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R Prevalence, antimicrobial resistance and clonal features MICs of penicillin, cefuroxime, cefotaxime, ceftriaxone, cefepime, of drug-resistant Enterococcus faecalis and E. Portela, A. Fernandes, T. Ferreira Oeiras, Lisbon, PT quinupristin-dalfopristin, vancomycin and tigecycline were determined Objectives: To establish the prevalence, antimicrobial resistance and by using the E-test method AB Biodisk, Solna, Sweden.
The asaI, and trimethoprim-sulfamethoxazole, Resistance to multiple cylA, gelE, hyl and esp virulence genes were screened by Multiplex- antimicrobial agents was observed among 27 GR isolates were and tigecycline was observed. Ragavendera, K. The esp gene alone and human pathogenic Candida albicans by poisoned food technique. Conclusions: These data provide further insights on the dynamics of colonisation by multidrug-resistant enterococci in a particular population of haematological malignancy patients, who may be used to monitor enterococcal carriage of epidemic and persistent clones useful for infection control measures.
Latronico, M. Greco, V. Martella, D. Buonavoglia Bari, IT Objectives: Recent epidemiological studies have demonstrated that veterinary students and veterinarians may have higher risks of exposure to Methicillin resistant Staphylococcus aureus MRSA than the general Figure: Structure of the active principle [6-ethoxymethyl -tetrahydro-2H- population.
The aim of the study was to analyze the prevalence of MRSA pyran-2,3,4, He presented with a sudden onset of fever, 3rd, 4th and 5th year. The students were asked to provide a nasal tachycardia and respiratory distress. As he was diagnosed vet-care associated factors and exposure to well-known MRSA risk to have endocarditis the patient was put on ampicilin and gentamicin factors health-care associated factors.
The samples were subjected to therapy. He underwent an emergent mitral and aortic valve surgery due bacteriological analysis and PCR for the mec A gene. The data collected to heart failure. While he was still on ampicilin and gentamicin therapy, with the questionnaire were evaluated by statistical analysis chi square E.
Twenty-two out of students MRSA carriers. Nine out of 22 MRSA carriers had either relatives Conclusion: Endocarditis due to vancomycin resistant enterococci is an working in health-care facilities or subjected recently to hospitalisation.
In review of the literature the commonly Fifteen out of 22 carriers attended the 4th and 5th years of the course. This patient had no carriers increased with having one or more healthcare-workers in the prior known valvular disease therefore having no cardiac predisposition family Odds ratio, OR 5. This patient is with being admitted to the 4th and 5th years of the course OR 3.
Nanetti Bologna, IT Introduction: The increased rate of methicillin resistance among R Spread of epidemic vancomycin-resistant Enterococcus fae- Gram-positive cocci is a general concern, especially in the hospital cium clonal complex 17 in haematological patients in Russia setting.
A prospective microbiological monitoring including a continued A. Kliasova, A. Mironova, G. Novichkova, surveillance of antimicrobial susceptibility rates, is ongoing at our V. The same pathogen haematological patients in Russia by Multilocus Sequence Typing cultured more than once from the same patient within one month, has MLST.
Methods: Genetic relatedness of VR E. Detection of virulence genes esp, gelE, September When considering antibiotics other than b-lactam Results: MLST analysis revealed that all isolates belonged to the ones, cotrimoxazole maintained a consistently elevated activity over time clonal complex 17 CC17 of hospital adapted, epidemic strains.
Strains It persisted during — together with ST Relatedness of ST18 and erythromycin Among antimicrobial compounds other than two genes esp and hyl simultaneously. These strains possessed epidemicity marker esp were observed during the study period, against Staphylococcus aureus and a potential virulence gene gelE, which is rarely found in E.
Our results demonstrate presence of virulence gene Staphylococcus aureus is relevant, to establish reliable guidelines of esp, a marker for epidemicity in different clonal types and its persistence antibiotic treatment and prophylaxis, on both local and regional basis.
Uguz, B. Aytacoglu, A. Recently many clinics reported VRE. However endocarditis due to VRE is still a rare entity and there are only a few cases reported in the literature. Nanetti Bologna, IT to decrease antimicrobial pressure and to control expenditures.
Through the regular activity of the AMT, this integrated approach may also Introduction: The increased temporal rate of antimicrobial resistance affect the appropriateness of antimicrobial prescription within the whole among Gram-positive cocci including Enterococci is a major concern, hospital.
The same pathogen isolated more than once from Cefotaxime 3, Eighteen strains of vancomycin- M. Marasinghe, J. You, N. Lee, J. Wong, M. Hui, resistant Enterococcus faecalis strains were detected 12 concentrated C. Cockram, B. Lee, R. Lai Hong Kong, HK in the July-September period , while vancomycin-resistant Enterococcus faecium strains were six through the entire observation year.
Its impact vancomycin-resistant strains. An increase in appropriate prescriptions was obtained during the intervention Antibiotic usage period O. The length of hospital stay in the two groups was not different but a reduction of 3.
Falciani, R. Aschbacher, G. Spoladore, C. Larcher, occupied BDO was reduced by 4. There was P. Methods: from January , an ASP has been carried out in Conclusion: The implementation of ASP in the hospital resulted in our bed referral hospital in the North-Eastern Italy by ID more rational use of antimicrobials, an overall reduced consumption of consultants, pharmacists and microbiologists, who constitute the antibiotics and improved clinical outcomes.
