Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 12th International Conference and Exhibition on Pharmacovigilance & Drug Safety Rome, Italy.

Day 2 :

Conference Series Pharmacovigilance 2018 International Conference Keynote Speaker Subodh Bhardwaj photo
Biography:

Subodh Bhardwaj, New York & Inventprise, USA

 

 

Abstract:

The global vaccine market size will touch 48 billion USD by 2025. With 15 new introductions this century millions of children and adults are being immunised globally. Research on new vaccines for HIV, Ebola, Zika, Dengue, Universal Influenza vaccines and yellow fever are in the pipeline. New manufacturing technologies, new routes of administration, advances in genomics, emerging disease pandemics & outbreaks, innovation and demand from emerging economies makes the vaccine segment profitable. Support from WHO, UNICEF, GAVI and Gates foundation has stirred new vaccine introductions in Asia, Africa e.g. Meningococcal, Pneumococcal vaccines. Vaccines have a high generic barrier and potential to generate blockbuster sales e.g. Shingrix. Vaccines differ from drugs as they are preventive while drugs are curative. Increased demand has necessitated increasingly stringent safety requirements during preclinical, clinical and post licensure thereby making vaccine vigilance and risk mitigation more precise to be able to pre-empt detection, assessment, analysis and prevention of new SAEs or SUSARs, to make vaccine recipients safe. The author discusses case reports to reinforce effective methods and outcomes. The immunization and pharmacovigilance gap needs to be addressed globally as 50% of 20.8 million unvaccinated children are from South Asia & Africa with poor PV facilities. Though 20.4 million deaths have been prevented by Measles vaccine from 2000-2016, yet 254 children die each day! It costs only 2 USD to protect a child against Measles, rubella in developing countries. There is need for enlarging the pharmacovigilance perspective with better understanding of vaccine components, linkage to clinical trials, increased awareness, PV concepts, pitfalls- as a child receives 37 shots from birth through 6 years of age & vaccine safety has a very narrow margin for error.

 

Keynote Forum

Eliana Silva de Moraes

Food and Drug Law, Brazil

Keynote: Legal tools for risk management in the global regulatory affairs framework

Time : 10:40-11:20

Conference Series Pharmacovigilance 2018 International Conference Keynote Speaker Eliana Silva de Moraes photo
Biography:

Eliana Silva de Moraes has her expertise in food and drug law. Twenty Six years’ experience helping international pharmaceutical, health and food companies to gain presence in markets of Latin America and Europe, specially. She has an active participation in the harmonization of regulatory affairs process through the organizations that she represents, ABPVS. Played an active role in setting up Brazil’s Public Health Regulator (ANVISA), organizing the agenda of its first Anvisa’s President in USA in order to explore the US specially the Food and Drug Administration (FDA) and Paho, in December 1998. President of the ABPVS a Regulatory Affairs Organization for Brazil and Latin America Countries and Lawyer at Silva de Moraes. Member of the Brazilian Bar Association and The Portugal Bar Association. Speaks Portuguese, English, French and Spanish

 

Abstract:

A medicinal product is authorised on the basis of the benefit-risk judged at the time of approval process registration. Besides, pharmaceutical companies need to deal regularly with necessary measures to mitigate risks and preserve the benefits of the product specially when working in a global market. Transforming risk management concepts into regulatory actions is crucial for a successful pharmaceutical projects. This presentation will cover the recent and relevant laws, international standards, and regulations contributing to the achievement of the essential tools to treat risks and evaluate the pharmaceutical products benefits; comprehensive survey of legal benefit-risk definition; evaluation and control of the registration approval process globally. Identification and analysis of different tools in the legislation to controls the risk; critereas for risk evaluation such as clinical trialpharmacovigilance and other important procedures.

