P E 2 0 0 C I 9

2 5 Y T R H A R S A N N I V E

International Conference On Pharmacoepidemiology & Therapeutic Risk Management

August 16-19, 2009 FinalFinal ProgramProgram Rhode Island Jointly sponsored by Convention Center • International Society for Pharmacoepidemiology • Program in Pharmacoepidemiology Providence, RI and Pharmacoeconomics, College of Pharmacy, University of Rhode Island • School of Medicine and College of Pharmacy, Virginia Commonwealth University • The Brown University Program in Public Health Photo credit: Providence/Warwick Convention & Visitors Bureau ISPE Board of Directors & Committees

Scientific Program Committee Local Host Committee Kate L. Lapane, FISPE, Chair Susan Andrade Jessica Jalbert Annlouise Assaf Kate L. Lapane, FISPE Kristen Butterfield Paul Larrat Jennifer Christian Tamar Lasky Core Program Committee Erin Degulis Rita Marcoux Annlouise Assaf David Dore Brian J. Quilliam, Chair M. Miles Braun, FISPE Mark H. Epstein Margaret Richards Corinne de Vries Joshua Gagne Chuck Wentworth Mark H. Epstein Crystal Holick Andrew Gilbert Joanna F. Haas, FISPE Kate L. Lapane, FISPE Development Committee James D. Lewis, FISPE Annlouise Assaf, Chair Hilal Maradit-Kremers Susana Perez-Gutthann, FISPE Dimitri Bennett Susan Oliveria June Raine Rhonda L. Bohn, FISPE, Vice Chair Brian Quilliam Elena Rivero, FISPE Melissa Campanelli Matthew Reynolds Patricia Saddier Andrzej Czarnecki, FISPE Cees Schep, FISPE Glenn Schumock David Dore Soko Setoguchi John Seeger Mark H. Epstein Marianne Ulcicklas Yood Scott Smith Jessica Jalbert Natalie Volkova Miriam CJM Sturkenboom Barbara King Alexander M. Walker, FISPE

25th Anniversary ISPE Board of Directors ICPE Committee Officers Directors Allison Burke Miriam CJM Sturkenboom Alejandro Arana, FISPE Wei Dong President Arial E. Arias David Dore Ulf Bergman, FISPE Mark H. Epstein Sebastian G. Schneeweiss, FISPE Stella Blackburn, FISPE Kate L. Lapane, FISPE, Co-Chair President-Elect Lolkje T. de Jong-van den Berg Susan Oliveria Daniel Fife, FISPE Michael Peng Yola Moride, FISPE Sonia Hernandez-Diaz, FISPE Brian J. Quilliam Immediate Past President Kate L. Lapane, FISPE Susan Sacks, FISPE, Co-Chair James D. Lewis, FISPE Nancy Santanello Nancy A. Dryer, FISPE Daniel Mines Teresa Simon Treasurer Nicholas D. Moore, FISPE Walter Straus Robert Reynolds Marianne Ulcickas Yood Mark H. Epstein Elena Rivero, FISPE Executive Secretary Scott R. Smith Alexander M. Walker, FISPE Songlin Xue Stan A. Edlavitch, Lifetime Emeritus

You will notice that the “ICPE 25th Anniversary” logo has been appended to selected sessions. These sessions have been selected because the topics are broad and reach into the future of our field.

2 August 16-19, 2009 r Providence, RI r ICPE Abstract Reviewers

Ana Afonso Jose Pedro Guerreiro James D. Lewis, FISPE Ingemar Persson Monika Stender Kadir Alam Jeff Guo Geoffrey Liu Jennifer Polinski Til Stürmer, FISPE Anna Birna Almarsdóttir Lia Gutierrez Sandra Lopez Leon Brian J. Quilliam Bharat Thakrar Keith Altman Gillian Hall, FISPE Jeanne Loughlin Jeremy Rassen Paula Thompson Daniel Ankrah Joseph Hanlon Kimberly Lowe Joe Reilly Thierry Trenque Ariel E. Arias Spencer Harpe Marie-Josee Martel Margaret (Meg) Richards Gianluca Trifiro Ali Artaman Kevin Haynes Ramona Mateos-Campos Roelof Risselada Ilse Truter Darren Ashcroft Eibert Heerdink Jay McDonald Elena Rivero, FISPE Jerzy Tyczynski Annlouise Assaf Sean Hennessy, FISPE Anita McGrogan Lewis Roht, FISPE Marianne Ulcickas Yood Kathleen Beach Sonia Hernandez-Diaz, Hans-Ulrich Melchert Annalisa Rubino Cristina Varas Begler Begovic FISPE Dominique Milea Stefan Russmann Zdravko Vassilev Paul Beninger Richard Hill Daniel Mines Susan Sacks, FISPE Priscilla Velentgas Dimitri Bennett Michie Hisada Eileen Ming Patricia Saddier Patrice Verpillat Bhajish Bharathan Alan Hochberg Allen Mitchell, FISPE Maribel Salas Steven Vlad Pipasha Biswas Laura Horne Jingping Mo Nancy Santanello Vera Vlahovic-Palcevski William Blumentals Amalia Issa Nicholas Moore, FISPE Delphine Saragoussi Peter Wahl Rhonda Bohn, FISPE Jessica Jalbert Elaine Morrato Bill Saunders Alexander M. Walker, Nancy Brandenburg Yonghua Jing Jonathan Morris Hedi Schelleman FISPE M. Miles Braun, FISPE Catherine Johannes Cristiano Moura Sebastian Schneeweiss, Alex Ward Kimberly Brodovicz Judith K. Jones, FISPE Pavel Napalkov FISPE Li Wei M. Alan Brookhart Judith Kelly C. Ineke Neutel, FISPE Marieke Schoonen Michael Wess Jeffrey Brown Mirjam-Colette Kempf Herbert Noack Glenn Schumock Sue L. West, FISPE Bin Cai Farhad Ali Khan Niklas Noren John Seeger Jim Wilson Herve Caspard Alena Khromava Mette Norgaard Harry Seifert Fei Xue Jordi Castellsague Victor Kiri Anthony Nunes Sarah Sellers Yu Yan Yan Chen Olaf Klungel Jude Nwokike Soko Setoguchi Rong-Yuan Zheng Jennifer Christian Scott Korn Fredrik Nyberg Gloria Shalviri Wei Zhou Barton Cobert Kate L. Lapane, FISPE Susan Oliveria Mary Lou Skovron Alexander Cole Tamar Lasky Sallie Pearson Emily Somers Lyn Colvin Deborah Layton Susana Perez Gutthann, Paul Stang, FISPE Michael Cook Charles Leonard FISPE Michael Steinbuch Deborah Covington Suellen Curkendall Wanju Dai, FISPE Johan De Haes August 19-22, 2010 | Hilton Brighton Metropole | Brighton, England, UK Carl de Moor Frank de Vries Corinne de Vries Rachael DiSantostefano International Conference David Dore Sascha Dublin on Pharmacoepidemiology & Tomasz Dyszynski 26th ICPE Therapeutic Risk Management Stanley Edlavitch Conference Chair Emeritus Monique Elseviers Sybil Eng Germano Ferreira Donnie Funch Kari Furu Joshua Gagne David Gagnon The online abstract site will be Christiane Gasse Tobias Gerhard operational by mid-December 2009. Dina Gifkins Andrew Gilbert Earl Goehring Abstract Submission Deadline: Jean-Pierre Gregoire, February 10, 2010 FISPE Patricia Grossman photo credit: www.britainonview.com

Meeting information will be posted at www.pharmacoepi.org

r August 16-19, 2009 r Providence, RI 3 Meeting At-A-Glance

Saturday, August 15, 2009 7:00am 8:00am 9:00am 10:00am 11:00am 12:00pm 1:00pm 2:00pm 3:00pm 4:00pm 5:00pm 6:00pm 7:00pm

11:30am - 6:00pm Registration Open 3rd Floor Foyer

1:00 - 5:00pm 5:15 - 6:30pm Introduction to Pharmacoepidemiology Journal Club 555AB 555AB

1:00 - 5:00pm 5:00 - 7:00pm Introduction to Pharmacogenetics — Part 1 Student Meet & Greet 554AB Cuban Revolution Grill

8:30am - 12:00pm 12:00 - 1:00pm 1:00 - 5:00pm B.O.D. Lunch ISPE Board of Directors Meeting ISPE Board of Directors Meeting South County Bristol/Kent - Westin Bristol/Kent - Westin - Westin

Sunday, August 16, 2009 7:00am 8:00am 9:00am 10:00am 11:00am 12:00pm 1:00pm 2:00pm 3:00pm 4:00pm 5:00pm 6:00pm 7:00pm

7:30am - 6:00pm Registration Open 3rd Floor Foyer

8:00am - 5:00pm Speaker Ready Room 553B

8:30am - 12:00pm 12:00 - 1:30pm 1:30 - 6:00pm Educational Sessions: Lunch Educational Sessions: Regulatory Epidemiology/ Public Health Decision Making on Your Own Introduction to Risk Management 555B 557 Introduction to Drug Utilization/Health Services Advanced Topics in Pharmacoepidemiology Research Ballroom D 555A Comparative Effectiveness Review 12:00 - 1:30pm 6:00 - 7:30pm Ballroom D New Members Welcome Reception/ Luncheon Academic Showcase Introduction to Pharmacogenetics-Part 2 Westin Waterplace Rhode Island 556A Ballroom State House Special Skills Workshop (Students Only) 554A Monday, August 17, 2009 7:00am 8:00am 9:00am 10:00am 11:00am 12:00pm 1:00pm 2:00pm 3:00pm 4:00pm 5:00pm 6:00pm 7:00pm

7:00am - 6:00pm Registration Open 3rd Floor Foyer 6:00 - 7:30pm 7:00am - 5:00pm PDS Editoral Board Speaker Ready Room (By invitation) 553B Bristol Room - Westin

7:00 - 8:00am 8:00am - 6:00pm 3:30 - 5:300pm 5:00 - 6:00pm Poster Session A Exhibitors/Poster Session A Symposia & ISPE Council Set-Up Hall B 10:00- 3:00- Workshops Meetings Continental 10:30am 3:30pm Automated Data (Westin) Breakfast Break/ Break/ Sources for Pharma- Academic 7:00- ? Hall B Posters/ Posters/ coepidemiology Narragansett C Student Social Exhibits Exhibits 556AB Event 8:00 - 10:00am Hall B Hall B Government/ 10:30am - 12:00pm 12:00 - 1:30pm 1:30 - 3:30pm Bravo Brasserie Opening General Session Drug Utilization-I Lunch/Poster Walks/ Analysis Methods I Can Registries Regulatory Ballroom A 552AB Poster Session A/ Ballroom B Deliver? Narragansett B Exhibits 555AB Manufacturing/ Welcome: Early Detection in -Sponsored by UBC Gastrointestinal Kate L. Lapane Pharmacovigilance Drugs: Going Beyond Confounding by Service Providers 7:00 - 8:00am Hall B Brian J. Quilliam 555AB the Intestines Indication–Epoetin Narragansett A Committees ISPE Committee/ 554AB Ballroom B Presidential Address: Effects of Cardiovas- Council Meetings Finance Miriam CJM Sturkenboom Evaluating Study cular Drugs Student Council Improving Linking 5:15 - 6:15pm 551A Designs for Drug 556AB Ballroom E Databases Fourth Asian Keynote Address: Exposure Education 555AB Meeting Planning Sander Greenland Hormones/ 552AB 551B Fellowship & Awards Committee Reproductive Agents Personalized Medicine: 25th Anniversary Presentation: 558A RICC - 554AB 554AB Molecular and Genetic Pharmacoepide- Thomas MacDonald Development Biomarkers of Efficacy miology, Policy & Medications in 558B and Toxicity Outcomes Pregnancy/ Birth 552AB 551AB Outcomes- I Public Policy Ballroom B 557 Vaccines Past, Present & 556AB Future of Pharma- coepi at FDA Ballroom A Is Accuracy at Odds with Privacy? 554AB 4 August 16-19, 2009 r Providence, RI r Meeting At-A-Glance

Tuesday, August 18, 2009 7:00am 8:00am 9:00am 10:00am 11:00am 12:00pm 1:00pm 2:00pm 3:00pm 4:00pm 5:00pm 6:00pm 7:00pm

