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Free Delivery! Research in Social and Administrative Pharmacy ; 1: — Spironolactone clopidogrel clopidogrel Cod Next Day clopidogrel Cheapest community. It is recommend to implement this as a complementary method in the current pharmacovigilance system. Pengirim : eberurafibiut – [irizekv ixmail. Serratia 4 75 25 75 75 0 0. Drug poisoning and drug abuse are the adverse event classes most associated with increased risk of death. Pengirim : amimghuroru – [avpiqex omofu. 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. Chuang, Y.
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The higher and anaerobic bacteria including multidrug resistant Gram positive and adhesion was observed with the adapted bacteria onto the conditioned Gram negative pathogens. PET coupons. These results highlight that the extent of adhesion is Trigecyclin was found to exhibit large volume of distribution in healthy greater the higher are the stress factors.
The strength of adhesion is also humans, indicating extensive tissue distribution and half-life elimination higher in the case of adapted bacteria since detachment only occurs with of 37 to 67 hours. Nevertheless, BZK attack causes loss of viability of the cells that Objectives: To measure T accumulation to body tissues at steady state remained adhered to the surfaces, this loss being more notorious in the in order to construct a full body physiological based PK model and to case of non adapted cells adhered in the conditioned surfaces.
After a on the adhesion surfaces did not impair the bacterial adhesion capacity loading IV dose of 75 mg T in 15 min, animals received It can also be concluded during a 2. Blood sample measurement at 60, 45, 30 and a common antimicrobial agent increased its adherence ability and 15 min prior and immediately after the end of the 2.
At the end of the 2. Tissue samples were taken to determine the eradication of pathogenic bacteria with increased virulence from drug accumulation. Blood samples were centrifuged at rpm for equipment and surfaces in the medical arenas. Poulakou, M. Souli, N. Lambri, Z. Chryssouli, Gallbladder Kanellakopoulou, H. Giamarellou Athens, GR Bile In view of Results: The result are presented in the table.
S 19th ECCMID, Abstracts accepted for publication only Conclusion: Results show that in rabbits T accumulates to well perfused fruiting body of macro fungi particularly to the members of Agaricales, tissues such as kidneys, liver, spleen, muscle and testicular tissue. Due edible as well as highly poisonous species. Medicinal mushrooms have to its hydrophilic nature tigecycline concentration in fat tissues is low been used in folk medicine throughout the world since the ancient times.
The present investigation aims to study the antimicrobial activity of medicinal mushroom namely Ganoderma Reishi. Waters, H. Sader, G. Moet North Liberty, US method and determination minimum inhibitory concentration by standard tube agglutination.
However, Assay susceptibility tests employed the CLSI M7-A7 method with 20 further separation and fraction of polysaccharide fractions need to be incremental dilutions steps between 0. Only MIC assays are presented. Doustdar, P. Farnia, A. Selection of generic products inhA regulatory region and oxyR-ahpC intergenic region. Results: The RL polymorphism in katG gene was detected with high frequency in both Isoniazid resistant and sensitive isolates.
The ahpC 46A was the most common mutation in the oxyR-ahpC intergenic region which was present in R Antimicrobial effect of polysaccharide extract of Ganoderma on some pathogen microorganisms R The accumulation of resistance mutations in Mycobacterium A.
Jahedi, M. Naghmachi Yasuj, IR tuberculosis in vitro I. Bergval, A. Schuitema, P. Klatser, R. Due to emergence of resistance to antibiotics amongst microorganisms, investigations for Objectives: In Mycobacterium tuberculosis MTB , antibiotic resistance novel antimicrobial agents have always been one of the major pre- is almost exclusively established by point mutations.
Multidrug- occupations of the medical society. Although the acquisition of resistance mutations is random, the genetic routes leading to the development of successful and virulent R High prevalence of mefE gene among macrolide-resistant Streptococcus pneumoniae isolates in Istanbul multi drug-resistant bacteria may be quite constrained Weinreich DM et al. Aksu, U. Over-Hasdemir Istanbul, TR of the strain in question. Macrolide MDR strains. Drug-resistant mutants were macrolides, lincosamids, or streptogramin B.
