Collaborative Practice: One giant leap for Maine Pharmacy!

1. Collaborative Practice: One giant leap for Maine Pharmacy! Brian Marden, PharmD Kenneth McCall, PharmD

2. The Maine Experience

3. What is your primary pharmacy practice setting? • Community • Health-systems • Long-term care • Academia • Other

5. LD 1134: An Act To Allow Collaborative Practice Agreements betweenAuthorized Practitioners and Pharmacists

6. Why Collaborative Drug Therapy Management? • CDTM is a team approach to providing continuous health care management • Maximizes the different areas of expertise of both pharmacists and physicians to achieve optimal patient care outcomes Collaborative Drug Therapy Management: A Coordinated Approach to Patient Care. Alliance for Pharmaceutical Care. http://www.pharmacist.com/AM/Template.cfm?Section=Home2&Template=/CM/ContentDisplay.cfm&ContentID=11866

7. Goals of CDTM • Decrease health care costs and utilization while improving patient outcomes • Increasing patient education, engagement and medication adherence • Improving patient safety by decreasing adverse drug events

8. Why Pharmacists? • Education is unique and establishes expertise in the comprehensive management of disease through medication use • ~80% of chronic disease management consists of targeted drug therapy • Estimated that ~50% of patients receiving drug therapy, for a chronic condition, do not adhere to their medication regimen • “Drugs don’t work in people that don’t take them.” - Dr. C. Everett Koop (former U.S. Surgeon General) • “..pharmacists are the most underutilized members of the health care team.” - George Halvorson (Chairman/CEO Kaiser)

9. CDTM - History • 1960’s - Indian Health Services developed pharmacist-managed healthcare programs • 1970’s – Veteran’s Administration credentialed pharmacists as primary care providers • 1974 – Health, Education and Welfare Department enact a drug regimen review regulation for nursing homes • 1984 study showed residents in prescribing pharmacist groups used fewer drugs and had lower mortality rates, more frequent transfers to lower levels of care, and lower costs of care • 1993 – seven states recognized pharmacists’ collaborative care abilities • 1995 – Veterans Health Administration began allowing pharmacists with advanced training to participate in CDTM, with the scope of practice determined at the practice site • 1996 – Improve Persistence and Compliance with Therapy project (ImPACT) is initiated, and its results showed significant benefit to care for patients with lipid disorders managed by pharmacists • 2008 – 46 states allow some level of pharmacist CDTM • 2009 – All 50 states allow pharmacists to administer at least some immunizations

10. Paving the way for CDTM • 1972 – California • 1979 – Washington • 1980 – Oregon • 1980 – Mississippi • 1986 – Florida • 1991 - Michigan • 1993 – New Mexico Koch KE. Trends in Collaborative Drug Therapy Management. 1 Jan 2000. www.medscape.com

11. Evidence in favor of CDTM

12. Letter from U.S. Surgeon General Regina Benjamin, MD, MBA(response to 2011 USPHS pharmacy practice report) • The report demonstrates through evidence-based outcomes, that many expanded pharmacy practice models (implemented in collaboration with physicians or as part of a health team) improve patient and health system outcomes and optimize primary care access and delivery www.usphs.gov/corpslinks/pharmacy

13. Letter from U.S. Surgeon General Regina Benjamin, MD, MBA(response to 2011 USPHS pharmacy practice report) • Health leadership and policy makers should further explore ways to optimize the role of pharmacists to deliver a variety of patient-centered care and disease prevention, in collaboration with physicians or as part of the healthcare team. The collaborative pharmacy practice models can be implemented to manage and prevent disease, improve health care delivery and address some of the current demands of the health care system www.usphs.gov/corpslinks/pharmacy

14. Letter from U.S. Surgeon General Regina Benjamin, MD, MBA(response to 2011 USPHS pharmacy practice report) • Utilization of pharmacists as an essential part of the healthcare team to prevent and manage disease in collaboration with other clinicians can improve quality, contain costs, and increase access to care. • Recognition of pharmacists as health care providers, clinicians and an essential part of the healthcare team is appropriate given the level of care they provide in many health care settings. • Compensation models, reflective of the range of care provided by pharmacists, are needed to sustain these patient oriented, quality improvement services. This may require further evolution of legislative or policy language and additional payment reform considerations. www.usphs.gov/corpslinks/pharmacy