7:00am - 6:00pm Registration Open 3rd Floor Foyer

7:30am - 5:00pm Speaker Ready Room 553B 10:30- 3:30- 4:00 - 5:30pm 11:00am 4:00pm Symposia & 7:00-8:00am ^Sponsored by CSD-EPIC 8:00am - 6:00pm Break/ Break/ Workshops Poster Session B Exhibitors/Poster Session B Set-Up Posters/ Posters/ CIOMS VIII Report Hall B Exhibits Exhibits 557 Continental Hall B Hall B Breakfast 8:00 - 9:15am 9:15 - 10:30am 12:30 - 2:00pm Conflict of Interest 5:30 - 6:30pm Hall B 11:00am - 12:30pm 2:00 - 3:30pm Plenary Session: Annual Meeting Anti-Infectives Lunch/Poster Walks/ Cancer All Over 552A SIGs National Phar- 7:00 - 8:00am of ISPE Members 552B Poster Session B/ the Place! maceutical Policy Guidance for Non- Biologics CERT’s & Awards Exhibits 551A Imperatives Information as a Randomized Studies 551A Breakfast Ceremony Hall B Ballroom A Basis for Risk Mgmt. Cardiovascular of Comparative Roundtable Ballroom A Database Ballroom D ISPE Committee/ Disease Effectiveness 557 551B Council Meetings Ballroom D Ballroom B Measurement Bylaws and Policies Drug Utilization/Health Methods ISPE Public 558A Potpourri Session Services Research Ballroom B Policy Forum- Ballroom B Ballroom B Global Development Communication The Spectrum of 554A Risk Factors, Surveil- Ballroom D Medications in Anti-Inflammatory lance, and Comordidity Pregnancy Therapies Providing Data for Membership Burden 552A 552A 554B 551B Drug Regulatory Decision Making Molecular Use and Risks of Publications To Do No Harm...? Ballroom A Epidemiology/ Psychotropics in 558B 557 Pharmacoegenetics Elderly Persons Who is a Patient’s 552B 557 1:00 - 2:00pm Main Prescriber Public Forum and How Should 7:30pm - Midnight on Core Clustering Influence Evening at the Competen- Analyses? Waterplace Restaurant cies for 552B Pharmacoep- idemiology Ballroom A

Wednesday, August 19, 2009 7:00am 8:00am 9:00am 10:00am 11:00am 12:00pm 1:00pm 2:00pm 3:00pm 4:00pm 5:00pm 6:00pm 7:00pm

7:30am - 5:00pm Registration Open 10:00- 10:30am - Noon 3rd Floor Foyer 10:30am Symposia & Break/ Workshops Posters/ 7:30am - 3:30pm Assessment of Exhibits Speaker Ready Room Prenatal Exposure to Hall B 553B Medications 552B 7:30-8:30am 8:00am - 1:45pm RMP, RiskMAP, and Poster Session C Exhibitors/Poster Session C Set-Up REMS: The Challeng- Hall B es of Epidemiology Continental Ballroom D Breakfast 8:30 - 10:00am 12:00 - 1:30pm 1:30 - 3:00pm 3:30 - 4:30pm 4:30- Hall B Analysis Methods II Benchmarking Lunch/Poster Walks/ Invited Plenary Hot Topics 5:00pm Ballroom B Databases to Improve Poster Session C/ FDA’s Sentinel Session: The Final Harmonization Exhibits Initiative Project Clopidogrel: Has the Word: Diabetes From Legs 551A Hall B Ballroom A 7:00 - 8:00am Pharmacogenetics • Poster to Death Era Arrived? Awards 2010 ICPE 551A Assessing the As- ISPE Board of Ballroom A • ICPE Scientific sociation of Pharma- Directors Luncheon 2010 Program Drug Utilization-II cotherapeutics and 554A B Committee 551B Suicidal Behavior • Adjourn- Meeting 551B ment 557 Medications in Pregnancy and Birth Safety Assessment Outcomes II and Risk Mgmt. of 552A Biologics (Biologics SIG) Psychotropics II: Ballroom B Safety of Psychotropics The Future of 552B Epidemiology 557 Using Databases for both Hypotesis Gener- ating and Hypothesis Confirmation 552A

r August 16-19, 2009 r Providence, RI 5 ISPE Exhibitors & Sponsors (as of July 30, 2009)

ISPE Sponsors Corporate Benefactor P E 2 0 0 Z Astra Zeneca R & D Z Pfizer C I 9 Annual Meeting Sponsor Platinum: $12,500 Z Pfizer Z Wiley-Blackwell

2 5 Y T R H A Gold: $6,500 S A N E R N I V Z Amgen Z Phase Forward Z Celegene Corporation Z PPD International Conference On Pharmacoepidemiology & Z Cephalon, Inc. Z ProSanos Therapeutic Risk Management Z Covance Z REGISTRAT-MAPI Z Eli Lilly & Company Z Roche ISPE gratefully acknowledges the generous support of Z GlaxoSmithKline Z RTI Health Solutions Z Genentech Z The Degge Group the following organizations and institutions. Their contri- Z HealthCore Z The Mattson butions helped to enhance the scientific program content Z i3 Drug Safety Jack Group and increase attendance at the ICPE 2009. Thank you Z IMS Health Z United BioSource Z Outcome Corporation Exhibitors Bronze: $1,500 Z Analysis Group, Inc. Z PharmIdeas Z Analysis Group Z Outcome Z CSD-EPIC Z WHISCON Z APCER Z Phase Forward Z EpiSource Pharma Solutions Z Premier Inc. Z Aris Global Z PPD Z Covance Z ProSanos Academic Showcase/ Z DrugLogic Z REGISTRAT-MAPI Z Exponent Z RTI Health Solutions Welcome Reception Z GPRD/MHRA Z The Degge Group Z Center for Clinical Epidemiology & Biostatistics, University Z HealthCore Z The Mattson of Pennsylvania School of Medicine Z i3 Drug Safety Jack Group Z Center for Drug Safety, School of Pharmacy, University Z IMS Health Z The Uppsala of Maryland Z Kendle Monitoring Centre Z Department of Pharmaceutical Outcomes and Policy, Z LA-SER Z Thomson Reuters College of Pharmacy, University of Florida Z Lovelace Respiratory Z TCC llc Z Drug Safety Research Unit, Associated Department, Research Institute Z United BioSource School of Pharmacy, Portsmouth University Corporation Z MedMining, a Geisinger Z Program in Pharmacoepidemiology and Pharmacoeco- System Business Z Wiley-Blackwell nomics, College of Pharmacy, University of Rhode Island Z National Death Z Wolters Kluwer Health Z Program in Pharmacoepidemiology, Department of Epi- Index, NCHS demiology, UNC Gillings School of Global Public Health University of North Carolina at Chapel Hill

6 August 16-19, 2009 r Providence, RI r ISPE Supporters

Organizational & $25 for 25th (ICPE) Campaign (as of July 30, 2009) Institutional Members The Society expresses its sincere appreciation to those supporters listed Corporate Benefactors below for their contribution in honor of ISPE’s 25th Annual Meeting (ICPE). (10-year membership) Edgar Adams Kjell Hermann Halvorsen Hans Petri Abraham Hartzema Cynthia Phillips Z Astra Zeneca R & D Z Pfizer Michael Adena Anna Birna Almarsdóttir Klaas Heinemann Richard Platt Susan Andrade Deborah Hennessey Mary Prince Panaccio Members Daniel Ankrah David Henry Brian J. Quilliam Ishan Hirji June Raine Pharmaceuticals Service Provider Maurits Arbouw Felix Arellano, FISPE Zhiping Huang Joe Reilly Z Roche Z RTI Health Janet Arrowsmith Jacqueline Hugtenburg Maria Elena Rivero Z Sanofi-Aventis Solutions Annlousie Assaf Anders Hviid Ferrer, FISPE Anita Assmann Michael Iskedjian Noah Robinson Academic Programs Elenie Bartzokis Betsey Jackson Daniel Rosenberg Keith Beard, FISPE Derek Johnson Annalisa Rubino Z Center for Clinical Epidemiology & Biosta- Ulf Bergman, FISPE Eric Johnson Ken Rothman, FISPE tistics, University of Pennsylvania School Harshvinder Bhullar Yea-Huei Kao Yang Leo Russo of Medicine Sebastien Bineau William Kelly, FISPE Susan Sacks, FISPE Stella Blackburn, FISPE Farhad Ali Khan Deborah Saltman Z Center for Drug Safety, School of Pharmacy, William Blumentals Ju-young Kim Lloyd Sansom University of Maryland Rhonda Bohn, FISPE Stephen Kimmel, FISPE Cees Schep, FISPE Z College of Pharmacy, University of Texas Alison Bourke Brice Kitio Dschassi Robert Schirmer Olaf Klungel Markus Schuerch at Austin Elliot Brown Rudolf Bruppacher, FISPE James Kotsanos, FISPE Harry Seifert Z Drug Safety Research Unit, Associated Claudia Cabrera-Moksnes Gottfried Kreutz Saad Shakir, FISPE Department, School of Pharmacy, Suzanne Cadarette Kiyoshi Kubota Gloria Shalviri Anais Lacasse Rosemarie Sift Carter Portsmouth University Stella Chang Robert Chen, FISPE Nancy Lass Daniel Solomon Z Harvard School of Public Health Lyn Colvin Deborah Layton Patrick Souverain Joongyub Lee Tommasco Staniscia Z McGill Pharmacoepidemiology & Research Anne Costello Suellen Curkendall Samuel Lesko Miriam CJM Sturkenboom Unit, McGill University Marie-Christine Cyr Linda Levesque Shinji Suzuki Z Program in Pharmacoepidemiology and Andrzej Czarnecki, FISPE James D. Lewis, FISPE Martina Teichert Pharmacoeconomics, College of Pharmacy, Hilda de Jong Michael Lewis, FISPE Bharat Thakrar Jeanne Loughlin Sengwee Toh University of Rhode Island Lolkje de Jong-van den Berg Frank De Vries Malcolm Maclure Marianne Ulcickas Yood Z Program in Pharmacoepidemiology, De- Dabashish Dey Milada Mahic John Urquhart, FISPE partment of Epidemiology, UNC Gillings Nancy Dreyer, FISPE William Maier Carla Van Bennekom Marie-Josee Martel Zdravko Vassilev School of Global Public Health University David Dore William Eastmann Colleen Maxwell Patrice Verpillat of North Carolina at Chapel Hill Carol Fairchild Frank May, FISPE Peter Wahl Z Slone Epidemiology Center, Sarah Frise Giampiero Mazzaglia Alexander M. Walker, Boston University Genevive Gabb Andrew McAfee FISPE Helga Gardarsdottir Anita McGrogan Mari-Ann Wallander, Churn-Shiouh Gau Joseph McLaughlin FISPE Brian Godman Dominique Milea Douglas Watson Jean-Pierre Gregoire, David Miller Sue L. West, FISPE In This Program FISPE Allen Mitchell, FISPE James Wilson 25th ICPE Agenda Lamiae Grimaldi- Jocelyne Moisan, FISPE Almut Winterstein Yola Moride, FISPE Fenglong Xie Saturday, August 15...... 9 Bensouda Zhenchao Guo C. Ineke Neutel, FISPE Songlin Xue, FISPE Sunday, August 16...... 10 Flora Haaijer-Ruskamp Anthony Nunes Shu-yu Yang Monday, August 17...... 12 James Haddox Axel Olsen Tuesday, August 18...... 22 Gillian Hall, FISPE Byung-Joo Park, FISPE Wednesday, August 19...... 32 Jesper Hallas Inger Nordin Olsson

25th ICPE Posters Poster-Presentation Guidelines...... 38 Abstract Index...... 64 Poster Session A...... 40 Advertisers Index...... 70 Poster Session B...... 48 Poster Session C...... 57

