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NorPEN The Nordic Pharmacoepidemiological Netw ork for know ledge exchange, research and research training Helle Kieler Centre for Pharmacoepidemiology Karolinska Institutet Sweden Nordic countries and Nordic countries and

  1. NorPEN The Nordic Pharmacoepidemiological Netw ork for know ledge exchange, research and research training Helle Kieler Centre for Pharmacoepidemiology Karolinska Institutet Sweden

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

  4. “The Nordic countries as a cohort The Nordic countries as a cohort” ” “ ICPE August 19, 2008 in Copenhagen ICPE August 19, 2008 in Copenhagen Pub Med Pub Med � Search terms Search terms � – “ “Nordic countries epidemiology Nordic countries epidemiology” ” 34 783 34 783 – – “ “Nordic countries Nordic countries pharmacoepidemiology pharmacoepidemiology” ” 110 110 – � 8 abstracts 8 abstracts – – comparisons of drug use comparisons of drug use �

  5. 65 years Nordic registers on dispensed medicines Nordic registers on dispensed medicines

  6. 2008 Nordic School of Public Health Gothenburg, Sweden

  7. Strong environment for Strong environment for population based and population based and cross- -country comparative research in country comparative research in cross pharmacoepidemiology pharmacoepidemiology

  8. Organisation Organisation Steering group Steering group Reference group Reference group Max Petzold, SE Max Petzold, SE Prominent senior researchers Mette Nø ørgaard, DK rgaard, DK Mette N in epidemiology & Morten Andersen,DK Morten Andersen,DK pharmacoepidemiology Timo Klaukka, FI Timo Klaukka, FI Sirpa Hartikainen, FI Sirpa Hartikainen, FI Magnú Magn ús s J Jó óhansson hansson, IS , IS Kari Furu, NO Kari Furu, NO Forum Forum Gunilla Ringbä Gunilla Ringb äck Weitoft, SE ck Weitoft, SE Supervisors and PhD students Supervisors and PhD students Helle Kieler, SE Helle Kieler, SE Collaborators Collaborators Database holders Authorities ENCePP

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

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

  11. Prioritised research areas research areas Prioritised � Rare exposures and rare events Rare exposures and rare events � � Prescribing quality indicators Prescribing quality indicators � � Reproductive health Reproductive health � � Medicine use in children Medicine use in children � � Mental health Mental health �

  12. Meetings and workshops Meetings and workshops 1. March 2009, Gothenburg, Sweden 1. March 2009, Gothenburg, Sweden Kick- -off meeting off meeting Kick Research with prescription medicine registers Research with prescription medicine registers Open invitation to Nordic researchers within the area Open invitation to Nordic researchers within the area 2. October 2009, Helsinki/Tampere, Finland 2. October 2009, Helsinki/Tampere, Finland Reproductive health, medicine use in pregnancy Reproductive health, medicine use in pregnancy 3. March 2010, Oslo, Norway 3. March 2010, Oslo, Norway Prescribing quality indicators Prescribing quality indicators Advanced methods for analysis of medicine use pattern in databases es Advanced methods for analysis of medicine use pattern in databas 4. October 2010, Reykjaví ík, Iceland k, Iceland 4. October 2010, Reykjav Medicine use in children Medicine use in children 5. March 2011, Odense, Denmark 5. March 2011, Odense, Denmark Rare exposures and rare events Rare exposures and rare events 6. October 2011, Gothenburg, Sweden 6. October 2011, Gothenburg, Sweden Mental health and psychotropic medicine use Mental health and psychotropic medicine use

  13. Nordic study on SSRIs SSRIs and risks and risks Nordic study on of Congenital Malformations, of Congenital Malformations, Abortions, Perinatal Perinatal Death and Death and Abortions, PPHN PPHN

