16^th International Conference and Exhibition on Pharmacovigilance & Drug Safety August 21-22, 2023 Barcelona, Spain

Biography:

Hayaa Banat is senior pharmacovigilance specialist and the Head of Pharmacovigilance Section in JFDA, Clinical Pharmacist. She received her PharmD Degree from Jordan University of Science and Technology and is currently working at Jordan food and Drug Administration (JFDA) as the head of pharmacovigilance section. She is a strong advocate of increasing awareness of the importance of rational drug use, Pharmacovigilance and drug safety. She participated in several national and international meetings and conferences regarding Pharmacovigilance, quality use of medicines, effective communication. She has an active role in Risk Management Plan (RMP) evaluation, Risk Minimization Measures (RMM) implementation, patient leaflet updates. She is anxious in encouraging health care providers to build a culture based on patient safety. She has a good experience in clinical practice mainly in Critical Care Units (ICU, CCU) as she worked as a clinical pharmacist in two of the biggest hospitals in Jordan, King Hussein Cancer Center and Jordan university Hospital.

Abstract:

Background: Post-marketing surveillance of drugs is a cornerstone of pharmacovigilance. This study was conducted to characterize patterns of Adverse Drug Reactions (ADRs) reporting in Jordan.

Research design and methods: ADR reports submitted to the pharmacovigilance database of the Jordan Food and Drug Administration during 2015-2021 were retrospectively analyzed. The most commonly reported drugs, drug classes, ADRs and ADRs consequences were explored. Logistic regression identified possible predictors of reporting serious ADRs.

Results: A total of 2744 ADR reports were included, among which 28.4% were classified as serious. An annual increase in ADR reporting was observed. The most commonly implicated drug classes were antineoplastic and immunomodulating agents (24.0%), anti-infective for systemic use (14.2%) and alimentary tract and metabolism (12.1%). COVID-19 vaccination was the most reported drug (22.8%). Fatigue (6.3%), injection site pain (6.1%) and headache (6.0%) were the top three common ADRs. Among ADRs with outcome information, 4.7% were fatal. Patient’s age and intravenous medication use largely predicted reporting serious ADRs.

Conclusions: This study provides contemporary insights into the post-marketing surveillance of drugs in Jordan. The findings are foundational for future studies exploring drug-ADRs causality relationships. Efforts that promote pharmacovigilance concepts should be sustained and enhanced at the national level.

Biography:

Shravan V has his knowledge in pharmacogenetic studies and pharmacovigilance (Monitoring and reporting adverse drug reactions). He has participated in many conferences (national and international) and won poster, quiz and essay competitions. He has published articles on pharmacogenetics and now currently pursuing DM in the field of Clinical Pharmacology in JIPMER, Puducherry. He has passed DNB examination (Pharmacology) conducted by National Board of Examinations to his credit. He has experience in teaching MBBS students and other allied subject students for 5 years. He is currently working on Systematic review and meta-analysis and he is open to constructive criticism.

Abstract:

Introduction: Even after approval of the drug and coming to the market, there are many tragedies reported due to drug resulting in withdrawal of drug from the market for that particular indication. Eg: Thalidomide tragedy. In order to monitor this, there should be vigilant people who should identify the adverse reaction of the drug and to report in an expedited way to the authorities concerned.

Case: An 18 year old patient had a history of Road Traffic Accident (RTA) followed by seizures. He was admitted in the hospital and prescribed Inj. Phenytoin 900 mg IV stat followed by Tab. Phenytoin 100 mg. Following the oral administration, patient developed fever and bullous lesions all over the body with oropharyngeal ulcer and eye infection. On examination, patient was found to have multiple vesicles over chest, abdomen, bilateral upper extremities, crusted erosion over lips and conjuctival congestion. Patient was stopped T. Phenytoin in suspect of phenytoin induced Lyell’s syndrome. Patient was treated with pulse therapy of Dexamethasone (80 ml in 250 ml of 5% dextrose), Azithromycin, Paracetamol infusion, Tobramycin eye drops and ointment. For the seizure complaint, the patient was started on Inj. Levetiracetam infusion.

Conclusion: Phenytoin should be stopped at the onset of development of rash and genetic cause (HLA-B*1502 and HLA-A*3101) should also be borne in mind as the susceptibility increases with genetic etiology. Preventive measures should be educated to the patient as RTA also increases the risk of seizures. 

Biography:

Xueli Ding has her expertise in pharmacovigilance and rational use of herbal medicines and passion in improving the health and wellbeing. Based on the literature and previous experimental studies, she has further clarified the effect of rhubarb on the development of Colonic Melanosis. She used various methods to investigate the mechanism of rhubarb-induced Colonic Melanosis from different dimensions of "molecule-protein-cell-whole", and based on the experimental results, she established a multi-dimensional vigilance strategy and early warning measures on the risk of rhubarb-induced colorectal melanosis, which provides a scientific basis for the vigilance management of rhubarb clinical use.