25th ICPE Abstract Index r August 16-19, 2009 r Providence, RI 7 Meeting Information Future Meetings ISPE’S Fourth Asian Meeting Badges (Asian Conference on Pharmacoepidemiology) 2009 All attendees at ICPE 2009 must wear their name badges to Convened in conjunction with the Pharmaceutical Society of Taiwan all events. Z October 23-25, 2009 Z National Cheng Kung University, Tainan, Taiwan A badge will be needed for admission to meeting related functions, such as the scientific sessions, the exhibit/poster hall, and social events. Badges will be included in the regis- ISPE Mid-Year Meeting Z April 10-12, 2010 tration packet material. In some cases, tickets for admission 2010 Z Marriott Raleigh City Center, Raleigh, North Carolina will be required. Badge Legend 26th International Conference on n Student – YELLOW n One Day Attendee – RED Pharmacoepidemiology & Therapeutic n New Member – BLUE n Local Host Comm.–GREEN Risk Management Z August 19-22, 2010 Z Hilton Brighton Metropole, Brighton, England, UK Rhode Island Convention Center (RICC) 5th Asian Conference on Pharmacoepidemiology Z October 29-31, 2010 All Pre-ICPE courses, the ICPE 2009, and ISPE Committee, Z Tokyo, Japan Council and SIG meetings will be held at the Rhode Island Convention Center, One Sabin Street, Providence, RI, ex- cept otherwise listed. Food/beverage will be available at all ISPE Mid-Year Meeting Z April TBD, 2010 committee meetings. Z Florence, Italy

8 August 16-19, 2009 r Providence, RI r Agenda - Saturday, August 15

8:30am-5:00pm ISPE Board of Pre-Conference Educational Sessions (RICC) Directors Meeting 1:00-5:00pm (Westin Providence- Introduction to Pharmacoepidemiology Anke-Hilse Maitland-van der Zee, Bristol/Kent) (Room 555AB) Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht University, [*Included as part of the full meeting registration; (Open to ISPE members; Pharmacogenetics Methods I notify staff if you plan to Registration required.] Efrosini Setakis, Division of General Practice attend) Chair: Andrew McAfee Research Database, Medicines & Health- 11:30-5:00pm Syed Rizwanuddin Ahmad, FDA, care Products Regulatory Agency, UK. Spontaneous Reporting Registration Pharmacogenetic Methods II and Databas- Andrew McAfee, i3 Drug Safety, es as Study Sources (Third Floor Foyer) Cohort Studies Andrew Freedman, National Institutes of Yu-Xiao Yang, University of Pennsylvania, Health, Pharmacogenomics Translation: Case-Control Studies From Discovery to Confirmation to Clinical Anita McGrogan, University of Bath, Utility Confounding and Bias Stephen Kimmel, Center for Clinical Epi- demiology and Biostatistics, University of New 1:00-5:00pm Pennsylvania School of Medicine, Warfarin Course! Introduction to Pharmacogenetics – as a PrototypePharmacogenetic Example Part 1* (Room 554AB) 5:00-7:00pm [*Admission by ticket only. Tickets will be included in * On Saturday registration materials for those that registered for this Student Meet and Greet afternoon (Day 1), session.] there will be didactic (Cuban Revolution Restaurant & Grill; teaching. On Sunday Educational Objectives 50 Aborn Street) morning (Day 2) par- ticipation is optional, • Understand the genetic and pharmacogenetic • Organized by the ISPE Student Council but there will be a terminology and how cellular and molecular biology small group workshop informs pharmacogenetic studies at analysis 5:15-6:30pm that will use real • Appreciate the challenges of utilizing biospecimens Literature Review Journal Club pharmacogenetic case • Know the study design and methodologic (Room 555AB) studies catering to both approaches, their strengths and weakness used in novice and advanced pharmacogenetic epidemiology • Open to Introduction to Pharmacoepide- participants. • Understand statistical approaches used in Pharma- miology Course participants as well as [Note: There is no cogenetics anyone who has registered to attend a separate registration • Understand how pharmacogenetics relates to Pre-ICPE course. for Part 2 only; you current focus of Personalized Medicine must register for Part • Have an overview of clinical utility of pharmacoge- • Participants are encouraged to read the 1 to take Part 2]. netics and associated regulatory issues. following article before attending this session: Wayne Ray, “Atypical Antipsy- Co-Chairs: Geoffrey Liu & Anke-Hilse chotic Drugs and the Risk of Sudden Maitland Cardiac Death” (NEJM 2009;360:225-35) Leah Sansbury, National Institutes of Health, Panelists: Pharmacogenetic Terminology: The Basics Alexander M. Walker, FISPE, World Health Geoffrey Liu, Alan Brown Chair in Molecu- Information Science Consultants lar Genomics, CCO Chair in Population Sean Hennessey, FISPE, Center for Clinical Studies and Experimental Therapeutics, Epidemiology & Biostatistics, University of University of Toronto, Biospecimen Issues Pennsylvania School of Medicine for Pharmacoepidemiologists Stephen Evans, London School of Hygiene Wei Zhou, Senior Epidemiologist, Merck and Tropical Medicine Pharmaceuticals, Biospecimen Databases

r August 16-19, 2009 r Providence, RI 9 Agenda - Sunday, August 16

7:30am-6:00pm Pre-Conference Educational Sessions (RICC) Registration (Third Floor Foyer) 8:30-Noon Regulatory Epidemiology/Public Health Robert Vander Stichele, Course Objectives, 8:00-5:00pm Decision Making* (Room 555B) Definitions of Research Fields and Method- Speakers’ ological Framework Educational Objectives Marit Rønning, The Anatomical Therapeutic Ready Room • Understand the intent and structure of regulation to Chemical Classification and the Defined (Room 553 B) protect the Public Health Daily Dose: Classifying and Quantifying • Appreciate the challenges of decision making with Drug Use for Cross National Comparison weak data Julie Zito, Overview of Drug Utilization • Know about practical approaches typically chosen Research in the US by regulators Monique Elseviers, Using DUR – Data for • Recognize the challenges epidemiology faces to Cross National Comparisons provide sufficient information for public health deci- sion making Flora Haaijer-Ruskamp, Using DUR – Data • Have an overview of world wide challenges for drug to Create Valid Prescribing Quality Indicators regulatory agencies and variation in approaches Colin Dormuth, Testing Interventions on • Know about current strategies to strengthen regula- Drug Utilization (Time Series Analysis and tion in the face of these challenges Other Methods) Chair: Gerald Dal Pan 8:30-Noon Gerald Dal Pan, US FDA, Regulation & Chal- Comparative Effectiveness New lenges of Decision-Making with Weak Data Research* (Ballroom D) Course! June Raine, EMEA, Regulatory Decision Making Approaches in Europe Educational Objectives Stephen Evans, London School of Tropical • Identify the differences between effectiveness and * NOTE FOR Medicine, An Epidemiologist’s View of efficacy research and implications for improving EDUCATIONAL Public Health Decision Making routine care SESSIONS: Ralph Edwards, WHO Collaborating Centre • Understand the basic study design issues for non- randomized data recorded in routine care settings Admission by for International Drug Monitoring, Global • Recognize the advantages and limitations of a va- ticket only. Tickets Perspective on Regulatory Utilization of will be included riety of data sources for comparative effectiveness in registration Pharmacovigilance Data research and how combining multiple sources can materials for those enhance the utility of a given dataset who registered for 8:30-Noon • Have an overview of methodological challenges this session. Introduction to Drug Utilization/Health and proposed solutions in non-randomized effec- tiveness research Services Research* (Room 555A) • Learn how to create and synthesize evidence with Educational Objectives the decision maker in mind • To explain the definition and scope of the eclectic Co-Chairs: Sebastian Schneeweiss, FISPE, discipline of Drug Utilization Research within the & Erick Johnson context of Pharmacoepidemiology. • To motivate researchers providing international Scott Smith, AHRQ, Objectives of CER cross-national comparisons of national drug utiliza- Eric Johnson, Kaiser, Cohort Studies tion data to cooperate on the collection of a minimal David Magid, Kaiser, Data Sources and dataset of reliable and comparable drug utilization Implications data in their country, in terms of volume, expendi- Sebastian Schneeweiss, Harvard, Method- tures and quality of drug use. ological Challenges in Non-Randomized • To explain the process of developing and validating CER prescribing quality indicators. David Atkins, Veteran’s Administration, Cre- • To give an applied overview of methods useful for ating and Synthesizing Evidence with the drug policy research (time series analysis) Decision Maker in Mind Co-Chairs: Robert Vander Stichele & Julie Zito, FISPE

10 August 16-19, 2009 r Providence, RI r Agenda - Sunday, August 16

8:30-Noon New 1:30-6:00pm Introduction to Course! Advanced Topics in Pharmacoepidemiology* (Ballroom D) Pharmacogenetics*– Part 2 (Room 556A) Chair: James D. Lewis, FISPE Must register for Part 1; attendance at Part 2 is optional. Sander Greenland, Bayesian Methods for Observational Research • Speakers will lead small discussion Tom MacDonald, FISPE, Clinical Trials or Observational Studies for groups addressing real life pharmacogenetic Drug Safety Assessment? examples. Joanna Haas, Unique Aspects of Studying Biologics Co-Chairs: Geoffrey Liu & Daniel Heitjan, Methods for Handling Missing Data Anke-Hilse Maitland 1:30-6:00pm Leah Sansbury, National Institutes of Health Introduction to Risk Management* (Room 557) Geoffrey Liu, University of Toronto Wei Zhou, Merck Pharmaceuticals Co-Chairs: Elizabeth Andrews, FISPE & Carla van Bennekom Anke-Hilse Maitland-van der Zee, Elizabeth Andrews, FISPE, Overview of Risk Management and the Utrecht University Role of Evaluation Efrosini Setakis, Medicines & Healthcare Mary Willy, US Regulatory Products Regulatory Agency, UK Stella Blackburn, FIPSE, EU Regulatory Andrew Freedman, National Institutes of Carla van Bennekom, Isotretinoin Health, USA Judith Jones, FISPE, Workshop for Participants to Develop an Stephen Kimmel, Center for Clinical Epi- Evaluation Plan demiology and Biostatistics, University of Pennsylvania School of Medicine 6:00-7:30pm Welcome Reception/Academic Showcase 8:30-12:00pm (Rhode Island Statehouse) Students Only – Special Skills Workshop: From Writing an Abstract to • Admission by badge or ticket. Cash Bar Planning a Career: Skills You Can Use Welcome (Room 554A) Kate Lapane, FISPE, Chair, 2009 Scientific Program Committee Miriam Sturkenboom, ISPE President [* Included as part of full meeting registration; registration required] Academic Showcase • Organized by ISPE Student Council • Center for Clinical Epidemiology & Biostatistics, University of Pennsylvania School of Medicine • Center for Drug Safety, School of Pharmacy, University of Maryland Noon -1:30pm • Department of Pharmaceutical Outcomes and Policy, College of Lunch on your own. Pharmacy, University of Florida • Drug Safety Research Unit, Associated Department, School of Noon-1: 30pm Pharmacy, Portsmouth University Luncheon for New Members/Student • Program in Pharmacoepidemiology and Pharmacoeconomics, Prize Winners/Scholarship Recipients College of Pharmacy, University of Rhode Island (Westin Providence Waterplace Ballroom) • Program in Pharmacoepidemiology, Department of Epidemiology, • By Invitation UNC Gillings School of Global Public Health University of North Carolina at Chapel Hill

r August 16-19, 2009 r Providence, RI 11 Agenda - Monday, August 17

7:00-8:00am 10:30am-12:00pm ISPE Committee Meeting • Open to all participants. Concurrent Sessions: Contributed Papers • Breakfast will be available in meeting rooms Drug Utilization–I (Room 552AB) Moderators: Jurgen Dinger & Julie Zito, FISPE Z Education Committee (Room 551B) Z Finance Committee (Room 551A) 10:30am Z Understanding the Prescribing Patterns of Lipid-Lowering 7:00-5:00pm Agents in the United States and Canada [1] Matthew W Reynolds, Yola Moride. (United States) Speakers’ Ready Room (Room 553B) 10:45am 7:00-8:00am Z Comparison of Prescription Patterns of Statins in Primary Care Poster Session A Set-up (Hall B) in Five European Countries: Results from the LIPIDE Observa- tional Survey [2] Continental Breakfast (Hall B)) Gaelle Desamericq, Laurent Laforest, Marie-Sophie Schwalm, Philippe Moulin, Emilie Michel, Caroline Eteve, Gabriel Coffin, 7:00-6:00pm Cecile Ritleng, Eric Van Ganse. (France) Registration (Third Floor Foyer) 11:00am Z Variation in Initiation of Angiotensin Blocking Agents, Beta 8:00-6:00pm Blockers and Statins after Hospitalization for Acute MI in British Exhibits/Posters (Hall B) Columbia [3] Andrea V Margulis, Sebastian Schneeweiss. (United States) 8:00-10:00am 11:15am Opening Session (Ballroom A) Z An Intervention To Increase Statin Tablet Splitting among General Practitioners [4] Z Welcome Jennifer Polinski, Sebastian Schneeweiss, Malcolm Maclure, Kate L. Lapane, FISPE, Chair, 2009 Sam Ramsden, Blair Marshall, Colin Dormuth. (United States) Scientific Program Committee, & Co-Chair, 25th Anniversary Committee 11:30am Brian J. Quilliam, Chair, 2009 Local Z Pattern of Utilization of Pegfilgrastim (PEGFIL) in Patients with Host Committee Chemotherapy-Induced Neutropenia: A Retrospective Analysis of Administrative Claims Data [5] Z Presidential Address AT Skarin, F Vekeman, F Laliberté, O Afonja, MH Lafeuille, Miriam CJM Sturkenboom, ISPE President V Barghout, MS Duh. (United States) Z Keynote Address 11:45am Accounting for Uncertainty About Z Is Low Use of Inhaled Corticosteroids among Asthmatic Patients Investigator Bias Due to Inappropriate Prescribing or Low Patients’ Adherence? [6] Lucie Blais, Marie-France Beauchesne, Catherine Lemière, Sander Greenland, Professor of Sylvie Perreault. (Canada) Epidemiology, UCLA School of Public Health, and Professor of Statistics, UCLA College of Letters and Science

Z Special Anniversary Presentation Susan Sacks, FISPE, Co-Chair, 25th Anniversary Committee Thomas MacDonald, FISPE, ISPE Poet Laureate

10:00am -10:30am Break/Posters/Exhibits (Hall B) You will notice that the “ICPE 25th Anniversary” logo has been appended to selected sessions. These sessions have been selected because the topics are broad and reach into the future of our field.

