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1.
Swiss Med Wkly ; 151: w30084, 2021 12 06.
Article in English | MEDLINE | ID: covidwho-1573820

ABSTRACT

We report the occurrence of immune thrombocytopenia (ITP) in a 77-year-old man a few days after receiving the first dose of the COVID-19 mRNA vaccine tozinameran (Comirnaty®). The patient was treated with systemic corticosteroids, intravenous immunoglobulins and eltrombopag. He elected to proceed with the second dose of tozinameran 14 weeks after the first and his platelet count remained stable under a tapered eltrombopag dose. To our knowledge, this is the first case in which a second tozinameran dose has been administered to a patient who developed presumed secondary ITP after the first vaccination. We also report global pharmacovigilance data for the occurrence of ITP after vaccination with tozinameran.


Subject(s)
COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Aged , COVID-19 Vaccines , Humans , Pharmacovigilance , Purpura, Thrombocytopenic, Idiopathic/chemically induced , SARS-CoV-2 , Vaccines, Synthetic
2.
Cad. Saúde Pública (Online) ; 37(10): e00077721, 2021. tab
Article in English | LILACS (Americas) | ID: covidwho-1523494

ABSTRACT

Abstract: The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy.


Resumo: De acordo com a Agência de Controle de Alimentos e Medicamentos dos Estados Unidos (FDA), a prescrição do remdesivir deve ser feita com cautela em pacientes com taxa de filtração glomerular estimada (TFGe) < 30, sendo que diversos estudos relatam risco de eventos adversos renais. São limitados os dados disponíveis sobre o perfil de segurança renal do remdesivir. Assim, analisamos as reações adversas renais e urinárias atribuídas ao remdesivir e notificadas em um grande base de dados abertos de farmacovigilância. Obtivemos notificações sobre remdesivir e outros medicamentos usados para tratar a COVID-19 (tocilizumabe, hidroxicloroquina, lopinavir/ritonavir) registradas até 30 de setembro de 2020 do Sistema de Notificação de Eventos Adversos da FDA (FAERS). Analisamos as razões de chances de notificação (RORs) para notificações de eventos adversos renais e urinários referentes ao remdesivir e outros medicamentos. Encontramos 2.922 notificações sobre remdesivir registradas no FAERS para COVID-19. Entre esses casos, foram notificados 493 efeitos adversos renais e urinários (16,9%). Os eventos mais frequentes foram lesão renal aguda (338; 11,6%), comprometimento renal (86; 2,9%) e insuficiência renal (53; 1,8%). Comparado com a hidroxicloroquina, lopinavir/ritonavir ou tocilizumabe, o uso do remdesivir esteve associado com um aumento das chances de notificação de transtornos renais e urinários, independentemente do sexo e idade dos pacientes (2,53; IC95%: 2,10-3,06). A ROR permaneceu significativo quando limitamos a análise à hidroxicloroquina (4,31; IC95%: 3,25-5,71) ou ao tocilizumabe (3,92; IC95%: 2,51-6,12). Nossos resultados corroboram outros estudos e destacam a utilidade para profissionais da saúde que usam esse novo antiviral para tratar a COVID-19, sobretudo em função de sua baixa eficácia.


