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1.
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
2.
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
3.
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
4.
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
5.
J Korean Med Sci ; 35(4): e17, 2020 Feb 03.
Artigo em Inglês | MEDLINE | ID: mdl-31997613

RESUMO

BACKGROUND: Severe and life-threatening drug eruptions include drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). One class of medications that has been highly associated with such drug eruptions is antiepileptic drugs (AEDs). We attempt to investigate drug eruptions associated with AEDs as a class, as well as with individual AEDs, in Korea. METHODS: We used the Korea Institute of Drug Safety and Risk Management - Korea Adverse Event Reporting System (KIDS-KAERS) database, a nationwide database of adverse events reports, between January 2008 and December 2017 to investigate the reporting count of all drug eruptions and calculated the ratio of DRESS/SJS/TEN reports for each AED. RESULTS: Among a total of 2,942 reports, most were of rash/urticaria (2,702, 91.8%), followed by those of DRESS (109, 3.7%), SJS (106, 3.6%), and TEN (25, 0.85%). The common causative AEDs were lamotrigine (699, 23.8%), valproic acid (677, 23%), carbamazepine (512, 17.4%), oxcarbazepine (320, 10.9%), levetiracetam (181, 6.2%), and phenytoin (158, 5.4%). In limited to severe drug eruptions (DRESS, SJS, and TEN; total 241 reports), the causative AEDs were carbamazepine (117, 48.8%), lamotrigine (57, 23.8%), valproic acid (20, 8.3%), phenytoin (15, 6.3%), and oxcarbazepine (10, 4.2%). When comparing aromatic AED with non-aromatic AED, aromatic AEDs were more likely to be associated with severe drug eruption (aromatic AEDs: 204/1,793 versus non-aromatic AEDs: 37/1,149; OR, 3.86; 95% CI, 2.7-5.5). Death was reported in 7 cases; DRESS was the most commonly reported adverse event (n = 5), and lamotrigine was the most common causative AED (n = 5). CONCLUSION: Although most cutaneous drug eruptions in this study were rash or urticaria, approximately 8% of reports were of severe or life-threatening adverse drug reactions, such as SJS, TEN, or DRESS. When hypersensitivity skin reactions occurred, aromatic AEDs were associated with 4 fold the risk of SJS/TEN/DRESS compared with non-aromatic AEDs. Our findings further emphasize that high risk AEDs should be prescribed under careful monitoring, and early detection and prompt interventions are needed to prevent severe complications.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Anticonvulsivantes , Erupção por Droga/epidemiologia , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Idoso , Anticonvulsivantes/efeitos adversos , Criança , Pré-Escolar , Bases de Dados Factuais , Síndrome de Hipersensibilidade a Medicamentos/epidemiologia , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , República da Coreia , Fatores de Risco , Síndrome de Stevens-Johnson/epidemiologia , Adulto Jovem
6.
PLoS One ; 15(1): e0227712, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31961883

