unique
roles of the chemotherapy pharmacist for both product-focused and
service-focused responsibilities enabled the outpatient chemotherapy team
to adopt the same concepts of continuous quality improvement as those in
the Japanese automotive industry, and that multi-skilled personnel
development activities for the hospital pharmacist are important to carry out
the roles in improving quality of care and reducing costs associated with
preventable medication-related problems.
Conclusion
The case study suggests that the pharmacist’s commitment to
medication-use processes of outpatient chemotherapy at the point of care can
contribute to improvement in the quality of care and reduction of
preventable costs associated with medication-related problems (MRPs) in
team care by controlling product flow and information flow from both
product-focused and service-focused perspectives.
-4-
6. CONTENTS
CHAPTER I Background and objective---------------------------------------------8
1.1 Introduction----------------------------------------------------------------------------------8
1.2 Objective------------------------------------------------------------------------------------10
1.3 Background--------------------------------------------------------------------------------10
CHAPTER 2 Methods-------------------------------------------------------------------12
2.1 Methods-------------------------------------------------------------------------------------12
2.2 Observation items-----------------------------------------------------------------------12
CHAPTER 3 Results---------------------------------------------------------------------14
3.1 Introduction--------------------------------------------------------------------------------14
3.2 Findings from the case study--------------------------------------------------------15
3.2.1 Findings in prescribing and transcribing steps--------------------------15
3.2.2 Findings in dispensing and administration steps-----------------------18
3.2.3 Findings in monitoring and patient education steps-------------------22
CHAPTER 4 Discussion----------------------------------------------------------------24
4.1 Introduction--------------------------------------------------------------------------------24
4.2 Models to quantify values of pharmacist activities
in multidisciplinary team care of outpatient chemotherapy--------------24
4.2.1 Quality function deployment
in prescribing and transcribing steps--------------------------------------------24
4.2.2 Kanban-style model
in dispensing and administration steps-----------------------------------------27
4.2.3 SECI model
in monitoring and patient education steps-------------------------------------31
4.3 Needs for development of economic evaluation models
from Japan--------------------------------------------------------------------------------32
CHAPTER 5 Conclusion---------------------------------------------------------------33
5.1 Limitation-----------------------------------------------------------------------------------33
5.2 Conclusion---------------------------------------------------------------------------------33
REFERENCES----------------------------------------------------------------------------------34
ACKNOWLEDGEMENT----------------------------------------------------------------------36
-5-
7. LIST OF FIGURES
Figure 1. Observation items of medication-use process ------------------------13
Figure 2. Workflow of outpatient chemotherapy for lung cancer--------------14
Figure 3. Implementation cycle of treatment regimens of outpatient
chemotherapy for lung cancer----------------------------------------------------------16
Figure 4. Product and information flow chart of decentralized drug
distribution system for outpatient chemotherapy
(using kanban-style model) ------------------------------------------------------------19
Figure 5. Internal reporting flow of adverse drug events (ADEs)
through the Risk Management Committee----------------------------------------23
Figure 6. Comparison of the case study to quality function
deployment (QFD) in the Japanese automotive industry---------------------26
Figure 7. QFD framework of team care in outpatient chemotherapy---------27
Figure 8. Product and information flow model of centralized drug
distribution system for outpatient chemotherapy
(using kanban-style model) -------------------------------------------------------------29
Figure 9. Pull-push integration system in dispensing process of
outpatient chemotherapy (using kanban-style model) --------------------------30
Figure 10. Value-creating flow of pharmacist activities
and SECI model ----------------------------------------------------------------------------31
-6-
8. LIST OF TABLES
Table 1. Adopted pharmacy practice in medication-use process for
outpatient chemotherapy-----------------------------------------------------------------15
Table 2. Chemotherapy drugs and premedication drugs listed on treatment
regimens of outpatient chemotherapy for lung cancer ------------------------17
Table 3. Average cycle time of chemotherapy drug dispensing---------------21
-7-
9. CHAPTER I
Background and objective
1.1 Introduction
In the Japanese automotive industry, multidisciplinary team approaches
have been utilized to harmonize production leveling and market
diversification and have contributed to the efficiency and effectiveness
improvement. (*1)
Taiichi Ohno, the founder of the just-in-time system in the Japanese
automotive industry, noted that the key concepts of the process-focused tools
included "just-in-time" and "autonomation".
"Just-in-time" means that, in a flow process, the right parts needed in
assembly reach the assembly line at the time they are needed and only in the
amount needed. A tool for managing and assuring just-in-time production is
called a "kanban", a simple and direct form of communication always located
at the point where it is needed. In most cases, a kanban is a small piece of
paper inserted in a rectangular vinyl envelope and carries information
regarding pickup, transfer, and production.
"Autonomation", or automation with a human touch, means transferring
human intelligence to a machine. Autonomation prevents the production of
defective products, eliminates overproduction, and automatically stops
abnormalities on the production line allowing the situation to be investigated.
A tool for managing and assuring autonomation is called "visual control" or
management by sight. A means of visual control is paper-based "standard
work sheet", containing information with regard to elements of the standard
work procedure such as cycle time, work sequence and standard inventory.
The standard work sheet effectively combines materials, workers, and
machines to produce efficiently.
In addition, Ohno suggested that autonomation corresponded to the skill and
talent of individual players while just-in-time was the team-work involved in
reaching an agreed-upon objective. In the Japanese automotive industry,
operators acquire a wide range of skills and participate in building up a total
system in the production plant. Such multi-skilled personnel development
activities are consistent with the philosophy of "kaizen" or and contribute to
integration of just-in-time and autonomation at grassroots level.
-8-
10. While information technologies have been introduced to assembly lines for
paperless operations, the Japanese automotive manufacturers continue to
utilize paper-based tools such as "kanban" and "standard work sheet" for the
quality and safety improvement and the multi-skilled personnel
development. Going to a computer screen moves the workers' eyes from the
real workplace to the virtual screen and may weaken advantages of "visual
control".
As the automotive industry has tried to improve quality, safety and customer
satisfaction, the current health care industry is facing challenges to improve
the quality of care, medication safety and patient satisfaction at lower costs.
