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Rev. méd. Minas Gerais ; 31: 31118, 2022.
Article in Portuguese | LILACS | ID: biblio-1372676


Objetivo: Identificar as causas de não conformidades em Produtos para Saúde distribuídos por um centro de esterilização localizado na região metropolitana de Belo Horizonte, MG, Brasil. Métodos: Estudo descritivo, de natureza quantitativa que foi realizado entre janeiro e dezembro de 2019. Os dados foram coletados através de um instrumento estruturado para avaliação sistemática dos itens e analisados estatisticamente de forma descritiva. Resultados: Foram avaliados 2.944 produtos para saúde, que variou de 66 a 284/mês, com média de 245 (±56). Foram identificados 24 itens inadequados o que gerou uma taxa de não conformidade de 0,96%. As principais causas foram atribuídas à embalagem manchada (20,8%), aos produtos para saúde sem identificação (20,8%), problemas na selagem (16,6%) e embalagem violada (12,5%). Conclusão: As principais causas de não conformidades encontradas sugerem a realização de um controle criterioso de qualidade em cada etapa do reprocessamento de materiais para não comprometer a segurança do paciente.

Objective: To identify the causes of non-conformities in Health Products distributed by a sterilization center located in the metropolitan region of Belo Horizonte, MG, Brazil. Methods: This was a study described, of a quantitative nature that was carried out between January and December 2019. The data were collected through a structured instrument for systematic evaluation of the items and analyzed using the technique of descriptive statistics. Results: A total of 2,944 health products were evaluated during the study period, which ranged from 66 to 284/month, with an average of 245 (± 56). There were 24 inappropriate items that generated a noncompliance rate of 0.96%. The main causes were attributed to stained packaging (20.8%), health products without identification (20.8%), sealing problems (16.6%) and violated packaging (12.5%). Conclusion: The main causes of nonconformities found in this study suggest the performance of a careful quality control at each stage of the reprocessing cycle so as not to compromise patient safety.

Product Surveillance, Postmarketing , Quality Control , Surgical Instruments , Sterilization , Nursing
China Journal of Chinese Materia Medica ; (24): 1999-2003, 2021.
Article in Chinese | WPRIM | ID: wpr-879121


Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.

Drugs, Chinese Herbal , Marketing , Medicine, Chinese Traditional , Nonprescription Drugs , Product Surveillance, Postmarketing , Randomized Controlled Trials as Topic
Chinese Journal of Medical Instrumentation ; (6): 166-171, 2020.
Article in Chinese | WPRIM | ID: wpr-942721


To explore the law and characteristics of adverse events of medical devices and to provide research methods and basis for reducing the recurrence of similar adverse events, we collect medical devices safety information from five representative countries in the world, and make statistics and analysis on the types of events, the types of management and the causes of events. The results show that among 136 serious adverse events, the top three causes of recall are product design factors, software factors, and component defects. In order to reduce the application risk of medical devices, it is suggested that product designers, operating users and medical institutions should correctly implement the monitoring and evaluation system of medical devices.

Equipment Safety , Equipment and Supplies/adverse effects , Product Surveillance, Postmarketing , Software
Chinese Journal of Medical Instrumentation ; (6): 545-548, 2020.
Article in Chinese | WPRIM | ID: wpr-880408


OBJECTIVE@#By introducing the Medical Device Reporting (MDR) system and related inspection practice of the US, this paper puts forward some suggestions on implementing reporting responsibility of manufactures in China.@*METHODS@#The MDR system and the related inspection system in the US were systematically analyzed.@*RESULTS@#The US had established a sound system for discovering and reporting MDR, and a mechanism for inspecting the implementing of manufactures, forming an effective post-market surveillance system.@*CONCLUSIONS@#By learning from the experience of the US, we can carry out the post-market surveillance of medical devices adverse events in China from the aspects of implementing the existing system, strengthening the reporting ability and perfecting the inspection mechanism.

