12^th International Conference and Exhibition on Pharmacovigilance & Drug Safety June 21-22, 2018 Rome, Italy

Aaron Damien Barzey was the Global Labelling lead for the orphan drug ‘ofatumumab’. He was responsible for the company core datasheets, labelling strategy, EU labelling negations and oversaw the product launch in emerging markets. The major accomplishment was leading the launch of Arzerra for the treatment of chronic lymphatic leukaemia across the EU, Australia and other countries. In 2015 Aaron started his own regulatory consultancy, ADB Medical, providing ad-hoc support or project specific guidance to various companies. In 2016 Aaron was chosen as the pharmaceutical industry SME to discuss the possible impact of Brexit on the pharmaceutical industry, which included debating with Nigel Farage live on national television and to discuss further on live on UK TV with Piers Morgan and Susanna Reid.

The European Union (EU) has led the way in pharmacovigilance legislation, processes and understanding for many year and are the global leader in the review and approval of Biosimilars medicines, orphan drugs and paediatric medicines via the London based European Medicines Agency (EMA). Other countries, such as Australia, work side by side with the regulations and guidance produced from the EMA, and institutions, such as the World Health Organisation, have periodic meetings in London to discuss medicines. The United Kingdom is due to leave the EU on 29th March 2019 and the EMA and all its staff will have to relocate to remain in the EU as a result. All centralised registered products will need to be re-registered to one of the remaining 27 countries and there is the very real risk that this relocation will see losses in talented staff as well as hinder the approval and maintenance of innovative medicines and the maintenance of the current pharmacovigilance reporting mechanisms.

 

Sanjeev Miglani is an MD in internal medicine and has over 18 years of experience in the field of medicine, Pharmacovigilance and clinical research. He is the Vice President of Safety and Medical Affairs at APCER. Just before joining APCER, Sanjeev was the vice president for Pharmacovigilance and medical writing at Accenture. before joining Accenture, Sanjeev was the COO Officer and Scientific Director of CIDP Biotech. Prior to CIDP, Sanjeev was the Director of Medical Affairs at CliniRx. Before CliniRx, He has worked with Ranbaxy as a senior manager in the department of medical affairs and pharmacovigilance. He has also worked as a senior resident in cardiology and medicine department in some of the prestigious hospitals of New Delhi. He is a life time member of API and a fellow of Indian Association of Clinical medicine. He has numerous publications in medical journals and books to his credit.

The aim of this study was to assess levels of depressive symptoms present in patients with diabetic foot. A convenience sampling method was used to recruit 108 patients with diabetic foot. After having completed the Center for Epidemiologic Studies Depression Scale (CES-D), patients' demographic data and medical history were collected using pre-structured forms. Of the entire sample, 38.9% have CES-D score ≥27 which indicates risk for major depression. Logistic regression analysis showed that retinopathy was significantly associated with increased depressive symptoms among diabetic foot patients (odds ratio 3.41 (p=0.017)). Being on a combination of oral hypoglycemic agents and insulin treatment was significantly associated with lower depressive symptoms (odds ratio 3.38 (p=0.022)). Patients with primary education level have the highest odds ratio among all factors associated with risk for major depression (OR, 4.07; p=0.003). The risk for major depression among patients with diabetic foot in Jordan is high compared to general diabetic population. This was associated with low educational level, retinopathy and not taking combination of oral hypoglycaemic agents and insulin. There is a need for routine screening for depression in patients with diabetic foot to help in the prevention, early detection of depression and even referral to a psychiatrist.

 

 

Jyoti B Sharma has completed her Master’s degree in pharmacology and working as research associate in the Department of Clinical Pharmacology, Tata Memorial Centre, Mumbai, India. She is involved in early phase clinical trials (phase 1) as a young researcher and also a co-investigator and presently coordinating the biosimilar trial. She is also involved in the clinical studies like bioequivalence, therapeutic drug monitoring and collecting the adverse drug reaction data in oncology in renal cancer, hepatocellular cancer, lung and prostate cancer. She has one patent in process and two publications.

Cristina Scavone is a pharmacist attending the last year of PhD in translational medicine. She plays her scientific research as a PhD student at the Department of Experimental Medicine of University of Campania “Luigi Vanvitelli” and at the Pharmacovigilance and Pharmacoepidemiology Center. Her research activities are directed to the topic of pharmacovigilance and pharmaco epidemiology. Since 2014, she is a member of the Italian Society of Pharmacology.

Kety Mirkovic Kos is a passionate multilingual pharmacovigilance and regulatory expert with comprehensive domestic and international work experience and 60+ completed courses and trainings in the fields of  pharmacovigilance, regulatory affairs management, consultancy and quality assurance.

Additional risk minimisation measures pose a challenge to both industry and the regulators. Applicants are obliged to actively monitor safety profile of their medicinal product and to anticipate its important safety risks, based on their own experience or information already available for originator products licensed in the EU. Croatian legislation on pharmacovigilance was last updated around the time of accession to the EU. Any further update is presented through the publicly available news section on HALMED website. Especially news concerning nationally licensed medicinal product are obliging for MAHs for Croatia. Important safety information is usually first communicated to the HCPs via DHCPs and later on in aRMM, following particular country-specific protocols. Request for common aRMM assessments is strongly supported by HALMED, with educational materials on generic name, version and HALMED approval date inserted. Approval costs for the initial aRMM materials and their update is the same, with approval timelines from 6 months to 1.5 years with tendency to decrease. Preparation of common PASS/PAESS studies may be requested by the NCA, irrespective if the licensed medicinal product is marketed in Croatia. What can the industry do to decrease costs and enhance product safety?

 

Mugdha Chopra is a dentist by qualification and has over 14 years of experience in the field of dentistry, and pharmacovigilance. She is associate vice president for US PV and clinical safety at APCER and oversees the delivery and operations from India which includes but not limited to case processing aggregate reporting, literature Monitoring and signal detection. Before joining APCER, she was with Ranbaxy as a manager in the Department of Medical Affairs and pharmacovigilance. She comes with an extensive experience in various safety databases like Argus Safety and ARISg for case processing, reporting, and product/license management and has also met the challenges of business continuity planning and data restoration.

Oncology studies are required to be very intensively monitored than studies from many of the other therapeutic areas, because of the nature and severity of the disease and the complexity and potential toxicity of the treatment or the use of newer approaches such as biologics and personalized medicine. In oncology trials unlike the clinical trials in many of the other therapeutic areas, a higher number of subjects are likely to develop serious adverse events and these cases are often complex. The evaluation of drug event relationship and distinguishing from underlying disease and concomitant therapies can be very challenging. Many oncology trials are conducted in high mortality diseases and at times have efficacy endpoints that could also be reportable adverse reactions. The breaking of the blind for such cases as required for expedited reporting to regulatory authorities could compromise the integrity of the clinical trial. In such scenarios, it is advisable to reach agreement with regulatory authorities in advance concerning serious adverse events (SAEs) that would be considered disease related and not subject to systematic unbinding and expedited reporting. Making sure patient compliance with the necessities of a clinical study is quintessential to the success of a study meeting its intended objectives. Therefore, it is imperative to have experienced medical oversight throughout the design, implementation and reporting throughout all phases of a clinical development program. Safety monitors provide tactical drug development guidance as well as review key study documents and safety information and act as the prime medical resource to support the investigators and sites involved in the clinical trials. This session will describe the importance of safety in oncology trials, and how a rigorous and thorough monitoring can lead to the smooth conduct of oncology clinical trials.

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.

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

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.

 

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.

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.

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 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).

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

 

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.

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.