Resumen: La Agencia Americana de Control de Alimentos y Medicamentos (FDA) ha destacado que la prescripción de remdesivir debe ser prudente con pacientes con tasa de filtración glomerular estimada (TGFe) < 30; además, algunos estudios informaron del riesgo de reacciones adversas renales. La información disponible sobre el perfil de seguridad renal, en el caso del remdesivir, es limitada. Por ello, analizamos las reacciones adversas renales y urinarias atribuidas al remdesivir e notificadas en una extensa base de datos abierta de farmacovigilancia. Obtuvimos las notificaciones de remdesivir y otros medicamentos usados para tratar la COVID-19 (tocilizumab, hidroxicloroquina, lopinavir/ritonavir) registrados el 30 de septiembre de 2020 por el Sistema de Notificación de Eventos Adversos de la FDA (FAERS). Analizamos las odds ratios informadas (RORs) en el caso de informes de eventos adversos renales y urinarios adversos relacionados con el remdesivir y otros medicamentos. En el FAERS, encontramos 2.922 notificaciones de remdesivir registradas como medicament sospechoso usado en COVID-19. De estos, habían 493 con efectos renales y urinarios adversos (16,9%). Los efectos adversos más frecuentes fueron lesiones renales agudas (338; 11,6%), insuficiencia renal (86; 2,9%), y fallo renal (53; 1,8%). Frente a hidroxicloroquina, lopinavir/ritonavir, o tocilizumab, el uso de remdesivir se asoció con un riesgo mayor de notificar alteraciones renales y urinarios, independientemente del género y edad de los pacientes (2,53; IC95%: 2,10-3,06). La ROR permaneció significativo al restringir el análisis a la hidroxicloroquina (4,31; IC95%: 3,25-5,71) o tocilizumab (3,92; IC95%: 2,51-6,12). Nuestros resultados corroboran datos previos, algo que podría ser extremadamente útil para los profesionales de la salud que decidan usar este nuevo antiviral para tratar la COVID-19, sobre todo conociendo su baja eficacia.


Subject(s)
Humans , Pharmacovigilance , COVID-19/drug therapy , Brazil , Adenosine Monophosphate/analogs & derivatives , Adverse Drug Reaction Reporting Systems , Alanine/analogs & derivatives , SARS-CoV-2 , Kidney
4.
Drug Saf ; 43(8): 699-709, 2020 08.
Article in English | MEDLINE | ID: covidwho-1482336

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic that hit the world in 2020 triggered a massive dissemination of information (an "infodemic") about the disease that was channeled through the print, broadcast, web, and social media. This infodemic also included sensational and distorted information about drugs that likely first influenced opinion leaders and people particularly active on social media and then other people, thus affecting choices by individual patients everywhere. In particular, information has spread about some drugs approved for other indications (chloroquine, hydroxychloroquine, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, favipiravir, and umifenovir) that could have led to inappropriate and therefore hazardous use. In this article, we analyze the rationale behind the claims for use of these drugs in COVID-19, the communication about their effects on the disease, the consequences of this communication on people's behavior, and the responses of some influential regulatory authorities in an attempt to minimize the actual or potential risks arising from this behavior. Finally, we discuss the role of pharmacovigilance stakeholders in emergency management and possible strategies to deal with other similar crises in the future.


Subject(s)
Coronavirus Infections , Drug Utilization/trends , Information Dissemination , Pandemics , Pneumonia, Viral , Public Health , Attitude to Health , Betacoronavirus , COVID-19 , Coronavirus Infections/classification , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Coronavirus Infections/psychology , Humans , Information Dissemination/ethics , Information Dissemination/methods , Medication Therapy Management/ethics , Medication Therapy Management/standards , Pharmacovigilance , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Pneumonia, Viral/psychology , Public Health/methods , Public Health/standards , SARS-CoV-2 , Social Media/ethics , Social Media/standards , Social Medicine/ethics , Social Medicine/standards
5.
Drug Saf ; 43(7): 657-660, 2020 07.
Article in English | MEDLINE | ID: covidwho-1482335

ABSTRACT

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.


Subject(s)
Coronavirus Infections , Drug Interactions , Drug Therapy, Combination , Hydroxychloroquine , Metformin , Pandemics , Pneumonia, Viral , Adult , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Betacoronavirus/isolation & purification , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Drug Therapy, Combination/adverse effects , Drug Therapy, Combination/mortality , Female , Humans , Hydroxychloroquine/pharmacokinetics , Hydroxychloroquine/therapeutic use , Hypoglycemic Agents/pharmacokinetics , Hypoglycemic Agents/therapeutic use , Male , Metformin/pharmacokinetics , Metformin/therapeutic use , Middle Aged , Pharmacovigilance , Pneumonia, Viral/diagnosis , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , SARS-CoV-2
7.
Eur Rev Med Pharmacol Sci ; 25(19): 6003-6012, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1478938

