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

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

Defining Scope of Practice 1 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 2.16.16 2 3

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

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

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

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

Individualized scope of practice?

Provider responsibility 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 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.

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

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

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

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.

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

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.

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

Prevalence Of pharmacist prescribing authority in the US

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

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

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

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

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

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 Framework should be flexible to facilitate innovation in care delivery Decided by Individual Providers Safeguards should be established to ensure optimal patient care

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

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 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; 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 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; 166-173.

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 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; 166-173.

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; 166-173.

Increased access to valuable care Local innovation Provider responsibility Legal flexibility

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

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 Krystalyn Weaver, PharmD Vice President, Policy & Operations National Alliance of State Pharmacy Associations Email: kweaver@naspa.us Twitter: @Statepharmacy Check out www.NASPA.us for more information!