Clinical Pharmacy Education, Practice and Research: Clinical Pharmacy, Drug Information, Pharmacovigilance, Pharmacoeconomics and Clinical Research

Cover
Clinical Pharmacy Education, Practice and Research
Copyright
List of Contributors
Preface
Acknowledgments
1 -
Introduction to Clinical Practice, Research, and Pharmacy Education
	Objective 1.1. Describe Salient Features of Clinical Practice of Pharmacists
	Objective 1.2. Address Relevant Concepts in Pharmacy Education Leading to Clinical Practice
	Objective 1.3. Outline How Research in Pharmacy Is Improving Patient Outcomes
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
Section I: General Clinical Pharmacy
2 -
Evolution of the Pharmacy Profession and Public Health
	Objective 2.1. Outline Historical Developments in the Pharmacy Profession
	Objective 2.2. Overview Eras of Pharmaceutical Industries and Their Jobs for Pharmacy Graduates
		Comparison of Financial Volume of Pharmaceutical Industries With Other Industries
		Career Opportunities for Pharmacy Graduates in Pharmaceutical Industries
	Objective 2.3. Discuss Policies AND LAWS Governing the Pharmacy Profession and Public Health
		World Health Organization
		United States Drug Legislations
		International Pharmaceutical Federation or Fédération Internationale Pharmaceutique
			Good Pharmacy Practice
			Code of Ethics in Pharmacy Practice
		International Patient Safety Goals
	Objective 2.4. Detail an Overview of Public Health and Disease Prevention
		Organizations Involved in International Public Health
		Disease Prevention
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
3 -
Clinical and Social Perspectives on Pharmacy Services
	Objective 3.1. Position Pharmacists in the HealthCare System
	Objective 3.2. Describe the Patient Viewpoints on Clinical Pharmacy Services
		Polypharmacy and Inappropriate Drug Use
		Nonadherence to Pharmacotherapy-The Patients' Perspective on Taking Drugs
	Objective 3.3. Highlight the Pharmacist Perspective on Clinical Pharmacy Services
		Pharmaceutical Care-A Central Concept in Patient Care
		Medication Reviews and Drug Therapy Problems
		Cognitive Pharmaceutical Services
	Objective 3.4. Describe the Institutional and Societal Viewpoints on Clinical Pharmacy Services
		Barriers and Facilitators for Implementing Clinical Pharmacy Services
	Understanding the Environment and Structure of HealthCare
	Conclusion
	Practice Questions
	References
4 -
Pharmacy Management
	Objective 4.1. Outline the Major Principles in Managing a Pharmacy
		Financial Management
			Revenue
			Budgeting
				Planning
				Review and Approval
				Implementation
				Evaluation
		Personnel Management
			Productivity
			Job Design
			Recruitment
			Training
			Performance Management
		Regulatory Compliance
	Objective 4.2. Overview the Purchase, Inventory Control, Storage, Drug Distribution, Compounding, and Disposal of Drugs and ...
		Organization (Arrangement) of Products in a Hospital Pharmacy
	Objective 4.3. Illustrate a Model Pharmacy and Detail the Facilities Required
	Objective 4.4. Overview Pharmacy Practice Setting and Responsibilities of Professionals
		Responsibilities of Personnel Involved in Pharmacy Operations
	Objective 4.5. Explain Advantages and Limitations of Pharmacy Automation
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
5 -
Rational Drug Use, Formulary Management, Pharmaceutical Care/Medication Therapy Management/Pharmacists’ Patient Care Process
	Objective 5.1. Define Drug/Medicine, Medication, and Health Technology
		Drug Names
	Objective 5.2. Overview Rational Drug Use in Clinical Practice
	Objective 5.3. Detail the Constitution and Functions of A Drug and Therapeutics Committee
		Constitution of Drug and Therapeutics Committee
		Functions of Drug and Therapeutics Committee
	Objective 5.4. Discuss Essential Medicines Policy and Formulary Management
		WHO Criteria for Selection of Essential Medicines
			Formulary
	Objective 5.5. Explain Methods in Drug Use Evaluation (Drug Utilization Review)
	Objective 5.6. Explain Methods to Standardize Pharmacy Education and Practice: Pharmaceutical Care, Medication Therapy Mana ...
