Abstract
Since the thalidomide disaster in the 1960s, post-marketing surveillance has progressed rapidly: Spontaneous reporting systems were developed on national and international scale and in parallel methods for active surveillance such as in hospital case control surveillance systems were developed. Healthcare data sources such as electronic medical records, insurance claims, and disease registries have been used in the past four decades to identify, refine, and evaluate potential safety signals of marketed medical products.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Arlett P, Sarac SB, Thomson A et al (2014) The European Medicines Agency’s use of prioritised independent research for best evidence in regulatory action on diclofenac. Pharmacoepidemiol Drug Saf 23(4):431–434. https://doi.org/10.1002/pds.3594
Behrman RE, Benner JS, Brown JS et al (2011) Developing the sentinel system—a national resource for evidence development. N Engl J Med 364(6):498–499. https://doi.org/10.1056/NEJMp1014427
Blake KV, Devries CS, Arlett P et al (2012) Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Pharmacoepidemiol Drug Saf 21(7):690–696. https://doi.org/10.1002/pds.3281
Brown JS, Holmes JH, Shah K et al (2010) Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care. Med Care 48(6 Suppl):S45–S51. https://doi.org/10.1097/MLR.0b013e3181d9919f
Canadian Institutes for Health Information (2018) Drug safety and effectiveness network. https://cihr-irsc.gc.ca/e/40269.html. Accessed 6 Feb 2020
Coloma PM, Trifiro G, Schuemie MJ et al (2012) Electronic healthcare databases for active drug safety surveillance: is there enough leverage? Pharmacoepidemiol Drug Saf 21(6):611–621. https://doi.org/10.1002/pds.3197
CORDIS (2015) Safety evaluation of adverse reactions in diabetes (Safeguard). https://cordis.europa.eu/project/id/282521. Accessed 6 Feb 2020
CORDIS (2016) Gaining sage on the Epoetins’ saga: assessing long term risks and advancing towards better Epoetin driven treatment modalities (EPOCAN). https://cordis.europa.eu/project/id/282551. Accessed 6 Feb 2020
CORDIS (2017) CAncer Risk and INsulin analoGues. https://cordis.europa.eu/project/id/282526/de. Accessed 6 Feb 2020
CORDIS (2019a) Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE). https://cordis.europa.eu/project/id/115557. Accessed 6 Feb 2020
CORDIS (2019b) Arrhythmogenic potential of drugs (ARITMO). https://cordis.europa.eu/project/id/241679. Accessed 6 Feb 2020
CORDIS (2019c) Attention deficit hyperactivity disorder drugs use chronic effects (ADDUCE). https://cordis.europa.eu/project/id/260576. Accessed 6 Feb 2020
CORDIS (2019d) EUROmediCAT: safety of medication use in pregnancy in relation to risk of congenital malformations. https://cordis.europa.eu/project/id/260598. Accessed 6 Feb 2020
CORDIS (2019e) Long-term PHARMacovigilance for adverse effects in childhood arthritis focussing on immune modulatory drugs (PHARMACHILD). https://cordis.europa.eu/project/id/260353. Accessed 6 Feb 2020
CORDIS (2019f) Safety of non-steroidal anti-inflammatory drugs (SOS). https://cordis.europa.eu/project/id/223495. Accessed 6 Feb 2020
de Bie S, Coloma PM, Ferrajolo C et al (2015) The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study. Br J Clin Pharmacol 80(2):304–314. https://doi.org/10.1111/bcp.12610
Dieleman J, Romio S, Johansen K et al (2011) Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe. BMJ 343:d3908. https://doi.org/10.1136/bmj.d3908
EMIF (2019) European medical information framework (EMIF). https://www.emif.eu/. Accessed 6 Feb 2020
European Centre for Disease Prevention and Control (2011) VAESCO investigation into narcolepsy. https://www.ecdc.europa.eu/en/news-events/ecdc-vaesco-investigation-narcolepsy. Accessed 6 Feb 2020
Foundation for the National Institutes of Health (2019) Observational medical outcomes partnership (OMOP). https://fnih.org/what-we-do/major-completed-programs/omop. Accessed 6 Feb 2020
Furu K, Wettermark B, Andersen M et al (2010) The Nordic countries as a cohort for pharmacoepidemiological research. Basic Clin Pharmacol Toxicol 106(2):86–94. https://doi.org/10.1111/j.1742-7843.2009.00494.x
Innovative Medicines Initiative (2017) Pharmacoepidemiological research on outcomes of therapeutics by a European ConsorTium (PROTECT). https://www.imi-protect.eu/. Accessed 6 Feb 2020
Innovative Medicines Initiative (2020a) ConcePTION. https://www.imi.europa.eu/projects-results/project-factsheets/conception. Accessed 6 Feb 2020
Innovative Medicines Initiative (2020b) European health data and evidence network (EHDEN). https://www.imi.europa.eu/projects-results/project-factsheets/ehden. Accessed 6 Feb 2020
Institute of medicine. Committee on the assessment of the US drug safety system (2007) The future of drug safety: promoting and protecting the health of the public. National Academies Press, Washington, D.C.
