14th International Conference on Pharmacoepidemiology Agenda

August 16th-19th, 1998
Hotel Inter-Continental
Berlin, Germany


Saturday |Sunday |Monday |Tuesday |Wednesday

Saturday, August 15


08:30 - 11:00 Finance Committee Meeting Köpenick II/III
11:00 - 17:30 ISPE Board of Directors Meeting
(All members are invited to attend)
18:00 - 20:30 Board of Directors Dinner Meeting
Atrium (Private)

Sunday, August 16

08:30 - 10:15

Committee Meetings:
Membership/Public Relations (Tiergarten I)
Education (Tiergarten II)
Bylaws (Tiergarten III)
Data Privacy (Köpenick II/III)

10:30 - 12:30 Committee Meetings:
Publications (Tiergarten I)
Correspondents (Tiergarten II)
Public Policy/Ethics (Tiergarten III)
12:45 - 14:30 Long Range Planning Committee Meeting
(Members Only) Charlottenberg I
14:30 - 18:00 Seminar: Introduction to Pharmacoepidemiology
Session Moderators: Michael A. Lewis; Ulf Bergman
Potsdam I
14:30 - 14:45 Remarks by session chairs
History of Pharmacoepidemiology Objectives of this Introductory Course
14:45 - 15:30 Dr. Thomas MacDonald
Pharmacoepidemiology as a Scientific Discipline
Relationship to epidemiology
Uses of pharmacoepidemiologic Research
(Safety vs Outcome)
Issues in using databases as sources of data
15:30 - 16:00 Dr. Ulf Bergman
Introduction to drug utilization studies
16:00 - 16:30 Dr. Morten Andersen
Individualized drug utilization statistics
16:30 - 16:45 Coffee Break Potsdam Foyer
16:45 - 17:15 Dr. Jerry Avorn
Assessing costs of care/effectiveness of interventions using databases
17:15 - 18:00 Dr. Bernie O’Brien
“Pulp Fiction” or As Good As It Gets?” Building economic models with multiple data sources: The Case of Alzheimer’s Disease
Special address: Dr. Bergmann - Pohl
Parliamentary State Secretary from the German Ministry of Health

Monday, August 17

07:30 - 09:00 Poster Session I (Postdam II)
Continental Breakfast

Session 1: Opening Session
Session Chair: Keith Beard (Postdam II)
09:00 - 10:15 Michael A. Lewis, Past President and local host

Hans-Ulrich Melchert, Robert Koch Institute

Dieter Ernst, Secretary of State, Berlin Dept. of Economics & Municipal Corporations

Keynote Address:

Prof. Dr. Alfred Hildebrandt, BfArM Director, Bundesinstitut Für Arzneimittel Und Medizinprodukte German Federal Institute of Drugs and Medical Devices “What Do We Expect from Pharmacoepidemiology Now and in the Future?”

Jerry Avorn, President, ISPE “What Does Pharmacoepidemiology Expect to do in the Future.”
10:15 - 10:45 Coffee Break (Postdam Foyer)

Session 2: Joint ISPE - Eurodurg Session (Postdam I)
Session Chairs: Michael A. Lewis and Ulf Bergman
10:45 - 11:05 Antibiotic Prescribing for Preschool Children: A Linked Database Analysis [57]
Thomas Einarson, E. Wang, J. Kellner, J. Conly
11:05 - 11:25 Factors Associated with Antiepileptic Drug Use by Elderly Nursing Home Residents [261]
Judith Garrard, J. Cloyd, N. Hardie, T. Lackner, I. Leppik (USA)
11:25 - 11:45 Polypharmacy in General Practice - Differences between Practitioners [248]
Lars Bjerrum, J. Søgaard, J. Hallas, J. Kragstrup
11:45 - 12:05 NSAID Use and GI Toxicity Profiles by Country: A European Study [247]
Ulf Bergman (Sweden), B. Wettermark (Sweden), M. Andersen (Denmark), L. Bjerrum (Denmark), A. Vaccheri (Italy), N. Montanaro (Italy)
12:05 - 12:25 Results from an Educational Intervention in Five Countries to Implement Guidelines for Prescribing in Practice [232]
P. Denig (The Netherlands), M. Andrew (Norway), R.Wahlström (Sweden), M. Muskova (Slovakia),E. Hummers Pradier (Germany), C. Stalsby Lundborg (Sweden), FM Haaijer-Ruskamp (The Netherlands)
12:30 - 13:30 Lunch (La-Cafe, Windergarten)
13:30 - 14:00