We initially analyzed two surgical and three medical wards S. Kozlov, B. Makushkin, A. Fokin, A. Pavlukov, V. Mischenko Smolensk, RU pneumology. These data were then compared to the same data of tion in Russian Federation RF appears to be the main barrier for , in which the ASP had not yet been implemented. Hence we aimed Results: a remarkable decrease of restricted antimicrobials consumption our study to develop an on-line program of systemic AM use monitoring has been observed between the two years, whereas a comparable trend for hospital wards with intensive AM usage in different regions of RF.
Moreover, drug acquisition Methods: On-line database development used products and technologies costs strongly decreased. NET 2.
Salehi, P. Mohajeri, H. Tavakoli, S. Fazeli Isfahan, Results: The database consisted of two parts. The AM consumption is expressed as number of curved bacilli which is colonised in the human stomach.
It causes DDD per bed-days. This part of the program allows getting an instantaneous clinical outcomes. The second part of the database is designed Materials and Methods: H. Detailed analysis of AM from Iran use will allow establishing a correspondence between practice and Z. Sahebekhtiari, B. Noorinayer, H. Dabiri, P. Chiani, M.
Zali Tehran, IR optimisation and reduction of unreasonable expenses. The homology rate of Iranian Shigella strains was NL compared with each other in this study. Methods: Twenty Shigella isolates from diarrhoeal patients were studied. Biochemical and patients infected or colonised with the outbreaking strain is crucial. Complete gene of 16S rRNA consuming, taking several days. The phylogenetic tree based to manage several MRSA outbreaks in three different hospitals.
A total on 23S rRNA indicates that the homology between each specimens of of out of clinical samples 9. Conclusion: Phylogenetic-tree analysis is often used as a method to Of these samples In these remaining samples MRSA could be cultured in Our data were in accordance with the previous studies overview of the spread of MRSA within 24 hours after receiving the reported from other countries, indicating close relationship among samples.
Shigella species isolated from Iran. Mnatsakanyan, L. Burova, A. Totolian, A. Petersburg, RU Analysis of the prophage gene content is valuable approach for molecular epidemiology of Streptococcus pyogenes infections. Objectives: Streptococcus pyogenes or group A streptococci GAS is a leading cause of human infections varied from mild pharyngotonsillitis to severe invasive diseases.
It is supposed that the expression M. Ploy, D. Chainier, F. Blot, J. Vignaud, C. Duchiron, of the certain toxins encoded by prophage genes correlates with virulent B. The aim of the present study was to characterise the presence of phage-associated genes, including genes for Objectives: Early microbiological documentation is a key point for the toxins and integrases, in GAS strains of emm12 genotype isolated adapted antibiotherapy in patients with a septic shock.
Real-time PCR could provide an earlier Russia in — was used. Methicillin- selected epidemiologically unrelated strains was done according to sensible and methicillin-resistant Staphylococcus aureus MSSA and recommendation of the Centre for Disease Control. The community-acquired. This assay does not require sample preparation time.
The emm For the serum and abcess, the result was negative for S. Aghakhani, R. Hamkar, M. Mohraz, N.
Zamani, A. Eslamifar, emm12 genotype. They were characterised by the emm Banifazl, L. Adibi, A. The toxin genes smeZ, speI, speH, speC were predominant among the strains. They were revealed in 18, Objectives: Hepatitis B virus HBV is one of the major causative agents 17, 17 and 16 strains, respectively.
The integrase genes int5 and int3 were found genotypes. The aim of this study was to identify the HBV genotypes in in 17 and 14 strains, respectively, while the genes int6 and int9 were patients with HCC in Iran. Most of the strains samples of 40 patients 31 males and 9 females with HBV-associated contain 2 or 3 integrase genes, that indicates the presence of 2 or 3 HCC. PCR products were sequenced, and a single strain contained seven integrase genes, and 2 strains contained the genotype of each HBV sequence was determined by comparison with one integrase gene each.
Positive control reaction clustered in the genotype D. R The prenatal diagnosis for Cytomegalovirus in pregnant women G. Evcil, S. Kirdar, A. Odabasi, N. Avidity index was studied by EIA. Conclusion: We concluded that the fetal CMV infection rate is very low due to high maternal seroprevalence in our region.
Molecular typing R Genotypes of Helicobacter pylori isolated from the patients with hepato-biliary diseases G. Abuzarova, J. Valeeva, O. Method: 50 patients with chronic cholecystitis and 50 patients with N.
The presence of genes H. Genotypes of H. Materials and Methods: Blood samples from patients, suspective for vacAs1 15 Results of H. Alltogether, 88 perirectal, 52 nasopharyngal, 3 tracheal and 5 blood Conclusions: The prevalent genotype of H.
After restriction enzyme digestion, the fragments were positive CagA and BabA negative. The possible role of CagA negative H. Two haemato-oncology patients predominant K. Ricardo, A. Silva, C. Granato, R. In all but one subject within individual concordance Many reports have documented the emergence of non-albicans species of between nasopharyngeal and perirectal isolates was observed. Ampicillin endogenous. Vast majority of invasive disease was Material and Methods: From three hospitalised patients admitted in caused by only type A K.
From one of these patients, an additional C. From both rooms, air and surfaces samples were collected. Normanno, A. Susca, A. Miccolupo, L. Latorre, G. Quaglia, G. Restriction patterns were compared between strains.
It is the causative agent of listeriosis, a samples were found negative. Considering all the studied isolates, only severe food-borne disease associated with a high case fatality rate.
Isolates from different patients borne disease outbreaks suggests that contaminated foods, including were unrelated. Control of food-borne bacterial pathogens is predicated discriminatory power. It did not support the hypothesis of an outbreak. This fact should be taken in is ubiquitous in the environment and also because cases are generally account on future antifungal therapeutic protocols.