Abstract:

Statement of the Problem: Rhubarb is a widely used medicinal plant worldwide, and its main chemical components are anthrone, rhubarbic acid, rhodopsin, rhodopsin methyl ether, rhubarb phenol, polysaccharides and so on. It has a variety of pharmacological effects such as gastrointestinal regulation, anticancer, antibacterial, hepatoprotective, anti-inflammatory and cardiovascular protection. FDA surveillance data as well as academic reports have shown that rhubarb has some adverse effects, with anthraquinone-based laxatives, which may lead to colon blackening, being the most common. The purpose of this study was to clarify the exact mechanism of rhubarb-induced colon blackening, to explore the risk factors, and to refine and summarize the risk warning measures for the clinical application of rhubarb.

METHODS AND THEORY: The results of public data mining, network computer simulation prediction, in vivo and in vitro experiments were biologically validated, and the early warning of the risk of rhubarb clinical application was proposed from the four perspectives of "discovery-assessment-understanding-prevention". It was found that rhubarb and rhubarb acid, rhubarb phenol, aloe barbadensis, and rhubarbol methyl ether increased the protein expression of TP53 and induced apoptosis of colon cells. It is suggested that rhubarb-induced colonic melanosis is related to apoptosis, and TP53 protein-induced apoptosis may be one of the mechanisms of rhubarb-induced colonic melanosis.

CONCLUSIONS AND SIGNIFICANCE: The content of free anthraquinone components, clinical use of rhubarb, dosage, duration of treatment, and changes in the expression of key proteins are all important factors of rhubarb-induced colorectal melioidosis, and pharmacovigilance of rhubarb should be carried out from the perspectives of monitoring of adverse reactions, analysis of components, optimization of dosage, duration of treatment, and communication of risks.

Biography:

Alfiia Imanaeva is a MD, private cardiologist. Her PhD work was devoted to a preclinical development of the new method of treatment of rheumatoid arthritis–both systemic and topical. Since 2014 she is a QPPV in JSC “Tatchempharmpreparaty”-a Russian manufacturer and marketing authorization holder, based in Kazan city. The company produces over 120 generic medications along with some original formulations and a variety of surgical threads. She witnessed the formation of the pharmacovigilance system in EAEU, passed each and every stage of the process and assembled a devoted team to ensure effective pharmacovigilance functioning in the company. Alongside in 2020 she founded a successful company that offers a range of writing services in pharmacovigilance, clinical trials and registration in EAEU.

Abstract:

Abstract

Eurasian Economic Union (EAEU) was established in 2014 and includes Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. These countries are on the way to share legislation on preclinical and clinical trials, marketing authorization, manufacturing, distribution, pharmacovigilance, etc. The supranational legislation takes precedence over the local one and currently much effort is being made to harmonize them. First edition of EAEU Good practices was issued in 2016. Good pharmacovigilance practice was then updated in 2022 (EAE Commission Council decisions 87 and 81, respectively). The modules of EAEU GVP correspond to EU GVP modules and share the major idea of contributing to the protection of patients’ and public health.

The first revision guided the formation of pharmacovigilance systems of Marketing authorization holders, its assembly from separate parts, like PSURs, SOPs, educational activities, etc. Juxtaposition of the two revisions showed an increase of the document’s size by 1,5 times. Further calculations showed that this increase was due to 2 modules: Adverse reactions and Signal management. It is rational, that once the system is built, we can delve into the cornerstone of pharmacovigilance–safety information management. This line was supported by recent release of the Decision on formation of the EAEU adverse events database that will unite local databases of 5 states. Regarding RMPs and PSURs, their content was somewhat detailed and clarified. The submission of PSURs tends to be less frequent, which is closer to EMA legislation, whereas submission of RMPs was emphasized at the moment–in order to form an EAEU database of publicly available summaries. Interaction options between the manufacturer and authorized bodies have been expanded.

This brief observation period proved that pharmacovigilance can receive effectual development in conditions of wise legislation, industry alacrity and a generous share of publicity and dialogue.

Biography:

Antonio Steardo specialized in Pharmacology and graduated in Pharmacy and Pharmaceutical Chemistry. He has now gained years of experience since 2002 in the pharmaceutical products trade sector as he could have been behind the counter of the Steardo pharmacy from an early age. Already in elementary school, his curiosity for chemistry manifests itself during his games and continues lectures at the department of science at the University of Salerno. Therefore, during the cycle of studies, he prefers biochemistry and biochemistry of drug action, graduating in July 2007 with a thesis on the functioning of the endocannabinoid system on Alzheimer’s disease in pharmacology. Following the beginning of his pharmaceutical chemistry studies, he stopped for a competition as a postgraduate in pharmacology at the University of Rome La Sapienza in July 2014. Expecting constant improvement as a professional update, he enrolled in the continuing professional training department at the University of Oxford to follow courses in Experimental and Translation Therapy and Medical Research. His desire to improve leads him to attend international conferences and seminars.a

Abstract:

By a side, genetic engineering raises several ethical questions on gene editing and manipulation. On the other hand, drug safety development should lead to assure pharmaceutical manufacturing gene engineering tools are safe as they are effective. Two steps seem to be important to obtain this feature. The first starts from in silico creating a target molecule. The second should combine the test on molecular mechanism in phase I and so on the evaluation of the bioengineered drug by phases II and III. Trail Safety as well as Efficacy must be the most important characteristic to assess. Along with these clinical processes in vivo, the study can be the first step to understanding the role of the bioengineered pharmaceutical tool in the mechanism. Safety and efficacy get close to those warnings about gene manipulation. They should be considered for what they generate properly.

