List of Posters

Please use the below directory to navigate faster and more easily through the list of posters.

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P 180

P 001
Oncogeriatry, a French experience
M. Abou Taam1, B. Azzouz1, A. Hamdi1, T. Trenque1
1Reims University Hospitals, Regional Center of Pharmacovigilance and Pharmacoepidemiology, Reims, France

P 002
Direct Oral Anticoagulant bleedings : patient profile
M. Abou Taam1, M. Gerbaux2, A. Brabant-Viau2, T. Trenque1
1Reims University Hospitals, Regional Center of Pharmacovigilance and Pharmacoepidemiology, Reims, France
2Reims University Hospitals, Department of Internal Medicine, Reims, France

P 003
Current state of voluntary drug intoxications
A. Morel1, E. Pawula1, M. Abou Taam1, T. Trenque1
1Reims University Hospitals, Regional Center of Pharmacovigilance and Pharmacoepidemiology, Reims, France

P 004
Prevalence and Potential Risks from Psychoactive Substances & Analgesics in Counterfeit Products
F. Al Braik1, M. AlGhamrawi2, A.S. Elgharbawy2, M.Y. Hasan3
1Abu Dhabi Health Services, Pharmaceutical Department, Abu Dhabi, United Arab Emirates
2Ministry of Health, Drugs Department, Abu Dhabi, United Arab Emirates
3College of Medicine & Health Silences- UAE University, Pharmacology and Therapeutics, Abu Dhabi, United Arab Emirates

P 005
The comparative risk of all-cause mortality in older patients prescribed opioids for non-malignant pain: a retrospective observational cohort study
C. Allen1, W. Meeraus2, K. Donegan1
1Medicines & Healthcare Products Regulatory Agency, Vigilance & Risk Management of Medicines, London, United Kingdom
2Medicines & Healthcare Products Regulatory Agency, Clinical Practice Research Datalink, London, United Kingdom

P 006
Optimising methods for collecting participant-reported safety endpoints in antimalarial drug clinical research
E. Allen1, C.I. Chandler2, U. Mehta3, N. Mandimika1, C. Pace4, K.I. Barnes1
1University of Cape Town, Division of Clinical Pharmacology - Department of Medicine, Cape Town, Republic of South Africa
2London School of Hygiene and Tropical Medicine, Department of Global Health & Development, London, United Kingdom
3Independent Pharmacovigilance Consultant, Cape Town, Republic of South Africa
4Liverpool School of Tropical Medicine, Department of Clinical Sciences, Liverpool, United Kingdom

P 007
Compliance with legal requirements at community pharmacies in Saudi Arabia
A. Alreshedi1, S. Alhendi1, T. Alshammari1,2, M. Aljofan1
1University of Hail, College of Pharmacy, Hail, Saudi Arabia
2King Saud University, Medication Safety Research Chair - College of Pharmacy, Riyadh, Saudi Arabia

P 008
Completeness of Medications Prescriptions: Prescription Errors Study in Hail Region (PeSHR)
A. Altebenaui1, M. Alrashedi1, T. Alshammari1,2, M. Aljofan1
1University of Hail, College of Pharmacy, Hail, Saudi Arabia
2King Saud University, Medication Safety Research Chair- College of Pharmacy, Riyadh, Saudi Arabia

P 009
Notification systems allowing Marketing Authorisation Holders to inform Competent Authorities about new information related to their medicinal products
P. Arlett1, K. Plueschke1, E. Almeida1, B. Thi1, X. Kurz1
1European Medicines Agency, Pharmacovigilance Department, London, United Kingdom

P 010
Revision of Guidance on Screening for Adverse Drug Reactions in EudraVigilance
G. Candore1, J. Slattery2, X. Kurz2, P. Arlett2
1European Medicines Agency, Business Data and Analytics Department, London, United Kingdom
2European Medicines Agency, Pharmacovigilance Department, London, United Kingdom

P 011
Drugs withdrawn for hepatotoxicity from the EU and US market since 1997. What information could be useful?
S. Babai1, L. Auclert2, H. Le Louët1
1Henri Mondor Hospital, Pharmacovigilance, Créteil, France
2Biotechnology industry, Pharmacovigilance, Paris, France

P 012
Liver Transplantation for Drug fulminant Hepatitis in France
S. Babai1, P. Maison2, H. Le Louët1
1Henri Mondor hospital, Pharmacovigilance, Créteil, France
2Agence National de Sécurité du Médicament, Pharmacovigilance, Saint Denis, France

P 013
DILI and diagnosis tools improvements
S. Babai1, H. Le Louët1
1Henri Mondor Hospital, Pharmacovigilance, Créteil, France

P 014
Detection of Drug-Induced hydro-electrolytic Adverse Reactions by retrospective analysis of renal and metabolic physiological investigations data
H. Bagheri1, T.L.A. Dinh1, N. Mongkhonmath1, M. Vallet2, I. Tack2, J.L. Montastruc1
1Centre de Pharmacovigilance et de pharmacoépidemiologie – CHU Toulouse, Pharmacology – Faculté de Médecine, Université Paul Sabatier, Toulouse, France
2CHU Toulouse, Explorations fonctionnelles métaboliques et rénales, Toulouse, France

P 015
Hospital admission due to bleeding or thromboembolic events in patients with atrial fibrillation: Direct Anticoagulant versus Vitamin K Antagonists
L. Saliba1, L. Bieler2, L. Chebane1, L. Molinier2, J.L. Montastruc1, H. Bagheri1
1Toulouse University Hospital, Clinical Pharmacology and Pharmacovigilance, Toulouse, France
2Toulouse University Hospital, Medical Information, Toulouse, France

P 016
Hospital admission due to bleeding in patients with atrial fibrillation: antiplatelet agents or oral anticoagulants?
L. Saliba1, L. Bieler2, L. Chebane1, L. Molinier2, J.L. Montastruc1, H. Bagheri1
1Toulouse University Hospital, Clinical Pharmacology and Pharmacovigilance, Toulouse, France
2Toulouse University Hospital, Medical Information, Toulouse, France

P 017
Do we need pharmacovigilance education and do adolescents have adequate knowledge regarding proper medicine use?
M.A. Balazs1,2, B. Piko2
1Semmelweis University - School of Ph.D. Studies, Doctoral School of Mental Health Sciences, Budapest, Hungary
2University of Szeged - Faculty of General Medicine, Department of Behavioural Sciences, Szeged, Hungary

P 018
Characterising ADRs as Continuous or Binary Variables: Principles and Consequences for Terminologies, Labelling, Causality and Risk Assessment and Signal Detection
J. Beckmann1
1WHO Expert Advisory Panel on Medicine Safety, Pharmacovigilance, Berlin, Germany

P 019
Pharmacovigilance education in pharmaceutical company - an example of the Czech Republic and Slovakia Sanofi affiliate
R. Běla1
1Sanofi-aventis - s.r.o., Medical, Prague, Czech Republic

P 020
Pharmacovigilance in Undergraduate Medical and Pharmacy Education in Europe
T. Belkina1, K. Ladova1, J. Vlcek1
1Charles University in Prague - Faculty of Pharmacy in Hradec Kralove, Department of Social and Clinical Pharmacy, Hradec Kralove, Czech Republic

P 021
The role of pharmacovigilance centres as drug Information Centre: the moroccan experience
R. Benjelloun1, R. Benkirane1, G. Benabdallah1, R. Soulaymani-Bencheikh1
1Centre Anti Poison et de Pharmacovigilance du Maroc, Pharmacovigilance, Rabat, Morocco

P 022
Pharmacovigilance from a public health point of view –implications of reduced renal function
U. Bergman1, E. Höglund2, I. Odar-Cederlöf1, N. Pettersson3
1Karolinska University Hospital, Clinical Pharmacology - Karolinska Institutet, Stockholm, Sweden
2St Göran Hospital, Department of Internal Medicine, Stockholm, Sweden
3Karolinska University Hospital, Department of Emergency Medicine - Karolinska Institutet, Stockholm, Sweden

P 023
Risks associated with a new fixed-dose combination drug
M. Bertazzoli1, G. Clerici1, G. Furlan2
1Helsinn Healthcare SA, Corporate Drug Safety, Lugano, Switzerland
2Helsinn Birex Pharmaceuticals Ltd, Corporate Drug Safety, Dublin, Ireland

P 024
Use of the computerized hospital database in pharmacovigilance: is it relevant for the detection of drug-induced thrombocytopenia?
S. Passard1, M. Constantinescu1, B. Trombert-Paviot2, F. Bellet1, G. Mounier1, M.N. Beyens1
1University Hospital of Saint-Etienne, Centre de Pharmacovigilance, Saint-Etienne, France
2University Hospital of Saint-Etienne, Service de Santé publique et d’information médicale, Saint-Etienne, France

P 025
Before and after the 2013 alert concerning thromboembolic events with 3rd and 4th generation combined oral contraceptives: an impact study
M. Constantinescu1, F. Bellet1, B. Trombert-Paviot2, M.N. Beyens1
1University Hospital, Regional Pharmacovigilance Center, Saint-Etienne, France
2University Hospital, Public Health and Medical Information, Saint-Etienne, France

P 026
Medication persistence of dabigatran and rivaroxaban among patients with nonvalvular atrial fibrillation initiating anticoagulant therapy in early 2013 in France.
C. Billionnet1, G. Maura1, P. Ricordeau1, F. Alla2
1National Health Insurance CNAM-TS, Strategy and Research Department, Paris, France
2National Health Insurance CNAM-TS, Cabinet du Médécin Conseil National, Paris, France

P 027
Drug-drug interactions of statins in hospitalized patients: results from a prospective observational study
C. Bucsa1, A. Farcas1, D. Leucuta2, C. Mogosan1, M. Bojita1, D.L. Dumitrascu3
1“Iuliu Hatieganu” University of Medicine and Pharmacy, Drug Information Research Center, Cluj-Napoca, Romania
2“Iuliu Hatieganu” University of Medicine and Pharmacy, Department of Medical Informatics and Biostatistics, Cluj-Napoca, Romania
3“Iuliu Hatieganu” University of Medicine and Pharmacy, 2nd Medical Department, Cluj-Napoca, Romania

