Clinical Pharmacy: Education, Hospital Practice and Regulation in the USA Mary Anne Koda-Kimble, PharmD Professor and Dean School of Pharmacy University of California, San Francisco

Goals How did clinical pharmacy education evolve in the USA? How did clinical pharmacy education evolve in the USA? What does it look like today? What does it look like today? What clinical pharmacy services are being offered in USA hospitals? What clinical pharmacy services are being offered in USA hospitals? What is the scope of practice regulations in the USA? What is the scope of practice regulations in the USA?

Clinical Pharmacy: A Shift in Practice Philosophy and Education Drug Product PharmacyDispenserSoloKnowledge As ordered Drug Therapy BedsideCaregiverTeamInformation As best prescribed FROM TO

Pharmacy Education in the USA

Practice Stimulates Change Early 1970’s

New Roles Required New Skills Medical terminology Medical terminology Clinical use of drugs in disease and patients Clinical use of drugs in disease and patients Pathoph¨siology Pathoph¨siology Therapeutics Therapeutics Therapeutic problem-solving Therapeutic problem-solving Communication: verbal and written Communication: verbal and written Literature evaluation Literature evaluation

Need for New Skills Required: New Curriculum New Curriculum New Approach to Teaching New Approach to Teaching New Faculty New Faculty

Clinical PharmD Curriculum at UCSF Took Shape Quickly Strong basic sciences maintained Strong basic sciences maintained More biological and medical sciences More biological and medical sciences Chemistry and basic science laboratories decreased Chemistry and basic science laboratories decreased Therapeutics course added Therapeutics course added One full year of patient care clinical experience required One full year of patient care clinical experience required

New Teaching Methods Set in Motion Active learning Active learning Problem solving Problem solving Communication skills Communication skills Teamwork Teamwork

Pharmacists Added to Faculty to: Develop faculty practices in the UCSF Medical Center Develop faculty practices in the UCSF Medical Center Design new courses Design new courses Write new clinical textbooks: Therapeutics and Pharmacokinetics Write new clinical textbooks: Therapeutics and Pharmacokinetics

K K Primary - Middle - Upper School College or University 1 2 Education for a PharmD Degree Now Pharmacy School >95% have degrees (  4 years) at UCSF ~ 15% graduates pursue postgraduate training: residencies, fellowships, degrees

ACPE Accredits PharmD Programs Only Beginning 2000 “Standards 2000”

Standards 2000 Principles “New” PharmD “New” PharmD Prepare practitioners to deliver pharmaceutical care Prepare practitioners to deliver pharmaceutical care Early and advanced pharmacy practice experiences Early and advanced pharmacy practice experiences Community Community Hospital, other Hospital, other Learning outcomes (linked to content and…) Learning outcomes (linked to content and…) Teaching, learning, and evaluation processes Teaching, learning, and evaluation processes Systematic, continuous assessment and quality improvement (students and program) Systematic, continuous assessment and quality improvement (students and program) Experimentation and innovation Experimentation and innovation

Learning Outcomes Linked to Content and Methods Learning Outcomes Teaching Methods Course Content

ACPE Educational Outcomes Apply science and math to practice Apply science and math to practice Conceptual understanding of health care systems and pharmacy practice Conceptual understanding of health care systems and pharmacy practice Effective communication, interpersonal, and collaborative skills Effective communication, interpersonal, and collaborative skills Critical-thinking, problem-solving, and decision making skills Critical-thinking, problem-solving, and decision making skills Information management and analysis skills Information management and analysis skills

Educational Outcomes Design, implement, manage, and evaluate appropriate treatments for individual patients and diverse patient populations Design, implement, manage, and evaluate appropriate treatments for individual patients and diverse patient populations Professional values and ethical behavior Professional values and ethical behavior Patient orientation, cultural sensitivity, personal responsibility Patient orientation, cultural sensitivity, personal responsibility Self-learning and adaptive skills Self-learning and adaptive skills Leadership and entrepreneurial skills that effect change Leadership and entrepreneurial skills that effect change

Typical Curricular Design Today Basic and Applied Sciences Practice Courses Year 1Year 2Year 3Year 4 4 Professional Years