Methods: The prevalence of erythromycine resistance have been Results: Different clades have a preference for different distributions determined by disk diffusion method in 91 S. Most found to be resistant to erythromycin in disk diffusion test. The presence of mef genes and ermB genes were analysed resistance. Our results for the erythromycin resistant isolates were in cMLSB phenotype and 2 were in variation in distribution of spontaneous rpoB mutations between different M phenotype Table 1.
Phenotypic and genotypic test results in erythromycin resistant S. Clin Microbiol These results suggest the sequence Resistance phenotype No.
Bifidobacterium strains B. Sulaiman, F. Mustafa, Z. Sekawi, H. Ghazali, range. Of the 26 erytromycin resistant strains, 14 Hussin, B. Kabeir, A. Four different levels of pH were used 5. Adhesion was S. The evaluation ability of B. Nilgate, Y. Poovorawan Bangkok, TH for both strains were at pH level 5. The ability to inhibit the adhesion or competitive increasing problem worldwide. Other mechanisms Conclusion: Our results indicate that the ability to adhere and inhibit of resistance include mutations in 23S rRNA and ribosomal proteins L4 adhesion of pathogens can be used for preliminary screening in order and L The aim of this study was to investigate the prevalence and to identify potentially probiotic bacteria suitable for human or animal molecular mechanisms of macrolide resistance in invasive S.
Methods: A total of invasive S. Mutations in the genes encoding domain V of the four carbapenems and metronidazole. University Hospital. The specimens were collected, transported, and Results: Of the invasive S. Of the 36 erythromycin- 5-nitroimidazole were performed according to recommendations of CLSI resistant isolates, 12 There were no resistant strains against metronidazole.
Metronidazole resistance genes were not detected among all strains. Only B. Four strains of B. Rachdi, M. Hraoui, M. Saidani, I. Boutiba-Ben Boubaker, S. For the present, it looks like there was no risk for metronidazole resistance. A to be important to monitor B. MICs were determined by E-test for erythromycin, clarithromycin, clindamycin, Resistance surveillance azithromycin, quinupristin-dalfopristin and linezolid. Most erythromycin resistant isolates were recovered A.
Merentes, J. Delgado, R. Linezolid and Venezuela has a national surveillance program for bacterial resistance quinupristin-dalfopristin showed excellent activity MIC 0. We present here the historic evolution of S. Neither resistance to b-lactam nor high level in our country. All strains categorised as M phenotype carried the mefA system. The Whonet software was used for prospective data entry and gene in 7. For data management the Epi Info 3. MLSB constitutive phenotype conferring cross- computing were used.
Dengel Uzunkaya, N. Karavus, G. 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.
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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.
Conclusion: Through distance CRS of pharmacovigilance, medical students’ competences to identify and report adverse drug reactions were tested. The students experienced the pharmacovigilance skills necessary to detect adverse drug reactions in a manner directly relevant to patient care.
The overall evaluation of the students is in favor of this type of method. Methods: This research used a qualitative inductive methodology through thematic analysis. The first step was to identify, through a literature review, current practices for herbal pharmacovigilance. Based on the findings a semi-structured interview guide was designed, and purposive sampling was used to recruit the interview participants.
By using a snowballing technique more potential participants were reached. Most of these recommendations are applicable worldwide, while some are limited to certain regions. Tong, A. Consolidated criteria for reporting qualitative research COREQ : a item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19 6 , — Introduction: Although medical cannabis MC has been available in Canada since , lack of recognition of MC as a drug has restricted patient access.
The Quebec College of Physicians, between and , authorized MC use only within a research framework. Follow-up ended due to either MC discontinuation, loss to follow-up, 3 years follow-up, or end of data collection May , 6 months after the last patient in. Data were collected at inclusion and at follow-up visits every 3 months for the first 2 years, then at least once per year in the third year. MC mode of administration ingestion, inhalation, other , and cannabinoid content ratio tetrahydrocannabinol THC -dominant, cannabidiol CBD -dominant, or balanced were documented.
