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• • • • ICPE Exhibitors and Sponsors • • • • ANNUAL MEETING SPONSORS (as of July 23, 2007) Platinum: 23rd International Conference on $12,000 LJohn Wiley & Sons Pharmacoepidemiology & Therapeutic LPfizer Risk Management Gold: $6,000 Silver: $3,000 LAmgen LAstra Zeneca Canada Sponsors LEli Lilly and Company LGenzyme LGenentech, Inc. LHealthCore LGlaxoSmithKline LPharmaNet & Li3 Drug Safety LSanofi Pasteur LKendle LMerck Research Bronze: $1,500 The International Society for Pharmacoepidemiology Laboratories LAllergan (ISPE) gratefully acknowledges the generous sup- LPharmaceutical LCephalon port of the following organizations and institutions. Research Associates LDrugLogic, Inc. Their contributions helped to enhance the scientific LProctor & Gamble LGPRD program content and increase attendance at the Pharmaceuticals LOutcome ICPE 2007. Thank you. LRoche LRisk Management LRTI Health Solutions Resources Academic Showcase/ LUnited Biosource Exhibitors Welcome Reception Sponsors Corporation LWyeth LCenter for Clinical Epidemiology & Biostatistics, University of Pennsylvania School of Medicine LCollege of Pharmacy, University of Texas LDrug Safety Research Unit, University of Portsmouth LPharmaceutical Health Services Research, University of Maryland, Baltimore LSlone Epidemiology Center, Boston University IN THIS PROGRAM LUniversity of North Carolina at Chapel Hill LDivision of Pharmacoepidemiology & Pharmacotherapy, 23rd ICPE Agenda L Utrecht Institute for Pharmaceutical Sciences Saturday...... 7 L Sunday ...... 8 L Monday ...... 9 (as of July 23, 2007) Exhibitors L Tuesday ...... 17 LCerner LPharmIdeas Research L Wednesday...... 26 Corporation LRTI Health Solutions LDrugLogic, Inc. LThe Uppsala 23rd ICPE Posters L Poster Presentation Guidelines ...... 30 LGPRD Monitoring Centre L Poster Session A ...... 32 Li3 Drug Safety LThomson Healthcare L Poster Session B...... 40 L LTrialStat Corporation IMS Health L Poster Session C...... 49 LJohn Wiley & Sons LUnited BioSource LKendle Corporation 23rd Abstract Index LOutcome LUniform Data System L Abstract Index...... 57 LPHARMO Institute LWolters Kluwer LPhase Forward Health
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• • AGENDA Saturday, August 18 • • • • • 8:30am - 5:30pm / Hilton Courville/Montmorency / 2007 ISPE Board of Directors Meeting • ISPE’s Second Asian Meeting Noon - 5:00pm / Centre Foyer 4 / Convened in conjunction with the Japanese Society for Registration Pharmacoepidemiology October 26-27, 2007 PRE-CONFERENCE EDUCATIONAL SESSION Tokyo, Japan 1:00 - 5:00pm / Centre Room 205AB / 2008 Introduction to Pharmacoepidemiology ISPE Mid-Year Meeting [*Registration required; included as part of the full meeting registration] April 26-29, 2008 Chair: Andrew McAfee Radisson Hotel Boston • James Lewis, Case-Control Studies Boston, Massachusetts, USA • Andrew McAfee, Cohort Studies • Syed Rizwanuddin Ahmad, FISPE, Spontaneous Reporting 24th ICPE • Eileen Ming, Confounding by Indication August 17-20, 2008 Bella Centre 5:00 - 7:00pm / Centre Foyer 2 / Copenhagen, Denmark Student Meet and Greet 2009 (Meet at ISPE Registration Desk at 5:00 pm, then to Old Montreal Bar) • Open to all students. ISPE Mid-Year Meeting • Organized by the ISPE Student Council. April, TBD Stockholm, Sweden 7:00 - 10:00pm ISPE Board of Directors Dinner (By Invitation) 25th ICPE August 16-19, 2009 Rhode Island Convention Center Providence, Rhode Island, USA
Visit the ISPE website,
www.pharmacoepi.org, for meeting updates and information. •
Future Meetings
• • • BADGES • All attendees at ICPE 2007 must wear their name badges to ALL events.
A badge will be needed for admission to meeting related functions such as the scien- tific sessions, the exhibit/poster hall, and social events. Badges will be included in the registration packet material. In some cases, tickets will be required. Badge Legend Student = Yellow New Member = Blue Québec City, One Day Attendee = Red Canada Room Legend Centre = Quebec City Convention Centre Québec,Québec, Canada Hilton = Quebec Hilton Hotel
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• • • • AGENDA Sunday, August 19 • • • • 8:00am - 6:00pm / Centre Foyer 4 / Noon - 5:00pm / Centre 400A / Registration Exhibitor Move-In 8:00am - 5:00pm / Centre 201C / PRE-CONFERENCE Speakers’ Ready Room EDUCATIONAL SESSION
PRE-CONFERENCE EDUCATIONAL SESSIONS 1:30 - 6:00pm / Centre 205AB / Sunday 8:30am - 12:00pm / Centre 205AB / Advanced Topics in Pharmacoepidemiology - Introduction to Therapeutic Risk Management [*Admission by ticket only. Tickets will be included in registration materials for those who registered for [*Admission by ticket only. Tickets will be included in registration materials for this session.] those who registered for this session.] Chair: Sebastian Schneeweiss, FISPE Co-Chairs: Elizabeth Andrews, FISPE & Carla van Bennekom • Alan Brookhart, Instrumental Variable • Elizabeth Andrews, FISPE, Introduction to Therapeutic Risk Methods in Pharmacoepidemiology Management • Tim Lash, Probabilistic Sensitivity • Carla van Bennekom, Examples of Risk Management Programs Analysis in Pharmacoepidemiology and Evaluations • Jean-François Boivin, Measuring Agenda • Judith Jones, FISPE, Developing Risk Minimization Action Plans Covariate Data in Subsets of Study Populations: A Review of Design and 8:30am - 12:00pm / Centre 302AB / Sampling Options Introduction to Drug Utilization/Health Services Research • Mary Sammel, Multi-level Modeling for [*Admission by ticket only. Tickets will be included in registration materials for Pharmacoepidemiology those who registered for this session.] 5:00 - 6:00pm / Centre Foyer 4 / Chair: Robert Vander Stichele Academic Showcase/Welcome Reception • Robert Vander Stichele, Methodological Framework and Tools for Cross-National Comparisons of Drug Utilization Data Set-up • Morten Anderson, Assessing Validity of Prescribing Quality Indicators 6:15 - 8pm / Centre Foyer 4 / Monique Elseviers, DUR and Pharmacoepidemiology: Academic Showcase/Welcome Reception Case Study —Analgesic Nephropathy Admission by badge or ticket. Cash Bar • Sebastian Schneeweiss, FISPE, Time Trend Analysis for Program Evaluation Welcome • Jean-Pierre Grégoire, Chair, 2007 8:30am - 12:00pm / Hilton Beaumont/Beauport/Belair / Scientific Program Committee • Allen A. Mitchell, FISPE, ISPE President Skills Workshop – Students Only* [*Registration required; included as part of full meeting registration.]
