NACDS Institute:
Expanding Pharmacy Care Innovative Models from the US
& Abroad
August 22, 2015
Institute Agenda
– Changing Your Business Model for Future
Success:
Linda Garrelts McLean, RPh, CDE
Associate Dean & Professor, Washington State University College of
Pharmacy
– Community Pharmacy Practice in Canada:
Expanding Scope and Overcoming Barriers:
David Edwards, PharmD, MPh
Associate Dean & Hallman Director, University of Waterloo School of
Pharmacy
– Trends in Collaborative Practice Authority:
Krystalyn Weaver, PharmD
Director of Policy and State Relations, NASPA
Changing
Your Business
Model
for
Future
Success
Linda Garrelts MacLean, RPh, CDE
Clinical Professor and Associate Dean
Washington State University
Spokane, WA
lmaclean@wsu.edu
What would your business
plan look like if……
……. Your pharmacy was paid to keep people healthy?
……. Your pharmacists increased access to primary care?
Instead of……
……. Solely dispensing drugs?
Health Care Reform Aims
 Better
population health
 Improved
health care, including access
 Decreased
costs
Better Health
Better Care
Affordable Care
Making the
case
Why is
pharmacy
needed at the
table?
Where are the
gaps?
How...
Create a plan
to overcome
potential
challenges
associated with
non-traditional
pharmacy
Craft and
execute
collaborative
drug therapy
agreements
which support
a pharmacist
to function as a
provider.
Strategy…
Implement
pharmacist
delivered care
to increase
access to
primary care
Collaborate with other
members of the healthcare
team ….
to successfully implement a model of care in which
the pharmacist practices at the top of the
pharmacy license.
Construct ….

a reimbursement model of compensation
for these services that increases profits.
Research Project:
INCREASE ACCESS TO QUALITY
PATIENT CARE IN COMMUNITY
PHARMACIES FOR MINOR
ILLNESSES IN WASHINGTON
STATE
Three phase analysis assessing
feasibility and comparing care
 3-phase
analysis that will assess feasibility
and compare care provided by clinical
community pharmacists for 20 minor
ailments and conditions with care
received in other care settings: physician
offices, urgent care clinics, and
emergency departments.
Three phase analysis
assessing feasibility and
comparing care provided
by the pharmacist for minor
ailments and conditions to
three other care settings.
-Minor emergency
-Physician office
-Emergency
department
Conditions included in the
study









Bronchospasm, wheezing,
shortness of breath from
asthma or COPD
Animal Bite (Human, Dog, or
Cat)
Eye or nasal symptoms from
seasonal allergies or other
allergic conditions
Herpes virus infections (cold
sores, genital herpes, shingles)
Allergic reactions from bee
stings (not anaphylactic)
Acute otitis media
Anaphylactic allergic reactions
Lacerations and abrasions
Nausea and vomiting (not
related to motion sickness)











Contraceptive pregnancy
prevention
Conjunctivitis
Nausea and vomiting caused
by motion sickness
Wound infections from burns
Migraine headaches
Ear infections caused by
bacteria
Lack of fluoride for oral health
Diarrhea that occurs while
traveling
Uncomplicated urinary tract
infections
Vaginal yeast infections
Streptococcal pharyngitis
Feasibility and Sustainability
Phase One
Superiority analysis of
pharmacy site costs versus
costs from the alternate care
settings.
Phase Two
Equivalence analysis among
care settings for quality of
care of health outcomes per
ailment or condition.
Phase Three
Partners
 Health
plan
 Community
pharmacies in Spokane,
Seattle and Vancouver I-5 corridor
Fixing Healthcare Can be
as Close as Your
Neighborhood Pharmacy!
http://www.forbes.com/sites/johnnosta/2014/04/10/
fixing-healthcare-can-be-as-close-as-yourneighborhood-pharmacy/
How do we determine value?
What you receive
QUALITY
Value
COST
What you pay
“As leaders we must think
and act in transformative
ways to advance the
profession, ultimately
improving health.”
-Acting Surgeon General RADM Scott Giberson
Thank you!
Questions for
the team?
Julie Akers
Julie.akers@wsu.edu
Community Pharmacy Practice
in Canada: Expanding Scope
and Overcoming Barriers
David Edwards, PharmD, MPH
Director, School of Pharmacy
University of Waterloo
Health Care in Canada
• Universal coverage for
medically necessary
health care services
(excludes dental, vision
care)
• Primarily paid for and
delivered by provinces
• Health care spending 4050% of provincial budgets
Major Health Care
Expenditures
28
Who pays for medications?