Results: 2, patients were enrolled in the registry mean age Over follow-up, 3. Reports included a total of AEs average 1. The most common PTs were dizziness Conclusion: There were no new safety concerns identified in the Registry, although notable differences in AE profile between modes of administration and cannabinoid content ratios should be considered by health professionals.
Further work identifying and managing risk factors for AEs is warranted to maintain a favorable risk-benefit ratio for MC. Introduction: Dengue is one of top ten global health threats and is a serious burden in the Philippines. Dengvaxia immunization program was launched on April for children 9—year-olds in three regions with high statistics of dengue, hospitalization, and deaths. This was coincidentally the campaign period for national elections. Use of vaccine, once available, was part of a strategy to control epidemic.
Current measures were inadequate. What started as vaccine-vigilance information sparked a public outcry. This led to a series of parliamentary investigations, traditional and social media misinformation and disinformation vilifying the health decision makers and the company, and criminal charges filed against over 20 individuals by the state over alleged unproven vaccine caused deaths.
Despite attempts to correct these narratives by a few health professionals, the damage to institution, the program, the product, and individuals have been done. The consequences of such actions of emotional approach without understanding the science have resulted in creating general vaccine rejection, hesitancy, other outbreaks such as measles, lowered confidence even with recent COVID vaccines.
Objective: This abstract aim to describe the situation at that time in the Philippines and extract lessons that will inform better risk communications during crisis. Results: Some of the important lessons learned are in risk management and communications.
Adverse health product information should be announced with circumspect considering the level of health literacy and risk appreciation in a country. Partisan politics interfered with poorly understood science, fueled by imprudent comments by officials and health professionals who spoke out of turn, amplified by the media and created chaos.
The fear was so palpable that enlightened health professionals refused to provide countervailing facts. Reinstating the vaccine would be perceived as the government had back-pedaled on a mistake. In the meantime, the drama contributed to vaccination hesitancy and outbreaks.
Conclusion: Public health decisions are policy and regulatory decisions anchored in ethical and utilitarian principles. Edillo et al. Economic Cost and Burden of Dengue in the Philippines. Vannice, et al Mendoza, Dayrit, Valenzuela. Dengue researcher faces charges in vaccine fiasco. Lasco et. Medical populism and immunisation programmes: Illustrative examples and consequences for public health. Trolleyology and the Dengue Vaccine Dilemma. Dayrit, Mendoza, Valenzuela The importance of effective risk communication and transparency: lessons from the dengue vaccine controversy in the Philippines.
Dengue vaccination: a more balanced approach is needed. Introduction: Vaccines are vital tools to control epidemic and pandemic diseases, such as COVID, demonstrating safety and effectiveness.
However, rare adverse events of special interest AESIs following vaccination arise with every new emerging pathogen vaccine program. Adversomics, a set of technologies that measure the inventory of molecules e. The International Network of Special Immunization Services INSIS brings together vaccine safety, public health, and systems biology experts in middle- and high-income countries to investigate the causes of, and identify strategies to mitigate AESIs following vaccination insisvaccine.
Brighton Collaboration case definitions and harmonized protocols will be employed to collect detailed clinical data and serial blood samples suitable for adversomics e.
Integration of clinical and biological data will enable comparisons of analyte levels and immune responses within groups over time and between cases and controls. Global collaboration across five continents will ensure adequate sample size. Conclusion: INSIS-led studies will provide insight into pathways triggered in these AESIs and susceptible populations to inform vaccine development strategies to reduce the potential to trigger pathways involved in AESIs, risk-benefit assessment, and personalized vaccination strategies.
Introduction: During the covid 19 period, several countries needed to set up or develop their pharmacovigilance systems, unfortunately containment and the closure of borders prevented the organisation of classic training sessions.
Objective: The objective of this work is to present the pharmacovigilance simulation game developed by CAPM, RCC and the results of its pilot use with pharmacovigilants from 10 French-speaking African countries. The game is based on good practices in Pharmacovigilance PV , and inspired by the different WHO guidelines, the experience of the Moroccan PV center, and behaviors consensually considered as the norm in PV.
