The NorPen Register Project

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1 The NorPen Register Project, Professor Karolinska Institutet Department of Medicine Solna Clinical Epidemiology Unit, T2 Karolinska University Hospital Stockholm, Sweden 20 februari

2 NorPen was established 2008 The member organizations are research groups and authorities from all five Nordic countries working with pharmacoepidemiology 20 februari

3 Nordic countries and pharmacoepidemiological studies Population of almost 25 million people Homogeneous Genetically Socioeconomically National Health Registers Public health care system (almost free of charge) Reimbursement of medicines for the whole population Personal Identification Numbers (PINs) 20 februari

4 NorPEN members The pharmacoepidemiology research group, Nordic School of Public Health, Sweden Department of Clinical Epidemiology, Aarhus University, Denmark Institute of Public Health, University of Southern Denmark, Denmark Research group of USE OF ANTIDEPRESSANTS IN FINLAND, National Institutet for Health and Welfare, Finland The research group on Drug and Pregnancy (DAP), National Institutet for health and Welfare, Finland The Kuopio Research Centre of Geriatric Care (Cerho), University of Kuopio, Finland The Medicine group of the Social Insurance Institute, Finland University of Iceland, Iceland Department of pharmacoepidemiology, Norwegian Institute of Public Health, Norway Centre for Pharmacoepidemiology (CPE), Karolinska Institutet, Sweden Centre for Epidemiology, The National Board of Health and Welfare, Sweden 20 februari

5 Overall aim The overall aim of NorPen is to create a strong environment for this novel and worldunique possibility to cary out population based and cross-country comparative research in pharmacoepidemiology, thereby promoting safer and more efficient medicines and medicine use in a public health perspective. 20 februari

6 Specific aims To document, facilitate and promote Nordic pharmacoepidemiological research initiatives To increase quality of research and methodological development within pharmacoepidemiology in the Nordic countries To create an interactive forum for PhD-students and supervisors within several pharmacoepidemiological research areas 20 februari

7 Steering group Max Petzold, SE Mette Nørgaard, DK Morten Andersen, DK Jana Martikainen, FI Sirpa Hartikainen, FI Magnús Jóhansson, IS Kari Furu, NO Pinelopi Lundquist, SE Helle Kieler, SE NorPen Organisation Collaborators Database holders Authorities ENCePP Reference group Professor, Karolinska Institutet, Sweden; Professor Jesper Hallas, University of Southern Denmark; Professor Bert Leufkens, Utrecht University, the Netherlands; Professor Henrik Toft Sørensen, Aarhus University, Denmark Forum Supervisors and PhD students 20 februari

8 Nordic National Health Registries Cancers Registers Medical Birth Registers Cause of Death Registers Patient Registers Prescribed Drug Registers 20 februari

9 Nordic National Health Registries NO Cancer Registers DK FI IS SE Medical Birth Registers NO 1967 IS DK SE FI Cause of Death Registers DK 1943 NO 1951 SE 1961 FI 1969 IS februari

10 Nordic National Health Registries FI DK SE Patient Registers FI DK IS NO SE Prescribed Drug Registers februari

11 Register quality Reporting is compulsory Standardized information obtained from Physicians, midwives, pharmacies Forwarded to register holders Electronically or in a paper form Reporting rate depends on Type of disease Patients age Residential area 20 februari

12 Register quality All registers are upp-dated regularly 99 % of all cancers have been verified by pathological examinations Registers are routinely checked Current vs previous data Cancer Register vs Cause of Death Register Medical Birth Register vs Patient Register Possible to complete and correct data 20 februari

13 High validity in the Nordic databases Barlow L et al. The completeness of the Swedish Cancer Register: a sample survey for year 1998, Acta Oncol. 2009;48(1):27-33 Stensballe LG et al. Diagnosis coding in The Danish National Patient Registry for respiratory syncytial virus infections, Scand J Infect Dis. 2005;37(10): Cnattingius S et al. A quality study of a Medical Birth Registry, Scand J Soc Med Jun;18(2):143-8 Haukka J et al. High concordance between self-reported medication and official Prescription Database information. Eur J Clin Pharmacol Nov;63(11): februari

