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1.
MMWR Morb Mortal Wkly Rep ; 70(15): 547-551, 2021 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-33857066

RESUMO

High levels of coverage with safe and effective immunizations are critical to the successful control and prevention of vaccine-preventable diseases worldwide. In addition to stringent standards to regulate the safety of vaccines, robust postlicensure monitoring systems help ensure that the benefits of vaccines continue to outweigh the risks for the populations who receive them. National Expanded Programmes on Immunization (EPI) are typically responsible for identifying and investigating adverse events following immunization (AEFI), including assessment of causality. National regulatory authorities (NRAs) are mandated to perform postlicensure surveillance of adverse drug reactions, including those associated with receipt of vaccines. This report describes global progress toward meeting World Health Organization (WHO) indicators on minimal country capacity for vaccine safety surveillance and coordination of AEFI reporting between countries' EPI and NRAs. In 2019, among 194 countries, 129 (66.5%) reported having an operational national AEFI causality review committee, compared with 94 (48.5%) in 2010. During 2010-2019, the proportion of countries reporting ≥10 AEFI per 100,000 surviving infants per year (an indicator of country capacity to monitor immunization safety) increased, from 41.2% to 56.2%. In 2019, however, only 46 (23.7%) countries reported AEFI data from both EPI and NRAs. Although global progress has been made toward strengthening systems for vaccine safety monitoring over the past decade, new indicators for monitoring global immunization safety performance are needed to better reflect program functionality. Continued global efforts will be vital to address barriers to routine reporting of AEFI, build national capacity for AEFI investigation and data management, and improve sharing of AEFI data at national, regional, and global levels.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Saúde Global , Vigilância de Produtos Comercializados , Vacinas/efeitos adversos , Humanos
2.
Aust N Z J Public Health ; 45(2): 101-107, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33617131

RESUMO

OBJECTIVE: This study explored whether all-cause healthcare attendance rate post-vaccination could detect the two historical influenza safety episodes occurring in 2010 and 2015 using a large de-identified general practitioner (GP) consultations dataset. METHODS: A retrospective observational cohort study was conducted using GP consultation data routinely collected from 2008 to 2017 in Victoria, Australia. Post-vaccination GP consultation rates were monitored, over a 22-week surveillance period each year that aligned with each year's influenza vaccination season, using the Observed minus Expected (O-E) and the Log-Likelihood Ratio (LLR) CUSUM charts. Days 1-7 post-vaccination were considered as the risk period. The LLR CUSUM was designed to detect both a 50% and two-fold rise in the odds of the baseline post-vaccination GP consultation rates. RESULTS: Over the 10-year study period, more than 1.5 million seasonal influenza vaccines doses were administered to 295,091 persons. Overall, 1.29% had a GP consultation within one week of vaccination, but 98.53% of the consultations occurred in days 1-3 post-vaccination. The LLR CUSUM chart detected significant increases in the weekly rates of post-vaccination GP consultation in 2010 in children aged under ten years and in 2015 in adults aged 19-64 years. These increases were aligned by week, but one week earlier and by age category, with the historical adverse events following immunisation (AEFI) signals occurring in 2010 and 2015. However, in the absence of historical AEFI signals, increased rates of post-vaccination GP consultations were identified in three of the eight influenza vaccination years. CONCLUSION: The crude post-vaccination healthcare attendance rate has the potential to offer a sensitive proxy to monitor vaccine safety signal. Implications for public health: Vaccine safety monitoring using syndromic indicator has the potential to augment the existing surveillance systems as part of an integrated vaccine safety monitoring approach.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Assistência à Saúde/estatística & dados numéricos , Medicina Geral/estatística & dados numéricos , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Vigilância da População/métodos , Vacinação/efeitos adversos , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estações do Ano , Convulsões Febris/induzido quimicamente , Vitória/epidemiologia
3.
Expert Opin Drug Saf ; 20(5): 603-609, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33573405

