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Drug Consumption Databases in Europe

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Drug Consumption Databases in Europe WP2 Framework for pharmacoepidemiological studies WG3 Drug utilisation data DRUG CONSUMPTION DATABASES IN EUROPE Master document First version August 2011 Updated version October 2012 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 nº 115004. PROTECT Drug consumption databases in Europe Master document, updated October 2012 Page 2 of 170 Working Package 2 (Working Group 3) participants and affiliation Name Institution Country Role in WP2 Joan-Ramon Laporte Foundation Catalan Spain WG3 participants Luisa Ibáñez Institute of Mònica Sabaté Pharmacology (FICF) Elena Ballarín Pili Ferrer Paula Solari1 Sam Yeboa2 Amgen United Kingdom WG3 participants Kay Lay Goh3 Marieke Shoonen4 Joan Fortuny Novartis Spain WG3 participants Joerg Hasford Ludwig Maximilians Germany WG3 participants Marietta Rottenkolber Universität Olaf Klungel Utrecht University Netherlands WP2 colead Hans Petri L.A. Hoffmann-Roche United Kingdom WG3 participants Iain Tatt5 Switzerland Robert Reynolds Pfizer United States WP2 colead 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 4 Participation from April 2012 5 Participation from April 2012 PROTECT Drug consumption databases in Europe Master document, updated October 2012 Page 3 of 170 Document type : report First version: August 2011 Updated version: October 2012 Keywords: DRUG UTILISATION; AUTOMATED DATABASES; EUROPE; IN- AND OUTPATIENT HEALTHCARE SETTING; Suggested citation: Ferrer P, Ballarín E, Sabaté M, Rottenkolber M, Hasford J, Tatt I, Schoonen M, Fortuny J, Petri H, Goh KL, Yeboa S, Solari P and Ibáñez L, on behalf of the PROTECT project. Drug Consumption Databases in Europe. Barcelona, October 2012.170 pages WP2 Co-leaders: Olaf Klungel (UU) andRobert Reynolds (Pfizer) WG3 Coordinators: Luisa Ibáñez (FICF) and Hans Petri (Roche) up to March 2012. Joan Fortuny (Novartis) from April 2012. First version 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). Updated versions authors: Pili Ferrer (FICF), Elena Ballarín (FICF), Mònica Sabaté (FICF), Joan Fortuny (Norvartis), Iain Tatt (Roche), Marieke Schoonen (Amgen), Marietta Rottenkolber (LMU), Joerg Hasford (LMU) and Luisa Ibáñez (FICF). Reviewers (all versions): Olaf Klungel (UU), Robert Reynolds (Pfizer), Joan-Ramon Laporte (FICF). Conflicts of interest: The research leading to these results was conducted as part of the PROTECT consortium (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium), www-imi-protect.eu, which is a private- public partnership coordinated by the European Medicines Agency. The PROTECT project has received support from the Innovative MedicineInitiative Joint Undertaking (www.imi.europa.eu) under Grant Agreement n° 115004, resources of which are composed of financial contributionfrom the European Union's Seventh Framework Programme (FP7/2007-2013)and EFPIA companies' in kind contribution. The views expressed are those of the authors only. Authors’ disclosure information: Joan Fortuny, Iain Tatt, Marieke Schoonen, Hans Petri and Robert Reynolds belong to EFPIA (European Federation of Pharmaceutical Industries and Association) member companies in the IMI JU and costs related to their part in the research were carried by the respective company as in-kind contribution under the IMI JU scheme. PROTECT Drug consumption databases in Europe Master document, updated October 2012 Page 4 of 170 TABLE OF CONTENTS PREFACE ...................................................................................................................... 8 ACKNOWLEDGEMENTS ................................................................................................... 9 LIST OF ABBREVIATIONS ............................................................................................. 10 EXECUTIVE SUMMARY .................................................................................................. 14 1 INTRODUCTION ................................................................................................. 19 1.1 BACKGROUND ............................................................................................... 19 1.2 RATIONALE ................................................................................................... 19 1.3 OBJECTIVES .................................................................................................. 21 1.3.1 GENERAL OBJECTIVE ............................................................................... 