RESUMO

INTRODUCTION: Adverse drug reactions (ADRs) are global public health problems. In its severe form it may cause hospital admission, morbidity and mortality. Early reporting of suspected ADRs to regulatory authorities is known to be appropriate measure toinsure health and safety of public form such adverse drug reaction of drugs. In Addis Ababa, there is limited information on ADR reporting practices among medical doctors. Hence, this study aimed to assess ADR reporting practices and associated factors among doctors in government hospitals in Addis Ababa. METHODS: An institution based cross-sectional mixed-methods study design was used. Data werecollected from 407 doctors using self-administered questionnaire and five key informants using semi-structured questionnaire from October 01 to December 31, 2017. Binary logistic regression and thematic analysis methods for quantitative and qualitative data analysis were used respectively. RESULTS: Only 94(27.4%) of doctors had ever reported ADRs to national pharmacovigilance center. The study showed that sex (AOR = 3.51, 95% CI: 1.76-7.03), level ofeducation (AOR = 5.01, 95% CI: 2.23-11.28), work experience (AOR = 4.59, 95% CI: 1.21-17.40), existence of ADR reporting form (AOR = 3.96, 95% CI: 1.07-14.61) and reporting to respective marketing authorization holders (AOR = 21.41, 95% CI: 5.89-77.88) were significantly associated with ADR reporting practices. Poor awareness and training on risk of under-reporting, feeling that reporting is minor, absence of appropriate reporting tools, delay and/or absence of feedback on reported ADRs, overly burdened doctors, negligence, fear of legal liabilityand communication gap were cited by key informants as barriers for reporting practice. CONCLUSIONS: Adverse drug reaction reporting practice among doctors wasfound to be low. Sex, level of education, work experience, existence of reporting form and reporting to marketing authorization holderswere significantly associated with ADR reporting practice. In addition, there are gaps in availabilities of guidelines, reporting systems and structure, pre-service and in-service training, and awareness of doctors on impact of reporting. Hence, improving access to ADR reporting form, decentralize safety monitoring system, and conducting awareness training on ADR reporting are essential to improve the ADR reporting practice.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Atitude do Pessoal de Saúde , Farmacovigilância , Médicos/psicologia , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Competência Clínica/estatística & dados numéricos , Estudos Transversais , Escolaridade , Etiópia , Feminino , Hospitais Públicos/normas , Hospitais Públicos/estatística & dados numéricos , Humanos , Masculino , Médicos/normas , Médicos/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Fatores Sexuais , Inquéritos e Questionários/estatística & dados numéricos , Adulto Jovem
7.
Expert Opin Drug Saf ; 19(1): 99-106, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31661986

RESUMO

Objectives: Biological drugs have been successfully tested in asthma, especially in the most severe forms of the disease. The goal of this study was to characterize the safety profile of biologicals used in asthma.Methods: Retrospective and descriptive analysis of spontaneous reports (SRs) involving omalizumab and mepolizumab, sent to the Portuguese Pharmacovigilance System, since market launch until October 2018.Results: A total of 127 SRs for omalizumab and 10 SRs mepolizumab were found. Most patients were female (75.6% omalizumab and 90.0% mepolizumab), and aged 18-64 years (61.4% and 50.0%, respectively). 71.7% of the reports for omalizumab were serious, with 2 cases of anaphylaxis, 12 malignant neoplasms and 2 abortions. Only 20.0% of the reports for mepolizumab were considered serious. A total of 391 adverse drug reactions (ADRs) for omalizumab and 20 ADRs for mepolizumab were found. Most reported ADRs belonged to System organ class (SOC) groups: 'respiratory, thoracic and mediastinal disorders' and 'investigations', for omalizumab; 'musculoskeletal and connective tissue disorders' and 'general disorders and administration site conditions' for mepolizumab.Conclusion: Over the years, there was an increasing trend of SRs with these biological drugs. However, it is necessary to continue to develop educational programs in order to get a better reporting system.


Assuntos
Antiasmáticos/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Asma/tratamento farmacológico , Omalizumab/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Idoso , Antiasmáticos/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Terapia Biológica/efeitos adversos , Terapia Biológica/métodos , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Omalizumab/administração & dosagem , Farmacovigilância , Portugal/epidemiologia , Estudos Retrospectivos , Adulto Jovem
8.
Rev Chilena Infectol ; 36(4): 461-468, 2019 Aug.
Artigo em Espanhol | MEDLINE | ID: mdl-31859770

RESUMO

BACKGROUND: Passive surveillance systems for adverse events following immunization (AEFI) allow the monitoring of known adverse effects (AE) and the investigation of infrequent AE. AIM: To describe the AEFI notified in Chile between 2014 and 2016. METHODOLOGY: This was a study of epidemiological surveillance. A general analysis of AEFI and sub-analysis for pentavalent vaccine was carried out. It was calculated the global reporting rate of AEFI every 100,000 doses of vaccines, the reporting rate of AEFI considered of interest and the odds ratio of reporting (ROR) of apneas for pentavalent. RESULTS: The total AEFI reported was 2,552 with a global reporting rate of 9,13. 13.4% of AEFI were serious. The vaccine reporting rate of events of interest was generally lower than the reference rates. The vaccine with the highest reporting rate (44.3) was pentavalent, with an ROR of apnea versus other vaccines of 10.5 (95% CI 3.77-29.47). DISCUSSION: This study provides an overview of the AEFI notified in Chile. The global reporting rate was similar to other studies, but those of events of interest were lower than international references. A possible association between apnea and pentavalent vaccine is shown.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Vacinação/efeitos adversos , Vacinação/estatística & dados numéricos , Adolescente , Adulto , Criança , Pré-Escolar , Chile/epidemiologia , Notificação de Doenças , Feminino , Humanos , Lactente , Recém-Nascido , Pessoa de Meia-Idade , Vigilância da População , Índice de Gravidade de Doença , Vacinas/efeitos adversos , Adulto Jovem
9.
J. pediatr. (Rio J.) ; 95(6): 682-688, Nov.-Dec. 2019. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1056659

