Specialized Vaccine Care for Adverse Events Following Immunization and Impact on Vaccine Hesitancy in the Military Health System.

INTRODUCTION: The World Health Organization identified vaccine hesitancy as one of the top 10 threats to global health. Vaccine hesitancy is defined as a delay in acceptance or refusal of vaccination despite the availability of vaccination services. Because vaccine safety concerns are important contributors to hesitancy, people who have experienced adverse events following immunization (AEFI) may be at especially high risk for subsequent vaccine hesitancy. The Defense Health Agency Immunization Healthcare Division (DHA IHD) provides specialized vaccine care to persons who have experienced AEFI. The impact of this specialized vaccine care on subsequent vaccine hesitancy has not been fully explored. MATERIALS AND METHODS: A cohort of patients (n= 146) was identified among those who received consultative care from DHA IHD clinicians for AEFI concerns between April 2017 and September 2022. Analyses were restricted to non-uniformed beneficiaries of the Military Health System (MHS). Uniformed beneficiaries of the MHS were excluded from this analysis since vaccination mandates preclude the use of vaccine uptake as a measure of vaccine hesitancy. Outcomes were evaluated by reviewing MHS vaccination records after initial AEFI consultation through January 2023. Vaccine acceptance was considered the inverse of hesitancy, and was defined by: (a) receipt of any subsequent vaccination, (b) receipt of seasonal influenza vaccine, (c) receipt of subsequent doses of the AEFI-associated vaccine, if clinically recommended, and (d) receipt of COVID-19 vaccine. RESULTS: A diverse group of patients with a wide range of AEFI concerns received specialized vaccine care from DHA IHD clinicians during this period. Among the cohort, 78% of patients received any subsequent vaccination, 55.2% received seasonal influenza vaccine, 57.8% received a subsequent dose of their AEFI-associated vaccine when the vaccine was clinically recommended, and 48.9% received COVID-19 vaccine. The proportion of patients who received influenza vaccine exceeded the reported rate of influenza vaccine uptake by the general population during this time period. CONCLUSION: Specialized vaccine care after AEFI concerns was associated with relatively high acceptance of subsequent vaccinations. The experiences of DHA IHD clinicians, in providing specialized vaccine care to AEFI patients, may serve as a model for other organizations that are working to reduce vaccine hesitancy, even beyond the MHS.

Personality vulnerabilities and adverse event reporting in phase 1 clinical studies.

BACKGROUND: Phase 1 clinical trials involve rigorous safety monitoring to identify any adverse effects of investigational treatments. There is growing evidence that healthy volunteers recruited in these studies may differ with respect to personality traits from the general population. This, in turn, may have a significant impact on the reporting of adverse events, particularly in trials investigating psychoactive treatments, including the psychedelic substances. MAIN BODY: This analysis stems from our combined experience as investigators in phase 1 clinical trials and conveys an experiential understanding of the impact of psychological heterogeneity on study participation, reporting of adverse events and study outcomes. CONCLUSION: Participant variability due to psychological characteristics is regularly overlooked in phase 1 clinical trials and may significantly impact on reporting of the adverse events. In our opinion, healthy volunteers who present for these studies should not only be defined by the absence of past or current medical and psychiatric illness but also characterised by their psychological attributes.

Stakeholder perceptions of and attitudes towards problematic polypharmacy and prescribing cascades: a qualitative study.