RESUMO

Background: The polymyxins (colistin and polymyxin B) have recently reemerged in clinical practice. With the same antimicrobial activities, colistin has been more frequently prescribed in most countries, although available evidence on their nephrotoxicity is conflicting.Methods: The US Food and Drug Administration Adverse Event Reporting System (FAERS) data from Q1-2004 to Q1-2020 were used to identify adverse events (AE) reports. We described the reporting patterns and compare the reporting rates of serious AEs, acute kidney diseases (AKD), and death between colistin and polymyxin B using reporting odds ratios (RORs).Results: The annual number of AE reports increased over time for both drugs. Heterogeneity in reporting characteristics was observed in age and reporter region. RORs of serious, AKD, and death AEs were significantly higher for both drugs versus other drugs. RORs of serious and AKD AEs were higher for colistin compared to polymyxin B (p = 0.0479 and p = 0.0306, respectively), but no difference in death RORs was detected (p = 0.2211).Conclusions: This study showed higher reporting rates of serious AEs and AKD for colistin than polymyxin B, but no difference in death. The findings support future research with stronger study design and larger sample size for the safety comparison between colistin and polymyxin B.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Antibacterianos/efeitos adversos , Colistina/efeitos adversos , Polimixina B/efeitos adversos , Lesão Renal Aguda/induzido quimicamente , Lesão Renal Aguda/epidemiologia , Adolescente , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Colistina/administração & dosagem , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polimixina B/administração & dosagem , Estudos Retrospectivos , Estados Unidos , United States Food and Drug Administration , Adulto Jovem
4.
Clin Ther ; 43(2): 360-368.e5, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33509646

RESUMO

PURPOSE: The COVID-19 pandemic has been widely reported to present stress to medical systems globally and to disrupt the lives of patients and health care practitioners (HCPs). Given that spontaneous reporting heavily relies on both HCPs and patients, an understandable question is whether the stress of the pandemic has diminished spontaneous reporting. Herein, the hypothesis that the COVID-19 pandemic has negatively affected the spontaneous reporting of adverse drug events was assessed. METHODS: Spontaneous-report counts from 119 weeks (January 1, 2018, to April 12, 2020) were identified using Pfizer's safety database and were analyzed. Autoregressive integrated moving-average models were fitted to aggregated and disaggregated time series (TSs). Model residuals were charted on individual-value and moving-range charts and exponentially weighted moving-average charts for the identification of statistically unexpected changes associated with the pandemic. FINDINGS: Overall, the reporting of serious adverse events showed no unexpected decline. Total global reporting declined, driven by HCP reporting (of both serious and nonserious events), starting after week 8 of 2020 and exceeding model expectations by week 15 of 2020, suggesting the pandemic as an assignable cause. However, reporting remained within longer-term historical ranges. The TS from Japan was the only national TS that showed a significant decline, and an unusual periodicity related to national holidays. A few countries, notably Taiwan, showed unexpected statistical increases in reporting associated with the pandemic, commencing as early as week 3 of 2020. In the literature, the reporting of adverse drug events was stable. Ancillary findings included prevalent year-end/beginning reporting minima, with more reports from HCPs than from consumers. IMPLICATIONS: Using data from a large-scale and diverse safety database from a pharmaceutical company, a significant global decline in total reporting was detected, driven by HCPs, not consumers, and reports of nonserious events, consistent with the pandemic as an assignable cause, but the reporting remained within long-term ranges, suggesting relative durability. Importantly, the analyses found no unexpected decline in overall reporting of serious events. Future avenues of research include the use of data from large-scale, publicly available spontaneous reporting systems for assessing the generalizability of the present findings and whether they correlate with impaired signal detection, as well as a follow-up analysis of whether the effects on spontaneous reporting abate after the pandemic.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Bases de Dados Factuais , Saúde Global , Humanos , Análise de Séries Temporais Interrompida , Japão , Pandemias , Projetos de Pesquisa/estatística & dados numéricos , Taiwan
5.
BMC Cancer ; 21(1): 38, 2021 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-33413213