The US health care industry has adopted the multidisciplinary team
approaches that originated from Japan. Spear (2005) reported that doctors,
nurses, pharmacists, technicians, and managers increased the effectiveness
of patient care and lowered its cost by applying the same capabilities in
operations design and improvement that drive the Japanese automotive
production system. (*2)
In addition, the pharmacist's commitment to medication-use processes has
been widely recognized to be effective for improving the quality of care and
reducing medication costs. For example, Bair and Cheminant (1980)
reported that moving the pharmacist to the patient care unit decreased the
time that pharmacists spent handling drugs and improved the
communication with the medical and nursing staff, (*3) and Wadd and
Blissenbach (1984) reported that a decentralized drug distribution using a
satellite pharmacy was associated with more efficient use of nursing time
compared with a centralized drug distribution. (*4)
Regarding outpatient chemotherapy, the Japanese health care industry has
adopted a wide range of technologies and tools that originated from the US.
However, little has been reported on the total picture of
pharmacist-physician-nurse interactions in medication-use processes in
Japan, and the pharmacist's role and added value in quality improvement
and cost reduction might be underestimated by key decision makers on
health economics such as patients, medical insurance payers and health care
policy makers.
-9-
11. 1.2 Objective
This case study was undertaken to clarify the qualitative picture of
pharmacist-physician-nurse interactions in medication-use processes for
outpatient chemotherapy operations in a hospital-based setting in Japan.
1.3 Background
St. Luke's International Hospital is a non-profit, full-service hospital with
520 beds in downtown Tokyo. In 2004, the average inpatient stay was 10.9
days, and the average number of outpatients was approximately 2,551 per
day. As of October 2005, staff of the hospital included 250 doctors, 615 nurses,
21 pharmacists, 199 medical technicians, 64 nurse assistants, and 142
administration staff.
In 1998, an integrated hospital information system, including the
computerized physician order entry (CPOE) system and the pharmacy
computer system, was renewed. In July 2003, electronic medication
administration records (MARs) system was implemented.
The Blood Transfusion Unit is an integral part of outpatient oncology
practice at the hospital, and it aims to provide the appropriate space for
outpatient chemotherapy, improving the efficiency and effectiveness in
quality of care and patient safety, and responding to demands from patients
and families. The unit receives outpatients between 8:30 AM and 4:00 PM
every weekday. The integrated hospital information system made it possible
to establish an exclusive point-of-care drug distribution system with a
satellite pharmacy and safe dispensing cabinets at the unit.
As of July 2005, approximately 30 outpatients (max. 50 per day and min. 15
per day) received chemotherapy in the 15-bed treatment room in the unit
each day. Of these outpatients, 61% were from the Breast Surgery Dept.,
18% from the Respiratory Medicine Dept., 11% from the Digestive Surgery
Dept., 5% from the Digestive Internal Medicine Dept., 4% from the
Hematology Dept. and 1% from the Gynecology Dept. The unit was staffed
with 1 physician (Unit Director with expertise in hematology), 2
chemotherapy pharmacists (one chemotherapy-specific pharmacist and one
general pharmacist), 4 oncology nurse specialists and a clerical staff.
Among healthcare practices for cancer diseases at the unit, outpatient
-10-
12. chemotherapy practices for lung cancer were focused upon in the case study.
According to the National Vital Statistics, lung cancer has been the leading
cause of cancer death in Japan since 1998 and the treatment of lung cancer
still heavily depends on inpatient care. From the economic points of view, the
potential impact of quality and safety improvement in outpatient
chemotherapy practices for lung cancer seems larger than for other cancers.
-11-
13. CHAPTER 2
Methods
2.1 Methods
Guerrero et al. (1995) suggested that measuring the amount of time that
pharmacy teams spent on work activities provided a means of improving
organizational inefficiencies in order to give the pharmacists more time for
patient care. (*5) And Runciman (2002) suggested that qualitative research
would be well suited to probing the complex factors behind human errors and
system failure in health care. (*6)
To clarify the qualitative picture of pharmacist involvement in the team
medication process of outpatient chemotherapy for lung cancer, on-site
observation and a time study was performed at the Blood Transfusion Unit of
the St. Luke's International Hospital. With the approval of the Ethics
Committee of the hospital, researchers made observations at the outpatient
chemotherapy center during the period of July 1-31, 2005.
2.2 Observation items
For comparison of the results with pharmacy practices outside Japan, the
observation items of this study were organized in accordance with the
general steps for medication-use processes identified in the American Society
of Health-System Pharmacist (ASHP) National Surveys of Pharmacy
Practice in Hospital Settings in 2001-2003. (*7, *8, *9) Targeting pharmacy
directors in the US, the ASHP surveys were designed on the basis of
three-part series beginning in 2001 and concluding in 2003. The 2001 survey
was concerned with prescribing and transferring steps, the 2002 survey was
concerned with dispensing and administration steps, and the 2003 survey
was concerned with monitoring and patient education steps. When combined,
the 2001-2003 surveys represented composite picture of the role of
pharmacists in managing and improving the medication-use process.
-12-
14. Figure 1 shows the observation items for the study.
Figure 1. Observation items of medication-use process
[Medication-use process] [Observation item]
1) Activities of the pharmacy and therapeutics (P&T) committee
2) Use of clinical practice guidelines
3) Medication-use evaluation activities
(1) Prescribing and 4) Use of trend data to improve prescribing
5) Extent of pharmacist consultations
transcribing 6) Provision of drug information to prescribers
7) Evaluation of medication orders
8) Use of prescriber order-entry systems
9) Actions taken to ensure accurate transcription of medication orders
1) Patient drug distribution system
2) Use of technology in drug distribution
(2) Dispensing and 3) Medication preparation and dispensing
administration 4) Drug administration
5) Use of medication administration records
6) Collaboration in pharmacy operations and preparation activities
7) Quality improvement activities
1) Time pharmacists spend monitoring medication therapy
2) Trends in pharmacists' monitoring of medication therapy
3) Services and medications monitored
(3) Monitoring and 4) Steps taken to improve medication therapy monitoring
patient education 5) Methods used to monitor patients' adverse drug events (ADEs)
6) Internal and external ADE reporting
7) Pharmacists' patient education and counseling responsibility
(Adapted from American Society of Health-System Pharmacists(ASHP)National Surveys 2001-2003)
The prescribing and transcribing steps included activities of the pharmacy
and therapeutics (P&T) committee, use of clinical practice guidelines,
medication-use evaluation activities, use of trend data to improve
prescribing, extent of pharmacist consultations, provision of drug
information to prescribers, the evaluation of medication orders, use of
prescriber order-entry systems, and actions taken to ensure accurate
transcription of medication orders. The dispensing and administration steps
included patient drug distribution system, use of technology in drug
distribution, medication preparation and dispensing, drug administration,
use of medication administration records, collaboration in pharmacy
operations and preparation activities, and quality improvement activities.
