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Adams concern at shortage of epipen medication

15 October, 2015 - by Gerry Adams TD


Sinn Féin Louth TD Gerry Adams has praised the tenacity of Caroline Sloan whose daughter Emma died two years ago from an allergic reaction. As a result of her campaign the Minister for Health Leo Varadkar today announced a change in the law to allow for members of the public to administer life-saving rescue medicines in emergency situations, which was welcomed by Teachta Adams.  

However the Louth TD has raised concerns at the current shortage of the adult preparations for the three brands of medication for epipens that are in use in this state.

Gerry Adams said: “The Minister’s response does not explain why there is a shortage of injectors. This problem does not exist in other states where epipens are available. This is a matter I intend taking up with again with the Minister and the HPRA.”

The Louth TD said:

“The new laws signed by the Minister will allow for the wider use of adrenaline epipens to treat people suffering severe allergic reactions and other conditions.

“Sinn Féin has been consistently raising this issue, including in local councils. I have met Caroline Sloan the mother of 14 year old Emma Sloan, who died just before Christmas 2013 in O Connell Street after suffering an allergic reaction. Caroline’s campaign to ease the regulations around the availability of epipens attracted considerable public and media attention and the Ministers decision is in no small part a result of Caroline’s diligence. I want to commend her for her work.”

Note to Editor:

In Parliamentary Questions to the Minister I raised my concerns at the ‘current shortage of epinephrine injectors for Anaphylaxis within the State … and if he will clarify the reason pharmacists are experiencing the shortage of epinephrine injectors for Anaphylaxis; and the measures that can be undertaken to ensure that pharmacies are fully stocked.’

The Minister confirmed in his response that there is currently a shortage of the much needed medicine for the epipens. He states that: ‘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.’

It is vital that the department of Health urgently resolve this problem. Since Emma Sloan died, more than 140 children have been diagnosed with severe and potentially fatal anaphylaxis in the State. Those 140 children, plus the many more previously diagnosed and the countless others currently un-diagnosed are at risk without access to these essential epipens.

Note to Editor:

QUESTION NOS:  996 to 998

DÁIL QUESTIONS addressed to the Minister for Health (Leo Varadkar)

by Deputy Gerry Adams

 *  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.

                                                                                           - Gerry Adams T.D.

For WRITTEN answer on Tuesday, 22nd September, 2015.

*  997.  To ask the Minister for Health if he will clarify the reason pharmacists are experiencing the shortage of epinephrine injectors for Anaphylaxis; and the measures that can be undertaken to ensure that pharmacies are fully stocked.

                                                                                           - Gerry Adams T.D.

For WRITTEN answer on Tuesday, 22nd September, 2015.

*  998.  To ask the Minister for Health if he will confirm 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.

                                                                                           - Gerry Adams T.D.

For WRITTEN answer on Tuesday, 22nd September, 2015.

 

REPLY.

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.

 

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