1. Collaborative Practice Agreements
What you need to know about the new rules and the law
Joe Bruno, MBA, RPh
President, Maine Board of Pharmacy

2. 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 A Definitions of Collaborative Drug Therapy Management and Practice Agreements

3. 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

4. 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)

5. Subsection Authority
This grants a pharmacist licensed in this state to enter into a CPA if they meet all of the qualifications in section 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!

6. 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

7. CPA – what you need to do
Copy must go to both Boards-Pharmacy and licensing board of practitioner
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

8. 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
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?

9. 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

10. 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

11. 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

12. CPA Content 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

13. 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

14. 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

15. Protocol
Supervision-practitioner can override any decision made by the pharmacist
Must do periodic reviews with both practitioner and pharmacist

16. 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

17. 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

18. Any questions???

19. Self Assessment Questions

20. 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

21. 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

22. 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

23. Question 4 Which medical condition is NOT allowed in a CPA? Cancer
Thyroid disease
Hypertension
Diabetes
All are allowed