State Practice Act Changes Pharmacist Prescriptive Authority Trends Krystalyn Weaver, PharmD VP, Policy & Operations National Alliance of State Pharmacy Associations

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. June 2016.

Collaborative Practice Agreements Formal Relationship Delegation Negotiated Conditions

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

Collaborative Prescribing Patient- Specific CPAs Population-Specific CPAs

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

A Note on Standing Orders Product Specific CPA or Statewide Protocol?

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 Used for conditions that do not require a specific diagnosis 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 at pharmacy 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

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 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 March 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 Three or more statewide protocols for pharmacists FL *Kansas is awaiting rule promulgation. Their law is vague regarding services and calls for rules to be issued

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.

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

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

State Practice Act Changes Pharmacist Prescriptive Authority Trends Krystalyn Weaver, PharmD Vice President, Policy & Operations National Alliance of State Pharmacy Associations Email: kweaver@naspa.us Twitter: @Statepharmacy