Causality assessment of adverse drug reaction: A narrative review to find the most exhaustive and easy-to-use tool in post-authorization settings.

BACKGROUND: The core motive of pharmacovigilance is the detection and prevention of adverse drug reactions (ADRs), to improve the risk-benefit balance of the drug. However, the causality assessment of ADRs remains a major challenge among clinicians, and none of the available tools of causality assessment used for assessing ADRs have been universally accepted. OBJECTIVE: To provide an up-to-date overview of the different causality assessment tools. METHODS: We conducted electronic searches in MEDLINE, EMBASE, and the Cochrane database. The eligibility of each tool was screened by three reviewers. Each eligible tool was then scrutinized for its domains (the reported specific set of questions/areas used for calculating the likelihood of cause-and-effect relation of an ADR) to discover the most comprehensive tool. Finally, we subjectively assessed the tool's ease-of-use in a Canadian, Indian, Hungarian, and Brazilian clinical context. RESULTS: Twenty-one eligible causality assessment tools were retrieved. Naranjo's tool and De Boer's tool appeared the most comprehensive among all the tools, covering 10 domains each. Regarding "ease-of-use" in a clinical setting, we judged that many tools were hard to implement in a clinical context because of their complexity and/or lengthiness. Naranjo's tool, Jones's tool, Danan and Benichou's tool, and Hsu and Stoll's tool appeared to be the easiest to implement into various clinical contexts. CONCLUSION: Among the many tools identified, 1981 Naranjo's scale remains the most comprehensive and easy to use for performing causality assessment of ADRs. Upcoming analysis should compare the performance of each ADR tool in clinical settings.

Adherence to Psychotropic Medications and Associated Factors in Primary Health Care.

The study aims were to analyze patients' adherence to psychotropic medications and its association with sociodemographic factors, therapeutic regimen, presence of common mental disorders, and illness factors. A descriptive cross-sectional study was carried out in ten Primary Health Care units in Brazil. The tools were the Measurement of Treatment Adherence Test and the Self Reporting Questionnaire. Nonadherence to psychotropic drugs was 88.9%. There was association between adherence and age and among patients positive for Common Mental Disorders (97.8%). In the multivariate analysis this association was not maintained. Findings indicate strategies are needed to improve medication adherence in the Primary Health Care services. However, no strategy will be effective if patients and their families are not involved in the process.

Avaliação do conhecimento de profissionais de enfermagem sobre a injeção ventroglútea / Evaluación del conocimiento de las enfermeras respecto de la inyección ventroglútea / Evaluation of the nurses' knowledge about ventrogluteal injection

Objetivo: Avaliar o conhecimento da equipe de enfermagem com relação à técnica de injeção intramuscular na região ventroglútea antes e depois de uma atividade de capacitação profissional. Método: Estudo quase-experimental, tipo antes e depois, entre janeiro e julho de 2010, em uma unidade de emergência em Descalvado-São Paulo, Brasil. A pesquisa foi realizada em três fases: Antes da intervenção, os participantes responderam um questionário específico para identificar seus conhecimentos teóricos sobre a técnica de injeção intramuscular na região ventroglútea. Na segunda fase, foi realizada uma atividade educativa com carga horária de 5 horas, com dois grupos de enfermeiros, com conteúdo teórico e prático. Na terceira fase, o conhecimento dos participantes foi reavaliado, após a capacitação. Resultados: Antes da intervenção, questões relacionadas às estruturas anatômicas envolvidas no mapeamento da região ventroglútea foram respondidas corretamente apenas 20,8 por cento dos participantes, e após a intervenção, por 63,6 por cento deles. Além disso, após a intervenção houve 100 por cento de êxito na execução das 15 etapas contempladas na ferramenta de avaliação da prática. Conclusão: A intervenção de capacitação profissional foi efetiva em aumentar o conhecimento dos membros da equipe de enfermagem, mas ainda há falhas no uso de terminologias sobre estruturas musculares e ósseas envolvidas na delimitação da região ventroglútea.

Objective: To assess the knowledge of nursing staff regarding to the technique of intramuscular injection in the ventrogluteal site before and after professional training. Method: A single center, before-and-after study was carried out between January and July 2010 in an emergency unit in Descalvado-São Paulo, Brazil. The research was conducted in three phases. Before the intervention, participants were required to respond a questionnaire designed to identify their theoretical knowledge about intramuscular injection techniques in the ventrogluteal site. In the second phase, a five hour session of professional training was conducted to two groups of nurses and included theoretical and practical contents. In phase three, their knowledge was assessed, after having received the professional training. Results: Before the intervention, the question relating to the anatomical structures involved in mapping the ventrogluteal site were answered correctly by only 20.8 percent of the participants. However, after professional training, 63.6 percent of the participants correctly answered this question. Also, after the intervention, 100 percent successfully executed the 15 steps contemplated in the assessment tool. Conclusion: Professional training was effective in increasing the level of nurses' knowledge, but they still struggled with terminology regarding muscle and bone structures involved in mapping the site.

Objetivo: Evaluar el conocimiento del personal de enfermería en relación a la técnica de inyección intramuscular en la zona ventroglútea antes y después de la capacitación profesional. Material y método: Estudio de tipo antes y después realizado entre enero y julio de 2010 en una unidad de emergencia en Descalvado, São Paulo, Brasil. La investigación se realizó en tres fases. Antes de la capacitación se solicitó a los participantes que respondiesen a un cuestionario para identificar el conocimiento teórico acerca de la técnica de inyección intramuscular en la zona ventroglútea. En la segunda fase se llevó a cabo la capacitación profesional con una carga de trabajo de cinco horas a dos grupos de profesionales e incluyó contenidos teóricos y prácticos. En la tercera fase, el conocimiento de los profesionales fue reevaluado. Resultados: Antes de la intervención, la cuestión relacionada con las estructuras anatómicas implicadas en el mapeo de la zona ventroglútea fue respondida correctamente por solo el 20,8 por ciento de los participantes. Después de la capacitación profesional, el 63,6 por ciento de los participantes respondieron correctamente a esta pregunta. Además, el 100 por ciento fue ejecutado con éxito las 15 etapas previstas en el instrumento de evaluación después de la intervención. Conclusiones: La capacitación profesional fue efectiva para aumentar el nivel de conocimiento de los profesionales de enfermería, pero tuvieron dificultades en la terminología relacionada con las estructuras musculares y óseas envueltas en el mapeo del sitio de la inyección.