Poster Session I - Dessert and Coffee

Session Chair: Robert Marley

14:00 - 14:15 Proportional Reporting Ratios: The Uses of Epidemiological Methods for Signal Generation [55]
S.J.W. Evans, P. Waller, S. Davis (UK)
14:15 - 14:30 Identifying and Quantifying Signals Automatically [47]
Andrew Bate, M. Lindquist, R. Orre, R. Edwards (Sweden)
14:30 - 14:45 Anti-ulcer Drugs and Severe Cutaneous Adverse Reactions [71]
Judith Kelly (USA)
14:45 - 15:00 Drug Use in Pregnancy - A Population-based Survey on 15.756 Women [121]
Charlotte Olesen (Denmark), F. H. Steffensen (Denmark), L. de Jong-van den Berg (The Netherlands), J. Olsen (Denmark), H.T. Sørensen (Denmark)
15:00 - 15:15 Pregnancy Outcome Following Prescription for Sumatriptan [123]
Charlotte Olesen , F. H.. Steffensen , H.T. Sørensen, G. L. Nielsen, J. Olsen (Denmark)
15:15 - 15:30 The PEGASUS-project: A Prospective Cohort Study for the Investigation of Drug Utilization in Pregnancy [240]
Cornelia Irl, J. Hasford (Germany)

Session Chair: Samy Suissa (Postdam III)
14:00 - 14:15 Thromboembolic Stroke in Young Women and Oral Contraceptive Use [67]
L.A. J. Heinemann, T. DoMinh, M.A. Lewis (Germany)
14:15 - 14:30 Analysis of a Suspected Interaction Between Itraconazole and Desogestrel Containing Oral Contraceptives in a Spontaneous Reporting System [161]
Eugène P. van Puijenbroek, R. Meyboom, M. HAM Vinks, A. CG Egberts (The Netherlands)
14:30 - 14:45 Is Hormone Replacement Therapy Protective for Venous Ulcers of the Lower Limbs? [5]
Anick Bérard, S. Kahn, J. Collet, L. Abenhaim (Canada)
14:45 - 15:00 Postmenopausal Risk of Ischemic Heart Disease in Former Users of Ocs in the Dom-Cohort [286]
Hubert G. Leufkens, P. AH van Noord, M. de Bruijn, W. JMJ Gorgels, D. Grobbee (The Netherlands)
15:00 - 15:15 A Prescription Claims Data Assessment of Noncompliance with Hormone Replacement Therapy (HRT); Comparison of Two Definitions of Noncompliance [59]
Lela M. Lucy, D.L. Faulkner (USA)
15:15 - 15:30 The Awareness and Behaviour of Dutch Women Before and After the National Folic Acid Campaign [235]
Lolkje TW de Jong-van den Berg, H. EK deWalle, K.M. van der Pal-de Bruin, S. E. Buitendijk, M.C. Cornel
(The Netherlands)

Chair: Flora M. Haaijer-Ruskamp (Charlottenberg II/III)
14:00 - 15:30 Improving Prescribing Practices - Testing and Understanding the Effect of Educational Interventions [231]
Flora M. Haaijer-Ruskamp (The Netherlands), M. Andrew (Norway), P. Denig (The Netherlands), V. Diwan (Sweden), M. Muskova (Slovakia), C. Stalsby Lundborg (Sweden), R. Wahlstrom (Sweden)
15:30 - 15:45 Coffee Break (Postdam Foyer)