15. NC – The Ashville Project • The Asheville Project® began in 1996 as an effort by the City of Asheville, North Carolina, a self-insured employer, to provide education and personal oversight for employees with chronic health problems such as diabetes, asthma, hypertension, and high cholesterol • Pharmacists developed thriving patient care services in their community pharmacies from which diabetic patients began experiencing improved A1C levels, lower total health care costs, fewer sick days, and increased satisfaction with their pharmacist’s services • The Asheville Project has inspired a new health care model for individuals with chronic conditions.  The Asheville model is payer-driven and patient-centered.  Employers are adopting this approach as an additional health care benefit to empower their employees to control their chronic diseases, reduce their health risks, and ultimately lower their health care costs http://www.theashvilleproject.net/home

16. The Ashville ProjectAsthma Care • Conclusion: “A community-based asthma disease management program that provided asthma education, financial incentives, and face-to-face counseling by specially trained community pharmacists resulted in significant improvements in clinical, humanistic, and financial outcomes. • After participation in the program, patients were significantly less likely to have an asthma-related ED visit or hospitalization, and the health plans experienced significant reductions in net health care costs.” The Asheville Project: Long-Term Clinical, Humanistic, and Economic Outcomes of a Community-Based Medication Therapy Management Program for Asthma. J Am Pharm Assoc. 2006;46:133-147. http://www.theashevilleproject.net/research.

17. Ashville Project - Asthma The Asheville Project: Long-Term Clinical, Humanistic, and Economic Outcomes of a Community-Based Medication Therapy Management Program for Asthma. J Am Pharm Assoc. 2006;46:133-147. http://www.theashevilleproject.net/research.

19. The Ashville Project • What is the Return on Investment (ROI) seen by the City?Results of published data indicate that the City saves about $4.00 for every $1.00 they invest in the program.  These results have been fairly consistent across the board for other businesses who have appropriately implemented the model http://www.theashvilleproject.net

21. Project ImPACT • Project ImPACT (Improve Persistence and Compliance with Therapy) is a process of care requiring a collaborative effort among three essential health care parties: the patient (or caregiver), the patient's physician, and the pharmacist • Project ImPACT demonstrates pharmacist's drug therapy management skills can have a significant impact on the health outcomes of patients • APhA has currently established the Project ImPACT care model in the following disease states: • Hyperlipidemia, osteoporosis, depression, hypertension http://www.pharmacist.com/Content/NavigationMenu/ResearchProjects/ProjectImPACT/default.htm

22. Project Impact Practice Model • The Project ImPACT practice model is based upon the following mutual health care goals that include the desire to: • Improve patient care • Improve communication and feedback between • patient and pharmacist • pharmacist and physician • physician and patient • Increase the availability of measures to demonstrate improved outcomes (surrogate markers like compliance, risk reduction, etc.) • Reduce total cost for care to the system over time (absolute endpoints) http://www.pharmacist.com/Content/NavigationMenu/ResearchProjects/ProjectImPACT/default.htm

23. Project ImPACT: Hyperlipidemia • This study aims to demonstrate that pharmacists, working collaboratively with patients and physicians, can promote patient persistence and compliance with prescribed dyslipidemic therapy that enables patients to achieve their National Cholesterol Education Program (NCEP) goals • The study utilized 26 community-based ambulatory care pharmacy practices and nearly 400 patients for an average of 24 months per patient to evaluate rates of patient persistence and compliance with medication therapy and achievement of target therapeutic goals • As a result of this initiative, persistence and compliance with medication therapy were 93.6% and 90.1%, respectively, and 62.5% of patients had reached and were maintained at their NCEP lipid goal at the end of the project • The study concluded that working collaboratively with patients, physicians, and other health care providers, pharmacists can provide an advanced level of care that results in successful management of dyslipidemia Blum BM, Cziraky MJ, McKenney JM. Pharmaceutical Care Services and Results in Project Impact: Hyperlipidemia. J Am Pharm Assoc. 200;40:157-65. http://www.pharmacist.com/AM/Template.cfm?Section=Project_ImPACT&Template=/CM/ ContentDisplay.cfm&ContentID=21487.

