Section 856IAC4-1-2. Required components of immunization protocol for administering vaccinations

   (a) The protocol for the administration of immunizations must include the following:

(1) For each immunization to be administered by a pharmacist, or pharmacist intern, the following:

(A) The name and strength of the vaccine.

(B) Precautions and contraindications.

(C) The intended audience or patient population.

(D) The appropriate dosage.

(E) Administration schedules in accordance with the Centers for Disease Control and Prevention guidelines.

(F) Appropriate routes of administration.

(G) Appropriate injection sites.

(2) The length of time the pharmacist or pharmacist intern recommends an individual be observed for adverse effects, which shall be based on appropriate standards of care established by the physician approving the protocol. The location of the observation shall be in the general vicinity of the administering pharmacist or pharmacist intern to allow for ongoing evaluation.

(3) A method to address emergency situations including, but not limited to, adverse and anaphylactic reactions.

(4) Administration of epinephrine and appropriate dosages when required in the event of an adverse or anaphylactic reaction.

(5) A method to notify an individual's physician and the physician approving the protocol within fourteen (14) days after administering an immunization.

(6) A copy of the record of vaccination and notification to the primary care physician and physician approving the protocol shall be kept in accordance with the statutes and rules of the Indiana board of pharmacy.

  (b) Immunization protocols must be:

(1) approved and executed by a licensed physician actively practicing with a medical office in Indiana prior to implementation;

(2) maintained at the pharmacy and available for inspection by the individual receiving the immunization; and

(3) renewed annually.

  (c) The qualifying pharmacist is responsible for the following:

(1) Maintaining the immunization protocols.

(2) Ensuring that the protocols are renewed annually.

(3) Ensuring that the name, license number, and contact information of the physician who wrote the protocol is posted where the immunization is administered.

(Indiana Board of Pharmacy; 856 IAC 4-1-2; filed Dec 2, 2008, 4:03 p.m.: 20081231-IR-856070541FRA; filed Feb 21, 2014, 4:11 p.m.: 20140319-IR-856130449FRA)