		Pharmaceutical Care
			Definitions of Pharmaceutical Care
		Medication Therapy Management
			Core Elements of an MTM Service Model in Pharmacy Practice
		Nanjing Statements
		CAPE Educational Outcomes
		Pharmacists' Patient Care Process
			Collect
			Assess
			Plan
			Implement
			Follow-Up: Monitor and Evaluate
		Core Entrustable Professional Activities
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
6 -
Communication Skills and Patient History Interview
	Objective 6.1. Explain Why Communication Skills Are Essential for Pharmacists
		Pharmacists’ Communication Skills Relevant to Consumers
		Pharmacists’ Communication Skills Relevant to Other Healthcare Professionals
	Objective 6.2. Detail the Elements of Professional Communication
		Key Communication Skills
			Body Language or Nonverbal Language
			Verbal Language
			Tone of Voice
			Active Listening
			Empathy
	Objective 6.3. Identify Barriers to Communication and Suggest How to Overcome Them
	Objective 6.4. Discuss the Characteristics and Process of the Patient History Interview
		Involve the Patient in the Care Process
		History Interview for Clinical Diagnosis
		The Patient History Interview Should Be Ethical
		The Information Collected Should Be Reliable
			Steps in the Patient History Interview
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
7 -
Interpretation of Laboratory Data and General Physical Examination by Pharmacists
	Objective 7.1. Describe Common Laboratory Tests and Interpret Their Clinical Significance to the Practice of Pharmacists
		Electrolytes
			Sodium
			Potassium
			Chloride
		Blood Gas
			Carbon dioxide
		Blood Glucose
			Glucose
		Hematology
			Full Blood Count
			Hemoglobin
			Hematocrit
			Red Blood Cell Count
			White Blood Cell Count
			Platelets
			Prothrombin Time
			International Normalized Ratio
			Partial Thromboplastin Time and Activated Partial Thromboplastin Time
		Renal Function
			Serum Creatinine and Creatinine Clearance
			Blood Urea Nitrogen
			Urinalysis
		Liver Function
			Serum Bilirubin
			Urine Bilirubin and Bilirubinogen
			Alkaline Phosphatase
			Aminotransferases: Aspartate Aminotransferase and Alanine Aminotransferase
		Thyroid Function
			Thyroid-Stimulating Hormone
			Triiodothyronine
		Lipid Profile
			Low-Density Lipoprotein Cholesterol
			High-Density Lipoprotein Cholesterol
			Triglycerides
		Cardiac Enzymes
			Creatinine Kinase
			Troponin
	Objective 7.2. Discuss the Scope of General Physical Examination by Pharmacists
		Context
		Pharmacist-Patient Interaction
		Prerequisites
	Objective 7.3. Explain How to Measure and Interpret Vital Signs
		Body Temperature
		Peripheral Pulses
		Respiration Rate
		Blood Pressure
	Objective 7.4. Perform a Detailed Head-To-Toe Physical Examination and Explain Possible Findings
		Head and Neck
		Eyes
		Face
		Oral Cavity
		Neck
		Upper Limbs and Hands
		Lower Limbs
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
8 -
Dispensing Process, Medication Reconciliation, Patient Counseling, and Medication Adherence
	Objective 8.1. List Steps in the Dispensing Process
		Receive and Validate the Prescription
		Assess and Review the Prescribed Drugs
		Select/Prepare, Package, and Check Against the Original Prescription
		Label Drugs
		Supply and Provide Counseling
		Record the Intervention
	Objective 8.2. Detail Methods in Medication Reconciliation to Prevent Errors
	Objective 8.3. Explain Approaches to Patient Counseling
	Objective 8.4. Outline Strategies to Improve Medication Adherence
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
Section II: Drug Information
9 -
Drug Information Services and Sources of Information
