Collaborative Practice: One giant leap for Maine Pharmacy!

Collaborative Practice: One giant leap for Maine Pharmacy!

Brian Marden, PharmDKenneth McCall, PharmD

The Maine Experience

What is your primary pharmacy practice setting?

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20% 1. Community2. Health-systems3. Long-term care4. Academia5. Other

LD 1134: An Act To Allow Collaborative Practice Agreements between

Authorized Practitioners and Pharmacists

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/

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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

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)

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

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

Evidence in favor of CDTM

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

http://www.usphs.gov/corpslinks/pharmacy

1. 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





2. 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.

3. 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.

4. 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.





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 costshttp://www.theashvilleproject.net/home

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.

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.

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

http://www.youtube.com/watch?v=NsrqaePkeiQ

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

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

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.

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.

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.

The Asheville Project demonstrated all the following outcomes except:

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25% 1. Reduction in Asthma related costs2. Increase in hospitalizations3. Reductions in average HgbA1c4. Fewer employee sick days

State-by-State examples of CDTM rules and regulations

No CDTM established

CDTM established without practice site restrictions

CDTM limited to emergency contraception

CDTM restricted to specific practice sites

State medical practice act interpreted to allow CDTM

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

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

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

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

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

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

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

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

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=64B8-36.003http://www.doh.state.fl.us/mqa/medical/info_prescribe.pdf

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’s or 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).pdfhttp://kentandassociates.biz/documents/Navy_Core_2003.pdf

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 medicationshttp://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

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

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

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

The state that requires pharmacists to be registered as pharmacist clinicians in order to prescribe is?

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25% 1. Massachusetts2. Ohio3. North Carolina4. New Mexico

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 tests directly 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.

DefinitionsCollaborative 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; andC. Includes individually developed guidelines for the

prescriptive practice of the participating pharmacist or pharmacists.

DefinitionsPractice 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 ofnonprescription drugs and commercially packaged legend drugs and devices; theparticipation 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.

Number of States including Maine that permit CDTM, permit CDTM in Community Settings, allow initiation of

drug therapy, and allow ordering of labs

47

3934 32

05

101520253035404550

CDTM Community Initiate Rx Labs

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.

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

AuthorityScope of authority. A pharmacist engaging in collaborative drug therapy management is entitled to adequate access to a patient's history, disease status, drug therapy and laboratory and procedure results and may:

A. Collect and review a patient's history;B. Obtain and check vital signs;C. Order and evaluate the results of laboratory tests directly related to drug therapy under the supervision of, or in direct consultation with, a

practitioner and in accordance with approved protocols applicable to the practice setting and when the evaluation does not include a diagnostic component; and

D. Initiate, monitor, modify and discontinue drug therapy for a particular patient pursuant to the collaborative practice agreement with a

practitioner who is treating the patient, as long as the action is reported to the practitioner in a timely manner as determined by rules. The initial 3 months of a collaborative practice agreement is limited to monitoring drug therapy.

The scope of authority permitted under a collaborative practice agreement in Maine includes all of the following

EXCEPT?

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25% 1. Collect and review a patient’s history2. Obtain and check vital signs3. Order and evaluate lab tests4. Initiate drug therapy in the initial 3 months

Qualifications1. License. Hold a valid unrestricted pharmacist license in this State;2. Training. Submit evidence acceptable to the board that the pharmacist:

A. Possesses certification from the Board of Pharmacy Specialties or successororganization or has completed an accredited residency program. If the residencyprogram is not in the area of practice covered by the agreement, the pharmacist must complete a continuing education certificate program of at least 15 hours of continuing education in each clinical area of practice covered by the agreement;B. Has graduated with a Doctor of Pharmacy degree from a college of pharmacyaccredited by the American Council on Pharmaceutical Education, has 2 years ofprofessional experience and has completed a continuing education certificate

program of at least 15 hours of continuing education in each clinical area of practice covered by the agreement; or

C. Has graduated with a Bachelor of Science in Pharmacy degree from a college of pharmacy accredited by the American Council on Pharmaceutical Education, has 3 years of professional experience and has completed a continuing

education certificate program of at least 15 hours of continuing education in each clinical area of practice covered by the agreement.3. Renewal. A pharmacist who enters into a collaborative practice agreement must agree to complete, in each year of the agreement, 5 of the 15 hours of continuing education in the areas of practice covered by the agreement.

