Written answers

Tuesday, 12 March 2019

Department of Health

Medicinal Products Availability

Photo of Niamh SmythNiamh Smyth (Cavan-Monaghan, Fianna Fail)
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351. To ask the Minister for Health if he will review a matter (details supplied) regarding Orkambi; and if he will make a statement on the matter. [11775/19]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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Eligibility for public health services in Ireland is subject to the criteria of being 'ordinarily resident' in the State. 'Ordinarily resident' means a person is living in the State or can provide evidence that he/she intends to remain in the State for at least one year.

The Health Service Executive is responsible for assessing if a person meets the 'ordinarily resident' criteria.

Should the Deputy wish to provide the person's contact details, including her Irish address, I will forward to the HSE for examination and direct reply to the Deputy. Alternatively, the person should contact her local area health office for advice on entitlement to public health services in Ireland.

Photo of Jack ChambersJack Chambers (Dublin West, Fianna Fail)
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352. To ask the Minister for Health if his attention has been brought to a shortage of a medication (details supplied); the efforts under way to address same; and if he will make a statement on the matter. [11782/19]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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In Ireland, the Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines. The Agency’s role includes monitoring and inspecting medicinal products on the market to ensure their safety, efficacy and legality. The HPRA also leads the co-ordination of efforts by national agencies and stakeholders to manage medicine shortages.

I am informed that the supplier of this product has confirmed that there is currently no shortage of Risperdal® 2mg tablets (which contains the active ingredient risperidone) in Ireland.

However, the HPRA was made aware of a shortage of another medicine containing risperidone 4mg from a different supplier in February. This may have resulted in an increased demand for risperidone 4mg and 2mg tablets from other suppliers. However, there have been no reports of shortages of any other medicine containing risperidone. That said, some localised issues may arise for a period of time as stock levels return to normal throughout the system.

Unfortunately, medicines shortages do arise from time to time for a number of different reasons and are a feature of health systems around the world. The shortage of the risperidone 4mg product was not as a result of Brexit. I can confirm that no shortages currently affecting the Irish market are attributable to Brexit.

The Government does not anticipate an immediate impact on medicine supplies should there be a no deal Brexit on 29 March. There are already additional stocks of medicines built into the Irish medicine supply chain, and these additional stocks, together with planning by Revenue to allow fast-tracking of essential medicines into Ireland, will help deal with any delays that may arise.

It is important to note that there is no need for any patient to order extra quantities of medicines or for doctors to issue additional prescriptions, as this could disrupt existing stock levels and hamper the supply of medicines for other patients.

Risperdal®, and other medicines containing the active ingredient risperidone, have been designated as interchangeable by the HPRA. Interchangeable medicines contain the same active ingredient, in the same strength, and therefore other brands containing risperidone may be safely switched to if necessary. If a patient has any concerns regarding their treatment with this or any other medicine, I would encourage them to discuss this directly with their doctor or pharmacist.

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