March 2015
Objectives
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To assess characteristics of reported adverse drug events (ADEs)
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Time trends
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Country, region, macro structures
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Age and sex of medicine users
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Suspected medications
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ADEs (system organ class)
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Known/unknown status: label status
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Reporter
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To assess ADE characteristics for specific therapeutic groups and types of medicinal products
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To carry out critical literature reviews
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To describe characteristics of pharmacovigilance systems and assess implications of organisational structures
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To assess safety data in licensing materials
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To assess safety data in Summary of Product Characteristics/PIs
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To assess safety data in patient records
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To link safety data in patient records with other individual level data, incl. genetic data.
Background
It is well-established that knowledge about medicines safety is limited at the time of licensing of a new product and there are many examples of medications that have been withdrawn from the market due to serious adverse reactions. The design of preclinical and clinical studies provides narrow boundaries for the detection of not already known adverse reactions. Hence, it is necessary to apply designs that are placed at a low level in the evidence hierarchy.
Hitherto, spontaneous reports and other case reports of suspected side effects have proven to be the only source of information about “unknown” adverse reactions and are therefore important data sources for the analyses of adverse drug events. Patient records present another important source of data about “unknowns” but have been explored to a very limited extent. Information about possible adverse events from medicines is provided to health care professionals in Summary of Product Characteristics (SPCs)/Physician Information (PIs) and
SPCs/PIs therefore need to be studied to analyse the publicly available information about medicines safety.
Study material
1) Data files extracted from databases: the Danish Medicines Agency’s ADE database;
VigiBase, WHO’s ADR database; EudraVigilance, EUs ADE database
2) Documents available from regulatory authorities
3) Consumer ADE reports to consumer magazines
4) Product registration files and SPCs from various countries
5) Patient records, including electronic records
6) Patients’ genetic profiles
7) Qualitative interviews

Senior researchers
Professor Ebba Holme Hansen 1 ebba.holme@sund.ku.dk
Professor Lise Aagaard 2
Associate professor Susanne Kaae 1 susanne.kaae@sund.ku.dk
PhD students
Pernille Warrer 1 from 1/12-2010
Master’s students 1
Defended theses specified below.
1 University of Copenhagen, Faculty of Health and Medical Sciences, Section for Social and
Clinical Pharmacy
2 University of Southern Denmark, Institute of Public Health
In collaboration with researchers from other Danish and international institutions.
Publications
Peer reviewed articles and book chapters
33) Warrer P, Jensen PB, Aagaard L, Jensen LJ, Brunak S, Krag MH, Rossing P, Almdal T,
Andersen HU, Hansen EH. Identification of possible adverse drug reactions in clinical notes – the case of glucose-lowering medicines. Journal of Research in Pharmacy
Practice 2015;4(2):pages.
32) Warrer P, Aagaard L, Hansen EH. Comparison of pregnancy and lactation labeling for attention-deficit hyperactivity disorder drugs marketed in Australia, the USA, Denmark, and the UK. Drug Safety 2014;37:805-813.
31) Eriksson R, Aagaard L, J ensen LJ, Borisova L, Hørlück D, Brunak S, Hansen EH.
Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA. Pharmacology Research
& Perspectives 2014;2(3):e00038.
30) Aagaard L, Hansen EH. Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011. International Journal of Clinical Pharmacy
2014;36:1222-1229.
29) Aagaard L, Hansen EH. Adverse drug reactions in children reported by European consumers from 2007 to 2011. International Journal of Clinical Pharmacy 2014;36:295-
302.
28) Aagaard L, Hansen EH. Adverse drug reactions associated with asthma medications in children: systematic review of clinical trials. International Journal of Clinical Pharmacy
2014;36:243-252.
27) Aagaard L, Hansen EH. Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011. BMC Pharmacol Toxicol 2013;14(1):30.
Online June 13.
26) Aagaard L, Hansen EH. Side effects reported by European consumers for medications for erectile dysfunction. Journal of Research in Pharmacy Practice 2013;2:93-95.
25) Aagaard L, Hansen EH. Adverse drug reaction labelling for atomoxetine, methylphenidate and modafinil: comparison of product information for oral formulations in Australia,
Denmark and the United States. Current Drug Safety 2013;8:162-168.