Chair: Chris Delaney, Chair, Student Council • Toine Egberts, FISPE, Outcome Assessment: Databases vs.Clinical Data • Lucie Blais, Channeling and Confounding by Indication • Linda Levesque, Reverse Protapathic Bias • Tjeerd van Staa, Two Answers from the Same Data Source
Noon - 1:30pm Lunch – on your own
Noon - 1:30pm / Hilton Plaines/Citadelle / Luncheon for New Members/Student Prize Winners/ Scholarship Recipients (By Invitation)
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• • AGENDA Monday, August 20 • • • • • 7:00 - 8:00am / Centre 400A / OPENING SESSION • Poster Session A Set-up 8:30 - 10:00am / Centre 200AB / 7:00 - 8:00am Welcome ISPE Committee Meetings • Jean-Pierre Grégoire, Chair, Scientific Open to all interested participants. Program Committee • Jocelyne Moisan, Chair, Local Host • Education / Hilton Montmorency / Committee • Finance / Hilton Courville / Presidential Address 7:30am - 6:00pm / Centre Foyer 4 / • Allen A. Mitchell, FISPE, ISPE President Registration Keynote Address 8:00am - 5:00pm / Centre 201C / • Norman Fost, Speakers’ Ready Room The Dysregulation of Research 10:00 - 10:30am / Centre 400A / 8:00am - 5:00pm / Centre 400A / Break/Posters/Exhibits Exhibits/Posters • •
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• • • • AGENDA Monday, August 20 • • • 10:30am - Noon • CONCURRENT SESSIONS: CONTRIBUTED PAPERS
Methods I / Centre 200AB / Risk Assessment in Commonly Used Drugs Moderators: Miriam Sturkenboom & Annie Hutchinsom / Centre 205AB / 10:30am Moderators: Joanna Haas & Maureen Cronin • The Use of the Overlapping Coefficient in Propensity Score 10:30am
Monday Analysis [1] • Traffic Accident Risks Associated with Edwin P Martens, Wiebe R Pestman, Anthonius de Boer, Svetlana the Prescription of Medicinal Drugs: A - V Belitser, Olaf H Klungel. (Netherlands) Registry-Based Cohort Study [25] 10:45am Svetlana Skurtveit, Jorg Morland, Jorgen • Multilevel Confounding in Pharmacoepidemiologic Research: Bramness, Ineke Neutel, Ingebjorg An Application of Propensity Score Methods [2] Gustavsen, Liliana Bachs, Anders Andrea Gruneir, Kate L Lapane, Susan C Miller, Vincent Mor. Engeland. (Norway) (United States) 10:45am 11:00am • The Safety and Efficacy of Oral • Performance of Summary Risk Scores, Propensity Scores, and Contraceptives in Teenagers: Results from the EURAS-OC Study [26]
Agenda Multivariable Regression in the Presence of Multiple Confounders [3] Juergen C Dinger, Anita Assmann, Lothar Patrick G Arbogast, Lisa Kaltenbach, Wayne A Ray. (United States) AJ Heinemann, Doerthe Kuehl-Habich. (Germany) 11:15am • Using Imputation to Control Unmeasured Confounding: An 11:00am Internal Validation Study [4] • Use of Thiazide Diuretics and Risk of Til Stürmer, Sebastian Schneeweiss, Kenneth J Rothman, Jerry Hip/Femur Fracture: A Population- Avorn, Robert J Glynn. (United States) Based Case-Control Study and a Meta- Analysis of Double Blinded RCTs [27] 11:30am Frank de Vries, Brahm Thio, Kadir Ozer, • A Comparison of Alternative Approaches to Matching Using Didem Altug, Hubert Leufkens, Tjeerd Propensity Scores [5] van Staa. (Netherlands) Mark Lunt, Daniel H Solomon, Deborah P Symmons, Til Stürmer. (United States) 11:15am • The Prevalence of Antipsychotic Use 11:45am among Privately Insured Patients Ages • When Patients Are Treated Contrary to Prediction – Implications 0-64: Implications for Education and for Use of Propensity Scores in Extreme Cases [6] Safety Studies [28] Til Stürmer, Sebastian Schneeweiss, Kenneth J Rothman, Jerry Tami Mark, Stella Chang, Leigh Hansen. Avorn, Robert J Glynn. (United States) (United States) 11:30am • Lipid Lowering Therapy and the Risk of Parkinson’s Disease [29] Claudia Becker, Jick S Susan, Christoph R Meier. (Switzerland) 11:45am • The Risk of Death with Concurrent Use of Cholinesterase Inhibitors and Anticholinergics/Antipsychotics in Alzheimer’s Disease [30] 23rd International Conference on Alison Supina, David Hogan, Scott Patten, Joseph Amuah, Winanne Pharmacoepidemiology & Therapeutic Downey, Patricia Beck, Colleen Maxwell. (Canada) Risk Management
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• • AGENDA Monday, August 20 • • • • • •
Risk of Antidepressants: I’ve Got Plenty Cancer / Centre 302AB / of Nothing / Centre 301AB / Moderators: Michael Cook & Alec Walker, FISPE Moderators: Julie Zito & Patrice Verpillat 10:30am 10:30am • Selective Serotonin Reuptake Inhibitors (SSRIs) and Breast Cancer: • Risk of Cerebrovascular Diseases Preliminary Results of a Two-Stage Case-Control Study [19] Associated with Antidepressant Use in Janet Ashbury, Will King, Patricia Beck, Kristan Aronson. (Canada) Patients with Depression: A Population- 10:45am Based Case-Control Study [13] • Meta-Analysis of the Effects of Aspirin, NSAID and Yan Chen, Nick C Patel, Hong Li, Lawson Acetaminophen Use on Prostate Cancer Risk [20] Wulsin, Jeff J Guo. (United States) SM Mahmud, D Turner, E Franco, A Aprikian. (Canada) 10:45am 11:00am • Venlafaxine Use Was Not Associated • Cox-2 Selective Inhibitors, Other Non-Steroidal Anti- with an Increased Risk of Sudden Inflammatory Drugs, and the Risk of Breast Cancer [21] Cardiac Death [14] Deirdre P Cronin-Fenton, Lars Pedersen, Søren Friis, Timothy L Daniel Mines, Bruce Fireman, Janel Lee, Lash, John A Baron, Henrik Toft Sørensen. (Denmark) Alan S Go. (United States) 11:15am 11:00am • Renal Impairment in Cancer Patients Following Intravenous (IV) • Use of Antidepressive Agents and the Zoledronic Acid or IV Ibandronate Treatment [22] Risk of Diabetes: A Nested Case Control Ingo J Diel, Rudolf Weide, Hubert Köppler, Lucia Antràs, Michael Study [15] Smith, Jesse Green, Neil Wintfeld, Maureen Neary, Mei Sheng Frank Andersohn, René Schade, Samy Duh. (United States) Suissa, Edeltraut Garbe. (Germany) 11:30am 11:15am • The Effect of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) • Risks of Suicide and Poisoning among on Non-Melanoma Skin Cancer (NMSC) Incidence in the SKICAP- Elderly Patients Prescribed Selective AK Trial [23] Serotonin Reuptake Inhibitors: A Mary C Clouser, Robin B Harris, Denise J Roe, Janet A Foote. Retrospective Cohort Study [16] (United States) Elham Rahme, Kaberi Dasgupta, Gustavo Turecki, Hacene Nedjar, Guillaume 11:45am Galbaud du Fort. (Canada) • Risk of Lymphoma Risk among Users of Topical Corticosteroids and Topical Calcineurin Inhibitors. Preliminary Results [24] 11:30am Felix M Arellano, Alejandro Arana, Charles E Wentworth, Carlos • Gastrointestinal Bleed Risk with the Use Fernandez-Vidaurre, Raymond Schlienger, Eulogio Conde. (Spain) of Selective Serotonin Receptor Antagonists: A New Look [17] Lucie Opatrny, JA Delaney, Samy Suissa. (Canada) 11:45am • Antidepressants and Risk of Prostate Cancer: A Nested Case-Control Study [18] Hani M Tamim, Salaheddin Mahmud, Jean-Francois Boivin, James A Hanley, MaryRose Stang, Jean-Paul Collet. (Saudi Arabia)