	Objective 9.1. Outline Features of Drug Information Centers and Types of Drug Information Services Provided in a Hospital
		Drug Information Centers
		Responding to Drug Information Questions
		Formulary Management
			Formulary Reviews
			Strategies for Maintenance
		Adverse Drug Reactions/Medication Errors
		Education
			In-Services for Staff
			Precepting Students/Residents on Rotation
	Objective 9.2. Describe Applications of Common Sources of Drug Information
		Tertiary References
		Secondary References
			Cumulative Index to Nursing and Allied Health Literature
			Cochrane Library
			EMBASE
			Google Scholar
			International Pharmaceutical Abstracts
			PubMed
		Primary References
			New England Journal of Medicine
			The Lancet
			The Journal of the American Medical Association
			Nature
			BMJ (Formerly the British Medical Journal)
			Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy
			American Journal of Health-System Pharmacy
		Drug Information Website Descriptions
			US Food and Drug Administration-https://www.fda.gov/
			European Medicines Agency-http://www.ema.europa.eu/ema/
			Health Canada Drug and Health Products-https://www.canada.ca/en/health-canada.html
			Centers for Disease Control and Prevention-https://www.cdc.gov/
			Institute for Safe Medication Practices-https://www.ismp.org/
			Drug Information Portal-US National Library of Medicine-https://druginfo.nlm.nih.gov/drugportal/drugportal.jsp
	Objective 9.3. Overview of Drug Information Quality on the Internet
		Evaluation of Resources
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
10 -
Medical Literature Evaluation and Biostatistics
	Objective 10.1. Overview Medical Literature Evaluation and Common Features of Reputed Journals
		Journals
		Identifiers and Metrics
		Research Reporting Guidelines
	Objective 10.2. Explain How to Interpret and Evaluate a Typical Journal Article, Including the Common Biostatistics Methods
		Title of the Article
		Authors
		Abstract
		Introduction
		Methods
			Study Design
			Study Design Objectives
			Setting
			Patient/Subject Selection
			Patient Handling
			Data Handling
			Study Outcomes
			Follow-Up Procedures and Sample Size
			Variables
			Data
			Descriptive Statistics
			Inferential Statistics
			Power
			Error
			Univariate Analysis
			Multivariate Analysis
		Results
		Discussion
		Conclusion
		Bibliography
	Objective 10.3. Utilize Clinical Expertise to Identify the Overall Validity of a Given Clinical Trial
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
11 -
Evidence-Based Practice: Use in Answering Queries and Developing Systematic Reviews
	Objective 11.1. Define Evidence-Based Practice and Explain Its Framework
		Other Methods Used in EBP
	Objective 11.2. Recognize and Employ the Steps for the Modified Systematic Approach When Answering Drug Information-Related ...
		Secure the Demographics of the Requester
		Retrieving Necessary Background Information
		Determining the True Informational Need and Categorizing the Ultimate Question
		Developing a Sound Searching Strategy and Conducting a Thorough Search (Validate and Verify)
			Tertiary Resources
			Secondary Resources
			Primary Literature
		Evaluation, Analysis, and Synthesis of Gathered Information
			Formulate and Communicate the Response8,10
			Conduct Follow-Up/Provide Documentation8,10
	Objective 11.3. Describe the Process of Preparing Systematic Reviews Using Evidence-Based Practice
	Conclusion
	Practice Exercise
	References
12 -
Clinical Guidelines for Decision-Making
	Objective 12.1. Overview the Rationale for the Use of Clinical Guidelines
	Objective 12.2. Set the Framework for the Development of a Clinical Guideline
		Before Developing a Guideline
		Prioritization
		Who Is Involved?
