PDL has issued a practice alert on the topic of vaccinations, giving a number of examples of incorrect supply

“Vaccinations are a hot topic as the influenza season fast approaches,” PDL says.

“Pharmacists play a vital role in the community by reducing the spread of preventable diseases through vaccine supply and administration. Pharmacist members of PDL are covered for vaccination services provided an accreditation has been obtained to administer vaccines.”

The organisation says that the most frequently occurring vaccine involved in incident reports to PDL was Alfuria Quad®, dispensed for a patient younger than 18 years of age.

It cites two pharmacist reports to PDL. In the first, the customer presented with a script for Fluquadri for his seven-year-old son.

The pharmacist dispensed the Afluria Quad brand, which has the same strains of the influenza virus, but is only marketed for patients 18 years and above. The vaccination was administered to the seven-year-old.

In the second example, a script for Fluarix Tetra came in to the pharmacy and was dispensed as Afluria injection. This was subsequently given to an eight-year-old.

PDL says that “understandably, customers are very likely to be upset and make a formal complaint if an incident involves their child”.

Its advice is to “beware of generic prescriptions”.

“This can be demonstrated with the supply of Afluria Quad® where the prescription was written generically as ‘Influenza vaccine’. In the case of a generic prescription it is vital that the age of the patient be confirmed to avoid administering the incorrect dose.

“Incident reports highlighted other vaccination issues relating to incorrect technique or incorrect site of administration. Some of these incidents led to longer term consequences for the patient and claims for lost wages and medical expenses have arisen.

“It has been announced that a high dose trivalent influenza vaccine will be available through the National Immunisation Program in 2018 for people 65 years and over. Fluad® and Fluzone High Dose® are TGA-approved for patients in this age range.

“Currently there is no information or indication for these products in people younger than 65 years of age.

“If customers 65 years and over choose to pay for the convenience of vaccination in a pharmacy, they should be reminded by their pharmacist of the availability of the new high dose vaccines through the National Immunisation Program.”

PDL says it has also received several reports relating to the incorrect supply of conjugate 4vMenCV meningococcal (ACWY) vaccines.

“There are currently three vaccines in this group and pharmacists need to be mindful of the brand-specific guidelines based on the age of the child,” it says.

“Please review the product information for Menveo®, Nimenrix® and Menactra® as their administration is age-specific. The same age-based considerations apply for Japanese encephalitis vaccines JEspect® and Imojev®.

“Other incidents have occured where Gardasil 9® (9vHPV) is intended though Gardasil® (4vHPV) is supplied. The 9-valent Gardisil 9® vaccine was released in 2017 and is more likely to be prescribed.”

PDL also reminds pharmacists that vaccines may have a shorter shelf life compared to other products and monitoring of product expiry date is vital.

“Incidents relating to the supply of expired meningococcal B vaccine, Bexsero® have also occurred.

“This may have been due to supply difficulties. However, appropriate stock management can prevent such incidents occurring.

“Flag any item with a short shelf life and ensure a system is in place in your pharmacy to remove or quarantine the item once expired.”

PDL has also added a guide for vaccine administering and dispensing:

  • Pharmacists administering vaccines must have appropriate qualifications (adhering to State legislation and guidelines) and this applies also for staff monitoring customers post-vaccination.
  • Qualifications include annual renewal of CPR and anaphylaxis requirements where stipulated in State legislation.
  • Be prepared to manage anaphylactic and vasovagal responses – they happen!
  • For ALL vaccines – ALL dispensary staff to confirm the age if the patient is younger than 18.
  • Store vaccines separately according to age restrictions and identify age ranges by using a laminate or a sign with the stored vaccines. Recommended vaccines stored using this method include, but not limited to: hepatitis A, influenza, conjugate and Japanese encephalitis ACWY meningococcal.
  • Quarantine or discard all expired vaccines.
  • Review the Immunisation Handbook for the latest advice regarding vaccine recommendations and administration.
  • Report all incidents to PDL. Document using the incident reporting system in the pharmacy.
  • Check if your State Health Department requires the reporting of adverse reactions to vaccines.

It highlights that for the 2018 influenza season, the TGA has registered six vaccines which will be available for use in the following age groups:

 Sponsor

Tradename

Age group

 Quadrivalent vaccines

 Sanofi-Aventis

FluQuadri Junior*

6-35 months (<3 years)

FluQuadri

3 years and over

 GlaxoSmithKline

Fluarix Tetra

3 years and over

 Mylan Health

Influvac Tetra

18 years and over

 Seqirus

Afluria Quad**

18 years and over

 Trivalent vaccines

 Sanofi-Aventis

Fluzone High dose

65 years and over

 Seqirus

Fluad

65 years and over

* Guidance for the dose in children aged 6–35 months is available in the Product Information. 

** Note that for 2018, Afluria Quad is only supplied to individuals 18 years and over. Refer to the Product Information approved in November 2017.

PDL welcomed a win on product packaging, in which it cited a practice alert to members in October 2017 where it raised awareness of the similarities in the packaging of Targin 40 and 2.5mg strengths.

“PDL are pleased to advise members that Mundi Pharma has recently confirmed that packaging of the Targin 2.5 is to change to differentiate it from the Targin 40.”