Biography:

Denitsa Panayotova is a PhD student, Faculty of Pharmacy, Medical University of Sofia–Bulgaria. This study was conducted by a multidisciplinary team including leading scientists with long experience and interests in the field of drug safety and geriatrics, as well as PhD students from the Department of Pharmacy Organization and Economics at the Faculty of Pharmacy, Medical University-Sofia, Bulgaria. It is the integration of in-depth knowledge in both fields that makes possible the high level of expert assessment of suspected side effects in geriatric patients after vaccination and the definition of the pharmacist's role in preventing relevant ADRs after vaccination.

Abstract:

Statement of the problem: Over the last years, the European regulator has incorporated all available mechanisms and also created new regulatory approaches with pharmacovigilance focus to provide European citizens with quality, safe and effective vaccines. The aim of this study was to analyze the Suspected Side Effects (SSI) in geriatric patients following vaccination with COVID-19 vaccines and the possibilities for their prevention through the inclusion of clinical pharmacists in the vaccination process.

Methodology & theoretical orientation: Scoping literature review was conducted on the information concerning safety of vaccines in the scientific databases using keywords search (COVID-19 vaccines, Pharmacovigilance, Safety of COVID-19 vaccines). A critical analysis was performed on the information in EudraVigilance System (EVS) for the vaccines indicated for SARS-CоV-2 on the territory of the EU. The analysis included the period from first marketing authorization for vaccine with indication SARS-CoV-2 infection and ended approximately two years later.

Findings: From 21^st December to 14^th May 2022, the reported cases in the EVS for geriatric patients were 272 253 (26,8% of all reported cases), of which 61% affect women and respectively 38% men. The clinical pharmacist has a crucial role in discussing with geriatric patients any vaccine concerns emphasizing on the most prevalent side effects, importance of vaccination, managing drug-related problems and contraindications. Adding the peculiarities of elderly patients, exclusion from most clinical trials and the relatively lower rates of reporting for this age group, the clinical pharmacist should proactively monitor the course of vaccination, participate and encourage reporting of any relevant safety information.

Conclusion: Considering the age-related changes in pharmacokinetics and pharmacodynamics and the increased risk of side effects among geriatrics, more attention should be paid to this vulnerable group and the clinical pharmacist’s potential to provide them with quality pharmaceutical care, corresponding to the constant changing COVID-19 situation.

Biography:

Cristian is a graduated italian pharmacist and scientist by training, passion and vocation. He has a Master of Science (MSc.) in Pharmaceutical Sciences with strong experience and specialization in Clinical Research. He is a highly motivated and outgoing person with a genuine passion for scientific excellence in pharmacology and pharmacy. Cristian works with perseverance and dedication and enjoys teamwork and multidisciplinary research. He has specialized over the years in clinical pharmacology and pharmacokinetic and pharmacodynamic modeling in animal and human species (adult and pediatric population)

Abstract:

In Uruguayan veterinary medicine there is currently no regulation that ensures the biopharmaceutical quality of the products that are presented at the pharmaceutical market. Furosemide is widely used in cardiological therapies in canines (Bikdeli et al., 2013), however there is a lack of knowledge regarding the dose-exposure-response relationship and the impact of multi-source drug products with no bioequivalence evaluation. In this work, we aimed to predict the relative bioavailability between two furosemide oral local products available for use in dogs by means of physiologically based biopharmaceutics modeling (PBBM), integrating formulation-related parameters estimated through in vitro dissolution testing in a PBPK model (Ibarra et al., 2019; Lu et al., 2017). Further, the model predictions were validated with a bioequivalence study in healthy dogs (n=6). A previously reported furosemide PBPK model for humans (Britz et al., 2020) was adapted to dogs in PK-Sim® and MoBi® (Open Systems Pharmacology) using literature pharmacokinetic data in plasma and urine after intravenous and oral administration (Koh et al., 2021; Lee et al., 1986). Model was optimized including a concentration-dependent increase in renal blood flow, affecting furosemide renal excretion. Dissolution profiles from two local products obtained in biorelevant conditions were fitted with a gompertz model and included in the PBPK model to describe drug dissolution. Single-dose furosemide Cmax and AUC for both formulations were predicted with a relative bias below 20%. The PBBM approach predicted adequately furosemide pharmacokinetics and the relative product performance in dogs and has been shown in this research to be an effective tool that can be used by laboratories in the pharmaceutical industry and by state agencies in charge of pharmaceutical regulation of veterinary products. An alternative method to the clinical trial was developed that can make predictions with an adequate level of confidence and markedly lower requirements for infrastructure and research resources.