China , Equipment and Supplies/standards , Product Surveillance, Postmarketing
Braz. J. Pharm. Sci. (Online) ; 56: e17184, 2020. tab
Article in English | LILACS | ID: biblio-1132039


To evaluate the clinical outcomes of daptomycin therapy and adherence to treatment recommendations, a retrospective cohort study was conducted with patients that received daptomycin during the period of the study. The adherence and nonadherence to clinical guidelines were assessed through organism identification, dose and time of treatment, management of bacteremia, and vancomycin treatment failure. A multiple logistic regression model analyzed the association between independent variables and clinical success (dependent variable), considering 5% of statistical significance. The study presented 52 patients who received daptomycin for the treatment of bacteremia (21.1%) or infections (osteomyelitis [63.5%], synovial fluid [15.4%]). Most patients (86.5%) received daptomycin as the second line of treatment, and 51.9% achieved clinical success. The patients had a better chance of clinical success when they followed the guideline indications (OR = 16.86; 95% CI = 1.45-195.88) and the medication was prescribed by a specialist in infectious diseases (OR = 4.84; 95% CI = 1.11-21.09). The study demonstrated lower clinical success than that described in the literature because of patients who were not eligible according to the clinical guidelines. Adherence to recommendations and appropriate prescription of reserve antibiotics is important in limiting early resistance, and avoiding clinical failure and unnecessary expenditure.

Cohort Studies , Treatment Failure , Daptomycin/analysis , Anti-Bacterial Agents/adverse effects , Patients/classification , Product Surveillance, Postmarketing , World Health Organization , Communicable Diseases/complications , Gram-Positive Bacterial Infections/classification , Dosage/adverse effects
Cad. Ibero Am. Direito Sanit. (Impr.) ; 8(2): 31-43, abr.-jun.2019. ilus
Article in Portuguese | LILACS | ID: biblio-1016276


Objective: to analyze the contribution of patients in drug surveillance, considering some stages of development of these technologies and the interest of public health. Methodology: a bibliographic and documentary analysis was performed on patients' contributions and mechanisms of social participation. Results: we identified consolidated initiatives and results that support the importance of patients in drug surveillance in various segments. However, participation is limited due to the low scientific literacy and ineffectiveness of some social participation mechanisms. Conclusion: patient representative organizations can contribute more effectively to social participation initiatives in drug surveillance, as reported in international experiences. In addition, it is essential that regulatory agencies seek to improve participation mechanisms and the use of methods to collect social contributions, as well as to systematize patients' experiences. (AU).

Objetivo: analizar la contribución de los pacientes a la vigilancia de medicamentos, considerando algunas etapas del desarrollo de estas tecnologías y el interés de la salud pública. Metodología: se realizó un análisis bibliográfico y documental sobre las contribuciones de los pacientes y los mecanismos de participación social. Resultados: identificamos iniciativas y resultados consolidados que respaldan la importancia de los pacientes en la vigilancia de medicamentos en diversos segmentos. Sin embargo, la participación es limitada debido a la baja alfabetización científica y la ineficacia de algunos mecanismos de participación social. Conclusion: Las organizaciones representativas de pacientes pueden contribuir más eficazmente a las iniciativas de participación social en la vigilancia de drogas, como se informa en experiencias internacionales. Además, es esencial que las agencias reguladoras busquen mejorar los mecanismos de participación y el uso de métodos para recaudar contribuciones sociales, así como para sistematizar las experiencias de los pacientes. (AU).

Objetivo: analisar a contribuição dos pacientes na vigilância de medicamentos, considerando algumas etapas de desenvolvimento dessas tecnologias e o interesse da saúde pública. Metodologia: foi realizada análise bibliográfica e documental sobre as contribuições dos pacientes e os mecanismos de participação social. Resultados: identificou-se iniciativas consolidadas e resultados que sustentam a importância do paciente na vigilância de medicamentos em diversos segmentos. Todavia, a participação é limitada devido ao baixo letramento científico e à inefetividade de alguns mecanismos de participação social. Conclusões: organizações representativas de pacientes podem contribuir mais efetivamente em iniciativas de participação social na vigilância de medicamentos, conforme relatado em experiências internacionais. Também, é fundamental que as agências reguladoras busquem aprimorar os mecanismos de participação e a utilização de métodos que possibilitem coletar as contribuições sociais, bem como a sistematização das experiências dos pacientes. (AU).

Patient Participation , Product Surveillance, Postmarketing , Drug Monitoring , Pharmacovigilance
China Journal of Chinese Materia Medica ; (24): 2896-2901, 2019.
Article in Chinese | WPRIM | ID: wpr-773212


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.