14 Nordic register collaborations ANCR - The Association of the Nordic Cancer Registries (NORDCAN) NOMESCO - Nordic Medico-Statistical Committee NOMBIR - Association for Nordic Medical Birth Registers lreproductionsummary.htm NorPEN - The Nordic Pharmacoepidemiological Network 20 februari

15 NorPEN Research documentation Annual reviews of published studies, research groups, centers working with the Nordic registers on dispensed medicines Voluntary pre-registration of register based studies within the Nordic countries Overview of organisation and content of the Nordic national registers Process to obtain permission to access the register data Identify obstacles to register based research Web-based system for publishing of basic information februari

16 Prioritised research areas Rare exposures and rare events Prescribing quality indicators Reproductive health Medicine use in children Mental health 20 februari

17 Meetings and workshops 1. March , Gothenburg, Sweden Research using prescription medicine registers Open invitation to Nordic researchers within the area 2. October , Oslo, Norway Reproductive health, medicine use in pregnancy Method workshop, Medicine exposure during pregnancy 3. March , Kuopio, Finland Mental health and psychotropic medicine use Method workshop, Record linkage with registers in psychiatry 4. October 2010, Reykjavík, Iceland Medicine use in children Method workshop, Exposure status and duration in children, multi-generation studies 5. March 2011, Odense, Denmark Measuring quality of prescribing in chronic diseases and in the elderly Method workshop, Advanced methods for analysis of medicine use pattern in databases 6. October 2012, Stockholm, Sweden Monitoring safety Methods workshop, Advanced methods for confounder control 20 februari

18 Nordic collaborative study on SSRIs during pregnancy Miia Artama, FI Anders Engeland, NO Örjan Ericsson, SE Kari Furu, NO Mika Gissler, FI Bengt Haglund, SE Helle Kieler, SE Rikke Beck Nielsen, DK Mette Nørgaard, DK Olof Stephansson, SE Unnur A. Valdimarsdóttir, IS Helga Zoëga, IS Helle Kieler 20 februari

19 Background 20 februari

20 20 februari

21 Logistics 20 februari

22 Data sources FI DK Prescribed Drug Register Medical Birth Register Cause of Death Register Abortion Register Patient Register IS NO Psychiatry Register Malformation Register SE 20 februari

23 National collaborator A Karolinska Institutet National collaborator B Birth file Synchronizing data files Birth file Maternal disease file Maternal Medicines file Statistics Denmark Maternal disease file Maternal Medicines file Infant Outcome file Adding Danish prescription data Infant Outcome file Infant Death file Abortion file Analyses Infant Death file Abortion file 20 februari

24 SE FI NO DK IS Source Comments Source Comments Source Comments Source Comments Source Comments LMP (marked whether derived from true LMP or ultrasound) MBR ultrasound MBR TRUE MBR MBR MBR Cannot MBR/MR*/ give day of Birth date (yyyymmdd) MBR AR MBR birth? MBR MBR Mat weight in early pregnancy (kg) MBR MBR from 2004 NA NA NA Mat height (cm) MBR MBR from 2004 NA NA NA Mat age at delivery/termination of pregnancy (completed years) MBR Parity (number of pregnancies leading to a birth) MBR MBR/MR*/ AR MBR MBR MBR MBR/MR*/ AR MBR MBR MBR Smoking early pregnancy if available (Y/N) MBR MBR MBR For parts MBR NA Smoking late pregnancy if available (Y/N) MBR MBR MBR For parts NA NA Family (cohabiting/singel/other) MBR MBR MBR MBR MBR Education (1-4) SCB MBR soc.eco NA SDK NA ultrasound and LMP 20 februari

25 Additional challenges 20 februari

26 SSRIs and PPHN ICD-10 codes for outcome of interest DK NO SE FI IS PFC (PPHN & PDA) P29.3 P29.3 P29.3 P29.3 P29.3 PPHN P29.3A P29.3BP29.31 PPH I27.0 I27.0 I27.0 I februari