12 August 16-19, 2009 r Providence, RI r Pfizer Epidemiology: Committed to Patient Safety

Pfizer, Inc. discovers, develops, manufactures, and markets leading prescription medicines for humans and animals.

With 2008 actual spending of $7.9 billion in research & development (R&D), Pfizer has the industry’s largest pharmaceutical R&D organization.

Our search for new treatments spans hundreds of research projects across fifty- six major disease groups in 10 therapeutic areas.

We build our success on the innovation, skills, and entrepreneurial spirit of each of our colleagues.

Every year we help 150 million patients, utilize the skills of medical research- ers, and work in partnership with governments, individuals, and other payers for healthcare to treat and prevent illnesses – adding both years to life, and life to years.

The Epidemiology Group at Pfizer partners with development teams to bring new medicines to patients and to evaluate the safety of our medicines.

We are committed to the conduct of research meeting the highest scientific and ethical standards to assess the benefits and risks of our medicines.

Pfizer Epidemiology is proud to support the 25th International Conference on Pharmacoepidemiology and Therapeutic Risk Management and welcomes the opportunity for the open exchange of scientific ideas and research findings in order to advance the fields of pharmacoepidemiology and risk management. Agenda - Monday, August 17

Early Detection In Pharmacovigilance (Room 555AB) Moderators: Andrej Czarnecki, FISPE, & M. Miles Braun, FISPE 10:30am 11:30am Z A Comparison of MedDRA and WHOART for Signal Detection on Z Evaluation of Cardiovascular Diseases a Database of Spontaneous Adverse Drug Reaction Reports [7] (CVDs) Risk in French Patients Receiving Richard Hill, Kristina Star, G Niklas Norén. (Sweden) Milnacipran (MLN) Relative to Patients 10:45am Receiving Other Antidepressants Z Using Regression To Find Otherwise Undetected Drug Safety Therapies [11] Issues [8] PJ Mease, MS Duh, F Vekeman, A Guérin, Ola Caster, Kristina Star, Richard Hill, G Niklas Norén. (Sweden) M Boerstoel-Streefland, W Jiang, P Lefeb- vre, PJ Zimetbaum. (United States) 11:00am Z Comparison of Adverse Drug Reaction (ADR) Reports Submitted 11:45am to the FDA by Consumers and Healthcare Professionals (HCPs) [9] Z Near Real-Time Post-Marketing Surveil- Thamir M Alshammari, Syed Rizwanuddin Ahmad, Lynette Swartz, lance: The Experience of the Vaccine Tarek A Hammad. (United States) Safety Datalink [12] WK Yih, B Fireman, N Klein, M Kulldorff, E 11:15am Lewis, T Lieu, E Weintraub, R Platt. (United Z Using the Capture-Recapture Method To Assess the Incidence of States) Drug-Induced Liver Injury in a French University Hospital [10] Neda Tavassoli, Virginie Ramillon, Pauline Calvet, Laure Pourcel, Jean Louis Montastruc, Maryse Lapeyre-Mestre. (France)

14 August 16-19, 2009 r Providence, RI r Agenda - Monday, August 17

Effects of Cardiovascular Drugs (Room 556AB) Moderator: Jennifer Christian & Michael Lewis, FISPE

10:30am 11:30am Z Statins, Other Antihyperlipidemic Agents, and Psoriasis [13] Z Propranolol May Be Associated with In- Yolanda B Brauchli, Susan S Jick, Christoph R Meier. (Switzerland) creased Risk of Hospitalized Myopathy: 10:45am A Hypothesis Generated by Chemical Z Statin-CYP3A4 Inhibitor Drug Interaction Shows Differential Genomics [17] Increased Risk for Adverse Events Depending on Statin Soko Setoguchi, John Higgins, Levin Raisa, Metabolism [14] Vamsi Mootha, Jerry Avorn. (United States) Christopher G Rowan, Steven M Brunelli, James Flory, Jeffrey 11:45am Munson, Warren Bilker, Brian Strom. (United States) Z Use of Organic Nitrates and the Risk of 11:00am Hip Fracture: A Population-Based Case- Z Safety and Effectiveness of Bivalirudin in Routine Care of Pa- Control Study [18] tients Undergoing Percutaneous Coronary Intervention [15] Arief Lalmohamed, Sander Pouwels, Cyrus Jeremy A Rassen, Murray A Mittleman, Robert J Glynn, M Alan Cooper, Tjeerd van Staa, Bert Leufkens, Brookhart, Sebastian Schneeweiss. (United States) Lars Rejnmark, Anthonius de Boer, Peter Vestergaard, Frank de Vries. (Netherlands) 11:15am Z Association of Proton Pump Inhibitors with Clopidogrel Effec- tiveness in Elderly Stroke Patients [16] Mi-Sook Kim, Sun-Young Jung, Ye-Jee Kim, Nam-Kyong Choi, Byung-Joo Park. (Republic of Korea)

Hormones/Reproductive Agents (Room 554AB) Moderators: Stephen Evans & Annlouise Assaf 10:30am 11:30am Z Teen Pregnancy Rates Following Pharmacist-Initiated Z Oral Hormone Replacement Therapy: Emergency Contraceptives [19] An Update Report from the EURAS-HRT Vivian WY Leung, Judith A Soon, Marc Levine, Larry D Lynd, Study on Cardiovascular Safety [23] Carlo A Marra. (Canada) Anita Assmann, Juergen C Dinger. 10:45am (Germany) Z An Internet-Based Prospective Study of Pregravid Oral 11:45am Contraceptive Use and Time to Pregnancy [20] Z Risk of Cardiovascular Outcomes in Ellen M Mikkelsen, Lauren A Wise, Anders Riis, Elizabeth E Hatch, Users of Estradiol/Dydrogesterone or Henrik T Sørensen, Kenneth J Rothman. (United States) Other HRT Preparations [24] 11:00am Cornelia Schneider, Susan S Jick, Christoph R Meier. (Switzerland) Z Incident Anticoagulant Use among Users of Extended-Cycle Versus Conventional Oral Contraceptives [21] Joshua J Gagne, Tarek A Hammad, Solomon Iyasu. (United States) 11:15am Z Extended Results on the Risk of Venous Thromboembolism (VTE), Myocardial Infarction (MI), and Stroke in Users of Trans- dermal Norelgestromin/Ethinyl Estradiol (Patch) [22] David D Dore, Heather Norman, Clorinda Hoffman, Judy Wong, John D Seeger. (United States)

r August 16-19, 2009 r Providence, RI 15 Agenda - Monday, August 17

Medications in Pregnancy/Birth Outcomes – I (Ballroom B) Moderators: Jennita Reefhuis & Lolkje de jong van den Berg 10:30am 11:15am Z Pregnancy Exposure Registries: Chal- Z Effect of Correct Folic Acid Use on Spina Bifida in Pregnancies Ex- lenges in Identifying Comparison posed to Valproic Acid or Carbamazepine in the Netherlands [28] Groups [25] J Jentink, MK Bakker, LTW de Jong-van den Berg. (Netherlands) Deborah L Covington, Susan S Roberts, 11:30am Jessica Albano, Laura F McKain. (United Z Serotonin Reuptake Inhibitor and Pregnancy: Risk of Gestational States) Hypertension? [29] 10:45am Christine Damase-Michel, Veronique Duhalde, Caroline Hurault, Rob- Z Can the General Practice Research ert Bourrel, Jean Louis Montastruc. (France) Database Identify a Known Teratogenic 11:45am Association? [26] Z Use of Antidepressants during Pregnancy and the Risk of Pre- Rachel A Charlton, John G Weil, Julia M term Delivery and Fetal Growth Restriction [30] Snowball, Marianne C Cunnington, Corinne Sengwee Toh, Allen A Mitchell, Carol Louik, Martha M Werler, Chris- S de Vries. (United Kingdom) tina D Chambers, Sonia Hernandez-Diaz. (United States) 11:00am Z Valproic Acid Exposure & Specific Mal- formations [27] J Jentink, MA Loane, H Dolk, JK Morris, LTW de Jong-van den Berg, EUROCAT AED Working Group. (Netherlands)

16 August 16-19, 2009 r Providence, RI r Agenda - Monday, August 17

12:00pm-1:30pm 1:30-3:00pm Lunch/Poster Session A/Exhibits/ Poster Walks (Hall B) Concurrent Sessions: Contributed Papers Analysis Methods I (Ballroom B) —Lunch Sponsored by UBC Moderators: Til Stürmer, FISPE & Marieke DeBruin Poster Walks/Moderators Z Pharmacovigilance, Harry Seifert & 1:30pm Keith Beard, FISPE Z Estimating Absolute Risks in the Presence of Noncompliance: Z Medicines in Pregnancy/Birth Defects­­, An Application to a Women’s Health Initiative Randomized Lolkje T de Jong-van den Berg Trial [31] Z Drug Utilization Studies, Monique Elseviers Sengwee Toh, Sonia Hernandez-Diaz, Roger Logan, James M Robins, Z Uses of Linked Databases, Miguel A Hernan. (United States) Matthew W. Reynolds Student Award Recipient – Best Methods Abstract ISPE Committee/Council Meetings 1:45pm • Open to all participants. (Lunches will be Z Prior Event Rate Ratio Adjustment: A Magic Bullet or More of available in meeting rooms) the Same? [32] Arlene Gallagher, Frank de Vries, Tjeerd van Staa. (Netherlands) Z Development Committee (Room 558B) Z Fellowship & Awards Committee Student Award Recipient – Best Drug Utilization Abstract (Room 558A) 2:00pm Z Public Policy Committee (Room 557) Z Observed Performance of the High-Dimensional Propensity Z Student Council (Ballroom E) Score (hd-PS) Algorithm in Small Samples [33] Jeremy A Rassen, M Alan Brookhart, Sebastian Schneeweiss. (United States) 2:15pm Z Applying Propensity Scores Estimated in a Full Cohort To Achieve Balance in Subgroup Analyses [34] Jeremy A Rassen, M Alan Brookhart, Sebastian Schneeweiss. (United States) 2:30pm Z Bias from Excluded Event-Depleted Time in Cohort Studies [69] Frank Andersohn, Stefan N Willich. (Germany) 2:45pm Z Confounder Summary Scores When Comparing the Effects of Multiple Drug Exposures [36] Suzanne M Cadarette, Joshua J Gagne, Daniel H Solomon, Jeffrey N Katz, Til Stürmer. (Canada)

Despasquale Plaza Federal Hill Photo credit: Providence/Warwick Convention & Visitors Bureau r August 16-19, 2009 r Providence, RI 17 Agenda - Monday, August 17

