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Soyletir of MRSA, since then a high increased have seen. The reasons for these Istanbul, TR increase are no clear. The presence of Chilean clone has been observed. Background: Bacteroides fragilis group BFG is the most commonly encountered bacteria from anaerobic infections and more resistant to R Vascular catheter infection pattern.
A temporal surveillance study of consecutive episodes in a tertiary-care hospital antmicrobial agents than the other anaerobes. However carbapenems and nitroimidazoles are the most useful antibiotics against Bacteroides, R. Nanetti Bologna, IT resistant isolates have been reported.
R Ten-year survey of co-trimoxazole and quinolone resistance in Escherichia coli causing urinary tract infections Results: The trend of CVC infections monitored among our inpatients moderately varied during the observation period cases in January- V. Xanthaki, A. Tsiringa, G. Sarantopoulos, M. Epitropaki, M. Among the most frequent organisms, Staphylococcus epidermidis accounted for the majority of Objectives: During the recent years, the treatment of choice for isolates cases: Aim of this study was to determine the change in Enterococcus faecalis 5.
Classic microbiological , and Enterobacter cloacae from 2. Antibiotic susceptibility was tested by the Kirby-Bauer Gram-negative organisms. Although the major causative agents of to Conclusion: The co-trimoxazole and quinolone resistance of Escherichia R Surveillance of antimicrobial resistance and serotype coli in urinary tract infections was highly increased during the last ten epidemiology of Streptococcus pneumoniae in Crete, Greece years, not only in hospitalised but also in community patients.
Georgiladakis, Z. Gitti, E. Nioti, G. Samonis therapies, should be based on antimicrobial resistance surveillance Heraklion, GR studies. Wenger, G. Vallet, J. Bille, G. Zanetti Methods: A total of clinical isolates of Streptococcus pneumoniae Lausanne, CH collected over a 7-year period, were studied.
Antimicrobial susceptibility testing was performed by the E-test method and the results were inter- Objectives: Empirical antibacterial therapy in hospitals is usually preted following CLSI guidelines. Hospital-wide data were compared with Results: Of the isolates tested, 82 When compared to hospital-wide Conclusion: The results of the present study indicate that continuous antibiograms, susceptibility rates were lower in ICU and surgical units for surveillance remains important for guiding empirical antibiotic treat- E.
Important differences were also observed between units for P. Distinction according to the type of sample blood vs any other site also did not show relevant differences. Hospital-wide options. Hoeck, B. Grabein, H. Just, I. Schwede, B. Copy strains are excluded. Quality control is mandatory. Data are presented V. Altouvas, A. Giannouli, O. Zarkotou, E. Sotiropoulou, in the table. Kopsari, K. Digalaki Athens, GR regarded as obsolete and was not tested or documented.
The isolates were Objectives: Urinary tract infections UTI remain the most frequent from all specimen types. Analysing the data by specimen types, urine, infections diagnosed in outpatients as well as in hospitalised patients.
According to our data all tested aminoglycosides are still appro- pneumoniae and Proteus mirabilis among urinary isolates during priate drugs. The same holds true for aztreonam, cefepime, ceftazidime, the last three years. Amoxicillin should not be used also studied. A remarkable Cefazolin R Regarding E. A more than 5-fold increase was Cefuroxime Resistance rates are presented in detail in the table.
Lebessi, E. Voulgari, E. Koemtzidou, October Kourakis, A. Tsakris Athens, GR Further work is required to investigate the clinical impact of the emergence of increased mupirocin resistance. Scotland is currently Objectives: Isolation of metallo-b-lactamase MBL -producing Gram- conducting pilot studies into the viability of universally screening negative bacteria represents a serious health care problem.
Recently, patients for the presence of nasal MRSA upon admission. We present a case of MBL- producing E. The neonate was not treated with antibiotics and the mother had no exposure to antibiotics during pregnancy. Surveillance swabs were taken from the rectum upon admission and cultured in selective medium.
Figure 1. MRSA mupirocin bacteraemic isolates to Results: A strain of E. Etest-MBL was positive, indicating production of F. Galani, K. Orlandou, F. Kontopidou, H. Giamarellou MBL. The neonate was discharged two days after the admission in good condition. Such a study by antimicrobial agents.
