In recent weeks we have received a dramatic increase in inquiries to our Helpline with lots of our members and the wider allergic community expressing concern on a range of topics. Our helpline and information team have answered some of the most frequently asked questions that we have recently received.I am worried about the needle length of adrenaline auto injectors, are they okay?
Each of the 3 brands do have different needle lengths but all of them have shown through testing that is required as part of their license from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) that they are safe and effective.
Is adrenaline effective in the event of a severe allergic reaction?
Adrenaline auto injectors provide an effective dose of a life-saving medicine which long clinical experience has shown to be effective in treating the symptoms of anaphylaxis. Adrenaline acts quickly to open up the airways, reduce their swelling and raise the blood pressure. To work effectively, it must be given as soon as possible if there are any signs of a severe allergic reaction. With early treatment those more severe symptoms are easier to reverse, so the important message is to use adrenaline as soon as severe symptom starts as it is a very safe and effective drug. In the UK there are three different doses of AAI’s available. Jext® available in 150 or 300mcg, EpiPen® available in 0.15mg and 0.3mg and Emerade® available in 150 micrograms, 300 micrograms and 500 micrograms. The decision regarding which dose an individual should be prescribed should be made by an allergy specialist. Our advice is always to carry two adrenaline auto injectors with you at all times.
If an individual needs a second dose of adrenaline where should it be administered?
We have asked our clinical panel about the comments regarding the site of the second injection and they have asked us to reassure our members that the likelihood of requiring a second AAI injection is extremely small and that if it is needed then it may be given into the opposite leg but if this is not possible or would cause delay, then the second injection can be administered into the same leg.
What is the legislation for a food business that makes and sells food on the same site and will this now change?
At present when a food business sells prepacked food for direct sale the same regulations apply as to non-prepacked food under the EU Food Information for Consumers Regulation No. 1169/2011 commonly known as EU FIR 2014, this means food business preparing their products freshly on their premises are exempted from the obligation of labelling them with a list of ingredients including the provision of allergen information.
This is because it is expected that the customer is able to speak with the person who made or packed the product to ask about ingredients. All mandatory allergen ingredients information (the 14) should be available and easily accessible for the consumer and this can be communicated through a variety of means to suit the business format of the food business operator.
The coroner who preceded over the inquest of Natasha Ednan-Laperouse concluded that the current legislation is not adequate and has requested a review. The Anaphylaxis Campaign welcomes a review and would support a strengthening of the regulation to ensure food allergic consumers are well informed regarding the allergen information of food purchased from food business preparing their products freshly on their premises. The views of our members will help us inform the work we do with the Food Standards Agency and the food industry. We hope the review will cover all food business that sell food that has been prepared and packed on the same premises from which they are being sold, irrespective of the size of the business.
Does the extended shelf-life of EpiPen® 0.3mg autoinjectors apply to all devices?
No, the extended use by date does not apply to EpiPen 0.15mg auto injectors or any lot number of EpiPen® 0.3mg autoinjectors not specified. Mylan UK have obtained acceptance from the MHRA to extend the use of specific lot numbers of EpiPen® 0.3mg auto injectors, beyond the labelled expiry date by four months. The affected lot numbers, which have labelled expiry dates between July 2018 and November 2018, are listed in the table below.
LOT Labelled Expiry Date (end of the month) Extended Use by Date (end of the month)
6FA794J 07.2018 11.2018
6FA795Y 07.2018 11.2018
7FA112F 09.2018 01.2019
7FA106B 09.2018 01.2019
7FA283B 10.2018 02.2019
7FA251D 10.2018 02.2019
7FA250B 10.2018 02.2019
7FA265C 11.2018 03.2019
7FA265B 11.2018 03.2019
Is it safe to use an AAI after its use by date?
The expiry date given on all AAI’s is based upon the natural degradation of the drug adrenaline over a set time period, if in the event of an emergency if you have no other device available and the liquid is not discoloured or contains particles you may wish to use the device but the efficacy of the drug is not guaranteed passed the expiry date.