		Managing Conflict of Interests
	Objective 12.3. Introduce the Methodology of Clinical Guideline Development
		Developing a Guideline
		Definition and Purpose of Scope
		Gathering Evidence
		Developing Clinical Questions
		Systematic Search for Evidence
		Appraising Identified Research Evidence
		From Evidence to Recommendations
		Consultations
		Publishing
	Objective 12.4. Explain the process of implementation and update of a Clinical Guideline
		Implementation
		Reviewing and Updating Guidelines
	Conclusion
	References
	Further Reading
13 -
Drug Information Training for Pharmacists
	Objective 13.1. Explain Why Pharmacists in Any Work Setting Require Well-Founded Drug Information Skills
	Objective 13.2. Review Drug Information Training Strategies for Pharmacy Students
	Objective 13.3. Categorize Drug Information Skills to Be Covered During Training
	Objective 13.4. Plan a Week-Wise Follow-Up of Learning Objectives Achieved in Drug Information Training
	Conclusion
	References
Section III: Pharmacoepidemiology and
Pharmacovigilance
14 -
Essentials of Pharmacoepidemiology
	Objective 14.1. Outline Pharmacoepidemiology and Its Methodological Terminologies
		Link to Pharmacoeconomic Studies
		Methodological Terminology
			Confounding
			Bias
			Incidence
			Point Prevalence
			Matching
			Drug Utilization
			Adherence
			Disease Severity
	Objective 14.2. Explain Study Designs Used in Pharmacoepidemiology Research
		Ecological/Cross-Sectional Studies
		Case-Control Studies
		Measure of Association for a Case-Control Study
		Cohort Studies
		Measure of Association for a Cohort Study
		Summary Comparison Tables of Study Designs
		Data Used in Pharmacoepidemiological Research
		Postmarket Surveillance
		Pharmaceutical Policy Issues
	Objective 14.3. Discuss How Pharmacoepidemiology Influences Health Improvement
		Vaccination Services and Disease Prevention: an Example of Pharmaceutical Public Health
		Decision Making
		Determinants of Health
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
15 -
Pharmacovigilance Systems
	Objective 15.1. Introduce the concepts pharmacovigilance, adverse drug event, and adverse drug reaction
		Pharmacovigilance (WHO 2002)
	Overview of Pharmacovigilance Systems
		Poor Quality Product
		Suboptimal Drug Use
		Unidentified Factors
	Objective 15.2. Describe the Pharmacovigilance Framework and the Roles of Different Stakeholders in Patient Safety
		Patient/Carers
		Healthcare Professionals
		Manufacturers
		Regulators
		International Organizations and Healthcare Organizations
	Objective 15.3. Explain How to Report Adverse Drug Events
		Spontaneous Reporting on Adverse Drug Reactions
		Mandatory Reporting
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
16 -
Adverse Drug Events, Medication Errors, and Drug Interactions
	Objective 16.1. Classify and Detail Adverse Drug Events
		Classification of Adverse Drug Reactions
	Objective 16.2. Explain Methods for Prevention and Management of Adverse Drug Events
		Preventability of Adverse Drug Events
		Use of Signals
		Causality Assessment of Adverse Drug Reactions
	Objective 16.3. Classify and Detail Medication Errors
		Types of Medication Errors32,33
		The Scope of the Problem
		Categorization of Medication Errors
	Objective 16.4. Explain Methods for Prevention and Management of Medication Errors
		Common Causes of Medication Errors
		Measures to Be Taken to Prevent Medication Errors46
		The Institute for Safe Medication Practices-Sharing and Learning From Errors
	Objective 16.5. Classify and Detail Drug Interactions
		Desirable Drug Interactions
		Drug Interactions Precipitated by Agents Other Than Drugs
		Pharmaceutical Drug Interactions (Incompatibilities)
		Pharmacokinetic Drug Interactions
		Pharmacodynamic Drug Interactions
		Interindividual Variations
	Objective 16.6. Explain Methods for Prevention and Management of Drug Interactions
		Risk Ratings of Drug Interactions
		Discontinuation
		Therapy Modification
