Full Description
The guide pharmacists and students turn to first for cutting-edge coverage of drug information The goal of Drug Information: A Guide for Pharmacists, Sixth Edition is to teach students and practitioners how to effectively research, interpret, evaluate, collate, and disseminate drug information in the most efficient and effective manner possible. Updated to reflect the realities of today's practice, the book also addresses important issues such as the legal and ethical considerations of providing drug information. Drug Information: A Guide for Pharmacists begins by introducing the concept of drug information, including its history, and provides details on the various places drug information specialists may find employment. This is followed by information on how to answer a question, from the process of gathering necessary background information through determining the actual informational need, to answering the question. The chapter on drug information resources includes descriptions of the most commonly used references and contains new information on apps available to practitioners. As with past editions, practical examples are also provided.The Sixth Edition has been updated throughout, with chapters from previous editions rearranged to make the subject flow better. This edition is also enhanced by the addition of new chapters on journal clubs and counterfeit drugs/drug shortages. In addition, coverage of Policy Development, Project Design and Implementation has been greatly expanded.
Contents
Chapter One. Introduction to the Concept of Drug InformationIntroductionThe BeginningThe EvolutionOpportunities in Drug Information Specialty PracticeSummary and Direction for the FutureSelf-Assessment QuestionsChapter Two. Formulating an Effective Response: A Structured ApproachIntroductionSteps for Answering a QuestionFormulating the ResponseConclusionSelf-Assessment QuestionsChapter Three. Drug Information ResourcesIntroductionTypes of Biomedical ResourcesTertiary ResourcesSecondary ResourcesPrimary ResourcesAlternative ResourcesConclusionSelf-Assessment QuestionsChapter Four. Drug Literature Evaluation I: Controlled Clinical Trial EvaluationIntroductionBiomedical/Pharmacy LiteratureApproach to Evaluating Research Studies (True Experiments)ConclusionSelf-Assessment QuestionsChapter Five. Literature Evaluation II: Beyond the BasicsIntroductionBeyond the Basic Controlled TrialN-of-1 TrialsAdaptive Clinical TrialsStability Studies/In Vitro StudiesBioequivalence TrialsProgrammatic ResearchObservational Study DesignReports Without Control GroupSurvey ResearchPostmarketing Surveillance StudiesReview ArticlesPractice GuidelinesHealth Outcomes ResearchDietary Supplement Medical LiteratureGetting to a Clinical DecisionConclusionSelf-Assessment QuestionsAbbreviationsAcknowledgmentsChapter Six. The Application of Statistical Analysis in the Biomedical SciencesIntroductionPopulations and SamplingVariables and the Measurement of DataDescriptive StatisticsCommon Probability DistributionsEpidemiological StatisticsTypes of Study DesignThe Design and Analysis of Clinical TrialsStatistical InferenceSelecting the Appropriate Statistical TestIntroduction to Common Statistical TestsConclusionSelf-Assessment QuestionsChapter Seven. PharmacoeconomicsIntroductionPharmacoeconomics: What Is It and Why Do It?Relationships of Pharmacoeconomics to Outcomes ResearchModels of Pharmacoeconomic AnalysisAssessment of CostsAssessment of OutcomesPerforming an Economic AnalysisWhat Is Decision Analysis?Steps in Reviewing Published LiteratureSelected Pharmacoeconomic WebsitesConclusionSelf-Assessment QuestionsChapter Eight. Evidence-Based Clinical Practice GuidelinesIntroductionEvidence-Based Medicine and Clinical