 

 

  • Good Pharmacovigilance Practice | Clinical Trials on Various Disorders | Pharmacy Practices and its Challenges | Case Report in Clinical Trials
Location: Atlantis 2
Speaker
Biography:

Maria Amparo Lopez Ruiz has completed his PhD from Valencia University and postdoctoral studies from CEU Cardenal Herrera Health Sciences Faculty. She obtained her doctorate in Medicine with the doctoral thesis on “Analysis of the use of medication in the paediatric population that visit accident and emergency department” with summa cum laude. She has achieved the qualification of “University Expert in Neonatology” from the Catholic University in Valencia and “Master’s Degree in Neonatology (from de SENeo -Neonatology Spanish Society-)”. She is Medicine Degree Coordinator in CEU Cardenal Herrera University since 2015. She is the director of the “Master’s degree in Neonatal Intensive care and Neonatal Nursing”. She has attended to International Congresses of Pediatrics as a keynote speaker and she has been part of the Organizing Committee member for the 12th International Conference on Pediatric Pathology and Laboratory Medicine, and she has published in reputed international journals.

 

Abstract:

Self-medication is a common practice and an important problem of public health between the pediatric patients. The total number of patients who attended to the Accident and Emergencies Department during 1 year (from February 2017 to February 2018) was 2388. A total of 1538 patients attended to the private pediatric clinic taking some medication before the visit. The majority of drugs consumed by these patients (self-medication provided by parents or caregivers of children) were pain-killers and antipyretics (64.8%), followed by drugs for the respiratory system (20.1%) and drugs for the digestive system (11.2%) and antibiotics in a minority form (3.9%). The 1538 self-medicated patients, 143 had some adverse drug reaction due to the medication they were taking; and 35 of these reactions were due to self-medication. The patients from 1 to 4 years were the most self-medicated group (65.1%), followed by the group of 5 to 14 years (22.8%) and those under one year (12.1%). Self-medication among pediatric patients is common; and the most often with pain-killers and antipyretics under dosing leading to ineffectiveness and adverse reactions that could be prevented with proper use of drugs. Regarding the analysis of the dosage of pain-killers and antipyretics: ibuprofen recorded 343 cases of under treatment (54.6%), 28 cases of overtreatment (4.9%) and 251 cases of correct dosing (40.5%). While paracetamol recorded 200 cases of under treatment (35.9%), 32 cases of overtreatment (5.8%) and 331 cases of correct dosing (58.3%). The most frequent adverse drug reactions observed with self-medication were: vomiting (77.3%), skin rashes (12.5%) and diarrhea (10.2%). None of the adverse drug reactions was serious, and could be solved without requiring hospital admission. Although it should be noted that such adverse reactions could have been avoided if they had not made an inappropriate use of the drugs, due in large part to their own lack of knowledge of the indications of the same.

 

Biography:

Saed Amarneh has vast experience in hospital pharmacy and is presently director of pharmaceutical services at Laniado Hospital, Netanya, Israel. His primary degree (BSc) was obtained from Jordan's University of Science and Technology (Amman), and his MSc from The Hebrew University (Jerusalem).His interests include research projects, standard setting and lecturing. He is especially interested in improving standards in the hospital pharmacy and introducing clinical pharmacy to all hospital departments. He has a number of publications reflecting his interests

 

Abstract:

Statement of Problem: Many problems exist with polypharmacy, (the use of four or more medications).= Polypharmacy is associated with an ageing population and multimorbidity. Polypharmacy increases the risk of falls, confusion, functional decline; altered metabolic function; adverse drug interactions; serious side effects, and hospitalisation. Purpose: To determine the prevalence of polypharmacy. To determine the study’s influence on physicians. To determine the percentage of polypharmacy in-patients having a medication review. To document the main reasons for medication changes.

Methodology: Patients’ data was collected over two seven-week periods from one department. e.g. Name, Date of Birth, Medication numbers on admission and discharge, Medication Review Yes/No. Reasons for medication changes were given by each patient’s physician. The department received feedback after the first period. Findings: The prevalence of polypharmacy over both periods was 55% on admission and discharge. The results show a continuous influence on physicians over both periods. The percentage of patients discharged with net additional medications decreased over each period (P1 & P2) (P1 54%->30% , P2 38%->27%); net reductions increased (P1 25%->37%, P2 10%->28%), as well as those having “reduced medications only” (P1 10%->29%, P2 10%->23%). The percentage of patients having a medication review was 99%. 4. The reasons for medication changes were; Symptoms either controlled or not 55% ; New Indication 38% ; Interactions/Side Effects 7%Conclusions and Significance: The prevalence of polypharmacy remained unchanged because patients with reduced medications still continued with polypharmacy. The high prevalence of medication reviews is good practice and was expected. The low incidence of medication changes due to interactions/side effects was unexpected; other studies have shown this to be the major cause. Reasons maybe [a] multiple physicians involved with care; [b] lack of awareness, unwillingness to deprescribe; [c] physicians’ cultural differences.

