Chapter 40. Regulations Governing Collaborative Practice Agreements
18VAC110-40-10. Definitions.
The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:
"Agreement" means a collaborative practice agreement as defined in § 54.1-3300 of the Code of Virginia.
"Committee" means an Informal Conference Committee, comprised of two members of the Board of Pharmacy and two members of the Board of Medicine.
"Pharmacist" means a pharmacist who holds an active license to practice pharmacy from the Virginia Board of Pharmacy.
"Practitioner" means a person authorized to have an agreement with a pharmacist and his designated alternative pharmacists as prescribed in the definition of a collaborative agreement in § 54.1-3300 of the Code of Virginia.
Statutory Authority
§§ 54.1-2400 and 54.1-3300.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 17, Issue 7, eff. January 17, 2001; amended, Virginia Register Volume 24, Issue 3, eff. November 14, 2007; Volume 30, Issue 15, eff. April 23, 2014; Errata 30:19 VA.R. 2422 May 19, 2014.
18VAC110-40-20. Signed authorization for an agreement.
A. The signatories to an agreement shall be a practitioner involved directly in patient care and a pharmacist involved directly in patient care. Within the agreement, the pharmacist may designate alternate pharmacists, provided the alternates are involved directly in patient care at a single physical location where patients receive services.
B. An agreement shall only be implemented for an individual patient pursuant to an order from the practitioner for that patient. A patient who meets the criteria for inclusion in the category of patients whose care is subject to a collaborative agreement and who chooses to not participate in a collaborative procedure shall notify the prescriber of the patient's refusal to participate in such collaborative procedure.
1. The patient may decline to participate or withdraw from participation at any time.
2. The patient shall be informed by the practitioner or the pharmacist of the collaborative procedures that will be used pursuant to an agreement, and such discussion shall be documented in the patient record.
3. The practitioner and the pharmacist shall provide written disclosure to the patient of any contractual arrangement with any other party or any financial incentive that may impact one of the party's decisions to participate in the agreement.
Statutory Authority
§§ 54.1-2400, 54.1-3300, and 54.1-3300.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 17, Issue 7, eff. January 17, 2001; amended, Virginia Register Volume 24, Issue 3, eff. November 14, 2007; Volume 30, Issue 15, eff. April 23, 2014; Volume 37, Issue 5, eff. November 25, 2020.
18VAC110-40-30. Approval of protocols outside the standard of care.
A. If a practitioner and a pharmacist intend to manage or treat a condition or disease state for which there is not a protocol that is clinically accepted as the standard of care, the practitioner and pharmacist shall apply for approval. The committee shall, in accordance with § 2.2-4019 of the Code of Virginia, receive and review the proposed treatment protocol and recommend approval or disapproval to the boards.
B. Application and approval are not needed for treatment of conditions for which there is an accepted standard of care, but for which the practitioner wants to increase the monitoring and oversight of the condition over what the protocol recommends.
C. In order to apply for approval of a protocol outside the standard of care, the practitioner and the pharmacist shall submit:
1. An application and required fee of $750;
2. A copy of the proposed protocol; and
3. Supporting documentation that the protocol is safe and effective for the particular condition or disease state for which the practitioner and the pharmacist intend to manage or treat through an agreement.
Statutory Authority
§§ 54.1-2400, 54.1-3300, and 54.1-3300.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 17, Issue 7, eff. January 17, 2001; amended, Virginia Register Volume 24, Issue 3, eff. November 14, 2007.
18VAC110-40-40. Content of an agreement and treatment protocol.
A. An agreement shall contain treatment protocols that are clinically accepted as the standard of care within the medical and pharmaceutical professions.
B. The treatment protocol shall describe the disease state or condition, drugs or drug categories, drug therapies, laboratory tests, medical devices, and substitutions authorized by the practitioner.
C. The treatment protocol shall contain a statement by the practitioner that describes the activities the pharmacist is authorized to engage in, including:
1. The procedures, decision criteria, or plan the pharmacist shall follow when providing drug therapy management;
2. The procedures the pharmacist shall follow for documentation; and
3. The procedures the pharmacist shall follow for reporting activities and results to the practitioner.
D. The signatories shall implement a procedure for periodically reviewing and, if necessary, revising the procedures and protocols of a collaborative agreement .
E. If either the practitioner or the pharmacist who is a party to the agreement has a change of location or change of ownership, that person shall notify the other party and all patients who are participants in the collaborative agreement.
Statutory Authority
§§ 54.1-2400, 54.1-3300, and 54.1-3300.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 17, Issue 7, eff. January 17, 2001; amended, Virginia Register Volume 24, Issue 3, eff. November 14, 2007.
18VAC110-40-50. Record retention.
A. Signatories to an agreement shall keep a copy of the agreement on file at their primary places of practice.
B. An order for a specific patient from the prescribing practitioner authorizing the implementation of drug therapy management pursuant to the agreement shall be noted in the patient's medical record and kept on file by the pharmacist.
C. The patient's documented informed consent shall be retained by the practitioner in the patient record .
Statutory Authority
§§ 54.1-2400, 54.1-3300, and 54.1-3300.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 17, Issue 7, eff. January 17, 2001; amended, Virginia Register Volume 24, Issue 3, eff. November 14, 2007.
18VAC110-40-60. Rescindment or alteration of the agreement.
A. A signatory may rescind or a patient may withdraw from an agreement at any time.
B. A practitioner may override the collaborative agreement whenever he deems such action necessary or appropriate for a specific patient.
Statutory Authority
§§ 54.1-2400, 54.1-3300, and 54.1-3300.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 17, Issue 7, eff. January 17, 2001.
18VAC110-40-70. Compliance with statutes and regulations.
Any collaborative agreement or referral under an agreement governed by this chapter shall be in compliance with the requirements of the Practitioner Self-Referral Act (§ 54.1-2410 et seq. of the Code of Virginia) and with Chapters 29 (§ 54.1-2900 et seq.), 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and regulations promulgated pursuant thereto.
Statutory Authority
§§ 54.1-2400, 54.1-3300, and 54.1-3300.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 17, Issue 7, eff. January 17, 2001.