Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

463. To ask the Minister for Health if he will outline the well known documented risks related to the use of Roaccutane in women of child bearing potential; and what the Health Products Regulatory Authority and the company (details supplied) are doing to eliminate risks; and if he will make a statement on the matter. [33336/15]

Kathleen Lynch (Cork North Central, Labour)
Link to this: Individually | In context | Oireachtas source

Since it was first authorised for use in Ireland, Roaccutane (isotretinoin) has been contraindicated in women who are pregnant or breastfeeding. Use of isotretinoin has also been consistently contraindicated in women of childbearing potential since the product was first authorised, unless all of the conditions specified in the product information are met.

An EU wide Pregnancy Prevention Plan (PPP) was introduced in October 2003 to further reduce the potential risk of pregnancy in women by expanding the available information and highlighting the well-known and documented risks related to use in women of child-bearing potential. These measures include supplementary information distributed to prescribing doctors, pharmacists, other relevant healthcare professionals and patients, including the following:

- Physician’s guide to prescribing Roaccutane to female patients;

- Physician’s checklist for prescribing to female patients;

- Patient information brochure;

- Important information for patients prescribed Roaccutane on contraception; and

- Pharmacist’s guide to dispensing Roaccutane.

The PPP applies across all EU member states and is monitored and reviewed at EU level. The company submits the information gathered through the PPP on a yearly basis to the competent authority for each EU member state (i.e. HPRA in Ireland). The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC), (at which Ireland is represented by the HPRA) assesses the data provided to consider any need to strengthen/amend the PPP as part of the regular review of the effectiveness of these risk minimisation measures.

In addition, the Medicinal Products (Prescription and Control of Supply) Regulations 2003 were amended in 2005 to introduce restrictions on certain medicines containing Isotretinoin. Regulation 7(9) of the Regulations provides that the prescription of a medicine containing Isotretinoin (not being for external use) which is intended for the treatment of a woman of childbearing potential, shall not be dispensed later than seven days after the date on the prescription and the treatment shall not exceed a period of thirty days.