P 028
Severe cardiac events following treatment with trastuzumab in women with breast cancer: a meta-analysis of clinical trials and cohort studies
S. Mantarro1,2, M. Rossi3,4, C. Blandizzi1,5, A. Capogrosso Sansone1, I. Convertino5, S. Montagnani1, A. Marino1, A. Saporiti1, D. Garibaldi2, R. D’Amico6, E. Negri3, C. La Vecchia4, L. Moja7,8, M. Tuccori5
1University of Pisa, Department of Clinical and Experimental Medicine, Pisa, Italy
2Health District of Lucca, Pharmaceutical Unit, Lucca, Italy
3IRCSS Institute for Pharmacological Research “Mario Negri”, Department of Epidemiology, Milan, Italy
4University of Milan, Department of Clinical Medicine and Community Health, Milan, Italy
5University Hospital of Pisa, Unit of Adverse Drug Reaction Monitoring, Pisa, Italy
6University of Modena and Reggio Emilia, Italian Cochrane Centre, Modena, Italy
7University of Milan, Department of Biomedical Sciences for Public Health, Milan, Italy
8IRCCS Orthopedic Institute Galeazzi, Clinical Epidemiology Unit, Milan, Italy

P 029
Medication errors related to the administration of medicinal gases in France: one of the twelve French never events
M. Hervé-Bazin1, D. Durand1, F. Cardona1, P. Maison2
1The French National Agency for Medicines and Health Products Safety ANSM, Pharmacovigilance Department, Saint-Denis, France
2The French National Agency for Medicines and Health Products Safety ANSM, Surveillance Direction, Saint-Denis, France

P 030
Active search for adverse reactions using medication tracers
R.A. Caro-Rojas1, J.J. Delgadillo1, M.D.M. Avella2
1Fundación Santa Fe de Bogotá, Bogotá, Colombia
2National University of Colombia, Bogotá, Colombia

P 031
Implementing best practices for the safe use of medications: it is possible to reduce adverse events, a 7-year experience
R.A. Caro-Rojas1, H.M. Gallardo2, C.A. Franco3, B.S. Vanegas3
1Fundación Santa Fe de Bogotá, Pharmacovigilance, Bogotá, Colombia
2Fundación Santa Fe de Bogotá, University Hospital, Bogotá, Colombia
3Fundación Santa Fe de Bogotá, Pharmacovigilance Committee, Bogotá, Colombia

P 032
Medication reconciliation through pharmacy consultation: Criteria for surgical patient prioritization
R.A. Caro-Rojas1, E. Salinas2, D. Rojas2
1Fundación Santa Fe de Bogotá, Bogotá, Colombia
2National University of Colombia, Bogotá, Colombia

P 033
Empirical Evaluation of Statistical Signal Detection Based on Unexpected Time-to-Onset for Non-Vaccine Drugs in VigiBase
C. Wärn1, O. Caster1,2
1Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
2Stockholm University, Department of Computer and Systems Sciences, Kista, Sweden

P 034
vigiRank Improves Real-World Signal Detection Performance: Prospective Results from International Pharmacovigilance
O. Caster1,2, L. Sandberg1, K. Juhlin1, S. Watson1, G.N. Norén1,3
1Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
2Stockholm University, Department of Computer and Systems Sciences, Kista, Sweden
3Stockholm University, Department of Mathematics, Stockholm, Sweden

P 036
Human papilloma virus vaccines and gastrointestinal motility disorders
R. Chandler1, S. Hult1, P. Caduff-Janosa1
1WHO Collaborating Centre for International Drug Monitoring - Uppsala Monitoring Centre, Research, Uppsala, Sweden

P 037
Characteristics of adverse event reports after HPV vaccination: a global perspective
R. Chandler1, K. Juhlin1, O. Caster1, K. Star1
1WHO Collaborating Centre for International Drug Monitoring - Uppsala Monitoring Centre, Research, Uppsala, Sweden

P 038
An innovative software tool for the development, implementation and effectiveness evaluation of additional risk minimisation measures
M. Cushion1, S. Mayall1, J. Scrivener1, S. Ingate1
1Pope Woodhead & Associates Ltd., Regulatory and Risk Management, Saint Ives - Cambridge, United Kingdom

P 039
Switch between TNF-antagonists: a population based study
C. D'Amore1, R. Da Cas1, M. Rossi2, G. Traversa1
1National Institute of Health, National Centre for Epidemiology - Pharmacoepidemiology Unit, Roma, Italy
2Umbria Region, General Directorate for Health - Unit for Pharmaceutical Governance, Perugia, Italy

P 040
Plantar psoriasis associated with olmesartan
O. Charfi1, A. Zaïem1, M. Ben Sassi1, R. Sahnoun1, S. El Aïdli1, R. Daghfous1, S. Kastalli1
1 Centre National de Pharmacovigilance (CNPV),, Service de recueil et analyse des données, Tunis, Tunisia

P 041
Lyell syndrome after rituximab infusion
G. Lakhoua1, R. Sahnoun1, S. Kastalli1, M. Ben Sassi1, R. Daghfous1, S. El Aidli1, A. Zaiem1
1Centre National de Pharmacovigilance (CNPV), Service d'analyse et de recueil des données, Tunis, Tunisia

P 042
Digital ischemia induced by gemcitabine and cisplatin
R. Sahnoun1, G. Lakhoua1, O. Charfi1, S. El Aidli1, R. Daghfous1, S. Kastalli1, A. Zaiem1
1 Centre National de Pharmacovigilance (CNPV),, Pharmacovigilance, Tunis, Tunisia

P 043
Angioedema associated with angiotensin-converting enzyme inhibitor: a retrospective study
R. Sahnoun1, G. Lakhoua1, O. Charfi1, S. El Aidli1, R. Daghfous1, S. Kastalli1, A. Zaiem1
1 Centre National de Pharmacovigilance (CNPV), Pharmacovigilance, Tunis, Tunisia

P 044
Use of triggers in the characterization of adverse drug events in a Pediatric ICU
C. Dagli Hernandez1, P. Katayose Takahashi2, S. Carvalho Fabretti3, N. Silvana Romano-Lieber3
1University of 
São Paulo, Faculty of Pharmacy and Biochemistry, São Paulo, Brazil
2University of 
São Paulo, University Hospital, São Paulo, Brazil
3University of 
São Paulo, Department of Public Health Practice - Faculty of Public Health, São Paulo, Brazil

P 045
Web-based intensive monitoring of metformin
L. de Jong1, L. Härmark1, E. van Puijenbroek1,2
1Netherlands Pharmacovigilance Centre, Lareb, 's-Hertogenbosch, The Netherlands
2University of Groningen, Pharmacotherapy and pharmaceutical care, Groningen, The Netherlands

P 046
A Harmonised Scheme to Support Developing Risk Management Guidelines Beyond ICH Countries.
H. Le Louët1, J.C. Delumeau2, Y. Moride3, W.W. Chen4, S.A. Abdoellah5, H.A. Nguyen6, S. Shaikh Abdul Rahman7, W. Suwankesawong8, S. Thol9
1University Paris Est Creteil, Pharmacovigilance and Risk Management, Créteil, France
2Bayer South East Asia, Pharmacovigilance, Singapore, Singapore
3University of Montreal, Faculty of Pharmacy, Montréal, Canada
4Taiwan Drug Relief Foundation, National ADR Reporting Center, Taipei, Taiwan Republic of China
5National Agency of Drug and Food Control, Surveillance and Risk Analysis of Therapeutic Products, Jakarta, Indonesia
6Drug Information and ADR Centre, Pharmacovigilance, Hanoi, Vietnam
7Ministry of Health, National Pharmaceutical Control Bureau, Putrajaye, Malaysia
8Food and Drug Administration, Health Product Vigilance Centre, Bangkok, Thailand
9Ministry of Health, Cambodian Pharmacovigilance Centre, Phnom Penh, Cambodia

P 047
Patterns of spontaneously reported adverse drug reaction in Bhutan
C. Dorji1,2, P. Tragulpiankit1, N. Dema2
1Mahidol university - Thailand, Faculty of Pharmacy, Bangkok, Thailand
2Drug Regulatory Authority, Post marketing, Thimphu, Bhutan

P 048
Management of Medication Errors / Overdosage with Paracetamol (acetaminophen) in France
D. Durand1, J. Taransaud1, F. Cardona1, M. Maison2
1The French National Agency for Medicines and Health Products Safety ANSM, Pharmacovigilance, Saint-Denis, France
2The French National Agency for Medicines and Health Products Safety ANSM, Survey Department, Saint-Denis, France

P 049
Can drug disposal flow diagrams contribute to the control of pharmaceuticals in the environment?
Y. Esseku1, A. Dodoo2, E. Woode1, H. Esseku3
1Kwame Nkrumah University of Science and Technology, Department of Pharmacology, Kumasi, Ghana
2WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, Training, Accra, Ghana
3Rapha Consult, Consultancy, Accra, Ghana

P 050
Co-prescription of Renin-Angiotensin System Acting Agents and Assessment of Serum Creatinine and Potassium in Patients with Renal and Diabetic Disease
A. Farcas1, D. Leucuta2, C. Bucsa1, C. Mogosan1, M. Bojita1, D. Dumitrascu3
1Iuliu Hatieganu University of Medicine and Pharmacy, Drug Information Research Center, Cluj-Napoca, Romania
2Iuliu Hatieganu University of Medicine and Pharmacy, Medical Informatics and Biostatistics Department, Cluj-Napoca, Romania
3Iuliu Hatieganu University of Medicine and Pharmacy, 2nd Medical Department, Cluj-Napoca, Romania

P 051
ISoP Israel project to address Public Health Issues through a national multi-lateral collaborative risk management plan: time to move forward.
I. Fermont1, Y. Wexler2, O. Lavon3, L. Brezka4
1ISOP ISRAEL - IFC Ltd, Strategic Safety Consulting, Jerusalem, Israel
2Bioforum - ISOP ISRAEL, Education and Training, Ness Ziona, Israel
3Carmel Medical Center - The Rappaport Family Faculty of Medicine - Technion-Israel Institute of Technology, Clinical Pharmacology and Toxicology Unit, Haifa, Israel
4Kamada - ISOP ISRAEL, Pharmacovigilance & Risk Management, Beit Kama, Israel

