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Article History

Received: 14 July 2022

Accepted: 2 March 2023

First Online: 15 March 2023

Declarations

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: We requested the approval of the study to the Ethics Committee for Research with Medicines of the Principality of Asturias (CEImPA), attached to the Regional Ministry of Health, whose purpose is to evaluate all the research studies carried out on human beings in any of the health centers, services and establishments in the Autonomous Community of the Principality of Asturias. The Research Ethics Committee is the Committee of reference for any research study on human beings that is carried out, regardless of the methodology and the promoter of the study.The application for authorization of the study was submitted online at the following address: ExternalRef removedOne of the forms required by this Committee for the approval of observational studies, as in our case, is the authorization of the head of the department where the study is performed. In our case, since it is a study that includes consumption data from the entire region, we requested authorization from the Director General of Health Policy and Planning. This permission was sent to the CEImPA as part of the formal ethical approval required by that Committee (attached).Another form required by CEImPA for study approval is the Principal Investigator Commitment. In our case, the principal investigator commits to conduct the study anonymously, without access to the patients’ medical records, in compliance with the Organic Law on Data Protection 03/2018 of December 5. This commitment was sent to the CEImPA as part of the formal ethical approval required by that Committee (attached).We have also requested an informed consent exemption from the CEImPA, considering that this is a study of drug use, for which no personal data of the participants (name, surname, address, medical history number, etc.) or diagnoses or clinical and/or analytical variables are required, so that no permission is needed for access to the computerized clinical history of the patients, nor was it necessary to obtain an identification code of the patients. The data refer to the Defined Daily Doses per 1000 inhabitants consumed in each study year and to the number of containers dispensed for the 3 pharmacological subgroups (anxiolytics, hypnotics and sedatives and antidepressants). The data are presented aggregated by sex and age groups in the form of consumption tables. The study is anonymized, in compliance with the data protection law (Organic Law 3/2018, of December 5, on Personal Data Protection and Guarantee of Digital Rights) and was conducted in accordance with the relevant guidelines and regulations.The Ethics Committee for Research with Medicines of the Principality of Asturias (CEImPA) has waived the need for informed consent for this study.The approval of the study is given by the Ethics Committee for Research with Medicines of the Principality of Asturias (CEImPA). The approval is attached.This study was carried out in accordance with the relevant guidelines and regulations.

: Not applicable.

: The authors declare no competing interests.