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Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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auto injectorJuly 1 2015

The European Medicines Agency has asked companies marketing adrenaline auto-injectors to create more effective educational material on the devices’ use in anaphylaxis.

 

Among the measures being proposed by the EMA is that companies will develop:

  • a training device with which patients can practise;
  • audio-visual material to show in detail how the device is to be used;
  • a checklist for prescribers to ensure that sufficient information is given to the patient before they use the auto-injector.

“The product information of adrenaline auto-injectors will also be updated with further warnings and precautions, including a recommendation that patients should be prescribed two auto-injectors which they should carry at all times and a recommendation for family members, carers or teachers to be trained on how to use the auto-injector,” says the EMA.

The proposals come after the EMA’s Committee for Medicinal Products for Human Use (CHMP) studied a review of adrenaline auto-injectors over concerns that devices currently available can deliver adrenaline subcutaneously instead of intramuscularly, which may delay response to treatment.

Having assessed all the available data, CHMP “acknowledged that giving the medicine by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis.

“However, the CHMP noted that several factors may affect whether adrenaline is actually delivered into a muscle; these include needle length, the thickness of fat under the skin, the way the auto-injector works (eg if it is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection.”

CHMP is also calling for more data on the use of auto-injectors to be collected to better understand the pharmacokinetcis and pharmacodynamics of adrenaline delivery by each of the auto-injectors. Its recommendations now have to be ratified by the European Commission.

EMA has issued information to both patients and health professionals in the interim. It is advising patients that they will receive training from their doctor or nurse on how to use the adrenaline auto-injector, and that they will be supplied with a training device to practice self-injecting. A video on injection technique is also being produced.

For health professionals, the EMA points out that a study in 2013 “showed that 15% of the mothers were unable to use the auto-injector successfully in their children. This supports the introduction of proper training and comprehensive educational material for patients and healthcare professionals.”

Link:

EMA announcement    

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