Practice GuidelinesGuideline Development MethodsGuideline Evaluation ToolsImplementation of Clinical Practice GuidelinesSources of Clinical Practice GuidelinesConclusionSelf-Assessment QuestionsChapter Nine. Journal ClubsIntroductionConducting the Journal ClubPreparing the PresentationConclusionSelf-Assessment QuestionsChapter Ten. Legal Aspects of Drug Information PracticeIntroductionTort LawDefenses to Negligence and Malpractice ProtectionLabeling and AdvertisingDirect-to-Consumer (DTC) Drug InformationOff-Label Use and Informed ConsentLiability Concerns for Internet/Social Media InformationFraud and AbuseIntellectual Property RightsPrivacyIndustry Support for Educational ActivitiesConclusionSelf-Assessment QuestionsChapter Eleven. Ethical Aspects of Drug Information PracticeIntroductionBasics of Ethics AnalysisResources for Use by Professionals Seeking to Learn More about Medical Ethics, as Applied to Issues Involving Provision of Drug InformationStructures That Support Ethical Decision MakingConclusionSelf-Assessment QuestionsChapter Twelve. Professional Communication of Drug InformationIntroductionSteps in WritingSpecific DocumentsConclusionSelf-Assessment QuestionsChapter Thirteen. Pharmacy and Therapeutics CommitteeIntroductionOrganizational BackgroundPharmacy Support of the P&T CommitteeP&T Committee MeetingP&T Committee FunctionsCommunication Within an OrganizationConclusionStudy QuestionsSelf-Assessment QuestionsAcknowledgmentChapter Fourteen. Drug Evaluation MonographsIntroductionConclusionSelf-Assessment QuestionsAcknowledgmentChapter Fifteen. Drug Shortages and Counterfeit DrugsIntroductionDrug ShortagesCounterfeit DrugsConclusionSelf-Assessment QuestionsChapter Sixteen. Quality Improvement and the Medication Use SystemIntroductionThe Changing Environment for Health Care QualityPurpose of Measuring QualityQuality MeasuresQuality ImprovementQuality in Drug InformationPublication of Quality Improvement StudiesConclusionSelf-Assessment QuestionsChapter Seventeen. Medication Misadventures I: Adverse Drug ReactionsIntroductionImpact of Adverse Drug ReactionsDefinitionsCausality and Probability of Adverse Drug ReactionsClassification of Adverse Drug ReactionsImplementing a ProgramThe Role of Technology in Adverse Drug Reactions SurveillanceReporting Adverse Drug ReactionsFuture Approaches to PharmacovigilanceConclusionSelf-Assessment QuestionsChapter Eighteen. Medication Misadventures II: Medication and Patient SafetyIntroductionDefinitions: Medication Errors, Adverse Drug Events, and Adverse Drug ReactionsThe Impact of Errors on Patients and Health Care SystemsIdentification and Reporting of Medication Errors and Adverse Drug EventsClassification of Error TypesClassifying Patient OutcomesNational ReportingManaging an Event Reporting SystemTypes of Safety Event AnalysisTo Err Is HumanSystem ErrorA Just Culture-Not Shame and BlameRisk Factors for Errors and EventsHealth Professions EducationBest Practices for Error PreventionOther Principles of Error ManagementPutting It All TogetherConclusion: Safety as a PrioritySelf-Assessment QuestionsChapter Nineteen. Policy, Procedure, and Guideline DevelopmentIntroductionRegulatory ConsiderationsPractice Document Design and OrganizationFactors Influencing Practice Document DevelopmentSystematic Method for Practice Document Development and MaintenanceConclusionSelf-Assessment QuestionsChapter Twenty. Project ManagementIntroductionProjects, Programs, and PortfoliosSelecting ProjectsInitiating a ProjectPlanning a ProjectExecuting a ProjectMonitoring and Controlling a ProjectClosing a ProjectConclusionSelf-Assessment QuestionsChapter Twenty-One. Investigational DrugsIntroductionDefinitionsHistory of Drug Development Regulation in the United StatesThe