Chair: Bernie O'Brien (Postdam III)
15:45 - 16:00 A Longitudinal, Population Based, Controlled Study of Healthcare Resource Use and Mortality for Patients with Parkinson's Disease [242]
P.T. Donnan, C. Stubbings, D.T. Steinke, T.M. MacDonald, D.G. McDevitt, PG Davey (Scotland, UK)
16:00 - 16:15 A Cost Analysis of Drugs vs. Laser Surgery to Treat Glaucoma [16]
Rhonda L. Bohn, K. Kuntz, L. Pasquale, A. Walker, R. Glynn, J. Gurwitz,J. Avorn (USA)
16:15 - 16:30 The Effect of Open Access Endoscopy on the Prescribing Costs of Ulcer Healing Drugs [260]
Alex McMahon (Scotland, UK), B.M. Goudie (Scotland, UK), G. White (Scotland UK), T.M. MacDonald (Scotland, UK), M. Fe (Ireland, UK)
16:30 - 16:45 A Health Economic Evaluation of Paclitaxel and Carboplatin Versus Vinorelbine and Ciplatin Combination Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer [322]
Neeta Sinha (USA), J.D. Hainsworth (USA), T.R. Einarson (Canada), P.T. Lappas (USA)
16:45 - 17:00 Compliance with Inhaled Corticosteroids and Hospitalization for Asthma [258]
Alex McMahon, B.J. Lipworth, P.G. Davey, A.D. Morris, T.M. MacDonald (Scotland, UK)
17:00 - 17:15

Discounting the Economic Evaluation of Preventive Interventions and Compliance [LB22]
Sema Aydede, J. Bauman (USA)

Chair: David Goldsmith Potsdam I

15:45 - 16:00 Prevention of Hypotension Following Cardiopul- monary Bypass by Intravenous Calcium Chloride Administration [79, 80]
Stephen E. Kimmel, A. Haghighat, J.A. Berlin, M. A. Sekeres, N. Ellison, B. Strom, V. J. DiSesa (USA)
16:00 - 16:15 First Time Antihypertensive Drug Use and the Risk of Fatal and Non-Fatal Acute Myocardial Infarction [15]
Chantal Bourgault, E. Elstein, M. Baltzan, S. Suissa (Canada)
16:15 - 16:30 Selection of Anti-hypertensive Drug Classes and Pre Existence of Comorbid Conditions [115]
Rajiv Mallick, S. Leader, L. Roht (USA)
16:30 - 16:45 Exposure to Inhaled Corticosteroids and the Risk of Cataract Extraction in Elderly Patients [200]
Edeltraut Garbe (Germany), S. Suissa (Canada), J. LeLorier (Canada)
16:45 - 17:00 Lack of Intraocular Pressure Effect of Budesonide Inhalation Therapy in Mixed Asthma Population [90]
Mei-Sheng Duh (USA), A. Walker (USA), B. Lindmark (Sweden), A. Laties (USA)
17:00 - 17:15

Oral Contraceptives and Myocardial Infarction: The MICA Study [52]
Nick Dunn, R. Mann (UK)

Chair: Frank W. May, Liselotte von Ferber
Charlottenberg II/III

15:45 - 17:15 Academic Detailing Services for Better Drug Use - A Workshop For Discussions of Problems and Solutions [102]
Frank W. May (Australia), L. von Ferber (Germany), J. Avorn (USA), S. Chapman (UK) S. Whicker (Australia), L. Hensjø (Sweden), D. Rowett (Australia) H. McGavock (Ireland)

17:30 - 18:30 Academic Council (Tiergarten I/II)
17:30 - 18:30 Industry Council Meeting (Köpenick I/II)
17:30 - 18:30 Government/ Regulatory Council
17:30 - 18:30 Clinical Meeting (Charlottenberg I/II/III)
19:30 - 22:00 Reception by the Senate of Berlin Berlin City Hall (Rotes Rathaus)

