Transcript Law – A Review of Collaborative Practice

Collaborative Practice
Agreements
What you need to know about the new rules and
the law
Joe Bruno, MBA, RPh
President, Maine Board of Pharmacy
Know the difference between the
law and the rules
• The law was passed in 2013 – took until now to get the
rules in place
• What took so long? It was stated in the law that was
passed it would be rules developed by the Board of
Pharmacy and the Board of Licensure in Medicine in
conjunction and consultation with DHHS
• Title 32 Chapter 117 Maine Pharmacy Act
• Subsection 13702-A Definitions of Collaborative Drug
Therapy Management and Practice Agreements
Defined as:
• Therapy management-Initiating, monitoring, modifying
and discontinuing a patient’s drug therapy by a pharmacist
as authorized by a practitioner in accordance with a
Collaborative Practice Agreement (CPA).
• Allows you to collect and review patient histories, doing
vital signs that include pulse, temperature, BP, respiration.
• Ordering and evaluating results of laboratory tests related
to drug therapy and can’t include a diagnostic component
Practice Agreement Definition
• Written 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 engaging in drug therapy management.
• It must define the collaboration and the scope allowed,
have beginning and end dates, specific guidelines for the
prescriptive practice of the pharmacist(s)
Subsection 13841
Authority
• This grants a pharmacist licensed in this state to
enter into a CPA if they meet all of the qualifications
in section 13842 and meet the rules adopted by BOP.
• Also talks about scope of authority as we previously
discussed-patient history, vital signs, lab tests and
results, drug therapy!
Qualifications Section 13842
• License must be valid and unrestricted!!
• Training-it takes a lot! Possess certification from Board of
Pharmacy Specialties or completed an accredited pharmacy
residency. If the residency is not in the area of practice of the
CPA requires 15 hours of CE in each clinical area covered by
the CPA OR
• Graduated with a Pharm.D. from an accredited college, has 2
years of experience, 15 hours of CE in each clinical area OR
• BS Pharm, 3 years of experience, 15 hours of CE in each
clinical area
CPA – what you need to do
• Copy must go to both Boards-Pharmacy and
licensing board of practitioner
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Procedure for review and revision of the CPA
HIPAA compliant
Any amendments must be signed and dated
Must have liability insurance proof and how to
measure and assess outcomes
What must be in agreement
• First 3 months is drug therapy only!! After 3 months
practitioner and pharmacist are to meet and determine
scope of CPA
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Date started and end date
How can it be cancelled by either party
The site and setting where the practice will occur
Qualifications outlined of the participants
What is the procedure for referral?
Which conditions or diseases can be
managed?
• Conditions with generally accepted standards of care
• Prohibited from clinical or investigational trials
• Limited to what is specified in the agreement-there is
no wiggle room!
• Hospital Pharmacists doing this with inpatients are
not limited by this chapter
Now let’s look at the rules
• The rules all look back at the law that was enacted.
• Gives examples of disease states – you are not
limited to those that are listed!!!
• Defines an unrestricted license-you can’t have a
consent agreement affecting your scope of practice.
• The CE requirement must be met prior to signing an
agreement. You have two years to gather the 15
hours
Rules
• There will be an application form that must be
submitted to the Board along with any other
information the Board may require. Incomplete
applications will be returned. The CPA must be
submitted to the BOP and the licensing Board of the
practitioner
CPA Content
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3 month start up period
Who is in the agreement?
Either party may cancel with written notification
Site and setting
Qualifications of the participants
What diseases and drugs and drug categories will be allowed
How will patient’s be referred? No remuneration for referrals!!!
Practitioner is not obligated to refer patients to the pharmacist
• Proof of liability insurance
CPA content
• The treatment protocols must be included
• CPA terminates if pharmacist no longer holds
unrestricted license
• Death of either party results in termination
• How is the continuity of care handled if CPA is
terminated suddenly
Treatment protocol
• Describe all the activities that the pharmacist is authorized
to engage in. At a minimum:
• Informed consent procedure-patient must sign giving their
consent to sharing medical records
• Scope – what can the pharmacist do – what is the decision
criteria?
• Documentation-everything must be written down
• Communication procedures with the practitioner-how
frequent and content-one week for normal results and 24
hours for abnormal results or adverse drug results
Protocol
• Supervision-practitioner can override any decision
made by the pharmacist
• Must do periodic reviews with both practitioner and
pharmacist
Notifications
• 10 days to report to the Board any changes to the
CPA to both Boards that were originally notified
• Modifications must be signed and dated by both
parties
• Any amendments to the treatment protocol including
a copy of the new amended protocol
• Any change in liability insurance including policy
certificate
Record Keeping
• Must be adhered to as defined in Chapter 24 of the
Board’s rules
• Complaints about the CPA goes to both Boards and
may be investigated by both
• Any disciplinary action to any party in a CPA must be
reported within 10 days to the other participant
Any questions???
Self Assessment
Questions
Question 1
• To whom does the collaborative practice agreement
(CPA) need to be submitted?
• Board of Pharmacy
• The Board that licenses the practitioner
• Both Boards
• Neither Board
Question 2
• How much training is required for a pharmacist to enter into a
CPA? Certification in the specialty area or an accredited
residency program with a concentration in the area of the CPA
• 15 hours of CE in the clinical area of the CPA
• Pharm D degree, 2 years of experience, 15 hours of CE in
area
• BS Pharm, 3 years of experience, 15 hours of CE
• All of the above
Question 3
• What can be done under a CPA?
• Collect patient history
• Check vital signs
• Order and evaluate laboratory tests related to drug therapy
• Initiate, monitor, modify, and discontinue drug therapy
• All of the above
Question 4
• Which medical condition is NOT allowed in a CPA?
• Cancer
• Thyroid disease
• Hypertension
• Diabetes
• All are allowed