The monitoring and patient education steps included time pharmacists
spend monitoring medication therapy, trends in pharmacists' monitoring of
medication therapy, services and medications monitored, steps taken to
improve medication therapy monitoring, methods used to monitor patients'
adverse drug events (ADEs), internal and external ADE reporting, and
pharmacists' patient education and counseling responsibility.
-13-
15. CHAPTER 3
Results
3.1 Introduction
From on-site observation study, Figure 2 presents workflow of outpatient
chemotherapy for lung cancer at the Blood Transfusion Unit in the St. Luke's
International Hospital.
Figure 2. Workflow of outpatient chemotherapy for lung cancer
Outpatient Physician Nurse Pharmacist Computer
The day of preorder entering
Enter treatment order form
Print and preview treatment Print and preview treatment
The day before treatment order sheet (Red color) order sheet (Blue color)
Prepare and store i.v.
The day of treatment administration devices and drug Prepare and store chemotherapy drug
labels
Check-in at Returning
Outpatient Reception Premedication drug set
Chemotherapy drug set
(Treatment sheets, i.v.
(Treatment order sheet
administration devices
and chemotherapy drug)
and drug labels)
Test at blood collection
room Wear personal protective
equipment, clean safety
cabinet and prepare for
dispensing
Receive consultation at Confirm test results and
Respiratory Dept. decide administration
Confirm patient name, Audit prescription and
premedication drug and drug treatment order in
Visit reception at Blood label in accordance with accordance with protocol and
prescription and treatment sheet drug history
Transfusion Unit Reconfirm prescription and
treatment sheet in accordance
with protocol and MARs Dispense chemotherapy drug
Receive administration in safety cabinet
of premedication
Confirm patient name and Confirm patient name and
chemotherapy dose in accordance chemotherapy dose in
with prescription and treatment accordance with prescription
order and treatment order
Receive dispensed
Receive adminstration Provide nurse with dispensed
chemotherapy drug from
of chemotherapy drug pharmacist
chemotherapy drug
Dispose used devices and Enter drug history of the
Pay medical fee liquid residue treatment date
And, for comparison with the results of the ASHP national surveys in
2001-2003 as key benchmarks, Table 1 illustrates the pharmacy practice
adopted in the medication-use process for outpatient chemotherapy in the
Blood Transfusion Unit. For comparison between the case study and
hospitals in the US, percentages of adopting hospitals in the ASHP surveys
are also shown in Table 1.
-14-
16. Table 1. Adopted pharmacy practice in medication-use process
for outpatient chemotherapy
Medication-use Pharmacy practice adopted by the Blood Transfusion Unit Percentage of
process adopting hospitals
in ASHP national
surveys (Year)
(1) Prescribing 1) Having the pharmacy and therapeutics (P&T) committee 99.3% (2001)
and 2) Using clinical practice guidelines 68.8% (2001)
transcribing 3) Having medication-use evaluation activities 77.9% (2001)
4) Using trend data to improve prescribing on developing formulary decisions 69.5% (2001)
5) Having pharmacist consultations on drug information 91.9% (2001)
6) Having pharmacists routinely provide drug information to prescribers 98.0% (2001)
7) Reconcile MARs and pharmacy patient profiles at least daily 63.2% (2001)
8) Using computerized prescriber order-entry (CPOE) systems 4.3% (2001)
9) Double-checking chemotherapy regimen 72.1% (2001)
(2) Dispensing 1) Having decentralized drug distribution system 19.5% (2002)
and 2) Using point-of-care-activated devices for small-volume injectable products 82.0% (2002)
administration 3) Requiring pharmacists to review and approve all medication orders before drug 79.4% (2002)
4) Giving primary responsibility for drug administration to nurses 99.7% (2002)
5) Using computer-generated medication administration records 64.4% (2002)
6) Evaluating pharmacy dispensing errors discovered by nurses 86.1% (2002)
7) Evaluating the accuracy of the pharmacy patient medication record 58.4% (2002)
(3) Monitoring 1) Increase in the amount of time clinical-distributive pharmacists devoted to monitoring 77.7% (2003)
and patient medication therapy
education 2) Having a process for routine patient-profile monitoring by pharmacists 67.6%(2003)
3) Transfer of electronic information when patients are transferred between inpatient and 78.0%(2003)
outpatient settings
4) Increased access to patient-specific data 39.9%(2003)
5) Internal reporting of adverse drug events (ADEs) through the Risk Management 53.7%(2003)
6) Having an interdisciprinary team including a pharmacist for leading medication-use 85.5%(2003)
7) Giving primary responsibility for communication with outpatient regarding patient 87.9%(2003)
education and counseling to nurses
3.2 Findings from the case study
In accordance with Figure 1, Figure 2 and Table 1, the findings from the case
study are described in 3.2.1, 3.2.2 and 3.2.3.
3.2.1 Findings in prescribing and transcribing steps
As shown in Table 1, of 9 items of prescribing and transcribing steps in the
ASHP surveys, 9 items were adopted for outpatient chemotherapy at the
Blood Transfusion Unit. While percentage of hospitals using computerized
prescriber order-entry (CPOE) systems in ASHP national surveys (2001) was
4.3%, the St. Luke’s International Hospital implemented and utilized CPOE
system for outpatient chemotherapy.
-15-
17. With regard to using clinical practice guidelines, treatment regimens made a
role of standardized guidelines in the case study. Figure 3 illustrates
implementation cycle of treatment regimens of outpatient chemotherapy for
lung cancer.
Figure 3. Implementation cycle of treatment regimens of
outpatient chemotherapy for lung cancer
Physicians of the All team members of
Respiratory Medicine the outpatient
Dept. develop chemotherapy unit are
treatment regimens of involved in review and
outpatient implementation of
chemotherapy for new regimens
lung cancer
Pharmacists
Feedback
Role of pharmacists
1) Standardize the expressions to be used for reduction of
medication errors
2) Routinely explore the pharmacy computer system and
other resources online/offline and provide drug-related
information to physicians and nurses
Treatment regimens of outpatient chemotherapy for lung cancer were
developed by physicians from the Respiratory Medicine Dept. and were
distributed to the Blood Transfusion Unit.