 

 

Biography:

Safa Alizadeh has finished her education in pharmacy. Her first research was on the effect of Probiotics on Rota virus and cell culture. She continues her work on translational ophthalmology research center and passion in researching and studying about ophthalmology adverse drug effects. Currently, her research focused on some eye diseases and ophthalmology drugs such as drops, ointments and gels. This work presents the novel hypothesis about the relation of science and industry to improve health outcome about the patients.

 

Abstract:

The aim of this study was to evaluate adverse drug events (ADE) resulting in emergency department visits at Farabi eye hospital. Acute ADEs resulting in emergency department visits have a high prevalence however ophthalmic drugs such as eye drops have also a potential for ocular ADEs. The frequency of emergency department visits due to ADEs, the type of ADE, and the suspected drugs were also investigated. In this study all emergency department patients admitted to the emergency department between 8.00 a.m. and 1.00 p.m. during 7 days were included in the study. The patients’ eye disorders and drug history were evaluated by a pharmacist to detect ADEs. The national yellow card was completed for each ADE. Of the 1631 emergency visits, 5 (0.3%, 95% CI: 0.13 to 0.71%) were drug related. Tetracaine eye drops as a local anesthetic accounted for 4 (80%, 95% CI: 38 to 96%) cases. The last patient overused naphazoline drops for one month although it was prescribed by the ophthalmologist for 5 days to treat redness of the eye, resulting in rebound injection and hyperemia. Because all 5 patients abused their ocular drops without a prescription, the ADEs were preventable. Recovery was the outcome of four ADEs after drug discontinuation and appropriate management. Only one of them required penetrating keratoplasty. The most frequent ocular ADE was corneal involvement. Concise monitoring and proper diagnosis of ophthalmic ADEs may reduce ocular complications. As the most prevalent cause of ADE in our study was tetracaine, it seems that the general population should be educated and warned about the hazards of tetracaine drop over consumption drop use without supervision of a physician. The main problem about the local anaesthetic eye drop use occurred with self-administration of the drop without physician supervision; therefore restriction availability of tetracaine drop without prescription is essential.

 

 

Biography:

Safa Alizadeh has finished her education in pharmacy. Her first research was on the effect of Probiotics on Rota virus and cell culture. She continues her work on
translational ophthalmology research center and passion in researching and studying about ophthalmology adverse drug effects. Currently, her research focused on some eye diseases and ophthalmology drugs such as drops, ointments and gels. This work presents the novel hypothesis about the relation of science and industry to improve health outcome about the patients.

Abstract:

The aim of this study was to evaluate adverse drug events (ADE) resulting in emergency department visits at Farabi eye hospital. Acute ADEs resulting in emergency department visits have a high prevalence however ophthalmic drugs such as eye drops have also a potential for ocular ADEs. The frequency of emergency department visits due to ADEs, the type of ADE, and the suspected drugs were also investigated. In this study all emergency department patients admitted to the emergency department between 8.00 a.m. and 1.00 p.m. during 7 days were included in the study. The patients’ eye disorders and drug history were evaluated by a pharmacist to detect ADEs. The national yellow card was completed for each ADE. Of the 1631 emergency visits, 5 (0.3%, 95% CI: 0.13 to 0.71%) were drug related. Tetracaine eye drops as a local anesthetic accounted for 4 (80%, 95% CI: 38 to 96%) cases. The last patient overused naphazoline drops for one month although it was prescribed by the ophthalmologist for 5 days to treat redness of the eye, resulting in rebound injection and hyperemia. Because all 5 patients abused their ocular drops without a prescription, the ADEs were preventable. Recovery was the outcome of four ADEs after drug discontinuation and appropriate management. Only one of them required penetrating keratoplasty. The most frequent ocular ADE was corneal involvement. Concise monitoring and proper diagnosis of ophthalmic ADEs may reduce ocular complications. As the most prevalent cause of ADE in our study was tetracaine, it seems that the general population should be educated and warned about the hazards of tetracaine drop over consumption drop use without supervision of a physician. The main problem about the local anaesthetic eye drop use occurred with self-administration of the drop without physician supervision; therefore restriction availability of tetracaine drop without prescription is essential.

