Immunization Administration

This page is provided as a resource only and does not constitute legal advice or supercede any state or federal laws.  Please review the statutes/rules regarding immunizations, which are linked below. If there is any discrepancy between this guide or state law, state law controls.  If you require legal advice, please consult a private attorney as neither the Board nor the Board's staff can provide legal advice.

IC 25-26-13-31.2: Administration of immunizations; emergency immunizations; immunization data
IC 25-26-13-31.5: Immunizations by pharmacist interns and pharmacist students; rules
856 IAC 4:  Pharmacist Vaccinations Administered Via Protocol Authority

Administering Immunizations Under Drug Order or Prescription for a Specific Individual
Indiana law allows a pharmacist or pharmacist intern (includes student) to administer an immunization to an individual under a drug order or a prescription.  There are no restrictions regarding the type of immunization that can be administered to an individual via drug order or prescription.

Administering Immunizations for Influenza Under Drug Order, Prescription, or Protocol to a Group of Individual
 A pharmacist or pharmacist intern (includes student) may administer the following immunizations to a group of individuals under a drug order, a prescription, or according to a protocol approved by a physician: 

- Influenza, shingles (herpes zoster), pneumonia, tetanus, diphtheria, and acellular pertussis (whooping cough), human papillomavirus (HPV) injection, and meningitis.

Immunizations administered pursuant to a protocol must meet the following requirements:

1. the physician specifies in the drug order, prescription, or protocol the group of individuals to whom the immunization may be administered;
2. the physician who writes the drug order, prescription, or protocol is licensed and actively practicing with an office in Indiana and not employed by a pharmacy;
3. the pharmacist or pharmacist intern who administers the immunization is responsible for notifying the authorizing physician and the individual's primary care physician ("PCP") that the individual has received the immunization within 14 days of the immunization;
4. if the physician uses a protocol, the protocol may apply only to an individual or group of individuals who are at least:
   1. 11 years of age but less than 18 years of age, if the parent or legal guardian is present at the time of immunization and the pharmacist receives their consent;
   2. 18 years of age; or,
   3.  65 years of age for the pneumonia immunization.
5. the pharmacist or pharmacist intern must successfully complete a course of training in immunization that is provided by an ACPE accredited provider; and
6. the pharmacist or pharmacist intern must be certified in CPR and maintain this certification as required by that certifying body.

Protocol requirements
The protocol for the administration of immunizations must include the following:

1. For each immunization to be administered, the following:
   1. the name and strength of the vaccine;
   2. precautions and contraindications;
   3. intended audience or patient population;
   4. appropriate dosage;
   5. administration schedules in accordance with the CDC guidelines;
   6. appropriate routes of administration; and
   7. appropriate injection sites. 
2. The length of time the pharmacist or pharmacist intern recommends an individual to be observed for adverse effects, which shall be based on standards of care established by the physician approving the protocol.  The location of 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 reaction.
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 14 days after administering an immunization.
6. A copy of the record of vaccination and notification to the PCP and physician approving the protocol shall be kept in accordance with the statutes and rules of the Indiana Board of Pharmacy.

Immunization protocols must be approved and executed by the physician prior to implementation, maintained at the pharmacy, and renewed annually.

Qualifying pharmacist responsibilities
The qualifying pharmacist of the pharmacy is responsible for the following: 

1. ensuring that all pharmacist personnel engaging in immunization practice are trained as required and in the pharmacy's written policies and procedures of operation prior to performing any immunizations;
2. maintaining records of training in the administration of immunizations and CPR for each pharmacist engaging in immunization practice within the pharmacy;
3. maintaining the immunization protocols and ensuring that the protocols are renewed annually; and
4. ensuring that records of the reporting of adverse events is maintained by the pharmacy.

Reporting of adverse events
A pharmacist or pharmacist intern's supervising physician shall report adverse events to the patients PCP and the physician who approved the immunization protocol within 72 hours of the pharmacist's knowledge of the adverse event.  The pharmacist shall also report to the Vaccine Adverse Events Reporting Systems (VAERS).

A pharmacist or designee shall also report each immunization to the Children and Hoosiers Immunization Registry Program (CHIRP) unless the patient completes a written immunization data exception form.

Immunization practice voluntary
A pharmacist or pharmacist intern may not be required to administer an immunization or complete the accredited training program if the pharmacist or pharmacist intern chooses not to administer any immunization.  A pharmacist or pharmacist intern is not required to complete the accredited training program in order to maintain a license to practice as a pharmacist or pharmacist intern in Indiana, if that individual is not administering immunizations.

Delegation
A pharmacist or pharmacist intern is prohibited from delegating the administration of the immunization to another person. 

Pharmacist Interns/Students

Pharmacist interns and students must be supervised under direct supervision within a reasonable visual and vocal distance by a pharmacist, physician, physician assistant, and an advanced practice nurse.

Pharmacist interns and students must identify themselves as such to the patient and receive consent from the patient prior to administering an immunization.

Questions
If you have any questions, please contact our office at pla4@pla.IN.gov.