Clinical Pharmacy Education, Practice and Research: Clinical Pharmacy, Drug Information, Pharmacovigilance, Pharmacoeconomics and Clinical Research PDF
Preview Clinical Pharmacy Education, Practice and Research: Clinical Pharmacy, Drug Information, Pharmacovigilance, Pharmacoeconomics and Clinical Research
Clinical Pharmacy Education, Practice and Research Clinical Pharmacy, Drug Information, Pharmacovigilance, Pharmacoeconomics and Clinical Research Edited by Dixon Thomas Elsevier Radarweg29,POBox211,1000AEAmsterdam, Netherlands TheBoulevard, LangfordLane,Kidlington,OxfordOX51GB,UnitedKingdom 50HampshireStreet,5th Floor,Cambridge,MA02139,UnitedStates Copyright ©2019Elsevier Inc.Allrightsreserved. Nopartofthispublication maybereproducedor transmitted inanyformor byanymeans,electronicormechanical, including photocopying,recording,or anyinformationstorage andretrieval system,without permissioninwritingfrom thepublisher. Details onhowtoseekpermission, further informationaboutthePublisher’spermissionspoliciesandour arrangements with organizationssuchasthe CopyrightClearance CenterandtheCopyright LicensingAgency,canbefoundatour website: www.elsevier.com/permissions. Thisbookandthe individualcontributionscontainedinitareprotected undercopyright bythePublisher (otherthanas maybe notedherein). Notices Knowledgeandbest practiceinthisfieldareconstantly changing.Asnewresearchandexperiencebroadenour understanding, changesinresearchmethods,professionalpractices,or medicaltreatmentmay becomenecessary. Practitionersandresearchersmustalwaysrelyontheirownexperienceandknowledgeinevaluatingandusinganyinformation, methods,compounds,orexperiments describedherein.In usingsuchinformationor methodstheyshould bemindfuloftheir ownsafetyandthesafety ofothers,includingpartiesfor whomthey haveaprofessionalresponsibility. Tothefullestextentof thelaw,neither thePublishernor theauthors,contributors, oreditors, assumeanyliabilityforanyinjury and/ordamagetopersons orproperty asamatterof productsliability, negligenceorotherwise, orfromanyuseor operationof anymethods,products,instructions, orideascontained inthematerialherein. LibraryofCongress Cataloging-in-Publication Data Acatalogrecordforthisbookisavailablefrom theLibraryofCongress British LibraryCataloguing-in-Publication Data Acataloguerecordfor thisbookisavailablefrom theBritishLibrary ISBN:978-0-12-814276-9 ForinformationonallElsevier publicationsvisit our websiteathttps://www.elsevier.com/books-and-journals Publisher: AndreGerhardWolff AcquisitionEditor: ErinHill-Parks EditorialProjectManager:CarlosRodriguez ProductionProjectManager:SwapnaSrinivasan CoverDesigner:MarkRogers TypesetbyTNQTechnologies List of Contributors y OlaGhalebAlAhdab,MinistryofHealthandPrevention, Brian S. Decker Abu Dhabi, United Arab Emirates Piyameth Dilokthornsakul, Naresuan University, Phitsa- Alshabi Ali, Clinical Pharmacy Department, College of nulok, Thailand Pharmacy, Najran University, Najran, Saudi Arabia Benny Efendie, Monash University Malaysia, Bandar Anna Birna Almarsdóttir, University of Copenhagen, Sunway, Malaysia Copenhagen, Denmark Firuz Gamal Feturi, University of Pittsburgh, Pittsburgh, Lieven Annemans, Ghent University, Ghent, Belgium PA, United States NermeenAshoush,TheBritishUniversityinEgypt,Cairo, Elangovan Gajraj, NICE Scientific Advice, NICE, Egypt London, United Kingdom Danial E. Baker, Washington State University, Spokane, Manjiri Gharat, The Indian Pharmaceutical Association, WA, United States Mumbai, India; Prin.K.M.Kundnani Pharmacy Poly- technic, Ulhasnagar, India Anna Bryndis Blondal, University of Iceland, Reykjavik, Iceland Anne Gerd Granas, University of Oslo, Norway Emily Brennan, Medical University of South Carolina, Ronald A. Herman, The University of Iowa, Iowa City, Charleston, SC, United States IA, United States Lawrence Brown, Chapman University School of Mickael Hiligsmann, Maastricht University, Maastricht, Pharmacy, Irvine, CA, United States The Netherlands Daniel Buffington, University of South Florida, Tampa, Angela Hill, University of South Florida, Tampa, FL, FL, United States United States Sam Calabrese, Cleveland Clinic, Cleveland, OH, United Lilian H. Hill, The University of Southern Mississippi, States Hattiesburg, MS, United States Nathorn