P 052
Description of a process to optimize diagnosis and management of HIT in a university hospital.
V. Fulda1, M. Alhenc-Gelas2, T. Caruba3, D. Smadja2, A. Lillo-Le Louët1
ôpital Européen Georges Pompidou, Pharmacovigilance, Paris, France
ôpital Européen Georges Pompidou, Hematologie-Biologie, Paris, France
ôpital Européen Georges Pompidou, Pharmacie, Paris, France

P 054
Adverse events of antibiotics and their management in a department of infectious disease
M. Bastides1, M. Auffret1, J. Béné1, S. Gautier1, L. Gaboriau1
1CHRU Lille, Pharmacovigilance regional Center, Lille, France

P 055
Detection of Off-Label Drug Use: a Role for Pharmacists?
M. Auffret1, L. Gaboriau1, J. Béné1, J. Dekemp1, S. Gautier1
1CHRU de Lille, Medical Pharmacology, Lille, France

P 056
Underreporting adverse drug reactions (ADR) and medication errors (ME): a problem in hospital pharmacovigilance.
L. Garza-Ocañas1, J. Escobedo Peña2, C. González-Nieto2, E. Pérez-Rodríguez2, S. Guzmán-López2, E. Aponte1, P. Riojas-Hernández5
1Universidad Autónoma de Nuevo León, Pharmacology and Toxicology Medicine School and University Hospital "Dr José E González", Monterrey, Mexico
2Universidad Autónoma de Nuevo León, University Hospital "Dr José E González", Monterrey, Mexico

P 057
Adverse drug reactions induced by cotrimoxazole: still a lot of preventable harm
M. Coppry1, A.M. Rogues2, D. Berdaï1, G. Miremont-Salamé1, A. Fourrier-Réglat1, F. Haramburu1, P. Noize1
1CHU de Bordeaux - Univ Bordeaux, Clinical pharmacology, Bordeaux, France
2Univ Bordeaux - CHU de Bordeaux - Inserm U657, Hospital hygiene, Bordeaux, France

P 058
Case-by-case assessment of ICSRs from Marketing Authorization Holders: a pilot study
J. Scholl1, F. van Hunsel1, L. Härmark1
1The Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands

P 059
A Medicines Regulatory Perspective on Women’s Medicines
J. Nooney1, J. Raine1, M. Harrison-Woolrych1
1Medicines and Healthcare products Regulatory Agency, VRMM, London, United Kingdom

P 060
Analysis of UK spontaneous adverse drug reaction (ADR) reports from the Yellow Card Scheme (YCS) from 2010 to 2014
K. Harrison1, T. Jan1, M. Foy1
1Medicines and Healthcare products Regulatory Agency MHRA, Vigilance - Intelligence and Research Group - Vigilance and Risk Management of Medicines, London, United Kingdom

P 061
A follow-up questionnaire: a successful tool to study topics related to packaging changes of the drug Thyrax® in the Netherlands
J. Hartman1, G. Weits1, L. Rolfes1
1Netherlands Pharmacovigilance Centre, Lareb, 's-Hertogenbosch, The Netherlands

P 062
Seasonal and Geographic Variation In Adverse Event Reporting
M. Hauben1, E. Hung1, O. Marrero2
1Pfizer Inc., Safety Surveillance and Risk Management, New York, USA
2Villanova University, Department of Mathematics and Statistics, Villanova, USA

P 063
Potentially inappropriate prescribing and the risk of adverse drug reactions in the elderly Swedish population
K. Hedna1, K. Hakkarainnen2, H. Gyllensten3, A.K. Jönsson4, M. Petzold5, S. Hägg1
1Institution of Medical and Health Sciences. Linköping University, Department of Drug Research, Linköping, Sweden
2Nordic School of Public Health, NHV, Gothenburg, Sweden
3Karolinska Institute, Division of Insurance Medicine- Department of Clinical Neuroscience, Stockholm, Sweden
4Department of Clinical Pharmacology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden
5Centre for Applied Biostatistics, University of Gothenburg, Gothenburg, Sweden

P 064
Trends of drug-safety alerts from 2002 to 2014: data from Portugal
F. Roque1,2, A. Teixeira Rodrigues2,3, M.T. Herdeiro3,4
1UDI/IPG - Research Unit for Inland Development, Polytechnic of Guarda, Guarda, Portugal
2University of Aveiro, iBiMED & Health Sciences - Institute for Research in Biomedicine, Aveiro, Portugal
3University of Coimbra, Faculty of Pharmacy, Coimbra, Portugal
4CESPU, Institute of Research and Advanced Training in Health Science and Technologies, Gandra, Portugal

P 065
Impact of co-payments for primary care services in antibiotic use: a time-series analysis.
A. Teixeira Rodrigues1,2, F. Roque1,3, M.T. Herdeiro1,4
1Institute for Research in Biomedicine – iBiMED & Health Sciences, Aveiro, Portugal
2University of Coimbra, Faculty of Pharmacy, Coimbra, Portugal
3Polytechnic Institute of Guarda, Research Unit for Inland Development, Guarda, Portugal
4CESPU – Institute of Research and Advanced Training in Health Science and Technologies, Gandra, Portugal

P 067
Desloratadine and aggressive reaction reported in VigiBase
L. Sandberg1, S. Hult1, K. Star1, P. Caduff-Janosa1
1Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden

P 068
A Signal based on Spontaneous Reports of Atomoxetine and Neutropenia in Paediatric Patients
I. Boyd1, D. Sartori2, S. Hult2
1Ian Boyd, Consulting, Milton, Australia
2WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Uppsala, Sweden

P 069
Angiotensin-converting-enzyme inhibitors induced cough: diagnosis and management by 1,100 French-speaking GPs
X. Humbert1, S. Fedrizzi2, J.C. Robert1, A. Coquerel2
1Department of General Medicine - Medical School, Caen, France
2Pharmacovigilance Regional Center - CHU Caen, Caen, France

P 070
Spontaneous Reporting by Patients: Sociodemographic and Economic Factors that Promote Reporting
P. Inacio1, M. Airaksinen1, A. Cavaco2
1University of Helsinki, Faculty of Pharmacy - Division of Pharmacology and Pharmacotherapy, Helsinki, Finland
2Medical University Lisboa - Research Institute for Medicines and Pharmaceutical Sciences, Social Pharmacy, Lisbon, Portugal

P 071
Strengthening capabilities for benefit risk assessment in post-marketing – The Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action
J. Ivanovic1, I. Buajordet2, A. Schiel2, Q.Y. Yue3, A. Wennberg4, J. Woolley5, A. Shaw6, E. Carey7, N. Buckley7, E. Marotta8, V. Cuconato8, M. Di Girolamo8, I. Escudero9, M. Foy10
1Italian Medicines Agency - AIFA, Research and Clinical Trials, Rome, Italy
2Norwegian Medicines Agency, Pharmacovigilance Section Department for Medicinal Product Assessment, Oslo, Norway
3Medical Products Agency Sweden, Department of Efficacy and Safety 1, Uppsala, Sweden
4Medical Products Agency Sweden, International relations GD-stab/Office of the Director General, Uppsala, Sweden
5Medicines and Healthcare products Regulatory Agency -MHRA, Pharmacovigilance unit, London, United Kingdom
6Medicines and Healthcare products Regulatory Agency - MHRA, Benefit Risk Management Group - VRMM, London, United Kingdom
7Health Products Regulatory Authority Ireland, Pharmacovigilance unit, Dublin, Ireland
8Italian Medicines Agency - AIFA, Pharmacovigilance Unit, Rome, Italy
9Agencia Española de Medicamentos y Productos Sanitarios AEMPS, Pharmacoepidemiology and Pharmacovigilance Division, Madrid, Spain
10Medicines and Healthcare products Regulatory Agency MHRA, Vigilance- Intelligence & Research Group, London-, United Kingdom

P 072
Intensive Monitoring of Adverse Drug Reactions – State of the art
J.J. Joaquim1,2, L. Härmark3, C. Fontes Ribeiro4, R. Mateos-Campos5
1Coimbra Health School, Pharmacy, Coimbra, Portugal
2University of Salamanca, Pharmacy, Salamaca, Spain
3Netherlands Pharmacovigilance Centre Lareb, Innovation & Projects, ’s-Hertogenbosch, The Netherlands
4University of Coimbra, Faculty of Medicine - Pharmacology and Experimental Therapeutics, Coimbra, Portugal
5University of Salamanca, Faculty of Medicine, Medicina Preventiva - Salud Pública y Microbiología Médica, Salamanca, Spain

P 073
Fatal risk assessment of use of fluconazole during pregnancy
M.T. Costa1, C. Matos1, J.J. Joaquim1
1Coimbra Health School, Pharmacy, Coimbra, Portugal

P 074
Assessment of risk perception of ADR by patient’s – pilot study
A. Silva1, C. Matos1, T. Pires1, M.C. Rocha2, J.J. Joaquim1
1Coimbra Health School, Pharmacy, Coimbra, Portugal
2Coimbra Health School, Complementary Sciences, Coimbra, Portugal

P 075
Fatal Interaction Between Fusidic Acid and Pravastatin
C. Joyau1, J. Mahe1, M. Fiancette2, Y. Poirier3, A.L. Ruellan1, G. Veyrac1, P. Jolliet1
1Nantes University Hospital, Biology Institute, Clinical Pharmacology Department, Nantes, France
2District Hospital Center, Intensive Care Unit, La Roche sur Yon, France
3District Hospital Center, Pharmacy, La Roche sur Yon, France

P 076
Risk of extravasation injury with PEDIAVEN and other parenteral nutritions used with peripheral intravenous in French neonatal intensive care unit.
D. Bourneau-Martin1, B. Leboucher2, S. Le Bouedec2, V. Bastien1, G. Drablier1, L. Lagarce1, P. Laine-Cessac1, C. Joyau3
1CHU Angers, Pharmacovigilance, Angers, France
2CHU Angers, Neonatal Intensive Care Unit, Angers, France
3Nantes University Hospital, Pharmacovigilance Center, Nantes, France.

