Risk Management Plans

OP01. Training on Risk Management Planning
E. Brown

OP02. The Use of Internet Surveys to Measure the Effectiveness of Educational Materials for Use as Risk Minimisation Tools: What to Consider?
C.R. Knight

OP03. Measuring REMS Effectiveness: Time for a Program Overhaul?
M. Mease

Signal Detection

OP04. An Empirical Study of Exclusion Criteria for Disproportionality Analysis
J. Hopstadius, M. Hauben and G. Nore´n

OP05. A Reference Standard for Evaluating Methods for Drug Safety Signal Detection using Electronic Healthcare Record (EHR) Databases
P.M. Coloma,  P. Avillach, M.J. Schuemie, C. Ferrajolo,. Pariente,  A. Fourrier Reglat, A. Ottosson, J. van der Lei, M. Sturkenboom  and G. Trifiro

Periodic Safety Update Reports

OP06. The Outcome of PSUR Assessments of
H.C. Ebbers, A.K. Mantel Teeuwisse, F.A. Sayed Tabatabaei , E.H. Moors, H. Schellekens and H.G. Leufkens

Vaccine Pharmacovigilance

OP07. The Italian Surveillance of HPV Vaccination
S. Spila Alegiani, R. Da Cas, C. Giambi, R. Raschetti and S. Salmaso

OP08. Adverse Events of Special Interest and Pneumococcal Vaccination
C. Santuccio, F. Menniti Ippolito, L. Tartaglia, R. Da Cas, F. Trotta  and G. Traversa

OP09. Pilot Swine Flu Vaccination Active Surveillance Study: Final Results
D. Layton, M. Dryburgh, T.M. MacDonald, S.A. Shakir and I.S. MacKenzie

Pharmacovigilance in Public Health Programmes

OP10. Workshops and Telephone-Based Interventions to Improve ADR Reporting: A Cluster-Randomized Trial in Portugal
T.F. Herdeiro, I.R. Vaz, M.A. Ferreira, J.J. Polonia and A.G. Figueiras

OP11. Patient Reporting of Adverse Drug Reactions: First Italian Experience
S. Opri,  P. D’incau, L. Magro, L. Sottosanti , D. Costantini, S. Potenza, L. Catalano, F. Ferrazin and R. Leone

Cost-Effectiveness of Pharmacovigilance Systems

OP12. Cost Approach to Iatrogenic Drug
H. Filali

Communication in Drug Safety

OP13. Utilisation of Fentanyl Buccal Tablets in Primary Care in England: Focus on ‘Off Label’ Use in Support of Risk Management
V. Osborne, D. Layton, M. Al Shukri, C. Fogg and S. Shakir

OP14. Room for Improvement in Safety Learning of Same Class Drugs
G. Stefansdottir, M.J. Knol, H.G. Leufkens, A.H. Arnardottir, D.E. Grobbee1 and M.L. De Bruin

Medication Errors and Preventability

OP15. Preventable Hospitalisations to Departments of
Internal Medicine
S. Schmiedl, M. Rottenkolber,  J. Szymanski, B. Drewelow, S. Muller, A. Zachow,  Siegmund, K. Salje,  M. Arnold, M. Hippius, A. Scheuerlein, K. Farker, J. Hasford and
P. Thurmann

OP16. Evaluating Visual Strategies to Differentiate Look-Alike Medication Names During the Medication Administration Process
S. Gabriele, S. Hyland, L.L. Gosbee, M. Singh, A. Ninan, R. Evans, O. Fernandes  and J. Hart

OP17. Adverse Reactions after Medication Error Occurred in Children and Reported to the National Pharmacovigilance Network
C. Santuccio, D. Morlino, L. Tartaglia, F. Trotta and F. Ferrazin

OP18. Medication Errors Prevention Strategies: Examples of Partnerships
G. Benabdallah, R. Benkirane, A. Khattabi and R. Soulaymani

OP19. A Multicentric Study on Adverse Drug Reactions Preventability
R. Benkirane,  L. Alj, G. Benabdallah, H. Sefiani, S. Pal, S. Olsson and R. Soulaymani

OP20. Dose Omissions in Hospitalised Patients: An Analysis of the Relative Contribution of Adverse Drug Reactions
J.J. Coleman, S.E. McDowell, D. Westwood and R.E. Ferner

Post-Authorisation Safety Studies (PASS)