In fact, they are put in a real-life situation to choose actions and strategies for the development of a PV center and must be able to optimize the human and material resources at their disposal to make their center shine within their national health system but also at the level of the international PV network.
Better understand the challenges and outlooks linked to the creation and management of a PV center. Put into practice the theoretical concepts in causality assessment, signal detection and risk minimization actions. During the game, within 10 levels, participants have to set up a PV center following WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems as structural indicators, process indicators and outcome indicators, and following the pharmacovigilance process from collecting data, analyzing them, detecting signals, and setting up national technical pharmacovigilance committee to discuss about safety signals and risk minimization actions to put in place.
Conclusion: The use of the game by the pharmacovigilantes during the pilot phase gave good feedback on the ease of use and the effectiveness of the game in capacity building in pharmacovigilance.
University of Huddersfield, Huddersfield, pp. Introduction: Pharmacovigilance has traditionally been a reactive science with a significant dependence on spontaneous adverse event reporting. The pandemic on the other hand has accelerated application of novel technologies and approaches to engaging with the patient, remote connected care at their home and dependence on technologies to supplement regular communication channels.
Telemedicine is evolving rapidly and playing a key role in clinical interventions. Objective: Digital Health and novel technologies offer a significant opportunity to enhance pharmacovigilance thru proactive patient monitoring, risk communication, personalized care plans and access to real world data.
Leveraging such approaches will not only lead to early detection of risks but also to personalized interventions and improved patient outcomes. Educational material which is more interactive, visual and multi-dimensional can replace paper or text based risk communication material. This could provide early signal detection in individual patients and enable proactive patient level pharmacovigilance.
Educational and risk related material can be dynamically updated based on patient preferences, interactions and profiles. Machine learning approaches which link material with outcome can enhance impact of pharmacovigilance methods and tools. In order to utilize the full potential of such options it is critical that the regulatory framework is updated to enable such approaches which complement traditional PV and can drive efficiencies and higher effectiveness in the risk communication process.
Collaboration within the network of industry and regulators is essential to further such research and maximize the impact on value for patients, HCPs and sponsors. Introduction: Large amounts of data associated with safety issues are generated along the entire lifetime of drugs, from its infancy as preclinical leads, through its adolescence as clinical candidates, all the way up to its adulthood as marketed drugs exposed to the human population.
Across the different stages in the life of a drug, some of the data collected initially may be confirmed and consolidated with data at an advanced stage, whereas other data may not be translated, and in some cases may even contradict, those safety signals that are ultimately observed in the human population.
Collecting and properly integrating such an heterogenous pool of data is a complex and tedious task. But even if one manages to put all data together, the construction of useful models to anticipate and detect drug safety signals remains a challenge. Objective: The presentation will cover our efforts to connect data from in vitro safety pharmacology, preclinical toxicology, clinical safety and post-marketing spontaneous reports for over 9, small molecule drugs, combination drugs, and biologics.
A novel consensus approach using various statistical and machine learning methods to anticipate side effects of potential safety concern, detect adverse drug reaction signals and perform pharmacovigilance analyses will be introduced. Use case application examples to individual drugs and drug classes will be discussed.
Methods: Our consensus approach to post-marketing surveillance integrates four different methodologies based on detection of prior safety markers, identification of class reactions, statistical projection of disproportionalities based on reporting frequencies and velocities, and machine learning models of translational safety data.
Results: Results on the validation of our approach to anticipating adverse drug reactions of safety concern to the population at the postmarketing stage based on i in vitro safety pharmacology data, ii preclinical toxicology data, iii clinical safety data and iv the first sample of 25 postmarketing spontaneous reports will be presented. Based on data available in each case, the performance of the different methods varies for different drugs, drug classes, and side effects.
