Collaborative Practice: One giant
leap for Maine Pharmacy!
Brian Marden, PharmD
Kenneth McCall, PharmD
The Maine Experience
What is your primary pharmacy practice
setting?
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Community
Health-systems
Long-term care
Academia
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/Template.
cfm?Section=Home2&Template=/CM/Cont
entDisplay.cfm&ContentID=11866
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 evidencebased 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
Letter from U.S. Surgeon General
Regina Benjamin, MD, MBA
(response to 2011 USPHS pharmacy practice report)
1. Health leadership and policy makers should
further explore ways to optimize the role of
pharmacists to deliver a variety of patientcentered 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
Letter from U.S. Surgeon General
Regina Benjamin, MD, MBA
(response to 2011 USPHS pharmacy practice report)
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.
www.usphs.gov/corpslinks/pharmacy
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
The Ashville Project
Asthma 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
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:
25%
25%
25%
25%
1.
2.
3.
4.
Reduction in Asthma related costs
Increase in hospitalizations
Reductions in average HgbA1c
Fewer employee sick days
State-by-State examples of
CDTM rules and regulations
No CDTM established
CDTM restricted to specific practice sites
CDTM established without practice site restrictions
State medical practice act interpreted to allow CDTM
CDTM limited to emergency contraception
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/antiinflammatory
-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
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).pdf
http://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 noncontrolled 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
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 HealthSyst 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?
25%
25%
25%
25%
1.
2.
3.
4.
Massachusetts
Ohio
North Carolina
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.
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.
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.
Number of States including Maine that permit CDTM,
permit CDTM in Community Settings, allow initiation of
drug therapy, and allow ordering of labs
50
45
40
35
30
25
20
15
10
5
0
47
39
34
CDTM
Community Initiate Rx
32
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
Authority
Scope 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?
25%
25%
25%
25%
1.
2.
3.
4.
Collect and review a patient’s history
Obtain and check vital signs
Order and evaluate lab tests
Initiate drug therapy in the initial 3 months
Qualifications
1. 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 successor
organization or has completed an accredited residency program. If the residency
program 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 pharmacy
accredited by the American Council on Pharmaceutical Education, has 2 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; 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?
25%
25%
25%
25%
1.
2.
3.
4.
Pharmacists must obtain BPS certification
Pharmacists must have a PharmD degree
Pharmacists must be residency trained
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?
25%
25%
25%
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 clinic
area covered by the agreement
4. 15 hours of CE must be over the clinical area
covered by the agreement
Collaborative Practice Agreement
1. Submit to board. The pharmacist shall submit a copy of the collaborative
practice 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 shall
establish a procedure for reviewing and, if necessary, revising the procedures and
protocols of the collaborative practice agreement.
3. Health information privacy. Services provided pursuant to a collaborative
practice 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 include
a plan for measuring and assessing patient outcomes and must include proof that
liability insurance is maintained by all parties to the agreement.
Collaborative Practice Agreement
6. Contents of agreement. A practitioner and a pharmacist desiring to engage in
collaborative 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 Agreement
6. 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?
25%
25%
25%
25%
1.
2.
3.
4.
Initiate drug therapy
Monitor drug therapy
Modify drug therapy
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: 2.0-3.0
Current warfarin dose: 7.5 mg QD
O: INR: 1.74
BP: 128/78 HR: 84
RR: 20
A/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
Follow-up anticoagulation visit
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: 2.0-3.0
Current 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. Followup 1 week. Discussed positive fecal occult with primary
care physician and referred to gastroenterologist.
Follow-up anticoagulation visit
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: 2.0-3.0
Current warfarin dose: 11.25mg M,F and 7.5mg S,S,T,W,R
O: INR: 2.14
A/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?
17%
17%
17%
17%
17%
17%
1.
2.
3.
4.
5.
6.
Access to patient medical records
Access to pertinent laboratory tests
Documentation and communication
The knowledge and skills to perform CDTM
Commitment of time and resources
All of the above
Conditions or Diseases Managed
Scope 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