ABSTRACT

OBJECTIVE: The present study aims to identify potential safety signals of chloroquine (CQ) and hydroxychloroquine (HCQ), over the period preceding their repurpose as COVID-19 treatment options, through the analysis of safety data retrieved from the FDA Adverse Event Reporting System (FAERS) pharmacovigilance database. MATERIALS AND METHODS: We performed a disproportionality analysis of FAERS data between the first quarter of 2004 and December 2019 using the OpenVigil2.1-MedDRA software. Disproportionality was quantified using the reporting odds ratio (ROR) and its 95% confidence interval (CIs). The reported mortality of CQ and HCQ was also investigated. RESULTS: The dataset contained 6,635,356 reports. Comparison of the RORs revealed significant differences between CQ and HCQ for the following adverse events: cardiomyopathy, cardiac arrhythmias, retinal disorders, corneal disorders, hearing disorders, headache, hepatic disorders, severe cutaneous reactions, musculoskeletal disorders, and cytopenia. Only CQ was associated with psychotic disorders, suicide, self-injury, convulsions, peripheral neuropathy, and decreased appetite. In multivariable logistic regression, death was more frequently associated with CQ use, advanced age, male sex, co-reported suicide and self-injury, cardiomyopathy, cardiac arrhythmias, and decreased appetite. CONCLUSIONS: Our results confirm previously published evidence and suggest that HCQ has a safer clinical profile compared to CQ, and thus could serve as the drug of choice for future therapeutic purposes.


Subject(s)
Adverse Drug Reaction Reporting Systems , Chloroquine/adverse effects , Hydroxychloroquine/adverse effects , United States Food and Drug Administration , COVID-19/drug therapy , Confidence Intervals , Databases, Factual , Humans , Male , Middle Aged , Odds Ratio , Pharmacovigilance , Suicide , United States
9.
Yearb Med Inform ; 30(1): 233-238, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1392947

ABSTRACT

OBJECTIVES: To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2020. METHOD: A bibliographic search using a combination of Medical Subject Headings (MeSH) descriptors and free-text terms on CRI was performed using PubMed, followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. After peer-review ranking, a consensus meeting between two section editors and the editorial team was organized to finally conclude on the selected four best papers. RESULTS: Among the 877 papers published in 2020 and returned by the search, there were four best papers selected. The first best paper describes a method for mining temporal sequences from clinical documents to infer disease trajectories and enhancing high-throughput phenotyping. The authors of the second best paper demonstrate that the generation of synthetic Electronic Health Record (EHR) data through Generative Adversarial Networks (GANs) could be substantially improved by more appropriate training and evaluation criteria. The third best paper offers an efficient advance on methods to detect adverse drug events by computer-assisting expert reviewers with annotated candidate mentions in clinical documents. The large-scale data quality assessment study reported by the fourth best paper has clinical research informatics implications, in terms of the trustworthiness of inferences made from analysing electronic health records. CONCLUSIONS: The most significant research efforts in the CRI field are currently focusing on data science with active research in the development and evaluation of Artificial Intelligence/Machine Learning (AI/ML) algorithms based on ever more intensive use of real-world data and especially EHR real or synthetic data. A major lesson that the coronavirus disease 2019 (COVID-19) pandemic has already taught the scientific CRI community is that timely international high-quality data-sharing and collaborative data analysis is absolutely vital to inform policy decisions.


Subject(s)
Biomedical Research , Medical Informatics , Computer Security , Data Mining , Electronic Health Records , Humans , Machine Learning , Pharmacovigilance , Phenotype
11.
Vaccine ; 39(40): 5968-5981, 2021 09 24.
Article in English | MEDLINE | ID: covidwho-1347848