• Public funding ~ 40%
• Over age 65, unemployed, low income
• Private Insurance ~ 40%
• Provided by many employers
• Out of pocket payment ~20%
• Includes co-pays and payments by uninsured
for medications
Pharmacy Practice in Canada
• As of January 2014:
• 37,490 registered pharmacists in Canada (~ 1
pharmacist per 1,000 citizens)
• 75% of pharmacists practice in community
pharmacy
• 9,558 community pharmacies
• Mix of chain (Shoppers Drug Mart, Rexall), banner,
franchise, grocery and independent pharmacies
Rationale for Expanded
Scope of Pharmacy Practice
• Governments as the primary payer want:
• Improved access to health care, reduced wait times
• More cost-effective health care
• Patient-focused care, improved co-ordination
• Expanded scope benefits patients and frees up
physician time for other tasks
Pharmacists Scope of
Practice 2005
Pharmacists Scope of
Practice 2015
http://www.pharmacists.ca/index.cfm/pharmacy-in-canada/scopeof-practice-canada/
What can Pharmacists Do?
Pharmacists in many provinces can:
Renew and Extend Prescriptions (chronic conditions)
Adapt Prescriptions (change dose, formulation)
Therapeutic Substitution (eg. one ACE inhibitor to another)
Prescribe for minor ailments (eg. acne, allergic rhinitis,
dysmenorrhea, headache, GERD, oral thrush, superficial skin
infections, erectile dysfunction)
What can Pharmacists Do?
Pharmacists in many provinces can:
Order and interpret lab tests
Administer a drug by injection eg. immunizations
Provide emergency prescription refills
Initiate Prescription Therapy (need Additional Prescribing Authority
designation – Alberta; limited to smoking cessation treatment in Ontario)
Alberta – The Promised Land
(for Pharmacy)
Expanded Scope Varies by
Province
Service
Alberta
Ontario
Sask.
Emergency Refills
Yes
Yes
Yes
Renew/extend prescriptions
Yes
Yes
Yes
Change dosage/formulation
Yes
Yes
Yes
Therapeutic Substitution
Yes
No
Yes
Minor Ailment Prescribing
Yes
No
Yes
Initiate Prescription Therapy
Yes
Smoking
Cessation
Smoking
Cessation
Order and interpret lab tests
Yes
Pending
Pending
Administer a drug by injection
Yes
Flu Vaccine
Only
Pending
http://www.pharmacists.ca/index.cfm/pharmacy-in-canada/scope-of-practice-canada/
Payment for Professional
Services
Service
Ontario
Alberta
Sask.
$60
$60/$65
$60
$75-$150
$100/$125
$25
$20/$25
$7.50
$20
Adapt or renew prescription
0
$20
$6
Refusal to fill
0
$20
1.5 x DF
$20
0
Medication Reviews
Advanced Medications Reviews
(diabetes, long-term care, etc.)
Medication Review Follow-up
Immunization
Pharmaceutical Opinion
$15
Therapeutic Substitution
Minor Ailments
Smoking Cessation
Emergency Refill
$18
$125/yr
0
$300/yr
$20
$10
Supporting Expanded Scope:
Regulated Pharmacy Technicians
• Most provinces have regulated pharmacy
technicians
• Accountable and responsible for the technical aspects
of both new and refill prescriptions, (i.e. the correct
patient, drug dosage form/route, dose, doctor)
• Liability for actions
• Independent double check
• Ability to receive/transfer Rxs
Embracing the Opportunity?
• Immunizations, medication reviews widely
available in pharmacies but …..
• Many pharmacists are not adapting or renewing
prescriptions or doing therapeutic substititions
• Fear of disrupting the health care hierarchy, relationship with
physicians
• Two years after govt. approval, only 30% of Ontario
pharmacies offer smoking cessation services (Wong et al.,
Can Pharm J 2015: 148: 29-40)
• Number of pharmacists applying for advanced
prescribing authority has been low but increasing …
Embracing the Opportunity?
Not so fast ….
Alberta Pharmacists with prescribing
Authority
1000
800
600
Number of pharmacists
400
200
0
2006
2008
2010
2012
2014
www.pharmacists.ca/index.cfm/education-practice-resources/pharmacy-practice-research/
canadian-pharmacy-practice-research-group/cpprg-webinars/cpprg-webinar-archives
2016
Barriers to Implementing
Professional Services
• Pharmacist Perspective
•
•
•
•
•
Workload, too little time (lack of support staff)
Workflow
Pharmacy design/lack of privacy
Lack of training/expertise/competence
Not enough reimbursement
• Conflict between business model and clinical practice model
• Billing numbers for pharmacist employees, salary incentives
for professional services
• Interference with patient-physician relationship
• Personality characteristics of pharmacists
Are Pharmacists the ultimate
barrier to practice change?