24. Project Impact: Hyperlipidemia • Project Impact helped to establish a model of practice that: • Provided a seamless flow of patient care data between patients, pharmacists and physicians • Showed that point-of-care testing can be used to obtain timely, objective information about a patient’s therapy progress in community settings • Organized a method for pharmacists to document, interpret, and report their interventions Blum BM, Cziraky MJ, McKenney JM. Pharmaceutical Care Services and Results in Project Impact: Hyperlipidemia. J Am Pharm Assoc. 200;40:157-65. http://www.pharmacist.com/AM/Template.cfm?Section=Project_ImPACT&Template=/CM/ ContentDisplay.cfm&ContentID=21487.

25. Pharmacist Value • Pharmacists yield a great return on investment! • Likely why USPHS and other large integrated managed care organizations are widely utilizing for clinical expertise • Numerous studies over decades have demonstrated average benefit gained was $10 for every $1 invested in clinical pharmacy services! Perez, et al. Pharmacotherapy 2008;28:285-323.

26. The Asheville Project demonstrated all the following outcomes except: • Reduction in Asthma related costs • Increase in hospitalizations • Reductions in average HgbA1c • Fewer employee sick days

27. State-by-State examples of CDTM rules and regulations

28. CDTM restricted to specific practice sites No CDTM established CDTM established without practice site restrictions CDTM limited to emergency contraception State medical practice act interpreted to allow CDTM

29. New Hampshire • Pharmacists may administer drugs by injection upon completion of a board-recognized training program • Collaborative Practice may be performed only in hospitals, long-term care facilities, hospice settings, or ambulatory care clinics with onsite practitioner supervision • Protocol development is detailed and specific • Must be reviewed every 2 years • Pharmacists must complete 5 contact hours of CE requirements within their area of CDTM practice yearly http://www.gencourt.state.nh.us/rsa/html/XXX/318/318-16-a.htm

30. Massachusetts • Board of Registration in Medicine and Board of Registration in Pharmacy involved in policy implementation • Collaborative practice regulations outlined for each practice area – limited practices outlined for community pharmacy settings • Guidelines for written patient referral and patient consent in community settings • The Board issued a sample CPA for any setting • Specifies physician and pharmacist qualifications for CDTM practices as well as CE requirements • Required agreement terms for all practice settings are outlined • Biannual renewal and plans for termination are outlined to allow for uninterrupted continuation of care Http://www.lawlib.state.ma.us/source/mass/cmr/247cmr.html

31. Connecticut • Restricted to hospital outpatient and nursing home patients • Disease states are limited in hospital outpatient setting to: • Diabetes, asthma, HTN, hyperlipidemia, osteoporosis, CHF, smoking cessation • Written protocols required to be very specific and individualized to the particular patient. • A 2006-2008 pilot program for 10 pharmacists to manage drug therapy of individual patients receiving therapy for diabetes, asthma, hypertension, hyperlipidemia, osteoporosis, congestive heart failure, or smoking cessation was established within community pharmacy settings •  intended to demonstrate the safety and effectiveness of collaborative practice in the community setting in Connecticut http://www.cga.ct.gov/2011/pub/chap400j.htm

32. Ohio • Pharmacists and physicians may enter into a consult agreement allowing pharmacists to manage an individual’s drug therapy • Limited to monitoring and modifying of a prescription • A separate consult agreement must be arranged for each individual patient, and must be signed by the patient or their care giver • Prior to any action, pharmacist shall make reasonable attempts to confer with physician. May commence action without conferring but shall immediately cease action taken if pharmacist has not conferred with physician within 48 hours. • Pharmacists may not substitute drugs or dispense a drug that has not been prescribed by the physician • The pharmacist must contact the prescriber in writing at intervals specified in the consult agreement, and ALL records must be kept for 3 years http://www.pharmacy.ohio.gov/phreq.htm

33. North Carolina • NC establishes Clinical Pharmacist Practitioners (CPP) that are approved to provide drug therapy management – including controlled substances – under the supervision of licensed physicians who provide written instructions for a patient and disease specific therapy • Includes ordering, changing, and substituting therapies; ordering necessary tests • Only pharmacists approved by the Pharmacy Board and Medical Board may legally identify themselves as a CPP • Supervising physician is held accountable for patient outcomes, and must countersign all pharmacist initiatives • Very lengthy CPP application for approval http://www.ncbop.org/lawandrules.htm

