Comprehensive Inhaler Database for Spain

The present study is a cross-sectional analysis of the current situation of inhaled therapy in Spain and is based on a systematic search of the different inhalation devices available in the country in July 2023. To include all the inhalation devices available, without exceptions, we performed a search on the Spanish Ministry of Health Billing List (https://www.sanidad.gob.es/profesionales/nomenclator.do (accessed on 22 August 2023)). This billing list provides information on all the products included within the National Health System pharmaceutical provision that are available in pharmacies. It is freely accessible to the public and provides basic information for healthcare professionals on each drug, with information on its marketing, availability, characteristics, and current price. For the present study, we used this database exclusively to obtain the list of inhalers available when the study was carried out. The search was performed for each of the active principles available for inhalers in Spain with the three different families of molecules: long-acting ß agonists (LABA), long-acting muscarinic antagonists (LAMA), and inhaled corticosteroids (ICS). We also carried out a secondary search on the same database using the names of the inhalers. For simplicity, trade names representing licenses of the same molecule or combination of molecules from the original laboratory were considered as a single option and were referred to in the results with the original commercial brand name used in Spain. Each inhaled drug or drug combination was then identified by the original trade name and its accompanying inhalation device, along with the dose quantity appearing on the publicly available commercial package.
After obtaining the list of inhaled drugs or drug combinations, we consulted the Spanish Agency for Medicines and Health Products (https://www.aemps.gob.es/ (accessed on 22 August 2023)), a branch of the Ministry of Health, to find the most recent technical data sheet for each one, consulting specifically Section 2 of the document to obtain information on the exact composition of each product. These showed us the molecules they contained for therapeutic purposes, excluding excipients, and were expressed in µg per dose, with two types of dose: the metered dose, which is the dose contained in the device available to be inhaled, and the delivered dose, which is the dose that actually comes out of the inhaler and reaches the patient’s lungs during the inhalation procedure. Additionally, for each type of dose (metered and delivered), two other types of doses are also mentioned when available: the dose that refers to the molecule with therapeutic action combined with a transporter in salt form, and the dose that refers to the amount of the pure drug. For example, in the case of tiotropium bromide, the amount of µg per dose of both tiotropium bromide and tiotropium alone was specified. In this way, we could have up to four different doses for each molecule. The results showed both the drugs or their combinations of long-acting bronchodilators (LABA and/or LAMA) and the ICS with their double and triple combinations.