Tuesday, August 18

07:30 - 09:00 Poster Session II (Postdam II)
Continental Breakfast

Session 6a: PEER REVIEW - DISCUSSED PAPERS Chair: Richard Farmer (Postdam I)
09:00 - 09:40 Newer Antidepressants: a Comparison of Tolerability [106]
Fiona Mackay, R. Martin, G. Pearce, S. Freemantle, R. Mann (UK)
09:40 - 10:15 The Differential Risk of Oral Contraceptives: the Impact of Full Exposure History [86]
Michael A. Lewis (Germany), K. MacRae (UK), D. Kühl-Habich (Germany)

Chairs: Elizabeth Andrews, Christian von Ferber
(Postdam III)
09:00 - 9:15 Introduction : ISPE recommendations –
Status of legislation in the USA
Elizabeth Andrews, PhD, MPH
Glaxo Wellcome, Inc., USA
09:15 - 09:25 Report from Canada
Donald Willison, PhD
McMaster University, Canada
09:25 - 09:35 Report from Germany
Annekarin Bertelsmann, PharmD, DipEpid
Federal Institute for Drugs and Medical Devices, Germany
09:35 - 09:45 Report from Australia
Frank May, MA
Repatriation General Hospital, Australia
09:45 - 10:00 Discussion
10:00 - 10:15

Resolutions: Standards for Independent Review Boards Christian von Ferber

Referees will report on the solutions for central problems of protecting privacy in pharmacoepidemiological and drug utilization research e.g. record linkage or secondary use of health data etc. in their countries.

10:15 - 10:45 Coffee Break (Postdam Foyer)

Chair: Jerry Avorn (Postdam I)
10:45 - 12:00

Anorexiant Debacle
Chair: Jerry Avorn

Chairs: Hubert Leufkens, Jürgen Brockmöller
(Postdam III)

10:45 - 10:55 Introduction
Dr. H. Leufkens, PhD, PharmD
University of Utrecht, Utrecht
The Netherlands
10:55 - 11.15 Patient typing and comparative risk/benefit evalu- ation in drug therapy: from epidemiology to molecules and visa versa.
Dr. H. Leufkens, PhD, PharmD
University of Utrecht, Utrecht
The Netherlands
11:15 - 11:35 Perspectives of molecular epidemiology in pharmacoepidemiology
Dr. Jürgen Brockmöller
Humboldt University,
Berlin, Germany
10:35 - 12:00 From genes to epidemiology: osteoporosis as a case example
Dr. Huib Burger, MD, PhD
University of Utrecht, Utrecht
The Netherlands
12:00 - 13:00 Lunch (La Cafe, Roof Garden )
12:00 - 13:00 Correspondents Lunch (Bellevue)
13:00 - 13:30 Poster Session II - Coffee & Dessert (Postdam II)

Chair: Jerry Avorn, President (Potsdam I)
13:30 - 14:30 Membership Meeting
Chair: Hugh Tilson

Pharmacoeconomics: Identifying the Issues for Pharmacoepidemiology [277]
Hugh Tilson (USA), N. McElwee (USA), J. Kotsanos (USA), P. Davey (Scotland, UK), T. Einarson (Canada)
15:30 - 16:00 Coffee Break (Potsdam Foyer)
Chair: Stanley A. Edlavitch
Chair: Gottfried Kreutz
19:00 - 22:00 Berlin Brass Band at the Renaissance Theater

Wednesday, August 19

07:30 - 09:00 Poster Session III (Potsdam II)

