An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.
If the minor is under 12 years of age, participation will require the consent and signature of the informed consent document by both parents (or their guardian).
If the minor is between 12 and 16 years of age, a proxy informed consent form will be provided and signed by both parents (if both parents are present at the time of the interview) or only one of them (in which case one of the following two conditions must be stated: that the other parent is not present at the time of the interview but does not object to the participation of the minor in the study or that the signatory is the sole legal guardian of the minor).
Be registered or potentially/have been attended in the Extremadura Health Service.
Not have language or communication barrier or present disability being totally dependent on another person.
Failure to meet any of the inclusion criteria described above.
Refusal by the patient to be part of the cohort initially, or to continue to be part of the cohort during follow-up.
Manifest difficulty for follow-up.
Consecutive sampling is a widely used non-probability sampling that, if performed correctly, can be considered as random sampling. In this case, patients are selected as they come for consultation and as long as they meet the inclusion criteria. SES patients are eligible for inclusion in the study, so that a minimum of 3000 participants are expected to be included in the study in order to ensure adequate frequency of genetic polymorphisms of pharmacogenetic relevance. During the Deployment Phase of the Prescription Support Program, it is estimated that an additional 4,000 to 8,000 patients will be included, with a target of 0.1% of the population of Extremadura.
Other
Prospective
Not listed
17
Trial groupsSee each trial group below.
Evaluation of the implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.
To analyze the implementation in the clinical routine of a pharmacogenetics and personalized medicine program in SES patients, evaluating the overall impact on the health system, and at the individual level, general modifications in the clinical response and its temporal evolution.
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