3 Colo. Code Regs. § 719-1-19.00.00
Current through Register Vol. 47, No. 23, December 10, 2024
Section 3 CCR 719-1-19.00.00 - ADMINISTRATION19.01.00 Vaccines and Immunizations.19.01.10 Qualifications. a. A pharmacist certified in immunization, pharmacy intern, or pharmacy technician under the supervision of a pharmacist certified in immunization, may administer vaccines and immunizations per authorization of a physician. Administration and processing of vaccines and immunizations may occur in a Telepharmacy setting so long as the quality of supervision does not compromise the standard of care of a patient, and all other regulations are followed. A copy of the authorization shall be maintained at the prescription drug outlet. Routine childhood immunizations, as defined by the Colorado State Board of Health, shall comply with CDC guidelines. The CDC guidelines pertaining to the immunization schedule, incorporated by reference, may be examined at the State Board of Pharmacy, 1560 Broadway, Suite 1350, Denver, Colorado 80202, during normal business hours, Monday through Friday, except when such days are state holidays. Certified copies of the incorporated guidelines shall be provided at cost upon request. The Program Director or the Program Director's designee will provide information regarding how the incorporated guideline may be examined at any state public depository library. The guideline is also available from the organization originally issuing the guideline as follows: Centers for Disease Control and Prevention (https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html (reviewed February 3, 2020)). This rule does not include any later amendments or editions of the guideline.
b. Pharmacy interns, as directly part of their normal schedule or college of pharmacy curriculum, who are trained to administer vaccines and immunizations under this Board Rule 19.01.10 may administer vaccines and immunizations under the direct supervision of another regulated individual as defined by Board Rule 4.00.10 authorized by law to administer vaccines and immunizations as part of their scope of practice.c. Licensees shall be considered "trained" to administer vaccines and immunizations to a person only if: (1) The pharmacist or pharmacy intern has completed a pharmacy-based immunization delivery course of at least twenty hours of training, including didactic and live hands-on training that is either accredited by the Accreditation Council for Pharmacy Education or provided by an ACPE accredited school or college of pharmacy as part of obtaining a pharmacy degree.(2) The pharmacy technician has completed a pharmacy based immunization administration course of at least four hours of training including didactic and live hands-on training that is accredited by the Accreditation Counsel for Pharmacy Education. Proof of completion of this training shall be posted at the pharmacist's, pharmacy intern's, or pharmacy technician's main practice location(s).(3) The pharmacist, pharmacy intern, or pharmacy technician holds a current basic cardiopulmonary resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross or a basic cardiac life support certification. If the CPR certification has no expiration date, current means the certification must have been issued within the last two years. Proof of certification shall be available at licensee's main practice location.(4) The vaccines are administered in accordance with CDC guidelines. The CDC guidelines pertaining to vaccine administration, incorporated by reference, may be examined at the State Board of Pharmacy, 1560 Broadway, Suite 1350, Denver, Colorado 80202, during normal business hours, Monday through Friday, except when such days are state holidays. Certified copies of the incorporated guidelines shall be provided at cost upon request. The Program Director or the Program Director's designee will provide information regarding how the incorporated guideline may be examined at any state public depository library. The guideline is also available from the organization originally issuing the guideline as follows: Centers for Disease Control and Prevention (https://www.cdc.gov/vaccines/hcp/admin/admin-protocols.html (reviewed May 16, 2018)). This rule does not include any later amendments or editions of the guideline.d. The prescription drug outlet shall have a current version available, either in hard copy or electronically available, of the CDC reference "Epidemiology and Prevention of Vaccine-Preventable Diseases". The CDC guideline referencing "Epidemiology and Prevention of Vaccine-Preventable Diseases," incorporated by reference, may be examined at the State Board of Pharmacy, 1560 Broadway, Suite 1350, Denver, Colorado 80202, during normal business hours, Monday through Friday, except when such days are state holidays. Certified copies of the incorporated guideline or reference shall be provided at cost upon request. The Program Director or the Program Director's designee will provide information regarding how the incorporated guideline or reference may be examined at any state public depository library. This guideline or reference is also available on the Centers for Disease Control and Prevention's website: https://www.cdc.gov/vaccines/pubs/pinkbook/ (13th Edition (2015). This rule does not include any later amendments or editions of the guideline or reference.