P 077
Delayed iodinated contrast media hypersensitivity after coronary angiography
G.W. Kim1, H.R. Kang2
1Seoul National University Hospital, Internal Medicine, Seoul, South Korea
2Seoul National University College of Medicine, Internal Medicine, Seoul, South Korea

P 078
Better knowledge access for capacity building of community midwives to reduce maternal morbidity and mortality: Use of ICT
N. Khan1
1UCL /FGC, Health Informatics/ Gynaecology, London/Karachi, Pakistan

P 079
Pilot project of recording and assessing medication errors within the German spontaneous reporting system
U. Köberle1, T. Stammschulte1, U. Gundert-Remy1
1Drug Commission of the German Medical Association, Pharmacovigilance, Berlin, Germany

P 080
Tacrolimus side effects in Tunisian kidney transplant recipients
M. Ben Sassi1, E. Gaies2, R. Charfi2, N. Jebabli2, H. El Jebari2, M. Lakhal2, A. Klouz2, I. Salouage2, S. Trabelsi2
1 Centre National de Pharmacovigilance (CNPV), Tunis, Tunisia
2 Centre National de Pharmacovigilance (CNPV), Service de Pharmacologie Clinique de Tunis, Tunis, Tunisia

P 081
Gestational pemphigoid induced by the anti-tetanus vaccine?
M. Ben Sassi1, G. Lakhoua1, A. Zaiem1, R. Sahnoun1, S. Sarairi1, S. El Aidli1, R. Daghfous1, S. Kastalli1, M. Lakhal1
1 Centre National de Pharmacovigilance (CNPV), Service de recueil et d'analyse des données, Tunis, Tunisia

P 082
Acute pancreatitis induced by Metformin
M. Ben Sassi1, S. Kastalli1, O. Charfi1, G. Lakhoua1, S. El Aidli1, M. Lakhal1, R. Daghous1, A. Zaiem1
1CNPV, Service de recueil et d'analyse des données, Tunis, Tunisia

P 083
Tolerability to fixed-dose combination antituberculosis therapy
O. Charfi1, S. El Aïdli1, R. Sahnoun1, G. Lakhoua1, R. Daghfous1, A. Zaïem1, S. Kastalli1, M. Lakhal1
1 Centre National de Pharmacovigilance (CNPV), Service de recueil et analyse des données, Tunis, Tunisia

P 084
Bullous eruption and skin necrosis following extravasation of vinorelbine.
O. Charfi1, R. Sahnoun1, G. Lakhoua1, M. Ben Sassi1, S. El Aïdli1, A. Zaïem1, S. Kastalli1, M. Lakhal1
1 Centre National de Pharmacovigilance (CNPV), Service de recueil et analyse des données, Tunis, Tunisia

P 085
Gender differences in pharmacokinetics of tacrolimus
M. Ben Sassi1, E. Gaies2, R. Charfi2, N. Jebabli2, H. El Jebari2, M. Lakhal2, A. Klouz2, I. Salouage2, S. Trabelsi2
1 Centre National de Pharmacovigilance (CNPV), Tunis, Tunisia
2 Centre National de Pharmacovigilance (CNPV), Service de Pharmacologie Clinique de Tunis, Tunis, Tunisia

P 086
Safety of Brotizolam in Patients Hospitalized in Internal Medicine Departments
O. Lavon1, S. Bejell2
1Carmel Medical  Center, Clinical Pharmacology and Toxicology, Haifa, Israel
2Technion-Israel Institute of Technology, The Rappaport Family Faculty of Medicine, Haifa, Israel

P 087
Educational materials can have positive impact on patients’ knowledge of ADRs – a randomized controlled trial of novel educational booklet
H. Lebanova1, K. Kalaijiev2, I. Getov2
1Medical University-Pleven, Medical college, Pleven, Bulgaria
2Medical University-Sofia, Faculty of Pharmacy, Sofia, Bulgaria

P 088
Adverse drug reactions reporting by patients – an observational study of the Bulgarian pharmacovigilance database
H. Lebanova1, M. Popova2, J. Eftimov2, A. Stoimenova3, I. Getov3
1Medical University-Pleven, Medical College, Pleven, Bulgaria
2Bulgarian Drug Agency, Department "Medicines use control", Sofia, Bulgaria

P 089
Contraindications involving citalopram or escitalopram in clinical practice: relevance of the pharmaceutical analysis?
A. Chastang1, C. Skalafouris1, H. Beaussier2, Y. Bezie1, A. Lillo-Le Louët3, T.T. Phan Thi1
1Groupe Hospitalier Paris Saint Joseph, Pharmacie, Paris, France
2Groupe Hospitalier Paris Saint Joseph, Centre de recherche clinique, Paris, France
3Hôpital Européen Georges Pompidou, Centre de Pharmacovigilance, Paris, France

P 090
Evaluation of a new classification of Adverse Drugs Reactions (ADR): applying DOTS to spontaneous reports
A. Lillo-Le Louët1, P. Puech1, C. Le Beller1, H. Le Louët1
1Hopital Européen Georges Pompidou, Pharmacovigilance, Paris, France

P 091
Safety of misoprostol for labour induction and delivery, an off-label use: partnership between regional pharmacovigilance centres and Regional Health Agency.
A. Lillo-Le Louët1, M. Marakian2, M.V. Senat3, P. Carlier2, A. Benachi4, P. Rozenberg5, H. Le Louët6, A. Castot-Villepelet7
1Hopital Européen Georges Pompidou, Pharmacovigilance, Paris, France
2Hopital Fernand Widal, Pharmacovigilance, Paris, France
3Hopital de Bicêtre, Maternité, Le Kremlin-Bicêtre, France
4Hopital Antoine Béclère, Maternité, Clamart, France
5Centre Hospitalier de Poissy-Saint Germain, Maternité, Poissy, France
6Hopital Henri Mondor, Fédération de Pharmacovigilance, Créteil, France
7Agence Régionale de Santé, Coordination des Vigilances et appui, Paris, France

P 092
Retrospective Study on Determinants of Ifosfamide Induced Neurotoxicity
J. Mahe1, N. Corradini2, C. Chauvin3, C. Joyau1, A.L. Ruellan1, G. Veyrac1, P. Jolliet1
1Institute of Biology- University Hospital Nantes, Clinical Pharmacology, Nantes, France
2University Hospital Nantes, Pediatric Oncology, Nantes, France
3University Hospital Nantes, Clinical Oncology Pharmacy, Nantes, France

P 094
Potential and actual drug-drug interactions in elderly patients admitted to an emergency department: data from the ANCESTRAL-ED study
A. Marino1, A. Capogrosso Sansone1, C. Blandizzi1, S. Mantarro1, I. Convertino2, S. Montagnani1, A. Saporiti1, G. Bini3, R. Sieli3, G. Pasqualetti3, F. Monzani3, M. Santini4, M. Tuccori2
1University of Pisa, Department of Clinical and Experimental Medicine, Pisa, Italy
2University Hospital of Pisa, Unit of Adverse Drug Reaction Monitoring, Pisa, Italy
3University Hospital of Pisa, Geriatric Unit- Department of Clinical and Experimental Medicine, Pisa, Italy
4University Hospital of Pisa, Emergency Department, Pisa, Italy

P 095
QT interval prolongation and hydroxyzine: a retrospective cohort analysis on hospitalized elderly patients
A. Marino1, C. Blandizzi1, S. Montagnani1, G. Pasqualetti2, A.A. Qasem2, S. Cottone2, A. Capogrosso Sansone1, S. Mantarro1, I. Convertino3, S. Salvadori4, M. Fornai1, L. Antonioli1, F. Monzani2, M. Tuccori3
1University of Pisa, Department of Clinical and Experimental Medicine, Pisa, Italy
2University Hospital of Pisa, Geriatrics Unit- Department of Clinical and Experimental Medicine, Pisa, Italy
3University Hospital of Pisa, Unit of Adverse Drug Reaction Monitoring, Pisa, Italy
4National Research Council, Institute of Clinical Physiology, Pisa, Italy

P 096
From Risk Assessment to the Risk Management in the use of Radiological Iodinated Contrast Media (RICM)
T. Marquez Cabrera1, J.A. Moran Dominguez2, L.M. Mendez Lopez1, A. Alducin Diaz3
1Benemérita universidad autónoma de Puebla, Centro institucional de farmacovigilancia BUAP-FCQ, Puebla, Mexico
2Benemérita universidad autónoma de Puebla, Centro de información de medicamentos BUAP, Puebla, Mexico
3Benemérita universidad autónoma de Puebla, Facultad de Ciencias Químicas, Puebla, Mexico

P 097
Adverse Drug Events Related To Approved Prophylactic Use of Omeprazole
P. Mastroianni1, F. Varallo1, S. Paulo1, S. Mieli1, T. De Nadai2, S. Abjaude1
1School of Pharmaceutical Sciences, UNESP - Univ Estadual Paulista,  Drugs and Medicines, Araraquara, Brazil
2Americo Brasiliense State Hospital and Ribeirão Preto School of Medicine - University of São Paulo, Surgery and Anatomy, Américo Brasiliense, Brazil

P 098
Patient reporting systems: a view across the European Union
C. Matos1
1University of Seville, Faculty of Pharmacy, Seville, Spain

P 099
Mitoxantrone treatment-induced cardiotoxicity in patients with multiple sclerosis
C. Matos1, D. Martins1, J. Joaquim1
1Coimbra Health School, Pharmacy, Coimbra, Portugal

P 100
Compromise of the effectivity of oral contraceptives in concomitant use with antibiotics
C. Matos1, A. Cruz1, J. Joaquim1
1Coimbra Health School, Pharmacy, Coimbra, Portugal

P 101
Right-Sized Signal Detection Systems that Meet Regulatory Expectations
D. McCarthy1
1Quintiles, Benefit Risk Management, Cambridge, USA

P 102
Acute hypersensitivity reactions to herbal remedies in children reported to the WHO VigiBase® database
R. Meincke1, J. Pokladnikova1, D. Niedrig2, S. Russmann2, R. Meyboom3
1Charles University in Prague - Faculty of Pharmacy, Social and Clinical Pharmacy, Hradec Kralove, Czech Republic
University Hospital Zurich, Division of Clinical Pharmacology and Toxicology, Zurich, Switzerland
Utrecht University, Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht, The Netherlands