ABSTRACT

BACKGROUND: In 2010, the Australian seasonal influenza vaccination program for children under 5 years of age was suspended due to an unexpected increase in fever and febrile convulsions causally associated with one particular influenza vaccine brand. A subsequent national review made seven recommendations to improve vaccine pharmacovigilance. Ten years on, in advance of implementing the COVID-19 immunisation program, we evaluated views on the capacity of Australia's vaccine pharmacovigilance system to promptly detect, examine and communicate a signal. METHODS: Semi-structured interviews were conducted between July and October 2020 with individuals with expertise in vaccine safety in Australia using an interview guide informed by key Australian and international frameworks. Interviews were digitally recorded and transcribed verbatim. Thematic analysis was used to code data using a deductive approach. RESULTS: Interviews with seventeen participants enabled six themes to be identified. Participants described improvement and significant innovation within Australia's vaccine pharmacovigilance system over the decade since 2010, particularly through establishment of a new active, cohort event monitoring system using short message service surveys. Participants thought Australia had a good foundation for COVID-19 vaccine safety surveillance; implementation of the COVID-19 immunisation program was seen as a potential driver for ongoing enhancement through: a) improved integration of the active surveillance and spontaneous reporting systems, and; b) development of population-level active surveillance, including through data linkage. Transparent communication was considered essential to address the unprecedented challenges of COVID-19 and broader vaccine safety concerns. CONCLUSIONS: Vaccine safety experts in Australia convey confidence in the innovative pharmacovigilance systems implemented over the past 10 years. While Australia has a multifaceted system incorporating both active surveillance and spontaneous reporting systems, COVID-19 vaccine implementation represents an opportunity to enhance current systems and to develop new, systematic approaches to vaccine pharmacovigilance that should make both a local and global contribution.


Subject(s)
COVID-19 , Influenza Vaccines , Australia , COVID-19 Vaccines , Child , Child, Preschool , Humans , Influenza Vaccines/adverse effects , Pandemics/prevention & control , Pharmacovigilance , SARS-CoV-2 , Vaccination
12.
Eur J Med Res ; 26(1): 87, 2021 Aug 06.
Article in English | MEDLINE | ID: covidwho-1344125

ABSTRACT

BACKGROUND: COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2. METHODS: We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects. RESULTS: The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled. CONCLUSION: Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Informed Consent/standards , Pharmacovigilance , SARS-CoV-2/immunology , Vaccination/standards , COVID-19/immunology , COVID-19/virology , Disclosure , Humans
13.
Clin Gastroenterol Hepatol ; 19(9): 1970-1972.e3, 2021 09.
Article in English | MEDLINE | ID: covidwho-1212376

ABSTRACT

Remdesivir has demonstrated clinical benefits in randomized placebo-controlled trials (RCTs) in patients with coronavirus disease 2019 (COVID-19)1-4 and was first approved for COVID-19 patients.5 However, whether remdesivir causes gastrointestinal adverse drug reaction (GI-ADRs) including hepatotoxicity is less clear.1-4,6 Therefore, we aimed to detect a diverse spectrum of GI-ADRs associated with remdesivir using VigiBase, the World Health Organization's international pharmacovigilance database of individual case safety reports.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Adenosine Monophosphate/analogs & derivatives , Adverse Drug Reaction Reporting Systems , Alanine/analogs & derivatives , COVID-19/drug therapy , Databases, Factual , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Pharmacovigilance , SARS-CoV-2 , World Health Organization
14.
J Autoimmun ; 123: 102688, 2021 09.
Article in English | MEDLINE | ID: covidwho-1293901

ABSTRACT

Unprecedented loss of life due to the COVID pandemic has necessitated the development of several vaccines in record time. Most of these vaccines have received approval without being extensively whetted for their adverse effect and efficacy profiles. Most adverse effects have been mild, nonetheless, more serious thromboembolic events have also been reported. Autoimmune hepatitis (AIH) can occur in predisposed individuals where an immune mediated reaction against hepatocytes is triggered by environmental factors. Vaccines are a very rare cause of AIH. We report two such cases of AIH triggered by COVID (Covishield) vaccination. While one patient made an uneventful recovery, another succumbed to the liver disease. Ours is the first report of Covishield vaccination related AIH and second ever after any form of COVID vaccination. We hope that our report does not deter COVID vaccination drives. However, we also hope to raise awareness of its potential side effects and the increased role of pharmacovigilance in guiding treatment.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Hepatitis, Autoimmune/etiology , Pandemics , SARS-CoV-2/immunology , Vaccination/adverse effects , Adult , Fatal Outcome , Female , Hepatitis B, Chronic/complications , Hepatitis, Autoimmune/immunology , Hepatitis, Autoimmune/pathology , Humans , Hypothyroidism/complications , Jaundice/etiology , Male , Middle Aged , Models, Immunological , Pharmacovigilance
15.
PLoS Negl Trop Dis ; 15(4): e0009354, 2021 04.
Article in English | MEDLINE | ID: covidwho-1287260

