Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 6th Pharmacovigilance Congress Toronto, Ontario, Canada.

Day 1 :

Keynote Forum

Gamal Hussein

South College School of Pharmacy, USA

Keynote: Pharmacovigilance and compliance of drugs labeling information with the 2015 FDA lactation guidelines

Time : 09:40-10:40

Conference Series Pharmacovigilance Congress 2016 International Conference Keynote Speaker Gamal Hussein photo
Biography:

Gamal Hussein is a Professor of Pharmacy and Director of Interprofessional Education. He has completed a Doctoral of Pharmacy and two Fellowships at the University of Texas and the University of California, San Francisco. His research led to the identification of therapeutic window for felbamate, topiramate and lamotrigine as well as the identification of drug reactions/interactions such as gabapentin-felbamate drug interaction, and propofol-induced dystonia. Tequin (gatifloxacin) was discontinued from the market after his and others’ findings on its potential to cause hypoglycemia. He received the “Innovation in Teaching” award from the American Association of Colleges of Pharmacy and the “Health-Systems Practitioner” award from the National Pharmaceutical Association.

Abstract:

This study was conducted to evaluate published and manufacturer labeling information (PI) for commonly prescribed drugs in the USA, and to examine compliance with the new 2015 FDA labeling guidelines. Data were also compared to the authors’ previously published information on the development of the first clinical classification of drugs used during lactation (FG-LA). Of the top 200 drugs prescribed in 2015, 85% included a lactation section but information was limited and not in compliance with all elements of FDA guidelines. Only 5% included risk versus benefits section, 54.5% were excreted into breast milk or included data on milk-plasma ratio. Utilizing FG-LA clinical classification, 53.5% were clinically compatible with lactation but 19.5% caused mild to moderate adverse effects on infants, and 1.5% caused mild to moderate adverse effects on the mothers. A total of 23.5% were classified as incompatible with lactation, secretion of 11.5% was unknown, 6.5% caused mild to moderate adverse effects on infants and 1.5% caused mild to moderate adverse effects on the mothers. A total of 23% were classified as unknown with compatibility and no data on adverse effects were reported on infants or mothers. A total of 25.5% caused adverse effects on infants and 3% had adverse effects on the lactating mothers. Several conflicts existed between data in the PI and the literature addressing secretion or concentrations in breast milk. A firmer deadline is recommended by the FDA to drug manufacturers to update PI data in order to enhance patient safety and therapeutic outcomes.

Conference Series Pharmacovigilance Congress 2016 International Conference Keynote Speaker Aleksander Skotnicki photo
Biography:

Dr. Aleksander Skotnick is working at Szpital Uniwersytecki w Krakowie, Poland.

Abstract:

Introduction: VONCENTO (CSL Behring) is a plasma-derived, high-concentration, low-volume, high-purity concentrate, which contains a high level of von Willebrand factor (VWF) high-molecular-weight multimers and a  VWF/factor VIII (FVIII) ratio of -2.4:1, similar to Haemate P (CSL Behring).

Methods: The pharmacokinetic, efficacy and safety profiles of VONCENTO were investigated in this multicentre double-blind, randomised study. Subjects aged _>12 years with haemophilia A who required treatment of non-surgical bleeds, treatment during surgical events or who were receiving prophylaxis were included. Pharmacokinetics were investigated with a single dose of 50 IU) FVIII/kg body weight of either VONCENTO or BIOSTATE reference product (Biostate-RP) (Day 1: Day 8 (n = 16), repeated on Day 180 [VONCENTO only; n = 15J).Efficacy and safety analyses were performed either during on-demand treatment (n = 52) or prophylaxis (n = 29)for ≥6 months and ≥50 exposure days, respectively.

Results: Besides the confirmation of bioequivalence between VONCENTO and Biostate-RP, which displayed comparable PK profiles, haemostatic efficacy was rated by the investigators as either "excellent" or " good" in 96.4% of all bleeding events (96.5% spontaneous, 96.6% traumatic. 96.9% joint bleeds) as well as in 80% of  major and 100% of minor surgical procedures at discharge. The median number of annualised bleeding events per subject (range) was significantly lower in the prophylaxis group (2.0 (0.0-34.6)) than in the on-demand group (14.0 (0.0-87.8), p = 0.0013).VONCENTO was well tolerated and no inhibitory antibodies were identified during the study period.

Conclusions: : This study demonstrated the bioequivalence of VONCENTO to Biostate-RP, and its excellent efficacy and safety profile in haemophilia A subjects.