INTRODUCTION: Problematic polypharmacy is the prescribing of five or more medications potentially inappropriately. Unintentional prescribing cascades represent an under-researched aspect of problematic polypharmacy and occur when an adverse drug reaction (ADR) is misinterpreted as a new symptom resulting in the initiation of a new medication. The aim of this study was to elicit key stakeholders' perceptions of and attitudes towards problematic polypharmacy, with a focus on prescribing cascades. METHODS: qualitative one-to-one semi-structured interviews were conducted with predefined key stakeholder groups. Inductive thematic analysis was employed. RESULTS: Thirty-one stakeholders were interviewed: six patients, two carers, seven general practitioners, eight pharmacists, four hospital doctors, two professional organisation representatives and two policymakers. Three main themes were identified: (i) ADRs and prescribing cascades-a necessary evil. Healthcare professionals (HCPs) expressed concern that experiencing an ADR would negatively impact patients' confidence in their doctor. However, patients viewed ADRs pragmatically as an unpredictable risk. (ii) Balancing the risk/benefit tipping point. The complexity of prescribing decisions in the context of polypharmacy made balancing this tipping point challenging. Consequently, HCPs avoided medication changes. (iii) The minefield of medication reconciliation. Stakeholders, including patients and carers, viewed medication reconciliation as a perilous activity due to systemic communication deficits. CONCLUSION: Stakeholders believed that at a certain depth of polypharmacy, the risk that a new symptom is being caused by an existing medication becomes incalculable. Therefore, in the absence of harm, medication changes were avoided. However, medication reconciliation post hospital discharge compelled prescribing decisions and was seen as a high-risk activity by stakeholders.

Oncology patients' willingness to report their medication safety concerns from home: a qualitative study.

PURPOSE: Oncology patients often struggle to manage their medications and related adverse events during transitions of care. They are expected to take an active role in self-monitoring and timely reporting of their medication safety events or concerns to clinicians. The purpose of this study was to explore the factors influencing oncology patients' willingness to report adverse events or concerns related to their medication after their transitions back home. METHODS: A qualitative interview study was conducted with adult patients with breast, prostate, lung, or colorectal cancer who experienced care transitions within the previous year. A semi-structured interview guide was developed to understand patients' perceptions of reporting mediation-related safety events or concerns from home. All interviews were conducted via phone calls, recorded, and transcribed for thematic data analysis. RESULTS: A total of 41 individuals participated in the interviews. Three main themes and six subthemes emerged, including patients' perceived relationship with clinicians (the quality of communication and trust in clinicians), perceived severity of adverse medication events (perceived severe vs. non-severe events), and patient activation in self-management (self-efficacy in self-management and engagement in monitoring health outcomes). CONCLUSION: The patient-clinician relationship significantly affects patients' reporting behaviors, which can potentially interact with other factors, including the severity of adverse events. It is important to engage oncology patients in medication safety self-reporting from home by enhancing health communication, understanding patients' perceptions of severe events, and promoting patient activation. By addressing these efforts, healthcare providers should adopt a more patient-centered approach to enhance the overall quality and safety of oncological care.

Association of adverse drug reaction to anti-tuberculosis medication with quality of life in patients in a tertiary referral hospital

Abstract INTRODUCTION: Adverse drug reactions can develop when using anti-tuberculosis medication, and the effects of the drugs can also significantly hinder the treatment of patients. METHODS: A cross-sectional survey was conducted in 73 patients using two standardized questionnaires and the World Health Organization Quality of Life-Bref. RESULTS: All patients reported the presence of adverse drug reactions, 71.6% of which are minor and 28.3% both major and minor. The global quality of life analysis showed that patients with tuberculosis have a good average (67.3%). CONCLUSIONS: There is an association between quality of life and adverse drug reaction, educational level, and vulnerability.

Uso do Coping Religioso/Espiritual diante das Toxicidades da Quimioterapia no Paciente Oncológico / Uso del Coping Religioso/Espiritual ante las Toxicidades de la Quimioterapia en el Paciente Oncológico / Cancer Patient use of Religious/Spiritual Coping to Deal with the Toxicities of Chemotherapy