RESUMO

BACKGROUND: Immune checkpoint inhibitors-induced myocarditis presents unique clinical challenges. Here, we assessed post-marketing safety of cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), programmed cell death-1 (PD-1), and programmed death-ligand 1 (PD-L1) inhibitors by mining the real-world data reported in two international pharmacovigilance databases. METHODS: We analyzed immune checkpoint inhibitors (ICIs)-associated fatal adverse drug events (ADEs) reports from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) collected from July 1, 2014 to December 31, 2019 and data from EudraVigilance (EV) database accessed on February 29, 2020. Three different data mining approaches were used to detect the signal of fatal myocarditis caused by ICIs. RESULTS: Based on 7613 ICIs-related ADEs reported to the EV database and 5786 ICIs-associated ADEs submitted to the FAERS database, the most frequently reported ADE was ipilimumab-related colitis. For myocarditis, nivolumab-associated myocarditis was the most common. Among the five fatal toxic effects associated with ICIs, the lethality rate of myocarditis was the highest. Therefore, we further analyzed ICI-associated myocarditis and found that elderly patients and male patients were more likely to develop ICIs-related myocarditis. The results of signal detection showed that the risk signal of avelumab-related myocarditis detected by reporting odds ratio (ROR) method and proportional reporting ratios (PRR) method was the highest, whereas the signal strength of ipilimumab-related myocarditis detected by Bayesian confidence propagation neural networks (BCPNN) method was the strongest. CONCLUSION: The findings of this study indicated the potential safety issues of developing myocarditis when using ICIs, which were consistent with the results of previous clinical trials and could provide a reference for clinical workers when using ICIs.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Miocardite/induzido quimicamente , Miocardite/patologia , Neoplasias/tratamento farmacológico , Farmacovigilância , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Teorema de Bayes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/patologia , Prognóstico , Adulto Jovem
6.
PLoS One ; 15(12): e0240276, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33338057

RESUMO

INTRODUCTION: Biological drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with adverse drug reactions (ADRs). OBJECTIVE: To identify the ADRs associated with the use of biological drugs in Colombia. METHODS: This was a retrospective study of ADR reports from 2014 to 2019, contained in the database of Audifarma SA pharmacovigilance program. The ADRs, groups of associated drugs, and affected organs were classified. RESULTS: In total, 5,415 reports of ADRs associated with biological drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most affected organ system (16.8%), followed by the skin and appendages (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%). CONCLUSIONS: The reporting of ADRs has increased in recent years and these reactions are mostly classified as tyoe A or B, categorized as serious in almost one-fifth of the reported cases and associated mainly with immunomodulators and antineoplastic agents. This type of study can support decision makers in ways that benefit patient safety and interaction with health systems.


Assuntos
Antineoplásicos/efeitos adversos , Produtos Biológicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Fatores Imunológicos/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Colômbia/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Incidência , Masculino , Segurança do Paciente , Farmacovigilância , Doenças Respiratórias/induzido quimicamente , Doenças Respiratórias/epidemiologia , Estudos Retrospectivos , Dermatopatias/induzido quimicamente , Dermatopatias/epidemiologia
7.
BMC Public Health ; 20(1): 1527, 2020 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-33032559

RESUMO

BACKGROUND: Spontaneous reporting (SR) of adverse drug reactions (ADRs) from patients can be considered as a valuable activity providing both objective and subjective data. However, improving the rate of under-reporting has been a major challenge to ensure successful operation of the SR system. This study aimed to assess knowledge, attitude, and intent to report ADRs and explore the factors contributing to consumers' reporting intent in South Korea. METHODS: Self-administered questionnaire was collected from a sex-, age-, and regionally stratified nationwide convenience sample of consumers using a commercial panel in December 2018. Univariate and multivariate logistic regression analyses were used to explore the factors contributing to the intent to report ADRs by consumers. RESULTS: A total of 1000 respondents were enrolled in the survey; 50.9% were males and the mean age was 44.4 (standard deviation, 13.3) years. While less than 15% of the respondents were aware of the SR system and even fewer (3.4%) had actual experience of SR, however, 59.2% expressed their intent to report ADRs. The positive attitude (adjusted odds ratio [aOR] 3.972, p < 0.001), awareness of the SR system (aOR 2.102, p < 0.01), self-efficacy for SR (aOR 1.956, p < 0.001), and experiences related to ADR counselling with healthcare professionals (OR 2.318, p < 0.001) are the significant factors contributing to reporting intent. CONCLUSIONS: Findings of this study highlight the need for increasing the awareness of the SR system among consumers and empowering them to report ADRs by themselves, which would ultimately improve the drug-safety environment.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Conhecimentos, Atitudes e Prática em Saúde , Intenção , Pacientes/psicologia , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pacientes/estatística & dados numéricos , República da Coreia , Inquéritos e Questionários
8.
PLoS Negl Trop Dis ; 14(9): e0008370, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32956348