P 103

The Effect Of Curcumin On Experimental Non- Alcoholic Fatty Liver Disease In Rat Models: Biochemical, Histochemical And Immunohistochemical Studies
M. Megahed1, H. Fayed2, S. Hassan3, M. Shamsyia4, M. Shaaba25
1Professor and Head of Department of Biochemistry, Biochemistry, Alexandria, Egypt
2Medical Research institute MRI - Alexandria University, Biochemistry, Alexandria, Egypt
3Medical Research Institute MRI - Alexandria University, Histochemistry and Cell Biology Department, Alexandria, Egypt
4Medical Research Institute MRI - Alexandria University, Internal Medicine, Alexandria, Egypt

P 104
Number needed to harm as a tool for post-marketing drug safety evaluation: a pilot study with thiazolidinediones
D. Mendes1,2, C. Alves1,2, F. Batel-Marques1,2
1AIBILI -  Association for Innovation and Biomedical Research on Light and Image, CHAD - Centre for Health Technology Assessment and Drug Research, Coimbra, Portugal
2University of Coimbra, School of Pharmacy, Coimbra, Portugal

P 105
Antibiotics-induced liver injury: a pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events
D. Mendes1,2, P. Dias1,3,4, C. Alves1,2, F. Batel-Marques1,2
1AIBILI -  Association for Innovation and Biomedical Research on Light and Image, CHAD - Centre for Health Technology Assessment and Drug Research, Coimbra, Portugal
2University of Coimbra, School of Pharmacy, Coimbra, Portugal
3CHUC - Coimbra Hospital and Universitary Centre, Internal Medicine, Coimbra, Portugal
4University of Coimbra, School of Medicine, Coimbra, Portugal

P 106
Ocular adverse drug events: analysis of spontaneous reports from a Portuguese regional pharmacovigilance database
A. Penedones1, D. Mendes1,2, C. Alves1,2, F. Batel-Marques1,2
1AIBILI -  Association for Innovation and Biomedical Research on Light and Image, CHAD - Centre for Health Technology Assessment and Drug Research, Coimbra, Portugal
2University of Coimbra, School of Pharmacy, Coimbra, Portugal

P 107
Henoch-Schönlein purpura and drug and vaccine use in childhood: a case-control study
F. Menniti Ippolito1, C. Zerbinati2, M.S. Strafella2, S. Renna3, L. Riceputi4, P. Di Pietro3, P. Barabino4, S. Scanferla5, U. Raucci6, N. Mores7, A. Compagnone7, R. Da Cas1, I.M.S. Group for Drug and Vaccine Safety in Children8
1National Institute of Health, National Center for Epidemiology - Surveillance and Health Promotion, Rome, Italy
2Treviso Hospital, Pediatric Department, Treviso, Italy
3Giannina Gaslini Children Hospital, Emergency Department, Genoa, Italy
4Giannina Gaslini Children Hospital, Pharmacy hospital, Genoa, Italy
5University of Padua, Department of Woman and Child Health, Padua, Italy
6Bambino Gesù Children’s Hospital, Pediatric Emergency Department, Rome, Italy
7Università Cattolica S. Cuore, Pharmacology and Pediatrics, Rome, Italy
8Rome, Italy

P 108
Liver Toxicity During Methotrexate Treatment: Analysis of Spontaneously Reported Cases in Serbia
M. Miljkovic1, I. Jovic2, M. Petronijevic2, J. Mirkovic1, J. Bucevac2, M. Mihailovic2, D. Hadzi-Djokic2
1Medicines and Medical Devices Agency of Serbia, Human Medicines Centre, Belgrade, Serbia
2Medicines and Medical Devices Agency of Serbia, National Pharmacovigilance Centre at Human Medicines Centre, Belgrade, Serbia

P 109
Potential drug-drug interactions in patients admitted to the cardiology ward of a Romanian teaching hospital
C. Pop1, E. Buzdugan2, I. Cazacu1, C. Bucsa3, O. Vostinaru1, F. Loghin4, D. Radulescu2, C. Mogosan1
1"Iuliu Hatieganu" University of Medicine and Pharmacy - Faculty of Pharmacy, Pharmacology - Physiology and Pathophysiology, Cluj-Napoca, Romania
2“Iuliu Hatieganu” University of Medicine and Pharmacy - Faculty of Medicine, Cardiology, Cluj-Napoca, Romania
3“Iuliu Hatieganu” University of Medicine and Pharmacy - Faculty of Pharmacy, Drug Information Research Center, Cluj-Napoca, Romania
4“Iuliu Hatieganu” University of Medicine and Pharmacy - Faculty of Pharmacy, Toxicology, Cluj-Napoca, Romania

P 110
Barriers and facilitators for a mobile app to report adverse drug reactions and receive drug information: A focus group study
P.G.M. Mol1, S.T. de Vries1, IMI WEB-RADR work package 3b2
1University of Groningen - University Medical Center, Department of Clinical Pharmacy and Pharmacology, Groningen, The Netherlands
2WEB-RADR work package 3b representatives: 

  1. Wong - C. Lasheras Ruiz - A. Sutcliffe - R. van Eemeren - S. Fernandes - F. Afsal - D. Costello - F. Houyez- J.V. Genestar

 The WEB-RADR project has received support from the Innovative Medicine Initiative Joint Undertaking under Grant Agreement n◦115632 - resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme FP7/2007-2013 and EFPIA companies’ in kind contribution,, United Kingdom

P 111
Drug-induced Panic Attacks: Analysis of the French PharmacoVigilance Database
A. Essilini1, D. Abadie1, F. Montastruc1, V. Fulda2, A. Gouraud3, M. Yéléhé-Okouma4, M.J. Jean-Pastor5, J.L. Montastruc1
1Toulouse University Hospital - Faculty of Medicine, Medical and Clinical Pharmacology Department - Toulouse Regional Pharmacovigilance Center, Toulouse, France
2Georges Pompidou University Hospital, Paris - Georges Pompidou Regional Pharmacovigilance Center, Paris, France
3Lyon University Hospital, Lyon Regional Pharmacovigilance Center, Lyon, France
4Nancy University Hospital, Nancy Regional Pharmacovigilance Center, Nancy, France
5Marseille University Hospital, Marseille Regional Pharmacovigilance Center, Marseille, France

P 112
Role of Serotonin 5-HT2C and Histamine H1 Receptors in Antipsychotic-induced Diabetes a PharmacoEpidemiological-PharmacoDynamic study in VigiBase
F. Montastruc1, A. Palmaro1, H. Bagheri2, L. Schmitt3, J.L. Montastruc1, M. Lapeyre-Mestre1
1University of Toulouse, Department of Medical Pharmacology - INSERM UMR 1027 - Pharmacoépidémiologie- Evaluation de l'utilisation et du risque médicamenteux, Toulouse, France
2University of Toulouse, Department of Medical Pharmacology - Pharmacopôle Midi-Pyrénées- Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le médicament, Toulouse, France
3University of Toulouse, Service Hospitalo-Universitaire de Psychiatrie et Psychologie Médicale - Faculté de Médecine de Toulouse, Toulouse, France

P 113
Signals Unmasked for Antipsychotics and Gastrointestinal Congenital Malformations: A study in VigiBase
F. Montastruc1,2, F. Salvo2, I. Lacroix1, C. Damase-Michel1, M. Arnaud2, B. Begaud2, A. Pariente2
1University of Toulouse, Department of Medical Pharmacology - Centre Midi-Pyrénées de Pharmacovigilance - Pharmacoépidémiologie et Informations sur le Médicament - Pharmacopôle Midi-Pyrénées – CHU - Faculté de Médecine, Toulouse, France
2University of Bordeaux, INSERM - U657-Pharmacoepidemiology - Centre Hospitalier Charles Perrens, Bordeaux, France

P 114
Atropinic burden of drugs: a new tool in pharmacovigilance
F. Montastruc1, G. Moulis1, E. Retailleau1, S. Rouanet1, F. Moulis2, V. Rousseau1, B. Vellas3, J.L. Montastruc1
1University of Toulouse, Department of Medical Pharmacology - Centre Midi-Pyrénées de Pharmacovigilance - Pharmacoépidémiologie et Informations sur le Médicamen - Pharmacopôle Midi-Pyrénées - INSERM U 1027- CHU - Faculté de Médecine, Toulouse, France
2University of Toulouse, Département Universitaire de Médecine Générale - Faculté de Médecine de Toulouse, Toulouse, France
3University of Toulouse, Gérontopôle- Hôpital La Grave-Casselardit – Toulouse - Inserm Unit 1027, Department of Medicine, Toulouse, France

P 115
Atropinic burden of medications during pregnancy and psychological development of the child: a cohort study in EFEMERIS
J.L. Montastruc1, A.B. Beau1, I. Lacroix1, F. Montastruc1, C. Hurault-Delarue1, C. Damase-Michel1
1Service de Pharmacologie Médicale et Clinique, CHU Toulouse - Pharmacopôle Midi-Pyrénées - Faculté de Médecine -  INSERM 1027, Toulouse, France

P 116
Improving Adverse Drug Reaction Reporting by General Practitioners in South-West of France
M. Bismuth1, G. Durrieu2, M. Mège2, J. Jacquot2, V. Rousseau2, S. Oustric1, J.L. Montastruc2
1Faculté de Médecine, Médecine générale, Toulouse, France
2Faculté de Médecine, Pharmacologie, Toulouse, France

P 117
Information Quality of Adverse Drug Reactions Reported by General Practitioners
G. Durrieu1, M. Mège1, J. Jacquot1, V. Rousseau1, J.L. Montastruc1
1Faculté de Médecine, Pharmacologie, Toulouse, France

P 118
Usage patterns of single-ingredient and combined analgesic paracetamol in France
M. Duong1, F. Salvo2, A. Abouelfath3, R. Lassalle3, C. Droz-Perroteau3, P. Blin3, N. Moore4
1INSERM U657, Bordeaux Pharmacoepi, Bordeaux, France
2INSERM U657, Pharmacology, Bordeaux, France
3Bordeaux Pharmacoepi, Pharmacoepi, Bordeaux, France
4Université de Bordeaux, Bordeaux Pharmacoepi, Bordeaux, France

P 119
A population database study of outcomes associated with vitamin K antagonists in atrial fibrillation.
N. Moore1, P. Blin1, C. Dureau-Pournin1, R. Lassalle1, A. Abouelfath1, C. Droz-Perroteau1
1Université de Bordeaux, Bordeaux Pharmacoepi, Bordeaux, France