More Medical Biology and Applied Sciences Anatomy, Microbiology, Histology, Immunology Physiology, Biochemistry, Pathology

Informatics Literature Evaluation Informatics Resource Center

Group and Interactive Learning Student Poster Session

Practitioner Teachers Advanced Practice Experiences

Becoming a Pharmacist in the USA PharmD graduate from an accredited School of Pharmacy PharmD graduate from an accredited School of Pharmacy Take and pass the national licensure examination Take and pass the national licensure examination Complete  1 year practice experience while in pharmacy school (internship) Complete  1 year practice experience while in pharmacy school (internship) Be in good standing with the legal authorities Be in good standing with the legal authorities Continuing education to maintain license Continuing education to maintain license

Clinical Pharmacy Practice in Hospitals

2006 Central Clinical Pharmacy Services in Hospitals Drug Use Evaluation 90% In-service Education 66% Drug Information 40% Poison Information 19% Clinical Research 24% Drug Safety Officer 35% Bond CA, Raehl, CL National Clinical Pharmacy Services Survey: Clinical Pharmacy Service, Collaborative Drug Management, Medication Erros, and Pharmacy Technology. Pharmacotherapy 2008;28(1):1-13.

2006 Patient-Specific Clinical Pharmacy Services in Hospitals Pharmacokinetic Consultation 87% ADR Management 81% Drug Protocol Management 77% Drug Therapy Monitoring 63% Medical Rounds Participation 51% Drug Therapy Counseling 46% TPN Team Participation 45% CPR Team Participation 37% Admission Drug Histories 7.5% Bond CA, Raehl, CL. Pharmacotherapy 2008;28(1):1-13.

Drug Protocol Management Aminoglycosides 64% Aminoglycosides 64% Vancomycin 64% Vancomycin 64% Warfarin 38% Warfarin 38% LMW Heparin 33% LMW Heparin 33% Heparin 30% Heparin 30% Antiparkinsonian Drugs 23% Antiparkinsonian Drugs 23% Proton Pump Inhibitors 23% Proton Pump Inhibitors 23% HIV Drugs 22% HIV Drugs 22% Cephalosporins 20% Cephalosporins 20% Bond CA, Raehl, CL National Clinical Pharmacy Services Survey: Clinical Pharmacy Service, Collaborative Drug Management, Medication Erros, and Pharmacy Technology. Pharmacotherapy 2008;28(1):1-13.

7 Hospital Clinical Pharmacy Services Save Lives Drug use evaluation Drug use evaluation In-service education In-service education Adverse drug reaction management Adverse drug reaction management Participation on CPR team Participation on CPR team Drug protocol management Drug protocol management Participation on medical rounds Participation on medical rounds Admission drug histories Admission drug histories Bond CA, Raehl CL. Clinical Pharmacy Services, Pharmacy Staffing, and Hospital Mortality Rates. Pharmacotherapy 2007;27(4):

Clinical Pharmacy Services Improve Care Decreased Decreased Adverse drug events Adverse drug events Adverse medication reactions Adverse medication reactions Medication errors Medication errors Improved Improved Medication adherence Medication adherence Drug knowledge Drug knowledge Appropriate medication use Appropriate medication use Shortened length of hospital stay Shortened length of hospital stay Kaboli PJ et al. Clinical Pharmacists and Inpatient Medical Care: A Systematic Review. Arch Intern Med. 2006;166:

Perhaps We Have Swung Too Far Distribution Pharmacist Product-centric Little interaction Physically isolated – Central pharmacy or satellite Specialist Pharmacist Physician-centric On the wards Little interaction with distribution pharmacist Blended/Integrated Pharmacist Nurse/physician/patient/product-centric On the wards

Pharmacist is the Chief Medication Safety Officer Safe and effective prescribing Safe and effective prescribing Physician interaction Physician interaction Safe and efficient drug delivery systems Safe and efficient drug delivery systems Drug selection Drug selection Drug preparation Drug preparation Drug dosing Drug dosing Drug storage and delivery Drug storage and delivery Safe administration and use Safe administration and use Nurse collaboration and education Nurse collaboration and education Patient/family education Patient/family education Safe and effective response Safe and effective response Monitoring for dose, therapeutic response, ADEs and medication errors Monitoring for dose, therapeutic response, ADEs and medication errors