Denks, U. Avi, T. Metsvaht, T. Karki, I. This carriage of K. Soeltan-Kaersenhout, A. Chiang-Ni, P. Zeng, H. Wu, W. Chuang, Y. Lin, M. Lin, thought to play a causal role in the development and sustenance of C. Liu, J. Our study found that all exist. Endoscopy was performed for screening Northern hybridisation for the covR expression pattern. The multi locus purposes in light of a positive family history of colorectal cancer. Amplimers were strains have the identical sequence type ST Cladograms genetic relatedness.
The differently washed biopsies pattern should be a potential determinant phenotype for pandemic showed a similarity of The DTT supernatants representing mucus associated bacteria showed R Molecular epidemiology of Brucella melitensis in Greece Conclusion: In this study, the microbiota of the luminal, mucosal and assessed by multilocus variable-number tandem repeat biopsy samples within one patient were similar.
The small differences markers observed seem largely due to differences in bacterial quantity rather than G. Vrioni, G. Spanakos, C. Gartzonika, G. Pappas, E. Kalogeropoulou, bacterial composition. This was in agreement with quantitative real-time N.
Charalambaki, A. Kyratsa, A. Kansouzidou, S. Trikka- PCR analysis of these samples. Vakalis, A. Future studies with a larger cohort of healthy patients and inclusion of patients with Brucellosis remains a common infectious disease in many parts of IBD should shed more light on this possible equilibrium between gut the world, notably in Mediterranean countries and the Middle East.
The availability of discriminatory molecular typing tools to inform and assist conventional epidemiological approaches would be invaluable in controlling these infections, but efforts have been hampered by the genetic homogeneity of the genus. Recently, a molecular subtyping system based on the number of an octameric tandem repeat sequence at eight loci in the Brucella genome has been developed.
These results indicate that VNTRs used in the HOOF technique could discriminate isolates originating from restricted geographical sources, indicating its potential as an epidemiological tool. Park, D. Cho, I. Yeo, J. Yang, M. Kim, S. Shin, S. Joo, R Diagnosis of the pre-patent Schistosoma mansoni infection E. Ra, S. Park, E. In this study, we prospectively evaluated the diagnosis. PCR technique was positive with all the gestation. Further serotyping was done using conventional minimal detectable amount of S.
DNA and molecular methods. The CVs of within-run, between-run Conclusion: Both assays have proved their validity as diagnostic tools and total precision were 2. Detection for S. All strains were susceptible to penicillin, but a considerable proportion was resistant to erythromycin Simple preparation and rapid results are attractive P. Fossati, C. Parlato, R. Serra Turin, IT points of this assay. Tapiainen, T. Kaijalainen, M. Uhari, A. One swab was used for the molecular test and the other was used to perform the culture Objectives: Xylitol is a sugar alcohol that inhibits the growth reference test.
Both the agar and the broth were nasopharyngeal carriage of pneumococci. Suspect colonies were capsule of pneumococci. The pneumococcal isolates negative in both methods. Four 2. Three 1. Fifty-four samples were vanB two hours. The cpsB and useful if testing needs to be performed at any time, day or night. The calibrator normalised gene expression levels were cultural methods require at least 48 hours. Some issues have been determined by using the Relative quantitation tool in the LightCycler highlighted for the vanB gene.
If the organism carrying the VanB gene software version 4. Roche Diagnostics. Capsular gene expression levels in glucose medium did not and inhibition of PCR reaction. None of the molecular tests was positive for C. Skentou, M. Stavropoulou, A. Anastassiadou, I. Messinis, E. Petinaki Larissa, GR protozoa indicates unnecessary treatment of Entamoeba histolytica in Turkish patients with intestinal complaints Objective: To examine the prevalence of genital pathogens including Z.
Verweij, L. Brienen, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex virus S. Cesur, C. Bulut, S. Kinikli, A. Laboratory diagnosis is usually limited to the University Hospital were included. Cervical swabs were obtained microscopy of a direct faecal smear, without further differentiation and DNA extraction was performed in all specimens.
The presence of between the pathogenic Entamoeba histolytica and the non-pathogen C. DNA of N. The consequences for clinical management of restriction method Maxim. Results: Four out women 4. In addition, two women 2. Conclusions: C.
Microscopy of a direct smear from unpreserved stool samples asymptomatic pregnant women in Central Greece. These results support was performed immediately after delivery. Aliquots were sent to a strategy of screening pregnant women for these pathogens followed the Netherlands for further molecular diagnosis.
DNA of E. Phocin Herpes Virus 1 PhHV 1 was added within the isolation lysis R Comparison of two commercial molecular tests for routine buffer to serve as an internal control to detect inhibition factors.
No helminths were V. Oresic, M. Rupnik Maribor, SI seen. In contrast, real-time PCR detected 2 2. However, currently available amoebiasis and a low sensitivity for giardiasis.
Unnecessary treatment immunological tests detecting toxins A and B have low sensitivity. New was given to 27 patients based on the detection of E. Improvement of microscopy skills, quality control and indicating the higher possibility of hypervirulent type Hubert, M. Delmee Brussels, BE and further processed according to manufacturer instructions. With toxigenic culture CDAB test used for direct detection of toxins is often negative for culture TC as gold standard, we evaluated the performances of this new assay positive samples also if containing toxigenic C.
Cultures were performed on CCFA. The conventional methods Results: A total of stool specimens collected in were tested. Ninety-one samples were shown to contain toxigenic C. Those of CTA were In all C. It is clinical response time for C. This could lead to improved patient outcomes. Guadarrama, B. Henrich Dusseldorf, DE J. We set out to show that such mutations can be detected qualitative detection of Mycobacterium tuberculosis complex DNA in directly in stool specimens using a real-time PCR-based method and thus human respiratory specimens.