34. South Carolina • "Pharmacist" means an individual health care provider licensed by this State to engage in the practice of pharmacy. A pharmacist is a learned professional authorized to provide patient care services within the scope of his knowledge and skills   • "Pharmacy care" is the direct provision of drug therapy and other pharmacy patient care services through which pharmacists, in cooperation with the patient and other health care providers, design, implement, monitor, and manage therapeutic plans for the purpose of improving a patient's quality of life. Objectives include cure of disease, elimination or reduction of a patient's symptomatology, arresting or slowing a disease process, or prevention of a disease or symptomatology. The process includes three primary functions:  • identifying potential and actual drug-related problems;  • resolving actual drug-related problems; and  • preventing potential drug-related problems • SC does not specify need for protocols and does not use the term “collaborative practice” http://www.scstatehouse.gov/code/t40c043.php

35. Washington • Pharmacists may initiate or modify drug therapy in accordance to written guidelines or protocols established with a practitioner authorized to prescribe drugs. • Protocol must include types of diseases, drugs or drug categories involved, type of prescriptive authority, decision or plan criteria and documentation/communication plan. http://www.doh.wa.gov/hsqa/professions/pharmacy/laws.htm

36. New Mexico • Has Pharmacist Clinician (PC) registration classification • 60 hrs board approved physical assessment course • 150 hrs (300 patient contact) preceptorship supervised by practitioner with prescriptive authority • Protocol with supervising practitioner required (detailing drugs, diseases, decision criteria, etc.) http://www.rld.state.nm.us/pharmacy/ruleslaw.html

37. Florida • Pharmacy Practice Act • Creates a drug formulary from which pharmacists have the authority to prescribe • Pharmacist Formulary product examples: -oral analgesics; limited to a 6 day supply-urinary analgesics up to a 2 day supply-otic analgesics-anti-nausea (up to 25 mg, scop patch <1.5 mg/patch)-antihistamines and decongestants if >6 years old-topical antifungals/antibacterials/anti- inflammatory-otic antifungal/antibacterial (acetic acid 2%)-keratolytic if >2 years old-vitamins with fluoride-lindane shampoo-smoking cessation products with special training https://www.flrules.org/gateway/ruleno.asp?id=64B8-36.003 http://www.doh.state.fl.us/mqa/medical/info_prescribe.pdf

38. Navy • Pharmacists become Licensed Independent Practitioners (LIP): • “Health Care Practitioners (Licensed Independent Practitioners). Licensed military (active duty and reserve) and DON civilian providers (federal civil service, foreign national hire, contract, or resource sharing agreement and clinical support agreement) required by reference (a) to be granted delineated clinical privileges to independently diagnose, initiate, alter or terminate health care treatment regimens within the scope of their licensure” • No requirement for CPA’sor physician oversight • Scope of practice is determined by individual commands • Disease State Management Programs include: • Asthma • Diabetes • Breast Health • Dental Health http://www.med.navy.mil/directives/ExternalDirectives/6320.66E%20.%20Part%201%20(Basic).pdf http://kentandassociates.biz/documents/Navy_Core_2003.pdf

39. VA Health Systems • The Veterans Health Administration (VHA) operates the nation's largest integrated health care system • Clinical pharmacy specialists (CPSs) working within Veterans Affairs medical centers (VAMCs) are Doctor of Pharmacy graduates, pharmacists who have completed an accredited residency, specialty board certified pharmacists, or pharmacists with equivalent experience • “It is VHA policy that medication prescribing privileges for non-controlled substances can be granted to clinical pharmacist specialists (CPSs) based on a locally-defined scope of practice” • In addition to performing the activities of a state-licensed and registered pharmacist, a CPS practicing under a VAMC protocol may initiate, continue, discontinue, or alter therapies; review and order appropriate laboratory tests; perform venipuncture to withdraw blood for laboratory testing; analyze laboratory and diagnostic test data; perform physical examinations; assist in the management of medical emergencies, adverse drug reactions, and acute and chronic diseases; and administer medications http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1852 Clause S, Fudin J, Mergner A et al. Prescribing privileges among pharmacists in Veterans Affairs medical centers. Am J Health-Syst Pharm. 2001; 58:1143-5. http://www.paindr.com/06-15-01%20Prescibing%20Privileges.pdf

