1. NACDS Institute: Expanding Pharmacy Care - Innovative Models from the US & Abroad August 22, 2015

2. Institute Agenda –Changing Your Business Model for Future Success: Linda Garrelts McLean, RPh, CDE Associate Dean & Professor, Washington State University College of Pharmacy –Community Pharmacy Practice in Canada: Expanding Scope and Overcoming Barriers: David Edwards, PharmD, MPh Associate Dean & Hallman Director, University of Waterloo School of Pharmacy –Trends in Collaborative Practice Authority: Krystalyn Weaver, PharmD Director of Policy and State Relations, NASPA

3. Changing Your Business Model for Future Success Linda Garrelts MacLean, RPh, CDE Clinical Professor and Associate Dean Washington State University Spokane, WA lmaclean@wsu.edu

4. What would your business plan look like if…… ……. Your pharmacy was paid to keep people healthy? ……. Your pharmacists increased access to primary care?

5. Instead of…… ……. Solely dispensing drugs?

6. Health Care Reform Aims  Better population health  Improved health care, including access  Decreased costs Better Care Better Health Affordable Care

7. Making the case Why is pharmacy needed at the table? Where are the gaps?

8. How... Create a plan to overcome potential challenges associated with non-traditional pharmacy

9. Craft and execute collaborative drug therapy agreements which support a pharmacist to function as a provider.

10. Strategy… Implement pharmacist delivered care to increase access to primary care

11. Collaborate with other members of the healthcare team …. to successfully implement a model of care in which the pharmacist practices at the top of the pharmacy license.

12. Construct ….  a reimbursement model of compensation for these services that increases profits.

13. Research Project: INCREASE ACCESS TO QUALITY PATIENT CARE IN COMMUNITY PHARMACIES FOR MINOR ILLNESSES IN WASHINGTON STATE

14. Three phase analysis assessing feasibility and comparing care  3-phase analysis that will assess feasibility and compare care provided by clinical community pharmacists for 20 minor ailments and conditions with care received in other care settings: physician offices, urgent care clinics, and emergency departments.

15. Three phase analysis assessing feasibility and comparing care provided by the pharmacist for minor ailments and conditions to three other care settings.

16. -Minor emergency -Physician office -Emergency department

17. Conditions included in the study  Bronchospasm, wheezing, shortness of breath from asthma or COPD  Animal Bite (Human, Dog, or Cat)  Eye or nasal symptoms from seasonal allergies or other allergic conditions  Herpes virus infections (cold sores, genital herpes, shingles)  Allergic reactions from bee stings (not anaphylactic)  Acute otitis media  Anaphylactic allergic reactions  Lacerations and abrasions  Nausea and vomiting (not related to motion sickness)  Contraceptive pregnancy prevention  Conjunctivitis  Nausea and vomiting caused by motion sickness  Wound infections from burns  Migraine headaches  Ear infections caused by bacteria  Lack of fluoride for oral health  Diarrhea that occurs while traveling  Uncomplicated urinary tract infections  Vaginal yeast infections  Streptococcal pharyngitis

18. Feasibility and Sustainability Phase One

19. Superiority analysis of pharmacy site costs versus costs from the alternate care settings. Phase Two

20. Equivalence analysis among care settings for quality of care of health outcomes per ailment or condition. Phase Three

21. Partners  Health plan  Community pharmacies in Spokane, Seattle and Vancouver I-5 corridor

22. Fixing Healthcare Can be as Close as Your Neighborhood Pharmacy! http://www.forbes.com/sites/johnnosta/2014/04/10/ fixing-healthcare-can-be-as-close-as-your- neighborhood-pharmacy/

23. How do we determine value? Value COST QUALITY What you receive What you pay

24. “As leaders we must think and act in transformative ways to advance the profession, ultimately improving health.” -Acting Surgeon General RADM Scott Giberson

25. Thank you! Questions for the team? Julie Akers Julie.akers@wsu.edu

26. Community Pharmacy Practice in Canada: Expanding Scope and Overcoming Barriers David Edwards, PharmD, MPH Director, School of Pharmacy University of Waterloo

