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Dose Counters and Indicators: A Real Patient Need

Asthma and chronic obstructive pulmonary disease (COPD) are chronic lung disorders responsible for millions of deaths every year. Both diseases are characterised by variable and recurring symptoms and, when poorly controlled, can result in severe limitations in patient quality of life. Therefore, controlling and monitoring treatments is not only a real need to reduce healthcare costs related to hospitalisations, but a real patient need. Patient expectations are towards a reliable system to support their correct and on-time use of inhalers, without changing the way of using them or adding any steps to their routine: intuitive and non-destructive, without much additional weight or form factor to carry in their daily lives.

The majority of marketed metered-dose inhalers (MDIs) offer no practical way for patients or doctors to know how many doses are left in their inhaler, specifically in case of emergency. Furthermore, there is a collective requirement to track adherence or compliance to medication. To address these requirements, the FDA published a guidance on integration of dose-counting mechanisms into MDI drug products. Under this guidance, devices should offer either clear numeric counting mechanisms or indication functions with colour code function or other means, leading to clear and unmistakable information to patients on the amount of drug left in their devices (1-2). The guidance also encourages drug manufacturers to update existing devices if possible.

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