While all team members of the outpatient chemotherapy unit were involved
in review and implementation of new regimens, pharmacists took care of
standardizing the expressions to be used for reduction of medication errors.
In addition, physicians and nurses routinely asked chemotherapy
pharmacists to provide drug-related information regarding not only clinical
outcomes but also economic issues, such as drug costs. The pharmacists
searched the pharmacy computer system and other online/offline resources
and provided drug-related information to other professionals.
As of July 2005, 20 kinds of regimens were used for outpatient chemotherapy
of lung cancer at the unit.
Table 2 presents chemotherapy drugs and premedication drugs listed on
treatment regimens of outpatient chemotherapy for lung cancer.
-16-
18. Table 2. Chemotherapy drugs and premedication drugs listed on treatment
regimens of outpatient chemotherapy for lung cancer (as of July 2005)
Regimen name Chemotherapy drug Premedication drug
1) Weekly paclitaxel single therapy paclitaxel
diphenhydramine hydrochloride,
2) Weekly paclitaxel+radiotherapy paclitaxel
dexamethasone sodium
3) Paclitaxel+CBDCA paclitaxel, carboplatin phosphate, famotidine,
ondansetron hydrochioride
4) Weekly paclitaxel+CBDCA+radiotherapy paclitaxel, carboplatin
5) Gemcitabine single therapy gemcitabine hydrochloride
6) Gemcitabine+CBDCA gemcitabine hydrochloride, carboplatin
7) Vinorelbine single therapy vinorelbine ditartrate
8) Vinorelbine+Gemcitabine vinorelbine ditartrate, gemcitabine hydrochloride
9) Vinorelbine+CBDCA vinorelbine ditartrate, carboplatin
10) Weekly docetaxel single therapy docetaxel
11) Gemcitabine+docetaxel gemcitabine hydrochloride, docetaxel
12) Vinorelbine+CBDCA+radiotherapy vinorelbine ditartrate, carboplatin dexamethasone sodium
phosphate, famotidine,
13) Docetaxel+CBDCA docetaxel, carboplatin
ondansetron hydrochioride
14) Triweekly docetaxel single therapy docetaxel
15) Biweekly docetaxel single therapy docetaxel
16) CBDCA+VP-16 carboplatin, etoposide
17) Weekly CPT-II+CBDCA irinotecan hydrochloride, carboplatin
18) Weekly CPT-II+CBDCA+radiotherapy irinotecan hydrochloride, carboplatin
19) Weekly CPT-II monotherapy irinotecan hydrochloride
20) Amrubicin single therapy amrubicin hydrochloride
The chemotherapy drugs included paclitaxel, carboplatin, gemcitabine
hydrochloride, vinorelbine ditartrate, docetaxel, irinotecan hydrochloride,
amrubicin hydrochloride and etoposide. The premedication drugs for
chemotherapy included diphenhydramine hydrochloride, dexamethasone
sodium phosphate, famotidine, and ondansetron hydrochioride.
The pharmacists were also involved in medication-use evaluation activities
to improve the procedure of prescribing. Pharmacist consultations on issues
such as dosage adjustment and adverse drug effects were provided to the
physicians responsible for prescribing in the Respiratory Medicine Dept.
Regarding transcribing, the computerized physician order entry (CPOE)
system and electric medication administration records (MARs) were
implemented in the hospital. However, the pharmacy computer system was
not linked to CPOE and required reentry of medication orders. Each day
before treatment, pharmacists printed, reviewed and double-checked the
treatment order sheets for verification with CPOE and pharmacy patient
profiles in preparation for dispensing.
In the hospital, a cross-functional lung cancer medication team was
developed and played the role of an information-sharing community for
-17-
19. patient-focused chemotherapy. The team was facilitated by physicians of the
Respiratory Medicine Dept. and pharmacists and nurses in both inpatient
and outpatient care, including the Blood Transfusion Unit. The team
organized monthly case conferences, internal seminars and other activities.
3.2.2 Findings in dispensing and administration steps
As shown in Table 1, of 7 items of dispensing and administration steps in the
ASHP surveys, 7 items were adopted for outpatient chemotherapy at the
Blood Transfusion Unit. While percentage of hospitals having decentralized
drug distribution system in ASHP national surveys (2002) was 19.5%, the St.
Luke’s International Hospital adopted an exclusive decentralized drug
distribution system for outpatient chemotherapy.
The certified pharmacy technician system is not adopted in Japan, and
Japanese pharmacists must cover all dispensing tasks. In other words,
Japanese pharmacists tend to be more product-oriented with technical
knowledge and skills than those in other countries.
While a centralized medication system at the Pharmaceutical Dept. had been
used for inpatients in St. Luke's International Hospital, at the Blood
Transfusion Unit, a point-of-care drug distribution system with a satellite
pharmacy and safe dispensing cabinets was adopted to meet the demands of
time-sensitive outpatients towards just-in-time care delivery.
In general, decentralized medication systems have the advantage of shorter
waiting times for outpatients with point-of-care dispensing. Challenges in
the point-of-care medication systems include requirements of prescribers for
multi-kind and small quantity dispensing with a variety of chemotherapy
regimens. Futhermore, in some cases, the outpatient may cancel an
appointment on the day of treatment and the cancellation may generate
high-cost waste.
Using kanban-style model developed in the Japanese automotive industry,
Figure 4 presents product and information flow chart of the point-of-care
drug distribution system for outpatient chemotherapy.
-18-
20. Figure 4. Product and information flow chart of decentralized drug distribution
system for outpatient chemotherapy (using kanban-style model)
Product flow: Information flow: Demand forecast
(via computer)
Based on lead time for dispensing of chemotherapy drug, dispensing schedule is
assigned at the centralized pharmacy.