Methods: A. Clinical samples were: bronchial secretions A. Wilson, S. Cairns Glasgow, UK It is used routinely for the elimination of instructions. CLSI interpretative criteria and guidelines were used. This sulfamethoxazole Among MRSA isolates. Out of meropenem Methods: Scotland participates in the European Antimicrobial Resis- resistant strains 22 Validated data collected over a two year period will be analysed for the Conclusion: Colistin remains active to the majority of A.
Further studies are needed to isolates resistant to mupirocin within the time period January to establish the extend to which tigecycline is useful in colistin resistant October Plasmid mediated CMY ampC was detected in all isolates. CTX-M found is plasmid mediated and, therefore, represents a V. The majority of these isolates correspond to multidrug resistant producers. The aim of this study was to investigate the presence of the genetic elements, the class 1 integrons as well as of R Clones, antibiotypes and virulence genotypes of group C SGI 1 in the resistant and MDR S.
Typhimurium DT and U strains. Bexiga, S. Nunes, L. Cavaco, C. Vilela, were included in this study. The strains were tested for susceptibility to I. Santos-Sanches Caparica, Lisbon, PT eleven antibiotics by the disk agar diffusion method on Mueller-Hinton Objectives: To determine the clonality, resistance to macrolides, agar plates.
This same multidrug resistance was from bovine mastitis milk samples collected at Portuguese herds also expressed by the 14 strains of U phagetype. The dominant during — Among sequencing of the 16S rDNA gene. Antimicrobial resistance 1. Part of the isolates Republic under the project Molecular analysis of antibiotic resistance Among all isolates, the following associations of virulence genes were of nontyphoid salmonella serovars.
Phage lysates were obtained from part of the putative lysogenic cultures. R Ocurrence of blaCTX-M gene in multidrug-resistant Conclusion: These results suggest an environmental source rather than Citrobacter freundii contagious origin of bovine GCS causing mastitis in Portuguese farms. Paradela, J. Velez, E. Ramalheira, T. Walsh, S. PCR, nucleotide sequencing and sequence G. Nistor, A. Bancescu, M. Andrei, S. Barbuceanu, analysis was employed to detect b-lactamase encoding genes.
However, these streptococci are often involved in the aetiology of different pyogenic infections. The aim of the present R In vitro activity of tigecycline versus imipenem and versus vancomycin and linezolid against clinical study was to investigate the susceptibility of anginosus streptococci isolates of ESBL-producing E.
Haefner, S. Lemmen Aachen, DE tract infections mostly oral abscesses and sinusitis. The aim of this study was to compare the tests. The investigation of the susceptibility of the isolates to: local in vitro activity of Tigecycline with Imipenem against ESBL- penicillin G, amoxicillin, erythromycin, clindamycin, chloramphenicol producing Enterobacteriaceae and with Vancomycin and Linezolid and tetracycline was performed by the Etest AB Biodisk, Solna, against Methicillin resistant S.
The phenotype of erythromycin resistance was detected using Methods: clinical isolates 70 E. The MICs values varied between: 0. Reduced susceptibility to b-lactam expert system BD, Germany was applied, MIC testing was performed antibiotics was found among the strains belonging to S. Almost half of the total number of the isolates were resistant to tetracycline. Conclusions: The results indicated that the susceptibility of the oral streptococci isolates of clinical importance should be periodically tested, mainly to the widely-used antibiotics.
Clindamycin was fully active as chloramphenicol and might represent a therapeutical alternative for patients allergic to b-lactam antibiotics, while tetracycline is not recommended in infections in which oral streptococci are involved. R Daptomycin susceptibility in methicillin-resistant Staphy- lococcus aureus strains isolated from paediatric patients R.
Castagnola Genoa, IT Objective: Daptomycin is a cyclic lipopeptide antibiotic that is rapidly bactericidal in vitro against a broad spectrum of Gram-positive bacteria. MICs of tigecycline, vancomycin and linezolid against MRSA Its mechanism of action involves calcium-dependent binding to the strains.
Resistance is rare. The aim of our study is the evaluation of daptomycin susceptibility in MRSA strains isolated in paediatric patients. Methods: MRSA strains isolated from 74 paediatric patients, between and , were studied.