Introdução: O adoecimento por câncer é considerado um grave problema de saúde pública e um evento estressante na vida dos pacientes. Isso porque é significativo o impacto emocional diante do diagnóstico e o desgaste psíquico durante o tratamento, sobretudo no que toca à quimioterapia antineoplásica, que expõe o paciente a toxicidades indesejáveis. Nesse sentido, emerge a necessidade de mobilização de recursos pessoais adaptativos para lidar com os diversos desconfortos, processo este compreendido como coping, podendo ainda estar associado ao uso da religião, espiritualidade ou fé (coping religioso/espiritual). Objetivo: Investigar a relação entre o uso do coping religioso/ espiritual e as respostas orgânicas às toxicidades da quimioterapia. Método: Estudo analítico, observacional, com corte transversal e delineamento correlacional. A amostra não probabilística foi composta por 40 pacientes da Unidade de Alta Complexidade em Oncologia de um Hospital Universitário. Como instrumentos, foram utilizados um questionário sociodemográfico e de saúde, e a escala de coping religioso/espiritual. Resultados: De um modo geral, o coping religioso/espiritual tanto positivo como negativo foi moderadamente utilizado por todos os participantes, independentemente do nível de toxicidades. Conclusão: A partir dos resultados encontrados, conclui-se que os pacientes com câncer submetidos à quimioterapia fazem uso tanto de estratégias de coping positivas como negativas, sendo as positivas utilizadas em maior intensidade.

Introduction: Cancer is considered a serious public health problem and a stressful event in the lives of patients. That is because the emotional impact of the diagnosis and the psychological damage during treatment are significant, especially in patients undergoing antineoplastic chemotherapy, which exposes them to undesirable toxicities. Therefore, cancer patients need to marshal adaptive personal resources to deal with various types of discomfort, a coping process that can be associated with a reliance on religion, spirituality, or faith (religious/spiritual coping). Objective: To investigate the relationship between the use of religious/spiritual coping and the organic responses to the toxicities of chemotherapy. Method: This was an analytical, observational, cross-sectional, correlational study. Using non-probability sampling, we selected 40 patients under treatment in the high complexity oncology unit of a university hospital. We applied a custom sociodemographic/health questionnaire and the brief religious coping scale. Results: In general, religious/spiritual coping, positive and negative, was moderately employed by all participants, regardless of the degree of the toxicities. Conclusion: We conclude that cancer patients undergoing chemotherapy use positive and negative coping strategies, although positive coping was used to a greater degree in our sample.

Introducción: La enfermedad por cáncer se considera un grave problema de salud pública y un evento estresante en la vida de los pacientes. Esto es porque es significativo el impacto emocional ante el diagnóstico y el desgaste psíquico durante el tratamiento, sobre todo, en lo que toca a la quimioterapia antineoplásica, que expone al paciente a toxicidades indeseables. En este sentido, emerge la necesidad de movilización de recursos personales adaptativos para lidiar con las diversas incomodidades, proceso este comprendido como coping, pudiendo aún estar asociado al uso de la religión, espiritualidad o fe (coping religioso/espiritual). Objetivo: Investigar la relación entre el uso del coping religioso/espiritual y las respuestas orgánicas a las toxicidades de la quimioterapia. Método:Estudio analítico, observacional, con corte transversal y delineamiento correlacional. La muestra no probabilística fue compuesta por 40 pacientes de la Unidad de Alta Complejidad en Oncología de un Hospital Universitario. Como instrumentos se utilizaron un cuestionario socio demográfico y de salud y la escala de coping religioso-espiritual. Resultados: En general, el coping religioso espiritual, tanto positivo como negativo, fue moderadamente utilizado por todos los participantes, independientemente del nivel de toxicidades. Conclusión: A partir de los resultados encontrados se concluye que los pacientes con cáncer sometidos a quimioterapia hacen uso tanto de estrategias de coping positivas como negativas, siendo las positivas utilizadas en mayor intensidad.