A discussion on performances in selected use cases will be included. As an example, the analysis of long-term PARP inhibition on circadian patterns and its dependence on the reporting bias by consumers will be discussed. Conclusion: Integration and modelling of the large amount of translational safety data currently available from all phases of drug discovery, development and post-marketing to anticipate and follow adverse drug reactions opens an avenue to a whole new perspective in pharmacovigilance.
Introduction: Psychedelics are unique psychoactive chemicals that can change consciousness by acting on 5-HT2A receptors []. There is limited knowledge concerning the online interest in psychedelics that we can extrapolate via trends websites. Objective: We aim to examine the online information-seeking behavior concerning the most popular psychedelics, including cannabis—a quasi-psychedelic—in the European Union EU members of interest and the UK before and during the pandemic.
Methods: We designed a “dictionary” of terms to extract online search data from Google Trends concerning psychedelics and cannabis from Jan to 1-Jan We conducted a triple Holt-Winters exponential smoothing—additive model—for time series analysis to infer seasonality [4, 5].
We utilized hierarchical clustering—an unsupervised machine learning method—to explore clusters of countries concerning the spatial geographic mapping of these chemicals.
We also implemented—a t-test—for comparing the slope difference of two trends before versus during the pandemic. Results: There was an evident seasonal pattern for cannabis, NBOMe, and psilocybin in almost all nations of interest. Similar patterns existed in France and the UK, while those in Germany, Sweden, and Romania had relatively shorter periodicity. Analysis of slopes and hierarchical clustering conveyed differentiated patterns concerning the temporal and spatial mapping, respectively, while contrasting the two periods before versus during the pandemic.
Conclusion: Cannabis and psychedelics follow somewhat a consistent pattern concerning seasonality across Europe; some correlate with the seasonal harvesting of mushrooms, and others with public holidays, including Christmas, the new year holiday, or school breaks.
The pandemic influenced some significant changes concerning the online interest in the EU and the UK; nonetheless, we should rely on more rigorous longitudinal and experimental study designs—possessing a superior level of evidence—to confirm the causal relationship. However, these patterns might be insightful for decision-makers and regulatory authorities—like the EMCDDA—to prognosticate and prevent addiction catastrophes.
Understanding and using time series analyses in addiction research. Carhart-Harris RL. How do psychedelics work?. Current Opinion in Psychiatry. Novel psychoactive substances: types, mechanisms of action, and effects.
British Medical Journal. Robust forecasting with exponential and Holt—Winters smoothing. Journal of Forecasting. Gardner Jr ES. Exponential smoothing: The state of the art—Part II. International Journal of Forecasting. Introduction: Continuous monitoring of the safety profile of drugs is one of the critical processes of pharmacovigilance. As medical literature might be valuable source of safety data, especially for rare, unlisted, serious cases, all MAHs are obliged to medical literature monitoring MLM in all marketing countries [1].
This approach can be changed through modern automation techniques. Objective: To develop and test a tool for automated monitoring of local literature and enhance drug safety data identification. Methods: Modern programming approaches were used to create PV platform, intended for automated literature screening. GAMP 5 recommendations were used to prove the validation status. Results: We developed a tool—DrugCard PV platform which screens local medical sources for updates on a weekly basis.
Till May we added around local journals originated from 10 countries that cover different therapeutic areas. Our tool automatically searches for defined keywords drug trade names, active substances in published articles.
Different file formats can be screened including text, pdfs, images etc. In case a new issue of a journal is published—a PV specialist will receive an email notification. The mandatory features of a validated computerized system, like audit trail, logs, reports are also present here. Instead of manual reading of the whole journal issue the user only should read a separate article, analyze whether there is a valuable safety data and label it depending on the content. PV specialists may work together inside the platform and provide a quality check for labeled articles.
Our pilot study of how a new tool may improve the efficiency revealed interesting results. Despite the dramatically decreased amount of time needed, the number of identified ICRSs from literature increased.
During the abovementioned pilot study of automated local literature monitoring lasting 2 months, 31 safety cases were identified valid and non-valid ICSRs. This is much more than usual rate of safety cases finding. It offers increasing efficiency in safety information identification with less time spent on routine activities.
