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04 July 2024
Asthma , COPD
CARE, - Medicines,

On 6 June, the European Medicines Agency (EMA) added salbutamol, a life-saving medicine for chronic respiratory disease and especially for children with asthma, to its EU-wide shortage catalogue. EFA and members are working with partners to inform the community about the lack of access to this crucial medicine.

Salbutamol is a life-saving medicine that makes the airways quickly react when a patient is experiencing an asthma attack or COPD exacerbation. Despite being a rescue medication, salbutamol is widely prescribed and used as a medicine to treat asthma. However, asthma and COPD patients may be prescribed other more suitable options to treat their asthma everyday and avoid exacerbations, which are the ones that do require the use of bronchodilators such as salbutamol.

The EMA has published its notice on the shortage of salbutamol inhalation products. EMA recommend patients that encounter issues with access to salbutamol to first consult their healthcare professionals and inquire about suitable alternatives for the management of their care. EFA community also recommends contacting the national associations of patients who may have further information on the steps taken at the national level to tackle the shortage of salbutamol. You may consult EFA’ national member associations here.

The scope of this shortage is extremely worrying for EFA community of members as it applies to inhaled salbumatol products, including drops to be used in nebulisers.

EFA has been involved in the EMA communication about this shortage and informed the EFA community of members, who were already perceiving the lack of access to the medicine in their countries, of the scale of the problem. Working closely with our member organisations, EFA is liaising with EMA, healthcare professionals and the producing companies to assess the evolution of the situation and inform patients about what do to against this shortage.

Information about the shortage

The shortage affects 21 EU Member States (Austria, Belgium, Bulgaria, Cyprus, Czechia, Germany, Denmark, Estonia, Spain, France, Greece, Ireland, Italy, Malta, Netherlands, Portugal, Poland, Romania, Slovenia, Slovakia, Sweden), and Norway. Other non-EU countries are likely to also be affected, given that supply chains are global.

The shortage affects especially salbutamol inhalation products that are taken using an inhaler or a nebuliser. The EMA, as well as one producer that we reached out to, have informed EFA that there has been an increase in demand for salbutamol inhalation products, which cannot be met by the current manufacturing capacity. To add to this, there are manufacturing issues for specific products, but the shortages are not related to a quality defect of the products or a safety issue. 

Duration of the shortage

The improvement in medicines supplies is foreseen by September 2024 in some countries but may last until the end of 2024 in others. For example, we have been informed that a shortage of salbutamol is expected until the end of the year in the Netherlands. 

EFA involvement in communication around salbutamol shortage

The EMA requested feedback from EFA on how to communicate about this shortage in their catalogue. In our feedback, for example, we have asked EMA to be more precise in the Salbutamol products in shortage (inhaler, nebulisers, tables or injections), as that can vary the alternatives for patients in the EU. 

On 6 June, EFA also held an extraordinary meeting with its community of members to inform about the EU-wide shortage and exchange knowledge on the national level action on the salbutamol shortage. We also discussed patient-led activities that could reduce the impact of the shortage on the patients’ community and discourage stockpiling. 

Next steps

Given the cruciality of this shortage, we will continue monitoring the developments and are closely liaising with EMA to inform patients with accuracy about this situation and how to face it. EFA is also liaising with European medical societies to understand if there are any actions to be taken or guidelines to be applied and communicated about collectively. 

EFA will organise a follow-up meeting with the EFA community of members to discuss the situation and update on any developments that may arise at the end of August. 

For any further information, you may contact EFA Prevention & Healthcare Policy Officer Irina Csender (This email address is being protected from spambots. You need JavaScript enabled to view it.).