1. Reimagining Pharmacist Scope of Practice
Krystalyn Weaver, PharmD
VP, Policy & Operations
National Alliance of State Pharmacy Associations

2. 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.

3. About NASPA
The National Alliance of State Pharmacy Associations (NASPA), founded in 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.

4. 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.

5. 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

6. 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

7. Defining Scope of Practice1
Defining Scope of Practice
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.
McGraw-Hill Concise Dictionary of Modern Medicine, © 2002 The McGraw-Hill Companies, Inc
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 3

8. Pharmacist Scope of Practice
Generally Consistent across state lines
Variations state to state
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
Formulary management
Others??
Medication administration
Prescriptive authority
Order/interpret labs
Administering tests
Dispensing medications
Compounding medications
Patient counseling
Disease state management
Medication administration
Prescriptive authority
Order/interpret labs
Administering tests
Dispensing medications
Compounding medications
Patient counseling
Disease state management

9. What determines an individual pharmacists’ scope in a specific state?
Detailed State Scope Laws
Variability State to State
Geographically Determined Scope

10. Missed Opportunities!!! National standards for pharmacy education
Geographically determined scope of practice

11. Competencies change over time
Plus:
Unused skills
Newly learned skills
Competencies change over time
Certificate training programs
On the job training
Specialization
Outbreaks
Access
Community needs

12. Individualized scope of practice?

13. Provider responsibility
Legal flexibility
Provider responsibility

14. Pharmacist Prescribing

15. 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):

16. Continuum of Pharmacist Prescriptive Authority
Collaborative Prescribing
Patient-Specific CPA
Population-Specific CPA
Statewide Protocol
Unrestricted (Category-Specific)
Autonomous Prescribing
Most Restrictive
Least Restrictive
Adams AJ, Weaver KK. The Continuum of Pharmacist Prescriptive Authority. Annals of Pharmacotherapy. In Press.

17. Collaborative Prescribing
Patient-Specific CPA
Population-Specific CPA
Requires a partnering prescriber
Voluntarily negotiated
Applies to individual patients
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
Requires a partnering prescriber
Voluntarily negotiated
Applies to patient populations
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

18. Chronic Care Management Public Health Services
Acute Care
Medication Adherence/ Formulary Management

19. Collaborative agreements are not essential for collaborative care
Collaborative agreements increase efficiency

20. Continuum of Pharmacist Prescriptive Authority
Collaborative Prescribing
Patient-Specific CPA
Population-Specific CPA
Statewide Protocol
Unrestricted (Category-Specific)
Autonomous Prescribing
Most Restrictive
Least Restrictive
Adams AJ, Weaver KK. The Continuum of Pharmacist Prescriptive Authority. Annals of Pharmacotherapy. In Press.

21. Crossing Over A note on standing orders Population-Specific CPA
Collaborative Prescribing
Autonomous Prescribing
Crossing Over
Population-Specific CPA
Statewide Protocol
Requires a partnering prescriber
Voluntarily negotiated
Apply to patient populations
Naturally inclusive of patient-specific
Promotes consistency in service provided at pharmacy
Used for acute OR chronic disease management OR preventive care/public health
Does not require a partnering prescriber
Issued by an authorized body of the state (e.g. take it or leave it)
Apply to patient populations
Promotes consistency in service provided across the state
Currently used for preventive care/public health
A note on standing orders

22. Continuum of Pharmacist Prescriptive Authority
Collaborative Prescribing
Patient-Specific CPA
Population-Specific CPA
Statewide Protocol
Unrestricted (Category-Specific)
Autonomous Prescribing
Most Restrictive
Least Restrictive
Adams AJ, Weaver KK. The Continuum of Pharmacist Prescriptive Authority. Annals of Pharmacotherapy. In Press.

