D.C. Mun. Regs. tit. 17, r. 17-10009

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 17-10009 - COLLABORATIVE PRACTICE IN INSTITUTIONAL FACILITIES

10009.1

The provisions of this subchapter shall apply to collaborative practice arrangements between pharmacists and physicians in institutional facility settings.

10009.2

To the extent that there is any conflict between this subchapter and any other sectio n of this chapter, the provisions of this subchapter shall prevail with respect to collaborative practice arrangements between pharmacists and physicians in institutional facility settings.

10009.3

Nothing in this chapter shall be construed to prohibit pharmacists who practice in institutional facility settings from participating in collaborative practice arrangements pursuant to an institutional facility practice protocol approved by the institutional facility's Pharmacy and Therapeutics Committee ("P and T Committee"), the institutional facility's medical staff executive committee, or the institutional facility's medical director.

10009.4

Pharmacists who practice in institutional facility settings shall only participate in collaborative practice arrangements pursuant to an institutional facility practice protocol approved by the institutional facility's P and T Committee, the institutional facility's medical staff executive committee, or the institutional facility's medical director.

10009.5

Nothing in this subchapter shall be construed or interpreted to allow a pharmacist to accept delegation of a physician's authority outside of or beyond the scope of the pharmacist's practice.

10009.6

The licensed physician and pharmacist who are parties to an institutional facility practice protocol shall hold an active license in good standing in the District of Columbia.

10009.7

The Boards may deny approval of a physician or pharmacist to participate in collaborative practice under an institutional facility practice protocol if the physician or pharmacist has:

(a) A final order by the governing Board disciplining the physician or pharmacist's license for a practice issue within the five (5) years immediately preceding the formation of the agreement; or

(b) Limitations placed on the physician or pharmacist's license by the governing board.

10009.8

The collaborative practice services under an institutional facility practice protocol shall be within the scope of the licensed physician(s)'s current practice.

10009.9

To be eligible to participate in an institutional facility practice protocol, a pharmacist:

(a) Shall possess relevant advanced training as indicated by one of the following:

(1) Certification as a specialist by:

(A) The Board of Pharmaceutical Specialties;

(B) The Commission for Certification in Geriatric Pharmacy; or

(C) Another credentialing body approved by the Board of Pharmacy; or

(2) Successful completion of:

(A) A residency accredited by the American Society of Health-Systems Pharmacists, a body approved by the Board of Pharmacy or offered by a body accredited by the Accreditation Council for Pharmacy Education; or

(B) A certificate program approved by the Board of Pharmacy; and

(b) Shall have successfully completed:

(1) A minimum of three (3) years of relevant clinical experience, if the pharmacist holds an academic degree of Doctor of Pharmacy; or

(2) A minimum of five (5) years of relevant clinical experience, if the pharmacist holds an academic degree of Bachelor of Science in Pharmacy; and

(c) Shall have documented training related to the area of practice covered by the institutional facility practice protocol.

10009.10

Prior to providing collaborative practice services, pharmacists who practice in institutional facility settings shall review the following information in the patient's chart:

(a) Patient's name, gender, date of birth, height, and weight;

(b) Patient 's diagnosis or diagnoses from the treating physician;

(c) Patient's medication history;

(d) Patient's prior lab values;

(e) Patient 's vital signs; and

(f) Patient 's known allergies.

10009.11

The institutional facility shall create an institutional facility practice protocol identifying where the information required in § 10009.10 will be located, and how it will be accessed throughout the facility by the participating pharmacists and physicians.

10009.12

The institutional facility practice protocol shall serve as the collaborative practice agreement in these settings, and the institutional facility practice protocol shall identify which physicians and pharmacists are authorized and have agreed to provide collaborative practice services.

10009.13

The institutional facility practice protocol shall contain a plan for development, training, administration, and quality assurance of the protocol.

10009.14

An institutional facility practice protocol based upon treatment protocols that are generally accepted as the clinical standard of care within the medical and pharmacy professions, and that complies with the applicable requirements of this subchapter is deemed approved by the Boards.

10009.15

An institutional facility practice protocol approved by the Boards of Medicine and Pharmacy in accordance with §10006 or § 10009.14 of this subchapter shall contain the following information:

(a) Identification of the physicians(s) and pharmacist(s) who are parties to the institutional facility practice protocol;

(b) The location(s) where the pharmacist(s) and physician(s) may provide services under the institutional facility practice protocol;

(c) The name, address, and telephone number of the person(s) who are to receive correspondence from the Boards related to the institutional facility practice protocol;

(d) A detailed description of the disease state or condition, drugs or drug categories, drug therapies, devices, and any necessary incidental tests, authorized by the physician, and the activities allowed in each case;

(e) A detailed description of the methods, procedures, decision criteria, and plan the pharmacist is to follow when conducting allowed activities;

