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Second Regular Session
Sixty-first General Assembly
LLS NO. 980635.01 PLC
HOUSE BILL 981216
STATE OF COLORADO
BY REPRESENTATIVE Paschall;
also SENATOR B. Alexander.
BUSINESS AFFAIRS & LABOR
A BILL FOR AN ACT
CONCERNING COLLABORATIVE DRUG THERAPY AGREEMENTS
BETWEEN PHYSICIANS AND PHARMACISTS.
(Note: This summary applies to this bill as introduced
and does not necessarily reflect any amendments that may be subsequently
Allows physicians and pharmacists to enter into collaborative drug therapy agreements for the purpose of drug therapy management.
Requires collaborative drug therapy agreements to be governed by a protocol that will set the terms and conditions for the delegation of authority from the physicians to the pharmacists.
Requires each supervising physician and each pharmacist covered by the protocol to sign it.
Allows the state board of pharmacy and the Colorado state board of medical examiners to inspect any protocol on request. The protocol is not subject to approval by either board.
Limits collaborative drug therapy agreements to institutions, longterm care facilities, managed care, group practice settings, and structured relationships between pharmacists and physicians.
Requires the disclosure of the existence of any financial arrangement between the physician and pharmacist for the activities specified in the agreement.
Prohibits a pharmacist from employing a physician for the purpose of establishing collaborative agreements.
Forbids a pharmacist from performing duties to manage
the drug therapy of any patient without an established collaborative
drug therapy agreement or another established relationship between
the supervising physician and pharmacist.
Be it enacted by the General Assembly of the State of Colorado:
SECTION 1. Part 1 of article 22 of title 12, Colorado Revised Statutes, is amended BY THE ADDITION OF A NEW SECTION to read:
1222130. Collaborative drug therapy agreements. (1) AS USED IN THIS SECTION, "COLLABORATIVE DRUG THERAPY MANAGEMENT" MEANS A VOLUNTARY WRITTEN AGREEMENT BETWEEN A PHYSICIAN OR GROUP OF PHYSICIANS AND A PHARMACIST OR GROUP OF PHARMACISTS WHICH DELEGATES THE AUTHORITY TO MODIFY DRUG THERAPY, OR ORDER DEVICES OR LABORATORY TESTS NECESSARY TO MONITOR DRUG THERAPY.
(2) ANY COLLABORATIVE DRUG THERAPY AGREEMENT ENTERED INTO IN THIS STATE SHALL:
(a) BE A VOLUNTARY AGREEMENT SIGNED BY ALL PHYSICIANS AND PHARMACISTS OR THE REPRESENTATIVES OF SUCH PHYSICIANS OR PHARMACISTS WHO ENTER INTO THE AGREEMENT;
(b) BE GOVERNED BY A PROTOCOL THAT WILL SET THE TERMS AND CONDITIONS FOR THE DELEGATION OF COLLABORATIVE DRUG THERAPY MANAGEMENT FROM THE PHYSICIAN TO THE PHARMACIST THAT SHALL BE PART OF THE COLLABORATIVE DRUG THERAPY AGREEMENT. THE ELEMENTS OF THE PROTOCOL SHALL INCLUDE:
(I) A WRITTEN STATEMENT BY THE PHYSICIANS OR GROUP OF PHYSICIANS SPECIFYING THE ACTIVITIES THE PHARMACIST MAY PERFORM PURSUANT TO THE COLLABORATIVE AGREEMENT;
(II) THE ACTIVITIES THAT MAY BE PERFORMED BY THE PHARMACIST, WHICH ACTIVITIES SHALL BE CLEARLY DEFINED AND AGREED UPON BY BOTH THE PHARMACIST AND PHYSICIAN;
(III) THE SCOPE OF PRACTICE FOR THE PHARMACIST, WHICH SHALL BE CLEARLY DEFINED FOR EACH PROTOCOL;
(IV) THE LIMITS OF THE ACTIVITIES OF THE PHARMACIST, WHICH SHALL BE CLEARLY DEFINED AND SHALL REQUIRE THAT THE PHARMACIST NOT EXCEED SUCH LIMITS WITHOUT THE SPECIFIC AUTHORIZATION OF THE PHYSICIAN;
(V) PROCEDURES FOR DOCUMENTATION BY THE PHARMACIST OF HIS OR HER ACTIVITIES AND THE CARE THAT HE OR SHE PROVIDES;
(VI) A REQUIREMENT THAT THE COLLABORATING PHYSICIAN SEE THE PATIENT BEFORE THE COMMENCEMENT OF THE COLLABORATIVE DRUG THERAPY MANAGEMENT AND EVERY SIX MONTHS THEREAFTER;
(VII) THE SIGNATURES OF THE SUPERVISING PHYSICIAN OR PHYSICIANS AND THE PHARMACIST OR PHARMACISTS AND THE DATES OF EXECUTION, ALL OF WHICH SHALL BE ON THE PROTOCOL. EACH SUPERVISING PHYSICIAN AND EACH PHARMACIST COVERED BY THE PROTOCOL SHALL SIGN THE PROTOCOL. IF THE AGREEMENT IS BETWEEN A GROUP OF PHYSICIANS AND GROUP OF PHARMACISTS, THE MEDICAL DIRECTOR AND PHARMACY DIRECTOR SHALL SIGN THE PROTOCOL ON BEHALF OF THEIR RESPECTIVE GROUPS.