P 120
Characteristics associated with psychotropic use in a French cohort of elderly farmers
S. Billioti de Gage1, F. Matharan2, K. Pérès2, B. Bégaud1, N. Moore1
1Université de Bordeaux, INSERM U657-Pharmacoepidemiology, Bordeaux, France
2Université de Bordeaux, INSERM U897-Epidemiology and Biostatistics, Bordeaux, France

P 121
Global mortality associated with benzodiazepine use
S. Billioti de Gage1, B. Bégaud1, N. Moore1
1Université de Bordeaux, INSERM U657-Pharmacoepi, Bordeaux, France

P 122
Application of the case-population approach to vaccine safety surveillance
H. Théophile1, N. Moore1, B. Bégaud1, A. Pariente1
1CHU-INSERM U657 - Université de Bordeaux, Service de Pharmacologie Médicale - Centre de Pharmacovigilance, Bordeaux, France

P 123
Pharmacovigilance program results in a public hospital oncology, experience in Mexico
M. Morales1, D.G. Luna1, P. Paredes1, D. Colin1, F. Patricio1, E. Toledo1, I. Toledo-Vigueras1, J.F. Hernandez1, I. Sanchez1
1Centro Oncólogico Estatal ISSEMYM, Farmacia Clinica, Toluca, Mexico

P 124
Hospitalisation due to adverse drug reactions in South Africa: a setting of high HIV and tuberculosis prevalence
J. Mouton1, C. Njuguna1, N. Kramer1, U. Mehta1, A. Stewart1, G. Maartens1, K. Cohen1
1University of Cape Town, Department of Medicine - Division of Clinical Pharmacology, Cape Town, Republic of South Africa

P 125
Standardized Messaging on Product Packaging as a Mechanism to Mitigate Potential Risks of Medicinal Products with Known Teratogenicity
D. Azzarello1, B. Marinac1, R. Bwire2, A. O'Reilly3
1Celgene Inc., Regulatory Affairs, Mississauga, Canada
2Celgene Corporation, Risk Management, Summit, USA
3Celgene Inc., Risk Management, Mississauga, Canada

P 126
Controlled Access Programs as a Mechanism to Mitigate Potential or Identified Medication Risks in Canada
D. Azzarello1, A. O'Reilly2, C. Renaud3, R. Bwire4
1Celgene Inc., Regulatory Affairs, Mississauga, Canada
2Celgene Inc., Risk Management, Mississauga, Canada
3Celgene Inc., Drug Safety, Mississauga, Canada
4Celgene Corporation, Risk Management, Summit, USA

P 127
Post-marketing withdrawal of medicines because of adverse drug reactions: an analysis of anti-obesity medications
I. Onakpoya1, C. Heneghan1, J. Aronson1
1University of Oxford, Primary Care Health Sciences, Oxford, United Kingdom

P 128
A combined causality method for spontaneous reports of adverse reactions on drugs and vaccines
I. Oosterhuis1, P.G.M.A. Zweers1, H.C. Rümke1, A.H.G. Hansma1
1Netherlands Pharmacovigilance Centre, Lareb, 's-Hertogenbosch, The Netherlands

P 129
Implementation of the PROTECT project recommendations into Signal Detection processes at the Medicines and Healthcare products Regulatory Agency (MHRA)
R. Owen1, S. Seabroke1
1Medicines and Healthcare products Regulatory Agency, Vigilance and Risk Management of Medicine, London, United Kingdom

P 130
Adverse Drug Events Identified by Thai ADEs Trigger Tool in Hospitalized Patients in Thailand
T. Paiboonvong1, P. Tragulpiankit2, N. Viriyakul1, W. Iamchoo1, K. Promtasarn1, A. Sangviroon3
1Faculty of Pharmacy - Siam University, Department of Pharmacy, Bangkok, Thailand
2Faculty of Pharmacy - Mahidol University, Department of Pharmacy, Bangkok, Thailand
3Police General Hospital, Pharmacy Department, Bangkok, Thailand

P 131
Analysis of patients admitted to the emergency service due to adverse reactions to antineoplastic drugs in Cancer Center - ISSEMYM
P. Paredes-Garcia1, I. Sanchez-Rodriguez1, D. Colin-Gomez1, J. F. Hernandez-Martinez1, M. Morales-Perez1, D. Luna-Mendoza1, I. Toledo-Vigueras1, A. Gomez-Sanchez1
1Centro Oncológico Estatal ISSEMYM, Clinical Pharmacy, Toluca, Mexico

P 132
False-Positive Pregnancy Tests in Females Receiving Lenalidomide for Treatment of Multiple Myeloma
L. Phillips1, E. Macchiaverna1, C. Renz1, C. Castaneda1, N. Minton1
1Celgene Corporation, Global Drug Safety & Risk Management, Summit, USA

P 133
Evaluation of Thai and Narnajo’s algorithm for assessing routine pharmacovigilance case reports using WHO-UMC causality assessment criteria as reference
W. Suwankesawong1, P. Sriphiromya1, P. Tragulpiankit2, C. Phetcharat3, V. Sornsrivichai3, P. Pokhagul1
1Health Product Vigilance Center, Food and Drug Administration, Nonthaburi, Thailand
2Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
3Southern Health Foundation, Prince of Songkla University, Songkla, Thailand

P 134
Characterization of Fatal Adverse Drug Reaction of Spontaneous Reporting in the Thai Vigibase
P. Pokhagul1, W. Suwankesawong2
1Health Product Vigilance Center, Food and Drug Administration, Muang, Thailand
2Health Product Vigilance Center, Food and Drug Administration, Nonthaburi, Thailand

P 135
Sources of Literature in Pharmacovigilance
S.Z. Rahman1, K. Singhal2
1Jawaharlal Nehru Medical College- Aligarh Muslim University, Pharmacology, Aligarh, India
2NIMS University Jaipur, Pharmacology, Jaipur, India

P 136
Are we delivering safe intravenous opioid infusions in paediatric patient?- Evaluation of the current practice in a UK paediatric hospital
A.N. Rashed2, S. Tomlin1,2
1King's College London, Pharmaceutical Sciences Division, London, United Kingdom
2Guy’s & St Thomas’ NHS Foundation Trust - Evelina London Children’s Hospital, Pharmacy, London, United Kingdom

P 137
Comparison of adverse events between drugs and consumer goods as collected within a spontaneous reporting system
1, T. Ernst1, B. Nyagode1, M. Steinbuch1
Procter & Gamble, Global Safety Surveillance & Analysis, Cincinnati, USA

P 138
A qualitative and quantitative review of additional risk minimisation measures for EU centrally authorised products, 2006-2014
E. Artime1, A. Rubino2, N. Qizilbash1,3
1Oxon Epidemiology, Risk Management Epidemiology, Madrid, Spain
2Oxon Epidemiology, Risk Management Epidemiology, London, United Kingdom
3London School of Hygiene & Tropical Medicine, Epidemiology, London, United Kingdom

P 139
Application of the International Society on Thrombosis and Haemostasis (ISTH) classification of major bleeds within a Post Authorization Safety Study
M. Davies1,2, V. Osborne1,2, D. Layton1,2, S. Shakir1,2
1Drug Safety Research Unit, Drug Safety, Southampton, United Kingdom

2University of Portsmouth, Portsmouth, United Kingdom

P 140
Development of a qualitative method to assist in interpretation of results from disproportionality analyses in the SAFEGUARD project
L. Hazell1,2, N. Schmedt3, L. Scotti4, I. Leal5, G. Trifiro6, M. C. Sturkenboom5, S. Shakir1,2
1Drug Safety Research Unit, Research, Southampton, United Kingdom
2University of Portsmouth, School of Pharmacy and Biomedical Sciences, Portsmouth, United Kingdom
3Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH, BIPS GmbH, Bremen, Germany
4University of Milan Bicocca, Unit of Biostatistics - Epidemiology and Public Health, Department of Statistics and Quantitative Methods, Milan, Italy
5Erasmus University, Department of Medical Informatics, Rotterdam, The Netherlands
6University of Messina, Department of Clinical and Experimental Medicine, Messina, Italy

P 141
Applying the Ready Reckoner tool for assessing antipsychotic prescribing within a post-authorisation safety study
D. Layton1,2, S. Shakir1,2
1Drug Safety Research Unit, Pharmacoepidemiology, Southampton, United Kingdom
2University of Portsmouth, School of Pharmacy and Biomedical Science, Portsmouth, United Kingdom

P 142
Potential for underdosing of antipsychotics in primary and mental health care: findings from post-authorisation safety studies on Seroquel XL ©.
D. Layton1,2, V. Osborne1,2, M. Davies1,2, I. Ratcliffe1, S. Clarke1, S. Shakir1,2, J. Reilly3, A. Hale4
1Drug Safety Research Unit, Pharmacoepidemiology, Southampton, United Kingdom
2University of Portsmouth, School of Pharmacy and Biomedical Science, Portsmouth, United Kingdom
3Wolfson Research Institute, Durham University Centre for Integrated Health care Research, Stockton on Tees, United Kingdom
4University of Kent, Psychiatry and Psychopharmacology, Canterbury, United Kingdom

P 143
Antipsychotic use in older adults with dementia: results from a Post-Authorisation Safety Study.
D. Layton1,2, M. Davies1,2, V. Osborne1,2, S. Shakir1,2
1Drug Safety Research Unit, Pharmacoepidemiology, Southampton, United Kingdom
2University of Portsmouth, School of Pharmacy and Biomedical Sciences, Portsmouth, United Kingdom

P 144
Defining risk profiles in special populations -results from a post authorisation safety study of Seroquel XL© conducted in England.
D. Layton1,2, V. Osborne1,2, M. Davies1,2, S. Shakir1,2
1Drug Safety Research Unit, Pharmacoepidemiology, Southampton, United Kingdom
2University of Portsmouth, School of Pharmacy and Biomedical Sciences, Portsmouth, United Kingdom

P 145
Observational Assessment of Safety in Seroquel (OASIS) – rates and patterns of common events
D. Layton1,2, S. Clarke1, I. Ratcliffe1, S. Shakir1,2, T. Hale3
1Drug Safety Research Unit, Pharmacoepidemiology, Southampton, United Kingdom
2University of Portsmouth, School of Pharmacy and Biomedical Sciences, Portsmouth, United Kingdom
3University of Kent, Psychiatry and Psycotherapy, Canturbury, United Kingdom