19.01.20 A trained pharmacist may delegate the administration of vaccines and immunizations only to a trained pharmacy intern or pharmacy technician.19.01.30 Policies and Procedures a. Prior to administering vaccines or immunizations, pharmacists, pharmacy interns, and pharmacy technicians must be trained in a pharmacy-based immunization course accredited as detailed in Rule 19.01.10(c).b. The prescription drug outlet must maintain and follow written policies and procedures for handling and disposal of used and contaminated equipment and supplies. The prescription drug outlet must obtain a physician protocol for addressing allergic reactions to immunizations.c. The prescription drug outlet must give the appropriate "Vaccine Information Statement" (VIS) to the patient or legal representative with each dose of vaccine covered by these forms. The pharmacist must ensure that the patient or legal representative has received and signed the informed consent form and has had their questions answered prior to the administration of the vaccine.d. The prescription drug outlet must report adverse events as required by the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider as identified by the patient.19.01.40 Recordkeeping. a. The following information must be maintained by the prescription drug outlet for three years for each dose of vaccine or immunization administered:(1) The name, address, and date of birth of the patient;(2) Patient responses to screening questions for indications/contraindications to the immunization or vaccine being administered;(3) The date of the administration and site of injection of the immunization or vaccine;(4) The name, dose, manufacturer, lot number, and expiration date of the vaccine or immunization;(5) The name or identifiable initials of the administering pharmacist. If the administration is by a pharmacy intern or pharmacy technician, the initials of both the intern or pharmacy technician and supervising pharmacist;(6) The signed informed consent document for each administration;(7) Which vaccine information statement (VIS) was provided;(8) The date the VIS was provided; and(9) The name and address of the facility at which the vaccine or immunization was administered, if administered off-site.b. The above records shall be maintained separately from other records of the prescription drug outlet.c. All records required to be maintained pursuant to this Rule 19.00.00 may be maintained electronically so long as such records are maintained in a uniform and readily retrievable manner, are printable upon request of the Board or its inspectors, and can be reviewed at a viewable rate that may customarily be reviewed when otherwise in hard-copy form.19.01.50 Off-Site Administration of Immunizations and Vaccines a. A prescription drug outlet may allow a licensed pharmacist to remove immunizations and vaccines from the prescription drug outlet, provided the following requirements are met: (1) The prescription drug outlet maintains records which detail the removal of the immunizations and vaccines with at least the following information: (a) Name, strength, dosage form, and NDC number of the immunization or vaccine removed;(d) Name and license number of pharmacist removing the immunization or vaccine.(2) The immunizations and vaccines are properly stored at compendial temperatures during transport and storage at the off-site location.(3) The vaccines and immunizations shall be secured during transport and storage at the off-site location so as to allow only licensed pharmacists, pharmacy interns, and pharmacy technicians affiliated with the prescription drug outlet to have access to them.(4) The remaining vaccines and immunizations shall be returned to the prescription drug outlet the day they were removed.(5) The prescription drug outlet shall maintain records detailing the vaccines and immunizations returned with at least the following information: (a) Name, strength, dosage form, and NDC number of the immunizations or vaccines returned;(d) Name and license number of pharmacist returning the immunization or vaccine.b. All required records shall be maintained in a manner that is uniformly maintained, readily retrievable, and available for inspection for a period of three years from the date of removal off immunizations or vaccines for off-site administration.37 CR 18, September 25, 2014, effective 10/15/201438 CR 16, August 25, 2015, effective 9/14/201539 CR 04, February 25, 2016, effective 3/16/201639 CR 19, October 10, 2016, effective 11/14/201640 CR 04, February 25, 2017, effective 3/17/201740 CR 20, October 25, 2017, effective 11/14/201741 CR 16, August 25, 2018, effective 9/17/201842 CR 21, November 10, 2019, effective 11/30/201943 CR 10, May 25, 2020, effective 5/1/202043 CR 08, April 25, 2020, effective 5/15/202043 CR 15, August 10, 2020, effective 8/30/202043 CR 20, October 25, 2020, effective 11/14/202044 CR 04, February 25, 2021, effective 3/17/202144 CR 08, April 25, 2021, effective 5/15/202144 CR 21, November 10, 2021, effective 11/30/202145 CR 20, October 25, 2022, effective 9/29/202245 CR 21, November 10, 2022, effective 11/30/202246 CR 21, November 10, 2023, effective 11/30/2023