Drug Approval ProcessThe Orphan Drug ActInstitutional Review Board/Institutional Ethics CommitteeRole of the Health Care ProfessionalConclusionSelf-Assessment QuestionsChapter Twenty-Two. Pharmaceutical Industry and Regulatory AffairsIntroductionOpportunities for Health Professionals within IndustryRegulation of Health Professionals in IndustryThe Code on Interactions with Health Care ProfessionalsFulfillment of MIRsAE ReportingStaying Connected with Pharmaceutical IndustryAnatomy of DHHS and FDADivision of Drug InformationOpportunities within the FDAConclusionSelf-Assessment QuestionsChapter Twenty-Three. Assessing Drug PromotionsIntroductionEthical Criteria for Medicinal Drug PromotionDirect-to-Consumer Advertising (DTCA)Promotions to Health Care ProfessionalsConclusionSelf-Assessment QuestionsChapter Twenty-Four. Drug Information in Ambulatory CareIntroductionProviding Drug Information in the Ambulatory Care SettingDrug Information Responsibilities in Ambulatory CareConclusionSelf-Assessment QuestionsChapter Twenty-Five. Drug Information and Contemporary Community Pharmacy PracticeIntroductionPharmacists as Drug Information ProvidersPatient Sources of Drug InformationA New Model of Drug InformationConclusionSelf-Assessment QuestionsChapter Twenty-Six. Pharmacy Informatics: Enabling Safe and Efficacious Medication UseIntroductionMedication Use ProcessPharmacy InformaticsOrder Entry (Prescribing Stage)Order Verification (Transcribing Stage)DispensingAdministrationMonitoringThe Future: Informatics in the U.S. Health Care SystemConclusionSelf-Assessment QuestionsChapter Twenty-Seven. Drug Information Education and TrainingIntroductionDrug Information in Pharmacy CurriculumPostgraduate Training in Drug InformationConclusionSelf-Assessment QuestionsAppendicesAppendix 2-1 Example of Drug Information Consult Documentation FormAppendix 2-2 Standard Questions for Obtaining Background Information from RequestorsAppendix 3-1 Performing a PubMed SearchAppendix 3-2 Selected Primary Literatures SourcesAppendix 4-1 Drug Literature Assessment Questions for Clinical TrialsAppendix 5-1 Beyond the Basics: Questions to Consider for Critique of Primary LiteratureAppendix 8-1 Grade Evidence Profile: Antibiotics for Children with Acute Otitis MediaAppendix 11-1 Code of Ethics for PharmacistsAppendix 12-1 Question ExampleAppendix 12-2 AbstractsAppendix 12-3 BibliographyAppendix 13-1 Pharmacy and Therapeutics Committee ProcedureAppendix 13-2 Formulary Request FormAppendix 13-3 P&T Committee Meeting AttributesAppendix 13-4 Example P&T Committee MinutesAppendix 13-5 Chairperson SkillsAppendix 13-6 Conflict of Interest DeclarationAppendix 14-1 Format for Drug MonographAppendix 14-2 Example Drug MonographAppendix 16-1 Tools Used in Quality AssuranceAppendix 16-2 Example of Criteria and Request for ApprovalAppendix 16-3 Example of MUE ResultsAppendix 16-4 Evaluation Form for Drug Information ResponseAppendix 17-1 Kramer QuestionnaireAppendix 17-2 Naranjo AlgorithmAppendix 17-3 Jones AlgorithmAppendix 17-4 Liverpool ADR Causality Assessment ToolAppendix 17-5 MedWatch FormAppendix 19-1 Policy Example: High-Alert MedicationsAppendix 20-1 Example of a Project CharterAppendix 20-2 Stakeholder Matrix-IV Compounding Software ProjectAppendix 20-3 Example PESTLE Analysis-IV Compounding Software ProjectAppendix 20-4 Example Work Breakdown Structure (WBS)-IV Compounding Software ProjectAppendix 21-1 Investigational New Drug ApplicationAppendix 21-2 Statement of InvestigatorAppendix 21-3 Protocol Medication Economic AnalysisAppendix 21-4 Investigational Drug Accountability RecordAppendix 22-1 Response Letter Drug A-Incidence of Yellow StripesGlossaryAnswers for Case StudiesAnswers for Self-Assessment QuestionsIndexNER(01): WOW