Keynote Forum

Ossama Roshdy

Alexandria University, Egypt

Keynote: The use of laser therapy in dermatology(Benign pigmented lesions)
Conference Series Pharmacovigilance Congress 2016 International Conference Keynote Speaker Ossama Roshdy photo
Biography:

Ossama Hussein Roshdy is a Professor in the Department of Dermatology and Venereology at the University of Alexandria, Egypt.

Abstract:

In pigmented epidermal lesions, the laser target is the melanosome contained the melanin pigment. A melanosome measures approximately 1 × (0.5-0.75) μm in diameter, and has thermal relaxation time about 10-100 n sec. Melanin has a broad absorption spectrum, being most intense in the ultraviolet (UV) range, dropping off through the visible to the near infrared (IR) spectra. During laser therapy of pigmented lesions, whatever the mode of pigment destruction (pressure waves, shock waves, or chemical alteration), destroyed or chemically altered melanin pigment is largely removed by macrophages. There are many laser types that can be used to treat pigmented lesions. Q-switched ruby laser emits a read beam of 694 nm wavelength with 20 to 50 n sec pulse duration. Many epidermal pigmented lesions could be treated by this type of laser (lentigo senilis, lentigo simplex, ephelides, syndromal lentigens, and café-au-lait macules). Pigmented Lesion Dye Laser produces pulsed green light at a wavelength 500-520 nm, with pulse duration 300-500 n sec. It is more suitable for superficial lesions only like ephelides, café-au-lait macules, and Becker’s nevi (penetration depth is only 0.25-0.5 mm). Q-switched Nd: YAG laser (1064 nm wavelength, and pulse duration 10 n sec) is highly effective for deep, densely pigmented tattoos. Frequency Doubled Q-switched Nd: YAG laser with 532 nm green beam, and pulse duration of 10-40 n sec is useful for epidermal pigmented lesions and café-au-lait macules. Another laser machine for pigmented lesions is the Flash Lamp Q-Switched Alexandrite laser. It emits a near infrared invisible beam at 755 nm wavelength, and pulse duration of 100 n sec. It is used successfully for deep, black, green, red, and yellow tattoos. Nevus of Ota is treated well with the Q-switched Ruby Laser with energy fluence of 6-10 J/cm2 at 40 n sec pulses. Argon laser produced resolution of the nevus of Ota lesions but with some hypo pigmentation. Post inflammatory hyper pigmentation showed an average improvement by over 75% when Pumped Dye Pulsed Laser (Candela) is used. Melasma is treated by Candela PDPL, Q-Switched Alexandrite, Q-Switched Ruby, and Q- YAG laser. Unfortunately, although results are initially encouraging, repigmentation is the rule in all lasers used.

  • Drug Safety | Case Study | Pharmacy Practice and its Challenges
Speaker

Chair

Sutapa Bandyopadhyay Neogi

Indian Institute of Public Health-Delhi (IIPH-D), India

Speaker
Biography:

Patricia Medeiros-Souza is a Doctor, Department of Health Sciences, Universidade de Brasilia, Brasilia, Brazil.

Abstract:

As of 2010, the global prevalence of dementia was estimated at approximately 35.6 million people, which corresponds to 5% to 7% of the world population. This figure is expected to double every 20 years, reaching 65.7 million in 2030 and 115.4 million by 2050. The objective of this study was to assess the frequency of tablet splitting of psychotropic drugs in a population of older adults with a diagnosis of dementia. This retrospective, cross-sectional study examined a sample of geriatric outpatients seen at a public center specializing in the care of elderly patients, a referral center for management of dementias in general, especially Alzheimer dementia to identify the frequency of tablet splitting of psychotropic drugs and the factors that may be involved in this practice. Comparison of the presence or absence of tablet splitting in relation to several parameters was assessed by means of P values; between group differences with an α < 5% (P < 0.005) were deemed significant. The presence of dementia was significantly associated with prescriptions implying to split tablets, which was found in 88 patients with dementia (34.9%) versus 90 patients without dementia (23.7%) (P=0.002). Among the 88 patients with dementia who split tablets, 64 (72.7%) split tablets of psychotropic drugs. When evaluating the effect of tablet splitting, in clinical practice or in futher research, it is important to consider the effect of drug-drug interactions. Because these interactions can also change the bioavailability or pharmacologic activity of many drugs, it is important to observe whether the variations in effectiveness of split tablet are not the result of drug-drug interactions. Nearly onethird of patients who split psychotropic drug tablets in this study had interactions in their drug regimens that could change the effectiveness of the split medications (n=20 [31.2%]). The most significant interactions were those between acetylcholinesterase inhibitors and anticholinergics (such as antipsychotics), which are precisely the agents used to control behavioral disturbances in patients with dementia. These results indicate the importance of identifying the practice of tablet splitting, particularly when it involves psychotropic drugs, because it entails several factors that can reduce the efficacy of the drug therapy.

