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1.
Artigo em Inglês | MEDLINE | ID: mdl-32178607

RESUMO

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2018 reported to the Therapeutic Goods Administration and describes reporting trends over the 19-year period 1 January 2000 to 31 December 2018. There were 4221 AEFI records for vaccines administered in 2018, an annual AEFI reporting rate of 16.9 per 100,000 population. There was a 2.9% increase in the overall AEFI reporting rate in 2018 compared to 2017. This slight increase in reported adverse events in 2018 was likely due to new additions to the National Immunisation Program schedule, namely meningococcal ACWY vaccination for children aged 12 months, enhanced immunogenicity trivalent influenza vaccines for adults aged ≥65 years, and state- and territory-funded seasonal influenza vaccination programs for children aged 6 months to <5 years. AEFI reporting rates for most individual vaccines in 2018 were similar to 2017. The most commonly reported adverse events were injection site reaction (34%), pyrexia (15%), rash (15%), vomiting (8%), headache (6%) and pain (6%). Two deaths were reported to the TGA but no clear causal relationship with vaccination was found.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Programas de Imunização , Vacinação/efeitos adversos , Adolescente , Adulto , Idoso , Austrália/epidemiologia , Criança , Pré-Escolar , Exantema/induzido quimicamente , Febre/induzido quimicamente , Humanos , Esquemas de Imunização , Lactente , Vacinas contra Influenza , Reação no Local da Injeção , Masculino , Adulto Jovem
3.
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
4.
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
5.
J Oncol Pharm Pract ; 26(1): 133-140, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31117914

RESUMO

PURPOSE: The aim of this study was to test the feasibility and the usefulness of an intensive safety monitoring program to identify adverse drug reactions for medicines under additional monitoring that are used to treat cancer patients within a Portuguese oncology hospital. METHODS: This pilot intensive safety monitoring program was a three-month prospective, observational study. Patients undergoing treatment with one of the following medicines were included: nivolumab, olaparib, palbociclib, pembrolizumab, pertuzumab, ramucirumab, ribociclib, trastuzumab emtansine, or trifluridine/tipiracil. Potential eligible patients were identified by pharmacists based on prescription data. Clinicians used proper paper-based reporting forms to record adverse drug reactions. Clinical secretariats sent those reports through an electronic platform to the pharmacovigilance department for analysis. RESULTS: Seventy-five patients were on treatment with selected medicines. Of those, 33 (44%) experienced adverse drug reactions: 23 (69.7%) cases were serious and 5 (15.2%) unexpected. Considering the number of patients exposed to each medicine and the number of patients experiencing adverse drug reactions, trifluridine/tipiracil (72.7%; 8/11) was associated with the highest rate of toxicity, followed by olaparib (66.7%; 2/3), trastuzumab emtansine (50.0%; 3/6), pertuzumab (47.8%; 11/23), pembrolizumab (45.5%; 5/11), palbociclib (25.0%; 1/4), and nivolumab (18.8%; 3/16). A total of 59 adverse drug reactions were identified (i.e. 1.8 adverse drug reactions/patient), mainly gastrointestinal disorders (n = 15; 25.4%), and blood and lymphatic system disorders (n = 14; 23.7%). CONCLUSION: This intensive safety monitoring program was feasible and allowed identifying serious and unexpected adverse drug reactions, adding value to pharmacovigilance and therefore contributing to improve patient safety. Further research is needed to confirm the findings of this pilot study.


Assuntos
Antineoplásicos/efeitos adversos , Institutos de Câncer/normas , Monitoramento de Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Segurança do Paciente/normas , Farmacovigilância , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Monitoramento de Medicamentos/métodos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologia , Projetos Piloto , Portugal/epidemiologia , Estudos Prospectivos
7.
Int J Med Inform ; 133: 103970, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31704490