		Monitoring Without Interventions
		Balance of Strategies
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
Section IV: Pharmacoeconomics and
Outcomes Research
17 -
Market Access, Pharmaceutical Pricing, and Healthcare Costs
	Objective 17.1. Outline Market Access Policies by Pharmaceutical and Medical Technology Industries
	Objective 17.2. Overview Pricing Practices of Pharmaceuticals
		Supply and Demand Curves
	Objective 17.3. Explain types of HealthCare Costs and their Estimation
		Costing Terms
		Cost Categorization
		Perspective
		Estimating Costs
		Methods to Measure Indirect Costs
		Time Adjustment for Cost
			Standardization of Cost
			Discounting
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
18 -
Pharmacoeconomic Analyses and Modeling
	Objective 18.1. Discuss the Purpose of Pharmacoeconomic Analyses
		Burden of Disease and Affordability
		Economic Evaluations Finding Value for Money Spent
		Pharmacoeconomic Evaluation Purpose
		Full Versus Partial Economic Evaluation
		Levels of Application
	Objective 18.2. Explain Pharmacoeconomic Analysis Approaches
		Cost-of-Illness
		Budget-Impact Analysis
		Cost-Comparison Analysis
		Cost-Minimization Analysis
		Cost-Benefit Analysis
		Cost-Consequence Analysis
		Cost-Effectiveness Analysis
		Cost-Utility Analysis
		Perspectives in Pharmacoeconomic Analysis
		Sensitivity Analysis in the Pharmacoeconomic Analysis
		Discounting in Pharmacoeconomic Evaluations
	Objective 18.3. Describe Common Pharmacoeconomic Modeling Methods
		Decision Analyses
			Elements of a Tree (Fig. 18.4)
		Markov Model
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
19 -
Interpreting Pharmacoeconomic Findings
	Objective 19.1. Describe the Influence of Pharmacoeconomics in HealthCare
	Objective 19.2. Explain How to Interpret Pharmacoeconomic Analysis Findings
		Pharmacoeconomic Reporting Guidelines
	Conclusion
	Practice Questions
		Use This Example for Questions 6-9
	References
	Answers to Practice Questions
20 -
Outcomes Research
	Objective 20.1. Define and Classify Outcomes Research
		Characteristics of Outcomes Research
		Economic, Clinical, and Humanistic Outcomes
		Donabedian's Structure-Process-Outcome Model
		Examples of Outcomes Research
	Objective 20.2. Contrast Outcomes Research With Traditional Clinical Trial Research
		Overlap Between Outcomes Reasearch and Clinical Trials
	Objective 20.3. Define and Explain How to Measure Health-Related Quality of Life and Patient-Reported Outcomes
		Defining Health-Related Quality of Life and Patient-Reported Outcomes
		Distinction Between Health-Related Quality of Life and Patient-Reported Outcomes
		Measuring Health-Related Quality of Life
			Generic Instruments: Common Examples
			Disease-Specific Instruments
			Reliability, Validity, and Responsiveness
		Measuring Domain-Specific Patient-Reported Outcomes
			Symptom Measures
			Adverse Event Reporting
			Patient Satisfaction
		Patient or Clinician, Who Should Fill a Questionnaire?
	Objective 20.4. Generalize How Outcomes Research Is Gaining Importance in Clinical Practice
		Scenario 1: Outcomes Research in Medical Reimbursement Decisions
		Scenario 2: Interpreting OR Data in a Particular Context
		Scenario 3: Outcomes Research Data in a Healthcare System Performance
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
21 -
Health Technology Assessment-Policy Objectives and Principles of System Design
	Objective 21.1. Overview of Health Technology Assessment From a Policy Perspective
		Meaning and Purpose of Health Technology Assessment
		Policy Objectives Related to Health Technology Assessment
	Objective 21.2. Describe Different Paradigms in the Assessment of Health Technologies
		Economic Evaluation
		Comparative Assessment
		Multidimensional Value Assessment Approaches
	Objective 21.3. Describe a High-Level Health Technology Assessment Process
	Objective 21.4. Explain Health Technology Assessment System Design in Current Practice