Chaiyakunapruk, Monash University Malaysia, Carrie Hoefer, Manchester University College of Phar- Selangor, Malaysia macy, Natural and Health Sciences, Fort Wayne, IN, United States Deepak C. Chilkoti, Consultant, Clinical Operations and Pharmacovigilance, Delhi, India Denny John, Campbell Collaboration, New Delhi, India Wai Yee Choon, Monash University Malaysia, Bandar Emily P. Jones, Medical University of South Carolina, Sunway, Malaysia Charleston, SC, United States Jason C. Cooper, Medical University of South Carolina, SibyJoseph,St.Joseph’sCollegeofPharmacy,Cherthala, Charleston, SC, United States India Ivellise Costa de Sousa, University Hospital Professor SachitaJoshi,NationalMedicinesLaboratory,Department Edgard Santos, Salvador, Brazil of Drug Administration, Ministry of Health, Nepal Dávid Dankó, Ideas & Solutions, Budapest, Hungary Toluwalope Junaid, University of Pittsburgh, Pittsburgh, PA, United States Amanda Davis, Medical University of South Carolina, Charleston, SC, United States Mark Decerbo, Roseman University of Health Sciences, Henderson, NV, United States; University of Nevada School of Medicine, Reno, NV, United States yDeceased. xvii xviii List of Contributors Balkrishna Khakurel, USAID Nepal Global Health Sup- Asawari Raut, Bharati Vidyapeeth, Pune, India ply Chain-Procurement and Supply Management, Mary E. Ray, The University of Iowa, Iowa City, IA, Kathmandu, Nepal United States Sherief Khalifa,GulfMedical University,Ajman, United JasonA.Roberts,TheUniversityofQueensland,Brisbane Arab Emirates St Lucia, QLD, Australia; Royal Brisbane and David F. Kisor, Manchester University College of Phar- Women’s Hospital, Herston QLD, Australia macy, Natural and Health Sciences, Fort Wayne, IN, Michael J. Rouse, Accreditation Council for Pharmacy United States Education, Chicago, IL, United States ChristophKlika,UniversityofDuisburg-Essen,Duisburg, Gunasakaran Sambandan, Azidus Laboratories Ltd., Germany Chennai, India Johann Kruger, University of Pretoria, Pretoria, South Douglas Scheckelhoff, American Society of Health- Africa; EDNA Medical Distributors, Pretoria, South System Pharmacists, Bethesda, MD, United States Africa ImamHussainShaik,UniversityofPittsburgh,Pittsburgh, Kiran Kumar, Gulf Medical University, Ajman, United PA, United States Arab Emirates RishavShrestha,NickSimonsInstitute,Kathmandu,Nepal Shaun Wen Huey Lee, Monash University Malaysia, Erick Sokn, Cleveland Clinic, Cleveland, OH, United Bandar Sunway, Malaysia States Federico Lega, SDA Bocconi School of Management, Douglas T. Steinke, University of Manchester, Man- Milan, Italy chester, Great Britain ChristineLeong,University ofManitoba, Winnipeg, MB, Yen-Huei (Tony) Tarn, Kaohsiung Medical University, Canada Kaohsiung, Taiwan HongLi,ShanghaiJiao-TongUniversity,Shanghai,China; Harisudhan Thanukrishnan, University of Pittsburgh, UniversityofCincinnati,Cincinnati,OH,UnitedStates Pittsburgh, PA, United States Kashelle Lockman, The University of Iowa, Iowa City, Dixon Thomas, Gulf Medical University, Ajman, United IA, United States Arab Emirates S.SureshMadhavan,WestVirginiaUniversitySchoolof ShuhuiTian,BeijingUnitedFamilyHealthcare,Chaoyang Pharmacy, Morgantown, WV, United States District, Beijing, China Lucinda L. Maine, American Association of Colleges of VincentW.L.Tsui,QueenElizabethHospital,HongKong Pharmacy, Alexandria, VA, USA Adina Turcu-Stiolica, University of Medicine and Phar- Jennifer Marriott, Monash University, Faculty of Phar- macy of Craiova, Craiova, Romania macy and Pharmaceutical Science, VIC, Australia Rao Vadlamudi, The Indian Pharmaceutical Association, Mohammad Kowser Miah, University of Pittsburgh, Mumbai, India Pittsburgh, PA, United States Allen J. Vaida, Institute for Safe Medication Practices, Saba Naeem, Gulf Medical University, Ajman, United Horsham, PA, United States Arab Emirates Raj Vaidya, Hindu Pharmacy, Goa, India James P. New, Medical University of South Carolina, Charleston, SC, United States Matthew P. Van Cuyk, Massachusetts General Hospital, Leeza Osipenko, NICE Scientific Advice, NICE, London, Boston, MA, United States United Kingdom Raman Venkataramanan, University of Pittsburgh, Pittsburgh, PA, United States; Thomas Starzl Trans- EmaPaulino,Pharmacy,NunoÁlvares,Almada,Portugal