RESUMO

Chagas disease (CD) and tuberculosis (TB) are important health problems in Bolivia. Current treatments for both infections require a long period of time, and adverse drug reactions (ADRs) are frequent. This study aims to strengthen the Bolivian pharmacovigilance system, focusing on CD and TB. A situation analysis of pharmacovigilance in the Department of Cochabamba was performed. The use of a new local case report form (CRF) was implemented, together with the CRF established by the Unidad de Medicamentos y Tecnología en Salud (UNIMED), in several healthcare centers. Training and follow-up on drug safety monitoring and ADR reporting was provided to all health professionals involved in CD and TB treatment. A comparative analysis of the reported ADRs using the CRF provided by UNIMED, the new CRF proposal, and medical records, was also performed. Our results showed that out of all patients starting treatment for CD, 37.9% suffered ADRs according to the medical records, and 25.3% of them were classified as moderate/severe (MS). Only 47.4% of MS ADRs were reported to UNIMED. Regarding TB treatment, 9.9% of all patients suffered ADRs, 44% of them were classified as MS, and 75% of MS ADRs were reported to UNIMED. These findings show that the reinforcement of the Bolivian pharmacovigilance system is an ambitious project that should involve a long-term perspective and the engagement of national health workers and other stakeholders at all levels. Continuity and perseverance are essential to achieve a solid ADR reporting system, improving patient safety, drug efficacy and adherence to treatment.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Doença de Chagas/tratamento farmacológico , Farmacovigilância , Tuberculose/tratamento farmacológico , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Bolívia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Conhecimentos, Atitudes e Prática em Saúde , Pessoal de Saúde/educação , Humanos , Inquéritos e Questionários
9.
Br J Radiol ; 93(1115): 20200596, 2020 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-32903029

RESUMO

OBJECTIVES: Considering the growing use of imaging modalities and contrast agents, radiologists are prone to encounter adverse drug reactions (ADR). In the current study, we mainly aim to evaluate the knowledge of radiologists regarding pharmacovigilance (PV). Also, we intend to gather information about their previous ADR experiences. Secondarily, we hope to increase the awareness about contrast-medium-related ADRs and attract attention to the importance of properly reporting these ADRs. METHODS: A survey was generated by using an online survey webpage, and the relevant link was e-mailed to radiologists and radiology residents. The survey begins with a short explanation about the study. The second section contains questions about PV knowledge level, and the final section aims to gather information about the experienced ADRs. RESULTS: The survey was completed by 202 participants. 65.3% stated that they were aware of PV. 24.8% of the participants said that they know the national PV program. 97% told that they knew the term ADR. 66.3% of the participants encountered an ADR. 53.7% of them reported these ADRs. 70.8% of them reported these ADRs to a clinician. CONCLUSIONS: Radiologists encounter ADRs almost as frequently as the other doctors. Their awareness about PV is similar with other healthcare professionals. They have fewer information about TUFAM and PvCPs. Radiologists generally prefer to communicate with a clinician about an ADR. Overall condition of radiologists about PV is quite similar with other healthcare professionals and education can improve it, as for the others. ADVANCES IN KNOWLEDGE: Radiologists encounters ADRs almost as frequently as the other doctors. Overall condition of radiologists about PV is quite similar with other healthcare professionals and education can improve it, as for the others.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Conhecimentos, Atitudes e Prática em Saúde , Internato e Residência , Farmacovigilância , Radiologistas , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Meios de Contraste/efeitos adversos , Humanos , Internato e Residência/estatística & dados numéricos , Radiologistas/estatística & dados numéricos , Inquéritos e Questionários/estatística & dados numéricos
10.
Mayo Clin Proc ; 95(8): 1594-1603, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32753134

