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Reimagining Pharmacist
Scope of Practice
K RYSTALYN WEAV ER, P HA R M D
V P, P OL I CY & OP E R ATIONS
N AT IONA L A L L I A NCE OF STATE P HA R MACY A S S OCI ATIONS
Disclosure
I do not have (nor does any immediate family member have) actual or potential
conflict of interest, within the last twelve months; a vested interest in or
affiliation with any corporate organization offering financial support or grant
monies for this continuing education activity; or any affiliation with an
organization whose philosophy could potentially bias my presentation.
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.
Objectives
Define the term scope of practice and describe the impact on the practice of pharmacy.
Describe the legal construct by which pharmacists’ and other practitioners’ scopes of practice
are determined.
Explain collaborative practice agreements and identify the conditions under which pharmacists
are acting as prescribers in various states.
Consider alternate points of view on how scope of practice should be defined.
Self-Assessment Questions
True or False:
◦ Nearly all states currently allow pharmacist prescriptive authority for at least 1 category of
medication.
◦ Patient-specific collaborative practice agreements provide a prescription framework for both acute
and chronic disease.
◦ Autonomous models of pharmacist prescribing are currently focused on the treatment of chronic
diseases.
◦ There are no non-pharmacy organizations who have publically supported the concept of
pharmacist collaborative practice authority.
◦ The Collaborative Practice Workgroup recommended that state laws and regulations be very
prescriptive with regards to collaborative practice authority because increased pharmacist
autonomy could be a risk to patient safety.
◦ Clinical competencies vary from one practitioner to another based on that practitioners education,
training, and experiences.
1
The range of responsibility – eg, types of patients or caseload
and practice guidelines that determine the boundaries within
which a physician, or other health professional, practices.
Defining
Scope of
Practice
• McGraw-Hill Concise Dictionary of Modern Medicine, © 2002 The McGrawHill Companies, Inc
2
The extent and limits of the medical interventions that a
healthcare provider may perform.
• Medical Dictionary, © 2009 Farlex and Partners
The Scope of Practice describes the procedures, actions, and
processes that a healthcare practitioner is permitted to
undertake in keeping with the terms of their professional
license.
• Wikipedia, accessed 2.16.16
3
What determines an individual
pharmacists’ scope?
Detailed State
Scope Laws
Geography
Determined
Scope
Variability
State to State
Missed
Opportunities!!!
National standards for
pharmacy education
Geography
determined scope
of practice
Plus:
Competencies • Unused skills
change over time • Newly learned skills
Specialization
Community needs
• Certification
• On the job training
• Outbreaks
• Access
Legal flexibility
Provider responsibility
Collaborative Practice Agreements
Formal
Relationship
Delegation
Negotiated
Conditions
Collaborative Practice
Authority
Statute/Regulations
Agreement
Protocol
Collaborative agreements
increase efficiency
Chronic Care
Management
Public Health
Services
Acute Care
Medication
Adherence/
Formulary
Management
Pharmacist Prescribing
Definitions of Prescribing Activities
Activity
Definition
Select
When pharmacotherapy is necessary, and after review of an individual patient’s history, medical
status, presenting symptoms, and current drug regimen, the clinician chooses the best drug regimen
among available therapeutic options.
Initiate
After selecting the best drug therapy for an individual patient, the clinician also determines the most
appropriate initial dose and dosage schedule and writes an order or prescription.
Monitor
Once drug therapy is initiated, the clinician evaluates response, adverse effects, therapeutic
outcomes, and adherence to determine if the drug, dose, or dosage schedule can be continued or
needs to be modified.
Continue
After monitoring the current drug therapy of a patient, the clinician decides to renew or continue the
same drug, dose, and dosage schedule.
Modify
After monitoring a patient’s drug therapy, the clinician decides to make an adjustment in dose and/or
dosage schedule, or may add, discontinue, or change drug therapy.
Administer
Regardless of who initiates a patient’s drug therapy, the clinician gives the drug directly to the patient,
including all routes of administration.
Carmichael JM, et al. Collaborative Drug Therapy Management by Pharmacists.
Pharmacotherapy. 1997;17(5):1050-1061.
Continuum of Pharmacist Prescriptive
Authority
PatientSpecific CPA
PopulationSpecific CPA
Statewide
Protocol
Adams AJ, Weaver KK. The Continuum of Pharmacist Prescriptive Authority. Annals of Pharmacotherapy. In Press.
