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Adrenaline auto-injectors: updated advice after European review.

Advice for healthcare professionals:

* it is recommended that 2 adrenaline auto-injectors are prescribed, which patients should carry at all times

* ensure that people with allergies and their carers have been trained to use the particular auto-injector that they have been prescribed-technique varies between injectors

* encourage people with allergies and their carers to obtain and practise using a trainer device (available for free from the manufacturers' websites)

Advice to give to people with allergies and their carers:

* it is recommended that you carry 2 adrenaline auto-injectors at all times; this is particularly important for people who also have allergic asthma because they are at increased risk of a severe anaphylactic reaction

* use the adrenaline auto-injector at the first signs of a severe allergic reaction

* take the following actions immediately after every use of an adrenaline auto-injector:

1. call 999, ask for an ambulance and state "anaphylaxis", even if symptoms are improving

2. lie flat with legs raised to maintain blood flow. However, if you have breathing difficulties, you may need to sit up to make breathing easier

3. seek help immediately after using the auto-injector and if at all possible make sure someone stays with you while waiting for the ambulance

4. if you do not start to feel better, use the second auto-injector 5-15 minutes after the first one

* check the expiry date of the adrenaline auto-injectors and obtain replacements before they expire; expired injectors will be less effective

Results of European review

The European Medicines Agency (EMA) has completed a review of all adrenaline auto-injectors approved in the EU. The review concluded that:

* due to uncertainties about the site of drug delivery and the speed of adrenaline action within the body, it is recommended that healthcare professionals prescribe 2 auto-injectors, which patients should carry at all times

* the needle length of the device is now stated in the product information because this may be an important factor for the prescriber to consider when choosing a suitable auto-injector

* the training of patients and their carers in the correct use of the product is important and manufacturers were required to update their educational materials--see table below

* manufacturers should carry out studies in humans to more fully understand when and how much adrenaline reaches the blood stream, and how quickly and effectively it acts on body tissues when given through an auto-injector

These studies have started and will help to inform future recommendations for adrenaline auto-injectors.

Patient and carer instructions

If you prescribe adrenaline auto-injectors, you should ensure that the patient or carer thoroughly understands the indications and use of the device.

You should review with the patient and their carers the instructions and operation of the adrenaline auto-injector.

The table below provides links to the patient information leaflets and educational material for all adrenaline auto-injectors licenced in the UK. People with allergies and their carers can also use manufacturer websites to order trainer devices and to sign up for expiry alert services.

Anaphylaxis

The Resuscitation Council1 recommends an intramuscular injection of adrenaline in the outer thigh to be treatment of choice for someone having an anaphylactic reaction. Because the onset of anaphylaxis can be very fast, the individual should use an adrenaline auto-injector at the first signs of a severe reaction, then call for emergency medical help.

Signs of a severe reaction include:

* swelling in the throat (altered voice, difficulty swallowing or breathing)

* wheezing

* dizziness, feeling faint, tiredness (symptoms of low blood pressure)

If in doubt about severity, or if previous reactions have been severe, the individual should use an adrenaline auto-injector. If the individual does not feel better after the first injection, the second auto-injector should be used 5-15 minutes after the first.

Article citation: Drug Safety Update volume 11 issue 1, August 2017: 3.

(1.) Resuscitation Council (UK). Emergency treatment of anaphylactic reactions. January 2008.

Annotated with links to NICE guidance July 2012. Published: 15 August 2017

From: Medicines and Healthcare products Regulatory Agency

Therapeutic area: Paediatrics and neonatology Respiratory disease and allergy

Please find online article below

https://www.gov.uk/drug-safety-update/ adrenaline-auto-injectors-updated-advice-after-european-review

Corticosteroids: rare risk of central serous chorioretinopathy with local as well as systemic administration

Medicines and Healthcare products Regulatory Agency

Published: 15 August 2017

Therapeutic area: Ophthalmology, Respiratory disease and allergy, and Rheumatology

Central serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of corticosteroids. Recently, it has also been reported after local administration of corticosteroids via inhaled and intranasal, epidural, intra-articular, topical dermal, and periocular routes.