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• • • • AGENDA Monday, August 20 • • • Drug Use and Diabetes Progression / Centre 303AB / Noon - 1:30pm • Moderators: Jeffrey Johnson & Cindy Girman Lunch/Poster 10:30am 11:15am Session A/Exhibits • Use of ACE Inhibitors and Angiotensin • Immortal Time Bias in an Observational / Centre 400A / Receptor Blockers by Elderly with Type Study of the Progression of Type 2 Sponsored by 2 Diabetes in Quebec [7] Diabetes [10] United BioSource Caroline Sirois, Jean-Pierre Gregoire, Linda E Levesque, Abbas Kezouh, Samy Corporation Jocelyne Moisan. (Canada) Suissa. (Canada) Monday ISPE Committee/ 10:45am
- 11:30am Council Meetings • Variation in Diabetes Drug Utilization • Rates of Hypokalemia after Open to all participants. among Medical Facilities in the Veterans Implementation of Aggressive Insulin (Lunch will be available in Health Administration (VHA) [8] Dosing in Critical Care Patients [11] meeting rooms) Kristijan H Kahler, Mangala Rajan, George Ahunna J Onyenwenyi, Almut G G Rhoads, Monika M Safford, Kitaw • Bylaws Winterstein. (United States) Demissie, Shou-En Lu, Leonard M / Hilton Bernieres / Pogach. (United States) 11:45am • Fellowship & • Association between Use of Awards 11:00am Thiazolidinediones, Other Oral / Hilton Beaumont / • Passage to Insulin in Elderly with Type
Agenda Antidiabetics and Psoriasis [12] • Public Policy 2 Diabetes [9] Yolanda B Brauchli, Susan S Jick, / Hilton Belair / Norma Perez, Jocelyne Moisan, Caroline Christoph R Meier. (Switzerland) • Student Council Sirois, Jean-Pierre Gregoire. (Canada) / Hilton Beauport /
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• • AGENDA Monday, August 20 • • • • • 1:30 - 3:00pm CONCURRENT SESSIONS: CONTRIBUTED PAPERS • Drug Utilization in the Elderly Pharmacogenomics and Drug Effects- It’s in the Genes / Centre 200AB / / Centre 205AB / Moderators: Ulf Bergman, FISPE, & Moderator: Steve Kimmel, FISPE Andrew Gilbert 1:30pm 1:30pm • Interactions between the Gly460Trp Alpha-Adducin Gene • Lower Use of Chemotherapy among Variant and Diuretics and the Risk of Myocardial Infarction Older Adult Patients with Metastatic among Treated Hypertensive Patients [49] Colorectal Cancer (mCRC) in the US [31] Diane BMA van Wieren-de Wijer, Anke-Hilse Maitland-van der Zee, W Dong, M Taylor, M Sugrue. (United Anthonius de Boer, Bruno Ch Stricker, Olaf H Klungel. States) (Netherlands) *Student Award Recipient – Edlavitch Award 1:45pm • Medication Prescribing for 1:45pm Institutionalized Demented Elderly [32] • Increased QTc Shortening to Digoxin in Common NOS1AP Monique M Elseviers, Robert H Vander Variants [50] Stichele. (Belgium) Albert-Jan LHJ Aarnoudse, Christopher Newton-Cheh, Andre G Uitterlinden, Bruno HCh Stricker. (Netherlands) 2:00pm • Does Receiving Care in a Nursing Home 2:00pm Dementia Special Care Unit Decrease • Influence of CYP2D6 Polymorphism on Dose and Switching of the Likelihood of Receiving Antidepressants [51] Psychotropic Medications for Residents Monique J Bijl, Loes E Visser, Ron HN van Schaik, Arnold G Vulto, with Dementia? [33] Teun van Gelder, Bruno HCh Stricker. (Netherlands) Andrea Gruneir, Kate L Lapane, Susan C Miller, Vincent Mor. (United States) 2:15pm • VKORC1, APOE, CYP2C9 Variants and Their Influences on 2:15pm Warfarin Dosing in African Americans [52] • Exposure of the Elderly to Potential H Schelleman, Z Chen, C Kealey, AS Whitehead, J Christie, M Price, Nephrotoxic Drug Combinations in CM Brensinger, CW Newcomb, CF Thorn, FF Samaha, SE Kimmel. Belgium [34] (United States) Johan FF De Haes, Hilde LE Smets, Philippe G Jorens, André De Swaef, Gert 2:30pm A Verpooten. (Belgium) • Association between the Genetic Variations on DRD2 and the Risk of Tardive Dyskinesia: A Meta-Analysis Study [53] 2:30pm Huei-Ting Tsai. (United States) • Patterns of Prescription Medication Utilization among the US Non- 2:45pm Institutionalized Elderly Population [35] • Canadian National Active Surveillance Network for Adverse Brian J Quilliam, Jonathan T Weiner, Rita M Drug Reactions: Genotypic Approaches to Therapy in Children Marcoux. (United States) (GATC): The First Year [54] BC Carleton, D Warn, S Stenton, R Rassekh, MA Smith, B Dhami, C 2:45pm Ross, MR Hayden. (Canada) • The Relationship between Number of Drugs and Drug-Drug Interactions in the Elderly [36] Kristina Johnell, Inga Klarin. (Sweden)
23rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management
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• • • • AGENDA Monday, August 20 • • • Pediatrics / Centre 301AB / Aspects of Patient Safety / Centre 302AB / • Moderators: William Cooper & Moderators: Toine Egberts, FISPE, & Juergen Dinjer Patricia Saddier 1:30pm 1:30pm • Frequency and Potential Risk Factors of Hospital Admissions • Diagnosing a Child as Being Asthmatic Related to Medication (HARM) in the Netherlands [55] Does Not Drive Prescribing of Asthma Anne J Leendertse, Toine CG Egberts, Patricia MLA van den Bemt. Medication [43] (Netherlands) Mira G Zuidgeest, Madelon Bracke, Monday Henriette A Smit, Liset van Dijk, Bert 1:45pm • Medication Errors: Impact of Prescribing and Transcription
- Brunekreef, Hubert G Leufkens. (Netherlands) Errors on Preventable Harm in Hospitalised Patients [56] Jasperien E van Doormaal, Patricia MLA van den Bemt, Peter GM 1:45pm Mol, Rianne J Zaal, Antoine CG Egberts, Flora M Haaijer-Ruskamp, • Psychotropic Treatment among Youths Jos GW Kosterink. (Netherlands) Newly Diagnosed with Attention Deficit/Hyperactivity Disorders (ADHD) 2:00pm [44] • Warning: Avoid Alcohol While Taking This Medication. The Chih-Ying Chen, Almut G Winterstein. Prevalence and Correlates of Non-Compliers [57] (United States) Jessica J Jalbert, Kate L Lapane, Brian J Quilliam. (United States)
Agenda 2:00pm 2:15pm • Safety of Methylphenidate Versus • Can Disproportionality Analysis Play a Role in Monitoring Amphetamine Salts in the Treatment of Medical Device Safety? [58] Attention-Deficit/Hyperactivity Disorder Hesha J Duggirala, Xionghu Yang, Robbert P Van Manen. (United (ADHD) [45] States) Almut G Winterstein, Tobias Gerhard, 2:30pm Julie Zito, Jonathan Shuster, Arwa Saidi. • A General Population Based Study of the Impact of (United States) Prescription-Only Medicines on the Risk of Road Traffic 2:15pm Accident [59] • Mortality Associated with ADHD Drug Jack E Gibson, Richard B Hubbard, Christopher JP Smith, Laila J Treatment [46] Tata, John Britton, Andrew W Fogarty. (United Kingdom) Suzanne McCarthy, Macey Murray, Noel 2:45pm Cranswick, Ian Wong. (United Kingdom) • Ongoing Spontaneous Reporting of Established Drug-Drug 2:30pm Interactions [60] • Young Age at Diabetes Diagnosis Johanna Strandell, Andrew Bate, Marie Lindquist, I Ralph Associated with an Increased Risk of Edwards, SFINX Group. (Sweden) Related Serious Adverse Events [47] Annie Hutchison, Esi Ikazoboh, David Effectiveness and Safety of Cardiovascular Medications Russel-Jones, Corinne de Vries. (United / Centre 303AB / Kingdom) Moderators: Jacques LeLorier, FISPE, & Michael Fischer 2:45pm 1:30pm • Trends in Pseudoephedrine Use among • Improvements in Long-Term Mortality after Myocardial U.S. Children 1999-2006: Results from Infarction Can Be Explained by Increased Use of Cardiovascular the Slone Survey [48] Drugs after Discharge: A 10-Year Trend Analysis among the Louis Vernacchio, Judith P Kelly, David W Community Dwelling Elderly [37] Kaufman, Lynn Rosenberg, Allen A Soko Setoguchi, Murray A Mittleman, Raisa Levin, Wolfgang C Mitchell. (United States) Winkelmayer. (United States) 1:45pm • Improved Treatment and Reduced Mortality in Patients with Acute Coronary Syndrome Using a Guideline-Based Critical Pathway [38] John C Corbelli, David M Janicke, Tracey Hoy, Mark J Cziraky. (United States)