• Current pharmacy culture
•
•
•
•
Product-focused (thorough, careful, attentive to detail)
Information gatherer and disseminator
Paralysis in the face of ambiguity
Uncomfortable with clinical decision-making
• Lack of confidence, reluctant to take
responsibility for patient care decisions
Rosenthal et al. Can Pharm J 2010; 143: 37-42
Barriers to Expanded Scope
• Government/payor perspective
• Failure to practice to full extent of current scope
• Inconsistency in delivery of professional services in a highly
visible profession
• Turf battles between professions
• CMA resolution in 2007: “the right to prescribe medications independently for medical
conditions must be reserved for qualified practitioners who are adequately trained to
take a medical history, perform a physical examination, order and interpret appropriate
investigations, and arrive at a working diagnosis.”
• Limited evidence in support of the value of expanded
professional services
Ongoing Research into
Professional Pharmacy Services
• Ontario Pharmacy Research Collaborative
• provide evidence of the quality, outcomes and value of recent
and emerging medication management services provided by
Ontario pharmacists
• Funded by Ministry of Health ($5.8 million dollars over 3 years)
• Canadian Foundation for Pharmacy
• The evaluation of pharmacy prescribing for minor ailments – the
clinical and economic value
• The impact of community pharmacist interventions in
hypertension management on patient outcomes: A randomized
controlled trial
Shifting the Focus from Product to
Patient: The Role of Academia
The Role of Academia
1. Provide a curriculum that recognizes that most
graduates will practice in the community
•
Strong community experiences to develop decision-making
skills and responsibility for patient care
2. Hire faculty members with community pharmacy
expertise and interest in practice-based research
3. Recruit and admit students with an aptitude for patientfocused medication management
•
Communication skills, critical thinking, problem-solving
Summary
• Alignment of interests of government (primary
payer) and profession has resulted in significant
expansion of scope of practice
• Pharmacists have been inconsistent in adopting
expanded scope due to real and perceived
barriers
• Academia has an important role in recruiting and
preparing the patient-focused pharmacist of the
future
Trends in Collaborative Practice
Authority
Krystalyn Weaver, PharmD
About NASPA
The National Alliance of State Pharmacy Associations (NASPA),
founded in 1927 as the National Council of State Pharmacy
Association Executives, is dedicated to enhancing the success of
state pharmacy associations in their efforts to advance the
profession of pharmacy. NASPA’s membership is comprised of
state pharmacy associations and over 70 other stakeholder
organizations. NASPA promotes leadership, sharing, learning,
and policy exchange among its members and pharmacy leaders
nationwide.
Collaborative Practice Agreements
• Creates formal relationship between pharmacists and
physicians or other providers
• Defines certain patient care functions that a pharmacist
can autonomously provide under specified situations and
conditions
• Many are used to expand the depth and breadth of
services the pharmacist can provide to patients and the
healthcare team
Components of a CPA Authority
Statute/Regulations
• Define collaborative practice authority and restrictions
• HIGHLY variable
Agreement
• Defined by collaborating practitioners
• Defines the conditions of the relationship, delegation of authority/expansion of
scope, defines the parties
• Legal document
Protocol
• Defines the clinical parameters for the provision of care
• Varying degrees of detail
• May or may not be required by state laws/regulations
Existing Landscape
• Collaborative practice authority: 48 states
• Proposed in AL and in the works in DE
• Pharmacist modification of therapy: 45 states
• Pharmacist initiation of therapy: 39 states
• Allow multiple pharmacists on one agreement: 25 states
• Many other parameters…
Elements Currently in State Law
Services/Authority
• Modify therapy
• Initiate therapy
• Physical
assessment
• Order labs
• Interpret labs
• Perform lab tests
Requirements
• Continuing
education
requirements
• Pharmacist
qualifications
• Liability
insurance
Restrictions
• Disease state
• Site of practice
• Drug
Who involved
• # of pharmacists
• # of prescribers
• # of patients
• Types of
prescribers
• Relationship
between patient
and prescriber
• Pharmacist to
prescriber ratio
Procedural
requirements
• Patient
involvement
• Agreements
approved or
reported to
whom
• Length of time
agreement valid
• Payment
provisions
• Documentation
• Physician review
Support for Collaborative Agreements
• Policy Considerations from the National Governors
Association
• Enact broad collaborative practice provisions that allow for specific
provider functions to be determined at the provider level rather than set
in state statute or through regulation.
• Evaluate practice setting and drug therapy restrictions to determine
whether pharmacists and providers face disincentives that unnecessarily
discourage collaborative arrangements.
• Examine whether CPAs unnecessarily dictate disease or patient specificity.