  14. Background Background Congenital Malformations Malformations Congenital Most studies found no statistical significant Most studies found no statistical significant increased risks for congenital malformations in increased risks for congenital malformations in users of SSRIs SSRIs users of Major limitations in previous studies Major limitations in previous studies – Low statistical power Low statistical power – – Uncertain information on exposure Uncertain information on exposure – – Exploratory analyses Exploratory analyses –

  15. Reported positive findings Reported positive findings Fluoxetine Any SSRI >2 minor anomalies 4 Malformations 1 Cardiovascular malformations 8 Cystic kidneys 2 Anencephaly 3 Citalopram Craniosystosis 3 >2 minor anomalies 4 Omphalocele 3 Cardiovascular malformations 9 ASD 9 Sertraline Paroxetine Omphalocele 7 Malformations 5,6 Septal defects 7 Cardiac malformations 2,3,5,6,7 Anal atresia 7 Neural-tube defects 7 Limb-reduction 7 Clubfoot 7 1 Wogelius, 2006, 2 Källén, 2007, 3 Alwan, 2007, 4 Chambers, 1996, 5 GSK, 2005, 6 Bérard, 2007, 7 Louik, 2007, 8 Diav-Citrin, 2008, 9 Oberlander, 2008

  16. Background Background Persistent Pulmonary Hypertension of the Newborn Persistent Pulmonary Hypertension of the Newborn ICD -10 P29.3B Term and post-term infants Incidence 1-2/1000 Mortality rate 15%

  17. Reported findings Reported findings Persistent Pulmonary Hypertension of the Newborn Persistent Pulmonary Hypertension of the Newborn � 3 studies 3 studies � – Cohort study (Chambers, 1996) Cohort study (Chambers, 1996) – � 2.7% PPHN among 2.7% PPHN among Fluoxetine Fluoxetine exposed exposed � compared with expected rate of 0.1% compared with expected rate of 0.1% – Case control study (Chambers, 2006) Case control study (Chambers, 2006) – � OR = 6.1 (95% CI 2.2 OR = 6.1 (95% CI 2.2 – – 16.8) 16.8) � – Cohort study ( Cohort study (K Kä ällen llen, 2008) , 2008) – � “ “RR RR” ” = 2.7 (95% CI 0.9 = 2.7 (95% CI 0.9 – – 6.3) 6.3) �

  18. Nordic study on SSRIs SSRIs Nordic study on � � Design Design Cohort study study - - 2 2 sub sub- -studies studies Cohort � � Data Data Nordic Health Registries Nordic Health Registries � Infants born in DK, FI, IS, NO or SE 1994- -2007 2007 � Infants born in DK, FI, IS, NO or SE 1994 Abortions > Gestational week 13 (FI, NO, DK) � Abortions > Gestational week 13 (FI, NO, DK) � � � Outcomes Outcomes 1. Malformations, perinatal , perinatal deaths deaths, , abortions abortions 1. Malformations 2. PPHN 2. PPHN

  19. 1994 1995 2003 2004 2005 2007 FI DK IS P rescribed D rug R egister M edical B irth R egister NO C ause of D eath R egister Abortion Register Neonatal Register SE P a t ient R egister Malformation Register Psychiatry Register

  20. FI - 1994 NO - 2004 PDR ( > 10 €) PDR MBR ( ┼ : gw 22, 500g+) MBR ( ┼ : gw 12, sp + induc abortions + indic, Malformation Register “smoking”) Abortion Register ( induced, + indication) Neonatal Register PtR CDR CDR IS – 2003 PDR (÷ dosage) MBR PtR CDR DK - 1995 PDR SE - 2005 MBR ( ┼ : gw 22, induced abortions, ÷ BMI) PDR MBR ( ┼ : gw 28, ÷ alcohol) PtR Psychiatry Register PtR (“psychiatric diagnoses”) CDR CDR

  21. Congenital malformations, Congenital malformations, abortions abortions Pregnant women in DK, FI, IS, NO, SE Dispensed SSRI YES NO 180 d 90 d 90 d Birth Psychiatric diagnosis LMP YES NO

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