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• • • • AGENDA Monday, August 20 • • • • Effectiveness and Safety of 3:30 - 5:00pm Cardiovascular Medications (Cont.) CONCURRENT SESSIONS 2:00pm SYMPOSIUM: Improvement in the Drug Approval Process: An • Analyzing Comparative Effectiveness / Centre 200AB / Using Inverse Probability-Weighted International Perspective [161] Estimators: Evidence-Based vs. Non- Chair: Yola Moride, FISPE Evidence-Based Beta-Blockers To Treat • Gerald Del Pan, USA, US FDA
Monday Heart Failure [39] • Akira Kawahara, Japan, Pharmaceuticals and Medical Devices K Anstrom, L Curtis, M Massing, D Pelter, Agency (PMDA)
- A Hernandez, C Dupree, J Kramer. • June Raine, Europe, Medicines and Healthcare Products (United States) Regulatory Agency (MHRA), & Pharmacovigilance Working Party (EMEA) 2:15pm • Maurica Maher, Canada, Health Canada • The Contribution of Observational Studies to the Knowledge of Drug WORKSHOP: The Monitoring of Drug Safety: Can Risk-Benefit Effectiveness in Heart Failure [40] Daniela Dobre, Dirk J van Veldhuisen, Models Detect Those Signals with High Impact? [154] Mike JL de Jongste, Eric van Sonderen, / Centre 205AB / Olaf H Klungel, Robbert Sanderman, • Tjeerd P van Staa, Frank de Vries, John Parkinson, Hubert GM Agenda Adelita V Ranchor, Flora M Haaijer- Leufkens. (United Kingdom) Ruskamp. (Netherlands) 2:30pm SYMPOSIUM: Pharmacogenetics (PG) for Epidemiologists: What • Declining Public Health Burden of We Know and What We Need to Know [153] / Centre 301AB / Digoxin Toxicity from 1991 to 2004 [41] Kevin Haynes, Dan F Heitjan, Sean • Richard B Kim, Canada, University of Western Ontario Hennessy. (United States) • Geoffrey Liu, Canada, University of Toronto • Wei Zhou, USA, CDC 2:45pm • Robert Ball, USA, US FDA • Beta-Blockers, Other Antihypertensives • Andrew Freeman, USA, National Cancer Institute/National and Psoriasis [42] Institutes of Health Yolanda B Brauchli, Susan S Jick, • David P Miller, RTI Health Solutions Christoph R Meier. (Switzerland) WORKSHOP: Placebo-based Study Methods for the 3:00 - 3:30pm / Centre 400A / Quantification of Postmarketing Risk [152]] / Centre 302AB / Break/Posters/Exhibits • Gerald Faich, Kelly Posner, John Clark. (United States) SYMPOSIUM: Prescribing Quality Indicators in Research and Practice [155] / Centre 303AB / • Jerry Avorn, Bjorn Wettermark, Sean McBride-Stewart, Debra Rowett, Flora M Haaijer-Ruskamp. (Netherlands)
5:00 - 6:00pm 7:00pm - ISPE Council Meetings 10:00pm Open to all interested participants Student Social • Academic / Hilton Dufferin / Event – A Night • Government/Regulatory Out in Québec City / Hilton Beauport / • Meet in Hilton • Industry / Hilton Plaines / lobby at 7:00pm. • Open to all 6:00 - 8:00pm students. PDS Editorial Board / Hilton Villeray / Organized by the (By Invitation) ISPE Student Council 16 23rd ICPE August 19-22, 2007 Québec City Convention Centre 41197 7/25/07 1:11 AM Page 19
• • AGENDA Tuesday, August 21 • • • • • 7:00 - 8:00am / Centre 400A / 8:00 - 9:30am • Poster Session B Set-up PLENARY SESSION 7:00 - 8:00am / Hilton Vieux-Port / How Do Our Annual Influenza Vaccines Measure Up? [145] CERTs Roundtable [548] / Centre 200AB / (The Centers for Education & Research Chair: M. Miles Braun, FISPE, US FDA on Therapeutics) Presenter: • Hugh Tilson, Sean Hennessy, • Gaston De Serres, Institut National de Santé Publique du Québec, Anne Trontell (invited). (United States) Important Impact of Study Design on Vaccine Effectiveness Estimates • Open to all participants Discussant: Ken Rothman, RTI Health Solutions. 7:30 - 8:00pm / Centre Foyer 4 / Presenter: Registration • Edward Belongia, Marshfield Clinic, Substantial Year to Year Variation in Influenza Vaccine Effectiveness and Antigenic Match 8:00 - 5:00pm / Centre 201C / Discussant: Speakers’ Ready Room David Shay, US Centers for Disease Control and Prevention. Presenter: 8:00 - 5:00pm / Centre 400A / • Lisa Jackson, Group Health Cooperative, Big Bias in Estimates of Exhibits/Posters Influenza Vaccine Effectiveness Discussant: Robert Glynn, Harvard University.
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• • • • AGENDA Tuesday, August 21 • • • • 9:30 - 10:30am / Centre 200AB / 11:00 - 12:30pm ANNUAL MEETING OF ISPE CONCURRENT SESSIONS – MEMBERS & AWARDS CEREMONY CONTRIBUTED PAPERS Methods II / Centre 200AB / Annual Meeting of ISPE Members open to all Moderators: Ken Rothman, FISPE • Allen A. Mitchell, FISPE, ISPE President participants. 11:00am Tuesday • Corinne de Vries, ISPE Vice President Finance • Increasing Restriction in Database
- Studies of Elderly Drug Use: Awards Ceremony Comparison with Randomized Trial ICPE 2007 Results [61] • Jocelyne Moisan, Chair, Local Host Committee Sebastian Schneeweiss, Amanda Patrick, • Jean-Pierre Grégoire, Chair, 2007 Scientific Program Committee Til Stürmer, Alan Brookhart, Jerry Avorn, Kenneth Rothman, Malcolm Maclure, Student Awards Robert Glynn. (United States) • Presented by Jean-Pierre Grégoire, Chair, 2007 Scientific Program 11:15am Committee • Does Incorporating Health-Related
Agenda Best Drug Utilization Abstract: Julie Blouin, University of Montreal, Quality of Life into Composite Outcome Impact of Non-Adherence to Bisphosphonates on the Incidence of Analyses Improve Transparency? [62] Osteoporotic Fractures: A Nested Case-Control Study Dean T Eurich, Sumit R Majumdar, Finlay A McAlister, Ross T Tsuyuki, Yutaka Yasui, Best Methods Abstracts: Dean Eurich, University of Alberta, Does Jeffrey A Johnson. (Canada) Incorporating Health-Related Quality of Life Into Composite *Student Award Recipient – Outcome Analyses Improve Transparency? Best Methods Abstract Third Best Abstract: Marie-Josee Martel, University of Montreal, 11:30am Control and Severity of Maternal Asthma During Pregnancy and the • A Review of PRR over Time Analyses for Incidence of Allergic Rhinitis and Atopic Dermatitis in the Offspring Various Drugs with Serious Adverse Event Second Best Abstract: Albert Jan Aarndouse, Erasmus Medical Center, Risks Unknown at Drug Launch [63] Increased QTc Shortening to Digoxin in Common NOS1AP Variants Keith L Altman. (United States) Edlavitch