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.

Reporting Rates of Opioid-Related Adverse Events Since 1965 in Canada: A Descriptive Retrospective Study.

BACKGROUND: Patients with chronic or acute/postoperative pain frequently use opioids. However, opioids may cause considerable adverse reactions (ARs), such as respiratory depression, which could be lethal. Unfortunately, only 5% of drug-related ARs (including those to opioids) are reported to health authorities. Therefore, little is known regarding the occurrence of opioid-related ARs at the population level. OBJECTIVE: The aim of this study was to investigate how the rates of reported opioid-related ARs have changed in Canada since 1965. METHODS: Our retrospective study examined trends of reported opioid-related ARs occurring in hospitalized and outpatients. Data on opioid-related ARs and mortality between 1965 and 2019 were obtained from the Canada Vigilance and Statistics Canada databases. Descriptive and Joinpoint regression analyses were performed. RESULTS: Oxycodone and normethadone were the most and least involved opioid agents, respectively, among the 18,407 reported ARs. The highest rate of reported opioid ARs (3.8 per 100,000 person-years) was recorded in 2012, whereas the lowest was recorded in 1965 (0.1 per 100,000 person-years). Between 1965 and 2019, annual rates climbed by 4.2% (95% confidence interval [CI] 3.1-5.2), and many fluctuations were observed: 1965-1974: +22.3% (95% CI 12.0-33.6); 1974-2000: - 4.1% (95% CI - 5.3 to - 2.9); 2000-2008: +30.3% (95% CI 22.6-38.4); 2008-2014: +4.1% (95% CI - 1.5 to 10.1); 2014-2017: -26.0% (95% CI - 44.7 to - 0.9); and, finally, 2017-2019: +35.4% (95% CI 3.8-76.7). CONCLUSION: Reported opioid-related ARs have increased since 1965, although fluctuations were observed in recent decades. The absolute number of opioid-related ARs might be seriously underestimated. Future studies should look into how to close this gap.

Programa de melhoria da qualidade na administração de medicamentos via sonda nasoenteral / Programa de mejora de la calidad en la administración de medicamentos por sonda nasoenteral / Quality improvement program in medication administration through nasogastric tube

Resumo Objetivo Avaliar o impacto de um programa de melhoria da qualidade relacionado aos indicadores de frequência de sondas nasoenterais obstruídas, do tempo despendido pela equipe de enfermagem no preparo e na administração de medicamentos orais por essa via, e dos custos associados ao incidente. Método Estudo de intervenção voltado para a comparação pré (Fase I) e pós (Fase II) implementação de um Programa Melhoria da Qualidade, proposto pelo Institute for Healthcare Improvement . Foram observadas 92 doses de medicamentos na Fase I e 66 doses na Fase II. Foram necessários quatro ciclos Plan-Do-Study-Act (PDSA) para atingir a meta proposta para o programa de melhoria. Resultados Houve redução no tempo médio gasto pelo profissional no preparo e na administração de medicamentos sólidos via sonda nasoenteral em ambas as fases. As frequências de sondas obstruídas reduziram de 33,3% (Fase I) para 7,4% (Fase II) e nenhuma sonda apresentou-se obstruída durante os ciclos 1, 2 e 4. O custo médio da obstrução por paciente foi de R$ 1.251,05 ao mês na Fase I e de R$ 23,31 na Fase II. Após as mudanças testadas, foi verificada economia de tempo para a equipe de enfermagem e de custo para a instituição. Conclusão Os ciclos PDSA foram eficazes na redução de não conformidades no preparo e na administração de medicamentos via sonda nasoenteral. Tal melhoria impactou a frequência de obstrução, os custos relacionados e o tempo médio gasto pelo profissional de enfermagem durante o preparo e a administração das doses.