Collaborative Practice
Workgroup
Convened by the National Alliance of State Pharmacy Associations
Workgroup Objective
• Develop a set of elements that are considered to be the
best practice for inclusion in collaborative practice
provisions
• Developed through a consensus based process by a panel
of experts convened by NASPA
• Can then be used as a resource for those advocating for
changes to their collaborative practice provisions in their
state
Committee Participants
State/National
National
National
National
National
National
National
National
National
National
State
State
State
State
State
State
State
State
State
Organization
NACDS
APhA
NCPA
ASHP
ACCP
AACP
ACPE
NABP
AMCP
Iowa
South Carolina
Maryland
Michigan
Pennsylvania
Minnesota
Arizona
Alaska
Arizona
Name
Alex Adams
Anne Burns
Carolyn Ha
Douglas Scheckelhoff
Ed Webb
Lynette Bradley-Baker
Pete Vlasses
Scotti Russell
Susan Oh
Anthony Pudlo
Bryan Ziegler
Christine Lee-Wilson
Dianne Miller
Jennifer Bacci
Julie Johnson
Kelly Ridgway
L. Michelle Vaughn
Sandra Leal
Process: Developing Recommendations
• Step 1: Examine existing authority
• Step 2: Make recommendations
• Is this recommendation in the best interest of the patient receiving
care under a collaborative agreement?
• Is this recommendation aligned with pharmacists’ education and
training?
Process: Modified Delphi Method
1. Level-setting conference call
2. Distribution of survey with 3 weeks to complete
3. Collect and compile survey results
4. Call to discuss differences of opinions
5. Repeat 2-4 until consensus is reached
Workgroup Recommendations
Participants
• Which providers?
• Which patients?
Authorized services
• What can be done under the agreement?
Requirements and Restrictions
• Logistics
• Education
• Others
Workgroup Recommendations
Included in Laws and
Regulations
Decided by Individual
Providers
Framework should be
flexible to facilitate
innovation in care delivery
Safeguards should be
established to ensure
optimal patient care
Participants
Included in Laws and Regulations
• Any prescriber may collaborate with pharmacists
• Single or multiple pharmacists/prescribers may be parties to one
agreement
• Single, multiple and populations of patients can be on one agreement
Decided by Individual Providers
• Specifically list which pharmacists and prescribers are included in
agreement
• Identify the pharmacist training or credentials, if any, necessary to
provide delineated services
• Identify which specific patients or patient populations are included in
agreement
Authorized Services
Included in Laws and Regulations
• Initiation and modification of drug therapy can be
authorized in the agreement
Decided by Individual Providers
• Specify which disease states are being managed
• Specify which specific services are includes
• Specify if/which protocols or clinical guidelines are
to be followed
Requirements & Restrictions
Included in Laws and Regulations
• All medications may be managed under the agreement, including
controlled substances
• Agreement should be available, upon request, to the Board of
Pharmacy
Decided by Individual Providers
•
•
•
•
•
Specify an appropriate level of patient consent for services
Specify the timeframe for renewal of agreement
Specify the documentation processes
Specify the liability insurance needs, if any
Identify the continuing education requirements for participation
CPA Applications
• Chronic Disease Management
• Anticoagulation
• Cardiovascular disease/hypertension
• Diabetes
• Others
• Acute Treatment
• Public Health
Another Approach to
Addressing Public Health
Needs
Statewide Protocols
• Used to address public health concerns
• Standard across the state, applies to all pharmacists
• Additional pharmacist education/training could be
required
• Allows pharmacist to prescribe for conditions with no
diagnosis or that are easily diagnosed
• Protocols can be in law (CA) or delegate authority to state
boards (OR)
Statewide Protocols
• Naloxone
• Immunizations
• Smoking Cessation
• Hormonal Contraceptives
• Travel Medications
Case Study: Naloxone
Based on data collected by NASPA (updated June 2015)
WA
MT
OR
ME
ND
ID
MN
VT
WI
SD
MI*
WY
NV*
CA
AZ
CO
PA
IA
NE*
UT
NY
IL
KS
OK
NM
MO
OH
WV VA
KY
MS
AL
DC
NC
TN
AR
AK
TX
IN
NH
MA
RI*
CT
NJ
DE
MD
SC
GA
LA
HI
FL
Statewide naloxone protocol or prescriptive authority for pharmacists
Broad** collaborative practice provisions
*
Broad collaborative practice provisions but need a separate agreement for each pharmacist
Pharmacists are authorized to dispense without a prescription
Statewide protocol or prescriptive authority bill proposed in 2015 session
**Broad = Allow initiation of therapy, community pharmacists authorized to participate, no drug restrictions (may need to
specify within the agreement), laws/regulations silent regarding the relationship between the prescriber and the patient
Next Steps
• Examine your state’s collaborative practice authority
• Best interest of the patient?
• Aligned with pharmacist education and training?
• Does the current authority present barriers or
opportunities to enhance patient care?
• Do legislative or regulatory changes need to be made?
Questions?
Krystalyn Weaver, PharmD
Director, Policy and State Relations
kweaver@naspa.us