Standards and Procedures for Pharmacist Administered Vaccines

Pharmacists certified to administer vaccines must comply with specific standards and procedures issued by the Department of Health. In part two of our series analyzing the requirements imposed on pharmacists for vaccine administration, we discuss some of those standards and procedures below.

Before administering the vaccine, a pharmacist must first assess the potential recipient for contraindications. Furthermore, prior to the immunization, pharmacists must inform each recipient of the potential side effects and adverse reactions orally and in writing. The pharmacists must also obtain a written consent from the recipient.

A vaccine recipient must also receive from the pharmacist written instructions regarding appropriate course of action in the event of an adverse reaction. In developing these instructions, pharmacists should look to reputable entities, such as the Centers for Disease Control and Prevention, which regularly issues vaccine information. Similarly, the vaccine recipient must receive a copy of the appropriate vaccine information statement prior to the administration of the immunization.

After vaccinating an individual, the pharmacist must provide him or her with a signed certificate of immunization which must include the following information: the recipient’s name, date of the immunization, address of administration, administering pharmacist, immunization agent, manufacturer and lot number. If consent from the recipient is obtained, the pharmacist shall communicate the immunization information to the recipient’s primary health care practitioner, if one exists, within one month of administering the vaccine.

The rules further require any adverse outcomes to be reported pursuant to the requirements established by Federal law.

The pharmacist must record and maintain the record of all persons vaccinated, including the recipients name, date of the immunization, address of administration, administering pharmacist, immunization agent, manufacturer and lot number. Proper documentation is important as failure to maintain the required records could be considered unprofessional conduct. Typically, adult patient records must be retained for at least six years from the date of the patient’s last visit.

Certified pharmacists are also authorized to administer medication for the emergency treatment of anaphylaxis to patients 18 years of age or older.  As such, pharmacist must have emergency anaphylaxis treatment agents, related syringes and needles readily available at the immunization location and should further become familiar with additional medical care requirements in case of such a reaction.

Each certified pharmacist is also required to provide information to recipients on the importance of having a primary health care practitioner, in a form or format developed by the Commissioner of Health.

In our next article, we will address pharmacists’ mandatory reporting requirements.

If you have questions pertaining to pharmacists’ immunization certification, standards and procedures, or record keeping requirements or have other questions, you may contact us here.