Resumen Objetivo Evaluar el impacto de un programa de mejora de la calidad relacionado con los indicadores de frecuencia de sondas nasoenterales obstruidas, del tempo invertido por el equipo de enfermería en la preparación y en la administración de medicamentos orales por esa vía y de los costos asociados con el incidente. Métodos Estudio de intervención direccionado para la comparación previa (Fase I) y posterior (Fase II) a la implementación de un Programa Mejora de la Calidad, propuesto por el Institute for Healthcare Improvement . Se observaron 92 dosis de medicamentos en la Fase I y 66 dosis en la Fase II. Se necesitaron cuatro ciclos Plan-Do-Study-Act (PDSA) para alcanzar la meta propuesta para el programa de mejora. Resultados Hubo reducción del tiempo promedio consumido por el profesional en la preparación y en la administración de medicamentos sólidos por sonda nasoenteral en ambas fases. La frecuencia de la obstrucción de las sondas se redujo del 33,3 % (Fase I) para el 7,4 % (Fase II) y ninguna sonda presentó obstrucción durante los ciclos 1, 2 y 4. El costo promedio de la obstrucción por paciente fue de R$ 1.251,05 al mes en la Fase I y de R$ 23,31 en la Fase II. Después de someter a pruebas los cambios, se verificó un ahorro de tiempo para el equipo de enfermería y de costo para la institución. Conclusión Los ciclos PDSA fueron eficaces en la reducción de no conformidades en la preparación y en la administración de medicamentos por sonda nasoenteral. Esa mejora impactó la frecuencia de obstrucción, los costos relacionados y el tiempo promedio consumido por el profesional de enfermería durante la preparación y la administración de las dosis.

Abstract Objective Evaluate the impact of a quality improvement program related to the frequency indicators of obstructed nasogastric tubes, the time the nursing team spent on oral medication preparation and administration through this route, and the costs associated with the incident. Method Intervention study aimed at comparing pre (Phase I) and post (Phase II) implementation of a Quality Improvement Program, proposed by Institute for Healthcare Improvement . Ninety-two medication doses were observed in Phase I and 66 doses in Phase II. Four Plan-Do-Study-Act (PDSA) cycles were needed to achieve the proposed target for the improvement program. Results The average time the professional spent on solid medication preparation and administration through nasogastric tube decreased in both phases. Frequencies of obstructed tubes dropped from 33.3% (Phase I) to 7.4% (Phase II) and no probe was obstructed during cycles 1, 2, and 4. The average cost of the obstruction per patient was R$ 1,251.05 per month in Phase I and R$ 23.31 in Phase II. After testing the changes, time savings for the nursing team and cost savings for the institution were verified. Conclusion The PDSA cycles were effective in reducing non-conformities in medication preparation and administration via nasogastric tube. This improvement influenced the obstruction frequency, related costs, and the average time the nursing professional spent on the preparation and administration of the medication doses.

Adenovírus e rotavírus em águas superficiais do córrego Ribeirão Preto, São Paulo, Brasil / Adenovirus and rotavirus in surface water of the Ribeirão Preto stream, São Paulo, Brazil

Com o desenvolvimento humano, os recursos hídricos sofrem modificações derivadas da expansão demográfica e principalmente da falta de saneamento básico, que interferem diretamente na qualidade desses recursos com a introdução de substâncias químicas tóxicas e bioagentes patogênicos. Os vírus entéricos de veiculação hídrica, como adenovírus e rotavírus, merecem destaque considerando seus impactos na saúde pública. O objetivo deste estudo foi avaliar a presença de adenovírus e rotavírus em águas superficiais do Córrego Ribeirão Preto, SP. A coleta foi realizada em 11 pontos distintos, da nascente até a confluência com o Rio Pardo. O Teste de ELISA foi o método utilizado para a detecção dos vírus (RIDASCREEN® Adenovirus, RIDASCREEN® Rotavirus - R-Biopharm). De acordo com os resultados obtidos, 73% das amostras foram positivas para adenovírus, enquanto que 36% foram positivas para rotavírus. Considerando a virulência desses vírus entéricos e a vulnerabilidade de indivíduos imunossuprimidos, idosos e crianças, é preocupante a contaminação por esses agentes patogênicos de veiculação hídrica amplamente disseminados em águas superficiais.

Water resources have been suffering with the changes in demographic expansion and the lack of basic sanitation. These factors directly interfere with the quality of these resources due to the discharge of toxic chemicals and pathogenic bio-agents. The waterborne enteric viruses, such as rotavirus and adenovirus, deserve attention considering its impact on public health. The aim of this study was to evaluate the presence of adenovirus and rotavirus in surface water of Ribeirão Preto stream. Samplings were conducted in 11 different points from the spring to the confluence with the Rio Pardo. The ELISA test was carried out for the detection of viruses (RIDASCREEN® adenovirus, rotavirus RIDASCREEN® - R-Biopharm). According to the results, 73% of the samples were positive for adenovirus, while 36% were positive for rotavirus. Given the virulence of these enteric viruses and the vulnerability of immunosuppressed individuals, i.e. the elderly and children, contamination with these waterborne pathogens widely disseminated in surface water is concerning