Transcript Reimagining Pharmacist Scope of Practice

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
At the end of this session, participants will be able to:
 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
Collaborative practice agreements are:
◦ A: an informal delegation of authority from a pharmacist to a pharmacy technician
◦ B: a formal relationship where a physician delegates authority to a pharmacist under negotiated
conditions
◦ C: an informal collaboration between a physician and a pharmacist
◦ D: none of the above
True or False: Nearly all states currently allow pharmacist prescriptive authority for at least
one category of medication.
◦ A: True
◦ B: False
Self-Assessment Questions
The Collaborative Practice Workgroup recommended that state laws and regulations
pertaining to collaborative practice authority should be:
◦
◦
◦
◦
A: very prescriptive because increased pharmacist autonomy could be a risk to patient safety
B: a flexible framework to facilitate innovation in care delivery
C: reversed, collaborative practice agreements are not useful for pharmacy practice
D: restricted only to the hospital setting
The following are all examples of existing statewide protocols, except:
◦
◦
◦
◦
A: immunizations
B: smoking cessation products
C: flu treatments
D: contraceptives
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
Pharmacist Scope of Practice
GENERALLY CONSISTENT ACROSS STATE LINES
Dispensing
medications
Compounding
medications
Patient counseling
Disease state
management
Drug utilization
review
OTC
Recommendations
Checking blood
pressures
Optimizing
medication regimen
value
Side effect
management
Physician referrals
Nutrition counseling
Smoking cessation
counseling
Weight
management
Medication dosing
recommendations
Dispensing
medications
Patient
counseling
Compounding
medications
Disease state
management
Formulary
management
Others??
VARIATIONS STATE TO STATE
Medication
administration
Prescriptive
authority
Order/interpret
labs
Administering
tests
What determines an individual
pharmacists’ scope in a specific state?
Detailed State
Scope Laws
Geographically
Determined
Scope
Variability
State to State
Missed
Opportunities!!!
National standards for
pharmacy education
Geographically
determined scope
of practice
Plus:
Competencies • Unused skills
change over time • Newly learned skills
Specialization
Community needs
• Certificate training programs
• On the job training
• Outbreaks
• Access
Legal flexibility
Provider responsibility
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)
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
within the pharmacy
Used for acute OR chronic disease
management OR preventive care/public
health
Chronic Care
Management
Public Health
Services
Acute Care
Medication
Adherence/
Formulary
Management
Collaborative agreements
increase efficiency
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
standing
(e.g. take it or leave it)
Promotes consistency in service provided at
pharmacy
Promotes consistency in service provided
across the state
Used for acute OR chronic disease
management OR preventive care/public health
Currently used for preventive care/public
health
A note on
Apply to patient populations
orders
Apply to patient populations
◦ Naturally inclusive of patient-specific
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
across the state
Currently used for preventive care/public
health
Currently used for preventive care/public
health
Prevalence
OF PHARMACIST PRESCRIBING AUTHORITY IN THE US

DE
States with CPA
laws
Allows initiation
of medications in
outpatient
settings
Limited to
inpatient
settings
NY
NH
Prevent initiation
of medications
NJ
PA
RI
WV
Populationspecific
Patient-specific
MA
Limited to one
prescriber
Allow multiple
prescribers
CT
MD
MA
DC
ME
VT
VA
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 August 2016)
AK
WA
MT
OR
ME
ND
ID
MN
VT
WI
SD
NY
WY
MI
NV
CA
HI
UT
AZ
CO*
IL
KS
OK
NM
TX
Two statewide protocols for pharmacists
Three or more statewide protocols for pharmacists
IN
MO
OH
WV VA
KY
NC
TN
AR
MS
One statewide protocol for pharmacists
PA
IA
NE
AL
SC
GA
LA
FL
NH
MA
RI
CT
NJ
DE
MD
DC
Best Practices and
Support
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.
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
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
Addressing Concerns
Training
Patient Safety
Conflict of Interest
Fragmentation of Care
Case Study
APPLYING A POPULATION SPECIFIC CPA: MEETING PATIENT NEEDS
AND ADDRESSING CONCERNS IN PRACTICE
Influenza CPA Study
55 pharmacies in 3 states (Michigan, Minnesota,
Nebraska).
◦ Meijer, Hometown, Hy-Vee, Thrifty White
All pharmacists completed the POC certificate
training program
All pharmacies identified a physician to sign a
population-specific collaborative practice
agreement.
Klepser ME, et al. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations
to reduce antibiotic resistance. Health Security 2015; 166-173.
Influenza CPA Study
Addressing Concerns:
Training
55 pharmacies in 3 states (Michigan,
Minnesota, Nebraska).
◦ Meijer, Hometown, Hy-Vee, Thrifty White
All pharmacists completed the POC
certificate training program
All pharmacies identified a physician to
sign a population-specific collaborative
practice agreement.
•
•
New skill: point of care testing
• Learned in a certificate training
program
Existing knowledge: clinical
management
• Signs/symptoms, flu treatment,
non-flu symptom management
with OTCs
Klepser ME, et al. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations
to reduce antibiotic resistance. Health Security 2015; 166-173.