RESUMO

OBJECTIVE: To examine differences in the frequency and severity of federally reported adverse events between caffeine-containing and non-caffeine-containing products while also identifying the category of caffeine-containing products associated with the highest frequency and severity of adverse events. PATIENTS AND METHODS: All adverse event reports that met specified eligibility criteria and were submitted to the Center for Food Safety and Applied Nutrition Adverse Event Reporting System between January 1, 2014, and June 29, 2018, were extracted. In this retrospective observational study, the most severe adverse event experienced, an ordinal variable, was categorized into death, life-threatening, hospitalization/disability, and emergency department visit. A nonproportional odds model was used to compare the odds of caffeine-containing products being associated with more severe adverse events relative to a noncaffeine group. The analysis is of data only from those reporting adverse events and may or may not be representative of the entire population exposed to these products, which is not known from the examined data. RESULTS: Energy and preworkout products saw a significant increase in the odds of the adverse event experienced being death rather than the other less severe outcomes relative to the noncaffeinated group. Those products, along with weight loss products, had greater odds of the adverse event being death or life-threatening vs the less severe outcomes relative to the noncaffeinated group. CONCLUSION: Caffeine-containing products have a greater association with severe adverse events compared with non-caffeine-containing products. Exposure to preworkout and weight loss products had greater odds of being associated with a more serious adverse event relative to noncaffeinated products. Health care practitioners should use these outcomes to better inform and educate patients about the many factors related to caffeine intake and adverse outcomes.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Cafeína/efeitos adversos , United States Food and Drug Administration , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Fármacos Antiobesidade/efeitos adversos , Fármacos Antiobesidade/toxicidade , Cafeína/toxicidade , Bebidas Gaseificadas/efeitos adversos , Bebidas Gaseificadas/toxicidade , Criança , Pré-Escolar , Café/efeitos adversos , Suplementos Nutricionais/efeitos adversos , Suplementos Nutricionais/toxicidade , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Chá/efeitos adversos , Estados Unidos , Adulto Jovem
11.
Yonsei Med J ; 61(7): 623-630, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32608206

RESUMO

PURPOSE: Vaccine hesitancy is among the top ten threats to global health, and access to precise data on adverse events following immunization (AEFIs) is imperative to alleviate public concerns surrounding vaccines. This study aimed to present the overall trends of AEFIs reported in South Korea. MATERIALS AND METHODS: We evaluated the trends of AEFIs using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System database between January 2005 and December 2017. AEFIs were classified into five categories to evaluate associations between vaccines and AEFIs through a case-non-case study: neurologic reactions, general systemic reactions, local reactions, allergic reactions, and others. RESULTS: Among 54378 reported adverse events (AEs) associated with all vaccines approved in South Korea, more than half (56.7%) occurred following influenza vaccination, followed by the pneumococcal (11.6%) and Bacillus Calmette-Guérin (BCG) vaccines (5.0%). After immunization with most vaccines, general systemic reactions were most common, followed by local and neurologic reactions. Adjusted reporting odds ratios were calculated for all neurologic, general, local, and allergic reactions: of all vaccines, rotavirus [neurologic 2.43, 95% confidence interval (CI), 2.25-2.62], BCG (general; 2.20, 95% CI, 1.91-2.53), BCG (local; 3.15, 95% CI, 2.69-3.68), and Japanese encephalitis (allergic 2.38, 95% CI, 1.98-2.87) vaccines showed the highest values. CONCLUSION: The majority of reported AEFIs were non-serious and mostly general systemic reactions. Sufficient knowledge on the AEFIs would secure public confidence on the safety of vaccines, thereby reducing public health burden from vaccine-preventable diseases.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hipersensibilidade/epidemiologia , Imunização/efeitos adversos , Vigilância de Produtos Comercializados , Vacinação/efeitos adversos , Adulto , Algoritmos , Vacina BCG , Bases de Dados Factuais , Feminino , Humanos , Imunização/psicologia , Masculino , República da Coreia , Vacinação/psicologia , Vacinação/estatística & dados numéricos
12.
Artigo em Inglês | MEDLINE | ID: mdl-32536336

RESUMO

Background: SAEFVIC is the Victorian surveillance system for adverse events following immunisation (AEFI). It enhances passive surveillance by also providing clinical support and education to vaccinees and immunisation providers. This report summarises surveillance, clinical and vaccine pharmacovigilance activities of SAEFVIC in 2018. Methods: A retrospective observational cohort study of AEFI reports received by SAEFVIC in 2018, compared with previous years since 2008. Data were categorised by vaccinee demographics of age, sex, pregnancy and Indigenous status, vaccines administered and AEFI reactions reported. Age cohorts were defined as infant (0-12 months); young child (1-4 years); school-aged (5-17 years); adult (18-64 years); and older person (65+ years). Proportional reporting ratios were calculated for signal investigation of serious adverse neurological events with all vaccines and with influenza vaccines. Clinical support services and educational activities are described. Results: SAEFVIC received 1730 AEFI reports (26.8 per 100,000 population), with 9.3% considered serious. Nineteen percent (n = 329) attended clinical review. Annual AEFI reporting trends increased for infants, children and older persons, but were stable for school-aged and adult cohorts. Females comprised 55% of all reports and over 80% of reports among adults. There were 17 reports of AEFI in pregnant women and 12 (0.7%) in persons identifying as Indigenous Australians. A possible signal regarding serious adverse neurological events (SANE) was detected, but was not supported by signal validation testing. A clinical investigation is ongoing. Two deaths were reported coincident to immunisation with no evidence of causal association. Conclusion: SAEFVIC continues to provide robust AEFI surveillance supporting vaccine safety monitoring in Victoria and Australia, with new signal detection and validation methodologies strengthening capabilities.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Imunização/efeitos adversos , Imunização/estatística & dados numéricos , Farmacovigilância , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Previsões , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Vigilância da População , Estudos Retrospectivos , Vitória/epidemiologia , Adulto Jovem
13.
Artigo em Inglês | MEDLINE | ID: mdl-32536339