McClellan M (2007) Drug safety reform at the FDA—pendulum swing or systematic improvement? N Engl J Med 356(17):1700–1702. https://doi.org/10.1056/NEJMp078057
McGettigan P, Henry D (2011) Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med 8(9):e1001098. https://doi.org/10.1371/journal.pmed.1001098
Nguyen M, Ball R, Midthun K et al (2012) The Food and Drug Administration’s Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise. Pharmacoepidemiol Drug Saf 21(Suppl 1):291–297. https://doi.org/10.1002/pds.2323
Observational Health Data Sciences and Informatics (2020) Welcome to OHDSI! https://www.ohdsi.org/. Accessed 6 Feb 2020
Platt R, Wilson M, Chan KA et al (2009) The new sentinel network—improving the evidence of medical-product safety. N Engl J Med 361(7):645–647. https://doi.org/10.1056/NEJMp0905338
Platt R, Carnahan RM, Brown JS et al (2012) The U.S. Food and Drug Administration’s Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf 21(Suppl 1):1–8. https://doi.org/10.1002/pds.2343
Robb MA, Racoosin JA, Worrall C et al (2012) Active surveillance of postmarket medical product safety in the Federal Partners’ Collaboration. Med Care 50(11):948–953. https://doi.org/10.1097/MLR.0b013e31826c874d
Romio S, Weibel D, Dieleman JP et al (2014) Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccines: a multinational self-controlled case series in Europe. PLoS ONE 9(1):e82222. https://doi.org/10.1371/journal.pone.0082222
Stang PE, Ryan PB, Racoosin JA et al (2010) Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 153(9):600–606. https://doi.org/10.7326/0003-4819-153-9-201011020-00010
Suissa S, Henry D, Caetano P et al (2012) CNODES: the Canadian network for observational drug effect studies. Open Med 6(4):e134–e140
Trifiro G, Coloma PM, Rijnbeek PR et al (2014) Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how? J Intern Med 275(6):551–561. https://doi.org/10.1111/joim.12159
U.S. Food and Drug Administration (2020) FDA’s Sentinel Initiative. https://www.fda.gov/safety/fdas-sentinel-initiative. Accessed 6 Feb 2020
VAC4EU (2020) VAccine monitoring Collaboration for Europe. https://vac4eu.org/. Accessed 6 Feb 2020
VAESCO Consortium (2012) Narcolepsy in association with pandemic influenza vaccination—a multi-country European epidemiological investigation. https://www.ecdc.europa.eu/en/publications-data/narcolepsy-association-pandemic-influenza-vaccination-multi-country-european
Valenciano M, Ciancio B (2012) I-MOVE: a European network to measure the effectiveness of influenza vaccines. Euro Surveill 17(39). https://doi.org/10.2807/ese.17.39.20281-en
Varas-Lorenzo C, Riera-Guardia N, Calingaert B et al (2013) Myocardial infarction and individual nonsteroidal anti-inflammatory drugs meta-analysis of observational studies. Pharmacoepidemiol Drug Saf 22(6):559–570. https://doi.org/10.1002/pds.3437
Wijnans L, Lecomte C, de Vries C et al (2013) The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns. Vaccine 31(8):1246–1254. https://doi.org/10.1016/j.vaccine.2012.12.015
World Health Organization (2015) The global vaccine safety initiative activities portfolio. https://www.who.int/vaccine_safety/news/highlight_3/en/. Accessed 6 Feb 2020
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2021 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Sturkenboom, M. (2021). Role of Real World Data in Pharmacoepidemiology Research: From Single Database Towards Global Collaboration. In: Sturkenboom, M., Schink, T. (eds) Databases for Pharmacoepidemiological Research. Springer Series on Epidemiology and Public Health. Springer, Cham. https://doi.org/10.1007/978-3-030-51455-6_1
Download citation
DOI: https://doi.org/10.1007/978-3-030-51455-6_1
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-51454-9
Online ISBN: 978-3-030-51455-6
eBook Packages: MedicineMedicine (R0)