IC 25-26-13-31.2: Administration of immunizations; emergency immunizations
856 IAC 4: Pharmacist Vaccinations Administered Via Protocol Authority
Administering Immunizations Under Drug Order or Prescription
Indiana law allows a pharmacist 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 via drug order or prescription.
Administering Immunizations for Influenza Under Drug Order, Prescription, or Protocol - Current law only allows for influenza immunizations to be given via protocol authority. Effective July 1, 2011, shingles (herpes zoster) will also be able to be given via protocol authority.
A pharmacist may administer an immunization for influenza to a group of individuals under a drug order, a prescription, or according to a protocol approved by a physician if the following requirements are met:
- the physician specifies in the drug order, prescription, or protocol the group of individuals to whom the immunization may be administered;
- the physician who writes the drug order, prescription, or protocol is licensed in Indiana and not employed by a pharmacy;
- the pharmacist 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;
- if the physician uses a protocol, the protocol may apply only to an individual or group of individuals who are at least:
- 14 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; or
- 18 years of age.
- the pharmacist must successfully complete a course of training in immunization that is provided by an ACPE accredited provider; and
- the pharmacist must be certified in CPR and maintain this certification as required by that certifying body.
The protocol for the administration of immunizations must include the following:
- For each immunization to be administered, the following:
- the name and strength of the vaccine;
- precautions and contraindications;
- intended audience or patient population;
- appropriate dosage;
- administration schedules in accordance with the CDC guidelines;
- appropriate routes of administration; and
- appropriate injection sites.
- The length of time the pharmacist 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 to allow for ongoing evaluation.
- A method to address emergency situations including, but not limited to, adverse and anaphylactic reaction.
- Administration of epinephrine and appropriate dosages when required in the event of an adverse or anaphylactic reaction.
- A method to notify an individual's physician and the physician approving the protocol within 14 days after administering an immunization.
- 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:
- 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;
- maintaining records of training in the administration of immunizations and CPR for each pharmacist engaging in immunization practice within the pharmacy;
- maintaining the immunization protocols and ensuring that the protocols are renewed annually; and
- ensuring that records of the reporting of adverse events is maintained by the pharmacy.
Reporting of adverse events
A pharmacist 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).
Immunization practice voluntary
A pharmacist may not be required to administer an immunization or complete the accredited training program if the pharmacist chooses not to administer any immunization. A pharmacist is not required to complete the accredited training program in order to maintain a license to practice as a pharmacist in Indiana.
A pharmacist is prohibited from delegating the administration of the immunization to another person.
If you have any questions, please contact our office at pla4@pla.IN.gov.