RESUMO

BACKGROUND: The drug information most commonly requested by patients is to learn more about potential adverse drug reactions (ADRs) of their drugs. Such information should be customizable to individual information needs. While approaches to automatically aggregate ADRs by text-mining processes and establishment of respective databases are well known, further efforts to map additional ADR information are sparse, yet crucial for customization. In a proof-of-principle (PoP) study, we developed a database format demonstrating that natural language processing can further structure ADR information in a way that facilitates customization. METHODS: We developed the database in a 3-step process: (1) initial ADR extraction, (2) mapping of additional ADR information, and (3) review process. ADRs of 10 frequently prescribed active ingredients were initially extracted from their Summary of Product Characteristics (SmPC) by text-mining processes and mapped to Medical Dictionary for Regulatory Activities (MedDRA) terms. To further structure ADR information, we mapped 7 additional ADR characteristics (i.e. frequency, organ class, seriousness, lay perceptibility, onset, duration, and management strategies) to individual ADRs. In a PoP study, the process steps were assessed and tested. Initial ADR extraction was assessed by measuring precision, recall, and F1-scores (i.e. harmonic mean of precision and recall). Mapping of additional ADR information was assessed considering pre-defined parameters (i.e. correctness, errors, and misses) regarding the mapped ADR characteristics. RESULTS: Overall the SmPCs listed 393 ADRs with an average of 39.3 ±â€¯18.1 ADRs per SmPC. For initial ADR extraction precision was 97.9% and recall was 93.2% leading to an F1-score of 95.5%. Regarding mapping of additional ADR information, the frequency information of 28.6 ±â€¯18.4 ADRs for each SmPC was correctly mapped (72.8%). Overall 77 ADRs (20.6%) of the correctly extracted ADRs did not have a concise frequency stated in the SmPC and were consequently mapped with 'frequency not known'. Mapping of remaining ADR characteristics did not result in noteworthy errors or misses. CONCLUSION: ADR information can be automatically extracted and mapped to corresponding MedDRA terms. Additionally, ADR information can be further structured considering additional ADR characteristics to facilitate customization to individual patient needs.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Coleta de Dados , Mineração de Dados , Bases de Dados Factuais , Processamento de Linguagem Natural
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.
N Z Med J ; 132(1488): 28-37, 2019 01 18.
Artigo em Inglês | MEDLINE | ID: mdl-31851659

RESUMO

AIM: Incomplete and incorrect documentation of adverse drug reactions (ADRs) can restrict prescribing choices resulting in suboptimal pharmaceutical care. This study aimed to examine the quality of information held within electronic systems in a hospital setting, to determine the preciseness of ADR documentation, and identify discrepancies where multiple electronic systems are utilised. METHOD: Over a four-week period, consecutive patients admitted to the general medical ward at the study hospital had their electronic profiles reviewed. Patient demographic information (de-identified), ADR history and discrepancies between information sources (as recorded in all electronic systems utilised at initial prescribing) were recorded and analysed. RESULTS: Over the four-week period, 332 patient profiles were reviewed, and over 1,200 alerts were identified and analysed (including duplicates of ADR reactions). Of these patients, 151 (45.5%) had at least one documented allergy or intolerance which generated 585 reactions, relating to 526 unique events. A further 151 (45.5%) were classified as having no known (drug) allergies or intolerances; however, 20 (15%) of these patients did have at least one allergy documented in at least one other electronic system. The remaining 30 (9%) patients were classified as having an unknown allergy status and of those nine had allergies documented in at least one other electronic system. Further, most systems contained information duplication, which had not been addressed during the admission process. CONCLUSION: ADR information was both imprecise and inaccurate, as multiple discrepancies between ADR information recorded in different electronic patient management systems were found to exist. Information sharing between systems needs to be prioritised in order to allow full, accurate and complete ADR information to be collected, stored and utilised; both to reduce current inadequacies and to allow optimal pharmaceutical care.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Documentação/normas , Troca de Informação em Saúde/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Centros de Atenção Terciária , Adulto Jovem
11.
Pediatrics ; 144(6)2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31740498

RESUMO

BACKGROUND AND OBJECTIVES: Human papillomavirus is the most common sexually transmitted infection in the United States and causes certain anogenital and oropharyngeal cancers. The 9-valent human papillomavirus vaccine (9vHPV) provides protection against additional types not included in the quadrivalent vaccine. We conducted near real-time vaccine safety surveillance for 24 months after the vaccine became available in the Vaccine Safety Datalink. METHODS: Immunizations and adverse events were extracted weekly from October 2015 to October 2017 from standardized data files for persons 9 to 26 years old at 6 Vaccine Safety Datalink sites. Prespecified adverse events included anaphylaxis, allergic reaction, appendicitis, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, injection site reaction, pancreatitis, seizure, stroke, syncope, and venous thromboembolism. The observed and expected numbers of events after 9vHPV were compared weekly by using sequential methods. Both historical and concurrent comparison groups were used to identify statistical signals for adverse events. Unexpected signals were investigated by medical record review and/or additional analyses. RESULTS: During 105 weeks of surveillance, 838 991 doses of 9vHPV were administered. We identified unexpected statistical signals for 4 adverse events: appendicitis among boys 9 to 17 years old after dose 3; pancreatitis among men 18 to 26 years old; and allergic reactions among girls 9 to 17 years old and women 18 to 26 years old after dose 2. On further evaluation, which included medical record review, temporal scan analysis, and additional epidemiological analyses, we did not confirm signals for any adverse events. CONCLUSIONS: After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Monitoramento Epidemiológico , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Vacinas contra Papillomavirus/efeitos adversos , Adolescente , Adulto , Apendicite/induzido quimicamente , Apendicite/epidemiologia , Criança , Hipersensibilidade a Drogas/epidemiologia , Feminino , Humanos , Masculino , Pancreatite/induzido quimicamente , Pancreatite/epidemiologia , Estados Unidos/epidemiologia , Adulto Jovem
12.
Pediatrics ; 144(6)2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31740500