OP21. NSAID Exposure and Risk of Acute Liver Failure Leading to Transplantation: Principal Results of the 7-Country Case-Population Study (SALT)
E. Gulmez, S. Lignot,  D. Larrey, C. De Vries, S. Perez Gutthann, J. Montastruc, M. Sturkenboom, J. Be´nichou, G. Velo, A. Caputi, F. Salvo, F. Hamoud, S. Micon, R. Lassalle,  J. Jove, G. Pageaux, Y. Horsmans, J. Bernuau, F. Bissoli, B. Stricker, D. Thorburn, A. Gatta, E. Monteiro,I. Vafiadis, A. McCormick, H. Metselaar, E. Sen, A. Nightingale, P. Blin and N. Moore

Perception of Risks and Communication

OP22. Indicators of Dependence and Aberrant Behaviours During Post-Marketing Use of Fentanyl Buccal Tablets: Risk Scores in Support of Risk Management
V. Osborne, D. Layton, M. Al Shukri, C. Fogg and S. Shakir

OP23. Which Aspects of New Glucose Lowering Drugs do Different Stakeholders Value? A Qualitative Study
A. Arnardottir, F. Haaijer Ruskamp, S. Straus, S. Piening, M. Monster Simons,  P. De Graeff and P. Mol

OP24. Patients, Medicines and Perceptions ‘‘Bridging Continents’’ for Improving Risk Assessment and Communication
P. Bahri

Paediatric Pharmacovigilance

OP25. Antidepressant Drug Prescribing in Children and Adolescents in Germany
M. Doerks, I. Langner, U. Dittmann, A. Timmer and E. Garbe

In vitro Fertilisation and Pharmacovigilance

OP26. Use of Ovulation Stimulation (OS) Alone, Intrauterine Insemination (IUI) and Assisted Reproductive Techniques (ART) and the Risk of Multiplicity: The TWINPREG Study
A. Berard, O. Sheehy, W. Fraser, F. Bissonnette, S. Tan, J. Trasler  and P. Monnier

New Horizons in Pharmacovigilance

OP27. Using Resources for Scientific Driven Pharmacovigilance: Switching from Many Product  Safety Documents to the Product Safety Master File
G. Furlan

OP28. Linking in Safety with Marketing Support Programmes
S. Tomczyk, D. Lewis and D. Lewis

OP29. Internet Accounts of Survivors of Serious Adverse Drug Reactions: A Study of Experiences of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
T.F. Butt, A.R. Cox, J. Oyebode  and R.E. Ferner

Other Topics

OP30. Venous Thromboembolism and Combined Hormonal Contraceptives: Where is the Signal?
P. Caduff Janosa, H.Y. Kwan, D. Pavelic Ferretti and R. Stoller

OP31. The Application of Pedagogy to Training in Pharmacovigilance
L. Fram and E. Brown

OP32. Study of Reliability of Medicines-Related Information in Internet-Based Health Sources
H. Lebanova, M. Bileva and I. Getov

OP33. Treatment of Paediatric Epilepsy in Germany: Antiepileptic Drug Utilisation in Children and Adolescents from 20042006
M. Doerks, I. Langner, A. Timmer and E. Garbe

OP34. QPPV Training Just the QPPV?
S.G. Douglas

OP35. Beyond Bureaucracy: How Pharmacovigilance Might be Resuscitated
Bruce P. Hugman


OP37. Pharmacovigilance of Contraceptives: Why does it Take so Long to Take Action?
K. van Grootheest, L. Ha¨rmark and E. van Puijenbroek

OP38. Characterization of Reporting of Drug-Induced Hepatic Failure to the WHO-UMC Database: Influence of Gender and Age
M. Petronijevic, K. Ilic and A. Suzuki

Countries ADR Reports

OP39. ADR Profiles and their Relation Associated with Nifurtimox-Eflornithine Combination Therapy (NECT) in the Treatment of Human African Trypanosomiasis (HAT)
P.N. Ntamabyaliro, B.Y. Salumu, D.B. Nzolo, Y.N. Lula,G.K. Mesia, S.M. Mampunza and G.L. Tona

OP40. The Yellow Card Scheme: Patient Reporting of Adverse Drug Reactions and Signals they have Generated
M. Foy, S. Gandhi, S. Suri, S. Cumber and M.M. Jadeja

OP41. The Yellow Card Scheme: Trends in Fatal ADR Reporting 20092010
M. Foy, S. Cumber, S. Gandhi and R. Webb