Speaker
Biography:

Zhihong Xu obtained her first PhD in Natural Product Chemistry from Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and her second PhD with a Double Major in Organic Synthesis and Biochemistry from Duke University, USA. She is currently an Associate Professor of Pharmaceutical Sciences in South College School of Pharmacy at Knoxville, Tennessee, USA. Her teaching and research are centered on medicinal chemistry at the interface of natural product chemistry, organic chemistry and biochemistry, including lead discovery and investigation of small molecule chemicals and pharmacological properties

Abstract:

Antiviral and anticancer nucleoside analogs have been used in clinical practice for decades. For example, a number of dideoxynucleoside drugs such as Zidovudine, Stavudine and Lamivudine are widely used in the treatment of HIV and HBV infections. However, major concerns such as drug toxicity, ineffectiveness and resistance resulting from the inefficient phosphorylation (by cellular kinases) and other processes are often associated. To overcome these disadvantages, various nucleosides and other prodrug analogs such as pronucleotides have been chemically synthesized and investigated. The pronucleotide approach involves modifying the drug to enable it to better enter the cell, and be converted to an active drug via either chemical and/or enzymatic activations. This approach allows the bypass of the rate-limiting phosphorylation step(s) with the prospect of improving the stability, bioavailability and efficacy of the parent nucleoside drug, and decreasing the toxicity as well. In this report, pronucleotide approaches and toxicity profiles for some typical nucleoside analogs are reviewed, and our pronucleotide chemical approach which might be useful for the synthesis of a number of nucleoside triphosphate prodrugs will be discussed. The chemical activation/degradation pathways of selected pronucleotides are proposed based on LC-MS analysis.

Biography:

Bruno J Gonzalez is PhD Researcher at the National Institute for Medical Research and Head of the NeoVasc Laboratory “Microvascular Endothelium and Neonatal Brain Lesions”, Normandy University, France. He developed a research program on pathologic neurodevelopment in preterm and term neonates with a particular attention to neurovascular defects. His working hypotheses are (1) microvessels contribute to injurious mechanisms with age-dependent specificities, (2) microvessels are targets for therapeutic actions, and (3) brain microvessels release factors with biomarker potential. Focusing on NMDA receptors, his objectives consist of molecular and functional characterizations of endothelial and neuronal interactions (GABA interneurons) and of deleterious/side effects of drugs (alcohol, anesthetics).

Abstract:

In neonates, excitotoxicity is a major process involved in hypoxic-ischemic brain lesions, and several studies reported neuroprotective effects of NMDA antagonists. However, there is more and more evidence indicating that, in the developing brain, glutamate exerts trophic effects on migrating GABAergic interneurons and that NMDA antagonists would present side effects. Consequently, characterizing mechanisms leading to these side effects would be therapeutically useful. Because macroautophagy is involved in the adaptive response to trophic deprivation, we investigated the impact of autophagy modulators on MK801-induced death of immature GABAergic interneurons. Using cortical slices from wild type and Gad67-GFP mice, we showed that blockade of the NMDA receptor resulted in an accumulation of autophagosomes due to the disruption of the autophagic flux. This effect preceded the activation of the mitochondrial apoptotic pathway, and the degeneration of immature GABAergic neurons present in the developing cortical layers II-IV. The autophagy inhibitor, 3-MA, prevented the apoptotic death of GABA interneurons whereas modulators of autophagy (3-MA, rapamycin) did not interfere with the anti-excitotoxic effect of MK801 observed in deep layers V and VI. In vivo, 3-MA blocked the rapid increase in caspase-3 cleavage induced by NMDA antagonists and prevented death of Gad67-GFP neurons in layers II-IV. Together, these data suggest that, in the developing cortex, blockade of the NMDA receptor in the developing cortex induces autophagy-mediated death of migrating cortical GABAergic interneurons. The use of autophagy modulators would create new opportunities to prevent side effects of NMDA antagonists used for neuroprotection or anesthesia.