RESUMO

ABSTRACT Objective: To assess spontaneous reports of suspected adverse drug reactions in children aged 0-12 years from the Brazilian Health Regulatory Agency between 2008 and 2013. Methods: A cross-sectional study on suspected adverse drug reactions reports related to medicines and health products in children was carried out for a six-year period (2008-2013). Year of report, origin of report by Brazilian state, gender, age, suspected drug, adverse reaction description and seriousness were included in the analysis. The data obtained was compared to the number of pediatric beds in health services and to global data from the VigiBase (World Health Organization). Results: A total of 3330 adverse drug reactions were reported in children in Brazil in the investigated period (54% were in boys). About 28% of suspected adverse drug reactions reports involved 0 to 1-year-old children. Almost 40% of reports came from the Southeast region. Approximately 60% were classified as serious events. There was death in 75 cases. Nearly 30% of deaths involved off-label use; 3875 medicines (465 active substances) were considered suspected drugs. Anti-infective (vancomycin, ceftriaxone, oxacillin, and amphotericin), nervous system (metamizole) and alimentary tract and metabolism medicines were more frequent in reports. Conclusions: The distribution of suspected adverse drug reactions reports by sex and age group corresponded to the profile of children hospitalized in Brazil. Data about seriousness and medicines reported may be useful to encourage regulatory actions and improve the safe use of medicines in children.


RESUMO Objetivo: Analisar relatos espontâneos de suspeitas de Reação Adversa a Medicamento (RAM) em crianças de 0 a 12 anos notificadas pela Agência Nacional de Vigilância Sanitária entre 2008 e 2013. Métodos: Um estudo transversal a partir de notificações de suspeitas de RAM relacionadas a medicamentos e produtos para a saúde em crianças foi realizado por um período de seis anos (2008-2013). O ano da notificação, a origem do relato por estado brasileiro, sexo, idade, o medicamento suspeito, a descrição da reação adversa e a gravidade foram incluídos na análise, bem como o número de leitos nos serviços de saúde e dados global da VigiBase. Resultados: Um total de 3330 reações adversas foram relatadas em crianças no Brasil no período investigado (54% em meninos). Cerca de 28% dos relatos de suspeitas de RAM envolveram crianças de 0 a 1 ano de idade. Quase 40% dos relatos vieram da região Sudeste. Aproximadamente 60% foram classificados como eventos graves. Houve ocorrência de morte em 75 casos. Quase 30% das mortes envolveram o uso off-label dos medicamentos. Um total de 3875 medicamentos (465 substâncias ativas) foram considerados fármacos suspeitos. Medicamentos anti-infecciosos (vancomicina, ceftriaxona, oxacilina e anfotericina), com ação no sistema nervoso (dipirona) e no trato digestivo foram os mais frequentemente notificados. Conclusões: As notificações de suspeitas de RAM por sexo e faixa etária corresponderam ao perfil de crianças hospitalizadas no Brasil. Os dados sobre gravidade e medicamentos relatados podem ser úteis para encorajar ações reguladoras e melhorar o uso seguro de medicamentos em crianças.