Unrestricted
(CategorySpecific)
States with CPA
laws
Allows initiation
of medications in
outpatient
settings
Limited to
inpatient
settings
Prevent initiation
of medications
Populationspecific
Patient-specific
Limited to one
prescriber
Allow multiple
prescribers
Collaborative Prescribing
PATIENT-SPECIFIC CPA
POPULATION-SPECIFIC CPA
Requires a partnering prescriber
Requires a partnering prescriber
Voluntarily negotiated
Voluntarily negotiated
Applies to individual patients
Applies to patient populations
◦ Require patients listed in agreement
◦ Limited to patient panel of collaborating
prescriber
◦ Limited to post-diagnostic care
Multi vs. single prescriber
Used for chronic disease management
◦ Naturally inclusive of patient-specific
Promotes consistency in service provided at
pharmacy
Used for acute OR chronic disease
management
Continuum of Pharmacist Prescriptive
Authority
PatientSpecific CPA
PopulationSpecific CPA
Statewide
Protocol
Adams AJ, Weaver KK. The Continuum of Pharmacist Prescriptive Authority. Annals of Pharmacotherapy. In Press.
Unrestricted
(CategorySpecific)
Collaborative Prescribing
Autonomous Prescribing
Crossing Over
POPULATION-SPECIFIC CPA
STATEWIDE PROTOCOL
Requires a partnering prescriber
Does not require a partnering prescriber
Voluntarily negotiated
Issued by an authorized body of the state (e.g.
take it or leave it)
Apply to patient populations
◦ Naturally inclusive of patient-specific
Apply to patient populations
Promotes consistency in service provided at
pharmacy
Promotes consistency in service provided
across state
Used for acute OR chronic disease
management
Used for conditions that do not require a
specific diagnosis
POPULATION-SPECIFIC CPA
STATEWIDE PROTOCOL
Requires a partnering prescriber
Does not require a partnering prescriber
Voluntarily negotiated
Issued by an authorized body of the state (e.g.
take it or leave it)
Apply to patient populations
◦ Naturally inclusive of patient-specific
Apply to patient populations
Promotes consistency in service provided at
pharmacy
Promotes consistency in service provided
across state
Used for acute OR chronic disease
management
Used for conditions that do not require a
specific diagnosis
Continuum of Pharmacist Prescriptive
Authority
PatientSpecific CPA
PopulationSpecific CPA
Statewide
Protocol
Adams AJ, Weaver KK. The Continuum of Pharmacist Prescriptive Authority. Annals of Pharmacotherapy. In Press.
Unrestricted
(CategorySpecific)
Autonomous Prescribing
STATEWIDE PROTOCOL
UNRESTRICTED (CATEGORY-SPECIFIC)
Does not require a partnering prescriber
Does not require a partnering prescriber
Issued by an authorized body of the state (e.g.
take it or leave it)
No restriction on authority (except for clinical
guidelines)
Apply to patient populations
No explicit restriction on patient populations
Promotes consistency in service provided
across state
Promotes consistency in service provided at
pharmacy
Used for conditions that do not require a
specific diagnosis
Used for conditions that do not require a
specific diagnosis
Addressing Concerns
Training
Patient Safety
Conflict of Interest
Fragmentation of Care
Prevalence
OF PHARMACIST PRESCRIBING AUTHORITY IN THE US
Prescribing Under a CPA
Based on data collected by NASPA (updated Dec 2015)
AK
WA
MT
OR
ME
ND
ID
MN
VT
WI
SD
NY
WY
MI
NV
CA
UT
AZ
HI
IA
NE
CO
IL
KS*
OK
NM
OH
WV VA
MO
KY
NC
TN
AR
MS
TX
IN
PA
AL
SC
GA
LA
Initiation and modification of
therapy allowed
Only modification of therapy
allowed
*Kansas is awaiting rule promulgation. Their law is vague regarding services and calls for rules to be issued
FL
NH
MA
RI
CT
NJ
DE
MD
DC
Prescribing Under a CPA in the Community
Based on data collected by NASPA (updated Dec 2015)
AK
WA
MT
OR
ME
ND
ID
MN
VT
WI
SD
NY
WY
MI
NV
CA
HI
IA
NE
UT
AZ
CO
IL
KS*
OK
NM
OH
WV VA
MO
KY
NC
TN
AR
MS
TX
IN
PA
AL
SC
GA
LA
FL
Initiation of therapy allowed in the
community pharmacy setting
*Kansas is awaiting rule promulgation. Their law is vague regarding services and calls for rules to be issued
NH
MA
RI
CT
NJ
DE
MD
DC
Population-Specific CPA in the Community
Based on data collected by NASPA (updated Dec 2015)
AK
WA
MT
OR
ME
ND
ID
MN
VT
WI
SD
NY
WY
MI
NV
CA
HI
IA
NE
UT
AZ
CO
IL
KS*
OK
NM
OH
WV VA
MO
KY
NC
TN
AR
MS
TX
IN
PA
AL
SC
GA
LA
FL
Initiation of therapy allowed in the
community pharmacy setting
