Decision on joint proposal with Health New Zealand to enable childhood vaccinations to be given in pharmacies

Medicines Decision

What we’re doing

We're pleased to announce a decision to remove the Xpharm restriction from certain childhood vaccines. Removing the Xpharm restriction is a technical change to the Pharmaceutical Schedule that will allow pharmacies to claim reimbursement for these vaccinations. This change supports Health New Zealand | Te Whatu Ora’s (Health NZ) plan to increase the vaccinator workforce, to improve access to childhood immunisations in the community, with a goal of increasing coverage of all childhood immunisations.

From 1 April 2024, the Xpharm restriction will be removed from the following vaccines:

  • Diphtheria, tetanus, pertussis and polio vaccine
  • Diphtheria, tetanus, pertussis, polio, hepatitis B and haemophilus influenzae type B vaccine
  • Haemophilus influenzae type B vaccine
  • Pneumococcal (PCV13) conjugate vaccine
  • Rotavirus oral vaccine
  • Varicella vaccine [Chickenpox vaccine].

The Xpharm restriction has already been removed from some vaccines that are given to older children, adolescents and adults. The vaccines that pharmacists can already claim reimbursement for are as follows:

  • Measles, mumps and rubella vaccine
  • Diphtheria, tetanus and pertussis vaccine
  • Meningococcal ACWY vaccine
  • Meningococcal B vaccines
  • Human papillomavirus vaccine
  • Varicella zoster vaccine [shingles]

We have also changed the Pharmaceutical Schedule listing for paracetamol oral liquid to allow pharmacies to provide this directly when vaccinating children under two years of age with the funded Bexsero brand of the meningococcal B multicomponent vaccine.

Health NZ will continue working with pharmacists to implement comprehensive upskilling and resources to support this change.

Follow this link to find out more information about Health NZ’s work to enable pharmacist vaccinators

Any changes to the original proposal?

This decision was subject to a consultation letter dated 15 January 2024. We sought further feedback via an additional consultation letter dated 9 February 2024.

We received a lot of responses from the primary health sector and consumers. Thank you to everyone who took the time to provide feedback. The responses raised lots of important considerations and highlighted the desire across the sector to improve childhood vaccination rates. We shared the feedback we received with Health NZ. Many of the matters raised in the feedback had already been considered by Health NZ in its initial planning, but all the concerns raised have contributed to refining Health NZ’s implementation plan.

We also received feedback that it would be important for pharmacists to be able to provide funded paracetamol oral liquid for children under two years of age when giving the meningococcal B vaccine (Bexsero). Paracetamol is recommended for children in this age group as they can experience fever and some pain at the injection site as part of their normal immune response to the meningococcal B vaccine. Paracetamol is used to reduce the likelihood of fever or injection site pain occurring. More details are available from the Immunisation Advisory Centre website(external link).

In response to this feedback, we changed the Pharmaceutical Schedule listing for paracetamol oral liquid to allow pharmacies to provide this directly when vaccinating children under two years of age with the funded Bexsero brand of the meningococcal B multicomponent vaccine.

Who we think will be most interested

  • Pharmacists
  • Healthcare professionals working in primary care and outreach vaccination settings
  • Pharmaceutical suppliers and wholesalers
  • Well Child Tamariki Ora providers
  • Hauora Māori providers
  • Pacific Health providers
  • Midwifery services
  • Social services
  • Organisations and people with an interest in immunisation.

Detail about this decision

Vaccines included in this decision

This proposal results in the removal of the Xpharm restriction from the following vaccines in Section I of the Pharmaceutical Schedule from 1 April 2024:

Vaccine

Brand (Supplier)

Diphtheria, tetanus, pertussis and polio vaccine

Infanrix IPV (GSK)

Diphtheria, tetanus, pertussis, polio, hepatitis B and haemophilus influenzae type B vaccine

Infanrix-hexa (GSK)

Haemophilus influenzae type B vaccine

Hiberix (GSK)

Pneumococcal (PCV13) conjugate vaccine

Prevenar 13 (Pfizer)

Rotavirus oral vaccine

Rotarix (GSK)

Varicella vaccine [Chickenpox vaccine]

Varivax (Merck Sharp & Dohme)

Pharmacists can already claim reimbursement for the funded meningococcal B multicomponent vaccine (Bexsero). This means that the Xpharm restriction has been removed from all vaccines that are given as part of the routine childhood immunisation programme up to 12 years of age.

You can read more about the distribution and reimbursement claiming for vaccines in the original consultation letter.

