Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department has made an assessment of the potential merits of mandating the installation of dosage counters in all NHS-provided emergency asthma inhalers.

The Medicines and Healthcare products Regulatory Agency (MHRA) understands the term “emergency asthma inhalers” in this context to refer to reliever inhalers containing short-acting beta agonist (SABA) licensed for the rapid relief of symptoms during acute asthma attacks or bronchospasm, as well as for the prevention of exercise-induced bronchospasm. The MHRA is aware of ongoing safety concerns associated with the absence of integrated dose counters on SABA pressurised metered dose inhalers (pMDIs), particularly the risk that patients may unknowingly use inhalers that are empty or near empty during an asthma attack.

The MHRA has assessed the potential merits of mandating the inclusion of dose counters on SABA pMDIs. As part of this review, the MHRA has actively engaged with external national healthcare stakeholders and pharmaceutical industry to explore the feasibility of the integration. While the safety case for improved dose visibility is recognised, it is equally important to consider the potential impact of the product design change on supply resilience. The United Kingdom market for SABA pMDIs is currently limited to a small number of market authorisation holders and introducing a regulatory requirement without fully considering implementation timelines, material and personnel resources, and manufacturing capabilities could risk destabilising the supply of these critical medicines.

Rather than mandating dose counters on SABA pMDIs, the MHRA is currently pursuing a more flexible, proportionate approach to strongly recommend the inclusion of dose counters. This strategy seeks to improve patient safety outcomes while avoiding the risk of unintended supply disruption. The MHRA remains committed to working closely with industry and other stakeholders to ensure that any changes are introduced within a robust and pragmatic framework and timeline that safeguards patient access to essential respiratory medicines.