Chair: Susanne Pérez-Guthann (Potsdam I)
09:00 - 09:15 Changes in the Treatment of Women with Depression in the United States: The National Ambulatory Medical Care Survey, 1993-1996 [167]
Sheila R. Weiss, J. Magno Zito, S. Qi (USA)
09:15 - 09:30 Changing Patterns of Methylpenidate Use and Costs: 1991-1996 [18]
Myde Boles, F. Lynch, R. Johnson, J. Zito, L Phelps (USA)
09:30 - 09:45 Drug-Induced Parkinsonism in Psychiatric Patients: A Case Control Study [220]
I.E.R.M. Schillevoort (The Netherlands), L. Kutikova (The Netherlands), R.M.C. Herings (The Netherlands), G.W.K. Hugenholtz (Czech Republic), R.A.C. Roos (Czech Republic), H.G.M. Leufkens (The Netherlands)
09:45 - 10:00 Road Traffic Accidents are Associated with Benzodiazepine Use [257]
F. Barbone, AD McMahon, PG Davey, AD Morris, DG McDevitt, TM MacDonald (Scotland, UK)
10:00 - 10:15 Long-Term Use of Benzodiazephines Among Community Dwelling Seniors in Ontario - Area Variation and Patient-Level Predictors [163]
Don Willison, A.J, Kirshen, G. Anderson (Canada)

Chair: J.W. Van der Velden (Postdam III)
09:00 - 09:15 Evaluation of the Varicella Vaccine (Varivax) Safety in 89,753 Vaccine Recipients and Long- Term Effectiveness Using of a Retrospective Healthcare Database [26]
Paul Coplan, S. Black, H. Shinefield, P. Ray, N. Lewis, J. Hansen, H. Guess (USA)
09:15 - 09:30 The Safety of Multiple Simultaneous Vaccinations, A Pilot Study [49]
Robert T. Chen, D. Gu, H. Takahasi, P. Gargiullo (USA)
09:30 - 09:45 A Cohort Study on the Risk of Acute Liver Injury Among Users of Ketoconazole and Other Antifungal Drugs [212]
Luis A. García Rodríquez (Spain), A. Duque (Spain), J. Castellsague (Spain) S. Pérez Gutthann (Spain), BHCh Stricker (The Netherlands)
09:45 - 10:00 Case-Crossover Study of Antibiotics and Vaginal Candidiasis: Estimation of Induction Time and Duration of Effect Period [299]
Morten Andersen, D. Gaist, J. Hallas, M. Maclure (Denmark)
10:00 - 10:15 Risk of Tendon-Ruptures Associated with Fluoroqinolone Use [223]
PD van der Linden, RMC Herings, HW Nab, BHCh Stricker (The Netherlands)

Chair: Morten Anderson, F. Barbone, T. MacDonald, M. Maclure, S. Suissa.
09:00 - 10:30 What Influences Whether a Case-Crossover Study is Simple or Complex? [118]
Morten Andersen (Denmark), F. Barbone (Italy), T. MacDonald (Scotland, UK), M. Maclure (Canada), S. Suissa (Canada)
10:15 - 10:45 Coffee Break

Session 10a: METHODS
Chair: Carlos Martinez
10:45 - 11:00 The Relative Excess Risk: an Alternative Measure of Comparative Risk [76]
Samy Suissa (Canada)
11:00 - 11:15 Utility of Control-to-Case Ratios Greater Than 4: The Role of Phi [70]
Sean Hennessy, W. Bilker, J. Berlin, B. Strom (USA)
11:15 - 11:30 Approaches to Duration Response Analysis [69]
Sean Hennessy, P. Allison, W. Bilker, J. Berlin, B. Strom (USA)
11:30 - 11:45 Accounting for Disease Severity in Assessing the Association of Influenza Vaccine with Asthma Exacerbations [82]
Piotr Kramarz, F. DeStefano, P. Gargiullo, R.Chen (USA)
11:45 - 12:00 Methods for the Estimation of Global Excess Risks of Medications with Multiple Adverse Effects [77]
Stephan Rietbrock, (Germany), C. Martinez (Germany), S. Suissa (Canada)
12:00 - 12:15 Use of Claims Data and a Cancer Registry to Investigate a Hypothetical Adverse Drug Effect [162]
Philip Wang, A. Walker, M. Tsuang, E.J. Orav, R. Levin, J. Avorn (USA)