Percepción entre médicos bogotanos del riesgo de reacciones adversas a grupos de medicamentos de uso común / Physicians´ insight about adverse drug reaction to frequently used medication groups in Bogotá (Colombia)

Introducción. Las reacciones adversas a medicamentos son un problema de salud pública; sin embargo, todavía son muchos los médicos que no parecen reconocer el riesgo asociado al uso de medicamentos. Objetivo. Valorar la percepción del riesgo de reacciones adversas asociado a los grupos de medicamentos más frecuentemente utilizados por los profesionales de la medicina en la práctica clínica. Materiales y métodos. Se llevó a cabo un estudio descriptivo y transversal con 200 médicos con un mínimo de dos años de experiencia clínica, y vinculados a hospitales públicos o clínicas privadas de Bogotá. La percepción del riesgo asociado a las reacciones adversas a medicamentos de 31 grupos farmacológicos o terapéuticos, se valoró usando una escala analógica visual (0-10 puntos). Resultados. La percepción del riesgo fue baja (puntaje promedio <5) con relación a 19 (61 %) de los 31 grupos de medicamentos. Los tres grupos que se relacionaron con una mayor percepción de riesgo de reacciones adversas a medicamentos (puntaje promedio >7) fueron: (a) la quimioterapia para el cáncer (mediana=8,5; rango intercuartílico: 1,8), (b) la insulina (mediana=8; rango intercuartílico: 4,8) y (c) los anticoagulantes (mediana=7,5; rango intercuartílico: 4). Conclusiones. Aunque existe una relación adecuada entre la percepción del riesgo y la frecuencia de las reacciones adversas a los medicamentos asociada con los grupos de mayor puntaje, también existe una importante subestimación del riesgo en medicamentos de uso común a nivel hospitalario y ambulatorio, como es el caso de los antiinflamatorios no esteroideos, los antihipertensivos y los anticonceptivos orales.

Introduction: Adverse drug reactions are a public health problem; however, still many prescribers do not seem to recognize the risk associated with the use of medications. Objective: To assess the perception of the risk of adverse reactions associated with the groups of drugs most frequently used in clinical practice. Materials and methods: Descriptive study made in 200 physicians with at least 2 years of clinical experience in Bogota, Colombia. The risk of adverse drug reactions associated with the use of medications was assessed using a visual analog scale (0-10 points). Results: The perception of risk was <5 points for 19 of the 31 (61%) therapeutic groups. The therapeutic groups that were related to increased perception of risk were chemotherapy for cancer (median, 8.5, interquartile range: 1.8), insulin (median, 8, interquartile range: 4.8) and anticoagulants (median, 7.5, interquartile range: 4). Conclusions: Although there is a relationship between the perception of risk and the frequency of adverse drug reactions associated with therapeutic groups of higher score, there is also a strong underestimation of the risk of medicines in common use at hospital and ambulatory level such as NSAID, antihypertensive drugs and oral contraceptives.

Dependencia à Amineptina: relato de caso e revisäo de literatura, con ênfase nas abordagens terapêuticas / Amineptine dependence: a case report and literature review with therapeutic considerations

Os antidepressivos têm sido considerados drogas seguras no que se refere ao potencial de causar dependência, tendo inclusive sido usados com liberdade em pacientes portadores de dependência química. Atualmente, existe uma tendência entre os médicos a usar as drogas de 2ª geraçäo em detrimento dos antidepressivos tricíclicos, mais conhecidos mas com efeitos colaterais mais severos. A amineptina, com seu efeito predominantemente dopaminérgico, teoricamente seria um antidepressivo muito interessante para ser usado em caso de comorbidade de depressäo e dependência química, pois atuaria também na via dopaminérgica comum das dependências, teoricamente diminuindo as compulsöes. Os autores relatam um caso onde um paciente dependente de álcool desenvolveu dependência á amineptina (Survector), após emprego terapêutico para tratamento de quadro bipolar concomitante. A revisäo de literatura feita através dos Unitermos amineptine/amineptina e dependence/dependência das bases de dados LILACS e MEDLINE revelou 16 trabalhos sobre o tema, dois deles ppublicados no Brasil. Esta complicaçäo da amineptina é relativamente comum, embora alguns autores näo a considerem significativa para impedir seu uso mesmo em pacientes com história prévia de dependência. O uso de Clonidina, como preconizado na literatura, mostrou-se eficaz para diminuir os sintômas de abstinência. Frente à piora do quadro básico,os autores concluem que esta droga deve ser utilizada com cautela em pacientes dependentes