Award: Diane van Wieren-de Wijer, Utrecht University, 11:45am Interactions Between the Gly460Trp Alpha-Adducin Gene Variant • Risk Indices Based on Administrative and Diuretics and the Risk of Myocardial Infarction Among Treated Data Failed To Control for Confounding Hypertensive Patients Caused by Healthy User Bias [64] Michael Jackson, Jennifer Nelson, Lisa Induction of ISPE Fellow (FISPE) Jackson. (United States) • Sean Hennessy, FISPE, Chair, Fellowship & Awards Committee 12:00pm Inductee: Rhonda L. Bohn, FISPE • Estimating Effects of Antihypertensive Therapy on Adverse Outcomes in the ISPE-PDS Prizes Presence of Time-Dependent • Presented by Sean Hennessy, FISPE, Associate Editor, Confounding by Blood Pressure [65] Pharmacoepidemiology & Drug Safety, and Richard Hughes, Tobias Gerhard, Almut Winterstein, Managing Editor, Pharmacoepidemiology & Drug Safety Jonathan Shuster, Julie Johnson, Abraham Prize winners for best paper published in PDS Volume 15 (20.06): Hartzema, Carl Pepine. (United States) Anita K. Wagner, FDA Drug Prescribing Warnings: Is The Black Box 12:15pm Half Empty or Half Full? • Variable Selection for Marginal Priscilla Velentgas, Cardiovascular Risk of Selective Structural Models [66] Cyclooxygenase-2 Inhibitors and Other Non-Aspirin Non- Joseph A Delaney, Geneviève Lefebvre, Steroidal Anti-Inflammatory Medications Robert W Platt. (Canada)
10:30 - 11:00am / Centre 400A / Break/Posters/Exhibits
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• • AGENDA Tuesday, August 21 • • • • • •
Effectiveness of Statins on Intended and Not Intended Outcomes / Centre 205AB / Moderators: Jim Kaye & Olaf Klugel 11:00am • A Systematic Review on the Therapeutic Equivalence of Statins [85] 12:00pm Der-Chang Wung, Yea-Huei Kao, Swu-Jane Lin, Shu-Hwa Tai. (Taiwan) • Effectiveness of Statins for the Prevention of Keratinocyte Carcinomas [89] 11:15am David D Dore, Kate L Lapane, Vincent • Therapeutic Substitution of Statins: A Real World Data Driven Mor, Amal N Trivedi, Martin A Weinstock. Approach Based on NCEP ATPIII Low Density Lipoprotein (United States) Cholesterol (LDL-C) Goals [86] Vincent Willey, Brian Sweet, Christy Fang, Mark Cziraky. (United States) 12:15pm • Statins and Cancer Risk [90] 11:30am Igor Karp, Hassan Behlouli, Jacques • Daily Medication Adherence and Dose Changes on the LeLorier, Louise Pilote. (Canada) Effectiveness of Statin Therapy in LDL Cholesterol Change [87] Elizabeth V Lawler, David R Gagnon, Richard E Scranton. (United States) 11:45am • The Effect of Changes in Statin Prescribing on Secondary Prevention after the First Acute Myocardial Infarction [88] Stella S Daskalopoulou, Joseph A Delaney, Kristian B Filion, James M Brophy, Nancy E Mayo, Samy Suissa. (Canada)
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• • • • AGENDA Tuesday, August 21 • • • • Psychotropics: To Die, To Sleep, Per Chance to Dream Going A “Lung” Way / Centre 302AB / / Centre 301AB / Moderators: Daniel Mines & Lucie Blais Moderators: Jan Willem van der Velden, FISPE, & Adrianne Einarson 11:00am 11:00am • Oral Corticosteroids and Mortality • Cardiovascular and Infection-Related Morbidity and Mortality in Following Hip Fracture: A Population- Conventional vs. Atypical Antipsychotic Medications in the Based Cohort Study [79] Elderly [73] Cynthia de Luise, Michael Brimacombe,
Tuesday Soko Setoguchi, Philip S Wang, Alan M Brookhart, Claire F Lars Pedersen, Henrik T Sørensen. Canning, Sebastian Schneeweiss. (United States) (United States) - 11:15am 11:15am • The Temporal Relationship between Antipsychotic Use and • Control and Severity of Maternal Stroke among Community-Dwelling Elderly: Further Support for Asthma during Pregnancy and the a Causal Relationship [74] Incidence of Allergic Rhinitis and Atopic Bart C Kleijer, Rob J Van Marum, Wilma Knol, Antoine C Egberts, Dermatitis in the Offspring [80] Eibert R Heerdink. (Netherlands) Marie-Josee Martel, Marie-France Beauchesne, Jean-Luc Malo, Evelyne Rey, 11:30am Sylvie Perreault, Amelie Forget, Lucie • The Incidence of Diabetes in Atypical Antipsychotic Users Blais. (Canada)
Agenda Differs According to Agent – Results from a Multisite *Student Award Recipient- Epidemiologic Study [75] Third Best Abstract Marianne Ulcickas Yood, Gerald deLorenze, Charles P Quesenberry, Jr., Gilbert L’Italien, Susan A Oliveria, Ai-Lin Tsai, Ulka Campbell, 11:30am Vincent Willey, Robert McQuade, John Newcomer. (United States) • Revisiting the Steroids-Oral Cleft Controversy [81] 11:45am Carol Louik, Michael Schatz, Sonia • Safety of Central Nervous System Stimulants in Youths with Hernandez-Diaz, Martha M Werler, Allen Attention-Deficit/Hyperactivity Disorder (ADHD) [76] A Mitchell. (United States) Almut G Winterstein, Tobias Gerhard, Jonathan Shuster, Julie M Zito, Michael Johnson, Arwa Saidi. (United States) 11:45am • Evidence for No Association between 12:00pm Use of beta-2-Agonists and Risk of • Psychotropics in French Children and Adolescents: Utilization Acute Myocardial Infarction in Patients Patterns and Safety Issues [77] with Hypertension [82] Christine Sevilla-Dedieu, Viviane Kovess-Masfety. (France) Frank de Vries, Sander Pouwels, Madelon Bracke, Olaf Klungel, Jan-Willem 12:15pm Lammers, Hubert Leufkens, Tjeerd van • The Impact of Benzodiazepine Use on Mobility in Community Staa. (Netherlands) Dwelling Elderly [78] Robert M Boudreau, Yazan F Roumani, Joseph T Hanlon, Anne B 12:00pm Newman, Stephanie A Studenski, Tamara B Harris, Michael C • Maternal Asthma Medication Use Nevitt, Ronald I Shorr, Eleanor M Simonsick. (United States) before and during Pregnancy [83] Faranak Firoozi, Catherine Lemiere, Marie-France Beauchesne, Francine M Ducharme, Anick Berard, Lucie Blais. (Canada) 12:15pm • Clinical Impact of an Integrated Care Program in Asthma: The RESPIRE Study [84] Marie-Sophie Jobin, Jocelyne Moisan, Nancy Manzerolle, Yves Bolduc, Eileen Dorval, Madone Turcotte, Louis-Philippe Boulet, Jean-Pierre Gregoire. (Canada)
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• • AGENDA Tuesday, August 21 • • • • • Health Care Policy / Centre 303AB / 11:45am Moderators: Tom Einarson, FISPE, & Niteesh Chowdry • The Effect of Medicare Part D on the • 11:00am Utilization of Essential Drugs by Seniors • The Impact of Cost Sharing on a Patient Compliance and without Prior Drug Coverage [70] Persistence for Smoking Cessation Pharmacotherapy [67] Sebastian Schneeweiss, Amanda R Diana Brixner, Carmen Kirkness, Scott Robinson, Eva Lydick. Patrick, Alex Pedan, Laleh Varasteh, Raia (United States) Levin, William Shrank. (United States) 11:15am 12:00pm • Impact of E-Prescribing on Medication Use and Cost in • Alternatives to Project-Specific Consent Community-Based Practices [68] for Access to Personal Information for MA Fischer, TG Ferris, C Vogeli, M Stedman, MA Brookhart, Health Research: Canadian Public JS Weissman. (United States) Opinion [71] Don Willison, Lisa Schwartz, Julia Abelson, 11:30am Cathy Charles, Marilyn Swinton, David • The Effect of Epoetin Dose on Haematocrit Response: Northrup, Lehana Thabane. (Canada) Implications for Health Policy [69] Dennis Cotter, Yi Zhang, Mae Thamer, James Kaufman, Miguel 12:15pm Hernan. (United States) • Innovation Drives Orphan Drug Development [289] Harald E Heemstra, Remco LA de Vrueh, Sonja van Weely, Hubert GM Leufkens. (Netherlands)