Gastrointestinal Drugs: Going Beyond the Intestine Improving Linking Databases (Room 554AB) (Room 555AB) Moderator: Dan Mines & Mari-Ann Wallander, FISPE Moderators: Thomas MacDonald, FISPE, 1:30pm & Earl Goehring Z Prokinetic Drugs in Children; Drug Utilization and Safety [37] 1:30pm S de Bie, KMC Verhamme, SMJM Straus, G Piceli, A Ceci, MCJM Z Automated Data Capture from Free Text Sturkenboom. (Netherlands) Radiology Reports To Enhance Accuracy 1:45pm of Hospital Inpatient Stroke Codes [43] Robert Flynn, Thomas MacDonald, Gordon Z No Evidence for Association of Tegaserod with Adverse Cardio- Murray, Alexander Doney. (United Kingdom) vascular Ischemic Events [38] Jeanne Loughlin, Sherry Quinn, Elena Rivero, Heather Norman, Da- 1:45pm vid L Earnest, Judy Wong, John D Seeger. (United States) Z Linking Inpatient and Outpatient Data 2:00pm [44] Suellen Curkendall, Daniel Huse. Z Use of Protonpump Inhibitors and Risk of Hip Fracture [39] (United States) Arief Lalmohamed, Sander Pouwels, Cyrus Cooper, Tjeerd van Staa, Bert Leufkens, Anthonius de Boer, Frank de Vries. (Netherlands) 2:00pm 2:15pm Z Sensitivity and Specificity of Acute Renal Failure Medical Claims Validated ZThe Role of Medical Comorbidities in the Association of Proton against Electronic Medical Records [45] Pump Inhibitors [PPIs] and Fractures [40] Marc B Rosenman, Peter M Wahl, Gregory David R Gagnon, Jennifer R Fonda, Richard Scranton, Elizabeth V Daniel, J Marc Overhage, Patricia McGuire, Lawler. (United States) Daniel Thompson, Keith Rodgers, Louise 2:30pm Short, Rhonda L Bohn, William M Tierney. Z Use of Proton Pump Inhibitors and Histamine Type 2 Receptor (United States) Blockers Is Not Associated with Pneumonia Risk [41] Sascha Dublin, Rod L Walker, Michael L Jackson, Jennifer C Nelson, 2:15pm Z Effect of Extended Mortality Ascertain- Noel S Weiss, Lisa A Jackson. (United States) ment in a Cohort Study of the Risk of 2:45pm Cancer in Regranex (Becaplermin) Users Z Proton Pump Inhibitors and Risk for Recurrent Clostridium and Matched Comparators [46] difficile Associated Diarrhea [42] Najat Ziyadeh, Daniel Fife, John D Seeger. Amy Linsky, Kalpana Gupta, Elizabeth Lawler, Jennifer Fonda, John (United States) Hermos. (United States) 2:30pm Z Signal Detection Beyond Spontaneous Reports: An Example of Acute Adverse Event Detection in Large Claims Data- bases [47] Zhenchao Guo, Gilbert J L’Italien, Jayanti Mukherjee, Hugh Kawabata, Andres Gomez Caminero. (United States) 2:45pm Z Validation of Persistent Pulmonary Hypertension in the Newborn (PPHN) within the UK-Based General Practice Research Database (GPRD): Comparing Two Approaches [48] Tarek A Hammad, Carol Pamer, Susan McCune, Sigal Kaplan, Hany Aly, Solomon Iyasu. (United States)

August 16-19, 2009 r Providence, RI r Water Fire Sound Session 18 Photo credit: Providence/Warwick Convention & Visitors Bureau Agenda - Monday, August 17

Personalized Medicine: Molecular and Genetic Biomarkers Vaccines (Room 556AB) of Efficacy and Toxicity (Room 552AB) Moderators: M. Miles Braun, FISPE, & Moderator: Frederick Nyberg & Andrew Freedman Robert Chen, FISPE 1:30pm 1:30pm Z Cisplatin, Nucleotide Excision DNA Repair Pathway, and Esopha- Z A Systematic Approach To Analyze geal Cancer Outcomes: A Pharmacogenetic Epidemiology Study Safety Data Clinical Trial Database [55] [49] Caroline Legendre, Alena Khromava, Gillis Penny Bradbury, Wei Zhou, Rihong Zhai, Kofi Asomaning, Li Su, Carrigan. (France) David Christiani, Geoffrey Liu. (Canada) 1:45pm 1:45pm Z Active Safety Surveillance of DTaP Vac- Z CYP2C9, CYP2C19 and ABCB1 Genotype and Hospitalization for cines by Linkage of Immunization Regis- Phenytoin Toxicity [50] try and Claims Database in Korea [56] Sean Hennessy, Charles E Leonard, Cristin M Palumbo, Joshua P Sun-Young Jung, Nam-Kyong Choi, Byung- Metlay, Xin Chu, Brian L Strom, Warren B Bilker. (United States) Joo Park. (Korea) 2:00pm 2:00pm Z Variation in Renin-Angiotensin System and Salt Sensitivity Z The Risk of Seizures after Acellular Genes and the Risk of Diabetes Mellitus Associated with the Use Pertussis Vaccines in Early Childhood — of Thiazide Diuretics [51] United States, 2002-2006 [57] Ozlem Bozkurt, Anthonius de Boer, Diederik E Grobbee, Peter W de Wan-Ting Huang, Paul Gargiullo, Irene Leeuw, Abraham A Kroon, Paul Schiffers, Olaf H Klungel. (Nether- Shui, Eric Weintraub, James Baggs, Karen lands) Broder, John Iskander. (United States) 2:15pm 2:15pm Z Single Nucleotide Polymorphisms in Genes That Are Associ- Z Effectiveness of the Pentavalent Rotavi- ated with a Modified Response to Statin Therapy: The Rotterdam rus Vaccine in Preventing Gastroenteri- Study [52] tis in the United States: A Claims-Based Catherine E de Keyser, Mark Eijgelsheim, Albert Hofman, Eric JG Analysis [58] Sijbrands, Anke-Hilse Maitland-van der Zee, Cornelia M van Duijn, Florence T Wang, T Christopher Mast, Andre G Uitterlinden, Jacqueline CM Witteman, Bruno HCh Stricker. Roberta J Glass, Jeanne Loughlin, John D (Netherlands) Seeger. (United States) Student Award Recipient – Best Molecular Epidemiology - 2:30pm Pharmacogenetics Abstract Z Cautionary Example of Potential Expo- sure-Based Differential Misclassifica- 2:30pm tion in a Post-Marketing Vaccine Safety Z The Cost-Effectiveness of Genotype-Guided Warfarin Dosing for Study [59] Patients with Atrial Fibrillation [53] Nancy C Santanello, Christopher Mast, Amanda R Patrick, Jerry Avorn, Niteesh K Choudhry. (United States) Jeanne Loughlin, John Seeger. (United 2:45pm States) Z Mesothelin, a Biomarker of Pharmacologic Response in Malig- 2:45pm nant Pleural Mesothelioma, Evaluated in a Molecular Epidemio- Z A Post-Marketing Surveillance Program logic Study [54] for Pentavalent Rotavirus Vaccine [60] Boming Yang, Paul Wheatley-Price, Deval Patel, Clement Ma, Jeanne Loughlin, Wang Florence, P Mona Natasha Leighl, Ron Feld, Marc de Perrot, Geoffrey Liu. (Canada) Eng, T Christopher Mast, John D Seeger. (United States)

3:00-3:30pm Break/Posters/Exhibits (Hall B)

r August 16-19, 2009 r Providence, RI 19 Agenda - Monday, August 17

3:30-5:00pm 5:00-6:00pm ISPE Council Concurrent Sessions: Symposia And Workshops Meetings (Westin) Automated Data Sources for Pharma- Pharmacoepidemiology, • Open to all inter- coepidemiology in Asia-Pacific Region Medicines Policy and Health ested participants – Updates and Perspectives [61] Outcomes: The Next Steps [65] Z Academic (Room 556AB) (Room 551AB) Council Z Byung Joo Park, Yea Huei Kao Yang, Z Andrew L Gilbert, Richard Laing, (Narragansett C) Libby Roughead, Daisuke Koide, Jeff J Andreas Laupacis, Elizabeth Roughead, Z Government/Reg- Guo, Tomomi Kimura, Arnold K Chan, Kate L Lapane. (Australia) ulatory Council Judith K Jones, Brian L Strom. (Japan) (Narragansett B) The Past, Present and Future Z Manufacturing/ Can Registries Deliver? The Methods of Pharmacoepidemiology at Service Providers and Use of Registries for Biologics [62] CDER, FDA [66] (Ballroom A) Council (Room 555AB) Z Solomon Iyasu, Tarek A Hammad, Gerald (Narragansett A) J Dal Pan, Judy A Staff. (United States) – Sponsored by the Biologics SIG 5:15-6:15pm Z Sean Zhao, Nancy Dreyer, Alex Cole, Is Accuracy at Odds with Privacy? Fourth Asian Annette Stemhagen, Nils Feltelius, Jo- Meeting Planning anna Haas. (United States) Challenges and Solutions When Combining Data from Multiple Sources Committee (RICC- Confounding by Indication Studying [285] (Room 554AB) Room 554AB) Epoetin and Mortality [63] (Ballroom B) Z Jeremy Rassen, Lang Chen, Miriam 6:00-7:30pm Sturkenboom, Sebastian Schneeweiss, Z John Acquavella, Eric Weinhandl, Brian PDS Editorial Board Stephen Evans. (United States) Bradbury, Alan Brookhart, Til Stürmer, (Westin, Bristol Room, Kenneth J Rothman. (United States) Third Floor) • By Invitation Evaluating Study Designs for the Measurement of Drug Exposure in 7:00pm- ? Pregnancy [64] (Room 552AB) Student Social –Sponsored by the Medicines in Preg- Event – A Night Out nancy SIG and the Teratology Society in Providence Z Elizabeth B Andrews, Lyn Colvin, (Bravo Brasserie Sonia Hernandez-Diaz, Lewis Holmes, 123 Empire Street) Tina Chambers, Andrea Margulis, • Open to all Allen Mitchell. (United States) students. • Organized by the ISPE Student Council

Providence Skyline Photo credit: Providence/Warwick Convention & Visitors Bureau

You will notice that the “ICPE 25th Anniversary” logo has been appended to selected sessions. These sessions have been selected because the topics are broad and reach into the future of our field.

20 August 16-19, 2009 r Providence, RI r

Agenda - Tuesday, August 18

7:00-8:00am 9:15-10:30am Annual Roundtable Discussion/ Breakfast: Centers for Education and Annual Meeting Of ISPE Members, Awards Research on Therapeutics [608] Ceremony & Special Address (Ballroom A) (Room 557) • Open to all participants. Z Anne E Trontell, Mark Hornbrook, Stephen Crystal. (United States) Annual Meeting of ISPE Members Z Miriam CJM Sturkenboom, FISPE, ISPE President 7:00-8:00am Z Nancy Dreyer, ISPE Vice President Finance Poster Session B Set-up (Hall B) Continental Breakfast (Hall B) Awards Ceremony ICPE 2009 7:00-6:00pm Z Presented by: Miriam CJM Sturkenboom, ISPE President Registration (Third Floor Foyer) Z Brian J. Quilliam, Chair, Local Host Committee Z Susan Sacks, FISPE, Co-Chair, 25th Anniversary ICPE Committee 7:30-5:00pm Z Kate Lapane, FISPE, Chair, 2009 Scientific Program Committee & Speakers’ Ready Room (Room 553B) Co-Chair, 25th Anniversary ICPE Committee Student Awards 8:00-6:00pm Z Presented by: Kate Lapane, FISPE, Chair, Exhibits/Posters (Hall B) 2009 Scientific Program Committee 8:00-9:15am Best Drug Utilization Abstract: Arlene Gallagher Best Molecular Epidemiology/Pharmacogenetics Abstract: Invited Plenary Session Catherine de Keyser (Balllroom A) Best Methods Abstracts: Sengwee Toh Third Best Abstract: Nicole Pratt National Pharmaceutical Policy Imperatives: Implications for Pharma- Second Best Abstract: Mary Ritchey coepidemiologists Edlavitch Award (Best Student Abstract): Charlotte van Noord Chair: Andrew Gilbert Induction of ISPE Fellow (FISPE) Speaker: Lloyd Sansom, Emeritus Professor; Z Yola Moride, FISPE, Chair, Fellowship & Awards Committee University of South Australia: Chair, Phar- Inductees: maceutical Benefits Advisory Committee; Z Stella Blackburn, FISPE Australian Government Department of Health Z James D. Lewis, FISPE and Aging Pharmacoepidemiology & Drug Safety ISPE-PDS Prizes for Best Papers published in PDS Volume 17 (2008) Z Presented by, Brian Strom, FISPE, Regional Editor for the Americas, Joerg Hasford, Regional Editor for Europe, and Richard Hughes, Managing Editor, PDS

Special Anniversary Address Z 25 Years in 25 Minutes Hugh Tilson, Honorary Lifetime Fellow

10:30-11:00am Break/Posters/Exhibits (Hall B) –Sponsored by CSD-EPIC

You will notice that the “ICPE 25th Anniversary” logo has been appended to selected sessions. These sessions have been selected because the topics are broad and reach into the future of our field.