VanLangen KM, et al. Evaluation of student pharmacists’ knowledge on influenza. Currents in Pharmacy Teaching and Learning 4 (2012) 46-51
Influenza CPA Study:
Protocol parameters
Eighteen (18) years of age or older
Complain of signs/symptoms consistent with influenza-like illness (fever/feverish AND cough OR
sore throat) that began within the past 48 hours
Positive nasal swab rapid diagnostic influenza test
Clinical stability, defined as the absence of the following:
◦
◦
◦
◦
◦
◦
Altered mental status
Systolic blood pressure < 90mmHg or diastolic blood pressure < 60mmHg
Pulse > 125 beats/minute
Respiratory rate > 30 breaths/minute
Oxygen saturation < 92% on room air
Temperature > 103°F
Klepser ME, et al. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations
to reduce antibiotic resistance. Health Security 2015; 166-173.
Influenza CPA Study:
Protocol parameters
Eighteen (18) years of age or older
Complain of signs/symptoms consistent with influenza-like illness (fever/feverish AND cough OR
sore throat) that began within the past 48 hours
Positive nasal swab rapid diagnostic influenza test
Clinical stability, defined as the absence of the following:
◦
◦
◦
◦
◦
◦
Altered mental status
Systolic blood pressure < 90mmHg or diastolic blood pressure < 60mmHg
Pulse > 125 beats/minute
Respiratory rate > 30 breaths/minute
Oxygen saturation < 92% on room air
Temperature > 103°F
Addressing Concerns:
Patient Safety
•
Klepser ME, et al. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations
to reduce antibiotic resistance. Health Security 2015; 166-173.
Clear criteria for
referring high risk
patients
Influenza CPA Study:
Patient intake and follow up
During the intake process:
◦ Patients provide demographic and health information
◦ Read and sign a consent form
◦ Clarifies that the service of screening for influenza and the subsequent prescribing of treatment is NOT tied to the dispensing of the
treatment.
After the service:
◦ CPA required notification to primary care provider
◦ If one is identified by the patient
Influenza CPA Study:
Patient intake and follow up
During the intake process:
◦ Patients provide demographic and health information
◦ Read and sign a consent form
◦ Clarifies that the service of screening for influenza and the subsequent prescribing of treatment is NOT tied to the dispensing of
the treatment.
After the service:
◦ CPA required notification to primary care provider
◦ If one is identified by the patient
Addressing Concerns:
Conflict of Interest
•
Prescription can be filled
at pharmacy of patients
choice
Influenza CPA Study:
Patient intake and follow up
During the intake process:
◦ Patients provide demographic and health information
◦ Read and sign a consent form
◦ Clarifies that the service of screening for influenza and the subsequent prescribing of treatment is NOT tied to the dispensing of the
treatment.
After the service:
◦ CPA required notification to primary care provider
◦ If one is identified by the patient
Addressing Concerns:
Fragmentation of Care
•
Notification to primary
care provider
Influenza CPA Study
Approximately 11% of patients evaluated tested positive for influenza and received antiviral
Zero patients received an antibiotic
No adverse outcomes were reported by patients in the study
44% of patients visited the pharmacy outside of established physician office hours
37.3% of patients did not identify a primary care provider
Patient satisfaction with pharmacist provided service was >90%
Klepser ME, et al. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations
to reduce antibiotic resistance. Health Security 2015; 166-173.
Influenza CPA Study
Approximately 11% of patients evaluated tested positive for influenza and received antiviral
Zero patients received an antibiotic
No adverse outcomes were reported by patients in the study
44% of patients visited the pharmacy outside of established physician office hours
37.3% of patients did not identify a primary care provider
Patient satisfaction with pharmacist provided service was >90%
Addressing Concerns:
Patient Safety
•
One study found that up
to 30% of patients
presenting with flu
inappropriately received
an antibiotic
Klepser ME, et al. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations
to reduce antibiotic resistance. Health Security 2015; 166-173.
Influenza CPA Study
Approximately 11% of patients evaluated tested positive for influenza and received antiviral
Zero patients received an antibiotic
No adverse outcomes were reported by patients in the study
44% of patients visited the pharmacy outside of established physician office hours
37.3% of patients did not identify a primary care provider
Patient satisfaction with pharmacist provided service was >90%
Addressing Concerns:
Patient Safety
•
No patient reported
adverse outcomes
Klepser ME, et al. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations
to reduce antibiotic resistance. Health Security 2015; 166-173.
Provider
responsibility
Local
innovation
Legal
flexibility
Increased
access to
valuable
care
Patient-Specific
CPA
PopulationSpecific CPA
Statewide
Protocol
Unrestricted
(CategorySpecific)
Self-Assessment Questions
Collaborative practice agreements are:
◦ A: an informal delegation of authority from a pharmacist to a pharmacy technician
◦ B: a formal relationship where a physician delegates authority to a pharmacist under negotiated
conditions
◦ C: an informal collaboration between a physician and a pharmacist
◦ D: none of the above
True or False: Nearly all states currently allow pharmacist prescriptive authority for at least
one category of medication.
◦ A: True
◦ B: False
Self-Assessment Questions
The Collaborative Practice Workgroup recommended that state laws and regulations
pertaining to collaborative practice authority should be:
◦
◦
◦
◦
A: very prescriptive because increased pharmacist autonomy could be a risk to patient safety
B: a flexible framework to facilitate innovation in care delivery
C: reversed, collaborative practice agreements are not useful for pharmacy practice
D: restricted only to the hospital setting
The following are all examples of existing statewide protocols, except:
◦
◦
◦
◦
A: immunizations
B: smoking cessation products
C: flu treatments
D: contraceptives
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
Check out www.NASPA.us for more information!