Certificate of copyright in Ukraine. Hyperacute toxicity is a recent newly described entity, albeit incompletely characterized [3]. We selected reports with available information to calculate a plausible time-to-onset. Events of interest were classified into fulminant within 7 days and hyper-acute cases within 21 days, i. Cases were described in terms of demographic and clinical features: age, gender, anticancer regimen combination vs monotherapy , therapeutic indications, seriousness hospitalization , case fatality rate CFR, namely the proportion of cases where death was reported as outcome , co-reported symptoms, co-reported irAEs.
The Immune-Adversome was estimated considering events as nodes and co-reporting as links. Hyperacute cases 18, represented Monotherapy was reported in the majority of cases Pyrexia, diarrhea, fatigue, dyspnea were the most frequently reported symptoms. Hyperacute myocarditis was reported in Among fulminant cases, most frequent irAEs were interstitial lung disease , colitis , hypothyroidism , and myocarditis Other co-occurring irAEs were colitis-hepatitis-thyroiditis, and arthritis and psoriasis.
Our network approach may complement traditional disproportionality analyses in pharmacovigilance for a more effective signal detection technique, thus supporting regulatory and clinical monitoring, especially in complex scenario such as oncology. Target Oncol ; — Oncologist ; — Hyperacute toxicity with combination ipilimumab and anti-PD1 immunotherapy. Eur J Cancer ; — Introduction: The prolongation of the QT interval is a serious and potentially fatal adverse reaction that has led to the discontinuation of many drugs including some opioids.
Data mining on pharmacovigilance databases can detect signals that identify early the risk associated with some drugs. Results: A total of drug-reaction pairs was found in opioid reports. Analysis of individual opioids show significant signals for QT prolongation for each drug.
The temporal evolution of the different signals according to the number of reports included from to shows early significant positivization of signals in the first 6 to 12 months. Underlying mechanism is unknown, but it seems to be linked to hERG channel blocking.
We propose the evaluation of the trend of change in the confidence intervals of the disproportionality parameters as a measure that can predict the occurrence of clinical events at the population level and a posible usefull strategy to minimize adverse reactions.
Introduction: Language and speech are increasingly debated as potential markers for diagnosing and monitoring patients with affective and psychotic disorders 1—3. However, many neglected factors may confound communicative atypicalities. A comprehensive list of potential confounding drugs will support the design of robust communicative marker studies.
Objective: We aim at identifying a list of drugs potentially associated with speech and language disorders, within psychotic and affective disorders. Within the FAERS, we considered separately 3 populations psychotic, affective and non-neuropsychiatric disorders , to account for the confounding role of different underlying conditions.
Robustness analyses were performed to account for the biases. Results: We identified a list of potential expected and 91 unexpected confounding medications for the identification of communication markers of affective and psychotic disorders e. We developed also a MedDRA query proposal for speech and language conditions, formalization of possible biases, and related analyses to account for them.
Conclusion: We provided a list of medications to be accounted for in future studies of communicative bio-behavioral markers in affective and psychotic disorders. The methodological procedure we developed does not simply facilitate future investigations of communicative biomarkers in other conditions, more crucially it provides a case-study in more rigorous procedures for digital phenotyping in general. Insel TR. Automated assessment of psychiatric disorders using speech: A systematic review.
Laryngoscope Investigative Otolaryngology. Voice patterns in schizophrenia: A systematic review and Bayesian meta-analysis. Schizophr Res. Introduction: The comparison of safety profiles for products recently on the market is difficult. There is a lack of methodology for quantifying the potential differences between products that have the same indication.
Objective: Provide the tools to quantify the differences in spontaneous reporting between two products. An Euclidian distance from the EBGM to the diagonal line measures the deviation from what would have been expected under the null assumption of similar safety profiles.
As the deviation does not capture the statistical uncertainty around the estimate, we propose as measure of the deviation the minimal distance of the four Euclidian distances calculated from each of the credibility intervals around the EBGM post Product A and Product B. A visualization capturing the global trend of the most substantial differences in reporting was generated. Conclusion: This relatively simple method can provide quantification of the differences in reporting and could help prioritize one product over the other for some population subgroups.
