DRUG CONSUMPTION DATABASES IN EUROPE Master document WP2 Framework for pharmacoepidemiological studies WG3 Drug utilization data PROTECT: Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium The PROTECT project is receiving funding from the European Community’s Seventh Framework Programme (FP7/2007-2013) for the Innovative Medicines Initiative (IMI) IMI Call topic: Call No.6: Strengthening the Monitoring of Benefit/Risk (Call Identifier: IMI_Call_2008_1_06). Grant agreement n. 115004 Document type : report Release date: August, 2011 Keywords: DRUG UTILIZATION; AUTOMATED DATABASES; EUROPE; IN- AND OUTPATIENT SECTOR. Suggested citation: Ferrer P, Ballarín E, Sabaté M, Petri H, Goh KL, Yeboa S, Solari P and Ibáñez L., on behalf of the PROTECT project. Drug Consumption Databases in Europe. Barcelona, August 2011. 190 pages. WP2 Co-leaders: Olaf Klungel (UU) and Robert Reynolds (Pfizer). WG3 Coordinators: Luisa Ibáñez (FICF) and Hans Petri (Roche). Authors: Pili Ferrer (FICF), Elena Ballarín (FICF), Mònica Sabaté (FICF), Hans Petri (Roche), Paula Solari 1(FICF), SamYeboa2 (Amgen) , Kay Lay Goh3 (Amgen) and Luisa Ibáñez (FICF). Reviewers (in alphabetical order): Joan Fortuny (Novartis), Joerg Hasford (LMU), Olaf Klungel (UU), Robert Reynolds (Pfizer). Working Package 2 co-leaders and Working Group 3 participants affiliation Joan-Ramon Laporte Foundation Catalan Spain Luisa Ibáñez Institute of Mònica Sabaté Pharmacology (FICF) Elena Ballarín Pili Ferrer Paula Solari1 Sam Yeboa2 Amgen United Kingdom Kay Lay Goh3 Joan Fortuny Novartis Spain Joerg Hasford Ludwig Maximilians Germany Universität Olaf Klungel Utrecht University Netherlands Hans Petri Roche United Kingdom Robert Reynolds Pfizer United States Raymond Schlienger4 Novartis Switzerland 1Participated during the first 18 months of the project 2 Participated during the first 20 months of the project 3 Participated during the first 21 months of the project 4Participated during the first 12 months of the project TABLE OF CONTENTS Preface………………….….…………………………………………………………………7 Acknowledgements………………………………………………………………………..9 List of abbreviations……………….……………………………………………………….10 List of tables and figures………………………………….………………………….……16 Executive summary……………………………………………….………………………..17 1 INTRODUCTION ........................................................................................................25 1.1 BACKGROUND ................................................................................................25 1.2 RATIONALE .......................................................................................................26 1.3 OBJECTIVES ......................................................................................................31 1.3.1 General objective ....................................................................................32 1.3.2 Specific objectives ...................................................................................32 2 METHODOLOGY.......................................................................................................33 2.1 GENERAL METHODS........................................................................................34 2.2 SPECIFIC METHODS FOR OUTPATIENT DRUG UTILIZATION RESOURCES ...40 2.2.1 NON-COMMERCIAL DATA PROVIDERS .................................................40 2.2.2 COMMERCIAL DATA PROVIDERS ...........................................................41 2.3 SPECIFIC METHODS FOR INPATIENT DRUG UTILIZATION RESOURCES.......41 2.3.1 NON-COMMERCIAL DATA PROVIDERS .................................................41 2.3.1.1 HOSPITAL DRUG UTILIZATION (GENERAL OVERVIEW)..................41 2.3.1.2 ANTIMICROBIAL (J01FA, J01CR02) DRUG UTILIZATION IN HOSPITALS.............................................................................................................44 2.3.2 COMMERCIAL DATA PROVIDERS ...........................................................45 3 RESULTS......................................................................................................................46 3.1 BACKGROUND DATA .....................................................................................47 3.1.1 DATA PROVIDERS OF AUTHORISED MEDICINAL PRODUCTS...............47 3.1.2 HEALTH SYSTEMS ........................................................................................50 3.1.3 PRICING AND REIMBURSEMENT AGENCIES...........................................50 3.1.4 PHARMACEUTICAL INFORMATION .........................................................53 3.1.5 INTERNATIONAL NETWORKS AND WORKING GROUPS IN PHARMACOEPIDEMIOLOGY .................................................................................57 3.1.5.1 GENERAL RESEARCH GROUPS.........................................................58 