Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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628. To ask the Minister for Health the details of availability of ocular Zovirax; if recommendations on prescribing alternative medications will be made for any period during which it is not available; and if he will make a statement on the matter. [11507/15]

Kathleen Lynch (Cork North Central, Labour)
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Zovirax® Eye Ointment is produced by Glaxo Smithkline (GSK) and is an ocular preparation of the anti-viral drug aciclovir. It is licensed in Ireland for treatment of herpes simplex keratitis.

There has been a shortage in Ireland and in other countries of the product since late last year due to a number of batches of the active ingredient (aciclovir) having small metal particles larger than allowed. As a result, a number of batches across the globe were recalled in November 2014.

While none of the affected batches had been distributed in Ireland, supplies of unaffected batches have been available in only very limited quantities in Ireland since then.

There are no generic versions of Zovirax® Eye Ointment authorised in Ireland but Zovirax® tablets have remained available. A small number of unauthorised alternative products (other anti-viral eye preparations) have been available for pharmacies to order since the shortage began. These include eye products such as Virupos® ointment, or Virgan® eye gel. Limited supplies of the Zovirax® Eye Ointment product from other countries have been available for ordering in Ireland, as an unauthorised product.

On 4 November 2014 the Health Products Regulatory Authority (HPRA- the medicines regulator in Ireland) informed doctors and pharmacists that GSK was rationing product supplies in light of the global shortage. Information on alternative products was provided. GSK issued a letter providing similar information on 5 November 2014 (and was posted on the HPRA's website.)

On March 19th, 2015, GSK informed the HPRA that stocks of Zovirax ®Eye Ointment in Ireland would be exhausted completely by April 2015, and that the expected resupply date was the first quarter of 2016. The HPRA is currently working with GSK to communicate this information to doctors and pharmacists. The unauthorised anti-viral eye products have continued to be imported into Ireland in recent months. The advice issued in November 2014 to doctors and pharmacists in relation to prescribing alternative medications remains valid.