Raymond R Mattingly

Wayne State University School of Medicine, USA

Title: Pharmacovigilance education for medical students

Time : 14:10-14:40

Speaker
Biography:

Raymond R Mattingly is a Professor and Chair of Pharmacology at Wayne State University, which has the largest single campus medical school in the USA. He was a course director for medical pharmacology and therapeutics for the medical students from 2007-2015. He is a Member of the Academy of Pharmacology Educators of the American Society for Pharmacology and Experimental Therapeutics (ASPET).

 

Abstract:

In 2006, the Institute of Medicine reported in Preventing Medication Errors that at least 1.5 million preventable adverse drug events occur each year in the USA. A related concern may be whether there is an increase in poor patient outcomes in July, when newly trained medical residents enter practice. Although most such reports are anecdotal, e.g., there are also peer reviewed studies. For example, the highest risk myocardial infarction patients suffer increased mortality in July in hospitals that are categorized as teaching intensive. Most pharmacology education in US medical schools occurs in the early years of the medical school curriculum through introduction to basic principles of pharmacodynamics and pharmacokinetics and then system-specific drug coverage that is often integrated into system-based pathophysiology units. Clinical pharmacology coverage in later years of the US curriculum is rarely required but more often offered as an elective, whereas a recent study shows that compulsory clinical pharmacology education may be more prevalent in the EU. To provide a consistent and universal introduction to the topics of adverse drug events and pharmacovigilance, we instituted a multi-part module in the year-2 of medical student curriculum. We first provide a concise self-study packet of principles and then have faculty facilitation for case-based, small group discussion sessions, with the adverse event cases specifically designed to integrate material across systems. We assess knowledge through multiple-choice questions in the regular course examinations. Student and faculty evaluation of these sessions has been very positive. The pharmacovigilance curriculum has become a key component of our longitudinal curricular theme on patient safety and quality improvement

 

 

Biography:

Furqan Muhammad Iqbal, is working as Assistant Professor of Pharmaceutics in Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan. He started his carrier in product development and quality control in Pharmaceutical Industry (Pharmacia). Up till now, he has more than 10 year experience in teaching Industrial Pharmacy and conducting pharmaceutical research. He has his expertise in Pharmaceutical Technology regarding drug delivery systems, stimuli responsive polymeric drug carriers and their evaluation. Presently, he is working on Research projects on nanotechnology and drug targeting. He has a keen interest and passion in improving the health by minimizing the adverse effects of new as well as already existing therapeutic agents.

 

Abstract:

We report a highly swellable copolymeric hydrogel prepared by crosslinking poly- vinyl alcohol (PVA) with 2-acrylamido- 2-methyl-1-propanesulfonic acid (AMPS) by microwave radiation using N, N’-methylenebisacrylamide (MBA) as crosslinker and very low quantities of potassium persulfate (KPS) as initiator. The prepared hydrogels were loaded with captopril and subjected to in-vitro and in-vivo evaluation. The swelling studies were performed at pH 2 and pH 7.4 to determine water absorption at lower and higher pH. The hydrogel formulations with higher proportions of AMPS and appropriate dose of radiation demonstrated maximum swelling. The prepared PVA-co-poly (AMPS) hydrogels were evaluated by FT-IR, SEM, XRD, and thermal analysis (DSC and TGA). The crosslinking in components was confirmed by FT-IR, XRD, TGA and DSC analysis. The in-vitro drug release was measured at wavelength of 205 nm using UV spectrophotometer. Drug release observed was higher at pH 2 than at pH 7.4, due to relatively more swelling capacity at lower pH in Aqueous medium. Pharmacokinetic  parameters determined by oral administration to rabbits presented increased AUC, AUMC, MRT, t1/2(el), Vss and HVD for hydrogel formulations as compared to control. We can conclude that polyvinyl alcohol and AMPS polymeric network was developed successfully under the influence of microwave radiations as a controlled release drug delivery system for captopril.