Scope of Practice Defined by Pharmacy Practice Acts Role of the practitioner in the health care setting

Pharmacy Practice Acts Dispensing100% Compounding92% Consultation85% Drug Utilization Review 69% Drug Product Selection 54% Drug Administration 21% PK Consultation 13% Young MD et al. Pharmacy practice acts: a decade of progress. Ann Pharmacother Sep;33(9):920-6

Purpose of Practice Regulations Protect the public Protect the public Assure competency Assure competency DisÃipline DisÃipline Changes in Healthcare Professions’ Scope of Practice: Legislative Considerations. A collaboration of six healthcare regulatory organizations.

Overlap in Practice Among Pharmacists, Nurses, Physicians Many common skills Many common skills Many common procedures carried out by all Many common procedures carried out by allBUT: Can pharmacists provide expanded services safely and effectively? Can pharmacists provide expanded services safely and effectively? Will expanded services provided by pharmacists improve access and care? Will expanded services provided by pharmacists improve access and care? Changes in Healthcare Professions’Scope of Practice: Legislative Considerations A collaboration of six healthcare regulatory organizations.

Arguments for Expanded Scopes of Practice Established history of practice scope within the profession Established history of practice scope within the profession Education and training prepares practitioners to perform the skill Education and training prepares practitioners to perform the skill Standards for education and training Standards for education and training Supporting evidence for competency Supporting evidence for competency Evidence for a public health benefit Evidence for a public health benefit Appropriate regulatory environment Appropriate regulatory environment Changes in Healthcare Professions’Scope of Practice: Legislative Considerations. A collaboration of six healthcare regulatory organizations.

Collaborative Drug Therapy Management Occurs Across the USA Alabama, Kansas, Maine, New York, Oklahoma, Vermont Only 6 States Do Not Allow

Collaborative Practice Agreement An agreement between one or more physicians and pharmacists An agreement between one or more physicians and pharmacists Under a defined protocol, prescriptive authority is delegated to specific pharmacists Under a defined protocol, prescriptive authority is delegated to specific pharmacists Reviewed and approved by appropriate bodies in the hospital (e.g. Executive Medical Committee) Reviewed and approved by appropriate bodies in the hospital (e.g. Executive Medical Committee) Hammond R, et al. Coìlaborative drug therapy management by pharmacists-2003 American College of Clinical Pharmacy. Pharmacotherapy 2003;23(9):

Collaborative Practice Agreement Activities Initiating, modifying, and monitoring a patient’s drug therapy Initiating, modifying, and monitoring a patient’s drug therapy Ordering and performing laboratory and related tests Ordering and performing laboratory and related tests Assessing patient response to therapy Assessing patient response to therapy Counseling and educating a patient on medications Counseling and educating a patient on medications Administering medications Administering medications

Pharmacy Practice Acts Inconsistent among states Inconsistent among states No uniform legal responsibility reflecting contemporary practice No uniform legal responsibility reflecting contemporary practice New laws primarily address progressive practice functions New laws primarily address progressive practice functions Young MD et al. Pharmacy practice acts: a decade of progress. Ann Pharmacother Sep;33(9):920-6

Pharmacy Today and Tomorrow

USA Pharmacy Today PharmD curriculum in all schools PharmD curriculum in all schools Clinical pharmacy services in most hospitals Clinical pharmacy services in most hospitals Expanded scope of practice regulations for cl°nical practice in most states Expanded scope of practice regulations for cl°nical practice in most states Pharmacist-managed drug therapy in some ambulatory clinics (not widespread) Pharmacist-managed drug therapy in some ambulatory clinics (not widespread)

US Pharmacy Today Clinical practice in community pharmacies limited, but growing Clinical practice in community pharmacies limited, but growing Broader physician recognition of pharmacists as clinicians Broader physician recognition of pharmacists as clinicians Greatly expanded opportunities for PharmDs Greatly expanded opportunities for PharmDs

Our Patients – Our Passion