Active Pharmacovigilance Project on the safety profile of Dolutegravir in Brazil.

A quantitative descriptive study based on Brazilian Active Pharmacovigilance of Dolutegravir (DTG) Project was performed to describe the adverse drug reactions (ADRs) to DTG reported and to evaluate the noncompleteness of data from DTG active pharmacovigilance in Brazil. ADRs and clinical and individual data were obtained from information from the Pharmacovigilance Questionnaire from April 2017 to August 2019. The reported ADRs were classified using the Medical Dictionary for Regulatory Activities (MedDRA). In the evaluated period, 249,066 individuals using DTG participated in the active pharmacovigilance of DTG, with 3472 (1.39%) reporting ADRs at least once. A total of 6312 ADRs were reported, of which 57.56% were persistent and 81.46% were not serious according to the individuals' reports. Most of the reported ADRs were gastrointestinal, neurological and psychiatric. ADRs related to neural tube defects and serious neuropsychiatric ADRs have been reported. Completion of more than half of the fields in the Pharmacovigilance Questionnaire was excellent. The frequency of ADR was low in relation to the number of people living with HIV (PLHIV) using DTG in Brazil, which suggests good tolerability and safety of DTG. The DTG active pharmacovigilance database in Brazil showed good data completeness.

Trends in HIV post-exposure prophylaxis following sexual exposure in Brazil (2011-2019).

We examined trends in the prevalence of post-exposure prophylaxis following sexual exposure (PEPSE) per million population (2011-2019) and the proportion of repeated PEPSE within 365 days of the first PEPSE dispensing (2011-2018) in Brazil. We also compared the prevalence of repeated PEPSE according to patient and health services characteristics in 2018. The prevalence of PEPSE increased 55.5% from 2011 to 2019. Repeated PEPSE increased 11.8%, reaching 8.4% among people with their first dispensing in 2018. The prevalence of repeated PEPSE was higher in cis men or trans women (versus cisgender women); homosexuals (versus heterosexuals); and people aged 25-29 years (versus other age groups). We also observed greater prevalence of repeated PEPSE in HIV services in populous cities or services with elevated caseloads. Our findings highlight the need for strategies to reduce repeated PEPSE and promote other HIV-prevention technologies, particularly among young adults, cisgender men, transgender women, and homosexuals.

RESUMEN: Examinamos las tendencias de la prevalencia de uso de la profilaxis posterior a la exposición sexual (PEPSE) por millón de población (2011­2019) y la proporción de PEPSE repetida dentro de los 365 días de la primera dispensación de PEPSE (2011­2018) en Brasil. También comparamos la prevalencia de PEPSE repetida según las características del paciente y de los servicios de salud en 2018. La prevalencia de PEPSE aumentó un 55,5% de 2011 a 2019. La PEPSE repetida aumentó un 11,8%, alcanzando el 8,4% entre las personas con su primera dispensación en 2018. La prevalencia de PEPSE repetida fue mayor en hombres cis o mujeres trans (versus mujeres cisgénero); homosexuales (versus heterosexuales); y personas de 25 a 29 años (versus otros grupos de edad). También observamos una mayor prevalencia de repetición en los servicios de VIH de las ciudades más pobladas o con un elevado número de clientes. Nuestros hallazgos ponen de manifiesto la necesidad de estrategias para reducir la repetición de la PEPSE y promover otras tecnologías de prevención del VIH entre los adultos jóvenes, especialmente los hombres, las trans y los homosexuales.

Medication literacy: A conceptual model.

BACKGROUND: Medication literacy reflects the specific literacy skills necessary to act on medication-related information. A comprehensive and clear conceptual model that reflects medication literacy is lacking. Conceptual models describe the components that represent a construct, allowing for its understanding and providing a rationale for its measurement. OBJECTIVES: To propose a conceptual model to support the development of an instrument to measure medication literacy. METHODS: This is a three-phase methodological study. A literature review was conducted to identify the components that should be part of the preliminary conceptual model. Subsequently, the importance of its components was judged on a Likert-5 scale. Then, the model was refined, and the dimensions and subdimensions of medication literacy were defined. RESULTS: Forty-five experts were included, with a mean age of 39.9 (SD = 10.5) years, most of them females (86.7%) and pharmacists (80%). All components of the preliminary conceptual model were considered important to extremely important by most experts. "Dosing information", "medication name", and "processing the information received about their medication and acting upon medication instructions" were the components considered most important. In the refinement phase, we identified that the construct has four dimensions - functional literacy, communicative literacy, critical literacy, and numeracy, which include the subdimensions to access, understand, evaluate, calculate, and communicate medication-related information. CONCLUSIONS: The conceptual model allowed identifying the components that represent medication literacy, which will support the development of an instrument for measuring the construct in Brazil.