AML: HMRC flexes enforcement muscle to the tune of £7.8 million
My son is age 4 and is allergic to peanuts. He has an EpiPen. The EpiPen is a medical device which is used to inject a dose of epinephrine to treat him in case he goes into anaphylactic shock. I keep an EpiPen at home and one is in his bag. I never have more than two at a time even though, as a parent, I’d like to have one in the car, in my handbag, in his sports bag.... This would be for all those ‘just in case’ thoughts that creep into your mind, especially when reading the tragic story about Natasha Edelman-Laperouse who sadly passed away after suffering an allergic reaction on a flight, and even though her father had administered two EpiPens. (Read Terry Donavan's blog: Should Pret a Manger pay compensation to the family of the teenager who died after eating a Pret sandwich?)
However, I know I can’t arm myself with medication at all times and in all eventualities and I do what I can every day to ensure my son doesn’t come into contact with peanuts. I read every food label. I think about what I’ve eaten before I kiss him good night. Just in case.
It was therefore a surprise to receive a letter from my GP, via NHS England, telling me about a supply problem with EpiPens. The letter advised that due to a problem which will last ‘several months’, parents were advised to follow all the usual advice regarding avoiding allergens, using the Epipen and dialling 999. A copy of the letter can be found here.
What was very interesting to me as a medical negligence solicitor and mother of a child who is prescribed an EpiPen were the following recommendations:
My first thought was that I wish I hadn’t used an old out of date pen to practise injecting on an orange a few months before I got the letter. However, it was a good job I did practise, given I nearly injected my own thumb (apparently a frequent occurrence).
Medicines go through years of development, extremely rigorous trials and testing and then I imagine there is a great deal of very careful consideration that goes into the leaflet tucked inside the box. I read it very carefully again before my practice run on the orange. Suddenly, we are being told to ignore expiration dates of one drug and the safe weight limit of another.
What is even more difficult is that I have to trust other parents. If a child who needs an epinephrine dose after a severe allergic reaction does not receive it, there is a chance they could die. We are now being told to give a less effective dose from an out of date pen. We are also being told not to get new pens until our current pens have expired. This relies on all parents who have children with allergies not rushing to the pharmacy to get repeat prescriptions. This relies on trust amongst people I do not know and involves me enduring the next few months during the supply problem not knowing whether all the other parents are all stocked up and I am close to being without (although when I read the forums for parents of children with allergies, it seems everyone is struggling).
So the lawyer in me wonders about how the advice in the UK to ignore manufacturers' advice can ever be right. How many months is “too” out of date? Who are the experts who deem that the weight range can differ to what the drug was designed for?
The root of the problem is obviously the suppliers. Brexit is on the horizon. There is talk of how medical supplies will not be subject to the same importation issues as other goods but there will inevitably be some panic come March 2019. Given the risks of not having an EpiPen, or any other medication for that matter, surely that alone should force a review of the policies that result in shortages like this. Any drug shortage adds a burden on the NHS and patients. When a shortage like this occurs, the Department of Health and Social Care has had to spend a considerable amount of time and money addressing the issue and ways around it rather than what they should be doing – improving healthcare.
The memo from NHS Improvement to GPs on 9 October advises ‘conserving supplies for patients who truly need them’. As a parent, I am pleased that food labelling is improving all the time and I will forever work hard to avoid allergens but for now I am reliant on every GP and parent interpreting what the ‘true need’ is for their child in what might be a life or death situation, which is an obviously impossible task.
It is sometimes a defence to medical negligence claims that patients haven’t followed the correct discharge advice, or taken their medication according to the leaflet that was enclosed with it. Patients obviously have a duty to follow advice when it is given but I’m not sure how any patient can be confident they are doing the right thing when following emergency guidance like this rather than the years of research that went into that vital guidance leaflet.
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