Our objective was to evaluate the test in facilitate the rapid detection of virulent strains in clinical specimens. This PCR was designed in such a way that in the subsequent Methods: Using the results from Coletsos culture as gold standard melt curve analysis of the amplicon the presence of the deletion resulted we evaluated the sensitivities and the predictive values of the three in a higher melting temperature.
The positive predictive value; and As described, or absence of the 18 bp deletion in the tcdC gene in all the C. Nielsen, T. Bjarnsholt, H. Seraceni, L. Badia, A. Grilli, E. Fainardi, C. Previous studies have demonstrated that respectively, all and only virulent strains.
Knowing the cagA positive in a subset of MS patients with Relapsing-Remitting RR forms, Cpn HP strains will be useful in predicting the chance for complications as could induce a chronic persistent brain infection acting as a cofactor in well as for epidemiological and clinical studies of HP infection. Literature evidence has sensitive than the latter for detecting HP. For this reason, we suggest established that there is a high expression of Toll like receptors TLR that the nested PCR using the new set of primers targeting the glmM in various neurodegenerative disorders including SM active lesions of gene is a suitable tool to detect HP in clinical samples and it might be microglia and astrocytes.
We have evaluated the link between Cpn and included in routine clinical practice. TLR2 and C. Azevedo, C. Keevil, M. All samples elevations consistent with chronic infections were previously enriched in a rich medium 8 hours for PIF and overnight for the other samples and analyzed by both PNA-FISH and culture-based methods. Laboratory testing on representative strains from the N.
The method Introduction: Helicobacter pylori HP is a Gram-negative spiral has been successfully adapted to detect this bacterium in blood, faeces, bacterium that causes gastritis, peptic ulcer disease and seems to be water and PIF.
Moreover, the probe was able to Methods: One hundred frozen gastric biopsies from patients were discriminate the bacterium in a mixed microbial population by counter- thawed prior to extract the DNA of HP. PIF samples where the analysis takes less than 12 hours. These so-called positional R Mean neutrophil volume: a new automated haematologic parameters PP can detect morphologic changes in neutrophil population parameter for acute infection and can be an additional indicator for diagnosing acute infection.
Papakonstantinou, E. Yfantis, S. Chaniotaki, P. Grafakos, E. Manti Athens, GR additional predictor of acute infection.
We then studied whether changes characteristically seen in reactive neutrophils during infection. Furthermore, the results are subjective hematology analyzer. Comparisons between means were performed by because they depend on human interpretation, and only a few hundred analysis of variance. Comparison between 2 means was performed by cells can be analyzed for any given sample. The Coulter LH using the Student t test.
A P value less than 0. The and can be an additional indicator for diagnosing acute infection. We then studied whether changes in MVI correlated with the type of microorganism.
Comparisons between means were performed by analysis of variance. Schuster, K. According to recently published sepsis decreases. As part of our that MVI is a good predictor of acute infection. On receipt in the laboratory the weight difference for each individual bottle was recorded and expressed as R Quantitative determination of neutrophil volume collected blood volume.
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Pengirim : ebqenexaz – [oqakepo pazew. Pengirim : zuveretadaf – [imejasi egiuz. From the suspected medicines identified, From the reports including PIM as suspected medication, the population showed a mean age of Conclusion: These results reinforce the importance of improving medication appropriateness in older adults and promote the development and use of clinical decision support systems to avoid inappropriate prescriptions and, therefore, severe adverse reactions.
Lavan AH, Gallagher P. Predicting risk of adverse drug reactions in older adults. Ther Adv Drug Saf. Published online Arch Intern Med. The EU 7 -PIM list: a list of potentially inappropriate medications for older people consented by experts from seven European countries. Eur J Clin Pharmacol. Introduction: A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient [1].
Use of medicinal products in children is identified as a risk factor for occurrence of medication errors [2, 3]. Objective: Aim of this study is to describe medication errors and identify causes of medication errors in children and adolescents spontaneously reported to HALMED, in order to propose and implement appropriate risk minimisation measures.
Results: Out of cases in patients up to 18 years of age, cases included terms pertaining to SMQ: Medication errors Broad. Grouping of cases was observed for the following pharmaceutical formulations of the active substances: salbutamol nebuliser solution, paracetamol solution for infusion, valproate oral solution and syrup and cholecalciferol oral drops, solution. Identified root causes for medication errors were the following: misinterpretation of prescribed dosage due to very small volume resulting in 10 times higher administered dose e.
Review of root causes for medication errors led to implementation of further risk minimisation measures, namely notifications for healthcare professionals salbutamol and valproate , additional risk minimisation measures i. Following implementation of risk minimisation measures, it is concluded there is a further need for evaluation or their effectiveness.
Systematic review of medication errors in paediatric patients. The Annals of Pharmacotherapy. Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation. Res Social Adm Pharm. Introduction: Digital features such as videos and infographics are used to make scientific literature more understandable and accessible to a wider audience [1, 2]. Plain language summaries and graphical abstracts are fast becoming the norm in complementing scientific publications across disciplines, including pharmacovigilance.
However, the use of video explainers is limited, and the usefulness of such features is not well known. Objective: To evaluate the effectiveness of an animated explainer video in communicating a statistical method in pharmacovigilance. Communication specialists and data scientists collaborated to create the video, focusing on identifying key elements of the method and how to best illustrate its application in a visual narrative. A survey of 10 multiple choice and rating scale questions was used to assess comprehension, perceived effectiveness of communication, enjoyment, and desire to learn more.