【The day before appointment 】 【The day of outpatient’s treatment】 Physician responsible
for prescribing
(via computer) (via computer) <Nurse-driven time management>
Treatment Stock
order review Premedication drug point Premedication drug
by pharmacist dispensing administration
Treatment
(kanban)
order sheet Feedback from
Stock nurse: signal of Feedback from
Premedication drug point starting nurse: signal of
preparation premedication finishing
Out-
(→ nurse) (Face-to-face) premedication
Stock (Face-to-face) patient
Chemotherapy drug point
preparation Stored place of
(→pharmacist) drugs to be used
Stock Chemotherapy
Chemotherapy drug
point drug
dispensing
administration
<Pharmacist-driven time management >
[Blood Transfusion Unit ]
To meet fluctuations in outpatient demand, the Blood Transfusion Unit
adopted the same kind of operating methods as those utilized in the
Japanese automobile industry. The medications for outpatient chemotherapy
were divided into a standardized chemotherapy premedication set and a
customized chemotherapy medication set. This was originally from the
"module" concept, defined as "the parts group made into the sub-system from
a certain specific viewpoint", and it is widely utilized for process
improvement in the manufacturing industries. (*10)
The first chemotherapy premedication set was composed of premedication
drugs, i.v. administration devices and drug labels. The premedication sets
were commonly listed and used in treatments not only for lung cancer but
also other types of cancer. Based on treatment order sheets, the
premedication sets were arranged by nurses according to the opening time of
the unit.
The second chemotherapy medication set was composed of chemotherapy
drug, medication order sheet and rectangular transparent bag. The
treatment order sheet and chemotherapy drug were bundled into the
rectangular transparent bag. The bag, which carried information about types
-19-
21. and quantities of drugs, regimen and product labeling, always accompanied
the chemotherapy drug, and served as an essential communications tool for
just-in-time dispensing and administration at the unit. This concept seemed
to be the same as "kanban" in the Japanese automotive industry, playing the
role of providing the information that connects the earlier and later
processes at every level and contributing to continuous quality improvement.
(*1) Based on treatment sheets, the pharmacists arrange the chemotherapy
medication sets the day before the outpatient's appointment.
Regarding the premedication set, a team of two nurses or a
pharmacist-nurse team checked what was required before dispensing the
medication. Each step of the premedication process was designed in every
aspect to offer the administration needed at the time needed.
The standard cycle time of preparation for premedication was approximately
1 minute, and that of administration of premedication was approximately 30
minutes, based on the administration of diphenhydramine hydrochloride.
Regarding the chemotherapy medication set, the two-pharmacist team or the
pharmacist-nurse team checked what was required before dispensing
medication. When starting to administer premedication to each patient,
team nurses provided the pharmacists with signal of starting premedication
through face-to-face communications at the point of care. After receiving the
signal, the pharmacists prepared for dispensing of the chemotherapy drugs
so that dispensing task could be completed before starting time of
chemotherapy drug administration.
From time study, Table 3 shows average cycle time of chemotherapy drug
dispensing in accordance with treatment regimens of outpatient
chemotherapy for lung cancer.
-20-
22. Table 3. Average cycle time of
chemotherapy drug dispensing
Regimen name Chemotherapy drug Standard dose Average cycle
(AUC: Area time of
under the curve) dispensing
1) Weekly paclitaxel single therapy paclitaxel 60~80mg/m2 1 min. 57 sec.
2) Weekly paclitaxel+radiotherapy paclitaxel 30mg/m2 1 min. 57 sec.
3) Paclitaxel+CBDCA paclitaxel 60~80mg/m2 1 min. 57 sec.
carboplatin AUC=4~6 3 min. 00 sec.
4) Weekly paclitaxel+CBDCA+ paclitaxel 30~40mg/m2 1 min. 57 sec.
radiotherapy carboplatin AUC=2 3 min. 00 sec.
5) Gemcitabine single therapy gemcitabine hydrochloride 1000mg/m2 2 min. 26 sec.
6) Gemcitabine+CBDCA gemcitabine hydrochloride 800~1000mg/m2 2 min. 26 sec.
carboplatin AUC=4 3 min. 00 sec.
7) Vinorelbine single therapy vinorelbine ditartrate 25~30mg/m2 1 min. 51 sec.
8) Vinorelbine+gemcitabine vinorelbine ditartrate 20~25mg/m2 1 min. 51 sec.
gemcitabine hydrochloride 800~1000mg/m2 2 min. 26 sec.
9) Vinorelbine+CBDCA vinorelbine ditartrate 20~25mg/m2 1 min. 51 sec.
carboplatin AUC=4~6 3 min. 00 sec.
10) Weekly docetaxel single therapy docetaxel 35~40mg/m2 14 min. 14 sec.
11) Gemcitabine+docetaxel gemcitabine hydrochloride 800~1000mg/m2 2 min. 26 sec.
docetaxel 60mg/m2 14 min. 14 sec.
12) Vinorelbine+CBDCA+ vinorelbine ditartrate 15~20mg/m2 1 min. 51 sec.
radiotherapy carboplatin AUC=2 14 min. 14 sec.
13) Docetaxel+CBDCA docetaxel 60mg/m2 14 min. 14 sec.
carboplatin AUC=4 3 min. 00 sec.
14) Triweekly docetaxel single docetaxel 60~70mg/m2 14 min. 14 sec.
therapy
15) Biweekly Docetaxel single docetaxel 25~40mg/m2 14 min. 14 sec.
therapy
16) CBDCA+VP-16 carboplatin AUC=4~6 3 min. 00 sec.
etoposide 100mg/m2 2 min. 00 sec.
17) Weekly CPT-II+CBDCA irinotecan hydrochloride 60mg/m2 2 min. 22 sec.
carboplatin AUC=5 3 min. 00 sec.
18) Weekly CPT-II+CBDCA+ irinotecan hydrochloride 50mg/m2 2 min. 22 sec.
radiotherapy carboplatin AUC=2 3 min. 00 sec.
19) Weekly CPT-II monotherapy irinotecan hydrochloride 60~100mg/m2 2 min. 22 sec.
20) Amrubicin single therapy amrubicin hydrochloride 35~45mg/m2 2 min. 30 sec.
The standard cycle time for chemotherapy drug dispensing differed
according to the type of medication drug: a minimum of 1 minute 51 seconds
for vinorelbine ditartrate and a maximum of 14 minutes 14 seconds for
docetaxel with normal saline.
