New Study Adds Further Weight to MHRA Call for Longer Needles in Adrenaline Auto-Injectors

LONDON, June 4, 2015 /PRNewswire/ --

- For 87% of women and 68% of all participants AAI needles may be too short to be effective -  

One year on from the MHRA's recommendations^[1] regarding adrenaline auto-injectors (AAIs), a growing body of evidence continues to highlight potential issues in relation to effective and safe AAI use. Recently published research in the journal Allergy^[2] has focused again on the importance of needle length to the effective use of AAIs for emergency treatment of people with anaphylaxis.

In an analysis of subcutaneous tissue depth, the study found that the majority of women had a skin-to-muscle depth (STMD) greater than the needle length of the most commonly used AAI.

Researchers used an ultrasound scanner to measure the STMD of 23 women and 5 men attending an allergy clinic at Worcester Royal Hospital, UK. The study found that 87% of women and 68% of all participants had a STMD at the anterolateral thigh greater than the needle length of the most commonly used AAI (p=0.0003). At the alternative injection site on the anterior thigh, 50% of all participants also had a greater STMD than the most commonly used needle length (p=0.008). Increased BMI was also found to correlate with increased STMD.

"The patients at most risk of failure to deliver an intramuscular dose are females, even with a normal BMI, and patients with a BMI greater than 30," commented Prof. Stephen O'Hickey of the National Pollen and Aerobiology Research Unit, University of Worcester. "AAIs require longer needles to ensure intramuscular administration, and ultrasound at point of prescription would aid needle length selection."

Another study, published in 2013 in the Journal of Allergy and Clinical Immunology^[3], investigated STMD in children with a range of BMIs and showed that longer AAI needle lengths that were available at the time of the study would improve the chance of intramuscular injection in patients who are obese.

These findings echo conclusions from the June 2014 MHRA report commissioned to investigate UK-licensed AAIs following the death of a patient using an AAI to self-treat anaphylaxis. The report reviewed the most effective site for injection, clarity of instructions and the most appropriate needle length for intramuscular injection.

MHRA recommendations suggested that the needle length of all AAIs should be reviewed and that licence holders be requested to provide data that an intramuscular injection is delivered consistently. Continued research in this area adds weight to these recommendations currently being considered at a European level by the EMA, with the report due early this summer and likely to contain further guidance for manufacturers and healthcare professionals.

"In 2014, the MHRA concluded^[1]  that a commonly used needle length of 15mmwould not be sufficient to reach the muscle tissue in a substantial number of adults and children," added Rob Travers, Product Specialist, Bausch + Lomb. "With a longer needle length of 25mm, the Emerade AAI meets the MHRA recommendations to deliver intramuscular adrenaline effectively to more people in emergency situations.As bee and wasp stings are an important cause of anaphylaxis during the upcoming summer months^[4], the safety and effectiveness of AAI injections, particularly in women with higher BMI values is a particularly relevant issue. We look forward to receiving the EMA'srecommendations and guidance later in 2015 as we positively look to improve AAI patient safety."

References 

1. MHRA, Adrenaline Auto-injectors: A Review of Clinical and Quality Considerations, 2014. Available from: http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con423091.pdf.
2. Johnstone J, et al. Allergy. 2015:Online ahead of print. DOI: 10.1111/all.12595.
3. Arkwright, P. et al. Journal of Allergy and Clinical Immunology. 2013: 1(6): 692-694
4. Walker, S. & Sheikh, A. Clinical & Experiemental Allergy. 2003. 33:1015-1018

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EME-UK-1505-01

Emerade Prescribing Information 

Emerade^® 150, 300 and 500 micrograms of adrenaline solution for injection in a pre-filled pen.

Indications      

For the emergency treatment of severe acute allergic reactions (anaphylaxis) triggered by allergens in foods, medicines, insect stings or bites, and other allergens as well as for exercise-induced or idiopathic anaphylaxis.

Dosage 

ADULTS AND ADOLESCENTS: The recommended dose is 300 to 500 micrograms.

CHILDREN: Patients between 15 kg and 30 kg in weight: The usual dose is 150 micrograms.

For intramuscular injection only. Emerade should only be injected into the anterolateral aspect of the thigh through clothing if necessary. A second injection with an additional Emerade injector may be administered after about 5 - 15 minutes if necessary.

As Emerade is designed for emergency treatment, the patient should always seek immediate medical attention even if symptoms have disappeared.

Contraindications 

There are no absolute contraindications to the use of Emerade in an allergic shock.

Precautions. 

Emerade must be administrated only into the anterolateral thigh. Patients should be advised not to inject Emerade into the gluteus maximus due to the risk of accidental injection into a vein. Accidental injection into the hands or feet can result in peripheral ischemia that may require treatment. Patients must be instructed in the proper use of Emerade. Use with caution in patients with heart diseases including angina pectoris, cardiac arrhythmia, cor pulmonale, obstructive cardiomyopathy and atherosclerosis. There is also a risk for adverse reactions after the administration of adrenaline to patients with hyperthyroidism, hypertension, phaeochromocytoma, glaucoma, severe renal impairment, prostate adenoma, hypercalcaemia, hypokalaemia, diabetes, and in elderly patients and pregnant women. The effects of adrenaline may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors. Adrenaline should be used in pregnancy only if the potential benefit justifies any potential risk to the foetus.

Side effects 

May include headache, palpitations, tachycardia, sweating, nausea and vomiting, respiratory difficultly, pallor, dizziness, nervousness and anxiety. Cardiac arrhythmias may follow administration of adrenaline. Overdoses of adrenaline may cause cerebral haemorrhage or arrhythmias. For a complete list of warnings and side effects, you should consult the Summary of Product Characteristics.

Legal category 

POM

Price; Emerade 150 mcg £26.94, Emerade 300 mcg £26.94, Emerade 500 mcg £28.74

Package and quantity 

Emerade 150, 300 and 500 are available as single unit doses.

Product licence number 

Emerade 150 PL 33616/0013. Emerade 300 PL 33616/0014. Emerade 500 PL 33616/0015.

Marketing authorisation holder

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Date of preparation of prescribing information 15 July 2014

Reporting Side Effects
If your patient has any side effects they can report these directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard. They can also report any side effects to Bausch + Lomb at Pharma_cs@bausch.com. By reporting side effects your patients can help provide more information on the safety of this medicine.

SOURCE Bausch & Lomb