3.1.5.1.1 ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance). ...............................58 3.1.5.1.2 EuroDURG (European Drug Utilization Research Group) ......59 3.1.5.1.3 CNC (Cross-National Comparison of Drug Utilization Research) 61 3.1.5.1.4 DURQUIM (Drug Utilization Research Quality Indicator Meeting) 62 3.1.5.1.5 EUROMEDSTAT (European Medicines Statistics)......................63 3.1.5.1.6 ISPE’S SIG-DUR (International Society of Pharmaco Epidemiology’s Special Interest Group on Drug Utilization/Health Service Research)...........................................................................................64 3.1.5.1.7 NorPen (The Nordic Pharmacoepidemiological Network) ..65 4 3.1.5.1.8 PIPERSKA Goup.............................................................................66 3.1.5.2 DRUG RESEARCH GROUPS WITH FOCUS ON SPECIFIC DRUGS/DISEASES .................................................................................................67 3.1.5.2.1 ARITMO (Arrhytmogenic potential of drugs)...........................67 3.1.5.2.2 ARPAC (Antibiotic Resistance Prevention and Control) .......69 3.1.5.2.3 ESGAP (European Study Group on Antibiotic Policy)............70 3.1.5.2.4 ESAC (European Surveillance of Antimicrobial Consumption) 71 3.1.5.2.5 ESEMeD (European Study of the Epidemiology of Mental Disorders) 72 3.1.5.2.6 EUROASPIRE (European Action on Secondary and Primary Prevention by Intervention to Reduce Events)..........................................73 3.1.5.2.7 TEDDY (Task-force in Europe for Drug Development for the Young) 74 3.1.6 PROTECT PARTNERS’ RESOURCES ...........................................................75 3.2 OUTPATIENT DRUG UTILIZATION RESOURCES...............................................76 3.2.1 NON-COMMERCIAL DATA PROVIDERS .................................................76 3.2.1.1 NATIONAL DRUG CONSUMPTION DATABASES IN EUROPE .........76 3.2.1.1.1 Denmark ........................................................................................76 3.2.1.1.2 Finland............................................................................................78 3.2.1.1.3 France ............................................................................................80 3.2.1.1.4 Germany .......................................................................................82 3.2.1.1.5 Italy .................................................................................................84 3.2.1.1.6 Norway...........................................................................................85 3.2.1.1.7 Poland............................................................................................87 3.2.1.1.8 Spain...............................................................................................88 3.2.1.1.9 Sweden ..........................................................................................89 3.2.1.1.10 The Netherlands .........................................................................91 3.2.1.1.11 The United Kingdom ..................................................................93 3.2.2 COMMERCIAL DATA PROVIDERS ...........................................................98 3.3 INPATIENT DRUG UTILIZATION RESOURCES ................................................101 3.3.1 NON-COMMERCIAL DATA PROVIDERS ...............................................101 3.3.1.1 DRUG UTILIZATION IN HOSPITAL SETTINGS....................................101 3.3.1.2 ANTIBACTERIAL UTILIZATION IN HOSPITAL SETTINGS....................108 4 VALIDITY OF DRUG CONSUMPTION DATABASES...............................................115 4.1 SPECIFIC METHODOLOGY ...........................................................................115 4.2 SPECIFIC RESULTS...........................................................................................118 5 DISCUSSION............................................................................................................124 5.1 OUTPATIENT DRUG UTILIZATION RESOURCES.............................................125 5.2 INPATIENT DRUG UTILIZATION RESOURCES ................................................129 5.3 VALIDITY OF DATABASES ..............................................................................132 6 CONCLUSIONS.......................................................................................................138 7 RECOMMENDATIONS............................................................................................139 5 8 APPENDICES ...........................................................................................................140 9 BIBLIOGRAPHY .......................................................................................................205