Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing

PRIMARY OBJETIVES

• To assess whether an advanced nursing intervention improves the identification and reporting of suspected ADR.

SECONDARY OBJECTIVES

• To determine if an advanced nursing intervention improves the experience related to the use of medications measured through the QExPac-21 patient experience questionnaire.
• Identify which factors associated with medications increase the risk of ADRs and the characteristics of the patients.
• Know the incidence and describe ADRs: severity, preventability, and causality using validated scales.
• Describe the degree of nursing intervention according to the North American Nursing Diagnosis Association (NANDA) Taxonomy, and the classification of nursing interventions (NIC) Related to drug use.
• Quantify the number of interconsultation generated by patients and professionals related to the use of drugs.
• Determine the degree of adherence and compliance with the regimens prescribed to the patients.

STUDY DESIGN Prospective, randomized and controlled study of an intervention that compares a group of patients according to the usual practice of the nursing care process, against another on which a more intensive nursing intervention is carried out for the identification and notification of ADRs. It is carried out on a representative sample of patients admitted to a tertiary level hospital with 860 beds of the Madrid Health Service during the year 2022.

Inclusion criteria

• Patients with pharmacological treatment.
• Patients of both sexes aged between 0 and 100 years.
• Patients admitted to medical or surgical hospitalization units or emergency services for at least 24 hours.
• Patients who have received the information and agreed to participate in the study.

Exclusion criteria

• Patients included in other clinical trials or drug studies at the time of selection.
• Patients with significant cognitive impairment, without adequate family support or primary caregiver.
• Patients and/or caregivers who, once offered to participate in the study, do not give their consent
• Impossibility of communication due to language barriers or other biopsychosocial problems.