Dáil Éireann Debate, Tuesday - 12 February 2019
339. Deputy Caoimhghín Ó Caoláin asked the Minister for Health if the public information leaflet and associated stickers are being included mandatorily in the dispensing of sodium valporate to prescribed patients. [6735/19]
Amharc ar fhreagra446. Deputy Caoimhghín Ó Caoláin asked the Minister for Health if an impact study being carried out by an organisation (details supplied) is delaying action on commitments made to raise public awareness regarding the use of sodium valproate for certain groups of persons. [6736/19]
Amharc ar fhreagra447. Deputy Caoimhghín Ó Caoláin asked the Minister for Health the status of an agreement to place a public information poster in all general practitioner and primary care practices concerning warnings about side effects from the prescribing of sodium valproate. [6737/19]
Amharc ar fhreagraI propose to take Questions Nos. 339, 446 and 447 together.
My Department continues to liaise closely with the HSE and the Health Products Regulatory Authority (HPRA), as well as other stakeholders, to help address concerns raised over the use of sodium valproate, also known as Epilim.
As part of its Valproate Response Project, the HSE undertook a communication programme in 2018 to provide information to support the safe prescribing of valproate treatment in women with epilepsy, bipolar disorder and other conditions, to help prevent current and future harm to women of childbearing age who are pregnant or who could become pregnant while taking valproate medicines. To date, the communications plan has included:
1. Issuing letters to all prescribers and pharmacists in relation to new European Medicines Agency (EMA) and HPRA guidelines on the use of sodium valproate;
2. Issuing patient-specific letters to GPs;
3. Issuing 2500+ letters to patients who were dispensed sodium valproate;
4. Issuing letters to pharmacies advising them of the patient support service and requesting that they include a patient information leaflet every time they dispense sodium valproate;
5. Developing an information web page regarding sodium valproate; and
6. Using social media to provide regular updates to patients and stakeholders.
In addition to this HSE programme, the HPRA has collaborated with national stakeholders, including patient representatives and healthcare professionals, to implement the EMA’s new risk minimisation measures in Ireland.
These measures have included changes to the product information for patients and healthcare professionals; a visual warning on the packaging of valproate medicines; updated educational materials to reflect the new measures and provide age-appropriate advice; and a patient alert card to be attached to the packaging so that pharmacists can go through it with the patient when valproate is dispensed.
In tandem with the actions taken by the HPRA, the Pharmaceutical Society of Ireland (PSI), as pharmacy regulator, has directed pharmacists that they must inform women of child-bearing age of the potential risk of abnormal pregnancy outcomes when supplying medicines containing valproate. This includes providing a patient leaflet and Alert Card with each supply of these medicines.
It is important to note that many of these actions, as well as other strands of work within the HSE Valproate Response Project, are continuing while an impact assessment led by the Royal College of Surgeons in Ireland (RCSI) is taking place, and are not dependent on the outcome of the RCSI's report.
The Deputy may also be aware that the HSE is planning a public conference on sodium valproate at the end of March to expand the scope of communication around this medicine and increase awareness among women age who are currently taking, or have previously taken, sodium valproate.
