Dáil Éireann Debate, Tuesday - 13 November 2018
379. Deputy Clare Daly asked the Minister for Health to identify the person who authorised the HSE not to include the vaccine manufacturers' package leaflets in school packs, instead substituting these leaflets with the HSE vaccine information leaflets and booklets. [46831/18]
View answerThe Health Service Executive is committed to providing accurate information for parents about diseases, the vaccines to prevent them and potential side effects to allow them to choose whether or not to give consent to vaccination.
The HSE's National Immunisation Office has developed a comprehensive range of materials for parents, schools and medical practitioners as part of the immunisation programme. All the information provided to parents about vaccination takes account of the available licensed documentation for each vaccine, the Summary of Product Characteristics and Patient Information Leaflet.
The information is presented in clear and simple language which has been approved by the National Adult Literacy Agency, ensuring that it can be understood by all adults. The Health Information and Quality Authority guide ‘Communicating in plain English’ (2015), developed in partnership with NALA, states that “one in six people find reading and understanding everyday texts difficult: for example, reading a health leaflet, bus timetable or medicine instructions”. Therefore, like other countries providing school immunisation programmes, the Patient Information Leaflet was replaced by an information leaflet which provides the same information on the potential side effects of the vaccine in a manner that ensures that it is easily understood.
Prior to all school immunisation, parents receive an information pack in a sealed package with an information leaflet, consent form and cover letter. The information packs for all immunisations are standardised nationally. The information booklets include information on all the known potential side effects that can occur after each vaccination (as was the case with the HPV vaccine, Gardasil). Parents are also given contact details for their local immunisation office and advised to speak to a member of the school immunisation team if they have any further questions.
It is not the case that parents are being denied the information on the Patient Information Leaflet. In fact, the HSE parent information leaflet refers parents to the website hpv.ie where links to additional information including the licensing documentation, the Summary of Products Characteristics and the Patient Information Leaflet for each vaccine can be found. The HPV website has been endorsed by the World Health Organisation.
