Own volition examination of the HSE’s administrative actions in relation to the HPV vaccination programme

Background

In 2016 we received 11 complaints from parents on behalf of their children about the HSE’s HPV vaccination programme.  At the outset, we explained to parents that we have no clinical or scientific role to investigate any potential link between a child’s reported adverse reactions and the vaccine, nor the professional conduct of medical staff.

Following careful consideration of the collective nature of the complaints received, we decided to carry out an own volition examination of the general concerns about the HSE’s administrative actions that fell within our remit.

What we did

We examined the HSE’s administrative actions in relation to:

  • Information provided to parents to inform decision making on the vaccination
  • HSE guidelines for the reporting of adverse effects by the HSE Immunisation team to the Health Products Regulatory Authority
  • Information on supports available to children and young people who reported adverse reactions

We sought information from the HSE and analysed the various issues involved.

What we found

Following the conclusion of our examination, we made the following encouragements to the HSE to improve the administration of the HPV school immunisation programme:

  • to increase accessibility of the Patient Information Leaflet for parents and guardians further to those already provided by the HSE
  • to provide greater clarity in their guidelines on the obligations of the HSE Immunisation Team to report adverse events to the Health Products Regulatory Authority.

We also encouraged the HSE to ensure that it clearly signposts the relevant pathways so that children and young people can directly access relevant health services and supports.

Outcome

The HSE’s information leaflet for 2017/2018 now includes a QR code and a link to access the manufacturer’s Patient Information Leaflet. Further, the HSE has amended the guidelines for the Immunisation Teams that provides greater clarity on their obligations to report adverse events to the Health Products Regulatory Authority.

With respect to supports for children and young people who report side effects, the HSE stated that it strives to provide the appropriate care for all patients no matter what their illness and that interagency liaison occurs when it is required in the care of each patient.

For more information see the OCO Helpsheet.

Posted in: Investigations Health