12:30 - 2:00pm Lunch/Poster Session B/Exhibits / Centre 400A / ISPE Committee Meetings Open to all interested participants. (Lunch will be available in meeting rooms)
• Development / Hilton Orleans / • Global Development / Hilton Villeray / • Membership / Hilton Lauzon / • Publications / Hilton Sillery /
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• • • • AGENDA Tuesday, August 21 • • • 2:00 - 3:30pm • CONCURRENT SESSIONS – CONTRIBUTED PAPERS The Benefits of Adherence / Centre 200AB / Hematology / Centre 205AB / Moderators: Lynn Bosco & Monique Elseviers Moderators: Alec Walker, FISPE, & Mitchell Levine 2:00pm • Impact of Non-Adherence to Bisphosphonates on the Incidence 2:00pm of Osteoporotic Fractures: A Nested Case-Control Study [91] • Hormonal Contraceptives and Risk of Tuesday Julie Blouin, Alice Dragomir, Yola Moride, Louis-Georges Ste-Marie, Aneurysmatic Subarachnoid
- Julio C Fernandes, Sylvie Perreault. (Canada) Haemorrhage [103] *Student Award Recipient – R Risselada, A van der Lugt, WJ Niessen, Best Drug Utilization Abstract MCJM Sturkenboom. (Netherlands) 2:15pm 2:15pm • Impact of Statin Adherence on Chronic Heart Failure among • Effect of Oral Antiplatelet Drugs on Patients Newly Treated for Primary Prevention [92] Major Bleeding among Users of Sylvie Perreault, Alice Dragomir, Lucie Blais, Lyne Lalonde, Anick Coumarin Anticoagulants [104] Bérard, Michel White. (Canada) Tom Schalekamp, Olaf H Klungel, Patrick C Souverein, Anthonius de Boer. 2:30pm Agenda (Netherlands) • Non-Persistent Use of Antihypertensive Drugs Increases Risk of Hospitalizations for Acute Myocardial Infarction by 10% in 2:30pm Patients with Low or Intermediate Cardiovascular Risk [93] • Case-Finding of Possible Heparin- Nancy S Breekveldt-Postma, Satu J Siiskonen, Fernie JA Penning- Induced Thrombocytopenia in an Van Beest, Joelle A Erkens, Gabor Vincze, Heather Falvey, Ron MC Academic Teaching Hospital by Linking Herings. (Netherlands) Laboratory and Medication Data [105] Maarten ten Berg, Albert Huisman, 2:45pm Patricia van den Bemt, Fred Schobben, • Impact of Medication Adherence on Health Care Cost among Toine Egberts, Wouter van Solinge. Patients Newly Treated with Antihypertensive Agents for (Netherlands) Primary Prevention [94] Sylvie Perreault, Alice Dragomir, Lucie Blais, Lyne Lalonde, Anick 2:45pm Bérard. (Canada) • Preadmission Oral Anticoagulant Therapy and 30-Day Mortality from 3:00pm Peptic Ulcer Bleeding [106] • Adherence to Gastroprotection and the Risk of NSAID-Related Pernille Larsen, Steffen Christensen, Else Upper Gastrointestinal Complications [95] Tønnesen, Søren P Johnsen, Reimar W Eva M van Soest, Miriam CJM Sturkenboom, Jeanne P Dieleman, Thomsen, Henrik T Sørensen. (Denmark) Katia MC Verhamme, Peter D Siersema, Ernst J Kuipers. (Netherlands) 3:00pm 3:15pm • Anti-Thrombotic Drug-Drug Interactions • Prospective Assessment of Risk Factors for Warfarin and the Risk of Gastro-Intestinal Nonadherence: The Program for the Reduction in Medical Bleeding [107] Errors (PRIME) Study [96] Joseph A Delaney, Lucie Opatrny, James AB Platt, AR Localio, JD Christie, CM Brensinger, R Gross, A Cohen, M Brophy, Samy Suissa. (Canada) M Price, JP Metlay, BL Strom, SE Kimmel. (United States) 3:15pm • Non-Chemotherapy Drug-Induced Agranulocytosis: A Systematic Review of Case Reports [108] Frank Andersohn, Christine Konzen, Edeltraut Garbe. (Germany)
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• • AGENDA Tuesday, August 21 • • • • • •
Disease Epidemiology / Centre 301AB / Miscellaneous / Centre 302AB / Moderators: Judith Jones, FISPE, & Moderators: Keith Beard, FISPE, & Annie Fourrier Elena Rivero, FISPE 2:00pm 2:00pm • Brand and Generic Substitution in Australia: Are Patients • Incidence of Interstitial Pneumonitis in Switched between Products Multiple Times? [115] Danish Breast Cancer Patients 1994- Lisa Kalisch, Elizabeth Roughead, Andrew Gilbert. (Australia) 2004 [109] Steffen Christensen, Lars Pedersen, 2:15pm Miriam Grotja, Annette Beiderbeck, • Influenza Vaccinations in Heart Disease: More Socially Deprived Henrik T Sørensen. (Denmark) Patients Are Less Likely to Receive Their Flu Jab [116] Annie Hutchison, Helen E Seaman, Corinne S de Vries. (United 2:15pm Kingdom) • Mortality in Systemic Lupus Erythematosus [110] 2:30pm Alison L Nightingale, Corinne S de Vries. • Effect of Antibiotics Taken for Other Illnesses on Spontaneous (United Kingdom) Clearance of Helicobacter pylori Infection in Children [117] Cheryl S Broussard, Karen J Goodman, Carl V Phillips, Mary A 2:30pm Smith, Lori A Fischbach, Corinne C Aragaki, R Sue Day. (United • Co-Existence of Autoimmune Diseases States) within Individuals [111] Emily C Somers, Sara L Thomas, Liam 2:45pm Smeeth, Andrew J Hall. (United States) • Sedation/Analgesic Use for Pediatric Joint Dislocation Injuries Presenting to the Emergency Department [118] 2:45pm Joshua H Tamayo-Sarver, Yu Yan, Cherri Hobgood. (United States) • Incidence of Rheumatoid Arthritis in General Practice and Its Association 3:00pm with Co-Morbidity and Drug Treatment • Timing, Type, and Indication of Anti-Infective Use and [112] Pregnancy Outcomes [119] Luis A Garcia Rodriguez, Laura Barreales Martha M Werler, Sonia Hernandez-Diaz, Carol Louik, Allen A Tolosa, Mari-Ann Wallander, Saga Mitchell. (United States) Johansson, Ana Ruigomez. (Sweden) 3:15pm 3:00pm • Association between Antidepressant Use during Pregnancy and • The Effect of Heart Rate and Its Infants Born Small for Gestational Age [120] Changes on Cardiovascular Disease and Élodie Ramos, Driss Oraichi, Anick Bérard. (Canada) Mortality [113] Efrosini Setakis, Hubert GM Leufkens, Tim J Williams, Tjeerd P van Staa. (United Kingdom) 3:15pm • Impact of Potential Selection Bias on Prevalence Estimates of Lower Urinary Tract Symptoms in a Primary Care Setting [114] Alicia W Gilsenan, Jianmin Wang, Kirk Midkiff, Elizabeth Andrews. (United States)