plantationInstitute,UniversityofPittsburgh,Pittsburgh, Mary Frances Picone, Medical University of South PA, United States; University of Pittsburgh Medical Carolina, Charleston, SC, United States Center, Pittsburgh, PA, United States Nicole A. Pilch, Medical University of South Carolina, Peter H. Vlasses, Accreditation Council for Pharmacy Charleston, SC, United States Education, Chicago, IL, United States Nisha Rajendran, Azidus Laboratories Ltd., Chennai, Susan S. Vos, The University of Iowa, Iowa City, IA, India United States List of Contributors xix Erin R. Weeda, Medical University of South Carolina, Xuemei Wu, University of Pittsburgh, Pittsburgh, PA, Charleston, SC, United States United States Christopher S. Wisniewski, Medical University of South SeebaZachariah,GulfMedicalUniversity,Ajman,United Carolina, Charleston, SC, United States Arab Emirates David J. Woods, University of Otago, Dunedin, New DawnG.Zarembski,AccreditationCouncilforPharmacy Zealand Education, Chicago, IL, United States Preface ClinicalPharmacyEducation,PracticeandResearchisaresourcetodevelopanintegratedfoundationinclinicalaspects of pharmacy. Pharmacists are involved in direct patient care. Practice-based research could improve the quality of care. Incorporation of relevant and good-quality research findings assures the practice to be evidence based. Evidence-based pharmacy practice has patient and population dimensions. The relevant pharmacy and health topics are organized in thisbooktosupportthemissionofpharmacistsorpharmacystudentsinclinical/healthcare.Itcoversthebasicsofgeneral clinical pharmacy, pharmacy management, drug information, evidence-based practice, pharmacoepidemiology, pharma- covigilance, pharmacoeconomics, outcomes research, health technology assessment, clinical research, pharmaceutical education, clinical pharmacokinetics, pharmacogenomics, and parenteral nutrition. It also serves as a reference for prac- ticingpharmacistsandpharmacyinstructorstoreviewthefundamentalsofpharmacyeducation,practice,andresearchwith aclinicalfocus.Theorganizationofsciencesisobvious,witheasy-to-navigatelearningobjectivesinthecontentsallowing readers to get their answers to focused areas, not necessarily reading through the full chapters. This book is designed to serve as a useful resource for undergraduate pharmacy students in various clinical/health courses. Contributions from a variety of leading pharmacy professionals in different areas of education, practice, and research enrich thebook.Though theauthorsare from different countries theconcepts discussed are universal. Readers should be abletocomprehendanyscenarios,becausethecontentrevolvesaroundthefundamentalsofpharmacy.Changeshappening to the profession have been incorporated, including both clinical and drug focus. Of note, “clinical” and “drug” are two important words used throughout this text. Pharmacists are and should be considered clinical staff, similar to doctors, nurses, physiotherapists, and other health professionals, who provide direct patient care. “Clinical” usually refers to human patients and all those who seek healthcare. Clinical pharmacy is more of a concept than a setting, because clinical services could happen in hospitals, community pharmacies, or even in a patient’s home. The majority of the time spent by pharmacists involves interactions withpatientsandotherhealthprofessionals,thearrangementofpracticesites,dispensing,documentation,andcontinuous professional development. Pharmacists often spend a significant amount of time preparing their pharmacy operations, layout, and services. However, pharmacy preparation time and dispensing time aredecreasing with thehelp ofpharmacy technicians and automation. From apatient’sviewpoint,pharmacistsareprimarilyinvolvedwith supplying medications,providinginstructions on howtotakemedicationsproperly,andansweringgeneralquestions.Pharmacistsalsoeducatetheirpatientsaboutrelevant diseases and healthcare needs. In hospital pharmacies, decreased interaction with inpatients sometimes results in phar- macists being seen as nonclinical staff. Though a hospital pharmacist does not always directly interact with inpatients, checkingtheappropriatenessofadrug,validatingthedose,andassuringitscorrectadministrationtopreventdrug-related