Adverse Drug Reaction Reporting Systems , China , Hospitals , Medicine, Chinese Traditional , Nonprescription Drugs , Product Surveillance, Postmarketing
Braz. J. Pharm. Sci. (Online) ; 55: e18148, 2019. tab, graf, ilus
Article in English | LILACS | ID: biblio-1039038


According to Anvisa risk rating, hypodermic needles offer medium risk to the user's health. This study discussed the importance of the corrosion resistance test in tubes of hypodermic needles, in the product quality control. A review of cannulas of hypodermic needles was carried out according to ISO 9626:2003 and 9259:1997 ABNT NBR. For the results evaluation, a scale which classifies the extent of corrosion was adjusted. 174 samples of PNI needles from 17 States and 9 different record holders were analyzed. According to the methodology of ISO 9626:2003, 100% of the samples were considered satisfactory. However, in accordance with the methodology of ISO 9259:1997, 97.1% of the samples were rejected. Irregularities can lead to impairment of product quality, resulting in risks to the consumer's health. Since 2011 the product has undergone certification, so it is necessary to reflect on the importance of corrosion resistance testing and mandatory certification for health monitoring.

Quality Control , Corrosion , Needles/standards , Product Surveillance, Postmarketing , Brazil/ethnology , Chromium/analysis , Cannula , Legislation as Topic/standards
China Journal of Chinese Materia Medica ; (24): 820-832, 2018.
Article in Chinese | WPRIM | ID: wpr-771662


To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication.

Humans , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal , Product Surveillance, Postmarketing , Randomized Controlled Trials as Topic , Wolfiporia , Chemistry
Chinese Journal of Medical Instrumentation ; (6): 129-132, 2018.
Article in Chinese | WPRIM | ID: wpr-774491


This article analyzes common problems and offers some suggestions on full life-cycle supervision and administration process of diagnostics, including premarket technical evaluations, pre-market QMS on-site inspections, postmarket adverse event surveillance, unannounced inspections and re-evaluation, from regulators' perspectives. It aims to provide technical reference for revisions on regulations, and help government administrators to figure out major points in daily regulatory practice.

Diagnosis , Equipment and Supplies , Product Surveillance, Postmarketing
Chinese Journal of Medical Instrumentation ; (6): 58-61, 2018.
Article in Chinese | WPRIM | ID: wpr-775554


OBJECTIVES@#To solve the problem that medical device adverse event monitoring entities perform their duties inadequately, to provide reference for perfecting the post-market surveillance system.@*METHODS@#Through theoretical and empirical research, the paper explored the ways to improve the performance of monitoring the adverse events of medical devices.@*RESULTS@#The survey found that the number of adverse event monitoring reports was few and the quality of report was poor. The root causes included lack of motivation of monitoring entities, the imperfect monitoring system, and the monitoring capability failure, etc.@*CONCLUSIONS@#The methods such as strengthening the main body responsibility consciousness, establishing evaluation system and accountability system, building social work network, are beneficial to the adverse events monitoring.

Equipment Safety , Equipment and Supplies , Product Surveillance, Postmarketing , Surveys and Questionnaires
China Journal of Chinese Materia Medica ; (24): 4198-4202, 2018.
Article in Chinese | WPRIM | ID: wpr-775359


With the rapid development of traditional Chinese medicine (TCM) in China as well as the implementation of the four most strict requirements, the quality of Chinese medicinal materials and decoction pieces had beem improved in recent years, however new problems and challenges were occurred. All the data of Chinese medicinal materials and decoction piece in special inspection,supervision test and evaluation inspection of drug administration department to were summarized and analyzed evaluate and analyze of the quality of Chinese medicinal materials and decoction pieces in 2017. On this basis, the relevant quality control strategies and suggestions were put forward for the relevant departments of China Food and Drug Administration to formulate and implement regulatory measures, furthermore to improve drug standards, and ensure the safety of medication.