27 Approvals 20 februari

28 External approvals SE DK FI IS NO Regional Ethical Review Board Danish Data Protection Agency National Board of Health National Institute for Health and Welfare Social Insurance Institution of Finland Statistics Finland National Bioethics Committee Data Protection Authority in Iceland Norwegian Data Inspectorate 20 februari

29 Internal approvals Research agreements between Karolinska Institutet and National Institute for Health and Welfare, Finland University of Iceland 20 februari

30 Can we combine Nordic data? 20 februari

31 Most common SSRIs Denmark Norway Sweden N06AB03 N06AB04 N06AB06 N06AB06 N06AB10 N06AB04 Denmark 63,0 21,6 46,2 Norway 29,3 52,0 44,0 Sweden 55,1 31,3 65,4 N06AB03 Fluoxetin N06AB04 Citalopram N06AB06 Sertralin N06AB10 Escitalopram 20 februari

32 SSRI use by county in Sweden Females years Patients/1000 inhabitants februari

33 Maternal age Finland Iceland Norway Sweden N % N % N % N % Smoking No Yes missing Gestational age w w w SSRI No Yes Prev psych No Yes Total februari

34 Collaborative compared to national study Pros: Better statistical power Higher generalisability Cons: More effort Longer time Barriers: Approvals Data access Facilitators: NorPEN Individual researchers Encouragement and support from outside 20 februari

35 What could we have done better? Define roles from start National PIs responsibilities/opportunities Permissions Data access and cleaning Keep up speed in their country Regular meetings between national PIs Pinpoint Collaboration 20 februari

36 Selective Serotonin Reuptake Inhibitors During Pregnancy and Risk of Stillbirth and Infant Mortality Stephansson O, Kieler H, Haglund B, Artama M, Engeland A, Furu K, Gissler M, Nørgaard M, Beck Nielsen R, Zoega H, Valdimarsdóttír JAMA. 2013;309(1):48-54 Risks of adverse pregnancy and birth outcomes in women treated or not treated with mood stabilisers for bipolar disorder: population based cohort study Bodén R, Lundgren M, Brandt L, Reutfors J, Andersen M, Kieler H BMJ. 2013;345:e7085 doi: /bmj 20 februari

37 Pharmacoepidemiol Drug Saf Jul;22(7): doi: /pds.357. Epub 2013 May 23 The Nordic prescription databases as a resource for pharmacoepidemiological research a literature review. Wettermark B, Zoëga H, Furu K, Korhonen M, Hallas J, Nørgaard M, Almarsdottir A, Andersen M, Andersson Sundell K, Bergman U, Helin-Salmivaara A, Hoffmann M, Kieler H, Martikainen J, Mortensen M, Petzold M, Wallach-Kildemoes H, Wallin C, Sørensen H. Centre for Pharmacoepidemiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Division of Clinical Pharmacology, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden 20 februari

38 Good pharmacoepi studies We must collaborate 20 februari

39 NorPEN The Nordic Pharmacoepidemiological Network for knowledge exchange, research and research training 20 februari

40 Nordic countries and pharmacoepidemiological studies Population of 24 million people Homogeneous Genetically Socioeconomically National health registries Public health care system (almost free of charge) Reimbursement of medicines for the whole population Personal Identification Numbers (PINs) 20 februari

41 NorPEN Document, facilitate and promote Nordic pharmacoepidemiological research initiatives Increase quality of research and methodological development Create an interactive forum for PhD-students and supervisors Assist researchers - Initiating and designing new studies - Improving quality - Avoiding common pitfalls and duplication of efforts 20 februari

42 NorPEN Research documentation Annual reviews of published studies, research groups, centers working with the Nordic registers on dispensed medicines Voluntary pre-registration of register based studies within the Nordic countries Overview of organisation and content of the Nordic national registers Process to obtain permission to access the register data Identify obstacles to register based research Web-based system for publishing of basic information - Contracted/Sponsored Nordic research 20 februari

43 NorPEN 20 februari

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