(f) A detailed description of the activities and procedures that the pharmacist is to follow, including documentation of decisions made, and a plan or appropriate mechanism for communication, feedback, and reporting to the physician activities and results concerning specific decisions made;

(g) The conditions under which the pharmacist may initiate, modify, or discontinue a drug therapy;

(h) Directions concerning the monitoring of a drug therapy, including the conditions that would warrant a modification to the dose, dosage regime, or dosage form of the drug therapy;

(i) The manner in which pharmacist's drug therapy management will be monitored by the prescriber, including method and frequency;

(j) A specified time within which the pharmacist must notify the prescriber of any modifications of drug therapy;

(k) A description of the continuous quality improvement efforts used to evaluate effectiveness of patient care and ensure positive patient outcomes;

(l) A provision that allows the prescriber to override any action taken by the pharmacist when the prescriber deems it to be necessary;

(m) The effective date; and

(n) A provision addressing how drug therapy management will be handled when the patient has more than one prescriber involved in evaluating or treating the medical condition which is the subject of the protocol. All prescribers who are actively involved in the management of the relevant conditions shall be parties to the protocol.

10009.16

The institutional facility practice protocol may include a physician(s) delegation of authority to the pharmacist(s) to obtain laboratory tests provided the tests relate directly to the drug therapy management under the protocol.

10009.17

Unless an alternative time period is stated in the institutional facility practice protocol, the pharmacist shall inform the physician within forty-eight (48) hours if the pharmacist modifies the drug dose or agent.

10009.18

Unless an alternative time period is stated in the institutional facility practice protocol, the pharmacist shall inform the physician within twenty- four (24) hours if the pharmacist detects an abnormal result from an assessment activity.

10009.19

Amendments to an institutional facility practice protocol must be documented, signed, and dated, and for institutional facility practice protocols containing approved protocols outside the generally accepted clinical standard of care, the amendments must be approved by the Boards before they are implemented.

10009.20

At a minimum, the institutional facility practice protocol shall have a documented review and, if necessary, be revised every year.

10009.21

The institutional facility's P and T Committee, medical staff executive committee, or medical director shall serve as the authorizing agent for the organization's medical staff, identifying which physicians or physician groups are authorized to participate under the institutional facility practice protocol, may restrict authorization for certain protocols to specific physicians, physician groups, or specialties, and shall ensure that the participating physicians are informed of the protocol and consent to participation.

10009.22

A pharmacist engaging in collaborative practice under an institutional facility's practice protocol shall read, sign, and date the protocol.

10009.23

The institutional pharmacy manager, or other designated person set forth in the institutional facility practice protocol, shall ensure that the institutional facility practice protocol is maintained current, that changes to the protocol are updated timely including the identification of the persons authorized to participate under the protocol, that copies of the protocol shall be maintained onsite where collaborative practice services take place, and that the protocol is revised as medically necessary.

10009.24

Pharmacists engaging in collaborative practice shall not delegate any collaborative practice activities to any other staff.

10009.25

All activity by the pharmacist, including changes in dose, duration or frequency of medication prescribed, shall be recorded in the pharmacist's prescription record, patient profile, a separate log book, or in some other appropriate system.

10009.26

A copy of the institutional facility practice protocol, an y amendments to the protocol, and the subsequent termination of any such protocol, if applicable, shall be available to:

(a) Any physician who is a party to the institutional facility practice protocol;

(b) Any pharmacist who is a party to the institutiona l facility practice protocol;

(c) Any patient who is being managed under the institutional facility practice protocol, upon request; and

(d) Representatives of the Boards of Pharmacy and Medicine, upon request.

10009.27

Documentation of activities performed under an institutional facility practice protocol or the physician's specific instructions shall be maintained in such a manner that it is accessible to the:

(a) Physician;

(b) Pharmacist; and

(c) The Boards of Pharmacy and Medicine upon request.

10009.28

Documentation may be maintained in written or electronic form.

10009.29

The Board of Pharmacy and the Board of Medicine may disapprove or revoke an institutional facility practice protocol if the Boards find:

(a) Inadequate training, experience, or education of the physician(s) or pharmacist(s) to implement the protocol or protocols;

(b) The institutional facility practice protocol fails to comply with the requirements of this subchapter or the Act;

(c) The institutional facility practice protocol is intended to manage or treat a condition or disease state for which there is not a protocol that is generally accepted as the clinical standard of care, or which is not approved by the Boards; or

(d) Any party to the protocol has been formally disciplined by any health professional licensing board in any jurisdiction, or is otherwise no longer licensed in good standing in the District of Columbia.

10009.30

The Boards may conduct random audits to ensure compliance with the provisions of the Act and this subchapter.

D.C. Mun. Regs. tit. 17, r. 17-10009

Final Rulemaking published at 65 DCR 8528 (8/17/2018)