RESUMO

Introduction: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system employing prospective case ascertainment for selected serious childhood conditions, particularly vaccine-preventable diseases and potential adverse events following immunisation (AEFI). This report presents surveillance data for 2017 and 2018. Methods: Specialist nurses screened hospital admissions, emergency department (ED) records, laboratory and other data on a daily basis in seven paediatric tertiary referral hospitals across Australia to identify children with the conditions under surveillance. In 2017 and 2018 these included acute flaccid paralysis (AFP; a syndrome associated with poliovirus infection), acute childhood encephalitis (ACE), influenza, intussusception (IS; a potential AEFI with rotavirus vaccines), pertussis, varicella-zoster virus infection (varicella and herpes zoster), invasive meningococcal, and invasive Group A streptococcus diseases. An additional social research component was added to evaluate parental attitudes to vaccination. Results: PAEDS captured 1,580 and 925 cases for 2017 and 2018, respectively, across all conditions under surveillance. Key outcomes of PAEDS included: contribution to national AFP surveillance to reach the World Health Organization reporting targets; identification of a third human parechovirus outbreak among other infectious diseases linked to ACE; demonstration of variable influenza activity between 2017 and 2018, with vaccine effectiveness (VE) analysis demonstrating that the protection offered through vaccination is season-dependent. All IS cases associated with vaccine receipt were reported to the relevant state health department. Varicella and herpes zoster case numbers remained unchanged, with vaccine uptake found to be suboptimal among eligible children under the NIP. Enhanced pertussis surveillance continues to capture controls for VE estimation. Surveillance for invasive meningococcal disease showed predominance for serotype B at 57% over 2 years among 77 cases where serotyping was available, and surveillance for invasive group A streptococcus captured severe disease in children. Conclusion: PAEDS continues to provide unique policy-relevant data on serious paediatric conditions using hospital-based sentinel surveillance.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Pediatria/estatística & dados numéricos , Pediatria/tendências , Vigilância da População , Doenças Preveníveis por Vacina/epidemiologia , Adolescente , Austrália/epidemiologia , Criança , Pré-Escolar , Feminino , Previsões , Humanos , Lactente , Recém-Nascido , Masculino , Estudos Prospectivos
14.
Drug Saf ; 43(7): 657-660, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32495148

RESUMO

INTRODUCTION: Hydroxychloroquine was recently promoted in patients infected with COVID-19 infection. A recent experimental study has suggested an increased toxicity of hydroxychloroquine in association with metformin in mice. OBJECTIVE: The present study was undertaken to investigate the reality of this putative drug-drug interaction between hydroxychloroquine and metformin using pharmacovigilance data. METHODS: Using VigiBase®, the WHO pharmacovigilance database, we performed a disproportionality analysis (case/non-case study). Cases were reports of fatal outcomes with the drugs of interest and non-cases were all other reports for these drugs registered between 1 January 2000 and 31 December 2019. Data with hydroxychloroquine (or metformin) alone were compared with the association hydroxychloroquine + metformin. Results are reported as ROR (reporting odds ratio) with their 95% confidence interval. RESULTS: Of the 10,771 Individual Case Safety Reports (ICSR) involving hydroxychloroquine, 52 were recorded as 'fatal outcomes'. In comparison with hydroxychloroquine alone, hydroxychloroquine + metformin was associated with an ROR value of 57.7 (23.9-139.3). In comparison with metformin alone, hydroxychloroquine + metformin was associated with an ROR value of 6.0 (2.6-13.8). CONCLUSION: Our study identified a signal for the association hydroxychloroquine + metformin that appears to be more at risk of fatal outcomes (particularly by completed suicides) than one of the two drugs when given alone.


