Application of auto-injectors with the active substance adrenaline
The European Medicines Agency (EMA) recommends new measures to ensure the safe and successful use of epinephrine auto-injectors.
- Introduction of new training material
- Patients should always carry two auto-injectors for safety.
Measures at EU level
Epinephrine auto-injectors are used for emergency self-treatment of anaphylaxis (severe allergic reactions) while the patient is waiting for emergency medical care. Due to existing concerns that currently available autoinjectors deliver epinephrine only under the skin instead of into the muscle, leading to a delay in efficacy, a review was conducted by the European Medicines Agency (EMA). After evaluating the available data, the Committee for Medicinal Products for Human Use (CHMP) concluded that intramuscular administration may provide a faster, more effective onset of action in the treatment of anaphylaxis. The CHMP states that several factors determine whether the administered epinephrine actually enters the muscle as intended, such as the length of the needle, the thickness of the subcutaneous fat layer (subcutaneous fat layer), how the autoinjector works (with a spring activation or without), the angle at which the device is placed on the skin, the force used to activate the device, and whether the instructions for use are adequately followed. The CHMP concluded that user education is of paramount importance. Marketing authorization holders who market epinephrine auto-injectors are therefore encouraged to develop more effective educational materials for patients and also for healthcare professionals to ensure optimal use. A training device should be made available for patients to practice, as well as audiovisual training materials to clearly demonstrate the use of the auto-injector. In addition, a checklist for physicians will ensure that patients are adequately informed before using the auto-injector. Further warnings will be added to the technical and instructions for use, including a recommendation that patients should always carry two auto-injectors for safety. In addition, there will also be instructions for use for family members, caregivers, or teachers on the use of the Auto-Injector. These CHMP recommendations now go to the European Commission for a legally binding decision.
Situation in Austria
The following proprietary medicinal products are approved in Austria:
- Anapen 300 micrograms in 0.3 ml - solution for injection (prefilled syringe)
- Anapen Junior 150 micrograms in 0.3 ml solution for injection (pre-filled syringe)
- EpiPen 300 micrograms solution for injection in a pre-filled pen
- EpiPen Junior 150 micrograms solution for injection in a pre-filled pen
- Jext 300 micrograms solution for injection in a prefilled pen
- Jext 150 microgram solution for injection in a prefilled pen
The BASG currently has 8 reports from Austria. BASG recommendations Recommendations for patients:
- Epinephrine auto-injectors are used to treat severe allergic reactions in the period while the patient is waiting for emergency medical care. They are designed to be used by the patient or by caregivers.
- A review indicated that in order to ensure successful and safe use of the auto-injectors, further patient education needs to occur.
- All patients will be trained by their physician or nurse in the use of the epinephrine auto-injector. A training device will be developed so that people can practice before the auto-injector is needed in an emergency. A training video will be provided to clearly demonstrate the use of the injector.
- It is important that the auto-injector is used correctly to ensure that the epinephrine gets into the muscle to work as quickly as possible.
- If you have been prescribed an epinephrine auto-injector because you are at increased risk of allergic reactions, you should be familiar with its use and always carry the injector with you.
- Your doctor will probably recommend that you always have two injectors handy in case one dose is not enough.
- Family members, caregivers, or teachers should be familiar with proper use.
- If you are unsure how to use it, ask your doctor or pharmacist to explain it to you again.
Recommendations for health professionals:
- Review of epinephrine auto-injectors has indicated that intramuscular administration is the preferred route of administration to provide effective treatment of anaphylaxis.
- Several factors are responsible for whether the administered epinephrine actually enters the muscle: needle length, subcutaneous adipose tissue, the way the autoinjector works (with or without spring activation), the angle of insertion, and the force that must be applied to activate the device.
- Due to the uncertainty of epinephrine release, it is recommended that two auto-injectors be prescribed for the patient to carry at all times.
- Various training materials are being developed to ensure effective use by patients or caregivers. This includes a training device for patients to practice ahead of time, audiovisual educational materials, and a checklist for the prescribing physician.
- A 2013 study by Brown et al. showed that 15% of mothers were unable to successfully use the autoinjector with their children. This fact supports the implementation of appropriate training and comprehensive educational materials for patients and healthcare professionals.
- Marketing authorization holders of epinephrine auto-injectors are encouraged to conduct pharmacokinetics/pharmacodynamics studies to further understand the mechanism of how epinephrine enters body tissues through the auto-injector.
More information: European Medicines Agency press release: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/06/news_detail_002351.jsp&mid=WC0b01ac058004d5c1
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: 050555/25000
E-mail: presse@ages.at