Assuntos
Humanos , Masculino , Feminino , Recém-Nascido , Lactente , Pré-Escolar , Criança , Bases de Dados Factuais/estatística & dados numéricos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Brasil/epidemiologia , Preparações Farmacêuticas/administração & dosagem , Preparações Farmacêuticas/classificação , Fatores Sexuais , Estudos Transversais , Fatores Etários , Distribuição por Idade
10.
Am J Health Syst Pharm ; 76(Supplement_4): S107-S113, 2019 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-31724037

RESUMO

PURPOSE: To evaluate the validity and reliability of select recommended triggers, defined as flags found on review of the medical record that prompt further investigation to determine the presence or absence of an adverse drug event (ADE), selected from a list initially constructed based on severity, frequency, and detectability of triggers within a pediatric population. METHODS: This was a single-center, retrospective cohort analysis of pediatric patients admitted to University of North Carolina (UNC) Children's Hospital who received trigger-associated medications between January 2015 and December 2016. Patient-care areas of the emergency department, operating rooms, and post-anesthesia care units were excluded. Trigger-detection encounters were evaluated by two reviewers using pre-established, consensus ADE criteria as determined by a panel of pediatric and medication safety specialists at UNC Medical Center. Events were categorized according to medication-related trigger and analyzed using descriptive statistics. RESULTS: A total of 3,836 positive triggers were included in this study. For the aggregate 12-part trigger tool package, 1,055 positive ADEs were identified, leading to a positive predictive value (PPV) of 27.5%. A 50% increase from baseline serum creatinine, resulting from co-administration of 2 or more nephrotoxic medications accounted for a total of 3,698/3,836 (96.4%). Incomplete documentation was the leading cause for event exclusion, 8/27 (30%). The triggers with the highest PPV included protamine 4/4 (100%), flumazenil 1/1 (100%), and vancomycin-related events 51/67 (76.1%), respectively. Phenytoin level >30 µg/mL or free level >2.5 µg/mL resulted in the lowest PPV, 1/12 (8.3%). CONCLUSION: This study lays the foundation for further studies to develop a robust pediatric trigger tool that may involve developing multi-element triggers, determining sensitivity and specificity of triggers, or mobilizing the trigger tool to an automated system. Trigger tools can be individualized to meet each institutions' needs and unique patient population.


Assuntos
Centros Médicos Acadêmicos/organização & administração , Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Hospitais Pediátricos/organização & administração , Indicadores de Qualidade em Assistência à Saúde , Centros Médicos Acadêmicos/estatística & dados numéricos , Adolescente , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Criança , Pré-Escolar , Registros Eletrônicos de Saúde/organização & administração , Registros Eletrônicos de Saúde/estatística & dados numéricos , Hospitais Pediátricos/estatística & dados numéricos , Humanos , Lactente , Recém-Nascido , North Carolina , Segurança do Paciente , Reprodutibilidade dos Testes , Estudos Retrospectivos
11.
Expert Opin Drug Saf ; 18(12): 1245-1253, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31580740

RESUMO

Objectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved. In this study, the authors reviewed the Eudravigilance publicly accessible database to describe the volume and expectedness of potentially unresolved outcomes for gustatory, olfactory and auditory (GOA) suspected ADRs associated with antibiotics for systemic use.Methods: 'Overall' and 'GOA' suspected ADRs were extracted from Eudravigilance to estimate the distribution of their outcomes among different antibiotic groups. Then, the authors identified the drugs contributing to at least 15% of all suspected GOA ADRs observed for the antibiotic groups, and evaluated the expectedness.Results: The frequency of persistent/permanent outcomes was higher for GOA suspected ADRs, as compared to the overall ones. Unresolved and undetermined outcomes for antibiotic-associated GOA ADRs in Eudravigilance might hide a large number of events with underestimated clinical consequences. Several persistent/permanent antibiotic-associated GOA reactions could be classified as serious and unexpected.Conclusion: Potential long-lasting or irreversible GOA reactions are often reported for all antibiotics drugs. Further studies are warranted to clarify whether this is an actual safety issue or simply it reflects a general difficulty in outcomes assessment for such reactions.


Assuntos
Antibacterianos/efeitos adversos , Audição/efeitos dos fármacos , Olfato/efeitos dos fármacos , Paladar/efeitos dos fármacos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Antibacterianos/administração & dosagem , Bases de Dados Factuais , Humanos , Farmacovigilância
12.
PLoS One ; 14(10): e0224233, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31648228

