(1) In order to administer or prescribe vaccinations, a pharmacist must have a collaborative practice agreement with a practitioner authorized to prescribe drugs, or in the case of a public health emergency, a directive from the state medical officer of the Montana Department of Public Health and Human Services.

(2) A pharmacist may administer vaccines to persons 18 years of age or older and administer influenza vaccine to persons 12 years of age or older provided that:

(a) the pharmacist has successfully completed a course of training approved by the Centers for Disease Control and Prevention (CDC), a provider accredited by the Accreditation Counsel on Pharmacy Education (ACPE), or other authority approved by the board;

(b) the pharmacist holds a current basic cardiopulmonary resuscitation certification issued by the American Heart Association, the American Red Cross, or other recognized provider, and documentation is on file at the practice site;

(c) the pharmacist and the pharmacist intern must provide a copy of the immunization certificate and CPR certification to the board for initial specialty recognition;

(d) the vaccines are administered in accordance with an established protocol that includes site-specific emergency measures; and

(e) the pharmacist has either a current copy of or online access to the most recent edition of the CDC reference "Epidemiology and Prevention of Vaccine-Preventable Diseases."

(3) The pharmacist must give a copy of the most current vaccine information statement (VIS) to the patient or the patient's legal representative for those vaccines which have them, and counsel the patient accordingly.

(4) The pharmacist must maintain written policies and procedures for disposal of used or contaminated supplies.

(5) The pharmacist must report any significant adverse events to the primary care provider if one is identified by the patient, and to the Vaccine Adverse Events Reporting System (VAERS), if applicable.

(6) A pharmacist administering any vaccine shall maintain the following information in the patient's medical records for a period of at least three years:

(a) the name, address, allergies, and date of birth of the patient;

(b) the date of administration;

(c) the name, manufacturer, dose, lot number, and expiration date of the vaccine;

(d) the vaccine information statement provided;

(e) the site and route of administration;

(f) the name or identifiable initials of the administering pharmacist; and

(g) any adverse events encountered.

(7) The authority of a pharmacist to administer immunizations may not be delegated, however, an immunization-certified intern may immunize under the direct supervision of a pharmacist or other healthcare provider qualified in vaccine administration and deemed appropriate by the preceptor.

(8) In order to maintain specialty recognition, an immunization certified pharmacist must maintain a current CPR certification.

(9) The board shall randomly select renewal notice forms of immunization-certified pharmacists for audit and verification of the requirements listed in this rule.