(VIII) A PROVISION FOR ANNUAL RENEWAL OF THE PROTOCOL.
(c) BE READILY RETRIEVABLE FROM EITHER OF THE PARTIES TO THE AGREEMENT. THE PROTOCOLS SHALL BE SUBJECT TO INSPECTION BY THE COLORADO BOARD OF PHARMACY, CREATED PURSUANT TO SECTION 1222103, AND THE COLORADO BOARD OF MEDICAL EXAMINERS, CREATED PURSUANT TO SECTION 1236103, UPON REQUEST BY EITHER BOARD. PROTOCOLS SHALL BE KEPT ON FILE BY THOSE BOARDS UNTIL THE EXPIRATION OF THE COLLABORATIVE DRUG THERAPY AGREEMENT SUCH PROTOCOL GOVERNS. PROTOCOLS SHALL NOT BE SUBJECT TO APPROVAL BY THE COLORADO BOARD OF PHARMACY OR THE COLORADO BOARD OF MEDICAL EXAMINERS.
(d) DISCLOSE THE EXISTENCE OF ANY FINANCIAL ARRANGEMENT BETWEEN THE PHYSICIAN AND PHARMACIST FOR THE ACTIVITIES SPECIFIED IN THE AGREEMENT. PHARMACISTS SHALL NOT EMPLOY PHYSICIANS FOR THE PURPOSE OF ESTABLISHING COLLABORATIVE AGREEMENTS.
(3) COLLABORATIVE DRUG THERAPY MANAGEMENT SHALL BE LIMITED TO INSTITUTIONS, LONGTERM CARE FACILITIES, MANAGED CARE, GROUP PRACTICE SETTINGS, AND STRUCTURED RELATIONSHIPS BETWEEN PHARMACISTS AND PHYSICIANS.
(4) A PHYSICIAN WHO WILL BE A PARTY TO THE COLLABORATIVE DRUG THERAPY AGREEMENT SHALL BE RESPONSIBLE FOR ASSESSING AND APPROVING THE COMPETENCY AND CREDENTIALS OF THE PHARMACIST BEFORE ENTERING INTO SUCH AN AGREEMENT.
(5) THE PHYSICIAN SHALL BE AVAILABLE IN PERSON OR THROUGH DIRECT TELECOMMUNICATION FOR CONSULTATION, ASSISTANCE, AND DIRECTION.
(6) THE PHARMACISTS AND PHYSICIANS SHALL BE LICENSED BY THE STATE OF COLORADO.
(7) THE AGREEMENT MAY BE TERMINATED AT ANY TIME BY EITHER PARTY WITH APPROPRIATE NOTICE SENT BY CERTIFIED MAIL. THE PHYSICIAN OR GROUP OF PHYSICIANS MAY TERMINATE THE AGREEMENT IMMEDIATELY. NOTICE OF A TERMINATED AGREEMENT SHALL BE REPORTED TO THE STATE BOARD OF PHARMACY AND THE COLORADO BOARD OF MEDICAL EXAMINERS WITHIN FIFTEEN DAYS AFTER TERMINATION.
(8) PHARMACISTS ENTERING INTO COLLABORATIVE DRUG THERAPY MANAGEMENT AGREEMENTS SHALL HAVE SUFFICIENT KNOWLEDGE, SKILLS, AND ABILITIES AS DETERMINED BY THE PHYSICIANS WHO ENTER INTO THE AGREEMENT.