Subsequently, responses were collected and analysed. Results: Fifty-four individuals from 30 countries participated in the survey. Additionally, most participants see Table 1 for detailed results found the video to be an enjoyable and helpful way to learn about vigiGroup; agreed that an animated explainer video could be a useful alternative to reading a scientific paper and an effective way to visualise scientific methods; and would like to see more scientific methods presented in this way.
Conclusion: The vigiGroup animated explainer video was effective in communicating cluster analysis of adverse event reports to an audience of both pharmacovigilance and non-pharmacovigilance professionals. Increasing the use of such videos, to complement scientific literature, could be an effective way of building knowledge of complex statistical methodology and scientific developments more broadly.
The power of storytelling and video: a visual rhetoric for science communication. Bredbenner K, Simon SM. Video abstracts and plain language summaries are more effective than graphical abstracts and published abstracts. PLoS One. Consensus clustering for case series identification and adverse event profiles in pharmacovigilance. Artif Intell Med. Introduction: Data from ongoing open-label clinical studies are assessed for safety signals on a set cadence, complying with regulatory requirements.
One challenge is the need to contextualize safety when individual subjects have different exposure times rolling enrollment. Such issues resolve at the end of the study. However, during the study, visualizations add considerable value to the multidisciplinary discussion of incoming safety data.
The tool produces a column x-axis for each subject with a height y-axis corresponding to exposed time. Subjects are grouped by exposure in open-label or completed studies , and AEs are displayed relative to start of exposure by symbols on each subject-column.
The entire population can be displayed, or the display can be limited to the patients with the event s of interest. This allows viewing of AEs in the context of total study population number of columns and total exposed time area of the graph as a whole , or to narrow the focus to affected patients.
Although the tool is capable of calculating AE incidence rates, its real value for the assessment of ongoing studies lies in the ability to display events and patient time in an adaptive and intuitive way that allows for meaningful discussion of safety data. Conclusion: Interactive data visualizations can enhance internal risk communication and clinical decision-making during ongoing clinical trials.
Introduction: In , European pregnancy prevention program for oral retinoids, i. Objective: To measure the impact of the RMMs on utilization patterns of oral retinoids, alternative medications, contraceptives, and on rates of pregnancies occurring concurrently with retinoid prescriptions.
Common analysis scripts were implemented by study sites. An interrupted time series analysis was performed to assess immediate changes after the implementation level change and over time trend change. Results: The study population comprised 11,, females of childbearing age 12—55 years , 88, persons used an oral retinoid at any point during the study period.
Monthly incidence and prevalence rates showed that retinoid prescriptions have a strong seasonal pattern with peaks of use in winter months. The low level of recording of pregnancy tests did not allow for trend analysis.
Pregnancy rates varied between 0. Conclusion: Based on the findings, there is very limited measurable impact of the RMMs among females of childbearing age in the included databases. Moreover, pregnancies still happen during oral retinoid treatment after the implementation. Updated measures for pregnancy prevention during retinoid use. Compliance with pregnancy prevention programmes of isotretinoin in Europe: a systematic review. Br J Dermatol. Isotretinoin exposure during pregnancy: a population-based study in the Netherlands.
BMJ Open ;4:e Clin Pharmacol Ther. Introduction: During the recent covid vaccination campaign, the number of ICSRs reported by patients and professionals has dramatically increased, reaching up to almost 1 M declarations only in Europe EMA numbers.
Before the covid pandemic, this system was successful in detecting ADRs from the patient reports declared through the French web national reporting system 1, 2. However, how it behaves in conditions of higher reporting flow rate is unknown at present.
The encoding of regional pharmacovigilance centers was employed as the reference ground truth to train the algorithm in a supervised manner. Moreover, a panel of three pharmacologists, with significant experience in ADRs encoding, was set-up to perform a case-by-case analysis of hundreds reports for which the algorithm provided improper encoding.
Results: Overall, Of this, Because the percentage of newly reported ADRs increased over time and was higher for vaccine than not-vaccine related reports, we split the training and validation sets in batches with similar ADRs distribution.
Performance evaluation is currently under process. Initial feedbacks from the analysis performed by the experts are showing an uneven distribution of false positive and false negative across samples. Results from the other experts are needed to confirm this finding.
Conclusion: The core findings of this study will be gathered in the forthcoming weeks and be ready for the ISoP meeting in September. This work will provide new insights about the effectiveness of deploying AI as a support to treat real world data in a context of sanitary crisis. Validation of an artificial intelligence pipeline to support the automatic coding of patient adverse drug reaction reports, using nationwide pharmacovigilance data.
Drug Safety. Introduction: The analysis of spontaneous reporting systems aims to identify potential adverse drug reactions in a timely and cost-effective manner. For their apparent simplicity, disproportionality analyses assessing the disproportionate presence of single drug-adverse event associations in spontaneous reports are rapidly expanding as a source of safety evidence complementary to clinical trials. However, the world and spontaneous reports is more complex than that: events occur in syndromes, drugs are taken in polytherapy, and patients are mosaics of multiple comorbidities.
Network science is one of the most promising approaches to tackle such complexity. Objective: To investigate the applications and promises of network science to spontaneous reporting data. Methods: We identified four key examples to highlight the potentiality of network approaches to pharmacosurveillance: multiple drug intake in suicidal attempts, iatrogenic syndromes i. Entities e.
We used co-reporting frequencies to describe cooccurrence patterns for example, polytherapy and iatrogenic syndromes. We used marginal and partial correlations to investigate the associations between entities and their direction: for example, to identify biases and secondary adverse events. We used multilevel algorithms to identify clusters of interest, and network measures to identify trends of co-reporting. Results: The multiple drug intake network showed paracetamol at the center, as a drug of choice both alone and in combinations, and common combinations separated by therapeutic area, plausibly because of availability The Covid adversome identified a cluster of drug-induced hepatic injury and arrhythmia, and a disease-related cluster with Covid infection and respiratory conditions 1.