Advice for healthcare professionals:

* advise patients to report any blurred vision or other visual disturbances during corticosteroid treatment

* consider referral to an ophthalmologist for evaluation of possible causes if a patient presents with vision problems

* report suspected adverse reactions to us on a Yellow Card

Background

Corticosteroids are indicated for a wide variety of indications in the treatment or suppression of inflammatory and allergic disorders, commonly including:

* asthma and allergic rhinitis

* systemic inflammatory disorders, for example, rheumatoid arthritis

* skin conditions, for example, eczema

Central serous chorioretinopathy

Central serous chorioretinopathy (CSCR) is characterised by the accumulation of subretinal fluid at the posterior pole of the fundus, ultimately causing retinal detachment. CSCR typically affects one eye only and can cause vision to be blurry and distorted, with objects often appearing smaller and distorted in the affected eye. Patients may also have difficulty with bright lights and contrast sensitivity.

Although the exact mechanism that leads someone to develop CSCR is unknown, several possible risk factors have been described, including use of systemic corticosteroids, pregnancy, and Cushing's syndrome. (1) These risks are thought to be associated with the effect of cortisol on the eye.

CSCR has recently also been described after local administration of corticosteroids via inhaled and intranasal, epidural, intra-articular, topical dermal, and periocular routes. (2 3 4 5 6) It is a rare side effect that occurs with all formulations.

Although blurred vision is a symptom of CSCR, it is also an established side effect of steroid treatment. The causes of blurred vision are various and can also include cataract and glaucoma.

Inform patients they should report any vision problems or disturbances. If a patient who has received local treatment with a corticosteroid presents with visual symptoms, consider referral to an ophthalmologist for evaluation of possible causes.

Article citation: Drug Safety Update volume 11 issue 1, August 2017: 2.

1. Royal National Institute of Blind People. Central Serous Retinopathy. Accessed August 2017.

2. Chan LY, et al. Localized topical steroid use and central serous retinopathy. J Dermatolog Treat 2016; 27: 425-26.

3. Ricketti PA, et al. Central serous chorioretinopathy secondary to corticosteroids in patients with atopic disease. Allergy Asthma Proc 2015; 36: 123-29.

4. Kleinberger AJ, et al. Bilateral central serous chorioretinopathy caused by intranasal corticosteroids: a case report and review of the literature. Laryngoscope 2011; 121: 2034-37.

5. Tliba A, et al. Central serous chorioretinopathy secondary to epidural corticosteroid infiltration. Tunis Med 2016; 94: 166

6. Balakrishnan S, et al. Sudden loss of visual acuity following intra-articular steroid injection in to the knee joint: a case report. Cases J 2008; 1: 428.
Product name                Patient information
                            leaflet

Emerade 150 [micro]g, 300   Emerade adrenaline auto-
[micro]g, and 500           injectors
[micro]g solution for
injection in pre-filled
pen

EpiPen 0.3 mg and EpiPen    EpiPen and EpiPen Jrauto-
Jr. 0.15 mg adrenaline      injectors
(epinephrine)
auto-injector

Jext 150 pg and Jext 300    Jext pre-filled pens
[micro]g solution for
injection in pre-filled
pen

Product name                Educational material
                            produced by the
                            manufacturer

Emerade 150 [micro]g, 300   Emerade patient brochure
[micro]g, and 500           and instruction video
[micro]g solution for
injection in pre-filled
pen

EpiPen 0.3 mg and EpiPen    EpiPen user guide and
Jr. 0.15 mg adrenaline      instruction video
(epinephrine)
auto-injector

Jext 150 pg and Jext 300    Jext instructions for use
[micro]g solution for       and instruction video
injection in pre-filled
pen


Andrew Robinson Chiropodist
COPYRIGHT 2017 Institute of Chiropodists and Podiatrists
No portion of this article can be reproduced without the express written permission from the copyright holder.
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Publication:Podiatry Review
Date:Oct 1, 2017
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