24) Aagaard L, Hansen EH. Side effects reported by European consumers for medications for erectile dysfunction. Journal of Research in Pharmacy Practice 2013;2:93-95.
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23) Aagaard L, Hansen EH. Cutaneous adverse drug reactions reported in children: a national register-based study. British Journal of Dermatology 2013;168:434-437.
22) Aagaard L, Strandell J, Melskens L, Petersen PSG, Hansen EH. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase. Drug
Safety 2012;35:1171-1182.
21) Aagaard L, Meyer U, Schaefer M, Hansen EH. Pharmaceutical production problems detected by adverse drug reactions reports: a documentary study from the German
Democratic Republic, 1982 to 1990. Journal of Clinical Toxicology 2012;2(2):10 p.
Available from http://dx.doi.org/10.4172/2161-0495.1000120
20) Warrer P, Hansen EH, Juhl-Jensen L, Aagaard L. Using text-mining techniques in electronic patient records to identify ADRs from medicine use. British Journal of Clinical
Pharmacology 2012;73:674-684.
19) Aagaard L, Hansen EH. The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Neuropsychiatric Disease and Treatment 2011:7;729-744.
18) Aagaard L, Schaefer M, Meyer U, Hansen EH. Adverse drug reactions reported in the
German Democratic Republic: a retrospective analysis of reports from the WHO-ADR database. Open Journal of Safety Science and Technology 2011;1:60-74.
17) Aagaard L, Hansen EH. Risks of off-label medicines in children: Adverse drug reactions.
PharmacoVigilance Review 2011;5(3):4-6.
16) Aagaard L, Hansen EH. Trends in the prescribing and adverse drug reactions patterns of psychostimulants among Danish children and adolescents. In: Norvilitis JM, ed. Current directions in ADHD and its treatment. 2012; pp. 111-124. ISBN: 978-953-307-868-7.
InTech, available from: http://www.intechopen.com/articles/show/title/trends-in-theprescribing-and-adverse-drug-reaction-patterns-of-psychostimulants-among-danish-childr
15) Aagaard L, Hansen EW, Hansen EH. Adverse drug reactions following immunization in
Danish children: retrospective analysis of spontaneous reports submitted to the Danish
Medicines Agency. In: Méndez-Vilas, ed. Science against microbial pathogens: communicating current research and technological advances. FORMATEX Microbiology
Book Series N o 3. Vol. 1. 2011; pp. 407-413. ISBN-13: 978-84-939843-1-1.
14) Aagaard L, Hansen EH. Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions. British Journal of Clinical Pharmacology 2011;71:751-757.
13) Aagaard L, Hansen EW, Hansen EH. Adverse events following immunization in children: retrospective analysis of spontaneous reports over a decade. European Journal of Clinical
Pharmacology 2011;67:283-288.
12) Aagaard L, Hansen EH. Knowledge creation about adverse drug reactions: experiences and perspectives from Denmark (Invited). Advances in Medicine and Biology. 2010,
Volume 6, Chapter 7;205-220. NY: Nova Science Publishers.
11) Aagaard L, Hansen EH. Adverse drug reactions for systemic antibacterials in Danish children over a decade. British Journal of Clinical Pharmacology 2010;70:765-768.
10) Aagaard L, Christensen A, Hansen EH. Information about adverse drug reactions reported in children: a qualitative review of empirical studies. British Journal of Clinical
Pharmacology 2010;70:481-491.
9) Aagaard L, Hansen EH. Consumers’ reports of suspected adverse drug reactions volunteered to a consumer magazine. British Journal of Clinical Pharmacology
2010;69:317-318.
8) Aagaard L, Hansen EH. Adverse drug reactions from psychotropic medicines in the paediatric population: analysis of reports to the Danish Medicines Agency over a decade.
BMC Research Notes 2010;3:176.
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7) Aagaard L, Weber CB, Hansen EH. Adverse drug reactions in the paediatric population in
Denmark: a retrospective analysis of reports made to the Danish Medicines Agency from
1998 to 2007. Drug Safety 2010;33:327-339.
6) Aagaard L, Thirstrup S, Hansen EH. Opening the white boxes: the licensing documentation of efficacy and safety of psychotropic medicines for children.