The immunotherapy adversome identified not only the known overlap syndrome cooccurrence of myocarditis, myasthenia, and myositis , but also another cluster with hepatitis, colitis and thyroiditis. Finally, investigating reactions to oxycodone, we observed that the reporting of crime and psychosocial reactions was secondary to the reporting of drug dependence. Conclusion: Networks allow to visualize and compare individual relations, identify clusters, and gather insights into the direction of correlation e.
Networks can complement traditional descriptive and disproportionality analyses characterizing the complexity of spontaneous reporting data. Frontiers in Pharmacology. Introduction: The spontaneous reporting system SRS has proven to be a cornerstone in the early and cost-effective detection of adverse drug reactions ADRs []. Electronic Health Records EHRs are relatively untapped sources of real-world information that can be used in order to facilitate signal detection in pharmacovigilance PV.
However, utilizing the EHR for PV involves a number of critical challenges including the efficient extraction of valuable pieces of information from unstructured bulk of free-text.
Objective: To explore whether targeted searches in structured and unstructured fields in EHRs can be used as a method to detect possible cases in addition to spontaneous reports to strenghten a potential safety signal. Suspected ADRs refer to potential signals based on the analysis of spontaneous reports with insufficient evidence insight into a possible relationship between the ADR and the drug. Per potential signal, a search with a validated text-mining software tool Ctcue was performed via combined queries on both structured and unstructured data [4].
In order to perform the process of case detection systematically, a step-by step search plan was developed and applied to each signal based on:. Results: The search retrieved 27 cases with flucloxacillin induced hypokalemia.
After five confirmed cases via manual validation, no further validation was performed for the established ADRs. For each suspected ADR potential signal , one validated case was detected. Conclusion: A targeted search on structured and unstructured fields in EHRs using text-mining can be used as a method to detect additional cases next to spontaneous reports for a potential safety signal. It is recommend to implement this as a complementary method in the current pharmacovigilance system.
Evaluation of FDA safety-related drug label changes in Pharmacoepidemiol Drug Saf ;22 3 — A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee. Drug Saf ;37 12 — Raine J. Risk management: a European Regulatory view. Clinical pharmacology and therapeutics, 3 , — Research has proven that when patients are admitted to hospital, there are often changes to medication regimens 2, 3. Further research is necessary to establish if pharmacists’ interventions on ensuring safety during patients’ healthcare journey from hospital admission to discharge, differs between MDS using patients and non-MDS using patients.
Objective: The aim of this study was to analyse hospital pharmacists’ interventions for patients’ healthcare journeys for MDS using and non-MDS using patients. The study took place over four months from 1st July to 31st October There were initially admission episodes included in the study, and for each adult patient their healthcare journey from hospital admission to discharge was analysed for interventions and workforce input.
Interventions were ranked using the validated Eadon Scale 4. Results: A total of patients’ healthcare journeys were analysed. Patients whom did not have complete healthcare journeys from hospital admission to discharge were excluded. These patients had either died, had been transferred to another hospital, or were still inpatients when the study ended. There were Of the total MDS using patient journeys, Of the total non-MDS using patient journeys, Conclusion: This study has identified that the use of MDS increase the burden to pharmacist workforce input.
It is evident from the findings, that interventions may be needed for the majority of MDS using patients. It has highlighted that more significant interventions, Eadon Scale 5, are more prevalent for MDS using patients in comparison to non-MDS using patients.
Relationship of in-hospital medication modifications of elderly patients to postdischarge medications, adherence, and mortality. Ann Pharmacother. Drug changes at the interface between primary and secondary care. Int J Clin Pharmacol Ther. Eadon H. Assessing the quality of ward pharmacists’ intervention.
International Journal of Pharmacy Practice. Validation of a hospital clinical pharmacy workforce calculator: a methodology for pharmacy? International Journal of Clinical Practice. Introduction: Hypertension is a serious disease that occurs when blood pressure is persistently elevated over time 1.
During the COVID vaccination campaign, several reports of hypertension occurred in plausible temporal relationship with immunization have been reported. Data have been extract on May 8th, All other reports have been defined as non-cases. All reports in which the suspected causative agent was a COVID vaccine were used as index reports and all other reports as reference. A meta-analysis of observational studies that includes , individuals reported 13, events of blood pressure abnormal or increased 2.
These events have been often described as short periods of hypertensive response and often observed in patients with risk factors. Conclusion: Our results confirmed a signal of risk of events of elevated blood pressure following immunization with COVID vaccines. However, there is no evidence that these episodes could result in serious complication typically associated with hypertension, such as stroke, aneurysms, heart failure, myocardial infarction and chronic kidney disease.
Introduction: Intravitreal drugs such as bevacizumab, ranibizumab, and aflibercept are widely used to treat a wide range of retinal diseases. Several studies suggest that repeated injections of these drugs may lead to a sustained rising of intraocular pressure increasing risk for glaucoma. To date, a comparative safety study of these three drugs with respect to the incidence of glaucoma diagnosis has not been done. Objective: The objective of this study was to evaluate the risk of glaucoma diagnosis compared among new users of bevacizumab, ranibizumab, and aflibercept in Tuscany.
Methods: A retrospective cohort study using the Tuscan regional administrative database was conducted. Subjects with a first intravitreal injection index date between January —June were identified and followed to the first occurrence of glaucoma diagnosis. Patients with less than a five-year look-back period, those with less than one year of follow-up, and those with previous use of intravitreal dexamethasone, diagnosis of diabetes or glaucoma were excluded.