22 August 16-19, 2009 r Providence, RI r Agenda - Tuesday, August 18

11:00-12:30pm Concurrent Sessions – Contributed Papers Anti-Infectives (Room 552B) Information as Basis for Risk Moderators: Patricia Saddier & Kerry LaPlante Management (Ballroom D) 11:00am Moderators: Elizabeth Andrews, FISPE & Z Effectiveness of an Information Technology Intervention To Nataliya Volkova Improve Prophylactic Antimicrobial Use in the Post-Operative 11:00am Period [227] Z Determinants of Metabolic Testing for Kevin Haynes, Darren Linkin, Neal Fishman, Warren Bilker, Eric Pifer, Patients Treated with Second-Genera- Sean Hennessy. (United States) tion Antipsychotics after the FDA Diabe- 11:15am tes Warning [233] Z Effectiveness of Palivizumab in Medicaid Infants [228] Elaine H Morrato, Benjamin Druss, Daniel M Almut G Winterstein, Christian Hampp, Arwa Saidi. (United States) Hartung, Robert J Valuck, Deborah Thomas, Richard Allen, Elizabeth Campagna, John W 11:30am Newcomer. (United States) Z Comparison of Infection-Related Hospitalization Risk among Patients Receiving Sargramostim, Filgrastim, and Pegfilgrastim 11:15am for Chemotherapy-Induced Neutropenia [229] Z Quantification of Patient Population Mei Sheng Duh, Edmond L Toy, Francis Vekeman, Francois Laliberte, Impact of Contra-Indications: Glaucoma Bree L Dority, Daniel Perlman, Victoria Barghout, Mark L Heaney. Therapy [234] (United States) Andrew Maguire, Sharon MacLachlan (United Kingdom) 11:45am Z Is Cigarette Smoking a Risk Factor for Subsequent Use of 11:30am Antibiotics? [230] Z Perceptions of Older Adults Regarding Hege S Blix, Vidar Hjellvik, Irene Litleskare, Marit Rønning, Aage Information Obtained from Pharmacists Tverdal. (Norway) and Medication Leaflets [235] Roberta Goldman, Anne L Hume, Brian J 12:00pm Quilliam, Pedro Pichardo, Devi Ross, Kate Z Reporting of Hepatic Events in Patients Using Vancomycin from L Lapane. (United States) Clinical Studies: A Meta-Analysis [231] Yan Chen, Xiao Yan Yang, Michael Zeckel, Chris Killian, Kennth Horn- 11:45am buckle, Simon Voss. (United States) Z Opioid Analgesic Abuse Surveillance: Convergence of Poison Control Center 12:15pm Intentional Exposure Calls and Media Z Outcomes of Antibiotic Use for Respiratory Infections [232] Reports [236] Sharon B Meropol, A Russell Localio, Joshua P Metlay. (United States) John Brownstein, Richard Dart, Meredith Y Smith. (United States) 12:00pm Z Evaluation of the Infliximab (Remicade®) Pediatric Crohn’s Disease Educational Plan [237] Alejandro Arana, Sam Allen, Ola Ghatnekar, María T Rico, Nathalie Vanhaverbeke, Jörg Burkowitz, Charles E Wentworth, Valerio Fan- toni, Max Brosa, Felix M Arellanom (Spain) 12:15pm Z A Comparison of Health Outcomes and Healthcare Utilization during Episodes of Modified-Release Opioid Analgesic Therapy with and without Evidence of an Alcohol-Related Disorder [238] Meredith Y Smith, J David Haddox, Liisa Palmer. (United States)

r August 16-19, 2009 r Providence, RI 23 Agenda - Tuesday, August 18

Measurement Methods (Ballroom B) The Spectrum of Anti-Inflammatory Moderators: Tobias Gerhard & Tamar Lasky Therapies (Room 552A) 11:00am Moderators: Sean Hennessy, FISPE & Z Prescription Changes and Chronic Disease Score as Predictors C. Ineke Neutel, FISPE for Hospitalization [239] 11:00am Carolien GM Sino, Rutger Stuffken, Eibert R Heerdink, Patrick C Sou- Z The Influence of CYP2D6, CYP3A4/3A5 verein, Marieke J Schuurmans, Antoine CG Egberts. (Netherlands) and UGT2B7 Genetic Polymorphisms 11:15am on Prescription of Other Analgesics in Z Positive Predictive Value (PPV) of Commercial Health Insurance Codeine Users [245] Claims Data for Identifying Acute Pancreatitis (AP) in Patients Monique J Bijl, Loes E Visser, Ron HN van with Diabetes Mellitus (DM) [240] Schaik, Mark Eijgelsheim, Albert Hofman, David D Dore, Clorinda Hoffman, Sherry G Quinn, Saadia Chaudhry, Andre G Uitterlinden, Arnold G Vulto, Teun John D Seeger. (United States) van Gelder, Bruno HCh Stricker. (Nether- lands) 11:30am Z Impact of Exposure Data Sources on Risk Estimates in Etiological 11:15am Studies: Application to Benzodiazepines in the Three-City (3C) Z Risk of Serious Infections Among Study [241] Patients with Rheumatoid Arthritis Fabienne Bazin, Pernelle Noize, Antoine Pariente, Nicholas Moore, Initiating Treatment with Tumor Necrosis Annie Fourrier-Réglat. (France) Alpha Antagonists [246] Carlos Grijalva, Lisa Kaltenbach, Patrick 11:45am Arbogast, Edward Mitchel, Marie Griffin. Z The Validity of Mother-Reported Asthma and Asthma Medication (United States) Use in Children [242] Kari Furu, Øystein Karlstad, Svetlana Skurtveit, Siri Haaberg, 11:30am Per Nafstad, Stephanie London, Wenche Nystad. (Norway) Z Changes in Overuse and Underuse of Prophylactic Strategies with NSAID 12:00pm Treatment over the Past Decade [247] Z Impact of Missing Data on Potential Confounders in Perinatal VE Valkhoff, EM van Soest, MCJM Sturken- Pharmacoepidemiologic Studies Using Administrative Databases boom, EJ Kuipers. (Netherlands) [243] Anick Bérard, Hamid R Nakhai-Pour, Sophie Kulaga. (Canada) 11:45am Z Concomitant Use of Gastroprotective 12:15pm Agents (GPAs) among NSAID/COX-2 Z Risk of Hospitalization among Rheumatoid Arthritis Patients Selective Inhibitor Users: A Hospital Initiating Treatment with TNFα-Antagonists: Effect of Different Register-Based Study [248] Exposure Measurements and Propensity Score Estimates [244] Jarir Atthobari, Erna Kristin, Iwan Dwipra- Carlos Grijalva, Lisa Kaltenbach, Patrick Arbogast, Edward Mitchel, hasto. (Indonesia) Marie Griffin. (United States) 12:00pm Z Randomized Controlled Trials on Cox-2 Inhibitors, Changes in Comparator Dose over Time [249] G Stefansdottir, ML de Bruin, MJ Knol, DE Grobbee, HGM Leufkens. (Netherlands) 12:15pm Z Association between Non-Steroidal Anti- Inflammatory Drugs and Keratinocyte Cancer Prevention: VATTC Trial [250] Anthony P Nunes, Kate L Lapane, Martin A Weinstock. (United States)

August 16-19, 2009 r Providence, RI r Downtown Providence 24 Photo credit: Providence/Warwick Convention & Visitors Bureau Agenda - Tuesday, August 18

Use and Risks of Psychotropics in Elderly Persons (Room 557) Moderators: Vincent Mor & Lauri Daiello 11:00am 11:45am Z Socioeconomic Determinants of Psy- Z Factors Associated with Discontinuation of Cholinesterase chotropic Drug Use Among Elderly [251] Inhibitors in the Netherlands [254] Eva Lesén, Karolina Andersson, Max Pet- Edeltraut Kröger, Rob van Marum, Patrick Souverein, Toine Egberts. zold, Anders Carlsten. (Sweden) (Netherlands) 11:15am 12:00pm Z Antipsychotics and the Risk of Hip Z Impact of Non-Persistence to Cholinesterase Inhibitor Treat- Fracture, Pneumonia and Stroke: Self- ments in Demented Elderly [255] Controlled Case Series and Instrumental Antoine Pariente, Annie Fourrier-Réglat, Alice Dragomir, Sylvie Per- Variable Analysis Results [252] reault, Nicholas Moore, Yola Moride. (France) Nicole Pratt, Elizabeth Roughead, Philip 12:15pm Ryan, Robert Peck, Andrew Gilbert. Z Risk of Upper Gastrointestinal Bleeding and Degree of Serotonin (Australia) Student Award Recipient– Reuptake Inhibitions among Elderly Patients in Korea [256] Third Best Abstract Ye-Jee Kim, Nam-Kyong Choi, Sun-Young Jung, Jong-Mi Seong, 11:30am Joongyub Lee, Byung-Joo Park. (Republic of Korea) Z Antipsychotic Use and the Risk of Hip Fracture in Nursing Home Residents with Dementia [253] Jessica J Jalbert, Susan C Miller, Charles B Eaton, Kate L Lapane. (United States)

r August 16-19, 2009 r Providence, RI 25 Agenda - Tuesday, August 18

12:30-2:00pm 2:00-3:30pm Lunch/Poster Session B/Exhibits/ Poster Walks (Hall B) Concurrent Sessions – Contributed Papers Cancer All Over the Place! (Room 551A) Poster Walks/Moderators Moderators: Annette Beiderbeck & Jim Kaye Z Pharmacovigilance Harry Seibert 2:00pm Z Molecular Epidemiology/ Z Half of Breast Cancer Patients Starting on Tamoxifen Complete Pharmacogenetics Five Years of Endocrine Treatment [257] Weu Zhou & David Miller Myrthe PP van Herk-Sukel, Adri C Voogd, Grard AP Nieuwenhuijzen, Z Drug Utilization Studies Ron MC Herings, Jan Willem W Coebergh, Lonneke V van de Poll- Monique Elseviers Franse. (Netherlands) Z Biologics 2:15pm Pavel Napalkov Z Dose Response of Retinol and Isotretinoin in the Prevention Z Use of Linked Database of Non-Melanoma Skin Cancer Recurrence [258] Matthew R. Reynolds Mary C Clouser, Denise J Roe, Janet A Foote, Robin B Harris. (United States) ISPE Committee/Council Meetings • Open to all participants. (Lunches will be 2:30pm Z Incidence Rates of ARDS in Solid Tumor Cancer Patients in the available in meeting rooms) THIN Database [259] Z Bylaws and Policies Committee Victor Gastanaga, Chuck Wentworth, Anthony Yeo, Gail Hughes, Wil- (Room 558A) liam Haddock, Sean Zhao. (United States) Z Global Development Committee (Room 554A) 2:45pm Z Patients (Pts) with Metastatic Renal Cell Carcinoma (mRCC) Z Membership Committee (Room 554B) Receiving Angiogenesis Inhibitor (AI) Therapies: Treatment Z Publications Committee (Room 558B) Efficacy and Safety in Clinical Practice [261] 1:00-2:00pm David McDermott, Toni K Choueiri, Jessica Clement, Ashley J Brick, Christabel Kwabi, Karishma Shah, Lucia Antras, Sujata S Jayawant, Public Forum on Core Competencies Si-Tien Wang, Andi Luka, Mei Sheng Duh, Maureen Neary, William K for Pharmacoepidemiology (Ballroom A) Oh. (United States) Sponsored by ISPE Education Committee 3:00pm Z Pattern of Bevacizumab (BV) Use in 1st-Line Therapy Metastatic • NOTE: Eat first–lunch will not be available Colorectal Cancer (mCRC) in Real-Life Practice: Results of the at this session ETNA Cohort Study [262] Introduction A Fourrier-R[eaculte]glat, D Smith, A Ravaud, M Rouyer, A Balestra, Z James D. Lewis, FISPE, Chair, Education D Jayles, N Moore, ETNA Study Group. Committee Moderator, Introduction Z Hugh Tilson, FISPE Data Presentation Z Judith Jones, FISPE Panel Comments Z Jennifer Polinski, Student Council Z Wei Dong, Manufacturing/Service Provider Council Z Anna Birna Almarsdóttir, Academic Council Z Richard Hill, Government/ Regulatory Council Open Discussion