In order to decrease the waiting time for outpatients, the pharmacists
adjusted the times for dispensing chemotherapy drugs and the nurses
adjusted the times for administration. Fine adjustments of waiting times by
pharmacist-nurse team collaboration were unique to the point-of-care drug
distribution system and significantly contributed to the improvement in
patient satisfaction. In the event that any drug-related problem occurred
incurred with an outpatient at the point of care, the pharmacists were able to
immediately stop product flow and communicate with other team members
for trouble shooting. Regarding the checking unit dose dispensed by the
pharmacists, double-check systems were conducted by the pharmacists and
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23. the nurses.
3.2.3 Findings in monitoring and patient education steps
As shown in Table 1, of 7 items of monitoring and patient education steps in
the ASHP surveys, 7 items were adopted for outpatient chemotherapy at the
Blood Transfusion Unit. While percentage of hospitals with increased access
to patient-specific data in ASHP national surveys (2003) was 39.9%, the St.
Luke’s International Hospital utilized patient-specific data in MARs and
pharmacy patient profile in the pharmacy computer system for outpatient
chemotherapy.
At the Blood Transfusion Unit, the chemotherapy pharmacists regularly
monitored the medication therapy for outpatients. Patient-profile monitoring,
including review of MARs and pharmacy patient profile, was conducted
following processing of the medication order. The pharmacists gained
experience in both technical and clinical tasks through a job rotation system
within the Pharmaceutical Dept., and this contributed to quick and in-depth
monitoring for team-performance improvement at the Blood Transfusion
Unit.
Regarding adverse drug events (ADE) monitoring and reporting, the hospital
established a Risk Management Committee and controlled medical safety
management, including internal incident reporting from health professionals
in the hospital. Under the committee, the Medical Safety Leader Meeting
handled safety promotion activities, and the Blood Transfusion Unit was
involved in those activities.
-22-
24. Figure 5 presents internal reporting flow of adverse drug events (ADEs)
through the Risk Management Committee.
Figure 5. Internal reporting flow of adverse drug events (ADEs)
through the Risk Management Committee
Hospital Executive
Meeting
(Report/approval)
Risk
Management
Risk Management Medical Safety Report
Committee Management (Monthly)
(Review) Pharmacist Office
Medical Safety Blood
Leader Meeting Transfusion Unit MARs
Pharmacist Pharmacist
(Monitoring) Pharmacy
patient
profile
Adverse drug
events
(ADEs)
Outpatient
At the Blood Transfusion Unit, nurses had more opportunities for contact
with outpatients during chemotherapy administration and they provided
patient education and counseling. In addition, the pharmacists supported
the nurses’ activities by providing detailed drug information from the
pharmacy computer system and developing patient education materials.
However, when patients with lung cancer were transferred between
inpatient and outpatient settings, the pharmacists counseled the patients
directly. SIS and NHI compensated for the pharmacist counseling as part of
inpatient medication fees.
-23-
25. CHAPTER 4
Discussion
4.1 Introduction
From benchmarking in the case study shown in Table 1, adoption trends for
pharmacy practice in medication-use process at the outpatient chemotherapy
unit seemed to be at relatively the same level as those at hospitals in the US.
The case study also found that outpatient chemotherapy team in the
Japanese health care setting adopted and utilized the same concepts of
continuous quality improvement as those in the Japanese automotive
industry, and that pharmacists made a unique role in the multidisciplinary
team care.
4.2 Models to quantify values of pharmacist activities in multidisciplinary
team care of outpatient chemotherapy
From the viewpoints of health economics, traditional cost-effective analysis
models require objective evidence of improvements in simplified outcome and
seem to have weakness in identifying direct and indirect impacts of
pharmacists towards complicated outpatient chemotherapy team. In
particular, development and implementation of alternative approaches is
required to quantify outcomes and evidence on medical safety improvement.
Based on the results of the case study, candidate models for economic
evaluation are discussed in accordance with steps of medication-use process
in 4.2.1, 4.2.2 and 4.2.3.
4.2.1 Quality function deployment in prescribing and transcribing steps
Regarding prescribing and transcribing steps, standardized chemotherapy
treatment regimens have been developed in diverse clinical departments and
have been implemented into a single outpatient-specific unit in the St.
Luke's International Hospital. The multidisciplinary members themselves
implemented the idea of "quality function deployment (QFD)", a conceptual
map that provides a means for interfunctional planning and communications
developed in Japanese manufacturing industries, on a consensus basis to
-24-
26. standardize operations for the quality of care, medication safety and patient
satisfaction.
According to Hauser et al. (1988), QFD was originated in 1972 at
Mitsubishi’s Kobe shipyard site, then developed by Toyota and its suppliers,
and has been used by the Japanese manufacturers. (*11) As a set of planning
and communication routines, QFD focuses and coordinates skills within an
organization, first to design, then to manufacture and market goods that
customers want to purchase and will continue to purchase. The foundation of
QFD is the belief that products should be designed to reflect customer’s
desires and tastes and marketing people, design engineers, and
manufacturing staff must work closely together from the time a product is
first conceived. From the economic viewpoints, qualitative and quantitative
case studies were conducted at Toyota, and Sullivan (1986) reported that
implementation of QFD contributed to a 20% reduction in start-up costs on
the launch of new van in October 1979, a 38% reduction in November 1982
and a cumulative 61% reduction in April 1984 at Toyota Auto Body. (*12)
Figure 6 illustrates comparison of the case study to QFD in the Japanese
automotive industry. While researchers, designers, production engineers and
marketing staff work together to develop a new car from the
customer-centered viewpoints in an automotive company, physicians,
pharmacists and nurses seem to work together to develop a new regimen
from the patient-centered viewpoints in the St. Luke’s International
Hospital.
-25-
27. Figure 6. Comparison of the case study to quality function deployment (QFD)
in the Japanese automotive industry
[New product development and designing process in the Japanese automotive industry]
Researcher
Product Quality
viewpoints
Customer- New product
centered
Designer Continuous
development Safety improvement
Production engineer and designing
Customer satisfaction
Marketing staff
[Development and implementation process of outpatient chemotherapy regimen]
Physician Standardizing expressions
Development of regimen
viewpoints
and
centered
Patient-
Preventing medication Continuous
Pharmacist implementation errors improvement
of treatment
regimen Controlling risks of hidden
Nurse costs
Kohler et al. (1998) emphasized the importance of easy-to-understand
expressions and nomenclature of clinical practice guidelines for cancer
treatment in order to reduce medication errors. (*13) The identification and
usage of technical terms in regimens were varied and differed according to
the clinical department and cross-department standardization of expressions
and nomenclature was necessary to prevent medication errors at the point of
care.