We also excluded patients for whom we could not track the first injection to bevacizumab, ranibizumab or aflibercept. Glaucoma diagnosis was identified from exemptions, diagnosis in hospital discharge records or drug dispensations. An intention-to-treat analysis was conducted to analyze risk of glaucoma diagnosis between the three drugs.
A Cox model was constructed to compute hazard ratios adjusting for age, sex comorbidities, corticosteroid use and binocularity.
The risk of incident glaucoma diagnosis compared to aflibercept was significantly higher among non-anticoagulant users who had received ranibizumab HR 2. Among anticoagulant users no statistically significant difference was observed. Moreover, we found an increase in the risk of glaucoma with ranibizumab and bevacizumab compared to aflibercept among non-anticoagulant users.
A time dependent exposure analysis is ongoing to confirm these results. Introduction: A method of time-to-onset TTO signal detection for screening unexpected temporal patterns from vaccine spontaneous report data has been published in [1]. Due to the large number of spontaneous reports associated to covid vaccines, highly significant TTO signals could be detected whereas there are no clinically relevant unexpected temporal patterns.
Methods: The revised method used only the most predictive measure [3] of the two Kolmogorov-Smirnov KS tests originally designed: the p-value of the KS test of the TTO distribution of a given event post a given vaccine against the TTO distribution of the same event post other vaccines. A threshold on the Kolmogorov-Smirnov distance, that can have values between 0 and for no difference between time-to-onset distributions and 1 for extreme differences—was set at 0.
A threshold on the p-value of the KS test was set at 0. The Vaccine Adverse Event Reporting System was prospectively frozen every week of the first quarter and the revised TTO signal detection method was prospectively applied on the two covid vaccines.
The performance in detecting events that were posteriori determined as causally related to the exposure of the covid vaccines, namely Pericarditis and Myocarditis, was retrospectively assessed. Conclusion: The revised TTO method allowed early detection of unexpected TTO patterns post exposure to covid vaccines by controlling both the level of significance and the magnitude of difference between the TTO distributions in a context of mass vaccination where individual case review is challenging.
Van Holle L et al. Using time-to-onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof-of-concept study, PDS 21 6 , — Use of logistic regression to combine two causality criteria for signal detection in vaccine spontaneous report data, Drug Safety 37 12 , — With the fast-tracked development and concurrent introduction of vaccines in all countries, there is a need for equitable safety surveillance to monitor adverse events following immunization AEFIs in high-income and low- and middle-income countries LMICs.
Reports from females made up The highest number of reports came from persons 18—44 years. Sputnik V contributed the highest percentage of AEs per vaccine for Africa. Headache, pyrexia, injection site pain, dizziness, and chills were the top 5 reported AEs for Africa and RoW. Qualitative findings revealed decisions of many funding organizations to fund safety surveillance in LMICs were influenced by considerations about country priorities, the perceived utility of the evidence generated for local decision making, and the contributions to global health by safety surveillance systems.
Funding decisions by donor organizations were influenced by country priorities and the perceived value added by data generated from safety surveillance systems in LMICs to local and global decision making. Coronavirus Vaccine Tracker. The New York Times [Internet]. Introduction: Therapeutic advances have reduced morbidity and mortality, but have led to an increase in adverse drug events ADE. This is a case-control type study, with the original information from the administrative data from the hospital information system of the public health system in Brazil-SIH-SUS, in the period from to After applying the exclusion criteria, , hospital admissions associated with at least one ADE were included in the study.
The proportion of patients with ADE in hospitalizations was 0. Drug poisoning and drug abuse are the adverse event classes most associated with increased risk of death. This study, confirm that the SIH-SUS is a robust source of data for the field of pharmacovigilance, enabling the identification of risk factors for death and facilitating the monitoring of ADEs in the hospital environment.
Mortality among patients due to adverse drug reactions that occur following hospitalisation: a meta-analysis. Prospective identification versus administrative coding of adverse drug reaction-related hospitalizations in the elderly: A comparative analysis. Pharmacoepidemiol Drug Saf. Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study.
Stausberg J, Hasford J. Drug-related admissions and hospital-acquired adverse drug events in Germany: a longitudinal analysis from to of ICDcoded routine data. Introduction: Transplant recipients are chronically ill patients, who require lifelong drug therapies to prevent reject and graft loss.
To date, there is no consensus on the optimal immunosuppressive strategy []. Objective: The aim of the study was to assess the effectiveness and safety of maintenance immunosuppressive drug therapies in kidney transplant.
Methods: A retrospective multicentre observational study, involving 4 Italian regions, was conducted based on the national transplant Information system and regional healthcare claims data. Specifically, the regional analytical datasets regarding incident patients underwent to kidney transplant in the years —19 were created using an open-source tool for distributed analysis.
Results: Overall, 3, kidney recipients were considered, of which During a median follow-up period of 4. Among safety outcomes, serious infections had the highest incidence 9.
Conclusion: In clinical practice, a significantly better benefit profile has been demonstrated for kidney recipients treated with TAC compared to CsA. In particular, the combination of TAC and mTOR appears to be the optimal strategy reducing the incidence of severe infections. Our findings on long term risk-benefit profile of immunosuppressive therapy may be helpful to define the optimal drug therapy in kidney recipients. Comparison of tacrolimus and cyclosporine for immunosuppression after renal transplantation: An updated systematic review and meta-analysis.
