Vaccine reconstitution

Summary

Incidents have occurred where vaccines were not correctly prepared or reconstituted before being administered.

Types of errors reported to the Therapeutic Goods Administration (TGA) include administering only one part of a 2-part vaccine, such as only giving the diluent and not reconstituting a powder or ‘pellet’ component that contains part of the vaccine.

This is a reminder for health care professionals to read the specific preparation and reconstitution requirements in the relevant Product Information (PI) document before administering a vaccine. We have included examples of vaccines where reconstitution errors have been reported below.

What health care professionals should do

As preparation varies for different products, you should be familiar with the instructions in the PI for the specific vaccine you are administering. You should also have strategies in place in the clinical setting to prevent product preparation errors.

These steps are important because giving an incorrectly prepared vaccine may lead to sub-optimal disease protection and the need to recall patients for re-vaccination.

In addition to reading the vaccine PI and following the instructions carefully, you can find further guidance on best practice for preparing and administering vaccines in the Australian Immunisation Handbook.

If a reconstitution or administration error does occur, we encourage you to report this to us: Reporting adverse events for health care professionals.

Examples of vaccines with reports of reconstitution errors

The PI documents for both Infanrix Hexa and Act-HIB have recently been updated to make the need for reconstitution of the Hib component clearer - see Section 4.2 Dose and Method of Administration.

• Infanrix Hexa is a combination vaccine that helps protect children against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliovirus and Haemophilus influenzae type B (Hib) infections. It is funded on Australia’s National Immunisation Program (NIP) Schedule for infants at 2, 4 and 6 months of age. It is supplied as a pre-filled syringe containing 5 antigens in a liquid solution and a vial containing a lyophilised (freeze-dried) Hib pellet. Infanrix Hexa must be reconstituted by adding the entire contents of the pre-filled syringe containing the liquid component to the vial containing the Hib pellet, and the mixture should be well shaken until the pellet is completely dissolved in the suspension.
• Act-HIB is a monovalent conjugate vaccine that helps protect children against Hib infections. It is included on Australia’s NIP schedule for infants as a booster dose to protect against Hib infections at 18 months of age. It is supplied as a vial containing lyophilised Hib antigen powder and a pre-filled diluent syringe. The antigen powder must be reconstituted with the diluent before injection.

Further information

• Australian Immunisation Handbook - Infanrix Hexa
• Australian Immunisation Handbook - Haemophilus influenzae type b (Hib)
• National Immunisation Program Schedule
• Australian Commission Safety and Quality in Health Care - Infanrix Hexa and Act-HIB.