21 1.3.2 SPECIFIC OBJECTIVES ............................................................................. 21 2 METHODOLOGY .................................................................................................. 23 2.1 GENERAL METHODS ....................................................................................... 24 2.1.1 SEARCH STRATEGY.................................................................................. 24 2.1.2 INCLUSION CRITERIA .............................................................................. 26 2.2 SPECIFIC METHODS FOR OUTPATIENT DRUG UTILISATION RESOURCES............... 28 2.2.1 NON-COMMERCIAL DATA PROVIDERS ........................................................ 28 2.2.2 COMMERCIAL DATA PROVIDERS ................................................................ 28 2.3 SPECIFIC METHODS FOR INPATIENT DRUG UTILISATION RESOURCES ................. 28 2.3.1 NON-COMMERCIAL DATA PROVIDERS ........................................................ 28 2.3.2 COMMERCIAL DATA PROVIDERS ................................................................ 30 3 RESULTS ............................................................................................................ 31 3.1 BACKGROUND DATA ....................................................................................... 33 3.1.1 DATA PROVIDERS OF AUTHORISED MEDICINAL PRODUCTS ......................... 33 3.1.2 HEALTH SYSTEMS.................................................................................... 35 3.1.3 PRICING AND REIMBURSEMENT AGENCIES ................................................ 35 3.1.4 PHARMACEUTICAL INFORMATION .............................................................. 39 3.1.5 INTERNATIONAL NETWORKS AND WORKING GROUPS IN PHARMACOEPIDEMIOLOGY .................................................................................... 43 3.1.6 PROTECT PARTNERS’ RESOURCES ............................................................. 55 3.2 OUTPATIENT DRUG UTILISATION RESOURCES .................................................. 57 3.2.1 NON-COMMERCIAL DATA PROVIDERS ........................................................ 57 3.2.2 COMMERCIAL DATA PROVIDERS ................................................................ 76 3.3 INPATIENT DRUG UTILISATION RESOURCES ..................................................... 77 3.3.1 NON-COMMERCIAL DATA PROVIDERS ........................................................ 77 3.3.2 COMMERCIAL DATA PROVIDERS ................................................................ 84 3.4 SUMMARY OF DRUG CONSUMPTION DATA SOURCES IN EUROPE ......................... 84 4 VALIDITY OF DRUG CONSUMPTION DATA .......................................................... 90 4.1 INTRODUCTION ............................................................................................. 90 PROTECT Drug consumption databases in Europe Master document, updated October 2012 Page 5 of 170 4.2 SPECIFIC METHODOLOGY ............................................................................... 91 4.3 SPECIFIC RESULTS ......................................................................................... 93 4.3.1 Table with drug consumption data ............................................................. 93 4.3.2 Sensitivity and specificity ......................................................................... 93 4.3.3 Questionnaire results ............................................................................... 94 4.3.4 Reimbursement policies........................................................................... 101 5 DISCUSSION ..................................................................................................... 112 5.1 OUTPATIENT DRUG UTILISATION RESOURCES ................................................. 112 5.2 INPATIENT DRUG UTILISATION RESOURCES .................................................... 114 5.3 VALIDITY OF DATA ........................................................................................ 116 6 CONCLUSIONS .................................................................................................. 120 7 APPENDICES ..................................................................................................... 121 7.1 ATC CODES OF DRUGS OF INTEREST FOR THE PROTECT PROJECT ...................... 121 7.2 KEY PAIRS ADVERSE DRUG EVENTS-DRUGS, SELECTED FOR THE PROTECT PROJECT 127 7.3 EUROPEAN HEALTH CARE SYSTEMS ................................................................ 128 7.4 SUMMARY TABLE OF GENERAL
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