*Kansas is awaiting rule promulgation. Their law is vague regarding services and calls for rules to be issued
NH
MA
RI
CT
NJ
DE
MD
DC
Prescribing Under a Statewide Protocol or
Unrestricted (Category-Specific) Authority
Based on data collected by NASPA (updated March 2016)
AK
WA
MT
OR
ME
ND
ID
MN
VT
WI
SD
NY
WY
MI
NV
CA
HI
UT
AZ
CO
PA
IA
NE
IL
KS*
OK
NM
MO
OH
WV VA
KY
NC
TN
AR
MS
TX
IN
AL
SC
GA
LA
One statewide protocol for pharmacists
Three or more statewide protocols for pharmacists
*Kansas is awaiting rule promulgation. Their law is vague regarding services and calls for rules to be issued
FL
NH
MA
RI
CT
NJ
DE
MD
DC
Best Practices
AS IDENTIFIED BY KEY STAKEHOLDERS
Support for Broad Collaborative Authority
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.
Support for Broad Collaborative Authority
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.
Support for Broad Collaborative Authority
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.
Support for Broad Collaborative Authority
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 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
Collaborative Practice Workgroup
Flexible
Framework
State laws
and
regulations
should
allow/
include:
Agreements between pharmacists and any prescriber
Single or multiple pharmacists/prescribers on one agreement
Single, multiple and populations of patients on one agreement
Agreements that can authorize initiation and modification of drug therapy
Any medication to be managed under the agreement, including controlled
substances
Agreement should be available, upon request, to the Board of Pharmacy
Building Consensus on Statewide Protocols
Step 1
Step 2
Step 3
Step 4
• Stakeholder meeting
• Develop consensus based document containing:
• Recommendations for the model elements of statewide protocol authority
• A template for what elements should be included in the clinical protocol used for pharmacist prescribing under a statewide
protocol
• Develop model language based on the consensus based model elements
• Develop sample/model protocols that could be used as a ready-to-go resource for states enacting statewide protocols
Patient-Specific
CPA
PopulationSpecific CPA
Statewide
Protocol
Unrestricted
(CategorySpecific)
What Can You Do?
Advocate
Support
Learn
Self-Assessment Questions
True or False:
◦ Nearly all states currently allow pharmacist prescriptive authority for at least 1 category of
medication.
◦ True! Nearly all states allow CPAs, have a statewide protocol or a limited formulary.
◦ Patient-specific collaborative practice agreements provide a prescription framework for both
acute and chronic disease.
◦ True—sort of. Though you could technically develop a patient specific CPA for acute conditions (think of a child who
repeatedly gets strep throat) they are best suited for chronic disease management.
◦ Autonomous models of pharmacist prescribing are currently focused on the treatment of
chronic diseases.
◦ False. Autonomous models of pharmacist prescribing—like statewide protocols and unrestricted (category-specific)
prescribing—are best used for public health purposes such as preventive care.
Self-Assessment Questions
True or False:
◦ There are no non-pharmacy organizations who have publically supported the concept of
pharmacist collaborative practice authority.
◦ False! This concept has seen support from many non-pharmacy organizations.
◦ The Collaborative Practice Workgroup recommended that state laws and regulations be very
prescriptive with regards to collaborative practice authority because increased pharmacist
autonomy could be a risk to patient safety.
◦ False! The Workgroup recommended that laws and regulations be flexible to allow for innovation.
◦ Clinical competencies vary from one practitioner to another based on that practitioners
education, training, and experiences.
◦ True! And this supports the idea of providing flexibility in scope of practice laws and regulations to allow for
innovation while maintaining an expectation of provider responsibility for patient safety
Reimagining
Pharmacist
Scope of
Practice
K RYSTALYN W EAV ER, P HA R M D
V I CE P R ESIDENT, P OL I CY & OP E R ATI ONS
N AT IONA L A L L I A NCE OF STATE P HA R MACY
A S S OCIATIONS
E MAI L: KWEAV [email protected]
T W I T TER: @ STATEPHAR MACY
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