3 Colo. Code Regs. § 719-1-26.00.00

Current through Register Vol. 47, No. 20, October 25, 2024

Section 3 CCR 719-1-26.00.00 - REMOTE PHARMACY PRACTICE

26.00.10 Definitions

a. "Drug regimen review" includes but is not limited to the evaluation of order(s) and patient records(s) for:

1. Known allergies;

2. Rational therapy and contraindications;

3. Reasonable dose, duration of use, and route of administration considering age, gender, and other patient factors;

4. Reasonable directions for use;

5. Potential or actual adverse drug reactions;

6. Drug-drug interactions;

7. Drug-food interactions;

8. Drug-disease contraindications;

9. Therapeutic duplication;

10. Proper utilization (including over- or under-utilization) and optimum therapeutic outcomes; and

11. Abuse/misuse.

b. "Final Evaluation" means the review of the final prescription to ensure that the ordered medication is properly prepared and placed in a suitable container with appropriate labeling. The pharmacist(s) conducting the final evaluation shall be held accountable for assuring that the identity of the drug that appears on the prescription label corresponds with identity of drug contained therein. When refills are dispensed, the pharmacist conducting the final evaluation shall be held accountable for the appropriate dispensing of refills including all drug utilization reviews as they pertain to refill dispensing.

c. "Initial Interpretation" means the review of an order accompanied by order entry. The pharmacist(s) conducting the initial interpretation shall be held accountable for the accuracy of the electronic order entry/manual transcription and/or drug regimen review.

d. "Remote Pharmacy Practice" may include, but is not limited to, duties conducted by pharmacists, pharmacy interns or pharmacy technicians at a location other than a registered prescription drug outlet or other outlet registered with the Board.

1. Receiving and initially inputting new written, facsimile, or electronic orders;

2. Maintaining proper records for drugs and devices;

3. Transferring prescriptions;

4. Administrative duties that may include, but are not limited to: answering questions telephonically concerning pharmacy hours and operation, processing insurance claims, routing medication questions to the appropriate pharmacist on duty; and

5. Other activities as authorized and defined by the Board by rule.

26.00.20. Requirements for Remote Pharmacy Practice.

a. A registered prescription drug outlet or other outlet may employ or contract with one or more pharmacists, pharmacy interns or pharmacy technicians for the purpose of conducting Remote Pharmacy Practice provided that all requirements, including those of confidentiality, privacy, and security are met, as required in this Rule.

b. All pharmacists, pharmacy interns or pharmacy technicians employed or contracted with to conduct Remote Pharmacy Practice must hold an active, unrestricted license or certification with the Colorado State Board of Pharmacy;

c. No drug inventory shall be stocked or maintained at any Remote Pharmacy Practice location;

d. Pharmacists, pharmacy interns or pharmacy technicians engaged in Remote Pharmacy Practice are not considered in the computation of the technician to pharmacist ratio;

e. All records of Remote Pharmacy Practice must be maintained at the prescription drug outlet or other outlet in accordance with applicable recordkeeping rules;

f. Remote Pharmacy Practice shall have adequate security and be conducted in a setting sufficient to maintain patient privacy and confidentiality;

g. Each prescription drug outlet or other outlet which employs or contracts with pharmacists, pharmacy interns or pharmacy technicians engaged in Remote Pharmacy Practice must maintain a written Policy and Procedure Manual. Such Policy and Procedure Manual shall be reviewed, updated, and revised as necessary to remain current, but at least annually. Written documentation of such review shall be maintained at the prescription drug outlet or other outlet. This policy and procedure manual shall be available for inspection upon request of the Board or its inspectors. This Policy and Procedure Manual shall include the following:

1. Operation of the Remote Pharmacy Practice;

2. Maintenance of security for Remote Pharmacy Practice;

3. Procedure to ensure that Remote Pharmacy Practice shall be conducted in a manner in which patient privacy and confidentiality is maintained, including a provision that patient information may not be printed; and

4. A detailed list of all pharmacists, pharmacy interns or pharmacy technicians engaged in Remote Pharmacy Practice and contact information for each pharmacist.

h. The prescription drug outlet or other outlet shall enter into Written Agreements with each pharmacist, pharmacy interns or pharmacy technicians engaged in Remote Pharmacy Practice, detailing all conditions, and policies and procedures governing Remote Pharmacy Practice. Such agreement shall be reviewed, updated and revised no less than annually. Such agreement shall be maintained at the prescription drug outlet or other outlet and be available for inspection upon request of the Board or its inspectors; and

i. A pharmacist, pharmacy interns or pharmacy technicians conducting Remote Pharmacy Practice is responsible for ensuring that his or her Remote Pharmacy Practice is conducted in accordance with the Policy and Procedure Manual and Written Agreement.

26.00.40. Equipment. All equipment, including computer equipment, utilized for Remote Pharmacy Practice shall meet at least the following requirements:

a. Computer equipment must be able to establish a secure internet connection;

b. Equipment must be configured so patient information may not be stored at the site at which Remote Pharmacy Practice is occurring;

c. Access to the site for Remote Pharmacy Practice must be locked or shut down when the pharmacist ceases to be engaged in Remote Pharmacy Practice; and

d. Security parameters must prevent unauthorized storage or transfer of patient information.

26.00.50 Requirements for Conducting Final Evaluation. If Remote Pharmacy Practice includes conducting the final evaluation of prescriptions for a prescription drug outlet or other outlet, the following requirements apply:

a. The pharmacist must have a visual connection with the prescription drug outlet or other outlet for the pharmacist to review the finished product prior to delivery to the patient; and

b. The prescription drug outlet or other outlet shall maintain records of final evaluation in accordance with all other applicable recordkeeping requirements.

3 CCR 719-1-26.00.00

37 CR 18, September 25, 2014, effective 10/15/2014

38 CR 16, August 25, 2015, effective 9/14/2015

39 CR 04, February 25, 2016, effective 3/16/2016

39 CR 19, October 10, 2016, effective 11/14/2016

40 CR 04, February 25, 2017, effective 3/17/2017

40 CR 20, October 25, 2017, effective 11/14/2017

41 CR 16, August 25, 2018, effective 9/17/2018

42 CR 21, November 10, 2019, effective 11/30/2019

43 CR 10, May 25, 2020, effective 5/1/2020

43 CR 08, April 25, 2020, effective 5/15/2020

43 CR 15, August 10, 2020, effective 8/30/2020

43 CR 20, October 25, 2020, effective 11/14/2020

44 CR 04, February 25, 2021, effective 3/17/2021

44 CR 08, April 25, 2021, effective 5/15/2021

44 CR 21, November 10, 2021, effective 11/30/2021

45 CR 20, October 25, 2022, effective 9/29/2022

45 CR 21, November 10, 2022, effective 11/30/2022

46 CR 21, November 10, 2023, effective 11/30/2023