RESUMO

BACKGROUND: The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched VAERS data for US reports of adverse events (AEs) after 9vHPV from December 2014 through December 2017. We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reporting. Physicians reviewed reports for selected prespecified conditions. RESULTS: VAERS received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. Dizziness, syncope, headache, and injection site reactions were most commonly reported; the most commonly reported AEs were similar between females and males. Two reports of death after 9vHPV were verified; no information in autopsy reports or death certificates suggested a causal relationship with vaccination. Approximately 28 million 9vHPV doses were distributed during the study period; crude AE reporting rates were 259 reports per million 9vHPV doses distributed for all reports and 7 per million doses distributed for serious reports. Syncope (a known AE associated with human papillomavirus vaccination) and several types of vaccine administration errors (eg, administered at wrong age) exceeded the statistical threshold for empirical Bayesian data mining findings. CONCLUSIONS: No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Vacinas contra Papillomavirus/efeitos adversos , Adolescente , Adulto , Criança , Bases de Dados Factuais/tendências , Tontura/induzido quimicamente , Tontura/epidemiologia , Feminino , Cefaleia/induzido quimicamente , Cefaleia/epidemiologia , Humanos , Masculino , Estados Unidos/epidemiologia , Adulto Jovem
14.
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
15.
Int J Med Inform ; 132: 103971, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31630063

RESUMO

CONTEXT: Adverse events in healthcare are often collated in incident reports which contain unstructured free text. Learning from these events may improve patient safety. Natural language processing (NLP) uses computational techniques to interrogate free text, reducing the human workload associated with its analysis. There is growing interest in applying NLP to patient safety, but the evidence in the field has not been summarised and evaluated to date. OBJECTIVE: To perform a systematic literature review and narrative synthesis to describe and evaluate NLP methods for classification of incident reports and adverse events in healthcare. METHODS: Data sources included Medline, Embase, The Cochrane Library, CINAHL, MIDIRS, ISI Web of Science, SciELO, Google Scholar, PROSPERO, hand searching of key articles, and OpenGrey. Data items were manually abstracted to a standardised extraction form. RESULTS: From 428 articles screened for eligibility, 35 met the inclusion criteria of using NLP to perform a classification task on incident reports, or with the aim of detecting adverse events. The majority of studies used free text from incident reporting systems or electronic health records. Models were typically designed to classify by type of incident, type of medication error, or harm severity. A broad range of NLP techniques are demonstrated to perform these classification tasks with favourable performance outcomes. There are methodological challenges in how these results can be interpreted in a broader context. CONCLUSION: NLP can generate meaningful information from unstructured data in the specific domain of the classification of incident reports and adverse events. Understanding what or why incidents are occurring is important in adverse event analysis. If NLP enables these insights to be drawn from larger datasets it may improve the learning from adverse events in healthcare.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Registros Eletrônicos de Saúde/tendências , Processamento de Linguagem Natural , Gestão de Riscos/classificação , Gestão de Riscos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Registros Eletrônicos de Saúde/normas , Humanos
16.
Zhongguo Zhong Yao Za Zhi ; 44(14): 2896-2901, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31602831

RESUMO

In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.


