Why HAVE we run out of life-saving EPIPENS?

In the wake of a world shortage, doctors say allergy sufferers should not panic

AS any parent of a child with a serious allergy can attest, being vigilant in case of reactions or instances of anaphylaxis (an acute reaction where the body becomes hypersensitive) can sometimes be a full-time job.

Reading food labels, being militant about what’s in restaurant or school meals, keeping an adrenaline auto-injector close to hand are all part and parcel of the life of a person with allergies.

And in recent months, a number of high-profile cases have hammered home the seriousness of the condition.

In September, an inquest heard that French teenager Natasha Ednan-Laprose died on a flight after suffering a serious allergic reaction to a Pret A Manger baguette with sesame seeds.

The same month, a British court was told that 13-year-old Karanbir Cheema died after a severe allergic reaction to cheese, reportedly thrown at him by a peer in school. The court also heard his school underestimated the severity of Karan’s reaction when reporting it to emergency services.

In tandem with these highprofile cases, it has been revealed that there has been a shortage of EpiPen devices worldwide for months. In what amounts to another challenge for allergy sufferers and children with severe allergies, the EpiPen was declared ‘out of stock’ amid the global shortage.

A statement issued to healthcare providers by the British Department of Health noted: ‘EpiPen and EpiPen Junior will be subject to limited availability for the remainder of 2018.

‘Mylan are now out of stock of EpiPen Junior and interruptions in the supply are anticipated to continue for the coming months.

‘Mylan have obtained acceptance from the Medicines and Healthcare products Regulatory Agency to extend the use of specific batch numbers of EpiPen 300mcg auto-injectors beyond the labelled expiry date for four months.’

THE Health Products Regulatory Authority, the Irish body responsible for coordinating the management of shortages of medicines on the Irish market, initially expected the shortage to be alleviated this month. It has, however, been speculated on whether the restock will be able to meet demand created by the shortage.

Estimates within the sector say that it will be closer to year’s end by the time the supply of EpiPens returns to normal.

Perhaps understandably, fears have risen over the shortage, although specialists note EpiPen buyers and users can and should avail of alternative brands.

Crucially, there are four brands of adrenaline auto-injectors on the Irish market, of which EpiPen, although the market leader, is just one. The other brands are Jext, Anapen and Emeraid, all of which have adjusted their own manufacturing output to meet demand.

Says Aideen Byrne, consultant allergist at Our Lady’s Children’s Hospital, Crumlin, and the National Children’s Hospital, Tallaght: ‘There should be no panic. In order to get a device, (people) perhaps won’t be getting it as quickly as they are used to, but the important thing to be aware of is that the device is effective up until the day of expiry — if the expiry date is October, it can be used until the end of October.’

Explaining the EpiPen shortage, some have cited manufacturing challenges on the part of Pfizer, the drug company that produces the adrenaline in EpiPens.

Yet Paul Carson, consultant allergist at the Slievemore Clinic, Dublin, says: ‘I’m not hearing or reading about problems with the manufacturing of the devices. And if the company is producing at its usual rate, (the shortage) isn’t due to supply; rather it’s due to demand.

‘You have to ask why more of these devices are being demanded. Could it reflect a higher number of children and adults being diagnosed with anaphylactic problems, or are other factors in play? Are some people hoarding too many of them?’

It is recommended that people with allergies have two EpiPens on their person at all times. Yet many parents, hoping to be extra vigilant, want to ensure their children have access to the device at all times. ‘It’s not a malicious or malevolent thing, but some parents might say, “I want two (devices) for school, two for Granny’s house, two for the childminder, and so on,’ he adds. ‘And it’s the same in every situation; if there is a shortage, everyone tries to get one in case they are caught short.’

Carson cites a study at a paediatric hospital in Bristol: though small, with only 29 subjects, the findings gave him, and many others, pause for thought. ‘Of the 29 children given the injectors, only three had actually used them and one was administered unnecessarily by nursery staff.

‘The children carried between two and nine devices. When the study was done, only eight children had the device with them.

‘The mantra I say to parents is that the device follows the child,’ he notes. ‘There’s no point in having the child at school and the device at home.’

Teenage years, Carson says, can be particularly challenging for both children who suffer allergy problems — and their parents.

‘The one issue that happens in teenage years is children go to dances or pubs and they don’t want to be seen with the devices,’ he observes.

Carson says that each brand of device is different, and parents and allergy sufferers need to familiarise themselves with the different modes of action for each one.

‘Some devices are prescribed by GPs, but there are no instructions on how or when to use the device,’ he says. Whatever about supply challenges the demand for adrenaline auto-injectors can be partly attributed to the rising rates of people being diagnosed with serious allergies.

‘(Some) waiting lists for allergy specialists (in hospitals) can be hovering around the three-year mark,’ observes Mr Carson. ‘There’s an enormous demand for expertise.

‘There is a definite increase in children developing food allergies that are dangerous — it’s not a massive jump, but enough to be creating a problem in schools.

‘If we go back ten years, it was very unusual to see a child turn up in school with an EpiPen, and now it’s the norm in almost every classroom to have one or two children with adrenaline auto-injectors.

‘At the moment it’s estimated that 24% have breathing allergies and are allergic to dust, pollen and so on, and the same experts believe this figure will rise to 50% in ten years’ time.

According to Dr. Ranbir Kaulsay, allergist at the Bon Secours and Beacon hospitals, Dublin, asking why there has been in increase in people being diagnosed with serious allergies is the ‘million dollar question’.

‘There are a few theories behind the sharp increase but it likely boils down to the fact that we may have become a little too clean, and we’re not exposing our children to enough bacteria, viruses and so on, and so the body attacks itself,’ he says.

‘We have too many vaccinations and antibiotics. The body doesn’t have much to fight itself naturally, and as a result of this it starts to attack substances that should be accepted by the body.’

KAULSAY says, too, that proper diagnosis is key to understanding the condition: ‘A lot of allergy work is done by non-medical practitioners and there is a lot of strange testing going on. Testing for hair and intolerance testing — none of this is advocated,’ he warns. ‘The only recommended test by all allergy specialists would be a skin prick test or a specific Immunoglobulin E (IgE) blood test.’

Carson offers the following advice to those facing the challenges of a serious food allergy: ‘Take ownership of the problem. People don’t like to hear this, but you can no longer rely on a health service, in most parts of the world, to protect a child or adults.

‘People need to take ownership and start to learn to deal (with the condition) themselves. Also, never trust caterers. I’ve seen huge casual indifference in the attitudes of restaurants to allergens. Always rely on your own judgment.’

In the event of an allergic reaction, Kaulsay notes that not just parents but childminders and teachers should be appropriately trained, equipped and prepared for a possible allergic reaction or anaphylaxis.

‘The slightest hint that someone might be allergic is when they might get itching in the throat or mouth, and may develop a rash around the mouth or whole body, or they may start to wheeze,’ he advises.

‘At the very first stage if you suspect something may have been eaten or a child is in the early stages of allergy, every association would recommend giving them a high dose of antihistamines and steroids.

‘Yet for severe reactions or anaphylaxis, the early administration of an auto-injector is vital, without wasting any time.

‘And in a certain number of cases, if the person’s symptoms don’t respond or if they start to feel unwell again, they might well require a second pen.’