Paracetamol oral liquid

We have also amended the Schedule listing for paracetamol oral liq 120 mg per 5 ml and 250 mg per 5 ml from 1 April 2024 as follows (additions in bold):

a) Maximum of 600 ml per prescription; can be waived by endorsement

b) Up to 200 ml available on a PSO

c) Not in combination

d)

1) Maximum of 200 ml per dispensing for non-endorsed patients. If quantities prescribed exceed 200 ml (for non-endorsed patients), then dispense in repeat dispensing not exceeding 200 ml per dispensing.

2) Subsidy by endorsement for higher quantities is available for patients with long term conditions who require regular daily dosing for one month or greater and the prescription is endorsed or annotated accordingly. Pharmacists may annotate the prescription as endorsed where dispensing history supports a long-term condition.

3) Note: 200 ml presentations of paracetamol oral liquid may be supplied on BSO to a Vaccinator (other than a Pharmacist) under the provisions in Part I of Section A

4) Note: Direct Provision by a pharmacist of up to 200 ml permitted under the provisions in Part I of Section A in conjunction with immunisation of a child under 2 years of age with meningococcal B multicomponent vaccine

Pharmacists will be able to claim reimbursement for paracetamol oral liquid provided for infants under two years of age receiving meningococcal B (Bexsero) vaccine at the time of administration, under Pharmaceutical Schedule Rule 1.3.7 Direct Provision.

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process. It gives us, and Health New Zealand, the opportunity to listen to the voices of the community and acknowledge and respond to feedback.

Theme

Pharmac & Health New Zealand response

Supportive of proposal

Some respondents outlined support for the proposal, highlighting potential benefits, including:

  • Increasing General Practice capacity for other tasks
  • Increasing vaccine access for those who may not be able to easily access their General Practice
  • Pharmacists already give a range of vaccines, and many are set up for vaccination
  • Pharmacists are familiar with the need for regular training and keeping clinical skill up to date

We acknowledge the support for the proposal.

This proposal is one part of Health New Zealand (Health NZ)’s plan to improve childhood vaccination rates. Vaccination can prevent diseases, allowing children to engage in daily activities such as education, sport and play.

Feedback on implementation requirements

Some respondents were supportive of the intent of the proposal but raised important implementation considerations. These specific considerations are addressed below in this table.

We acknowledge the support for the proposal. Health NZ has used the feedback to shape its implementation plan.

Maintaining the 6 week and maternal medical checks in General Practice

Several respondents highlighted the wider check-ups that occur for tamariki and whānau as part of vaccinations in General Practice. This includes medical, developmental, social and mental health checks. Particularly the 6-week checks which are part of the ‘wrap around’ care for pēpi, mum and wider whānau. The 6-week checks support the transfer of care from the midwife to general practice.

Health NZ advises that guidance for pharmacists will require pharmacists to enquire about whether 6-week and other medical checks have been conducted, and to refer whānau back into General Practice and primary care services where appointments are required. We note pharmacists often direct individuals to relevant health services for all medical issues which are outside of the scope of the pharmacist.

This proposal supports pharmacists to vaccinate infants that would not have gone to a GP.

Suggestion of an alternative approach

Some feedback suggested alternative approaches would improve childhood vaccination rates in New Zealand:

  • General practice focusing on immunisation for their enrolled patients, with appropriate funding, and enrolling those not enrolled
  • Investment in outreach immunisation services should be prioritised over pharmacy provision

Supporting pharmacies to vaccinate infants is part of a wider programme to improve childhood vaccination rates. For example, there has also been investment in Kaupapa Māori outreach immunisation services ($50 million in 2023-2025).

Health NZ noted that it is assessing options to improve enrolment at birth for every child born in New Zealand, including support for a national telehealth precall and recall service.

Connecting whānau with General Practice

Some responses highlighted the importance of connecting whānau with General Practice:

  • Need to maintain the relationship between general practice/GP and whānau
  • If pharmacists are enabled to provide childhood immunisations, it is important where possible that whānau who receive the vaccines from a pharmacist are connected into general practice
  • Need clear referral pathways into general practice to ensure children do not miss out of their health checks

This proposal provides whānau with a wider range of ways to engage with the healthcare system. Childhood vaccinations within a pharmacy setting provides an opportunity to engage with whānau and direct them towards appropriate services.

The training and guidance Health NZ has developed for pharmacists aims to use the opportunity to engage people with the health sector. When a child presents for vaccination the pharmacist vaccinator will discuss the infant’s current GP enrolment and facilitate enrolment where possible.