40. VAMC CPS clinics • Common clinic types within VAMCs: • Anticoagulation (most common) • Primary care • Renewal maintenance • Lipid • Mental health • Diabetes • Infectious diseases/HIV • Geriatric • Smoking cessation • Oncology/hematology Clause S, Fudin J, Mergner A et al. Prescribing privileges among pharmacists in Veterans Affairs medical centers. Am J Health-Syst Pharm. 2001; 58:1143-5. http://www.paindr.com/06-15-01%20Prescibing%20Privileges.pdf

41. VA Insulin Initiation Clinic - Baltimore • During 2003–04, the Veterans Affairs Maryland Health Care System (VAMHCS) at Baltimore reported that 24% of its patients with diabetes had an A1C value of >9% or no recently documented A1c and that 91% of its patients with an A1c value of >9% were treated with oral antihyperglycemic agents alone • Clinical pharmacists at VAMHCS at Baltimore developed the insulin initiation clinic with the goal of providing an appropriate infrastructure to address the needs of patients with poorly controlled type 2 diabetes who required insulin therapy • Study concluded that the use of a preplanned insulin initiation and titration protocol by pharmacists resulted in successful implementation of an insulin initiation clinic through CDTM and improved patients’ glycemic control Dombrowski R, Haines ST, Leon N, Rochester CD. Collaborative drug therapy management for initiating and adjusting insulin therapy in patients with type 2 diabetes mellitus. Am J Health-Syst Pharm—Vol 67 Jan 1, 2010

42. Clinical Benefits Dombrowski R, Haines ST, Leon N, Rochester CD. Collaborative drug therapy management for initiating and adjusting insulin therapy in patients with type 2 diabetes mellitus. Am J Health-Syst Pharm—Vol 67 Jan 1, 2010

43. The state that requires pharmacists to be registered as pharmacist clinicians in order to prescribe is? • Massachusetts • Ohio • North Carolina • New Mexico

45. Definitions Collaborative drug therapy management. "Collaborative drug therapy management" means the initiating, monitoring, modifying and discontinuing of a patient's drug therapy by a pharmacist as authorized by a practitioner in accordance with a collaborative practice agreement. "Collaborative drug therapy management" includes collecting and reviewing patient histories; obtaining and checking vital signs, including pulse, temperature, blood pressure and respiration; and, under the supervision of, or in direct consultation with, a practitioner, ordering and evaluating the results of laboratory testsdirectly related to drug therapy when performed in accordance with approved protocols applicable to the practice setting and when the evaluation does not include a diagnostic component.

46. Definitions Collaborative practice agreement. "Collaborative practice agreement" means a written and signed agreement between one or more pharmacists with training and experience relevant to the scope of the collaborative practice and a practitioner that supervises or provides direct consultation to the pharmacist or pharmacists engaging in collaborative drug therapy management that: A. Defines the collaborative practice, which must be within the scope of the supervising practitioner's practice, in which the pharmacist or pharmacists may engage; B. States the beginning and ending dates of the period of time during which the agreement is in effect; and C. Includes individually developed guidelines for the prescriptive practice of the participating pharmacist or pharmacists.

47. Definitions Practice of pharmacy. "Practice of pharmacy" means the interpretation and evaluation of prescription drug orders; the compounding, dispensing and labeling of drugs and devices, except labeling by a manufacturer, packer or distributor of nonprescription drugs and commercially packaged legend drugs and devices; the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records for these drugs and devices; the administration of vaccines licensed by the United States Food and Drug Administration that are recommended by the United States Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, or successor organization, for administration to adults; the performance of collaborative drug therapy management; the responsibility for advising, when necessary or regulated, of therapeutic values, content, hazards and use of drugs and devices; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of a pharmacy.

48. Number of States including Maine that permit CDTM, permit CDTM in Community Settings, allow initiation of drug therapy, and allow ordering of labs

49. Differences Between Medication Therapy Management and CDTM • Individual state practice laws do not establish the scope of MTM services. • In contrast to CDTM, MTM services doe not require formal practice agreements between pharmacists and physicians. • The scope of services provided under CDTM (which may include the initiation/modification of drug therapy and ordering laboratory tests) are typically broader than MTM.

50. CDTM – Preventative Health Services, Timely Access to Care, and Chronic Disease Management