Through cross-departmental and cross-professional communications on a
daily basis, the chemotherapy pharmacists were trained on the job to
experience both technical and clinical practices, and showed competence in
developing and adjusting comprehensive expressions for use with a diverse
oncology practitioners. This strength seems to be a significant contribution
to other members of the outpatient chemotherapy team. It would appear that
the pharmacists’ commitment to development of standardized chemotherapy
treatment regimens seems to enhance economic improvement by reducing
hidden costs associated with preventable medication-related problems
(MRPs).
QFD models in the Japanese automotive industry have focused on integrated
approaches of qualitative and quantitative research and seem well suited to
-26-
28. probing unique roles of chemotherapy pharmacists for economic evaluation.
Figure 7 illustrates conceptual QFD framework of team care in outpatient
chemotherapy for future economic evaluation study.
Figure 7. QFD framework of team care in outpatient chemotherapy
Outpatient
Physician Pharmacist Nurse
Profession-specific
Outpatient chemotherapy professional work methods
Standardized outpatient chemotherapy work Common work
methods
with point-of-care drug distribution system
(Just-in-time care delivery)
[Treatment regimens] [Medication-use process]
(Treatment order sheets)
Standard specifications
Standard procedures
Respiratory Medicine
Breast Surgery Prescribing and transcribing
Digestive Surgery
Digestive Internal Medicine Dispensing and administration
Hematology Integrated hospital
Gynecology information system Monitoring and patient education
…
Requirements: Quality of care – Medical safety – Patient satisfaction
It seems that pharmacists can enhance standard specifications and standard
procedures by controlling product flow and information flow continuously at
the point of care and contribute to economic improvement in the fields of
outpatient chemotherapy. As the next step, it is recommended that impact
of standard specifications and standard procedures towards clinical and
economic outcomes be examined.
4.2.2 Kanban-style model in dispensing and administration steps
Regarding dispensing and administration steps, the chemotherapy
treatment regimens with comprehensive expressions led to simplified
treatment order sheets, and were used by physicians, pharmacists, nurses
and clerical staff. Each order sheet contained an appropriate volume of
information for instant recognition and operations management by sight.
Moreover, by use of the rectangular transparent bag with the treatment
order sheet and chemotherapy drug, the actual progress of chemotherapy
-27-
29. operations in comparison to the daily drug distribution schedule was always
visible.
Hendershot et al. (2005) reported that shorter waiting times in outpatient
chemotherapy administration were linked to improvement in outpatient
satisfaction (*14). With the "kanban" bag, the chemotherapy pharmacists
were in the position to control both product flow and information flow during
dispensing and administration steps at the point of care. Our case study
indicated that members of the outpatient chemotherapy team aimed to
minimize waiting times between premedication drug administration and
chemotherapy drug administration by organizing production flow and
information flow. Control of product flow, knowledge and experience related
to physical, chemical and biological backgrounds seems important, and
control of the information flow related to multidisciplinary communications
in face-to-face and interactive methods seem important for the pharmacists.
In the present case study, the roles of the chemotherapy-specific pharmacist
were divided into two perspectives. From a product-focused perspective, the
pharmacist manages the product flow in the dispensing and administration
steps, aiming to control the production and distribution costs. Meanwhile,
from a service-focused perspective, the pharmacist plays the role of a
multidisciplinary coordinator of information flow in the medication-use
process, aiming to reduce medication-related problems (MRPs) and
therapeutic failure.
It seems that the unique roles of the chemotherapy pharmacist composed of
multi-focused perspectives enabled the outpatient chemotherapy team to
adopt the "module" concept in a workflow and utilize a simplified "kanban"
concept for the treatment order sheets. In addition, the multi-skilled
personnel development activities for the hospital pharmacist appear
important in developing these effective roles.
For comparison with Figure 4, Figure 8 illustrates a product and information
flow model of centralized drug distribution system for outpatient
chemotherapy. Based on an example of centralized drug distribution system
used for inpatient chemotherapy in the St. Luke’s International Hospital, the
model in Figure 8 was developed.
-28-
30. Figure 8. Product and information flow model of centralized drug distribution
system for outpatient chemotherapy
Product flow: Information flow: Demand forecast
(via computer)
Based on lead time for dispensing of premedication & chemotherapy drug,
dispensing schedule is assigned at the centralized pharmacy.
【The day before appointment 】 【The day of outpatient’s treatment】 Physician responsible
for prescribing
(via computer) (via computer)
Treatment
order review Premedication drug
by pharmacist administration
Treatment
Treatment
order sheet
order sheet (kanban) Signal of finishing
(kanban) premedication
(Nurse-to-nurse)
Premedication & Premedication & Out-
Stock Stock
chemotherapy Chemotherapy patient
point point
drug drug
preparation dispensing
Chemotherapy
Batch flow drug
method administration
with buffer
inventories
<Pharmacist-driven time management > <Nurse-driven time management>
[Pharmaceutical Dept. ] [Blood Transfusion Unit ]
Centralized drug distribution system adopts a batch flow method with buffer
inventories, and pharmacists and nurses work independently in separate
place. While there seems little difference between centralized and
decentralized drug distribution systems regarding drug and personnel costs,
centralized drug distribution system has weakness in a lack of face-to-face
communication between pharmacists and nurses on a real-time basis. In
addition, the batch flow method seems to have a risk of generating high-cost
waste in case of cancellation on the day of treatment.
-29-
31. Using kanban-style model, Figure 9 presents pull-push integration system in
dispensing process of outpatient chemotherapy.
Figure 9. Pull-push integration system in dispensing process of
outpatient chemotherapy (using kanban-style model)
Proceeding simultaneously
Push system (for simplified work) Pull system (for complicated work)
(Dispensing process of premedication drug) (Dispensing process of chemotherapy drug)
Order information Order Order
(schedule and dose) information information
Premedication Stock Premedication Stock Chemotherapy Stock Chemotherapy Stock
drug point drug point drug point drug point
preparation dispensing preparation dispensing
Treatment Treatment
order sheet Administration order sheet Administration
process process
Push system model can be applied to dispensing process of premedication
drug that requires simplified work, and pull system model can be applied to
dispensing process of chemotherapy drug that requires complicated work. On
the other hand, push system model can be applied to dispensing process of
premedication and chemotherapy drug under centralized drug distribution
system shown in Figure 8.