P 146
Use of antipsychotics in mental health secondary care setting versus primary care: results from two post-marketing safety studies
D. Layton1,2, V. Osborne1,2, M. Davies1,2, I. Ratcliffe1, S. Clarke1, S. Shakir1,2, J. Reilly3, A. Hale4
1Drug Safety Research Unit, Pharmacoepidemiology, Southampton, United Kingdom
2University of Portsmouth, School of Pharmacy and Biomedical Sciences, Portsmouth, United Kingdom
3Wolfson Research Institute, Durham University Centre for Integrated Health Care Research, Stockton on Tees, United Kingdom
4University of Kent, Psychiatry and Psychotherapy, Canterbury, United Kingdom

P 147
Utilisation of a once weekly injection for Type 2 Diabetes Mellitus: Interim results from an observational cohort study in England
V. Osborne1,2, N. Qayum1, A. Coughtrie1, D. Layton1,2, S. Shakir1,2
1Drug Safety Research Unit, Drug Safety Research Unit, Southampton, United Kingdom
2University of Portsmouth, School of Pharmacy and Biomedical Science, Portsmouth, United Kingdom

P 148
Utilisation and safety of deferasirox (Exjade®): Results from an observational cohort study in England
V. Osborne1,2, M. Davies1,2, D. Layton1,2, S. Shakir1,2
1Drug Safety Research Unit, Drug Safety Research Unit, Southampton, United Kingdom
2University of Portsmouth, School of Pharmacy and Biomedical Science, Portsmouth, United Kingdom

P 149
The Ribavirin Pregnancy Registry: an interim analysis at the mid-point of enrollment
S.M. Sinclair1, J.K. Jones2, R.K. Miller3, P.Y. Kwo4, M.F. Greene5, P.G. Thorpe6, W.C. Maddrey7
1University of North Carolina Wilmington, Clinical Research, Wilmington - North Carolina, USA
2The Degge Group Ltd., President, Fairfax - Virginia, USA
3University of Rochester School of Medicine & Dentistry, Department of Obstetrics/Gynecology, Rochester - New York, USA
4Indiana University, Gastroenterology, Indianapolis - Indiana, USA
5Harvard Medical School, Obstetrics - Gynecology and Reproductive Biology, Boston - Massachusetts, USA
6Centers for Disease Control and Prevention, Division of Birth Defects and Developmental Disabilities, Atlanta - Georgia, USA
7University of Texas Southwestern, Internal Medicine, Dallas - Texas, USA

P 150
The new definition of an Adverse Drug Reaction (ADR) with focus on abuse / misuse: the example of pregabalin
I. Skibicka-Stepien1, A. Łazowska1, S. Brosch1, T. Goedecke1, V. Newbould1, L. Pinheiro1, D. Pasquale2, G. Genov1, P. Arlett1
1European Medicines Agency, Inspections and Human Medicines Pharmacovigilance Division, London, United Kingdom
2European Medicines Agency, Information Management Division, London, United Kingdom

P 151
Pregnancy medication error: case report
N. Smiress1, H. Sefiani1, R. Soulaymani-Bencheikh1
1Centre anti Poison et de Pharmacovigilance, Pharmacovigilance, Rabat, Morocco

P 152
Antituberculosis Drugs Induced Hepatotoxicity: A Retrospective Study In The Moroccan Pharmacovigilance Database
L. Ait Moussa1, D. Soussi Tanani2, O. El Bouazzi13, S. Serragui4, R. Benkirane1, R. Soulaymani-Bencheikh1, H. Sefiani1
1Moroccan Poison Control and Pharmacovigilance Center, Pharmacovigilance, Rabat, Morocco
2Faculty of Medicine and Pharmacy. University of Abdelmalek Essaadi, Laboratory of Pharmacology, Tanger, Morocco
3Moroccan Poison Control and Pharmacovigilance Center, Laboratory of Toxicology and Pharmacology, Rabat, Morocco
4Faculty of Medicine and Pharmacy, Mohammed V University, Laboratory of Pharmacology, Rabat, Morocco

P 153
Antibiotic resistance: What is the situation in Morocco?
S. Serragui1, D. Soussi Tanani2, L. Ait Moussa3, S. Derraji4, R. Soulaymani-Bencheikh3, Y. Cherrah1, G. Benabdallah3
1Faculty of Medicine and Pharmacy, Pharmacology and Toxicology, Rabat, Morocco
2Faculty of Medicine and Pharmacy, Pharmacology, Tanger, Morocco
3Centre Anti Poison et de Pharmacovigilance, Pharmacovigilance, Rabat, Morocco
4Faculty of Medicine and Pharmacy, Pharmacology, Rabat, Morocco

P 154
Safety of anticoagulants in elective hip and knee replacement surgery: Pro-Change cohort study
S. Spila Alegiani1, C. D'Amore1, E. Romanini2, G. Traversa1, C. Conti3, R. D'Apolito3, L. D'Aviera2, S. Ghera4, C. Graci5, F. Pallotta5, R. Sgambriglia4, M. Venosa2
1National Institute of Health, National Centre of Epidemiology, Rome, Italy
2San Feliciano Clinic, ArtoGruppo, Rome, Italy
3Catholic University of the Sacred Heart, Orthopaedic Unit, Rome, Italy
4San Pietro Fatebenefratelli Hospital, Orthopaedic Department, Rome, Italy
5San Camillo Hospital, Division of Orthogeriatrics, Rome, Italy

P 155
Drug Commission of the German Medical Association – how to make use of expert knowledge for the National pharmacovigilance system
T. Stammschulte1, U. Köberle1, U. Gundert-Remy1
1Drug Commission of the German Medical Association, Pharmacovigilance, Berlin, Germany

P 156
Health care professional perspectives on adverse event reporting by treatment setting in the United States: underreporting and educational gap insights
S. Stergiopoulos1, C. Brown2, T. Felix3, G. Grampp3, K. Getz1
1Tufts University, Tufts Center for the Study of Drug Development, Boston, USA
2Tufts University, HNRC, Boston, USA
3Amgen Inc., Global Regulatory Affairs and Safety, Thousand Oaks, USA

P 157
Analysis of Adverse Drug Reactions of Medicines, Used in Assisted Reproduction Techniques, Extracted From Publications in Social Media in Bulgaria
S. Stoev1, H. Lebanova2, K. Kalaidjiev1, V. Georgieva3, I. Getov1
1Medical University - Sofia, Faculty of Pharmacy, Social Pharmacy, Sofia, Bulgaria
2Medical University Pleven, Medical college, Pleven, Bulgaria
3Ob/Gyn Hospital "Dr Shterev", Hospital Pharmacy, Sofia, Bulgaria

P 158
Safety Assessment of Food Additives in Top-selling Dietary Supplements in the Czech Republic
J. Strážnická1, J. Pokladníková1, L. Jahodář2
1Charles University in Prague - Faculty of Pharmacy, Department of Social and Clinical Pharmacy, Hradec Kralove, Czech Republic
2Charles University in Prague - Faculty of Pharmacy, Department of Pharmaceutical Botany and Ecology, Hradec Kralove, Czech Republic

P 159
Patient-generated data and digital engagement – Social Media: its impact and contribution to pharmacovigilance.
E. Suggate1, D. Layton2,3, D. Brown3, S. Shakir2,3
1Janseen-Cilag Ltd., Drug Safety, High Wycombe, United Kingdom
2Drug Safety Research Unit, Pharmacoepidemiology, Southampton, United Kingdom
3University of Portsmouth, School of Pharmacy and Biomedical Sciences, Portsmouth, United Kingdom

P 160
Antiretroviral treatment change study at the regional referral center for care of PLHIV of Agadir in Morocco
H. Farouk1, A. Tebaa2, R. Soulaymani-Bencheikh2
1Regional responsable of pharmacovigilance, Ministry of Health, Agadir, Morocco
2Centre Anti Poison et de Pharmacovigilance du Maroc, Ministry of Health, Rabat, Morocco

P 161
Metabolic side effects following the use of anti-TB drugs in Morocco
D. Soussi Tanani1, S. Serragui2, L. Ait Moussa3, O. El Bouazzi3, A. Tebaa3, A. Soulaymani4, R. Soulaymani-Bencheikh3, Y. Cherrah2
1Faculty of Medicine and Pharmacy of Tanger, Pharmacology, Tanger, Morocco
2Faculty of Medicine and Pharmacy of Rabat, Pharmacology, Rabat, Morocco
3Anti Poison and Pharmacovigilance center of Morocco, Pharmacovigilance, Rabat, Morocco
4Laboratory of Genetics and Biometry - University Ibn Tofail- Kenitra, Genetic, Kenitra, Morocco

P 162
Pharmacovigilance System Implementation in a Middle-Income Country: the Case of the Dominican Republic
N. Thurin1, A. Puello2,3, F. Haramburu4,5
1Université de Bordeaux, Pharmacoepidemiology, Bordeaux, France
2Universidad Autónoma de Santo Domingo, Public Health, Santo Domingo, Dominican Republic
3Hospital General de la Plaza de la Salud, Epidemiology Department, Santo Domingo, Dominican Republic
4Centre Hospitalier Universitaire de Bordeaux, Bordeaux Regional Pharmacovigilance Centre, Bordeaux, France
5INSERM, U657, Bordeaux, France

P 163
Assessing the Feasibility and Performance of the HAWK Electronic Medical Records for Drug Safety Surveillance
N. Thurin1, A.M. Castilloux2, C. Reich3, R. Hermann4, S. Frise5, Y. Moride1
1Université de Montréal, Faculty of Pharmacy, Montréal, Canada
2Yolarx Consultants Inc., Biostatistics, Montréal, Canada
3IMS Health Inc., Real-World Evidence System, Danbury, USA
4AstraZeneca, R&D Global Patient Safety, Gaithersburg, USA
5AstraZeneca, Patient Safety and Medical Information, Mississauga, Canada