27. Health Care in Canada Universal coverage for medically necessary health care services (excludes dental, vision care) Primarily paid for and delivered by provinces Health care spending 40- 50% of provincial budgets

28. Major Health Care Expenditures 28

29. Who pays for medications? Public funding ~ 40% Over age 65, unemployed, low income Private Insurance ~ 40% Provided by many employers Out of pocket payment ~20% Includes co-pays and payments by uninsured for medications

30. Pharmacy Practice in Canada As of January 2014: 37,490 registered pharmacists in Canada (~ 1 pharmacist per 1,000 citizens) 75% of pharmacists practice in community pharmacy 9,558 community pharmacies Mix of chain (Shoppers Drug Mart, Rexall), banner, franchise, grocery and independent pharmacies

31. Rationale for Expanded Scope of Pharmacy Practice Governments as the primary payer want: Improved access to health care, reduced wait times More cost-effective health care Patient-focused care, improved co-ordination Expanded scope benefits patients and frees up physician time for other tasks

32. Pharmacists Scope of Practice 2005

33. Pharmacists Scope of Practice 2015 http://www.pharmacists.ca/index.cfm/pharmacy-in-canada/scope- of-practice-canada/

34. What can Pharmacists Do? Pharmacists in many provinces can: Renew and Extend Prescriptions (chronic conditions) Adapt Prescriptions (change dose, formulation) Therapeutic Substitution (eg. one ACE inhibitor to another) Prescribe for minor ailments (eg. acne, allergic rhinitis, dysmenorrhea, headache, GERD, oral thrush, superficial skin infections, erectile dysfunction)

35. What can Pharmacists Do? Pharmacists in many provinces can: Order and interpret lab tests Administer a drug by injection eg. immunizations Provide emergency prescription refills Initiate Prescription Therapy (need Additional Prescribing Authority designation – Alberta; limited to smoking cessation treatment in Ontario)

36. Alberta – The Promised Land (for Pharmacy)

37. Expanded Scope Varies by Province ServiceAlbertaOntarioSask. Emergency RefillsYes Renew/extend prescriptionsYes Change dosage/formulationYes Therapeutic SubstitutionYesNoYes Minor Ailment PrescribingYesNoYes Initiate Prescription TherapyYesSmoking Cessation Order and interpret lab testsYesPending Administer a drug by injectionYesFlu Vaccine Only Pending http://www.pharmacists.ca/index.cfm/pharmacy-in-canada/scope-of-practice-canada /

38. Payment for Professional Services ServiceOntarioAlbertaSask. Medication Reviews$60$60/$65$60 Advanced Medications Reviews (diabetes, long-term care, etc.) $75-$150$100/$125 Medication Review Follow-up$25$20/$25 Immunization$7.50$20 Adapt or renew prescription0$20$6 Refusal to fill0$201.5 x DF Pharmaceutical Opinion$15 Therapeutic Substitution$200 Minor Ailments$18 Smoking Cessation$125/yr$300/yr Emergency Refill0$20$10

39. Supporting Expanded Scope: Regulated Pharmacy Technicians Most provinces have regulated pharmacy technicians Accountable and responsible for the technical aspects of both new and refill prescriptions, (i.e. the correct patient, drug dosage form/route, dose, doctor) Liability for actions Independent double check Ability to receive/transfer Rxs

40. Embracing the Opportunity? Immunizations, medication reviews widely available in pharmacies but ….. Many pharmacists are not adapting or renewing prescriptions or doing therapeutic substititions Fear of disrupting the health care hierarchy, relationship with physicians Two years after govt. approval, only 30% of Ontario pharmacies offer smoking cessation services (Wong et al., Can Pharm J 2015: 148: 29-40) Number of pharmacists applying for advanced prescribing authority has been low but increasing …

41. Embracing the Opportunity? Not so fast …. www.pharmacists.ca/index.cfm/education-practice-resources/pharmacy-practice-research/ canadian-pharmacy-practice-research-group/cpprg-webinars/cpprg-webinar-archives