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
22 -
NICE Guidance and Health Technology Assessment
	Objective 22.1. Overview of National Institute for Health and Care Excellence Guidance Development and Evidence-Based Practice
		NICE Guidance
	Objective 22.2. Explain the Purpose, Production, and Principles of Technology Appraisal Guidance
		Technology Appraisals (TAs)
		Methods
		Types of Appraisals and Processes
	Objective 22.3. Detail the NICE Technology Appraisal Committee Process and Decision-Making
	Conclusion
	References
Section V: Clinical Research
23 -
Clinical Trials
	Objective 23.1. Introduce Clinical Research Methods
		First Controlled Clinical Research
		Use of Placebo
		Use of Randomization
		Clinical Research Methods
	Objective 23.2. Detail Methodological Aspects in Clinical Trials
		Randomization
			Simple Randomization
			Block Randomization
			Stratified Randomization
			Adaptive Randomization
			Minimization
		Blinding
		Controls
	Study Designs
		Crossover Studies
		Parallel Studies
		Steady-State Studies
		Basket and Umbrella Trials
		Adaptive Study Design
		Registry Trials
	Objective 23.3. Explain the Phases of Clinical Trials
		Phases of Clinical Trials
		Phase 0
		Phase 1
			Single Ascending Dose Study
			Maximum Tolerated Dose
			Example of Single Ascending Dose
			Multiple Ascending Dose Study
			Example of Multiple Ascending Dose
		Phase 2-Therapeutic Exploratory Phase
			Phase 2a-Proof of Clinical Concept Studies
			Phase 2b
		Phase 3-Therapeutic Confirmatory Phase
			Example
				Phase 3 Type 1 Diabetic Study
		Phase 4-Postmarketing Surveillance
	Objective 23.4. Discuss the Role of Pharmacists and Newer Technologies in Clinical Research
		Review of Protocol and Trial-Related Documents
		Receipt, Storage, and Accountability of the Investigational Product
		Dispensing of the Investigational Product
		Return/Destruction of Investigational Products
		Blinding/Unblinding Procedure of Codes
			Details of the Pharmaceutical Development Used in Clinical Trials
	Conclusion
	Practice Questions
	Crossword Exercise
	References
	Answers to Practice Questions
	Crossword Answers
24 -
Ethics in Clinical Research
	Objective 24.1. Overview Untoward Drug Incidents That Influenced the Evolution of Ethics in Clinical Research
		Tuskegee Syphilis Study (1932-72)
		Elixir Sulfanilamide Disaster (1937)
		Nuremberg Trials (Nazi Trials 1945-49)
		Cutter Incident (1955)
		Thalidomide Disaster (1962)
		The Unfortunate Experiment (1960s-80s)
		Other Major Issues Reported in Recent Times
	Objective 24.2. Explain Salient Features of Laws and Guidelines in History to Counter Unethical Research
		Food, Drug and Cosmetic Act (1938)
		Nuremberg Code (1947)
		Kefauver Harris Drug Amendment Act 1962 (Amendment to Federal Food, Drug and Cosmetic Act)
		Declaration of Helsinki
			General Principles
			Scientific Requirements and Research Protocols
			Research Ethics Committees
			Privacy and Confidentiality
			Informed Consent
			Use of Placebo
			Posttrial Provisions
			Research Registration and Publication and Dissemination of Results
			Unproven Intervention in Clinical Practice
		Belmont Report (April 18, 1979)
		International Council on Harmonization and Good Clinical Practice
		Guidance From the Council for International Organization of Medical Sciences in Collaboration With the World Health Organiz ...
	Objective 24.3. Detail the Constitution and Process of Review by the Research Ethics Committee
		Composition of the IEC/IRB
		Registration of the IEC/IRB
		Documents that Need to Be Submitted to the IEC/IRB for Approval
		Communications and Functions of the IEC/IRB
		Expedited Review Procedure of the IEC/IRB
	Objective 24.4. Describe the Informed Consent Process in Clinical Research
		Consent Process
		Role of Legally Acceptable Representative
		Responsibilities of the Legally Authorized Representative
		What if the Legally Acceptable Representative is Illiterate?