Pharmacoepidemiology and Drug Safety 2009;18:401-411.
5) Aagaard L, Nielsen LH, Hansen EH. Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004-2006.
Drug Safety 2009;32:1067-1074.
4) Aagaard L, Hansen EH. Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs. BMC
Clinical Pharmacology 2009, 9: 4.
3) Aagaard L, Stenver DI, Hansen EH. Structures and processes in spontaneous ADR reporting systems: a comparative study of Australia and Denmark. Pharmacy World &
Science 2008;30:563-570.
2) Aagaard L, Soendergaard B, Stenver DI, Hansen EH. Knowledge creation about ADRs – turning the perspective from the rear mirror to the projector? British Journal of Clinical
Pharmacology 2008;65:364-376.
1) Aagaard L, Soendergaard B, Andersen E, Kampmann JP, Hansen EH. Creating knowledge about adverse drug reactions: a critical analysis of the Danish reporting system from 1968 to 2005. Social Science & Medicine 2007;65:1296-1309.
Master’s theses
Laura Guasch Rodríguez : The safety of biosimilars in the EU: an empirical case study on Epoetin
Alpha. 2014 (supervisor: Ebba Holme Hansen).
Thy Thanh Dinh : Bivirkningsinformation ved Orphan Drugs i Europa 2001-2012 –
Dokumentarstudie af produktinformation. [Information about adverse drug reactions associated with Orphan Drugs in Europe 2001-2012 – Documentary study of product information]. 2013
(supervisor: Ebba Holme Hansen).
Teresa Gonҫalves : Stakeho lders’ perspectives on user-industry communications: Chessing in communicating drug information. 2013 (supervisor: Ebba Holme Hansen).
Yi Huo : Evaluation of a customized risk management tool on products at different life cycle stages
– Implementation of failure mode, effects and criticality analysis. 2013 (supervisor: Ebba Holme
Hansen. External advisor: Suzanne Lisbet Hansen).
Marcin Jan Nowak : Evaluation of failure modes, effects and criticality analysis for different therapeutic areas – A tool customized for pharmacovigilance processes. 2013 (supervisor: Ebba
Holme Hansen. External advisor: Suzanne Lisbet Hansen).
Dorte Hørlück and Liza Borisova : Bivirkningsinformation for det samme lægemiddel markedsført i Danmark og USA: Sammenligning af produktinformationer. [Information about adverse reactions for the same drug marketed in Denmark and US: Comparison of product information]. 2012
(supervisor: Ebba Holme Hansen).
Maria Oxenbøll Knudsen : Karakteristik af bivirkninger hos børn og unge med ADHD i behandling med methylphenidat. En retrospektiv deskriptiv analyse af patientjournaler. [Characteristics of adverse drug reactions in children with Attention Deficit Hyperactivity Disorder (ADHD) treated with methylphenidate. A retrospective descriptive analysis of medical records]. 2012 (supervisor: Ebba
Holme Hansen).
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Lars Melskens and Paw Pedersen : Pharmacovigilance in a global perspective – A retrospective analysis of adverse drug reaction reports in VigiBase from 2000 to 2009. 2010 (supervisor: Lise
Aagaard).
Ditte Sloth-Lisbjerg : Bivirkningsrelaterede indlæggelser – journalgennemgang på
Akutmodtagelsen på Kolding Sygehus. [Adverse drug reactions leading to hospitalization – medical-chart review in the Emergency Department at Kolding Hospital]. 2010 (supervisor: Lise
Aagaard).
Line Winther : Karakteristika af bivirkninger for den farmakologiske behandling af Attention Deficit,
Hyperactivity Disorder (ADHD), registreret i Danmark 2000-2009. [Characteristics of adverse reactions for the pharmacological treatment of Attention Deficit, Hyperactivity Disorder (ADHD), registered in Denmark 2000-2009]. 2010 (supervisors: Lise Aagaard and Ebba Holme Hansen).
Camilla Blicher Weber : Bivirkningsrapporteringer på børn i Danmark. [Adverse drug reaction reporting on children in Denmark]. 2008 (supervisor: Ebba Holme Hansen).
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