RESUMO

Intensive care units (ICU) rely on multiple technical resources with extensive use of different medical devices, such as ventilators, vital sign monitors, infusion, and injection pumps. This study explored how ICU nurses approach adverse events related to medical devices in a single tertiary center and identify their level of awareness of the national reporting system for adverse events related to medical devices beside their source for risk information updates. Totally, 297 nurses working in the ICU at King Saud University Medical City completed a survey on medical devices and adverse events reporting and 198 reported experiencing an adverse event related to equipment failure. However, 195 nurses were unaware of an official national reporting system for reporting such events. It is important to develop a framework of safe operation of medical devices based on international standards. This reporting system should include the national patients' safety authorities, and should be anonymous, confidential, and non-punitive.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Equipamentos e Provisões/efeitos adversos , Unidades de Terapia Intensiva/organização & administração , Erros Médicos/prevenção & controle , Recursos Humanos em Hospital/estatística & dados numéricos , Centros de Atenção Terciária/normas , Centros Médicos Acadêmicos , Estudos Transversais , Feminino , Humanos , Masculino , Erros Médicos/estatística & dados numéricos , Segurança do Paciente , Gestão de Riscos , Inquéritos e Questionários
13.
Arch Pediatr ; 26(7): 400-406, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31611146

RESUMO

OBJECTIVE: To identify the discrepancies between the adverse drug reactions (ADRs) identified by medical records technicians and the ADRs identified by the pharmacovigilance team, and to validate the quality of the information collected by the medical records technicians. To propose improvements to the method for detection of serious ADRs by medical records technicians and the pharmacovigilance team to meet the new requirements of Canada's amended Food and Drug Act (Vanessa's Law) and its regulations. METHODS: This was a descriptive and retrospective study. We included all ADRs identified by medical records technicians in the coding of records after hospitalization, including active ADRs present at admission or identified during hospitalization between 1 April 2017 and 31 October 2017, and all ADRs identified and reported by the pharmacy through its pharmacovigilance program during the same period. We identified the discrepancies between the two identification systems and revised all cases from patient records. In addition, we identified improvements in the method for detecting and reporting serious ADRs. RESULTS: This study identified 343 ADRs, 322 of which were coded by the medical records technicians and 21 identified by the pharmacovigilance team for a period of 7 months in a mother-child university hospital center. Only 1.5% of the ADRs were identified by both medical records technicians and the pharmacovigilance team. The code Y43, which corresponds to the largest number of identified ADRs, mainly includes anticancer drugs and immunosuppressant drugs. Three corrective actions were set up: 1) implementation of a form to explain the addition and coding of an ADR to a patient's file, 2) weekly transmission of a working file between the medical records technicians and the pharmacovigilance team so that the files would be reviewed and a declaration made to the regulatory authority, and 3) creation of a standardized pharmacist's note to add to the patient file. CONCLUSION: It is possible to increase the reporting of ADRs, improve the quality of coding, and reduce discrepancies between the ADRs coded by these two teams through a structured intervention.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Registros Médicos/normas , Pediatria/normas , Farmacovigilância , Melhoria de Qualidade , Adolescente , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Canadá , Criança , Pré-Escolar , Codificação Clínica/normas , Codificação Clínica/estatística & dados numéricos , Hospitais Universitários/normas , Hospitais Universitários/estatística & dados numéricos , Humanos , Lactente , Recém-Nascido , Registros Médicos/estatística & dados numéricos , Garantia da Qualidade dos Cuidados de Saúde , Indicadores de Qualidade em Assistência à Saúde/normas , Indicadores de Qualidade em Assistência à Saúde/estatística & dados numéricos , Estudos Retrospectivos
14.
BMC Pharmacol Toxicol ; 20(1): 60, 2019 10 18.
Artigo em Inglês | MEDLINE | ID: mdl-31627740

