Medicines Healthcare Products Regulatory Agency
Advice for healthcare professionals:
- use of nebuliser devices at home to deliver asthma rescue medication to children and adolescents, without adequate medical supervision, can mask a deterioration in the underlying disease, which could result in delays in seeking medical attention and have fatal or serious consequences
- only specialists in asthma should initiate and clinically manage use of nebulisers and associated nebulised medicines at home for acute treatment of asthma in children and adolescents (see definition of specialists below)
- independent purchase of nebuliser devices outside of medical advice for use at home to deliver rescue therapy for the acute treatment of asthma in children and adolescents is not recommended
- pharmacists are asked to advise people seeking to purchase a nebuliser for this purpose that such home use of nebulisers is not recommended without specialist clinical management
- continue to report suspected adverse reactions to nebulised medications and adverse incidents involving nebulisers on a Yellow Card
Advice to provide to patients or caregivers:
- seek urgent medical assistance if worsening asthma symptoms are not relieved by rescue medicines prescribed by a healthcare professional, even if the child has short-term recovery following use of prescribed nebulised medication
- children under 18 years should only use a nebuliser to take asthma reliever medications under specific instructions of a doctor with expertise in asthma, so that deterioration in asthma control can be detected and treated without delay
- only use a nebuliser device recommended by a doctor and ask for training from your asthma nurse, pharmacist, or other healthcare professional on how it should be used and maintained and when to seek medical advice
- if your child or teenager have been using a nebuliser at home, and have not yet been referred to a specialist in asthma, talk to their GP about referral to a specialist
Concerns over nebulisers in paediatric acute asthma
Nebulised rescue (or reliever) asthma medicines are prescription-only medicines. Clinical guidance from NICE recommends use of nebulised rescue medicines only in severe or life-threatening acute exacerbations of paediatric asthma, or, on a regular basis, only in patients with severe asthma when they are unable to use other inhalational devices. Use of a nebuliser under both of these circumstances should be strictly under medical supervision see NICE treatment summary.
This advice is specific to use of nebulisers to deliver asthma rescue medication in paediatric asthma.
Healthcare professionals have expressed concern to the MHRA that use of nebuliser devices at home to deliver asthma rescue medication to children and adolescents, without adequate medical supervision, could mask a deterioration in asthma control and result in delays in seeking medical attention. These delays could increase the risk that a deterioration of asthma goes unrecognised, which may be fatal or may have serious consequences for the patient. The MHRA is aware of a number of fatal cases in children in England, which occurred between 2008 and 2022, in which clinically unsupervised use of a nebuliser was a potential contributory factor in the childs death from asthma.
The MHRA reviewed the evidence, taking into account independent advice from paediatricians, respiratory specialists, and medicines and medical devices safety experts. The product information for nebuliser solutions for asthma therapy has been updated to state that use of nebuliser devices, purchased to deliver rescue treatments for acute asthma in children and adolescents in the home without medical supervision, is not recommended.
It is also recommended that any use of home nebulisers for this purpose should be initiated and clinically managed by a specialist such as a respiratory specialist paediatrician.
Nebulised asthma medications affected by the recommendations
The following products are authorised in the UK for use in asthma with a suitable nebuliser device:
| Medicine | Specific brands and product information | Indications from the product information |
|---|---|---|
| Ipratropium | Atrovent UDVs, Ipratropium Bromide Nebuliser Solution | When used concomitantly with inhaled ?2-agonists, for treatment of reversible airways obstruction as in acute and chronic asthma: - for acute asthma in children younger than 5 years, - for acute and chronic asthma in adults and children older than 5 years |
| Salbutamol | Ventolin Respirator Solution, Salbutamol 2mg/ml Nebuliser Solution Salbutamol 2.5mg/2.5ml Nebuliser Solution | For use in the routine management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma in adults, adolescents and children aged 4 years or older. |
| Terbutaline | Bricanyl Respules, Terbutaline Nebuliser Solution | For the relief of severe bronchospasm in bronchial asthma in adults and children of all ages. |
Call for reporting
Please continue to report suspected adverse reactions to nebulised medications and adverse incidents involving nebulisers on a Yellow Card. Report on our website or via the Yellow Card App (Apple App Store or Google Play Store).
Please use the dedicated COVID-19 Yellow Card reporting site to report any suspected adverse reactions or medical device incidents associated with COVID-19 treatment.
Medical device incidents should be reported to Health Facilities Scotland in Scotland and to the Northern Ireland Adverse Incident centre in Northern Ireland.
Article citation: Drug Safety Update volume 16, issue 1: August 2022: 1.