Saudi J Kidney Dis Transpl. Target of rapamycin inhibitors TOR-I; sirolimus and everolimus for primary immunosuppression in kidney transplant recipients. Cochrane Database Syst Rev. Timing of mTORI usage and outcomes in kidney transplant recipients. Int J Med Sci. Published Jan 9. Due to the small sample size of pivotal trials in pediatrics, real-world evidence on the safety of those vaccines in the pediatric population is urgently required. Objective: i To investigate the safety of COVID vaccines by measuring frequencies of solicited and serious adverse events following immunization AEFIs with the first and the second doses of vaccines through active surveillance and, ii to compare the results with the published clinicaltrials in children and adolescents.
Of them, only Overall, Conclusion: This study confirmed safety profile of COVID vaccines in the pediatric population as already documented in the pivotal trials, with a high frequency of local solicited adverse events and an extremely low rate of serious adverse events.
Introduction: Advances in the treatment of cancer in young patients have led to great improvements in life expectancy. However, treatment with chemo or radiotherapy causes reduction of sperm counts often to azoospermic levels that may persist for several years or be permanent. Oligospermia or azoospermia and long-lasting testicular atrophy are common adverse consequences of cancer treatment 1.
Cases of oligospermia and azoospermia were identified using MedDRA v No Dis-Rep was found for any of the 14 AA TKIs: acalabrutinib, axitinib, cabozantinib, dacomitinib, lenvatinib, neratinib, nintedanib, pazopanib, ponatinib, regorafenib, sorafenib, sunitinib, tivozanib and vandetanib. The analysis in VigiBase database yielded similar results.
Our results however, should be interpreted with caution as disproportionality analyses are hypothesis generating rather than hypothesis testing. Meistrich, M. Clinical drug investigation. Bate A, Evans S. Quantitative signal detection using spontaneous ADR reporting. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Skin lightening products contain high concentrations of harmful ingredients such as hydroquinone, mercurials, and corticosteroids, and are reported to cause serious complications such as hyperpigmentation, exogenous ochronosis, wound dehiscence, nephropathy, steroid addiction syndrome, predisposition to infections, and other endocrinologic complications.
Despite all these public health risks, they have been used in many countries without regulation and consultation of healthcare professionals 3.
Similarly, in Eritrea, there is uncontrolled marketing and use of SLAs even those with banned harmful ingredients. Objective: This study was conducted to assess the perception and utilization of SLAs among females of Asmara, the capital city of Eritrea.
Methods: A cross-sectional descriptive study was conducted in representative samples of all beauty salons available in Asmara between May and July The study participants were selected using two-stage stratified cluster sampling technique.
The data collected through face-to-face interview was entered and analyzed using CSPro 7. Results: The study enrolled females. The majority of the respondents agreed that SLAs can make someone white About two-third Of those who ever used SLAs, About half of the respondents With the use of SLAs, Employed females AOR: 1.
Conclusion: Utilization of SLAs among females was prevalent. They were satisfied with its use despite experiencing adverse effects which urges coordinated efforts in tightening the regulation of cosmetics in general and establishment of cosmetovigilance systems in particular. Widespread use of toxic skin lightening compounds: medical and psychosocial aspects.
Dermatologic Clinics, Afr Health Sci. The global prevalence and correlates of skin bleaching: a meta-analysis and meta-regression analysis. Int J Dermatol. Introduction: Drug therapy in paediatrics is often associated with uncertainties due to lack of data from clinical trials.
Due to this off-label use, missing paediatric dosage forms and complex dose calculations, medication errors ME occur up to three times more frequently compared to adults [3]. Objective: The aim of the study was to investigate the nature, characteristics and preventability of drug-related hospital admissions in paediatrics. If parents had given consent for data transfer and further analysis, the suspected ADRs resp.
MEs were subsequently validated by a blinded, independent expert team [6]. All ADRs and MEs were assessed with regard to their nature, preventability, severity and drug association. Results: Of Consent for further analysis was obtained for 9. Allergic conditions, seizures incl. Treatment noncompliance, accidental exposure to product and dosing problems mainly underdosing were primarily identified as MEs in connection with the use of antiepileptic drugs, insulins and analogues and other beta-lactam-antibacterials.
Conclusion: Drug-related hospital admissions play a significant role in paediatrics. Moreover, almost half of them are considered preventable and therefore result in unnecessary harm and treatment costs. Dosing databases, training, and systematic screening for ADRs and MEs have great potential to increase the safety of drug therapy in children.
Kimland, E. Odlind, Off-label drug use in pediatric patients. Clin Pharmacol Ther, Magalhaes, J. Eur J Clin Pharmacol, Kaushal, R. JAMA, Smyth, R. PLoS One, Gallagher, R. Schulze, C. J Patient Saf, The lack of staff trained in PV is one of the most serious limiting factors affecting the development of PV in resource-constrained settings. Previous experiences suggest that blending learning programmes can be implemented in resource-limited countries to train health care professionals HCP with remarkable gains in terms of knowledge acquisition.
Methods: We developed the blended-courses integrated with a Train of Trainers scheme [1]. Two e-learning courses were made available on a web-based application, together with a manual on how to combine the e-learning courses together with face-to-face interactions. The blended course were given in Tanzania, Eswatini and Nigeria. Results: In the three countries 95 participants were trained Table 1.
All participants completed the two courses and the mean score of the post-test was significantly greater than on the pre-test Table 1. In the second level, the participants from the first training were training others. The majority of respondents to questionnaires have been satisfied, declared they felt more involved in PV and reported at least an ADR after the training both in the first and second level.
The trends of reporting increased in the twelve months after the training if compared to the previous twelve months: vs and vs ICSRs were reported to Vigibase for Tanzania and Eswatini National Agency respectively. Conclusion: Our results demonstrated that a blended course can reach an important number of participants and improve their knowledge. It is difficult to establish how much of the increase of reports was attributed to the blended learning training. Alammary A.
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