RESUMO

BACKGROUND: Adverse drug reaction (ADR) reporting practices by health care professionals remain poor. Over-the-counter (OTC) drugs are perceived as safe; however, they can also cause ADRs. The objective of this study was to analyze ADR reporting for OTC drugs in a 10-year period, in order to evaluate frequency of ADRs, population that ADRs most affect and reporters of ADRs of OTC drugs in Croatia. METHODS: Spontaneously reported ADRs of non-analgesic OTC drugs, collected from January 2008 to December 2017 were analyzed. Data was obtained from Agency for Medicinal Products and Medical Devices of Croatia (HALMED). RESULTS: There were 547 ADRs of OTC drugs reported in total and an increase in number of reports through the years was observed. Pharmacists reported 45.4% of all ADRs, and were most frequent reporters (p < 0.001). In 2017 majority of reports, 62 (49.2%), were obtained from consumers. ADRs were most frequently observed in patients aged 70 years and older (15% of ADRs). Five percent of all reports were accidental exposures among children. CONCLUSIONS: Pharmacists most frequently reported ADRs of OTC drugs and consumers' awareness of ADR reporting has risen. Other health care professionals (e.g., nurses and dentists) must be offered proper education in order to improve reporting practice of ADRs. Health care professionals should address concerns about OTC drug safety in elderly and children.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Medicamentos sem Prescrição/efeitos adversos , Adolescente , Adulto , Idoso , Criança , Croácia/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Farmacovigilância , Adulto Jovem
15.
Drug Saf ; 42(12): 1487-1498, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31559542

RESUMO

INTRODUCTION: Adverse event reporting patterns vary between countries, reflecting differences in reporting culture, clinical practice and underlying patient populations. Japan collects about 60,000 domestic adverse event reports yearly and shares serious reports with the World Health Organization (WHO) Programme for International Drug Monitoring in VigiBase, the WHO global database of individual case safety reports. Understanding these reports in the global context can be helpful for regulators worldwide and can aid hypothesis-generation for Japanese-specific vulnerabilities to adverse drug reactions. OBJECTIVE: The objective of this study was to explore differences in the reporting of adverse events between Japan and other countries. METHODS: vigiPoint is a method for data-driven exploration in pharmacovigilance. It outlines data subsets, pinpoints key features and facilitates expert review, using odds ratios subjected to statistical shrinkage to distinguish one data subset from another. Here, we compared 260,000 Japanese reports in E2B format classified as serious and received in VigiBase between 2013 and 2018 with 2.5 million reports from the rest of the world (of which 51% are from the USA). Reporting patterns for which the 99% credibility interval of the shrunk log-odds ratios were above 0.5 or below - 0.5 were flagged as key features. The shrinkage was set to the vigiPoint default corresponding to 1% of the size of the Japanese data subset. As a sensitivity analysis, additional vigiPoint comparisons were performed between Japan and, in turn, Africa, the Americas, the Americas except the USA and Canada, Asia and Europe. RESULTS: There were higher reporting rates in Japan from physicians (83% vs. 39%) and pharmacists (17% vs. 10%). It was also more common to see reports with more than five drugs per report (22% vs. 14%) and with a single adverse event (72% vs. 45%). More than half of the Japanese reports had a vigiGrade completeness score above 0.8 compared with about one in five from the rest of the world. There were more reports than expected for patients aged 70-89 years and fewer reports for adults aged 20-59 years. Adverse events reported more often in Japan included interstitial lung disease, abnormal hepatic function, decreased platelet count, decreased neutrophil count and drug eruption. Adverse events reported less often included death, fatigue, dyspnoea, pain and headache. Drugs reported more often in Japan included prednisolone, methotrexate and peginterferon alfa-2b. Drugs reported less often included rosiglitazone and adalimumab as well as blood substitutes and perfusion solutions. The findings were generally robust to the sensitivity analysis except for the less often reported drugs, many of which were rarely reported in most countries, except in the USA. CONCLUSION: Analysis of Japanese adverse event reporting patterns in a global context has revealed key features that may reflect possible pharmaco-ethnic vulnerabilities in the Japanese, as well as differences in adverse event reporting and clinical practice. This knowledge is essential in the global collaboration of signal detection afforded by the WHO Programme for International Drug Monitoring.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Feminino , Humanos , Japão , Doenças Pulmonares Intersticiais/complicações , Doenças Pulmonares Intersticiais/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Razão de Chances , Segurança do Paciente , Farmacovigilância , Organização Mundial da Saúde , Adulto Jovem
16.
Expert Opin Drug Saf ; 18(11): 1099-1108, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31519110

