Gerry Adams (Louth, Sinn Fein)
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996. To ask the Minister for Health if he is aware of a current shortage of epinephrine injectors for anaphylaxis within the State; and if he will make a statement on the matter. [31425/15]

Gerry Adams (Louth, Sinn Fein)
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997. To ask the Minister for Health if he will clarify the reason pharmacists are experiencing a shortage of epinephrine injectors for anaphylaxis; and the measures that can be undertaken to ensure that pharmacies are fully stocked. [31426/15]

Gerry Adams (Louth, Sinn Fein)
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998. To ask the Minister for Health if he will confirm the identity of the companies currently holding the franchise for supplying epinephrine injectors for anaphylaxis to the State; if this franchise is set to end or be reviewed; and if he will make a statement on the matter. [31427/15]

Leo Varadkar (Dublin West, Fine Gael)
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I propose to take Questions Nos. 996 to 998, inclusive, together.

Adrenaline (also known as epinephrine) autoinjectors are a prescription only medicine indicated for the treatment of anaphylaxis. There are currently 3 adrenaline autoinjectors authorised and marketed in Ireland. Brands include Anapen®, Epipen® and Jext®.

I am aware that there are shortages of supply of the adult preparations of all 3 brands at a wholesaler level. There may still be supplies within the system at a pharmacy level. Unfortunately, individual pharmacies and their patients may be experiencing difficulties.

The Health Products Regulatory Authority (HPRA) has been working with the suppliers to try to restore continuity of supply. The HPRA employs a number of procedures which help to reduce the occurrence, impact and length of medicines shortages. One such mechanism, used in the case of adrenaline autoinjectors, is to facilitate Batch Specific Requests (BSRs). BSRs enable the company to temporarily supply, essentially identical, medicines from other countries to the Irish market to alleviate shortages. BSRs are typically processed within 24 hours of submission by a company to the HPRA.

I understand that the HPRA is working with the companies concerned to facilitate the provision of further stock in the coming weeks.

Adrenaline autoinjectors are complex systems due to both the characteristics of the adrenaline active substance, which is chemically unstable, and of the delivery device, which is designed to be as patient friendly as possible. The manufacture of these products is also complex. For these reasons supply shortages can occur from time to time.

The availability is also impacted by the shelf life of these 3 autoinjector products (which ranges from 18 to 24 months). This is short compared to some other medicinal products.

The HPRA has recently granted a Marketing Authorisation (MA) for a fourth adrenaline autoinjector, Emerade®. This has a 3 year shelf life. The HPRA is proactively working to ensure that supplies of this product can be made available as soon as possible.

There is no franchise, per se, for supply of adrenaline autoinjectors in Ireland. Each of the 4 products referred to above is the subject of a separate MA, granted by the HPRA, which entitles the holder to place the product on the Irish market.

Gerry Adams (Louth, Sinn Fein)
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999. To ask the Minister for Health to set out the status of the promised legislation regarding availability of epinephrine injectors for anaphylaxis in view of the fact he stated nine months ago that this issue may be resolved within a six-month period; and if he will indicate a clear timeframe for this legislation. [31428/15]

Leo Varadkar (Dublin West, Fine Gael)
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Earlier this year I launched a review to explore how we might make certain prescription only medicines more available for use in emergency situations. More recently I have signalled my intention to make legislative changes to allow for suitably trained non-medical persons to supply a range of prescription only medicines in very specific circumstances. These medicines include epinephrine injectors, salbutamol, glyceryl trinitrate, glucagon and naloxone.

This is a significant change to existing regulations around the supply of prescription only medicines and officials from my Department have been working closely with colleagues from the Pre-Hospital Emergency Care Council, the Pharmaceutical Society of Ireland and the Health Products Regulatory Authority on the legislative changes necessary to allow for this. I expect this work to be completed in coming weeks.