In the Japanese automotive industry, push system model has been used for
mass production lines, and pull system model has been used for customized
production lines. Pull-push integration system model is combination of push
system and pull system and has been adopted by Toyota for production of
many models in small quantities. Economic advantages of pull-push
integration system in efficiency and effectiveness have been suggested
through qualitative and quantitative studies. (*15)
It seems that economic advantage of pharmacist activities with decentralized
drug distribution system in dispensing and administration steps can be
examined by applying pull-push integration system model.
-30-
32. 4.2.3 SECI model in monitoring and patient education steps
Regarding monitoring and patient education steps, multifunctional
experience in both technical and clinical tasks of the chemotherapy
pharmacists seemed to contribute to monitoring medication therapy for
team-performance improvement. While nurses were in the position to
frequently communicate with outpatients for outpatient medication
education and counseling, the chemotherapy pharmacists supported the
nurses' activities utilizing MARs and the pharmacy computer system with
pharmacy patient profiles and drug information database.
Figure 10 illustrates value-creating flow of pharmacist activities in
monitoring and patient education steps.
Figure 10. Added-value of service-oriented pharmacist and knowledge
management model
Medical “Multi-task” experience of pharmacist Service-oriented
information viewpoints
systems
Experience with centralized
drug distribution system in
Drug
information
Pharmaceutical Dept.
DB
Experience in inpatient
Pharmacy education
patient Added-value
profile
+ Experience with decentralized
drug distribution system in
= of pharmacist
in team care
MARs Blood Transfusion Unit.
・・・ ・・・
-Socialization
Explicit
knowledge + Tacit
knowledge = -Externalization
-Combination
SECI knowledge management model -Internalization
The flow to utilize existing data in information systems and experience in
operations seems to be the same as those in SECI model.
SECI model is a conceptual model of knowledge management, proposed by
Nonaka and Takeuchi in Japan and introduced to the US and Europe. (*16)
According to Nonaka and Takeuchi, knowledge creation is a spiraling process
of interactions between explicit and tacit knowledge. The interactions
between the explicit and tacit knowledge lead to the creation of new
-31-
33. knowledge. The combination of the two categories makes it possible to
conceptualize four conversion patterns: socialization, externalization,
combination and internalization. Socialization refers to a process of
acquiring tacit knowledge through sharing experiences. Externalization
refers to a process of converting tacit knowledge into explicit concepts
through the use of abstractions, metaphors, analogies, or models.
Combination refers to a process of creating explicit knowledge by bringing
together explicit knowledge from a number of sources. Internalization refers
to a process of embodying explicit knowledge, internalizing the experience
gained through the other modes of knowledge creation into individuals’ tacit
knowledge basis in the form of shared mental models or work practices.
SECI model has been widely used to analyze intangible values of knowledge
workers and is applicable to health care practitioners.
It seems that intangible values generated by pharmacist activities in
monitoring and patient education steps can be examined by applying SECI
model. Identification and quantification of intangible values also seems to
contribute to economic evaluation studies regarding use of drug information
database and other medical information systems.
In addition, if knowledge and experience of pharmacists in outpatient
chemotherapy can be shared with practitioners of other hospitals,
point-of-care pharmacist activities will contribute to the efficiency and
effectiveness improvement in the Japanese healthcare industry.
4.3 Needs for development of economic evaluation models from Japan
It is interesting to note that the QFD model, the kanban-style model and the
SECI model were originated from Japan and have been widely adopted by
researchers overseas. From the viewpoints of health economics, it seems that
implementation and integration of Japan-oriented models in future
quantitative studies will lead to appropriate evaluation of outcomes and
evidence on pharmacist activities in outpatient chemotherapy in Japan.
In addition, it is possible that those Japan-oriented models will be applicable
to qualify and quantify a wide range of team care activities. The Japanese
health care industry is populated by dedicated professionals with knowledge
and skills, and can demonstrate a capacity to develop and implement
standard models from inside.
-32-
34. CHAPTER 5
Conclusion
5.1 Limitation
The results of this study may not be applicable to other hospital-based
practices in Japan and qualitative approaches have challenges in gathering
quantified generalizable data. However, such a case study is essential to
minimize possible misunderstandings by key decision makers on health
economics concerning the pharmacist's role in complicated multidisciplinary
team care and in order to enhance quantitative evaluation studies with
regard to outpatient chemotherapy team care in Japan.
5.2 Conclusion
The study suggests that pharmacist’s commitment to medication-use
processes for outpatient chemotherapy at the point of care can contribute to
improvement in the quality of care and reduction of preventable costs
associated with medication-related problems in team care by controlling the
product flow and information flow from both product-focused and
service-focused perspectives.
-33-
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37. ACKNOWLEDGEMENT
I wish to place on record of my deep sense of gratitude to Dr. Shiro Ueda,
Professor, Drug Information and Communication Dept., Graduate School of
Pharmaceutical Sciences, Chiba University, Japan, for the unparalleled
guidance and encouragement throughout the tenure of this work. I gratefully
acknowledge the same.
Also, I would like to acknowledge with gratitude, Dr. Nobunori Satoh,
Associate Professor, and Dr. Tomoya Sakurada, Res. Assoc., Drug
Information and Communication Dept., Graduate School of Pharmaceutical
Sciences, Chiba University, Japan, for their valuable suggestions and advices
in improving the thesis.
I also gratefully acknowledge Dr. Tadao Inoue, Director of Pharmacy, and Mr.
Kazuhiro Watanabe, MS, Pharmaceutical Dept., the St. Luke’s International
Hospital, Tokyo, Japan, for their valuable suggestions and advices during
this study.
Lastly, it is a great pleasure to acknowledge the co-operation provided by my
colleagues at Drug Information and Communication Dept., Graduate School
of Pharmaceutical Sciences, Chiba University, Japan.
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38. 主論文目録
本学位論文内容は下記の発表論文による。
Sasahara,E. ; Inoue,T. ; Watanabe,K. ; Sakurada,T. ; Satoh,N. ; Ueda,S. :
Case study of pharmacist activities in the multidisciplinary practice of
outpatient chemotherapy in Japan
日本医薬品情報学会「医薬品情報学」
第 9 巻 1 号(平成 19 年 5 月発刊)掲載予定(受付番号:#2006-14-MS)
-37-