	Objective 24.5. Examples of Some Unethical Practices in Current Clinical Research
	Conclusion
	Practice Questions
	Crossword Exercise
	References
	Answers to Practice Questions
	Crossword Answers
25 -
Stakeholders, Resources, and Documents in Clinical Research
	Objective 25.1. Explain Responsibilities of Stakeholders in Clinical Research
		Institutional Review Board/Independent Ethics Committee
			Responsibilities
		Investigator
		Responsibilities of the Investigator
			Adequate Resources for the Conduct of the Trial
			Communication With the IRB/IEC
			Medical Care of Trial Subjects
			Compliance With Protocol
			Investigational Product(s)
			Randomization Procedures and Unblinding
			Informed Consent of Trial Subjects
			Records/Reports and Progress Reports
			Safety Reporting
			Premature Termination or Suspension of a Trial
			Final Report(s) by the Investigator
		Sponsor
		Responsibilities of the Sponsor
			Quality Assurance and Quality Control
			Contract Research Organization Selection
			Medical Expertise
			Trial Design
			Trial Management, Data Handling, and Record Keeping
			Investigator Selection
			Allocation of Responsibilities
			Compensation to Subjects and Investigators
			Financing
			Notification/Submission to Regulatory Authority(ies)
			Confirmation of Review by the IRB/IEC
			Information on Investigational Product(s)
			Manufacturing, Packaging, Labeling, and Coding Investigational Product(s)
			Supplying and Handling Investigational Product(s)
			Record Access
			Safety Information and Adverse Drug Reaction Reporting
			Monitoring
			Audit
			Premature Termination or Suspension of a Trial
			Clinical Trial/Study Reports
		Regulator
		Contract Research Organization
		Auditor
		Clinical Research Coordinator
		Clinical Research Associate
		Data and Safety Monitoring Board (Independent Data-Monitoring Committee)
		Participants (Subject/Trial Subject)
	Objective 25.2. Overview of the Common Resources and Documents Used in Clinical Research
		Documents in Clinical Trials
			Investigator's Brochure
			Study Protocol
			Informed Consent Form
			Case Report Form
			Clinical Study Report
			Clinical Trial Agreement
	Conclusion
	References
Section VI: Pharmacy Education
26 -
Quality Assurance in Pharmacy Education
	Objective 26.1. Describe Quality Assurance of Pharmacy Curricula in a Global Perspective
		Pharmacy Education Planning
		Framework-Based Quality Assurance Systems Development
	Objective 26.2. Explain the Role of ACPE in Accreditation and Certification of Pharmacy Programs
		Structure and Mission
		Standards Development
		Accreditation Process
	Objective 26.3. Detail the Curriculum Mapping Process in Pharmacy Education
	Conclusion
	References
27 -
Adult Learning Theories in Pharmacy Education
	Objective 27.1. Outline the Concepts in Adult Learning Relevant to Pharmacy Education
	Objective 27.2. Explain Applications of Adult Learning Principles in Pharmacy Education
	Objective 27.3. Describe How to Write Learning Objectives in Pharmacy Education
		Revised Bloom's Taxonomy
	Conclusion
	References
28 -
What to Expect From a Pharmacist Preceptor
	Objective 28.1. Differentiate the Roles of a Preceptor and Clarify the Terms Preceptor, Mentor, Faculty, Intern, and Resident
		The Roles of a Preceptor
	Objective 28.2. Describe the Qualities of Effective Preceptors and Responsibilities of Students
		Qualities of Effective Preceptors
		Receiving Effective Feedback
	Objective 28.3. Detail How to Develop a Productive Student-Preceptor Relationship
		Prior to the Experience
		During the Experience
		At the End of the Experience/Following the Experience
		Ready for Practice
	Conclusion
	References
Section VII: Pharmacokinetics/
Pharmacogenomics/Nutrition
29 -
Clinical Pharmacokinetics
	Objective 29.1. Explain the Basic Concepts in Clinical Pharmacokinetics
		Clinical Pharmacokinetics and Terminology
		Pharmacokinetic Models
			One Compartment Model
			Two Compartment Model
	Objective 29.2. Discuss Factors Affecting Pharmacokinetics of a Drug
		Absorption
		Distribution
		Metabolism
		Excretion
	Objective 29.3. Outline Pharmacometrics
		Population Pharmacokinetic Modeling and Simulation
		Application of Sparse or Limited Sampling in PopPK
	Physiologically Based Pharmacokinetic Modeling and Simulation