42. Barriers to Implementing Professional Services Pharmacist Perspective Workload, too little time (lack of support staff) Workflow Pharmacy design/lack of privacy Lack of training/expertise/competence Not enough reimbursement Conflict between business model and clinical practice model Billing numbers for pharmacist employees, salary incentives for professional services Interference with patient-physician relationship Personality characteristics of pharmacists

43. Are Pharmacists the ultimate barrier to practice change? Current pharmacy culture Product-focused (thorough, careful, attentive to detail) Information gatherer and disseminator Paralysis in the face of ambiguity Uncomfortable with clinical decision-making Lack of confidence, reluctant to take responsibility for patient care decisions Rosenthal et al. Can Pharm J 2010; 143: 37-42

44. Barriers to Expanded Scope Government/payor perspective Failure to practice to full extent of current scope Inconsistency in delivery of professional services in a highly visible profession Turf battles between professions CMA resolution in 2007: “the right to prescribe medications independently for medical conditions must be reserved for qualified practitioners who are adequately trained to take a medical history, perform a physical examination, order and interpret appropriate investigations, and arrive at a working diagnosis.” Limited evidence in support of the value of expanded professional services

45. Ongoing Research into Professional Pharmacy Services Ontario Pharmacy Research Collaborative provide evidence of the quality, outcomes and value of recent and emerging medication management services provided by Ontario pharmacists Funded by Ministry of Health ($5.8 million dollars over 3 years) Canadian Foundation for Pharmacy The evaluation of pharmacy prescribing for minor ailments – the clinical and economic value The impact of community pharmacist interventions in hypertension management on patient outcomes: A randomized controlled trial

46. Shifting the Focus from Product to Patient: The Role of Academia

47. The Role of Academia 1.Provide a curriculum that recognizes that most graduates will practice in the community Strong community experiences to develop decision-making skills and responsibility for patient care 2.Hire faculty members with community pharmacy expertise and interest in practice-based research 3.Recruit and admit students with an aptitude for patient- focused medication management Communication skills, critical thinking, problem-solving

48. Summary Alignment of interests of government (primary payer) and profession has resulted in significant expansion of scope of practice Pharmacists have been inconsistent in adopting expanded scope due to real and perceived barriers Academia has an important role in recruiting and preparing the patient-focused pharmacist of the future

49. Trends in Collaborative Practice Authority Krystalyn Weaver, PharmD

50. 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.

51. Collaborative Practice Agreements Creates formal relationship between pharmacists and physicians or other providers Defines certain patient care functions that a pharmacist can autonomously provide under specified situations and conditions Many are used to expand the depth and breadth of services the pharmacist can provide to patients and the healthcare team

52. Components of a CPA Authority Statute/Regulations Define collaborative practice authority and restrictions HIGHLY variable Agreement Defined by collaborating practitioners Defines the conditions of the relationship, delegation of authority/expansion of scope, defines the parties Legal document Protocol Defines the clinical parameters for the provision of care Varying degrees of detail May or may not be required by state laws/regulations

53. Existing Landscape Collaborative practice authority: 48 states Proposed in AL and in the works in DE Pharmacist modification of therapy: 45 states Pharmacist initiation of therapy: 39 states Allow multiple pharmacists on one agreement: 25 states Many other parameters…

54. Services/Authority Modify therapy Initiate therapy Physical assessment Order labs Interpret labs Perform lab tests Requirements Continuing education requirements Pharmacist qualifications Liability insurance Restrictions Disease state Site of practice Drug Who involved # of pharmacists # of prescribers # of patients Types of prescribers Relationship between patient and prescriber Pharmacist to prescriber ratio Procedural requirements Patient involvement Agreements approved or reported to whom Length of time agreement valid Payment provisions Documentation Physician review Elements Currently in State Law

55. Support for Collaborative Agreements 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.

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

57. Workgroup Objective Develop a set of elements that are considered to be the best practice for inclusion in collaborative practice provisions Developed through a consensus based process by a panel of experts convened by NASPA Can then be used as a resource for those advocating for changes to their collaborative practice provisions in their state