problems are considered to be direct patient care activities. Subsequently, a pharmacist performs as a patient advocate within the healthcare team to contribute to the overall clinical decision-making process. Clinical pharmacists with advanced training can provide additional healthcare services at the bedside, but this does not mean that dispensing pharmacists are nonclinical. Dispensing pharmacists, while applying the expected competence in preventing drug-related problems (e.g., wrong dose, wrong route of administration, drug interactions), are contributing to direct patient care. Clinicalpharmacypracticeinthecommunitysettingisofamoreambulatorynature.Theprofessionalservicesmaybe lesscomplexthanthoseinvolvedinacutecaremedicine,dependingonthelocationoftheirpractice,buttheirimportance to the overall health and well-being of the patient is just as important. Being the primary point of consultation and sometimestheonlyhealthcareprofessionalinvolvedindirectpatientcareforavisit,communitypharmacistsneedtoapply their clinical skills. The clinical skills enable a pharmacist to collect patient information, perform physical assessment, interpret laboratory data, suggest appropriate intervention for a defined problem, and educate patients. Chronic care management is an important component of this practice. xxi xxii Preface An educational program that prepares graduates to be eligible for licensure as a pharmacist should have sufficient clinicalcomponents.Theabilitytoprovidedirectpatientcareallowspharmaciststohelptheirpatientsgainthemostfrom their medication(s). Thus any pharmacist could provide clinical services irrespective of the practice setting. In this book, the concept of clinical pharmacy considers a broad perspective of direct patient care and health services, while not attemptingtodrawstrictlinesaround“clinicalpharmacy.”Again,toreassure,clinicalpharmacyisaconceptthatappliesto all practice settings. Social, behavioral, and administrative sciences complement pharmacists’ clinical activities. Overall, the approach is to integrate sciences that contribute to improved care provided by pharmacists. Throughout this book, “drug” and “medicine” are used synonymously to represent the product (e.g., amoxicillin tablets). Some countries/agencies prefer the term medicine over drug mainly because consumers perceive drugs as sub- stancesofabuse.Inthisbook,theterm“drug”iscommonlyused;“medicine”isusedespeciallyinchaptersmentioningthe World Health Organization. The other related term is “medication,” which refers to a drug for a particular patient. Focusingontheclinicalconceptsdoesnotunderminethefocusondrugs.Theroleofthepharmacistasthedrugexpert requires knowledge of various drug-related information ranging from compounding (e.g., parenteral nutrition) to the creationofuniqueformulations(e.g.,suspensionsforpediatricpatients)totheprovisionofclinicalservices.Thebusiness ofpharmacyinvolvesablendingofbothproduct-orientedactivitiesandpatientmanagement.Eventhoughtheinformation regardingspecificdrugsisimportant,thisbookfocusesmoreonclinicalservicesandskills,becausemoreprogressneeds to happen in direct patient care areas. Specific chapters on clinical trials and other forms of research guide pharmacists to perform or follow research. Pharmacists commonly perform “outcomes research.” Following research is a commitment to continuing professional development.Theevidence-basedpharmacypracticerequiresacriticalappraisalofinformation;justadoptingtheresearch findings without considering scientific rigor and applicability in local practice/patient care no good science or practice. Studyingtheprocessofdevelopmentofsystematicreviewsandclinicalguidelineswillhelpinusingthemmorelogically. Informed decision making is an integrated approach that connects topics covered in this book for safe, effective, and affordable drug use. The content in each chapter is organized under learning objectives and is easy to navigate. Hopefully, a well-read chapter, with further readings found in the references, will result in a good learning experience. At the end of each chapter, there are a few practice questions, cases, or other exercises. Case studies and a set of tools used in experiential educationare found inthe