Medicinal Products Supply

Thursday, 9 October 2014

Questions (163, 170, 171)

Michael Healy-Rae

Question:

163. Deputy Michael Healy-Rae asked the Minister for Health the monitoring requirements for the use of Roaccutane; and if he will make a statement on the matter. [38792/14]

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Michael Healy-Rae

Question:

170. Deputy Michael Healy-Rae asked the Minister for Health the guidelines issued for the use of a Roaccutane (details supplied); and if he will make a statement on the matter. [38815/14]

View answer

171. Deputy Michael Healy-Rae asked the Minister for Health the guidelines that were in place in 1998 regarding the prescribing of Roaccutane for acne; and if he will make a statement on the matter. [38816/14]

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Written answers

Minister of State at the Department of Health

I propose to take Questions Nos. 163, 170 and 171 together.

Roaccutane (containing the active substance, isotretinoin) is authorised in Ireland and the EU for treating severe forms of acne which have been resistant to other standard therapies. It should only be prescribed by or under the supervision of doctors with expertise in using the product and with a full understanding of the risks of therapy and the monitoring requirements.

The guidance to support appropriate use and monitoring of Roaccutane is based on assessment of the currently available data, which changes over time, as new information is generated on an on-going basis from a variety of sources, including post marketing experience, further studies, literature reviews etc. The current product information reflects these recommendations.

Roaccutane (isotretinoin) should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements. The requirements for specific monitoring of the patient are described in detail in the Summary of Product Characteristics (SPC) in relation to psychiatric disorders, sever skin reactions, allergic reactions, liver enzymes, serum lipids and the pregnancy prevention programme. Monitoring in these circumstances is through ongoing review of the patient by the prescribing doctor, as part of their clinical practice.

I have arranged for copies of the guidelines which were in place in 1998 and the current guidelines to be forwarded to your office.

Question No. 164 answered with Question No. 140.