Assuntos
Infecções por Coronavirus , Interações Medicamentosas , Quimioterapia Combinada , Hidroxicloroquina , Metformina , Pandemias , Pneumonia Viral , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/mortalidade , Feminino , Humanos , Hidroxicloroquina/farmacocinética , Hidroxicloroquina/uso terapêutico , Hipoglicemiantes/farmacocinética , Hipoglicemiantes/uso terapêutico , Masculino , Metformina/farmacocinética , Metformina/uso terapêutico , Pessoa de Meia-Idade , Farmacovigilância , Pneumonia Viral/diagnóstico , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia
16.
Therapie ; 75(4): 371-379, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32418730

RESUMO

INTRODUCTION: COVID-19 is an unprecedented challenge for physicians and scientists. Several publicized drugs are being used with not much evidence of their efficacy such as hydroxychloroquine, azithromycin or lopinavir-ritonavir. Yet, the cardiac safety of these drugs in COVID-19 deserves scrutiny as they are known to foster cardiac adverse ADRs, notably QTc interval prolongation on the electrocardiogram and its arrhythmogenic consequences. METHODS: Since March 27th, 2020, the French Pharmacovigilance Network directed all cardiac adverse drug reactions associated with "off-label" use of hydroxychloroquine, azithromycin and lopinavir-ritonavir in COVID-19 to the Nice Regional Center of Pharmacovigilance. Each Regional Center of Pharmacovigilance first assessed causality of drugs. We performed a specific analysis of these cardiac adverse drug reactions amidst an array of risk factors, reassessed the electrocardiograms and estimated their incidence in coronavirus disease 2019. RESULTS: In one month, 120 reports of cardiac adverse drug reactions have been notified, 103 of which associated with hydroxychloroquine alone (86%), or associated with azithromycin (60%). Their estimated incidence is 0.77% to 1.54% of all patients, notwithstanding strong underreporting. Lopinavir-ritonavir came third with 17 reports (14%) and chloroquine fourth with 3 reports (2.5%). There were 8 sudden, unexplained or aborted deaths (7%), 8 ventricular arrhythmias (7%), 90 reports of prolonged QTc (75%) most of them "serious" (64%), 48 of which proved ≥ 500ms, 20 reports of severe conduction disorders (17%) and 5 reports of other cardiac causes (4%). Six reports derived from automedication. DISCUSSION AND CONCLUSION: "Off-label" use of treatments in COVID-19 increases the risk of cardiac ADRs, some of them avoidable. Even if these drugs are perceived as familiar, they are used in patients with added risk factors caused by infection. Precautions should be taken to mitigate the risk, even if they will be proven efficacious.


Assuntos
Infecções por Coronavirus/tratamento farmacológico , Cardiopatias/induzido quimicamente , Uso Off-Label , Farmacovigilância , Pneumonia Viral/tratamento farmacológico , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Idoso , Azitromicina/administração & dosagem , Azitromicina/efeitos adversos , Cloroquina/administração & dosagem , Cloroquina/efeitos adversos , Combinação de Medicamentos , Eletrocardiografia , Feminino , França/epidemiologia , Cardiopatias/epidemiologia , Humanos , Hidroxicloroquina/administração & dosagem , Hidroxicloroquina/efeitos adversos , Síndrome do QT Longo/induzido quimicamente , Síndrome do QT Longo/epidemiologia , Lopinavir/administração & dosagem , Lopinavir/efeitos adversos , Masculino , Pessoa de Meia-Idade , Pandemias , Fatores de Risco , Ritonavir/administração & dosagem , Ritonavir/efeitos adversos
18.
Healthc Q ; 23(1): 40-46, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32249738

RESUMO

Annually, thousands of individuals die and tens of thousands are hospitalized in association with suspected adverse drug reactions (ADRs) in Canada. We analyzed the reports from the Canada Vigilance Adverse Reaction online database and present a synopsis of the state of ADRs in Canada between 2009 and 2018. Our synopsis includes both cross-sectional and longitudinal insights into ADR demographics, outcomes, associated drugs and disease indications. In closing, we highlight five overarching issues uncovered in our analysis, which have potential implications for future policy formulation. Further in-depth exploration is required to shine some additional light on these issues.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Canadá/epidemiologia , Interações Medicamentosas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Metotrexato/efeitos adversos , Segurança do Paciente
19.
Cancer Immunol Immunother ; 69(5): 683-687, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32152702