(9) A PHARMACIST PRACTICING WITHIN A LICENSED HEALTH CARE FACILITY SHALL NOT BE AUTHORIZED TO PERFORM DRUG THERAPY MANAGEMENT DUTIES PURSUANT TO PROTOCOL THAT ARE NOT IN ACCORDANCE WITH THAT FACILITY'S POLICIES, PROCEDURES, OR BYLAWS.
(10) PHARMACISTS PRACTICING IN LICENSED HEALTH CARE FACILITIES OR PROVIDING SERVICES TO A LICENSED HEALTH MAINTENANCE ORGANIZATION MAY BE AUTHORIZED TO PERFORM DRUG THERAPY MANAGEMENT DUTIES IN ACCORDANCE WITH POLICIES, PROCEDURES, OR PROTOCOLS OF THE FACILITY OR ORGANIZATION. IN THESE INSTANCES, THE POLICIES, PROCEDURES, OR PROTOCOLS SHALL MEET THE REQUIREMENTS OF PROTOCOLS FOR COLLABORATIVE DRUG THERAPY MANAGEMENT BY PHARMACISTS AS DESCRIBED IN THIS SECTION; EXCEPT THAT THE SUPERVISING PHYSICIAN SHALL BE A PHYSICIAN OR A GROUP OF PHYSICIANS AUTHORIZED TO REPRESENT THE FACILITY OR ORGANIZATION AND THE PHARMACIST SHALL BE A PHARMACIST OR A GROUP OF PHARMACISTS AUTHORIZED TO REPRESENT THE PHARMACY SERVICES IN THAT INSTITUTION.
(11) A PHARMACIST SHALL NOT PERFORM DUTIES TO MANAGE DRUG THERAPY OF ANY PATIENT IN THE ABSENCE OF AN ESTABLISHED RELATIONSHIP OR COLLABORATIVE DRUG THERAPY AGREEMENT BETWEEN THE SUPERVISING PHYSICIAN AND THE PHARMACIST. THIS DOES NOT SUPERSEDE ESTABLISHED POLICIES AND PROCEDURES WITHIN AN ORGANIZED HEALTH SYSTEM OR INSTITUTIONAL SETTING.
SECTION 2. 1222122 (1), Colorado Revised Statutes, is amended to read:
1222122. Prescription required
exception. (1) Except
as provided in
SECTIONS 1222130 AND 1818414, C.R.S.,
and subsection (2) of this section, an order is required prior
to dispensing any prescription drug. Orders shall be readily
retrievable within the appropriate statute of limitations.
SECTION 3. 1236106 (3), Colorado Revised Statutes, is amended BY THE ADDITION OF A NEW PARAGRAPH to read:
1236106. Practice of medicine defined exemptions from licensing requirements repeal. (3) Nothing in this section shall be construed to prohibit, or to require a license under this article with respect to, any of the following acts:
(u) THE RENDERING OF COLLABORATIVE DRUG THERAPY MANAGEMENT PURSUANT TO A COLLABORATIVE DRUG THERAPY AGREEMENT PURSUANT TO SECTION 1222130.
SECTION 4. Part 1 of article 36 of title 12, Colorado Revised Statutes, is amended BY THE ADDITION OF A NEW SECTION to read:
1236106.4. Collaborative agreements with pharmacists. (1) A PERSON LICENSED PURSUANT TO THE "COLORADO MEDICAL PRACTICE ACT" MAY ENTER INTO A COLLABORATIVE AGREEMENT FOR THE PURPOSES OF COLLABORATIVE DRUG THERAPY MANAGEMENT BY PHARMACISTS PURSUANT TO SECTION 1222130.
(2) A COLLABORATIVE DRUG THERAPY AGREEMENT SHALL, IN ADDITION TO THE REQUIREMENTS OF SECTION 1222130, INCLUDE:
(a) AN ACKNOWLEDGMENT THAT BOTH THE PHYSICIAN AND THE PHARMACIST ARE RESPONSIBLE FOR THE GENERALLY ACCEPTED STANDARDS OF HEALTH CARE; AND
(b) THE DUTIES AND RESPONSIBILITIES OF EACH OF THE PARTIES TO THE AGREEMENT.
SECTION 5. Effective date applicability. (1) This act shall take effect September 1, 1998, unless a referendum petition is filed during the ninetyday period after final adjournment of the general assembly that is allowed for submitting a referendum petition pursuant to article V, section 1 (3) of the state constitution. If such a referendum petition is filed against this act or an item, section, or part of this act within such period, then the act, item, section, or part, shall take effect on the specified date only if approved by the people.
(2) The provisions of this act shall apply to all collaborative drug therapy agreements executed on or after the applicable effective date of this act.