RESUMO

Objectives: To examine the signals of bullous pemphigoid (BP) with dipeptidyl peptidase-4 inhibitors (DPP-4i) in VigiBase® and the potential role of their pharmacodynamic/pharmacokinetic parameters in the occurrence of BP. Methods: Case/non-case analyses were performed in VigiBase® to examine the signal of BP [reporting odds ratio (ROR)] for gliptins. Secondly, the authors performed linear regression analyses to explore the association between DPP-4i signals for BP and their affinities toward different target enzymes (DPP-2, DPP-4, DPP-8, and DPP-9) and their volume of distribution (Vd). Results: A significant BP signal was found for DPP-4i. The ROR for pooled DPP-4i was 179.48 (95% CI: 166.41-193.58). The highest ROR was found for teneligliptin 975.04 (801.70-1185.87) and lowest for saxagliptin 18.9 (11.5-30.9). Linear regression analyses showed a considerable trend to significance for the linear correlation between the BP signal and gliptin affinity at DPP-4 (slope = 1.316 [-0.4385-3.21], p = 0.067, R2 = 0.40) but not the other enzyme targets, nor for Vd. Conclusion: The findings suggest a clinical relevance of gliptins selectivity for DDP-4 in the development of BP as a result of exposure to these drugs. Future preclinical and clinical studies are needed for a better understanding of this correlation.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Inibidores da Dipeptidil Peptidase IV/efeitos adversos , Penfigoide Bolhoso/induzido quimicamente , Farmacovigilância , Adulto , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais/estatística & dados numéricos , Inibidores da Dipeptidil Peptidase IV/farmacocinética , Inibidores da Dipeptidil Peptidase IV/farmacologia , Feminino , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Penfigoide Bolhoso/epidemiologia , Distribuição Tecidual
17.
J Neurooncol ; 145(1): 1-9, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31452071

RESUMO

INTRODUCTION: Immune checkpoint inhibitors (ICPI), a breakthrough immunotherapy for cancer, can cause serious neurological adverse events (AEs). We aimed to investigate the characteristics of the neurological and related AEs associated with ICPI treatment, using a large pharmacovigilance database from Japan. METHODS: We conducted disproportionality analysis using the Japanese Adverse Drug Event Report (JADER) database containing 566,698 patient cases recorded between April 2004 and March 2019, to detect neurological and related AE signals associated with ICPI treatment by calculating reporting odds ratio (ROR). RESULTS: Among 7604 cases with ICPI usage, we identified 583 cases (7.67%) with a significantly high reporting of neurological and related AEs (lower 95% of the ROR > 1), including myasthenia gravis (MG), inflammatory myositis, non-infectious encephalitis/myelitis, non-infectious meningitis, hypophysitis/hypopituitarism, and peripheral neuropathy including Guillain-Barre syndrome (GBS). Among the ICPI subtypes, when compared to nivolumab as a reference, number of hypophysitis, hypopituitarism, and meningitis reports from the use of ipilimumab and number of encephalitis/myelitis and meningitis reports from the use of anti-programmed cell death-ligand-1 (PD-L1) agents were significantly higher. Additionally, time to AE onset of symptoms post administration was short in meningitis (median 21 days), MG (median 28 days), myositis (median 28 days), and encephalitis/myelitis (median 32.5 days), while it was longer in peripheral neuropathy (median 42 days), hypophysitis (median 94 days), and hypopituitarism (median 112 days). CONCLUSIONS: Our results showed characteristic features of neurological and related AEs associated with each ICPI subtype, reported in a large number of Japanese patients. This would help in prompt identification and treatment of neurological AEs associated with ICPI treatment.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Antineoplásicos Imunológicos/efeitos adversos , Bases de Dados Factuais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Neoplasias/tratamento farmacológico , Doenças do Sistema Nervoso/etiologia , Farmacovigilância , Pontos de Checagem do Ciclo Celular/efeitos dos fármacos , Feminino , Humanos , Imunoterapia/efeitos adversos , Masculino , Neoplasias/patologia , Prognóstico
18.
BMC Public Health ; 19(1): 1166, 2019 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-31455314