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• • • • AGENDA Tuesday, August 21 • • • • Pregnancy and Birth Defects 4:00 - 5:30pm / Centre 303AB / CONCURRENT SESSIONS Moderators: Lolkje de Jong - van den Berg & Anick Berard, FISPE SYMPOSIUM: The Need for Research on the Comparative 2:00pm Effectiveness of Therapy [156] / Centre 200AB / • Prescription Drug Use Before, During Moderator: Sebastian Schneeweiss, FISPE and After Pregnancy Among 50,000 • Marcus Wilson, HealthCore Tuesday Women in Norway in 2004-2005 [97] • Bob Nakagawa, British Columbia Ministry of Health Anders Engeland, Jørgen Bramness, • Jean Slutsky, US Agency for Healthcare Research & Quality - Anne Kjersti Daltveit, Marit Rønning, • Wayne Ray, FISPE, Vanderbilt University Svetlana Skurtveit, Kari Furu. (Norway) 2:15pm WORKSHOP: Can Pharmacoepidemiology be Patented? How Do • Discontinuation of Antidepressant ISPE Members View the Potential Impact of Patents in the Medication in Pregnancy and Practice of Pharmacoepidemiology: An ISPE Public Policy Postpartum Suicide Risk: A Population- Based Cohort of 81,975 Women [98] Forum [159] / Centre 205AB / Janet R Hardy, Sybil L Crawford, Tiffany • Elizabeth B Andrews, Susana Perez-Gutthann. (Spain) A Moore-Simas, Sherry Pagoto. Agenda (United States) SYMPOSIUM: The Quality of Pharmaceutical Care Among 2:30pm Institutionalized Elderly [160] / Centre 301AB / • Sensitivity and Specificity of Co-chairs:Jerry Avorn, FISPE & Robert Vander Stichele Computerized Databases for Use of Anti-Infectives Early in Pregnancy [99] Speakers Sengwee Toh, Allen A Mitchell, Martha • Jerry Avorn, FISPE, USA, Conceptual Framework for Geriatric M Werler, Sonia Hernández-Díaz. Assessment in Nursing Homes. (United States) • Sabine Ruths, Norway, Multidisciplinary Medication Review in 2:45pm Nursing Homes: Experiences from the Bergen District Nursing • Lost to Follow-Up Rates in Pregnancy Home Study (BEDNURS) Registries by Enrollment Source [100] • Monique Elseviers, Belgium, Institutional Characteristics of Deborah L Covington, Susan S Roberts, Belgian Nursing Homes and Quality of Medication Management Ann E Mallard. (United States) • Robert Vander Stichele, Belgium, Institutional Characteristics of 3:00pm Belgian Nursing Homes and Quality of Prescribing: Using • Maternal Use of Loratadine during Several Sets of Indicators in a Single Evaluation Pregnancy and Prevalence of • Mike Steinman, USA, Characterizing and Comparing Measures of Hypospadias in Offspring: A Danish Prescribing Quality in OlderAdults Nationwide Case-Control Study [101] Lars Pedersen, Mette Nørgaard, Kenneth • Terry Field, USA, Preventable Adverse Drug Events Among J Rothman, Henrik T Sørensen. (Denmark) Nursing Home Residents 3:15pm WORKSHOP: What Can Pharmacoepidemiology Mean for • Use of Analgesics Early in Pregnancy and Pediatric Use Marketing Authorization (PUMA)? [157] the Risk of Specific Birth Defects [102] Sonia Hernández-Díaz, Martha M Werler, / Centre 302AB / Carol Louik, Allen A Mitchell. • Miriam CJM Sturkenboom, Antje Neubert, Ian Wong. (United States) (Netherlands) 3:30 - 4:00pm / Centre 400A / SYMPOSIUM: Tools for Monitoring the Safety and Effectiveness Break/Posters/Exhibits of Influenza Vaccines During an Influenza Pandemic [158] / Centre 303AB / • Ann McMahon, Penina Haber, Edward Belongia, Dina Pfeifer, Patrick Caubel, David Shay, Robert Davis, Miles Braun. (United States)
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• • AGENDA Tuesday, August 21 • • • • • 5:30 - 6:30pm 7:30 - Midnight Special Interest Group (SIG) Meetings Evening at the Musée National des Beaux-Arts du Québec • • Open to all interested participants. • The Museum is located in the heart of the Plains of Abraham • Drug Utilization/Health Services overlooking the Saint Lawrence River. The museum presents Research SIG / Hilton Beauport / exhibits featuring Quebec artists from the past and present. You also will have an opportunity to visit the Baillairgé • Medications in Pregnancy SIG Pavilion, which used to house the Old Prison on the Plains, / Hilton Beaumont/Belair / and to dance the night away to the music of the David • Molecular Epidemiology/ Jacques’ Band. Pharmacogenetics SIG / Hilton Courville/Montmorency / • Admission by badge or ticket. • Getting to the museum. Walking: the museum is an easy 20 minutes walk from the Convention Centre along Grand Allee. Bus: buses will shuttle between the Convention Centre and the Museum beginning at 7:00pm. • Cash bar.
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• • • • AGENDA Wednesday, August 22 • • • • 7:00 - 8:00am / Centre 400A / Current Trends in Pharmacovigilance Poster Session C Set-up / Centre 205AB / Moderators: Nicholas Moore, FISPE, & Alina M Fernandez 7:00 - 8:00am / Hilton Panorama/Plaines / open to interested 2008 Scientific Program Committee Meeting participants. 8:30am • Estimating the Extent of Adverse Event 7:30am - 4:30pm / Centre Foyer 4 / Reporting to the US Food and Drug Registration Administration: A Case-Study of the Statin-Associated Rhabdomyolysis Data 8:00am - 3:30pm / Centre 201C / [146] Mara McAdams, Judy Staffa, Gerald Dal Wednesday Speakers’ Ready Room Pan. (United States) - 8:00am - 1:45pm / Centre 400A / 8:45am • Risk of Hospitalized Rhabdomyolysis Exhibits/Posters Associated with Lipid Lowering Drugs in a Real World Setting [147] 8:30 - 10:00am Mark Cziraky, Siddhesh Kamat, James CONCURRENT SESSIONS – CONTRIBUTED PAPERS McKenney, Vincent Willey, Maxine Fisher, John Guyton, Terry Jacobson, Michael NSAIDs and Cardiovascular Risk: Is There Consistency in the Davidson. (United States) Evidence? / Centre 200AB / 9:00am Agenda Moderators: Elham Rahme & Tjeerd Van Staa • A Population Based Study of IV 8:30am Bisphosphonate Therapy and • Risk of Stroke in Arthritis Patients Treated with Cox-2 Selective Osteomyelitis or Surgery of the Jaw and Non-Selective NSAIDs [139] [148] David J Graham, Gurkirpal Singh, H Wang, A Mannalithara, V Gregg S Wilkinson, Yong-fang Kuo, Lingala, Alka Mithal, George Triadafilopoulos. (United States) Jean L Freeman, James S Goodwin. (United States) 8:45am • COX-Selectivity of Nonsteroidal Antiinflammatory Drugs and the 9:15am Risk of Stroke [140] • Guidelines for Submitting Adverse Mendel Haag, Monique Breteler, Bruno Stricker. (Netherlands) Events Reports for Publication [149] 9:00am William N Kelly. (United States) • NSAID Use and Risk of Myocardial Infarction in U.S. Veterans [141] 9:30am Donald R Miller, David W Kaufman, Michael A Lewis, Elham Rahme, • Missing Data in FDA Adverse Event Lynn Rosenberg, Jaques LeLorier, Francesca Cunningham. Reporting Systems [150] (United States) Sheila Weiss Smith, Victor V Gogolak, 9:15am Gaurav Deshpande, Stephanie Chung, • Use of Cox-2 Inhibitors, Other NSAIDs, and the Risk of Myocardial Shekhar H Mehta. (United States) Infarction in Three Populations from UK, Canada, and the US [142] 9:45am Michael A Lewis, Donald R Miller, Elham Rahme, Dörthe Kühl- • A New Quantitative Method for Drug- Habich, Fran Cunningham, David W Kaufman, Lynn Rosenberg, Drug Interaction Screening in Jaques LeLorier. (Germany) Collections of Individual Case Safety 9:30am Reports [151] • Analgesic Use and Risk of Cardiovascular Disease in Women [143] Niklas G Norén, Rolf Sundberg, Andrew Tobias Kurth, Gregory Kotler, Julie E Buring, J Michael Gaziano. Bate, Ralph I Edwards. (Sweden) (United States) 9:45am • Gastrointestinal and Thromboembolic Events with Etoricoxib: Case Series from a Prescription-Event Monitoring (PEM) Study in England [144] Deborah Layton, Vanessa Marshall, Saad AW Shakir. (United Kingdom)