23. Autonomous Prescribing
Statewide Protocol
Unrestricted (Category-Specific)
Does not require a partnering prescriber
Issued by an authorized body of the state (e.g. take it or leave it)
Apply to patient populations
Promotes consistency in service provided across state
Currently used for preventive care/public health
Does not require a partnering prescriber
No restriction on authority (except for clinical guidelines)
No explicit restriction on patient populations
Promotes consistency in service provided across the state
Currently used for preventive care/public health

24. Prevalence
Of pharmacist prescribing authority in the US

25. Most Restrictive Least Restrictive
States with CPA laws
Limited to inpatient settings
Prevent initiation of medications
Allows initiation of medications in outpatient settings
Patient-specific
Limited to one prescriber
Allow multiple prescribers
Population-specific  DE NY NH DC ME VT VA NJ PA RI WV MA CT MD MA
Most Restrictive
Least Restrictive

26. Prescribing Under a CPA
Based on data collected by NASPA (updated Dec 2015) AK WA ME MT ND NH MN VT OR MA WI ID SD NY RI WY MI CT PA IA NJ NV NE OH IN DE UT IL WV MD CA CO VA
KS* MO DC KY NC TN OK AZ NM AR SC HI AL GA MS TX LA FL
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

27. Prescribing Under a CPA in the Community
Based on data collected by NASPA (updated Dec 2015) AK WA ME MT ND NH MN VT OR MA WI ID SD NY RI WY MI CT PA IA NJ NV NE OH IN DE UT IL WV MD CA CO VA
KS* MO DC KY NC TN OK AZ NM AR SC HI AL GA MS TX 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

28. Population-Specific CPA in the Community
Based on data collected by NASPA (updated Dec 2015) AK WA ME MT ND NH MN VT OR MA WI ID SD NY RI WY MI CT PA IA NJ NV NE OH IN DE UT IL WV MD CA CO VA
KS* MO DC KY NC TN OK AZ NM AR SC HI AL GA MS TX 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

29. Prescribing Under a Statewide Protocol or Unrestricted (Category-Specific) Authority
Based on data collected by NASPA (updated August 2016) AK WA ME MT ND NH MN VT OR MA WI ID SD NY RI WY MI CT PA IA NJ NV NE OH IN DE UT IL WV MD CA
CO* VA KS MO DC KY NC TN OK AZ NM AR SC HI AL GA MS TX LA
One statewide protocol for pharmacists
Two statewide protocols for pharmacists
Three or more statewide protocols for pharmacists FL

30. Best Practices and Support
As identified by key stakeholders

31. 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.

32. Collaborative Practice Workgroup
Convened by the National Alliance of State Pharmacy Associations

33. Workgroup Recommendations
Included in Laws and Regulations
Framework should be flexible to facilitate innovation in care delivery
Decided by Individual Providers
Safeguards should be established to ensure optimal patient care

34. Building Consensus on Statewide Protocols
Step 1
Stakeholder meeting
Step 2
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
Step 3
Develop model language based on the consensus based model elements
Step 4
Develop sample/model protocols that could be used as a ready-to-go resource for states enacting statewide protocols

35. Addressing Concerns Training Patient Safety Conflict of Interest
Fragmentation of Care

36. Case Study
Applying a Population Specific CPA: meeting patient needs and addressing concerns in practice

37. 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;

38. Influenza CPA Study Addressing Concerns: Training
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
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;
VanLangen KM, et al. Evaluation of student pharmacists’ knowledge on influenza. Currents in Pharmacy Teaching and Learning 4 (2012) 46-51

39. 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;

40. 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
Clear criteria for referring high risk patients
Klepser ME, et al. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations
to reduce antibiotic resistance. Health Security 2015;

41. 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

42. 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

43. 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

44. 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;

45. Influenza CPA Study Addressing Concerns: Patient Safety
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;

46. Influenza CPA Study Addressing Concerns: Patient Safety
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;

47. Increased access to valuable care Local innovation
Provider responsibility
Legal flexibility

48. Reimagining Scope of Practice Provider responsibility
Patient-Specific CPA
Population-Specific CPA
Statewide Protocol
Unrestricted (Category-Specific)
Legal flexibility
Provider responsibility

49. 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

50. 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

51. Reimagining Pharmacist Scope of Practice
Krystalyn Weaver, PharmD
Vice President, Policy & Operations
National Alliance of State Pharmacy Associations
Check out for more information!