RESUMO

BACKGROUND: Vaccine safety surveillance is an essential requirement in vaccination programmes. It supports signal identification, hypothesis generation, and the identification and rectification of gaps in vaccine pharmacovigilance systems. The objectives of this study were to determine the characteristics and trends of adverse events following immunisation (AEFI) and to assess the performance of the Zimbabwe Expanded Immunisation Programme safety surveillance system. METHODS: We carried out a descriptive study of passively collected vaccine-related Individual Case Safety Report (ICSR) data submitted to the World Health Organization global adverse drug reaction database (VigiBase®) from Zimbabwe during the period 1997 to 2017. We extracted AEFI/ICSR data using VigiLyze® for analysis with respect to the demographic distribution, AEFI characteristics, reporting trends over time, ICSR timeliness and case completeness. RESULTS: A total of 272 vaccine-related ICSRs were included in the analyses with a median completeness score of 0.90 interquartile range, IQR (0.63; 0.90). The overall annual reporting rate was 0.58 per 100,000 vaccine doses and the AEFI reporting ratio ranged between 0 and 30.2 AEFI reports per 100,000 surviving infants. The majority of ICSRs were male (55.3%; p value = 0.641) and the median age was 12 (0-168) months. The majority of ICSRs were reported in children who had received measles (n = 133; 48.9%) and OPV/DTP-Hib-HepB (n = 107; 39.3%) vaccines. Of the 387 observed AEFIs, 301 (77.8%) were systemic events and 86 (22.2%) were local reactions. Systemic events were more frequently reported with doses containing the measles antigen (n = 190; 49.1%) while local events were associated with the multiple antigen OPV/DTP-Hib-HepB (n = 62; 16.0%). The multiple antigen OPV/DTP-Hib-HepB was associated with higher rates for injection site abscess (n = 57), pyrexia (n = 27), diarrhea (n = 15), vomiting (n = 12), and seizures (n = 6). The measles antigen was associated with higher rates for rash (n = 44), ocular disorders (n = 26), pyrexia (n = 26), urticaria (n = 22), diarrhea (n = 8), and vomiting (n = 12). CONCLUSIONS: Most of the ICSRs were associated with measles and OPV/DTP-Hib-HepB vaccines. Zimbabwe's vaccine safety surveillance system is still developing and is not yet fully functional. However, the current system provides a reference point for the monitoring of the ongoing AEFI reporting trends and characteristics.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Imunização/efeitos adversos , Vigilância da População , Vacinas/efeitos adversos , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Programas de Imunização/organização & administração , Lactente , Recém-Nascido , Masculino , Farmacovigilância , Zimbábue/epidemiologia
19.
J Clin Pharm Ther ; 44(6): 952-957, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31407823

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Cluster adverse drug events (CADEs) are multiple ADEs with similar clinical manifestations involving the same drug, manufactured by the same company, that occur within a short time period. The disproportionality filter algorithm (DFA) is a promising tool for the identification of historical clusters related to ADEs. The Chinese spontaneous adverse drug reaction reporting system (SRS) may serve as an important database for the detection of CADEs. The objective of this study was to evaluate the usefulness of DFA as an approach to identify CADEs using SRS. METHODS: Suspected adverse drug reaction (ADR) reports collected by the Chinese SRS in 2014-2015 were examined to identify potential CADEs. The reports were divided into 48 15-day subsets. Disproportionate excess reporting of ADEs for drugs from specific companies may be a signal for CADEs. The clusters were categorized as 'confirmed', 'potential', 'unlikely', 'indecisive' or 'information-loss' ADEs when evaluated by report units. Furthermore, early warning information in 2014-2015 from the Chinese early warning system (EWS) classified as 'concern', 'monitoring', 'ignorance' or 'rest' was compared with DFA to explore the applicability of the novel algorithm in Chinese SRS. RESULTS AND DISCUSSION: In total, 2294 CADEs, comprising of 380 confirmed, 1753 potential, 15 unlikely and 59 indecisive clusters, were generated; 87 clusters were missing additional information. There were 263 'significant' clusters with DFA, but only 26 'significant' clusters in EWS. The sensitivity of DFA was 88.5%, but the specificity and positive predictive value were low. WHAT IS NEW AND CONCLUSION: Spontaneous adverse drug reaction reporting system in China may be a potential database for the identification of CADEs engaging the DFA. This could supplement the EWS of CADEs in China. The DFA may be of value in detecting CADEs with high sensitivity, although expert screening is required given the low specificity and positive predictive value.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Algoritmos , China , Bases de Dados Factuais , Humanos , Sensibilidade e Especificidade
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