Which of the following statements is true regarding the qualifications of a pharmacist in Maine who

participates in a collaborative practice?

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25% 1. Pharmacists must obtain BPS certification2. Pharmacists must have a PharmD degree3. Pharmacists must be residency trained4. Pharmacists without BPS certification or

residency training must complete at least 15 hours of CE in each clinical area

Which of the following statements is true regarding annual license renewal for a pharmacist in Maine in a

collaborative practice agreement?

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25% 1. 2 of 15 hours of CE must be over the clinical area covered by the agreement

2. 5 of 15 hours of CE must be over the clinical area covered by the agreement

3. 10 of 15 hours of CE must be over the clinical area covered by the agreement

4. 15 hours of CE must be over the clinical area covered by the agreement

Collaborative Practice Agreement1. Submit to board. The pharmacist shall submit a copy of the collaborativepractice agreement to the board and the licensing board that licenses the practitioner prior to the commencement of the collaborative practice.2. Review and revision. The signatories to a collaborative practice agreement shallestablish a procedure for reviewing and, if necessary, revising the procedures andprotocols of the collaborative practice agreement. 3. Health information privacy. Services provided pursuant to a collaborativepractice agreement must be performed in compliance with the federal Health Insurance Portability and Accountability Act of 1996, 42 United States Code, Section 1320d et seq.and its regulations, 45 Code of Federal Regulations, Parts 160-164.4. Amendments to agreement. Amendments to a collaborative practice agreement must be documented, signed and dated.5. Assessment; risk management. A collaborative practice agreement must includea plan for measuring and assessing patient outcomes and must include proof that liability insurance is maintained by all parties to the agreement.

Collaborative Practice Agreement6. Contents of agreement. A practitioner and a pharmacist desiring to engage incollaborative practice in accordance with this subchapter shall execute a collaborative practice agreement that must contain, but is not limited to:

A. A provision that states that activity in the initial 3 months of a collaborative practice agreement is limited to monitoring drug therapy. After the initial 3 months, the practitioner and pharmacist shall meet to review the collaborative practice agreement and determine the scope of the agreement, which may after the initial 3 months include a pharmacist's initiating, monitoring, modifying and discontinuing a patient's drug therapy and reporting these actions to the practitioner in a timely manner in accordance with rules adopted

B. Identification and signatures of the parties to the collaborative practice agreement, the dates the agreement is signed and the beginning and ending dates of the period of time during which the agreement is in effect;

Collaborative Practice Agreement6. Contents of agreement. Continued…

C. A provision that allows either party to cancel the collaborative practice agreement by written notification;

D. Specification of the site and setting at which the collaborative practice will occur;E. Specification of the qualifications of the participants in the

collaborative practice agreement;F. A detailed description of the types of diseases, drugs or drug

categories involved and collaborative drug therapy management allowed in each patient's case; and

G. A procedure for the referral of each patient to the practitioner.

The scope of authority in the initial 3 months of a collaborative practice agreement in Maine may include

which of the following?

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25% 1. Initiate drug therapy2. Monitor drug therapy3. Modify drug therapy4. Discontinue drug therapy

Examples of CDTM Drug Therapy Protocols

• Emergency contraception• Asthma• Immunizations• Hypertension• Dyslipidemia• Warfarin/anticoagulation• Diabetes• Depression• Smoking cessation• Flu/antiviral

Anticoagulation Protocol

Anticoagulation Case

• 62-year-old man• PMH: atrial fibrillation, congestive heart failure,

obesity, hypertension, myocardial infarction and type 2 diabetes.

• FH: colon cancer in 1 of 8 first-degree relatives• Meds: warfarin 7.5 mg QD, digoxin 0.25 mg QD,

glyburide 10 mg QD, furosemide 80 mg BID, KCl 20 mEq BID, lisinopril 10 mg QD, atenolol 25 mg QD, calcium carbonate 500 mg BID.