Assuntos
Medicina Tradicional Chinesa , Medicamentos sem Prescrição , Vigilância de Produtos Comercializados , Sistemas de Notificação de Reações Adversas a Medicamentos , China , Hospitais
17.
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
18.
Rev Inst Med Trop Sao Paulo ; 61: e43, 2019 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-31531621

RESUMO

In March 2014, the Quadrivalent human papilloma virus vaccine (4vHPV) was introduced in the female adolescents vaccination schedule of the National Immunization Program (PNI). A school-based vaccination program was implemented. We conducted a retrospective, descriptive study of the adverse events that took place after HPV vaccination, reported to the Adverse Events Following Immunization (AEFI) Information System in Sao Paulo State, from March 2014 to December 2016. All reports that fit the definitions of the 2014 National Manual on AEFI surveillance were included. AEFI risk was estimated by dividing the number of reports by the number of vaccine doses administered in the period. In the three-year period, 3,390,376 HPV vaccine doses were administered and 465 AEFI reports were registered, with 1,378 signs and symptoms. The reporting rate was 13.72 per 100,000 vaccine doses administered. The reports peaked in the first year of the program. The most frequent AEFI was syncope, with 5.7 reports per 100,000 doses administered, followed by dizziness, malaise, headache and nausea. Overall, 39 AEFI cases (8.4%) were classified as severe , with a reporting rate of 1.15 per 100,000 vaccine doses administered. Most cases were classified as severe because of hospitalization. Among them, there were cases of Guillain-Barré Syndrome, deep vein thrombosis, seizures and miscarriage. All young women recovered without sequelae. We identified five clusters of AEFI reports in four cities; the larger AEFI cluster occurred in the city of Bertioga, in September 2014, involving 13 female adolescents. Our data are in accordance with those from other countries and corroborate the safety of HPV vaccines.


Assuntos
Vacina Quadrivalente Recombinante contra HPV tipos 6, 11, 16, 18/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Brasil/epidemiologia , Criança , Feminino , Vacina Quadrivalente Recombinante contra HPV tipos 6, 11, 16, 18/administração & dosagem , Humanos , Esquemas de Imunização , Infecções por Papillomavirus/prevenção & controle , Vigilância da População , Estudos Retrospectivos , Adulto Jovem
19.
Drug Discov Ther ; 13(4): 183-188, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31534069

RESUMO

Patient narratives of adverse drug events (ADEs) often differ from the symptoms listed on the package inserts of pharmaceutical products using common ADE terminology and could be a source of great comfort to patients with the same disease. To explore this idea, we analyzed written narratives obtained from 48 patients with breast cancer using the NPO Corporation Database of Individual Patients' Experiences, Japan (DIPEx-Japan). Our analysis aimed to determine the utility of an "Adverse Drug Event Database" for use in clinical settings as a novel source of disease information in patients' own words. An analysis of transcripts from 29 patients, in which they recounted their treatment drugs and the time of onset and duration of ADEs in great detail, revealed several discrepancies between the language they used to describe various side effects and the standard ADE terminology on package inserts. We conclude that the language used to describe ADEs on package inserts is insufficient for helping patients as they struggle to recognize, internalize, and overcome ADEs, and argue the need for available, detailed information in the words of real patients about the nature of the ADEs predicted, as well as their clinical course and duration. Such information would be invaluable in supplementing the standardized language used on package inserts. Databases of patients' narrative accounts of ADEs are needed as information sources that can be reliably disseminated among patients.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Neoplasias da Mama/tratamento farmacológico , Bases de Dados Factuais , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Feminino , Humanos , Japão , Medicina Narrativa , Autorrelato , Terminologia como Assunto
20.
Expert Opin Drug Saf ; 18(12): 1237-1243, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31538503

RESUMO

Objectives: No studies describing UK patient Yellow Card reports have been published since the evaluation of the first two years of direct patient reporting (2005-7), when 5,180 reports were analyzed.Methods: Patient Yellow Card reports submitted July-December 2015 for vaccines and other drugs were analyzed. Comparisons to the initial evaluation were made of: reporting method, number of suspect drugs, proportion classed as serious. Factors affecting seriousness of reports were examined.Results: There were 3,060 patient Yellow Card reports analyzed. Vaccine reports have increased from very few in 2005-7 to 25% of reports. The proportion of reports citing one drug (94.3%) and the proportion considered serious (70.3%) increased from the 84% and 58% respectively found in 2005-7. The main method of reporting had changed from paper (61%) to internet (88.5%). Serious reports were more common in females, for vaccines in young persons, but in adults for other drugs, and included more reaction terms than non-serious reports.Conclusion: Patient reporting, in particular to vaccines, has increased dramatically since 2005-7. Increases in the proportion of reports concerning one drug and the proportion considered serious could indicate that the usability of patient reports may have improved in comparison to early reporting.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Vacinas/efeitos adversos , Adolescente , Adulto , Fatores Etários , Idoso , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Reino Unido , Adulto Jovem
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