China , Drugs, Chinese Herbal , Reference Standards , Medicine, Chinese Traditional , Product Surveillance, Postmarketing , Quality Control
Asian Journal of Andrology ; (6): 587-592, 2018.
Article in English | WPRIM | ID: wpr-1009631


Once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction (n = 635). The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event (serious or nonserious). The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg (least squares [LS] mean change: 6.3; 95% confidence interval [CI]: 5.4-7.1; P < 0.001) and 5.0-mg (LS mean change: 7.4; 95% CI: 6.8-7.9; P < 0.001) tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function (IIEF-EF ≥26) following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.

Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Asian People , Double-Blind Method , Erectile Dysfunction/drug therapy , Patient Safety , Phosphodiesterase 5 Inhibitors/therapeutic use , Product Surveillance, Postmarketing , Prospective Studies , Tadalafil/therapeutic use , Treatment Outcome
Rev. panam. salud pública ; 42: e82, 2018. tab
Article in Spanish | LILACS | ID: biblio-961828


RESUMEN La giardiasis es una enfermedad causada por Giardia duodenalis, protozoario enteropatógeno que también es responsable de la enfermedad diarreica aguda y la gastroenteritis en humanos. Dadas las características de excreción intermitente propias de este parásito, la probabilidad de obtener resultados falsos negativos durante el proceso de diagnóstico es alta. En el Grupo de Parasitología del Instituto Nacional de Salud de Colombia se identificaron proteínas inmunogénicas presentes en quistes y trofozoítos del parásito en aislamientos colombianos de Giardia con potencial comercial y posibilidad de ser patentadas. Se realizó un estudio exploratorio descriptivo a partir de las características de la técnica en estudio, su estado de desarrollo y la viabilidad comercial de la invención. Se encontraron 390 patentes y se seleccionaron cinco invenciones similares que no representaban ningún riesgo frente a una eventual solicitud de patente. De los 36 estuches para el diagnóstico de Giardia disponibles en el mercado y las 21 licencias sanitarias otorgadas hasta diciembre del 2017, sólo cuatro y tres, respectivamente, proponen técnicas similares a la de la estudiada, pero ninguna de ellas cuenta con un registro de patente relacionado. La técnica en desarrollo es innovadora y puede aplicarse en el campo de la salud pública en la Región de las Américas con beneficios previsibles.

ABSTRACT Giardiasis is a disease caused by Giardia duodenalis, an intestinal protozoan that causes acute diarrhea and gastroenteritis in humans. Given the characteristic intermittent excretion of this parasite, there is a high probability of false negative results during diagnosis. The Parasitology Group of Colombia's National Institute of Health identified immunizing proteins present in the parasite's cysts and trophozoites in Colombian Giardia isolates with commercial and patentability potential. A descriptive exploratory study was conducted that focused on characteristics of the technique under study, its state of development, and the commercial viability of the invention. A total of 390 patents were found and five similar inventions were selected that did not pose any risk regarding an eventual patent application. Of the 36 Giardia diagnostic kits available on the market and the 21 health licenses granted as of December 2017, only four and three, respectively, offer techniques similar to the technique studied, but none of them has a related patent on record. The technique under development is innovative and can be applied in the field of public health in the Region of the Americas with foreseeable benefits.

RESUMO A giardíase é uma doença causada pela Giardia duodenais, protozoário enteropatogênico causador de doença diarreica aguda e gastroenterite em seres humanos. Como uma das características deste parasita é a excreção intermitente, a probabilidade de se obter resultados falso-negativos no processo diagnóstico é alta. O Grupo de Parasitologia do Instituto Nacional de Saúde da Colômbia identificou proteínas imunogênicas presentes em cistos e trofozoítos do parasita em isolados colombianos de Giardia com potencial comercial e possibilidade de patenteamento. Foi realizado um estudo exploratório descritivo das características da técnica em estudo, situação de desenvolvimento e viabilidade comercial da invenção. Foram encontradas 390 patentes e selecionadas cinco invenções similares sem risco de eventual pedido de patente. Dos 36 kits de diagnóstico de Giardia comercializados e 21 licenças sanitárias concedidas até dezembro de 2017, apenas quatro kits e três licenças de produtos empregam técnicas semelhantes à estudada, mas nenhum deles tem um registro de patente relacionado. A técnica em desenvolvimento é inovadora e pode ser empregada em saúde pública na Região das Américas com benefícios esperados.