Of all this strains None of this strains were vancomycin and linezolide resistant. The minimum inhibitory concentration MIC of daptomycin were determined by using E test. Moreover we studied the eventual slime production using Congo red agar. Result: All strains of staphylococci were susceptible to daptomycin and MICs values were between 0. None of 74 MRSA strains were slime producers. Conclusion: The increasing prevalence of Methicillin-Resistant Staphy- lococcus aureus requires the need to search for more effective agents.
Vancomycin remains the reference standard for the treatment of systemic infection caused by MRSA. However the need for alternative therapies MIC distribution of tigecycline and imipenem against E. Klebsiella sp. Results: The tested strains presented different behaviours in their All MRSA strains were sensitive against the tested antibiotics, thus interaction with cellular and inert substrata in the presence of antibiotics Tigecycline can be used for the indications studied and recommended.
In the case of E. Oliveira Nunes, A. Delamare, F. Formolo, L. For S. The biological activity of substratum. The capacity of adherence to the inert substratum was not this plant has been attributed to its essential oil. These chemotypes are characterised by host immune effectors. For the E.
Bacterial or yeast growth was evaluated in I. Bernatoniene Vilnius, LT a microtiter plate reader at nm. Local data on antimicrobial Results: The results obtained showed that the antimicrobial and resistance is necessary in the empirical therapy. The most was to evaluate antimicrobial resistance of SP in — In general, criteria. Gram-positive bacteria species were more sensitive than Gram-negative Results: Overall rates of resistance to antimicrobial agents in SP are ones.
Citral, carvone and limonene were the most Antimicrobial agent S. Sterile sites Non-sterile sites Conclusion: These data showed that antimicrobial activity is highly dependent of essential oil composition, and this fact should be take in Penicillin 2.
Erythromycin Bleotu, C. Iordache, Conclusions: Highest rate of resistance has been observed for A. Stanciuc, C. Delcaru-Larion, O. Banu, V. Resistance to penicillin is low at present and resistance range was lowest against isolates from blood and CSF.
Methods: This study was performed on two E. Susceptibility according to the infection site and microorganism strains isolated from human faecal samples were evaluated with regard to the antibiotic resistance. Probiotic lyophilised stock culture Acinetobacter 22 36 31 31 31 31 27 50 0 90 86 0. Klebsiella spp. Serratia 13 53 76 61 92 0 1 1 marcescens The effect of UV on antibiotic and susceptibility was examined for 3 Staphylococcus 73 65 79 0.
Escherichia 58 98 86 70 86 86 79 Respiratory tract Acinetobacter 21 33 4 4 9 9 9 9 0 76 0. R In vitro activity of tigecycline and other broad spectrum Escherichia coli 9 77 66 77 88 77 Leal, G. Buitrago, J. Ovalle, C. Alvarez, Staphylococcus 32 59 68 0. Castillo, J. La Rotta, S. Surgical site infection Acinetobacter 12 66 66 58 75 66 66 75 0 91 83 0.
Surveillance studies spp. Escherichia 43 81 79 69 79 79 74 14 27 0. Serratia 4 75 25 75 75 0 0. Microorganisms isolated from hospitalised patients aureus with a microbiologically proven diagnosis of infection were sent to a Enterococcus 13 0. Antimicrobial activity was tested by a microdilution Bone 32 method for tigecycline Trek diagnostics, London and other broad spec- Acinetobacter 6 16 16 0 33 33 16 16 0 83 83 0.
For Enterobacter 2 50 50 50 50 50 50 50 0. Escherichia 4 75 0 50 0. No Pseudomonas species were collected. Isolates were recovered from blood- Staphylococcus 13 53 84 0. Susceptibility spp. The lack of in vitro antagonism between R Anti-picornaviral activity of novel pirodavir derivatives PTZ and tobramycin indicates that this empirical combination to R. Timpanaro, A. Garozzo, B. Castro, S. Laconi, provide adequate anti-pseudomonal coverage warrants further study.
Pompei Catania, Cagliari, IT Objectives: The early steps of the Picornavirus replicative cycle seem to be priviledged targets for some antiviral compounds like Disoxaril and Pirodavir.
These drugs were shown to be strong inhibitors of virus adsorption in Picornavirus infected HeLa cells. On the basis of drug sensitivity, the division of Rhinovirus in groups A and B was proposed. Pirodavir was shown to be effective on both several group A and B strains of Rhinoviruses. The main weakness of Pirodavir is its cytotoxicity on cell cultures at relatively low doses.