Introduction: The application of text mining approaches to identify adverse events AEs from electronic health records EHRs is a growing area of interest in pharmacovigilance research.
In veterinary medicine, the majority of EHRs consist of unstructured clinical narratives, hence the development of appropriate methods for identifying AEs of interest is an important step in the research process.
Identifying renal disease poses a specific challenge as the event may be described in narrative form or implied by reported test results or the use of renal disease specific medications. In this study we developed regular expressions regexes to identify relevant mentions of renal disease in veterinary free text clinical narratives. Objective: To develop a method for identifying veterinary patients with renal disease in free text clinical narratives.
Methods: Using VeDDRA terminology as a starting point, we used an iterative approach to develop a series of regexes which were then applied to a random sample of 10, clinical narratives. In order to measure precision, clinical narratives containing a match to the regexes were reviewed against a case definition by two independent reviewers and disagreement was settled by consensus. Terms in the final regex were derived from three sources—VeDDRA, a word embedding model and expert opinion.
To determine recall, the final regex was applied to a sample of consults where the main presenting complaint was deemed to be renal disease by a veterinary clinician. Expanding this terminology using a word embedding model improved the PPV to 0. Following changes suggested by a veterinary expert, the PPV of the final regex was improved to 0. When the regex was divided into three components, the PPV for these individual portions was mentions of renal disease 0. When compared against the veterinary clinician validated sample of renal disease consults recall was 0.
Conclusion: The developed regex can be used to identify animals with renal disease, with mentions of renal disease treatment being the most specific indicator of clinical disease.
This method can be employed to filter potential cases of interest from large datasets for use in observational studies. Introduction: We use AI in our everyday lives probably without even realising it. There are many discussions about the use of AI in PV and the potential innovation that it could bring but given the conservative nature of our business and having to work in a highly regulated environment, how can we build confidence to get us over that barrier.
Will having the regulators use the same AI make us more comfortable or will legislation be necessary to drive us forward? Objective: Explore why PV has lagged behind with AI technology that is commonplace in other parts of our lives and business.
Aspects of AI, such as machine learning, are used in areas such as early disease prediction, clinical diagnosis, outcome prediction and prognosis evaluation, personalized treatments, drug discovery, manufacturing, clinical trial research, and more. In our personal lives, services like Amazon and Google use AI to understand and target their customers and we accept that as normal.
The objective of this presentation is to explore the reluctance of accepting AI in PV and how we can move towards overcoming those obstacles. We will look at some real-life practical examples where AI in PV has worked and what it took to get there. Conclusion: We will show that the practical application of AI is achievable and has been achieved in the high volume environment of a regulatory authority.
Many of the AI features used by the RA, and the lessons learned from that project, can also be applied in industry, so why are we waiting? Introduction: Access to case narratives during signal assessment is crucial to provide a more complete picture of the cases [1], however patient confidentiality needs to be considered.
Sharing of narratives while preserving privacy requires de-identification—the removal or replacement of personal identifiers. Automating this task can help with increasing data load. To ensure patient confidentiality throughout the full pharmacovigilance process, the narratives should be de-identified early in the process.
Person names—one of the more common identifiers in case narratives—can lead to in- direct identification of patients but are challenging to recognise in free text. Objective: To develop and evaluate a method for automated de-identification of names in case narratives.
Methods: We use an ensemble of BERT [2]—a state-of-the-art language model using deep-neural network—combined with hand-engineered rules for detecting names. Our model is trained on i2b2 deidentification challenge data [3] combined with unprocessed data from the Yellow Card system[4] provided by the MHRA.
Because names are rare in the Yellow Card data, the training dataset is prepared using active learning through an independent model. Model testing is done on a separate, manually annotated dataset.
Evaluation of the deidentification is guided by: 1 how often clinically relevant information is removed and 2 how identifiable the narratives that the model fails to completely de-identify are.
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