Humans , Product Surveillance, Postmarketing , Technological Development , Giardiasis/prevention & control , Colombia/epidemiology
Rev. eletrônica enferm ; 20: 1-12, 2018. ilus, tab
Article in English, Portuguese | BDENF, LILACS | ID: biblio-1118812


Objetivou-se avaliar as queixas técnicas submetidas ao Sistema de Notificação e Investigação em Vigilância Sanitária entre 2006 a 2014. Pesquisa documental, transversal, quantitativa de um banco de dados secundário público. Identificou-se que das 245.940 notificações encaminhadas, 109.311 eram referentes a queixas técnicas. A região Sudeste apresentou maior repasse de informações (53,5%) e a região Norte maior diferença na quantidade de notificações entre os Estados (coeficiente de variação= 159,2), seguida pela região Nordeste (coeficiente de variação= 124,8). A maioria dos casos de notificações foram de artigos médico-hospitalares (53,09%) e o equipo foi o produto mais notificado (19%). O risco à saúde do paciente foi identificado em 56.777 casos, com maior frequência quanto aos materiais de baixo ou médio risco. Os hospitais da Rede Sentinela foram os principais notificadores. No período analisado houve aumento anual gradativo no número de notificações de queixas técnicas, principalmente de artigos médico-hospitalares utilizados em procedimentos invasivos

This study aimed to evaluate technical complaints submitted to the Regulatory Health Notification and Investigation System between 2006 and 2014 through cross-sectional, quantitative, documental research of a secondary public database. It was identified that, of the 245,940 notifications put forward, 109,311 referred to technical complaints. The Southeast region presented the highest information submission (53.5%) and the North presented the greatest difference in quantity of notifications between states (coefficient of variation = 159.2), followed by the Northeast (coefficient of variation = 124.8). Most of the cases of notifications were on medical articles (53.09%) with equipment being the most notified product (19%). Risk to patient health was identifiedin 56,777 cases, with the highest frequency being in regard to materials of low or medium risk. SentinelaNetwork hospitals were the principal sources of notifications. In the analyzed period there was a gradual annual increase in the number of technical complaint notifications, especially regarding medical articles used in invasive procedures.

Product Surveillance, Postmarketing , Equipment Safety , Patient Safety , Notification
Ciênc. Saúde Colet. (Impr.) ; 22(10): 3247-3257, Out. 2017. tab, graf
Article in Portuguese | LILACS | ID: biblio-890172


Resumo O objetivo deste artigo é identificar, quantificar e categorizar a ocorrência de notificações de eventos adversos e queixas técnicas relacionados ao uso de cateter vascular recebidas pelo sistema NOTIVISA no período de janeiro de 2007 a junho de 2016. Estudo descritivo, retrospectivo, documental, com abordagem quantitativa. Os dados solicitados e fornecidos pela Anvisa foram analisados e apresentados na forma de gráficos e tabelas. Fizeram parte do estudo 4682 notificações de queixas técnicas e 671 de eventos adversos. Houve aumento progressivo das notificações no período estudado. Quanto ao tipo de queixa técnica, a maioria delas se referiu a 'produto com suspeita de desvio de qualidade' sendo em maior quantidade o motivo 'rompimento do cateter durante o procedimento'. O evento adverso mais notificado foi 'Cateter rompeu na veia e migrou para outra parte do corpo'. Destaca-se que no período estudado ocorreram 4 notificações de óbitos, a forma mais grave de evento adverso. O estudo permitiu visualizar a importância da vigilância pós-comercialização dos cateteres vasculares além de fornecer um panorama de seu uso, o que pode apoiar ações de Tecnovigilância e subsidiar as políticas públicas voltadas a esse produto.

Abstract This article identifies, quantifies and categorizes adverse event notifications and technical complaints related to the use of vascular catheters, received by the Notivisa system in the period from January 2007 to June 2016. It is a descriptive, retrospective, documental study with a quantitative approach. Data requested and supplied by Anvisa were analyzed and presented in the form of charts and tables. The study covered 4,682 notifications of technical complaints, and 671 adverse events. There was a progressive increase in notifications during the period studied. As to the type of technical complaint, the majority referred to 'suspected quality failings', the largest component being due to 'catheter rupture during procedure'. The adverse event most notified was 'catheter broke in the vein and migrated to another part of the body'. In the period studied there were four notifications of deaths, the most severe level of adverse event. The study made it possible to visualize the importance of after-sales surveillance of vascular catheters, as well as supplying a wide-ranging overview of their use. Provision of this overview could support technical surveillance activities and serve as input for public policies relating to this product.