Follow-up anticoagulation visit

S: He reports adherence to his warfarin regimen and a single episode of “red blood in his stool.” Denies alcohol. No diet or med changes.

Indication: atrial fibriallation Goal INR: 2.0-3.0Current warfarin dose: 7.5 mg QDO: INR: 1.74 BP: 128/78 HR: 84 RR: 20A/P: Subtherapeutic INR. Increase warfarin dose by 5%;

11.25mg Friday and 7.5mg QD all other days. Provided 3 fecal occult blood cards. Follow-up 1 week.

Pharmacist-Managed Anticoagulation Clinic


S: He reports no complaints, no additional episodes of bleeding, and no missed warfarin doses. Denies alcohol. No diet or med changes.

Indication: atrial fibriallation Goal INR: 2.0-3.0Current warfarin dose: 11.25mg F and 7.5mg S,S,M,T,W,R O: INR: 1.65 Fecal occult: 1/3+ Hgb 13.9 Hct 43%A/P: Subtherapeutic INR. Increase warfarin dose by 5%;

11.25mg Mon, 11.25mg Fri and 7.5mg S,S,T,W,R. Follow-up 1 week. Discussed positive fecal occult with primary care physician and referred to gastroenterologist.


S: He reports no complaints, no additional episodes of bleeding, and no missed warfarin doses. Denies alcohol. No diet or med changes.

Indication: atrial fibriallation Goal INR: 2.0-3.0Current warfarin dose: 11.25mg M,F and 7.5mg S,S,T,W,R O: INR: 2.14A/P: Therapeutic INR. Maintain warfarin dose. Colonoscopy

scheduled in 1 week. Stop taking warfarin 4 days before procedure. INR 1 day prior to procedure. Restart warfarin at 11.25 mg M,F and 7.5 mg S,S,T,W,R the day of the procedure. Follow-up 1 week after procedure.

Patient Outcomes• Colonoscopy revealed a sessile, raised, 5-cm lesion in the

distal colon. A biopsy histologically identified the mass as Dukes’ A adenocarcinoma (tumor penetration into but not through bowel wall, with mucosa and submucosa involvement only). No smooth muscle or mesenteric lymph node involvement was detected.

• Approximately 6 weeks later, the patient underwent an abdominal perineal resection with colonostomy. Exploratory laparotomy did not show liver metastasis. Follow-up colonoscopy 1 year later revealed normal mucosa except for a single benign 3-mm polyp in the proximal ascending colon.

As this case illustrates, effective CDTM practices require which of the following elements?

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17% 1. Access to patient medical records2. Access to pertinent laboratory tests3. Documentation and communication4. The knowledge and skills to perform CDTM5. Commitment of time and resources6. All of the above

Conditions or Diseases ManagedScope of Practice

1. Generally accepted standards of care. A pharmacist may engage in collaborative drug therapy management pursuant to a collaborative practice agreement only for conditions or diseases with generally accepted standards of care.

2. Prohibition. A pharmacist who is engaged in collaborative drug therapy management pursuant to a collaborative practice agreement may not, as part of the collaborative practice, participate in research or clinical or investigational trials.

3. Limitation. A collaborative practice agreement may include only the conditions or diseases to be managed that meet the qualifications and scope of practice for each party to the agreement.

Practice Protocols

• A pharmacist may engage in collaborative drug therapy management in compliance with a treatment protocol established by the practitioner with whom the pharmacist has a collaborative practice agreement. A copy of the treatment protocol must include a statement by the practitioner that describes the activities in which the pharmacist is authorized to engage and a provision that allows the practitioner, when appropriate, to override a collaborative practice decision made by the pharmacist.

Rules

• The board and the Board of Licensure in Medicine, after consultation with the Department of Health and Human Services, shall adopt rules to implement this subchapter. The rules must include rules establishing record-keeping and documentation procedures and reporting requirements and must allow for electronic filing when possible.

Exemptions

• Nothing in this subchapter may be construed to limit the scope of practice of a pharmacist pursuant to this chapter or to apply to collaborative practice agreements entered into between a pharmacist and a hospital solely for the treatment of inpatients at the hospital.

Discussion & Questions

Collaborative Practice: One giant leap for Maine Pharmacy!

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