26 August 16-19, 2009 r Providence, RI r Agenda - Tuesday, August 18

Cardiovascular Disease (Ballroom D) Moderators: Annlouise Assaf & Cristina Varas 2:00pm 3:00pm Z Antipsychotic Use and Myocardial Infarction in Demented Z Oral Bisphosphonates and the Risk of Patients Treated with Cholinesterase Inhibitors [263] Atrial Fibrillation in a Cohort of Older Antoine Pariente, Yola Moride, Alice Dragomir, Sylvie Perreault, Adults [267] Nicholas Moore, Annie Fourrier-Réglat. (France) Linda Lévesque, Ana Blagojevic, Mahyar Etminan, James Brophy. (Canada) 2:15pm Z Do Selective Cyclooxygenase-2 Inhibitors and Nonselective Non- 3:15pm steroidal Antiinflammatory Drugs Increase the Risk of Cardiovas- Z Case-Control Study: Use of Oral Contra- cular Events and Death after Intracoronary Stenting? [264] ceptives Containing Dienogest and Risk M Schmidt, M Maeng, L Pedersen, JF Lassen, TT Nielsen, of Venous Thromboembolism [268] HT Sorensen. (Denmark) Juergen C Dinger, Kristina Voigt, Sabine Moehner. (Germany) 2:30pm Z Evaluation of the Level of Anticoagulation Control in Patients with Non-Valvular Atrial Fibrillation [265] Bill Zang, Efrosini Setakis, Tjeerd P van Staa. (United Kingdom) 2:45pm Z Non-Selective β-Blockers Decrease Thrombotic Events in Patients with Heart Failure [266] Olav R De Peuter, Patrick C Souverein, Olaf H Klungel, Ton de Boer, Harry R Büller, Pieter-Willem Kamphuisen. (Netherlands)

r August 16-19, 2009 r Providence, RI 27 Agenda - Tuesday, August 18

Potpourri Session (Ballroom B) Risk Factors, Surveillance, and Moderators: Gianluca Trifiro and Rene Schade Comorbidity Burden (Room 551B) 2:00pm Moderators: Wei Dong & Brian J. Quilliam Z Population-Based Studies of Antithyroid Drugs and Sudden 2:00pm Cardiac Death [609] Z Validation of the National Respiratory Charlotte van Noord, Miriam CJM Sturkenboom, Sabine MJM Straus, and Enteric Virus Surveillance System Jacqueline CM Witteman, Bruno HC Stricker. (Netherlands) for the Detection of Respiratory Syncy- Student Award Recipient- Best Abstract tial Virus Seasons [269] 2:15pm Christian Hampp, Almut Winterstein. (United States) Z Outcomes Following a Hip Fracture and Length of Hospitaliza- tion: The General Practice Research Database (GPRD) [610] 2:15pm Arlene Gallagher, Frank de Vries, Rinat Ariely, Tjeerd van Staa. Z Heptitis C Virus Genotype and Basal (United Kingdom) Viral Load Distribution in Different 2:30pm Regions of Mexico [270] Ricardo Jimenez-Mendez, Felipe Uribe-Sa- Z Polymorphisms in Two Regions of the Cyclo-Oxygenase-2 Gene las, Paulo Lopez-Guillen, Gilberto Castane- Associated with Variation in Risk of Coronary Thrombosis with da-Hernandez. (Mexico) Cyclo-Oxygenase-2 Inhibitors [611] D Henry, L Lincz, J Attia, P McElduff, L Bisset, R Peel, S Hancock, 2:45pm K Henderson, D Whitaker, M Seldon, P McGettigan. (Canada) Z Modifiable Risk Factors among Unin- 2:45pm sured, Insured and Medicaid-Insured United States Adults Aged 18 to 64 Years Z Human Avian Influenza: Development of a Shoe-Leather [271] Approach to Evaluating Treatment Effectiveness [612] Margaret McDonald, Robin P Hertz, W Adisasmito, M Zaman, P Chan, N Lee, V Gasimov, FF Aghayev, Michael B Lustik, Alan N Unger. (United A Oner, E Bamgboye, N Dogan, K Starzyk, A Layton, R Coker, S States) Toovey, N Dreyer. 3:00pm 3:00pm Z Type 2 Diabetes and Incidence of Urinary Z Gabapentin Use in the US Department of Veterans Affairs [613] Tract Infections (UTIs). Experience from JE Lavigne, D Ganoczy, KL Knox, M Valenstein. the General Practice Research Database 3:15pm (GPRD) [272] Z Changing Rate of Blood-Stream Infection across Duration of Ishan Hirji, Zhenchao Guo, Susan An- Central Venous Access [614] dersson, Niklas Hammar, Andres Gomez Mary Ritchey, Michele Jonsson Funk, Stephen Marshall, Danica Caminero. (United States) Marinac-Dabic, William Rutala, David Weber. (United States) 3:15pm Student Award Recipient- Second Best Abstract Z Comorbidity in Patients with Non-Small Cell Lung Cancer (NSCLC) – The Cancer and Comorbidity (CACOM) Study [273] Fredrik Nyberg, Tobias Svensson, Helle Kieler, Mats Lambe, Anders Ekbom, Fredrik Granath. (Sweden) 3:30pm Z Renal Cell Carcinoma Patients Are Twice as Likely To Develop Thromboembolic Events Compared to Cancer-Free Con- trols [274] Myrthe PP van Herk-Sukel, Sumitra Shantakumar, Mariel K Casparie, Page E Abrahamson, Fernie JA Penning-van Beest, Ron MC Herings. (Netherlands)

28 August 16-19, 2009 r Providence, RI r Agenda - Tuesday, August 18

To Do No Harm….? (Room 557) 4:00-5:30pm Moderators: Frank May, FISPE, & Yea-Huei Kao Yang Concurrent Sessions: Symposia & Workshops 2:00pm Practical Aspects of Signal Detection in Pharmacovigilance – Z Prevalence, Nature and Severity of Pre- The CIOMS VIII Report [469] (Room 557) scribing Errors in Hospital Inpatients: Z June M Raine, Gerald Dal Pan, Manfred Hauben, Atsuko Shibata. Prospective Study in 20 UK Hospitals (United Kingdom) [275] Darren M Ashcroft, Penny J Lewis, Emma Carter, David Taylor, Mary P Tully, Valerie Conflict of Interest (COI) – What Is It? What Can Be Done To Wass, Steven Williams, Timothy Dornan. Minimize It? [282] (Room 552A) (United Kingdom) Z Proposed by Wei Dong, Susan Oliveria, Robert F Reynolds, Pavel 2:15pm Napalkov, Paul Stang, Marianne Ulcickas Yood. (United States) Z Prevalence, Clinical Profile, and Prevent- ability of Drug-Related Hospital Admis- Z Bob Levine, Director of Law, Policy and Ethics, Yale University, An sions: Prospective Observational Study Overview and Theoretical Framework of COI [276] Z Jill Hartzler Warner, Office of Policy, Planning and Preparedness/Of- Darren M Ashcroft, Chuenjid Kongkaew, fice of the Commissioner, FDA, An Overview of Policies and Consid- Steven Williams, David Metcalfe, Jaydeep erations from FDA Mandal, Peter Noyce. (United Kingdom) Z Stella Blackburn, FISPE, EMEA, ENCePP’s Perspective on COI 2:30pm Z Cary Gross, Division of Internal Medicine, Yale University, Consider- Z Computerized Clinical Decision Support ations from Academia during Medication Ordering for Long- Z Walter Straus, Merck Research Laboratories, Considerations from Term Care Residents with Renal Insuf- the Industry ficiency [277] Terry S Field, Paula Rochon, Monica Lee, Developing Good Practice Guidance for Non-Randomized Joann L Baril, Jerry H Gurwitz. (United States) Studies of Comparative Effectiveness: A Workshop on Quality 2:45pm and Transparency [283] (Ballroom B) Z RCT of a Computer Hard Stop Order Z Nancy Dreyer, Gilbert J L’Italien, Scott Smith, Sebastian Alert vs Routine Practice To Prevent Schneeweiss. (United States) Concurrent Orders of Trimethoprim/ Sulfamethoxazole and Warfarin [278] How Should We Plan and Communicate Interim Results of Brian L Strom, Rita Schinnar, Faten Aberra, Warren Bilker, Sean Hennessy, Charles E Pharmacoepidemiology Studies? An ISPE Public Policy Leonard, Eric Pifer. (United States) Forum [284] (Ballroom D) 3:00pm Z Susana Perez-Gutthann, Til Stürmer, Richard Platt, Brian L Strom, Z The Effectiveness of Collaborative Medi- Patricia Saddier, June Raine. (Spain) cine Reviews in Delaying Time to Next Hospitalisation for Heart Failure Patients Providing Pharmacoepidemiological Data Intended for Drug in the Ambulatory Setting: Results of a Regulatory Decision Making [286] (Ballroom A) Cohort Study [279] Z Joanna F Haas, Sebastian Schneeweiss, Elizabeth B Andrews, Andrew L Gilbert, Elizabeth E Roughead, Edward Bortnichak, Judith Jones, Gerald Dal Pan. (United States) John D Barratt, Emmae Ramsey, Nicole Pratt, Phillip Ryan, Robert Peck, Graeme Who Is a Patient’s Main Prescriber and How Should Clustering Killer. (Australia) Within Prescriber Influence Analyses? [67] (Room 552B) 3:15pm Z Niteesh K Choudhry, Robert J Glynn, M Alan Brookhart, Jeremy Z Quality of Consumer Generated Adverse Event Reports [280] A Rassen. (United States) Rose C Plummer, Elisa F Cascade. (United States)

3:30-4:00pm Break/Posters/Exhibits r August 16-19, 2009 r Providence, RI 29 Agenda - Tuesday, August 18

5:30-6:30pm 7:30-Midnight Special Interest Group (SIG) Meetings Evening at the • Open to all participants. Waterplace Restaurant Z Biologics SIG (Room 551A) Join your colleagues to help celebrate Z Database SIG (Room 551B) ISPE’s Silver Anniversary ICPE on this Z Drug Utilization/Health Services special evening. Brass Attack, Southern Research SIG (Ballroom B) New England’s finest dance band, will Z Medications in Pregnancy SIG provide the music. And ISPE will host a (Room 552A) WaterFire – an award-winning sculpture Z Molecular Epidemiology/ by Barnaby Evans Pharmacogenetics SIG and truly an unfor- (Room 55B) gettable sensory experience, at dusk. Admission is by badge or ticket. Cash bar

Brass Attack Water FIre Photo credit: Providence/Warwick Convention & Visitors Bureau