Humans , Product Surveillance, Postmarketing , Foreign-Body Migration/epidemiology , Catheters/adverse effects , Brazil/epidemiology , Retrospective Studies , Equipment Failure
Espaç. saúde (Online) ; 18(1): 108-116, jul. 2017. Tabelas
Article in Portuguese | LILACS | ID: biblio-849055


Objetivo: Analisar na perspectiva do idoso as evidências científicas relativas ao emprego terapêutico e a segurança de relaxantes musculares registrados no Brasil. Método: estudo de análise da oferta de medicamentos contendo fármacos do grupo M03B - Relaxantes musculares de ação central da classificação Anatômica Terapêutica Química. Verificaram-se os fármacos do grupo M03B registrados no Brasil. Pesquisaram-se as evidências científicas relativas à segurança e eficácia. Analisou-se a disponibilidade de informações sobre segurança na bula. Resultados: Identificou-se 18 fármacos do grupo M03B, dos quais 7 (38,9%) estão registrados no Brasil. Das 67 especialidades registradas, 35 (52,2%) são associações farmacológicas. Conclusão: As evidências para uso de relaxantes musculares em idosos são limitadas. As bulas desses medicamentos não apresentam informações relevantes sobre eventos adversos (AU).

OBJECTIVE: To analyze the scientific evidence regarding the therapeutic use and safety of muscle relaxant medicines registered in Brazil from the perspective of the health of the elderly. METHODS: This is a study of the analysis of the supply of medicines containing group M03B drugs ­ Centrally acting muscle relaxants of the Anatomical Therapeutic Chemical classification. The M03B group drugs registered in Brazil were observed. The scientific evidence on safety and efficacy has been investigated. The availability of safety information in the package leaflet was analyzed. RESULTS: We identified 18 drugs from group M03B, of which 7 (38.9%) are registered in Brazil. Of the 67 specialties registered, 35 (52.2%) are pharmacological associations. CONCLUSION: Evidence for the use of muscle relaxants in the elderly is limited. The package leaflets do not contain relevant information on adverse events (AU).

Product Surveillance, Postmarketing , Health of the Elderly , Medicine Package Inserts , Muscle Relaxants, Central
Braz. J. Vet. Res. Anim. Sci. (Online) ; 54(3): 225-237, 2017. tab, graf, mapas
Article in English | LILACS, VETINDEX | ID: biblio-879458


The animal trade is an important risk factor that affects the spread of diseases among animals and herds. The goal of the present study was to characterize the cattle movement network in Pernambuco, Brazil, based on the animal movement permits (Guias de Trânsito Animal; GTAs) from 2012 to 2013, and identify the intensity of the commercial relationship between farm premises. A total of 737,950 GTAs were issued, and the movement of 3,481,185 cattle (1,688,585 in 2012 and 1,792,600 in 2013) was analyzed. Of the moved animals analyzed, 52.57% (1,829,907/3,481,185) were involved in the movement of cattle in or out of livestock markets, indicating that livestock markets played a major role in the network. Approximately 20% of the more-connected premises were responsible for approximately 87% of the movement related to sales and 95% of the movement related to purchases. Considering the important role of livestock markets and the intense cattle trade between farm premises, surveillance, and control measures could be more efficient if targeted to livestock markets and highly connected premises to prevent the spread of infectious diseases.(AU)