RESUMO

More than 2000 immuno-oncology agents are being tested or are in use as a result of the cancer immunotherapy revolution. Manipulation of co-inhibitory receptors has achieved tumor eradication in a minority of patients, but widespread immune-related adverse events (irAEs) compromised tolerance to healthy self-tissues in the majority. We have proposed that a major mechanism of irAEs is similar to a graft-versus-malignancy effect of graft-versus-host disease. To verify our hypothesis, we retrieved post-marketing data of adverse events from the U.S. Food and Drug Administration Adverse Event Reporting System. A significant positive correlation was revealed in 7677 patients between the reporting odds ratio of irAEs during immune checkpoint inhibitor therapy and the corresponding tumor mutational burden across 19 cancer types. These results can be interpreted to mean that the ICI drugs unleashed T cells against "altered-self," self, and tumors resulting in better overall survival.


Assuntos
Antineoplásicos Imunológicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/genética , Neoplasias/tratamento farmacológico , Tolerância a Antígenos Próprios/genética , Linfócitos T/efeitos dos fármacos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Antígenos de Neoplasias/genética , Antígenos de Neoplasias/imunologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/imunologia , Humanos , Mutação , Neoplasias/genética , Neoplasias/imunologia , Tolerância a Antígenos Próprios/efeitos dos fármacos , Linfócitos T/imunologia
20.
Eur J Cancer ; 129: 71-79, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32143106

RESUMO

BACKGROUND: Aging is an important risk factor for cancers and is associated with poor prognosis. Weakness of the immune system, also called immunosenescence may occur with older age. The impact of aging on efficacy and safety of immune checkpoint blockers, such as anti-programmed death (ligand) PD-(L)1, remains undetermined. This study aims to evaluate the incidence of immune-related adverse events (irAEs) in patients aged 70 years or older than their younger counterparts. METHODS: Patients with advanced solid tumors treated at Gustave Roussy with an anti-PD-(L)1 monotherapy between June 2014 and October 2017 were prospectively included within the dedicated irAEs pharmacovigilance registry REISAMIC (Registre des Effets Indésirables Sévères des Anticorps Monoclonaux Immunomodulateurs en Cancérologie). The incidence of irAEs of grade ≥II was compared between patients aged ≥70 (old patients, OP) versus patients aged < 70 years (young patients, YP) using a chi-squared test. Survivals were estimated using the Kaplan-Meier method. RESULTS: Among the 603 patients treated by anti-PD(L)1, 191 were ≥70 y.o (OP) and 424 < 70 y.o (YP). The median (range) age of OP and YP were respectively 77 (70-93) and 59 years old (17-69). A total of 165 irAEs occurred in these patients (103 grade II and 58 grade III-IV). The overall incidence of grade ≥II irAEs was higher in OP than in YP (33% versus 25%, p = 0.03). In addition, OP were more prone of having multiples irAEs compared with YP (p = 0.037). Skin toxicities were more frequent in OP than in YP (p = 0.007) but endocrine toxicities were less frequent in OP than in YP (p = 0.044). This higher level of irAEs seems to be responsible for a higher rate of treatment discontinuation in OP (p = 0.2). There was no statistical difference in median time to toxicity, exposure to steroids or survival between the two groups. CONCLUSION: Although anti-PD-(L)1 immunotherapies remain an acceptable treatment option for older patients, prescribers should be aware that irAEs are more frequent in the elderly. Further translational studies are warranted to better understand the relationship between aging and irAEs.


Assuntos
Envelhecimento/imunologia , Antineoplásicos Imunológicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etnologia , Neoplasias/tratamento farmacológico , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Antígeno B7-H1/antagonistas & inibidores , Antígeno B7-H1/imunologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/imunologia , Feminino , França/epidemiologia , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Neoplasias/imunologia , Neoplasias/mortalidade , Nivolumabe , Seleção de Pacientes , Farmacovigilância , Receptor de Morte Celular Programada 1/antagonistas & inibidores , Receptor de Morte Celular Programada 1/imunologia , Estudos Prospectivos , Fatores de Risco , Índice de Gravidade de Doença , Resultado do Tratamento
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