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• • AGENDA Wednesday, August 22 • • • • • Measurement Methods / Centre 301AB / Drug Utilization Potpourri / Centre 302AB / Moderators: Til Sturmer, FISPE & Moderators: Bjorn Wettermark & Jesper Hallas • Gergana Zletava 8:30am 8:30am • Onset and Offset of Fracture Benefits Associated with • Medicine Use Among 11- and 13-Year- Bisphosphonate Use [133] Olds: Agreement between Parents’ Arlene M Gallagher, Stephan Rietbrock, Melvin Olson, Hubert GM Reports and Children’s Self-Reports [121] Leufkens, Tjeerd P van Staa. (United Kingdom) Anette Andersen, Rikke Krolner, Bjorn E Holstein, Pernille Due, Ebba H Hansen. 8:45am (Denmark) • Non-Steroidal Anti-Inflammatory Drug (NSAID) Utilization Factors in the Netherlands [134] 8:45am Deborah Layton, Patrick C Souverein, Eibert R Heerdink, Toine CG • The Validity of Self-Reported Egberts, Saad AW Shakir. (United Kingdom) Prescription Medication Use among Adolescents Varied by Therapeutic 9:00am Class. A Comparison of Questionnaire • A Comparison of the Impact of the Atrial Fibrillation Follow-Up Survey and Prescription Database [122] Investigation of Rhythm Management (AFFIRM) Trial on Svetlana Skurtveit, Randi Selmer, Aage Prescribing Patterns in Canada and the United States [135] Tverdal, Kari Furu. (Norway) Niteesh K Choudhry, Brandon Zagorski, Raisa Levin, Kathy Sykora, Jerry Avorn, Andreas Laupacis, Muhammad M Mamdani. 9:00am (United States) • Assessing the Validity of an Approach Dealing with Missing Drug Information 9:15am in the Saskatchewan Prescription Drug • Data Collection Agreement in Pharmacoepidemiology: Plan Database [123] Comparison of Patients, Physician and Database Sources [136] Hani M Tamim, Vicky Tagalakis. (Saudi Fanny Depont, Regis Lassalle, Cuong Huynh Minh, Cecile Droz, Arabia) Abdelilah Abouelfath, Patrick Blin, Nicholas Moore, Annie Fourrier- Réglat. (France) 9:15am • Evaluation of Health Insurance Claims 9:30am as a Method for Identifying Patients with • Multi-Day Lapses in Drug Dosing: Incidence and Durations in a Systemic Lupus Erythematosus [124] Database of >20000 Ambulatory Patients’ Electronically Patricia M Eng, Lisa B Weatherby, Judy Compiled Drug Dosing Histories [137] Wong, Pavel Napalkov, Wei Dong, Bernard Vrijens, Anne-Catherine Lange, John Urquhart. (Belgium) Alexander M Walker. (United States) 9:45am 9:30am • The Australian Rise of Esomeprazole – Is Expenditure on • Empirical Evaluation of Statistical Samples a Contributor? [138] Approaches for Analyzing Physician- Greg Kyle, Lisa Nissen, Sue Tett. (Australia) Randomized Quality Improvement Interventions [125] Margaret R Stedman, David R Gagnon, Robert A Lew, Daniel H Solomon, M Alan Brookhart. (United States) 9:45am • A New Sample Size Formula Useful for Case-Cohort Studies [126] Akira Wakana, Kiyoshi Kubota. (Japan)
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• • • • AGENDA Wednesday, August 22 • • • • Vaccine and Antiinfective Safety 10:30 - Noon Issues Centre / 303AB / CONCURRENT SESSIONS Moderators: Xavier Kurz & Bob Ball SYMPOSIUM: Selective Serotonin Reuptake Inhibitors (SSRIs) 8:30am • Hepatitis B Vaccination and the Risk of and Birth Defects [549] / Centre 200AB / Childhood Onset Multiple Sclerosis • Sonia Hernández-Díaz, John Seeger, Jennita Reefhuis, Carol [127] Louik. (United States) Yann Mikaeloff, Guillaume Caridade, Melanie Rossier, Samy Suissa, Marc WORKSHOP: Introducing Doubly Robust Estimation of Tardieu. (France) Treatment Effects [164]
Wednesday 8:45am • Intussusception Reports Following / Centre 205AB / - RotaTeq™ Vaccination: Vaccine Adverse • Michele Jonsson Funk. (United States) Event Reporting System (VAERS), 3/2006-02/2007 [128] SYMPOSIUM: Dynamics of Chronic Medication Use: A New Penina Haber, Hector Izurieta, Manish Patel, James Baggs, Parashar Umesh. Conceptual Framework and Empirical Approach for Adherence (United States) and Persistence Research [163] / Centre 301AB / 9:00am • Boris L Van Wijk, Alan M Brookhart, Suzanne M Cadarette, • Infliximab Use in Patients with Amanda R Patrick, John Urquhart. (Netherlands) Inflammatory Bowel Disease and the Agenda Risk of Serious Bacterial Infections [129] WORKSHOP: Beyond Claims: Using Patient Registries for Sebastian Schneeweiss, Daniel Solomon, Joshua Korzenik, Claire Canning, Brian Effectiveness and Safety Evaluations [162] / Centre 302AB / Bressler. (United States) • Rhonda L Bohn, Nancy A Dreyer, Kathryn Starzyk, Elizabeth B 9:15am Andrews, Joseph Singer. (United States) • Evaluation of Occurrence of Guillain- Barré Syndrome among Recipients of SYMPOSIUM: Risk Management Planning [165] / Centre 303AB / Influenza Vaccine in 2000 and 2001 [130] • Patrick Waller, Saad Shakir, June Raine, Susana Perez-Gutthann, Dale R Burwen, Robert Ball, Wilson W Sally Lettis, Gerald Faich. (United Kingdom) Bryan, Hector S Izurieta, Lawrence La Voie, Neville Gibbs, Rebecca Kliman, M Miles Braun, Team. (United States) Noon - 1:30pm / Centre 400A / 9:30am Lunch/Poster Session C/Exhibits • A Pharmacoepidemiological Study of the Risk of Severe Hepatic Injury in ISPE Board of Directors Luncheon / Hilton Panorama/Vieux-Port / Users of Telithromycin and • By Invitation Clarithromycin [131] Andrew T McAfee, Alexander M Walker. (United States) 1:30 - 2:30pm / Centre 200AB / 9:45am INVITED PLENARY • Racial Differences in Discontinuation of Efavirenz Treatment [132] • Samy Suissa, Newest Methods in Pharmacoepidemiology: Mirjam-Colette Kempf, Maria Pisu, Back to Basics and Beyond Anastasiya Maherya, Andrew O Westfall, Gretchen Cloud, Michael S Saag. (United States)
10:00 - 10:30am / Centre 400A / Break/Posters/Exhibits
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• • AGENDA Wednesday, August 22 • • • • • 2:30 - 4:00pm / Centre 200AB / 4:00 - 4:30pm • HOT TOPICS SESSION / Centre 200AB / Pharmaceutical Risk Management in a Generic Rich Environment The Final Word • Hubert GM Leufkens, FISPE, Chair Poster Awards • June Raine, MHRA/EMEA • Lolkje T. de Jong- • Andrew Fox, Amgen van den Berg • Allen A. Mitchell, FISPE Chair, Poster Awards • Colin D’Cunha, Apotex, Inc. Committee Who is responsible or What about harmonization How to handle inappro- ‘owns’ a safety issue in a of safety sections of priate linkage of generic ICPE 2008– generic rich market, par- SmPCs and other infor- drug related safety issue Copenhagen, ticularly in the context of mation sources? to innovator products, e.g. Denmark individual drug risks ver- in case of biosimilars. • Jesper Hallas, Who takes responsibility sus class effects? Chair, 2008 for risk management pro- Scientific Program Are producers of generic grams when generics Committee pharmaceuticals providing enter the market, e.g. enough funding for isotretitoin and terato- Adjournment of research on questions genicity prevention? ICPE 2007 related to drug safety?
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