Speaker
Biography:

Nermine El Maraghy is Associate Professor of Medical Microbiology & Immunology. He had Master’s and PhD in Medical Microbiology & Immunology from Faculty of Medicine, Suez Canal University, Ismailia, Egypt. He is a Member of Tumor Oncology Unit, Clinical Epidemiology Units at Faculty of Medicine Suez Canal University. He had great experience in the area of clinical immunology, allergy skin prick test, immunotherapy, diagnostic microbiology and infection control. He has several international publications (13) on PubMed and Google Scholar. He is Reviewer of the Infectious & Non-Infectious Diseases (online), Suez Canal University Medical Journal and Eastern Mediterranean Health Journal (online). He also has a Professional Diploma of Infection Control from AUC, Egypt.

Abstract:

Background: Hospital acquired pneumonia occurs more than 48 h after hospital admission and was not present at the time of admission, while ventilator associated pneumonia occurs after 48–72 h of endotracheal intubation or within 48 h of extubation. HAP is the second most common nosocomial infection and accounts for approximately 25% of all infections in the intensive care unit worldwide.

 

Purposes: To identify the etiology, initial evaluation, prevention and treatment of adult patients with ICU HAP, and VAP (Ventilator-Associated Pneumonia) in Suez Canal University Hospital and their management strategies.

 

Methods: This study was conducted in the Department of ICU, Suez Canal University Hospital; Ismailia, Egypt in the period from May to August 2013. All the patients were subjected to clinical and radiological assessment, endotracheal aspirate samples for culture, and sensitivity to determine the causative organisms. Clinical pulmonary infection score was done in order to determine the severity of HAP.

 

Results: 89% of patients were suffering from VAP, while 11% were suffering from HAP, with mean age of 63.8±10.47 years. Methicillin-resistant Staphylococcus aureus, and Klebsiella pneumoniae represented the most common isolated organisms that accounted about 65% of the studied population. The isolated microorganisms were resistant to Amoxicillin. MRSA showed highest sensitivity (44.4%) to Vancomycin and (27.8%) to Imipenem. K. pneumoniae were sensitive mainly to Imipenem (75.9%) and to Levofloxacin (44.8%).

 

Conclusion: Gram-negative organisms were isolated in 46% of cases, gram-positive organisms in 41% and the isolated organisms showed high resistance to most of the tested antibiotics.

Liaquat Ali

Bangladesh University of Health Sciences, Bangladesh

Title: Pharmacovigilance as a tool for conducting clinical trials with plant-based medicines

Time : 16:20-16:50

Speaker
Biography:

Liaquat Ali is a Medical Graduate from University of Dhaka and completed his PhD, in 1990, from University of Uppsala, Sweden. He served as a Professor of Biochemistry & Cell Biology in BIRDEM, Dhaka during 1991-2007 and is presently the Vice-Chancellor of the Bangladesh University of Health Sciences. He has published nearly 100 papers in peer reviewed journals. For his works, he has received awards from many organizations including Bangladesh Academy of Sciences, Indian Public Health Association and Islamic World Academy of Sciences.

Abstract:

Plant-based medicines can potentially be incorporated into mainstream medicine due to its fulfillment of the ‘Verification’ or ‘Falsification’ criteria, at least ‘on principle’, as required by any scientific investigation. Verification of claims regarding safety and efficacy of any medicine should ideally be resolved through clinical trials, but optimally designed clinical trial poses a difficult challenge in these systems of medicine. Due to long tradition as well as market demand, plant-based medicines are being legally prescribed in many countries of the world and a large section of human population, particularly in low resource settings, are still dependent on these medicines. Pharmacovigilance on these medicines is an urgent requirement in such countries and the investment may profitably be utilized if the requirement of some initial phases (1st and 2nd phases) of clinical trials in so called modern medicine can be skipped using data from the pharmacovigilance system. With proper study design, standardization of clinical and laboratory/other investigations and scientific approach towards data collection, analysis and interpretation, a combined approach in this respect may be possible. This will, on the one hand, generate some basic idea about the scientific validity of these medicines and, at the same time, it will create the ground for the next phase clinical trials in a much quicker pace. The first outcome is a moral responsibility of the scientific community and it is a legal responsibility of the policy makers and regulators. The second outcome, by saving lot of animal, natural and financial resources, may significantly contribute towards drug discovery and healthcare all over the world.