appendices. Clinical PharmacyEducation, Practice andResearch isa goodcompanion inthe professional development of pharmacy students and pharmacists who wish to develop/refresh their clinical practice and research fundamentals. Contributionsofexpertsfromdifferent worksettingsandcountrieshaveenrichedthisresourceasImentionedbefore. Thefoundationalconceptthatdrivesthepharmacyprofessionisitsclinicalfocus.Thecollectivewisdomofcontributorsto this book will guide readers to achieve the core mission of the pharmacy profession. Dixon Thomas Acknowledgments Ithankthepublishingteamandallcontributorstothisbookbothauthorsandreviewers;threespecialmentionsareJason C. Cooper, Hong Li, and Seeba Zachariah for their outstanding support. xxiii Chapter 1 Introduction to Clinical Practice, Research, and Pharmacy Education Dixon Thomas1, Jennifer Marriott2, Rao Vadlamudi3, Benny Efendie4 and Lucinda L. Maine5 1GulfMedicalUniversity,Ajman,UnitedArabEmirates;2MonashUniversity,FacultyofPharmacyandPharmaceuticalScience,VIC,Australia; 3TheIndianPharmaceuticalAssociation,Mumbai,India;4MonashUniversityMalaysia,BandarSunway,Malaysia;5AmericanAssociationof CollegesofPharmacy,Alexandria,VA,USA Learning Objectives: Objective1.1 Describesalientfeaturesofclinicalpracticeofpharmacists. Objective1.2 Addressrelevantconceptsinpharmacyeducationleadingtoclinicalpractice. Objective1.3 Outlinehowresearchinpharmacyisimprovingpatientoutcomes. OBJECTIVE 1.1. DESCRIBE SALIENT FEATURES OF CLINICAL PRACTICE OF PHARMACISTS AccordingtotheOxfordDictionaryofEnglish,theterm“clinical”isusedinvariousmedicalfieldstomeanthatitrelatesto the treatment of actual patients. Pharmacists, regardless of where they are working, are clinical staff and healthcare professionals. In 2005, the American College of Clinical Pharmacy (ACCP) defined clinical pharmacy as a health science discipline in which pharmacists provide patient care that optimizes medication therapy and promotes health, wellness,anddiseaseprevention.1 Thepracticeofclinicalpharmacyembracesthephilosophyofpharmaceuticalcare2;itblendsacaringorientationwith specialized therapeutic knowledge, experience, and judgment to ensure optimal patient outcomes. All direct patient care activitiessuchaspatientcounseling,medicationreconciliation,medicationtherapyassessment,andanyotherpatientcare service areclinicalservicesatthebedsideorotherwise (Figs.1.1and1.2).Practice-basedresearch mustcontributetothe generation of new knowledge that improves practice and the quality of life of patients.2 Significant developments in the pharmacy profession have occurred since the introduction of the concept “pharma- ceuticalcare”intheearly1990s.2Pharmacistsprovideawiderangeofclinicalservices3irrespectiveofthesettinginwhich they work.4 Advising a patient to take an irritant drug with plenty of water will improve quality of life if the patient is adherent to the advice. The clinical expertise of a pharmacist helps to judge if the patient would use medicines appro- priately.Tailoringadviceorothersupportingservicestoimproveadherenceofpatientstotherapyandactionstobetaken to prevent adverse outcomes are clinical services. In some countries, pharmacists have also been granted independent or supplementary prescribing rights. Administration of certain vaccines is another such clinical service provided by phar- macistsinmanyjurisdictions.Pharmacistshavealonghistoryofmanagingminorailmentswithnonprescriptionproducts or just with lifestyle advice. All these activities involve clinical skills. Pharmacy education has evolved to address the necessary clinical pharmacy competencies. Bachelors of pharmacy programs in many countries have less clinical education, though its importance is increasing. To develop expertise in clinical pharmacy means obtaining a specialized master’s program. Although bachelors make pharmacists, masters in clinicalpharmacymakeclinicalpharmacists.IntheUnitedStates,DoctorofPharmacy(PharmD)istheonlyprogramthat makes pharmacists. Pharmacists are considered to have clinical expertise in community pharmacy, hospital pharmacy, or 1 ClinicalPharmacyEducation,PracticeandResearch.https://doi.org/10.1016/B978-0-12-814276-9.00001-5 Copyright©2019ElsevierInc.Allrightsreserved.
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