Poliovirus 1, Echovirus 6, 9, 11, Figure: Effect of the combination of two carbapenems with tobramycin were propagated in HEp-2 cell culture. Coxsackievirus B1 and A9 were 0.
The antiviral activity assay was carried passages of P. Results: The substitution of the oxygen atom in the central chain of Pirodavir with an amino group resulted in an increased antiviral activity against Echo and Coxsackie viruses, although a decreased activity R PTZ evaluation of the pharmacokinetics following against Rhinoviruses and Poliovirus was observed.
Compound I was single intravenous administration with and without about ten times less toxic than Pirodavir, but it was equally active. The cilastatin to male Sprague-Dawley rats and beagle dogs substitution of the oxygen atom in the central chain with a thio group as A. Fiorentini, G. Di Gallo, L. The objective of this study was to investigate lower cytotoxicity and that a higher PI against some Picornaviruses can the pharmacokinetics of PTZ in Sprague-Dawley rats and in beagle be obtained starting from the Pirodavir.
Hamrick, M. Corrigan, D. Pevear, C. Burns, L. Xerri 3 male dogs housed singly in metabolic cages for concomitant urine Malvern, US collection. Results: In rats, the systemic clearance CL of PTZ administered Objectives: Evaluate the potential for antagonism between tobramycin alone was high Renal clearance CLr , 2. Coadministration with cilastatin resistant Gram-positive and Gram-negative bacteria, and study the effect increased by 10 times the systemic exposure AUC0-inf: In dogs, PTZ CL without cilastatin multiple resistance mechanisms, were performed daily for 20 days in 4.
The inoculum for each subsequent passage was taken from 0. In a lack of antagonism between PTZ and tobramycin. On the basis of these results, Results: Following 20 passages of P. The objective of our experiment at reducing the kidney burden. The spider silk then dissolved in hydrochloric acid C.
Karaca, N. Kreischitz, W. Graninger, A. Georgopoulos and acetic acid v:v and neutralised with sodium hydroxide. The MIC values were ethoxyethyl-guanidinium-chlorid], show broad in vitro activity against determined after serial dilution of the protein in liquid M H broth in bacteria and fungi. The aim of this pilotstudy was to evaluate the activity micro dilution plates followed by challenge with different microbes and of the novel polymeric guanidines against the non-pathogenic reference measuring absorbances at nm in Micronaut system Germany.
Conclusion: Cob web protein showed prominent antibacterial activities. In each case the reduction factor and Candida albicans in murine models of sepsis between prevalue and postvalue was calculated. Sharp, S. After Objectives: Humic acid is a major component of humic substances single and double application of kalisoap alone mean reductions factors which are dark brown constituents of soil organic matter formed by of 9.
Male CD1 hygienic handwash. In the C. Pompilio, C. Picciani, M. Treatment started 1 hour post M. Benincasa, A. Di Primio, R. Piccolomini, E. Fiscarelli, R.
Gennaro infection. Physicians are increasingly faced with infection animals were euthanised 50 h MRSA or 53 h Candida post infection. The peptides included members of the alfa-helical group had high burdens 3. All assays were resistant Acinetobacter baumannii isolates performed at least in duplicated and repeated twice.
Since it has an extraordinary ability to acquire antibiotic against P. For these reasons, the aim of the by S. Escherichia coli ATCC was used as a control strain. R Outcomes of pan-resistant Acinetobacter baumannii Tests for the susceptibility to meropenem and tigecycline were performed infections treated with tigecycline by the broth microdilution method as recommended by CLSI guidelines. The MICs of colistin methanesulfonate were determined by using a A. Tezer Tekce, B. Mert Dinc, H.
Cabadak, N. Sen Ankara, TR The effects of antibiotics in combination were assessed by using the microbroth checkerboard technique. Tigecycline Education and Research Hospital, a bed, tertiary care hospital. All adult patients who received tigecycline at least 5 days for treatment demonstrated excellent inhibitory activity against A. Tigecycline susceptibility was determined resistant to meropenem. According to our results, with a FIC index using the Etest method.
It should be pointed out that additive Results: Tigecycline therapy was administered to thirteen patients interaction was more frequent. No antagonism was observed. Of these, 11 patients who Conclusion: Tigecycline exhibited potent in vitro antibacterial activity received tigecycline at least 5 days included in the study.