30 August 16-19, 2009 r Providence, RI r

Agenda - Wednesday, August 19

7:00-8:00am 7:30-5:00pm Diabetes From Legs To Death 2010 ICPE Scientific Program Registration (Room 551A) Committee Meeting (Room 557) (Third Floor Foyer) Moderators: Niklas Hammar & • Open to interested ISPE members Andrej Czarnecki, FISPE 7:30-3:30pm 8:30am 7:30-8:30am Speakers’ Ready Z Use of Thiazolidinediones and the Risk Poster Session C Set-up (Hall B) Room (Room 553B) of Fracture in Patients with Type II Dia- Continental Breakfast (Hall B) betes in Taiwan [444] 8:00-1:45pm Churn-Shiouh Gau, Yi-Shiu Lin. (Taiwan) Exhibits/Posters 8:45am (Hall B) Z Thiazolidinediones and Fractures in Men and Women [445] Colin R Dormuth, Greg Carney, Bruce Carleton, Ken Bassett, James M Wright. 8:30-10:00am (Canada) Concurrent Sessions – Contributed Papers 9:00am Analysis Methods II (Ballroom B) Z Effect of Angiotensin Receptor Block- Moderators: John Seeger & Tomasz Dyszynski ers and Angiotensin Converting Enzyme Inhibitors on Limb Amputation [446] 8:30am David Margolis, Ole Hoffstad, Tim Cromble- Z Using Different Types of Priors in a Bayesian Hierarchical holme. (United States) Model for the Analysis of Drug Adverse Events [438] David Prieto-Merino, Stephen JW Evans. (United Kingdom) 9:15am Z Incidence of Acute Pancreatitis in 8:45am Exenatide Initiators Compared to Other Z The Effect of Psychotropic Medication Among Children On Anitdiabetic Drug Initiators: A Retro- Changes in Mental Health: A Comparison of Marginal Structural spective, Cohort Study [447] Models (MSM) with Standard Regression Adjustment [439] David Dore, Gary Bloomgren, Ruth Pat- Shirley Wang. (United States) terson, Sherry Quinn, Clorinda Hoffman, 9:00am Saadia Chaudhry, Rebecca Noel, Daniel Z Predictors of Nucleoside Reverse Transcriptase Inhibitor Use: Braun, John Seeger. (United States) Channeling Bias in HIV Clinical Care [440] 9:30am Emily S Brouwer, Sonia Napravnik, Joseph J Eron Jr. (United States) Z Adverse Cardiovascular Events during 9:15am Treatment with Pioglitazone and Rosigli- Z Hurdle or No Hurdle? Select Appropriate Statistical Methods for tazone [448] Modeling Rare Events [441] David N Juurlink, Tara Gomes, Lorraine Liping Huang, George Quartey, Jamie Robinson. (United States) L Lipscombe, Peter C Austin, Jan E Hux, Muhammad M Mamdani. (Canada) 9:30am 9:45am Z Reporting of Case-Series in Drug Safety: A Review of Published Z Combination Therapy of Sulfonylureas Studies [442] and Metformin and the Risk of Death in Antoine Pariente, Claire Nour Abou Chakra, Marion Pinet, Nicola Patients with Type 2 Diabetes [449] Moore, Yola Moride. (Canada) Laurent Azoulay, Verena Schneider-Lindner, 9:45 am Sophie Dell’Aniello, Alicia Schiffrin, Samy Z Significance of Incorporating Real World Clinical Non-Adherence Suissa. (Canada) and Drug Adverse Events Data into Pharmacoeconomic Models: Statins Example [443] Pendar Farahani, Gray Ellrodt. (United States)

32 August 16-19, 2009 r Providence, RI r Agenda - Wednesday, August 19

Drug Utilization: Session II (Room 551B) Moderators: Andrew Gilbert & Monique Elsevier 8:30am 9:15am Z Is Persistence Fading? Time Trends and Determinants of Anti- Z Levetiracetam One Year Retention Rate biotic Prescriptions in the Community for Children in the United in Real-Life Practice in France, Final Kingdom 1993-2007 [450] Results of the EULEV Study [453] V Schneider-Lindner, S Dell’Aniello, A Kezouh, C Quach, J Hanley, C Droz, C Dureau, H Vespignani, C Mar- S Suissa. (Canada) chal, J Jové, N Moore, A Fourrier. (France) 8:45am 9:30am Z Off-Label Use of Antipsychotic Drugs in Privately and Publicly Z Use of Cardioprotective Drugs in Newly Insured Youth in the US [451] Treated Individuals with Type 2 Diabetes Stephen Crystal, Tobias Gerhard, Cecilia Huang, Mark Olfson. Aged Under 65 [454] (United States) Anis Ben Abdeljelil, Jocelyne Moisan, Jean-Pierre Grégoire. (Canada) 9:00am Z Physician Preference Motivates Use of Anti-TNF Therapy 9:45am Independent of Clinical Disease Activity [452] Z Polypharmacy in Chronic Diseases in Jeffrey R Curtis, Lang Chen, Leslie Harrold, Pongthorn the Elderly: Evidence-Based or Poten- Narongroeknawin, George Reed, Daniel H Solomon. (United States) tially Inappropriate Prescribing? [455] Gillian Caughey, Agnes Vitry, Andrew Gilbert, Elizabeth Roughead. (Australia)

r August 16-19, 2009 r Providence, RI 33 Agenda - Wednesday, August 19

Medications in Pregnancy and Birth Outcomes II (Room 552A) Moderators: Janneke Jentink & Sara A. Ephross 8:30am 9:15am Z Descriptive Study of the Administration of Category X Medica- Z Maternal Use of Bupropion and Risk for tions during Pregnancy Using an Outpatient Electronic Health Congenital Heart Defects [459] Record [456] Sura Alwan, Jennita Reefhuis, Lorenzo Brian L Strom, Rita Schinnar, Joshua Jones, Warren Bilker, Mark Botto, Adolfo Correa, Sonja Rasmussen, Weiner, Sean Hennessy, Charles E Leonard, Peter Cronholm, Jan Friedman. (United States) Eric Pifer. (United States) 9:30am 8:45am Z Early-Pregnancy Opioid Analgesic Z Trimethoprim Use Prior to Pregnancy and Risk of Congenital Treatment and Risk for Congenital Heart Malformation: A Register Based Nationwide Cohort Study [457] Defects [460] Jon T Andersen, Morten Petersen, Jeppe N Rasmussen, Nadia LT CS Broussard, SA Rasmussen, J Reef- Andersen, Christian Torp-Pedersen, Henrik E Poulsen. (Denmark) huis, JM Friedman, MW Jann, MA Honein. (United States) 9:00am Z Linking a Pharmaceutical Claims Database with a Birth Defects 9:45am Registry To Investigate Birth Defect Rates of Known Teratogens Z Does Decongestant Use during Preg- [458] nancy Reduce Preterm Delivery? [461] Lyn Colvin, Linda Slack-Smith, Fiona J Stanley, Carol Bower. (Australia) Rohini K Hernandez, Allen A Mitchell, Martha M Werler. (United States)

34 August 16-19, 2009 r Providence, RI r Agenda - Wednesday, August 19

Psychotropics II: Safety of 10:30-Noon Psychotropics (Room 552B) Moderators: James Wilson & Concurrent Sessions: Symposia & Workshops Jessica Jalbert Assessment of Prenatal Exposure to Medications [616] 8:30am (Room 552B) Z General Population Risk of Suicide At- Z Lyn Colvin, Sonia Hernandez-Diaz, Elizabeth Andrews, tempt Compared to Depressed Untreated Allen Mitchell, Tina Chambers, Pamela E Scott, Richard Hill. and Antidepressant Treated Populations (United States) [462] Sponsored by the Medicines in Pregnancy SIG and Robert J Valuck, Heather D Orton, Anne M Libby. (United States) the Teratology Society 8:45am RMP, RiskMAP and REMS: The Challenges of Epidemiology Z Use of Antiepileptic Drugs in Epilepsy [470] (Ballroom D) and the Risk of Self Harm and Suicidal Behaviour [463] Z Patricia Saddier, Susana Perez-Gutthann, Annette Stemhagen, Frank Andersohn, René Schade, Carlos Rekha Garg, Stella Blackburn, Gerald Dal Pan. (United States) Martinez, Stefan N Willich, Edeltraut Garbe. (Germany) Benchmarking of Healthcare Databases To Improve Harmoni- 9:00am zation [468] (Room 551A) Z Use of Dopaminergic Drugs and Risk Z Miriam Sturkenboom, Martijn Schuemie, Gianluca Trifiro, Annie of Hip or Femur Fracture: A Population- Fourrier, Preciosa Coloma, Jeffrey Brown, BJ Park, Helle Kieler, Based Case-Control Study [464] Ron Herings. (Netherlands) Maurits Arbouw, Kris Movig, Tjeerd van Staa, Toine Egberts, Patrick Souverein, Assessing the Association of Pharmacotherapeutics and Frank de Vries. (Netherlands) Suicidal Behavior: Lessons from the Front [281] (Room 551B) 9:15am Z Jamie Geier, Juhaeri Juhaeri, Daniel Mines, Andrew Mosholder, Z Renal Outcomes in People with Bipolar Madhukar Trivedi, Sybil Eng, Mary Lou Skovron, Paul Stang, Disorder Treated with Lithium: A Retro- Nataliya Volkova. (United States) spective Cohort Database Study [465] Joe Reilly, Helen Close, John Main, Mukesh Safety Assessment and Risk Management of Biologics– Kripalani, Pali Hungin, Douglas Wilson, James Mason. (United Kingdom) Challenges and Opportunities (Biologics SIG) [471] (Ballroom B) 9:30am Z Thijs J Giezen, Brigitte Keller, Anders Sundstrom, Aaron S Z Effects of Preexisting Cardiovascular Kesselheim, Wei Dong, Judith K Jones, Hans Petri. (Netherlands) Risk Factors on Initiation of Stimulants in Adults Newly Diagnosed with ADHD [466] The Future of Epidemiology [472] (Room 557) Tobias Gerhard, Almut Winterstein, Mark Z Ken Rothman, Gerald Dal Pan, Stephen Evans, Olfson, Arwa Saidi, Stephen Crystal. Paul Stang, Judith Jones, Til Sturmer. (United States) (United States) 9:45am Using Databases for both Hypothesis Generating and Hypoth- Z Extensive Psychotropic Drug Use esis Confirmation: One Database or Two? [473] (Room 552A) among Icelandic Children: A Nationwide Z Larry Gould, Alec Walker, Patrick Ryan, Sebastian Schneeweiss, Population Based Study [467] Nancy Santanello, Susan Sacks. (United States) Helga Zoega, Gísli Baldursson, Birgir Hrafnkelsson, Anna B Almarsdóttir, Unnur Valdimarsdóttir, Matthías Halldórsson. (Iceland) You will notice that the “ICPE 25th Anniversary” logo has been appended 10:00-10:30am to selected sessions. These sessions have been selected because the topics are broad and reach into the future of our field. Break/Posters/Exhibits (Hall B)

r August 16-19, 2009 r Providence, RI 35 Agenda - Wednesday, August 19

Noon-1:30pm 4:30-5:00pm Lunch/Poster Session C/Exhibits/ Poster Walks (Hall B) (Ballroom A) Poster Walks/Moderators The Final Word Z Pharmacovigilance –Harry Seifert Moderator Z Use of Linked Databases – Matthew R.Reynolds Kate L. Lapane, FISPE, Chair, 2009 Scientific Z Biologics – Pavel Napalkov Program Committee Z Drug Utilization Studies – Monique Elseviers Poster Awards ISPE Board of Directors Luncheon (Room 554AB) Z Wei Dong, Chair, Poster Awards Committee • Meeting open to all members; check with staff if you wish to attend ICPE 2010 Brighton, England, UK Z Corinne de Vries, Chair, 2010 Scientific 1:30-3:00pm Program Committee

Invited Plenary 5:00pm FDA’s Sentinel Initiative Project Adjournment of ICPE 2010 (Ballroom A) Chair: Scott Smith, Agency for Healthcare Research & Quality Panelists: Z Richard Platt, Harvard University Z Mark McClellan, Engelberg Center for Health Care Reform, The Brookings Institution Z Invited, FDA Z Miriam CJM Sturkenboom, Erasmus University Medical Center

3:00-4:30pm P E 2 0 0 Hot Topics Session: C 9 Clopidogrel: Has the Pharmacogenetics Era Arrived? I (Ballroom A) Chair: Leah Sansbury, National Cancer Institute, National Institutes of Health Panelists: Z Jessica Mega, Thrombolysis in Myocardial Infarction Study Group, Brigham and Women’s Hospital, Harvard Medical School; Clopidogrel Pharmacogenetics: Overview of The TIMI 2 5 Y Study Results T R H A S Z O.H. Klungel, Department of Pharmaceutical Sciences, Utrecht A N E R University; Methodological Aspects of Clopidogrel Pharmacogenetics N I V Z Alan R. Shuldiner, Professor of Medicine, University of Maryland School of Medicine; Perspective on Potential Clinical Utility of Clopidogrel Pharmacogenetics (Recent MI, Recent Stroke or International Conference Established Peripheral Arterial Disease) On Pharmacoepidemiology & Z Bonny Lewis Van, Pharmacogenetic Epidemiologist; Potential Therapeutic Risk Management Clinical Utility with Coronary Stents/ Summary Perspective of Future Direction of Pharmacogenetic Epidemiology.

36 August 16-19, 2009 r Providence, RI r

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International Conference On Pharmacoepidemiology & Therapeutic Risk Management Fifth Level