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
30 -
Therapeutic Drug Monitoring
	Objective 30.1. Describe the concept and need for therapeutic drug monitoring
		Drug Dosing and Personalized Drug Therapy
		Optimizing the Use of Medications: Therapeutic Drug Monitoring
			Goal of Therapeutic Drug Monitoring
			Why Is Therapeutic Drug Monitoring Necessary
			Drugs that Require Therapeutic Drug Monitoring
		Measurement of Systemic Drug Levels
			Laboratory Techniques Used for Therapeutic Drug Monitoring
			Samples Used for Therapeutic Drug Monitoring
			Timing of Sample Collection
		Clinical Interpretation of Therapeutic Drug Monitoring Reports
		Limitations of Therapeutic Drug Monitoring
	Conclusion
	References
31 -
Pharmacogenomics and Precision Medicine
	OBJECTIVE 31.1. DEFINE TERMS AND EXPLAIN BASIC CONCEPTS IN PHARMACOGENETICS/PHARMACOGENOMICS
		Genetic Variations
		Nomenclature
		Pharmacogenomic Testing in Pharmacotherapy
	OBJECTIVE 31.2. EXPLAIN THE RELATIONSHIP OF PHARMACOGENOMICS WITH PHARMACOKINETICS AND PHARMACODYNAMICS
		Example Drug-Gene Interactions
			Drug-Metabolizing Enzyme Pharmacogenes
			Transporter Pharmacogene
			Pharmacodynamic Pharmacogenes
	OBJECTIVE 31.3. DESCRIBE PHARMACIST COMPETENCIES IN GENOMICS/PHARMACOGENOMICS AND THEIR ROLES IN PRECISION MEDICINE
		Basic Genetic Concepts
		Genetic and Disease
		Pharmacogenetics/Pharmacogenomics
		Ethical, Legal, and Social Implications
		Growth and Future Direction of Pharmacogenomics
	CONCLUSION
	PRACTICE QUESTIONS
	REFERENCES
	ANSWERS TO PRACTICE QUESTIONS
32 -
TPN Primer for the Pharmacist: Approach to Nutrition Therapy
	Objective 32.1. Explain the Need of Parenteral Nutrition
		Determine if Parenteral Nutrition Needed
		Assessing the Patient
	Objective 32.2. Plan Administration, Calculation, and Preparation of Parenteral Nutrition
		Protein
		Carbohydrate
		Fat
		Micronutrients
		Electrolytes
		Parenteral Nutrition Preparation
	Conclusion
	Practice Questions
	References
	Answers to Practice Questions
Section VIII: Conclusion
33 -
Advanced Clinical Pharmacy Practitioner
	Objective 33.1. Review the Outcomes of Pharmacist-Provided Interventions
		Inpatient Practice
		Ambulatory Practice
		Community Pharmacy Practice
	Objective 33.2. Overview Innovative Specialty Pharmacy Practice Models
		Prescriptive Authority
		Pharmacist Providers
	Objective 33.3. Explain the Development of Competencies in Pharmacy Workforce Leadership
		Vision
		Communication Skills and Relationship Building
		Emotional Intelligence
		Challenge the Status Quo/Change Management
		Resilience
	Objective 33.4. Detail Continuing Education Needs of Pharmacists
		Certificate Programs
		Certification
		Residency Training
	Conclusion
	References
Appendix
I - Case Studies With Pharmacist Interventions
	Case 1: Drug-induced Electrolyte Disturbances
		How Is the Relationship Between the Suspected Drug and the Reported Reactions Established?
		How Are the Causality and Severity of the ADR Determined?
		What Type of Adverse Drug Reaction Is It Likely to Be (Type A or Type B)?
		What Follow-Up Actions Need to Be Taken in This Case?
	Case 2: Antipsychotic Drug-Induced Metabolic Encephalopathy
		Could These Signs and Symptoms Be ADRs? How Can They Be Assessed?
		What Follow-Up Actions Need to Be Considered in This Case?
	Case 3: Drug-Induced Liver Injury
		Could the Signs and Symptoms Be ADRs? How Is the Relationship Between the Suspected Drug and the Reported Reaction Established?
		How Are the Causality and Severity of the ADR Determined?
		What Follow-Up Actions Need to Be Considered in This Case?
	Case 4: Phenytoin Toxicity
	Case 5: Vancomycin Dilution Error
	Case 6: Irrational Empirical Antibiotics
	Case 7: Untreated Indication
	Case 8: Drug Interaction-Induced Hypoglycemia
	References
Appendix
II - Sample Evaluation Tools in Pharmacy Experiential Education
	Patient Case Presentation Checklist
	Drug Information Question Checklist
	In-Service Presentation Checklist
	Journal Club Evaluation Checklist
	Case Presentation Evaluation
	Journal Club Evaluation
	Patient Data Collection Form
	Overall Evaluation Form for the Advanced Pharmacy Training Experience
Index
	A
	B
	C
	D
	E
	F
	G
	H
	I
	J
	K
	L
	M
	N
	O
	P
	Q
	R
	S
	T
	U
	V
	W
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