Mean age against clinical A. The results of combination of the patients was All of the patients had comorbidities, 6 All of the patients were followed up in ICUs. The mean time between hospital admission to the development of pan-resistant A. Ten of the patients had surgical operation. Enterobacteriaceae clinical isolates Seven Seven S. Georgiladakis, A. Christidou, Z. Gitti, G. Samonis Objective: To evaluate the in vitro activity of tigecycline against The mean duration of the tigecycline treatment was Five patients had additional nosocomial infections.
Three patients had a fatal outcome and two deaths were over a month period, were studied. The minimum inhibitory thought to be related to the A. The mean interval concentrations MICs for tigecycline and 14 other antimicrobial agents from the initiation of tigecycline treatment to death was 7. All of the patients with fatal outcome and CLSI MS18 breakpoints were used to interpret all other agents, had surgical site infection.
No microbiological failure was observed where applicable. All E. As a consequence, both these compounds were setting. In the meantime, an active, systematic surveillance effective therapeutic options program interested the entire Hospital with special focus on surgery R. The micro- Introduction: Multiresistant Gram-positive cocci, including Staphylo- cluster of 6 cases of multiresistant A.
The selection of eventual, synergistic agents may be conducted are of concern, and broad-spectrum antibiotics are widely used in the empirically, or better with the aid of enlarged in vitro susceptibility environment. The spectrum of antimicrobial compounds now available assays. Svetoch, B. Eruslanov, Y. Kovalev, E. Mitsevich, V. Levchuk, N. Fursova, V.
Perelygin, also methicillin-resistant staphylococci, and a number of experimental Y. Stepanshin, B. Seal, N. Susceptibilities available compounds compared with the standard of care of treatment of were determined by Kirby-Bauer disc-diffusion assays using 12 resistant Gram-positive infections, and an updated overwiew of data on antibiotics belonging to different functional groups.
Extended investigation, are updated and outlined on the ground of an extensive spectrum b-lactamase ESBL genes were detected using a standardised review of all available, recent evidences coming from clinical trials polymerase chain reaction PCR method.
ESBL genes were detected in 27 of strains in orthopaedics setting. Effective treatment with the 32 C. In conclusion, for the 64 diverse clinical isolates tested, antibiotic Methods and Results: Six unrelated cases of A. The potentials for application during Oct Jun , at a specialised Orthopedics Hospital of of bacteriocins in clinical settings as therapeutic agents appear quite Bologna, Italy.
In all cases a concurrent, local polymicrobial infection promising. The a tertiary care hospital structure of the active principle was elucidated by Mass spectroscopy, S. Georgiladakis, E. These results revealed that the compound is 6- ethoxymethyl -tetrahydro-2H-pyran-2, 3, 4, 5-tetraol Objective: Tigecycline is a glycylcycline with promising broad-spectrum compound with 1-isopropylmethoxybenzene.
The compound was activity, including resistant Gram-positive organisms. We compared found responsible for antifungal activity against both F. 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. With a prescription from your doctor, you can buy Robax Platinum Muscle Relaxant Methocarbamol Ibuprofen to relieve the pain associated. Fast shipping. Montreal laser. Our prices on Prozac tablets cannot be.
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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. Blended learning models for introductory programming courses: a systematic review.
Plos one. The views and opinions of authors expressed herein do not necessarily state or reflect those of EDCTP. Introduction: Considering data from the literature in favor of active educational intervention to teach pharmacovigilance, we describe an innovative model of distance learning clinical reasoning sessions CRS of pharmacovigilance with 3rd year medical French students.
Objective: The three main objectives were to identify the elements necessary for the diagnosis of an adverse drug reaction, report an adverse drug reaction and perform drug causality assessment. Methods: The training was organized in 3 stages.
First, students practiced clinical reasoning CRS by conducting fictive pharmacovigilance telehealth consultations. Second, students wrote a medical letter summarizing the telehealth consultation and analyzing the drug causality assessment.
This letter was sent to the teacher for a graded evaluation. In the third stage was a debriefing course with all the students. Results: Of the third-year medical students enrolled in this course, participated in the distance learning CRS. The evaluation received feedback from students, with an average score of 8.
The qualitative evaluation had only positive feedback. The students appreciated the different format of the teaching, with the possibility to be active.