58. Committee Participants State/NationalOrganizationName NationalNACDSAlex Adams NationalAPhAAnne Burns NationalNCPACarolyn Ha NationalASHPDouglas Scheckelhoff NationalACCPEd Webb NationalAACPLynette Bradley-Baker NationalACPEPete Vlasses NationalNABPScotti Russell NationalAMCPSusan Oh StateIowaAnthony Pudlo StateSouth CarolinaBryan Ziegler StateMarylandChristine Lee-Wilson StateMichiganDianne Miller StatePennsylvaniaJennifer Bacci StateMinnesotaJulie Johnson StateArizonaKelly Ridgway StateAlaskaL. Michelle Vaughn StateArizonaSandra Leal

59. Process: Developing Recommendations Step 1: Examine existing authority Step 2: Make recommendations Is this recommendation in the best interest of the patient receiving care under a collaborative agreement? Is this recommendation aligned with pharmacists’ education and training?

60. Process: Modified Delphi Method 1. Level-setting conference call2. Distribution of survey with 3 weeks to complete3. Collect and compile survey results4. Call to discuss differences of opinions5. Repeat 2-4 until consensus is reached

61. Workgroup Recommendations Participants Which providers? Which patients? Authorized services What can be done under the agreement? Requirements and Restrictions Logistics Education Others

62. 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

63. Participants Included in Laws and Regulations Any prescriber may collaborate with pharmacists Single or multiple pharmacists/prescribers may be parties to one agreement Single, multiple and populations of patients can be on one agreement Decided by Individual Providers Specifically list which pharmacists and prescribers are included in agreement Identify the pharmacist training or credentials, if any, necessary to provide delineated services Identify which specific patients or patient populations are included in agreement

64. Authorized Services Included in Laws and Regulations Initiation and modification of drug therapy can be authorized in the agreement Decided by Individual Providers Specify which disease states are being managed Specify which specific services are includes Specify if/which protocols or clinical guidelines are to be followed

65. Requirements & Restrictions Included in Laws and Regulations All medications may be managed under the agreement, including controlled substances Agreement should be available, upon request, to the Board of Pharmacy Decided by Individual Providers Specify an appropriate level of patient consent for services Specify the timeframe for renewal of agreement Specify the documentation processes Specify the liability insurance needs, if any Identify the continuing education requirements for participation

66. CPA Applications Chronic Disease Management Anticoagulation Cardiovascular disease/hypertension Diabetes Others Acute Treatment Public Health

67. Another Approach to Addressing Public Health Needs

68. Statewide Protocols Used to address public health concerns Standard across the state, applies to all pharmacists Additional pharmacist education/training could be required Allows pharmacist to prescribe for conditions with no diagnosis or that are easily diagnosed Protocols can be in law (CA) or delegate authority to state boards (OR)

69. Statewide Protocols Naloxone Immunizations Smoking Cessation Hormonal Contraceptives Travel Medications

70. Case Study: Naloxone HI AK DC MO WV MS NH NC FL KY WA SC OH CA MD DE TN MANY RI* IL CT VT NJ MI* ME MN OR ID MT ND SD NV* UT AZNM TX WY CO NE* OK KS IA WI IN PA VA AR ALGA LA Based on data collected by NASPA (updated June 2015) Statewide naloxone protocol or prescriptive authority for pharmacists Broad** collaborative practice provisions *Broad collaborative practice provisions but need a separate agreement for each pharmacist Pharmacists are authorized to dispense without a prescription Statewide protocol or prescriptive authority bill proposed in 2015 session **Broad = Allow initiation of therapy, community pharmacists authorized to participate, no drug restrictions (may need to specify within the agreement), laws/regulations silent regarding the relationship between the prescriber and the patient

71. Next Steps Examine your state’s collaborative practice authority Best interest of the patient? Aligned with pharmacist education and training? Does the current authority present barriers or opportunities to enhance patient care? Do legislative or regulatory changes need to be made?

72. Questions? Krystalyn Weaver, PharmD Director, Policy and State Relations kweaver@naspa.us