Dáil Éireann Debate, Tuesday - 20 June 2017
1182. Deputy Brendan Ryan asked the Minister for Health if all patient information leaflets published by the HSE regarding the HPV vaccine Gardasil contain all known side effects; and if he will make a statement on the matter. [27204/17]
Amharc ar fhreagra1186. Deputy Louise O'Reilly asked the Minister for Health if the manufacturer product information leaflet for the human papillomavirus vaccine which lists certain adverse effects not listed on the HSE leaflet is being made available to parents and children before consent is being given for administration of the vaccine; and if not, the reason therefor. [27215/17]
Amharc ar fhreagraI propose to take Questions Nos. 1182 and 1186 together.
The HSE is committed to providing accurate information for parents about diseases, the vaccines to prevent them and side effects to allow them to choose whether to give consent to vaccination. All the information provided to parents about vaccination is prepared from the available licensed documentation for each vaccine, the Summary of Products Characteristics (SPC) and Patient Information Leaflet (PIL). The information is presented in clear simple language and approved by the National Adult Literacy Agency (NALA) so that it can be understood by all adults.
The Health Information and Quality Authority (HIQA) 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. One in four has difficulties in real world maths from simple addition and subtraction to the calculation of averages”. Therefore, like other countries providing school immunisation programmes, the Patient Information Leaflet (PIL) is replaced by this information leaflet and like other countries the HSE information leaflet provides the same information on side effects of the vaccine.
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 immunisation are standardised nationally. The information booklets include information on all the known side effects that can occur after each vaccination. All the known side effects of the HPV vaccine Gardasil are outlined in the information booklet given to parents. 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.
Parents are not being denied the information on the Patient Information Leaflet. The HSE parent information leaflet refers parents to the national immunisation website www.immunisation.ie where links to additional information including the licensing documentation, the SPC and the PIL for each vaccine can be found at: www.hse.ie/eng/health/immunisation/pubinfo/schoolprog/HPV/HPV/.
The website allows members of the public to contact the National Immunisation Office (NIO) to ask a question if they require further information. These questions, when possible, are answered by the staff of the NIO within one working day. The NIO website has been accredited by the World Health Organisation (WHO).