O comércio de animais é um importante fator de risco para a disseminação de doenças entre animais e rebanhos. O objetivo do presente estudo foi caracterizar a rede de movimentação de bovinos em Pernambuco, com base nas guias de trânsito animal (GTAs) de 2012 a 2013, e identificar a intensidade da relação comercial entre os estabelecimentos. Foram analisadas 737.950 GTAs emitidas, e as movimentações de bovinos totalizaram 3.481.185 animais (1.688.585 em 2012 e 1.792.600 em 2013). Um percentual de 52,57% (1.829.907/3.481.185) das movimentações de bovinos envolveu entrada ou saída de feiras de gado, indicando que as feiras desempenharam um papel importante na rede. Aproximadamente 20% dos estabelecimentos mais conectados foram responsáveis por aproximadamente 87% das movimentações relacionadas às vendas, e 95% das movimentações, relacionadas às compras. Considerando o importante papel das feiras e o intenso comércio de bovinos entre as propriedades, medidas de vigilância e controle podem ser mais eficientes se aplicadas em feiras e estabelecimentos altamente conectados, para prevenir a propagação de doenças infecciosas.(AU)

Animals , Cattle , /standards , Product Surveillance, Postmarketing , Products Commerce , Brazil
Chinese journal of integrative medicine ; (12): 226-232, 2017.
Article in English | WPRIM | ID: wpr-327234


The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in mainland China recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for effificacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this fifield both in China and abroad are urgently needed.

Humans , Clinical Trials as Topic , Drug Evaluation, Preclinical , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal , Therapeutic Uses , Hospital Information Systems , Medicine, Chinese Traditional , Product Surveillance, Postmarketing , Registries , Research , Research Report
Vitae (Medellín) ; 24(1): 13-22, 2017. Ilustraciones
Article in English | LILACS, COLNAL | ID: biblio-988504


Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow detection and evaluation of the causal likelihood of AE related to herbal medicines. Methods: A quantitative methodological development research intervention was performed with primary care health professionals. Two cases were distributed in an interval of one week in order to allow for completion of the proposal form. The within-rater reliability was calculated and classified into satisfactory, regular, and unsatisfactory, according to essential, necessary, and recommended items reported. Results: Fifty-seven professionals were enrolled. A high degree of the within-rater reliability was observed for the most essential, necessary, and recommended fields. The instrument contributed to assessment of definite causal association, once the duration of reactions including evolution, withdrawal, and reposition items showed high reliability. Most fields poor and weak filled were related to quality defects, such as popular name and appearance. Conclusions: Data suggest the instrument is adequate to report AE arising from herbal medicines. Owing to information regarding to organoleptic characteristics, the instrument is different from drug instruments. Therefore, it is intended to improve AE reports related to herbal medicines and contribute for appropriate use.

Antecedentes: Hierbas medicinales son utilizadas empíricamente con la base en el conocimiento etnofarmacobotánico, los cuales tienen limitaciones. Los informes de los eventos adversos (EA) pueden contribuir a la seguridad, la calidad y la evaluación de la eficacia de estos productos. Objetivos: El objetivo del estudio fue desarrollar un formulario para permitir la detección y evaluación de la probabilidad causal de EA relacionado al uso de plantas medicinales e fitoterápicos. Métodos: Investigación cuantitativa, de desenvolvimiento se llevó a cabo con los profesionales sanitarios de atención primaria. Dos casos fueran distribuidos, en un intervalo de una semana, con el fin de ser llenado en el formulario propuesto. La fiabilidad inter-observadores del instrumento fue evaluada y los resultados fueran clasificados en satisfactorio, regular e insatisfactorio, según los datos esenciales, necesarios y recomendados que fueran rellenados en el formulario de notificación. Resultados: Cincuenta y siete profesionales fueran elegibles. Se observó alto grado de fiabilidad entre observadores para la mayoría de los campos esenciales, necesarios y recomendados. El formulario contribuyó para la evaluación de la asociación causal definitiva, una vez que los campos de duración de las reacciones; evolución, retirada y re- exposición tuvieran alta fiabilidad. La mayoría de los campos flacamente llenados estaban relacionados con defectos de calidad, tales como: nombre popular y apariencia. Conclusiones: Los datos sugieren que el formulario propuesto es adecuado para reportar EA derivados de hierbas medicinales. Por la información relativa a las características organolépticas, el instrumento es diferente de lo instrumento para notificación de medicamentos. Por lo tanto, se pretende mejorar los informes de EA relacionados con los productos naturales y contribuir para el uso apropiado.

Humans , Plants, Medicinal , Drug-Related Side Effects and Adverse Reactions , Product Surveillance, Postmarketing , Risk Assessment , Pharmacovigilance