Precall / recall funding and capacity

General practice undertakes follow ups and recalls for immunisation, particularly of people who might be ‘harder to reach’

  • It was noted that this is not funded
  • Questions were raised about: who would be responsible for this going forward?
  • Whether general practice would receive payment for this activity?

Health NZ advises that accountability for childhood immunisations, including ensuring children are up to date and receiving on time vaccinations, remains with general practice.

Health NZ has developed communications to clarify this and ensure consistent understanding across healthcare workers.

Health NZ will work with general practice on options to resolve ongoing concerns around funding.

Immunisation notifications

All immunisations outside of the general practice must be notified to the person’s general practice

Health NZ advises that immunisation notifications will be provided through the Aotearoa Immunisation Register (AIR) into the practice management software.

Training for pharmacist vaccinators

  • The need for pharmacist vaccinators to be upskilled in the administration of vaccines to those under 3 years old
  • Training in handling pēpi
  • Training in giving outer thigh intramuscular injections
  • Confirming identity of pēpi / children
  • Gaining informed consent
  • Who will provide the training?

The Immunisation Advisory Centre (IMAC) will provide online training and support materials to pharmacists free of charge. These will cover:

  • Communication, and informed consent
  • Vaccine administration for pēpi and tamariki, practical issues around administering vaccine to children in this age range, and error prevention strategies
  • Assessment and treatment of anaphylaxis for pēpi and tamariki
  • Vaccine schedule revision and processes related to scheduling catch up vaccinations.

Pharmacist assessment and authorisation

Questions were raised about:

  • How will pharmacists gain the clinical experience with pēpi/tamariki before their clinical assessment?
  • What form will the clinical assessment take, by whom?

Health NZ has developed a comprehensive training and assessment plan that includes:

  • Online training
  • Supervision
  • Practical training
  • In-person clinical assessment by an accredited assessor or an experienced vaccinator with more than 6 months experience, as needed.
  • Refresher requirements

Vaccination facilities in pharmacy

It was noted that pharmacies would need to have suitable spaces for administering childhood vaccines. This includes:

  • Private space, large enough to accommodate attending whānau
  • Space/equipment for changing/weighing
  • Access to a toilet
  • Culturally safe spaces
  • Access to resuscitation equipment and training

There is already considerable pharmacy vaccination infrastructure available, which was accelerated with the national COVID-19 vaccine rollout.

Health NZ advises that guidance on appropriate facilities will be provided to pharmacies. This includes child and whānau-friendly spaces, and access to resuscitation equipment. Up to date CPR certificates will be required.

Site sign-off will be required before vaccines can be ordered.

Pharmacy cold chain facilities

Concerns were raised over the cold chain

  • Lack of fridge space to accommodate the increased range of vaccines
  • Mixed practice / compliance with the standards with the current model (under Medsafe Pharmacy licencing)
  • Should pharmacy cold chain accreditation (CCA) be brought under the immunisation coordinators’ responsibilities?

Health NZ has developed onboarding guidelines and a checklist for new pharmacy immunisation vaccination sites, which cover cold chain requirements and oversight.

Requests to remove Xpharm restriction from additional vaccines

Increase the range of childhood vaccines a pharmacist can provide – to enable catch-up through pharmacy

  • Poliomyelitis vaccine (IPOL)
  • Hepatitis B recombinant vaccine.

Special group immunisations:

  • Pneumococcal (PPV23) polysaccharide vaccine (Pneumovax23)
  • Hepatitis A vaccine (Havrix and Havrix Junior).

Some vaccines that are not a part of the core childhood immunisation schedule were not included in the Xpharm removal proposal - Polio, Hep A and Hep B.

These vaccines are very low usage vaccines. The National Vaccine Store does not carry a lot of stock because usage is so low. If pharmacists were able to administer these, they would need to have stock on hand. This could result in supply issues, and high wastage if doses were not used.

Hep A vaccine is also used for outbreak responses, so a central stockpile is maintained to support the sporadic outbreaks that occur.

Paracetamol should be given with meningococcal B vaccine (Bexsero)

Responses to our initial consultation highlighted that pharmacists would need access to funded paracetamol oral liquid for children under two years of age when administering meningococcal B vaccine (Bexsero).

Based on this feedback, Pharmac released a further consultation. This was to capture any further feedback on changing the funding of paracetamol oral liquid to enable this.

Feedback was supportive, noting that it would be important for pharmacists to be able to claim for paracetamol oral liquid provided when administering meningococcal B vaccine to children of this age group.

Pharmacists will be able to claim for paracetamol oral liquid when vaccinating children with meningococcal B vaccine (Bexsero).

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.