Session 10b: ANALGESICS
Chair: Kuni Hiashi
10:45 - 11:00 Proactive Surveillance Program to Assess Ultram (Tramadol) Abuse [324]
Theodore Cicero, E. Senay, A. Muñoz (USA)
11:00 - 11:15 Risk of Seizures Associated with Tramadol: A Cohort Study in an Ambulatory Setting [252]
Jacqueline Gardner, D. Blough, D. Shatin, C. Drinkard, L. Powler, R. Alderfer, D. Graham, G. Anderson, A. Stergachis (USA)
11:15 - 11:30 Non-Steroidal Anti-Inflammatory Drugs and the Incidence of Alzheimer's Disease The Rotterdam Study [88]
B.A. In 't Veld, L.J. Launer, A.W. Hoes, A. Ott, A. Hofman, M.M.B. Breteler, B.H.Ch.Stricker (The Netherlands)
11:30 - 11:45 Alcohol Abuse as Effect Modifier in Risk of GI Complications after NSAID Use [282]
C. Ineke Neutel (Canada)
11:45 - 12:00 Tylenol and Upper Gastrointestinal Bleeding [83]
Judith Kelly (USA), D. Kaufman (USA), R. Köff (USA), B.E. Wilholm (Sweden), A. Laszlo (Hungary), S. Shapiro (USA)

Session 10c: WORKSHOP - Pharmaco- epidemiological Studies in Germany: An Overview
Chair: Annakarin Bertelsman, Hans-Ulrich Melchert
10:45 - 10:50 Introduction
10:50 - 11:00 M. Mockenhaupt:
The Registry of severe cutaneous adverse reactions (SCAR)
11:00 - 11:05 C. Martinez:
Anti-diabetic drugs and the risk of Stevens-Johnson syndrome and toxic epidermal necrolysis
11:05 - 11:10 J. Schlingmann:
Severe cutaneous adverse reactions (SCAR) due to Chlormezanone and Diciofenac
11:10 - 11:15 M. Mockenhaupt:
Antimycotic agents as etiologic factors for severe cutaneous adverse reactions (SCAR)
11:15 - 11:25 L. von Ferber:
A Nation Wide Random Sample of Health Insurance Members in Germany - Opportunities for Pharmacoepidemiologic Research
11:25 - 11:35 Gasse:
Trends in Antihypertensive drug use in a German population from 1984 to 1995
11:35 - 11:45 T. Stürmer/Erb:
The Ulm Osteoarthritis Study
11:45 - 11:55 U. Melchert:
The German Health Survey
11:55 - 12:05 M. Lewis:
Adverse event monitoring in a population of German children
12:05 - 12:15 Discussion
12:15 - 13:15 Lunch
12:15 - 13:45 Lunch Meeting - Scientific Program Committee
13:15 - 13:45 Poster Session III - Dessert and Coffee

Session 11: HOT TOPICS
13:45 - 15:00 Lessons Learned from the Controversies over Calcium Channel Blockers

Dr. A. Walker, Professor of Epidemiology
Harvard University, Boston, MA, USA

Cancer Data and the Barriers to Dissemination
Samuel Lesko, Assoc. Professor Epidemiology
Boston University, Boston, MA, USA

Cardiovascular Effects of CCBs:
What’s known and What’s been claimed.

Michael Weber, Professor of Medicine &
Assistant Dean
State University of New York , New York, USA

Calcium Channel Blockers and Suicide
Dr. Ulf Bergman, Division of Clinical
Pharmacology & Pyschiatry
Karolinska Institute, Huddinge University Hospital
Huddinge University, Stockholm, Sweden

Clinicians: Responsible for or Reacting to the Controversy
Paul Hugenholtz, Professor of Cardiology
Medical Faculty of Rotterdam, The Netherlands

Session 12: CLOSING
15:00- 16:00 Closing Remarks (Potsdam I)
Michael A. Lewis
Jerry Avorn
Keith Beard