P 165
Bleeding related to oral anticoagulant drugs as cause of emergency department admission: analysis of data from the Tuscan MEREAFaPS Network
A. Saporiti1, A. Capogrosso Sansone1, S. Mantarro1, I. Convertino2, S. Montagnani1, A. Marino1, M. Rossi3, M. Moschini4, A. Vannacci4, M. Santini5, L. Spisni6, C. Blandizzi1,2, M. Tuccori2
1University of Pisa, Department of Clinical and Experimental Medicine, Pisa, Italy
2University Hospital of Pisa, Unit of Adverse Drug Reaction Monitoring, Pisa, Italy
3University Hospital of Siena, Unit of  Pharmacology, Siena, Italy
4University of Florence, Department of Neurosciences - Psychology - Drug Research and Child Health NeuroFarBa, Florence, Italy
5University Hospital of Pisa, Emergency Department, Pisa, Italy
6Hospital of Pontedera, Emergency Department, Pontedera, Italy

P 166
Use and toxicities of linezolid as used in severely-ill patients in two teaching hospitals: a retrospective study
P. Papachristoforou1, C. Briquet2, F. Jacobs3, C. Yombi4, F. Van Bambeke1, P. Tulkens1
1Université catholique de Louvain, Louvain Drug Research Institute, Brussels, Belgium
2Groupe de Gestion de l’Antibiothérapie, Cliniques universitaires St-Luc, Université catholique de Louvain, Brussels, Belgium
3Cliniques universitaires de Bruxelles Erasme, Service des maladies infectieuses, Bruxelles, Belgium
4Service de médecine interne, Cliniques Universitaires St-Luc, Université catholique de Louvain, Brussels, Belgium

P 167
Effects on Blood of Clozapine in Patients under Schizophrenic Antipsychotic Therapy Incorporated in a Drug Surveillance Program in Venezuela
L.H. Valdivieso1, R. Mardomingo2
1Central University of Venezuela, Faculty of Pharmacy, Caracas, Venezuela
2Novartis Laboratories, Consumer Health, Caracas, Venezuela

P 168
Children adverse drug reactions in Emergency Department: an analysis of MEREAFaPS study national database
N. Lombardi1, M. Moschini1, R. Bonaiuti1, A.M. Calvani2, M. Parrilli3, L. Innocenti4, E. Lucenteforte1, F. Mandò Tacconi3, S. Masi4, C. Blandizzi5, G. Vighi6, A. Mugelli1, M. Tuccori5, A. Vannacci1
1University of Florence, Department of Neurosciences – Psychology - Drug Research and Child Health, Florence, Italy
2Anna Meyer Children's University Hospital, Hospital Pharmacy Unit, Florence, Italy
3Tuscan Regional Centre of Pharmacovigilance, Local Health Authority N° 10, Florence, Italy
4Anna Meyer Children's University Hospital, Department of Emergency Medicine, Florence, Italy
5Tuscan Regional Centre of Pharmacovigilance, University Hospital of Pisa, Pisa, Italy
6Lombardy Regional Centre for Pharmacovigilance, Unit of Clinical Pharmacology and Pharmacovigilance - Niguarda Ca'Granda Hospital, Milan, Italy

P 169
Acute epigastric pain and liver toxicity associated with acetaminophen-codeine use in cholecystectomized patients
M.C. Lenti1, M. Moschini1, R. Bonaiuti1, L. Giovannelli1, N. Lombardi1, E. Lucenteforte1, R. Leone2, V. Maggini1, A. Pugi1, E. Gallo1, A. Mugelli1, A. Vannacci1
1University of Florence, Department of Neurosciences – Psychology - Drug Research and Child Health, Florence, Italy
2University of Verona, Pharmacology Unit – Reference Centre for Education and Communication within the WHO Programme for International Drug Monitoring, Verona, Italy

P 170
Ticagrelor-related dyspnea in patients with acute coronary syndrome: a three year cohort study
E. Lucenteforte1, N. Lombardi1, A. Barchielli2, M. Torrini3, A. Mugelli1, A. Vannacci1
1University of Florence, NEUROFARBA, Firenze, Italy
2Local Health Authority n°10, Department of Epidemiology, Florence, Italy
3University of Florence and Azienda Ospedaliero - Universitaria Careggi, Department of Critical Care Medicine and Surgery, Florence, Italy

P 171
Comparison of adverse drug reaction imputation with different causality algorithms
F. Varallo1, C. Planeta2, P. Mastroianni1
1School of Pharmaceutical Sciences – UNESP, Univ Estadual Paulista- Araraquara SP, Drugs and Medicines, Araraquara, Brazil
2School of Pharmaceutical Sciences – UNESP, Univ Estadual Paulista- Araraquara SP, Natural Active Principles and Toxicology, Araraquara, Brazil

P 172
Impact of pharmacovigilance multifaceted educational intervention on knowledge, skills and attitudes of a multidisciplinary healthcare team
F. Varallo1, C. Planeta2, P. Mastroianni1
1School of Pharmaceutical Sciences – UNESP, Univ Estadual Paulista- Araraquara SP, Drugs and Medicine, Araraquara, Brazil
2School of Pharmaceutical Sciences - UNESP, Univ Estadual Paulista- Araraquara SP, Natural Active Principles and Toxicology, Araraquara, Brazil

P 173
Active pharmacovigilance to determine the incidence and severity of adverse reactions associated with anthracyclines-based chemotherapy in cancer paediatric patients
J.L. Vargas-Neri1, R. Rivas-Ruiz2, O.D. Castelán-Martínez3, G. Castañeda-Hernández1, P. Clark-Peralta3, M.Á. Palomo-Colli4, M.D.J. Estrada-Loza5, N.A. Balderrábano-Saucedo6
1Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacion, Farmacología, Gustavo A. Madero, Mexico
2Instituto Mexicano del Seguro Social, Centro de Adiestramiento en Investigación Clínica, Distrito Federal, Mexico
3Hospital Infantil de México Federico Gómez, Unidad de Epidemiología Clínica, Distrito Federal, Mexico
4Hospital Infantil de México Federico Gómez, Departamento de Hemato-Oncología, Distrito Federal, Mexico
5Instituto Mexicano del Seguro Social, Hospital de Pediatría de Centro Médico Nacional Siglo XXI, Distrito Federal, Mexico
6Hospital Infantil de México Federico Gómez, Cardiología, Distrito Federal, Mexico

P 174
Unintended central nervous system risks with dextromethorphan in different indications. Preliminary results; systematic review and meta-analysis of randomised clinical trials.
L. Velez-Nandayapa1,2,3
1Pharmacovigilance Network, Pharmacovigilance & Epidemiology, Zurich, Switzerland
2University of Portsmouth, Drug Safety Research Unit, Portsmouth, United Kingdom
3University of London, London School of Hygiene and Tropical Medicine, London, United Kingdom

P 175
Study of Compliance with the Isotretinoin Pregnancy Prevention Programme regarding Pregnancy Testing in France Using the EGB Database
M.L. Veyries1, M. Bertrand2, S. Miranda2, P. Maison1, M. Zureik2
1Agence Nationale de Sécurité du Médicament et des produits de santé ANSM, Direction de la surveillance, Saint-Denis, France
2Agence Nationale de Sécurité du Médicament et des produits de santé ANSM, Direction scientifique et de la stratégie européenne, Saint-Denis, France

P 176
Non hemorrhagic adverse effects of fluindione: a comparative study with coumarine derivatives
T. Vial1, A. Gouraud1, B. Lebrun-Vignes2, E. Polard3, M. Biour4, J. Cottin1
1Hospices Civils de Lyon, Centre régional de pharmacovigilance, Lyon, France
2Groupe hospitalier Pitié-Salpêtrière – Charles-Foix - APHP, Centre régional de pharmacovigilance, Paris, France
3Centre hospitalier universitaire de Rennes, Centre régional de pharmacovigilance, Rennes, France
4Hopital Saint-Antoine AP-HP, Centre régional de pharmacovigilance, Paris, France

P 177
Anti-tuberculosis drug-associated DRESS syndrome: a case series
M. Allouchery1, J. Cottin2, S. Logerot1, P. Pralong3, T. Vial2, B. Ben Saïd4
1Grenoble University Hospital, Pharmacovigilance Center of Grenoble, Grenoble, France
2Lyon University Hospital, Pharmacovigilance Center of Lyon, Lyon, France
3Grenoble University Hospital, Department of Dermatology, Grenoble, France
4Lyon-Sud University Hospital, Allergology & Immunology Department, Lyon, France

P 179
Use-case for Big Data Technology in Pharmacovigilance
A. Sutan1, B. Gallien2, S. Warhaftig2
1November Research Group, San Lorenzo, USA
2November Research Group, Oakland, USA

P 180
New oral anticoagulants: what do their adverse drug reactions reports suggest?
N.N. Wasicovichi1, A.G. Ribeiro1, S. Espósito1, M.E.F.G. ZampierI1, M.D.L.V. Oliveira1, M. Peinado1, E.K. Kano2
1Health Surveillance Center, Department of Pharmacovigilance, São Paulo, Brazil
2College of Pharmaceutical Sciences - University of São Paulo, Department of Pharmacy, São Paulo, Brazil

P 181
Study of Iodinated Contrast Media induced Anaphylaxis Based on Korea Adverse Event Reporting System, 1989-2013
Y. Woo1, S. Chung1, B.K. Koo2
1Korea Institute of Drug Safety & Risk Management, Office of Safety Information I, Anyang, South Korea
2Korea Institute of Drug Safety & Risk Management, President, Anyang, South Korea

P 182
Pharmacovigilance network, a tool kit for enhancing risk management; Lessons learned from Thailand.
K. Thiankhanithikun1, W. Suwankesawong2
1Chiang Mai University, Faculty of Pharmacy, Chiang Mai,Thailand
2Ministry of Public Health, Food and Drug Administration, Nonthaburi, Thailand

P 183
Evolving nature of evidence in pharmacovigilance to inform on regulatory decision making
R. Mouchantaf1, S. Frise2
1Health Canada, Marketed Health Product Directorate, Ottawa, Canada
2AstraZeneca Canada, Dalla Lana School of Public Health - University of Toronto, Toronto, Canada

P 184
Practical Aspects of Developing Relevant Key Performance and Quality Indicators (KP-QIs) for Risk-Based Quality Management in Pharmacotherapy.
M. Malikova1
1Boston University - Boston Medical Center, Surgery, Boston, USA

P 185
Implementation of Quality by Design (QbD) and Quality Risk Management (QRM) Strategies in Pharmacovigilance for Wound Care Trials.
M. Malikova1, B. Krafcik1
1Boston University - Boston Medical Center, Surgery, Boston, USA



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