ABSTRACT

BACKGROUND: Ivermectin is known to cause severe encephalopathies in subjects infected with loiasis, an endemic parasite in Sub-Saharan Africa (SSA). In addition, case reports have described ivermectin-related serious adverse drug reactions (sADRs) such as toxidermias, hepatic and renal disorders. The aim of this study was to identify suspected sADRs reported after ivermectin administration in VigiBase, the World Health Organization's global individual case safety reports database and analyze their frequency relative to the frequency of these events after other antinematodal drugs reported in SSA and other areas of the world (ROW). METHODS: All antinematodal-related sADRs were extracted from VigiBase. Disproportionality analyses were conducted to investigate nervous, cutaneous, psychiatric, respiratory, renal, hepatic and cardiac suspected sADRs reported after ivermectin and benzimidazole drug administration across the world, in SSA and RoW. PRINCIPAL FINDINGS: 2041 post-ivermectin or post-benzimidazole suspected sADRs were identified including 667 after ivermectin exposure (208 in SSA and 459 in the RoW). We found an increased reporting for toxidermias, encephalopathies, confusional disorders after ivermectin compared to benzimidazole drug administration. Encephalopathies were not only reported from SSA but also from the RoW (adjusted reporting odds ratios [aROR] 6.30, 95% confidence interval: 2.68-14.8), highlighting the fact these types of sADR occur outside loiasis endemic regions. CONCLUSION: We described for the first time suspected sADRs associated with ivermectin exposure according to geographical origin. While our results do not put in question ivermectin's excellent safety profile, they show that as for all drugs, appropriate pharmacovigilance for adverse reactions is indicated.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Ivermectin/adverse effects , Adolescent , Adult , Africa South of the Sahara/epidemiology , Aged , Databases, Factual , Female , Humans , Logistic Models , Male , Middle Aged , Pharmacovigilance , Young Adult
16.
Expert Opin Drug Saf ; 20(9): 1125-1136, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1286513

ABSTRACT

BACKGROUND: Elevated inflammatory cytokines in Coronavirus disease 2019 (COVID-19) affect the lungs leading to pneumonitis with a poor prognosis. Tocilizumab, a type of humanized monoclonal antibody antagonizing interleukin-6 receptors, is currently utilized to treat COVID-19. The present study reviews tocilizumab adverse drug events (ADEs) reported in the World Health Organization (WHO) pharmacovigilance database. RESEARCH DESIGN AND METHODS: All suspected ADEs associated with tocilizumab between April to August 2020 were analyzed based on COVID-19 patients' demographic and clinical variables, and severity of involvement of organ system. RESULTS: A total of 1005 ADEs were reported among 513 recipients. The majority of the ADEs (46.26%) were reported from 18-64 years, were males and reported spontaneously. Around 80%, 20%, and 64% were serious, fatal, and administered intravenously, respectively. 'Injury, Poisoning, and Procedural Complications' remain as highest (35%) among categorized ADEs. Neutropenia, hypofibrinogenemia were common hematological ADEs. The above 64 years was found to have significantly lower odds than of below 45 years. In comparison, those in the European Region have substantially higher odds compared to the Region of Americas. CONCLUSION: Neutropenia, superinfections, reactivation of latent infections, hepatitis, and cardiac abnormalities were common ADEs observed that necessitate proper monitoring and reporting.


Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , Antibodies, Monoclonal, Humanized/adverse effects , COVID-19/drug therapy , Pharmacovigilance , Adolescent , Adult , Age Distribution , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Databases, Factual/statistics & numerical data , Female , Humans , Male , Middle Aged , Sex Distribution , World Health Organization , Young Adult
17.
Int J Mol Sci ; 22(12)2021 Jun 08.
Article in English | MEDLINE | ID: covidwho-1266745

ABSTRACT

With advanced technology and its development, bioinformatics is one of the avant-garde fields that has managed to make amazing progress in the pharmaceutical-medical field by modeling the infrastructural dimensions of healthcare and integrating computing tools in drug innovation, facilitating prevention, detection/more accurate diagnosis, and treatment of disorders, while saving time and money. By association, bioinformatics and pharmacovigilance promoted both sample analyzes and interpretation of drug side effects, also focusing on drug discovery and development (DDD), in which systems biology, a personalized approach, and drug repositioning were considered together with translational medicine. The role of bioinformatics has been highlighted in DDD, proteomics, genetics, modeling, miRNA discovery and assessment, and clinical genome sequencing. The authors have collated significant data from the most known online databases and publishers, also narrowing the diversified applications, in order to target four major areas (tetrad): DDD, anti-microbial research, genomic sequencing, and miRNA research and its significance in the management of current pandemic context. Our analysis aims to provide optimal data in the field by stratification of the information related to the published data in key sectors and to capture the attention of researchers interested in bioinformatics, a field that has succeeded in advancing the healthcare paradigm by introducing developing techniques and multiple database platforms, addressed in the manuscript.


Subject(s)
Computational Biology , Drug Development , Drug Discovery , MicroRNAs , Microbiological Techniques/methods , Whole Genome Sequencing , Animals , COVID-19 , Drug Industry , Genome-Wide Association Study , Humans , Pharmacovigilance , Public Health
18.
J Neuroimmunol ; 357: 577627, 2021 08 15.
Article in English | MEDLINE | ID: covidwho-1260801

ABSTRACT

In this consensus statement, we provide updated recommendations on multiple sclerosis (MS) management during the COVID-19 crisis and the post-pandemic period applicable to neurology services around the world. Statements/recommendations were generated based on available literature and the experience of 13 MS expert panelists using a modified Delphi approach online. The statements/recommendations give advice regarding implementation of telemedicine; use of disease-modifying therapies and management of MS relapses; management of people with MS at highest risk from COVID-19; management of radiological monitoring; use of remote pharmacovigilance; impact on MS research; implications for lowest income settings, and other key issues.


Subject(s)
COVID-19/epidemiology , COVID-19/therapy , Internationality , Multiple Sclerosis/epidemiology , Multiple Sclerosis/therapy , Practice Guidelines as Topic/standards , Disease Management , Humans , Pandemics/prevention & control , Pharmacovigilance , Telemedicine/standards , Telemedicine/trends
20.
Int J Clin Pharm ; 43(4): 1133-1138, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1252181

ABSTRACT

The COVID-19 pandemic presents several challenges to the organisation and workflow of pharmacovigilance centres as a result of the massive increase in reports, the need for quick detection, processing and reporting of safety issues and the management of these within the context of lack of complete information on the disease. Pharmacovigilance centres permanently monitor the safety profile of medicines, ensuring risk management to evaluate the benefit-risk relationship. However, traditional pharmacovigilance approaches of spontaneous reporting, are not suitable in the context of a pandemic; the scientific community and regulators need information on a near real-time point. The aim of this commentary is to suggest six interrelated multidimensional guiding axes for drug safety management by pharmacovigilance centres during the COVID-19 pandemic. This working plan can increase knowledge on COVID-19 and associated therapeutic approaches, support decisions by the regulatory authorities, oppose fake news and promote more efficient public health protection.


Subject(s)
Adverse Drug Reaction Reporting Systems , Antiviral Agents/adverse effects , COVID-19/drug therapy , Pharmacovigilance , Adverse Drug Reaction Reporting Systems/organization & administration , Antiviral Agents/therapeutic use , COVID-19/epidemiology , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/etiology , Humans , Patient Safety , SARS-CoV-2/drug effects
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