Under-reporting of Adverse Drug Reactions: The Need for an Automated Reporting System

  • Benjamin R Pearson
Keywords: Adverse drug reactions, Canadian Adverse Reaction Newsletter, CARN, e -Health, electronic patient record, health informatics, health systems, pharmacovigilance, reporting, voluntary reporting

Abstract

Although upwards of 32,000 adverse drug reactions are reported to Health Canada annually, this represents only approximately 5% of cases experienced by Canadians every year. This gross display of underreporting not only results in unrepresentative data in regards to adverse drug reactions, but further discredits databases used by healthcare professionals and in turn compromises the health and safety of Canadians. Major causes of underreporting seen in the literature are ignorance, diffidence and lethargy displayed by healthcare professionals. While Health Canada relies on these professionals to voluntarily report adverse drug reactions, the potential exists for an automated reporting system to remove causes of underreporting. Through integrating such a system with current health informatics technologies such as the electronic health record and utilizing existing health system communication technologies, healthcare professionals will be provided with representative data of adverse drug reactions in Canada and in turn be able to better serve their patients. 

References

Brewer, T., & Colditz, G. A. (1999). Postmarketing surveillance and adverse drug reactions: Current perspectives and future needs. JAMA : The Journal of the American Medical Association, 281(9), 824-829. doi: 10.1001/jama.281.9.824

Canada Health Infoway. (2013a). Health level 7 international. Retrieved from https://www.infoway-inforoute.ca/ index.php/programs-services/standards-collaborative/ international-standards-organizations/hl7-international

Canada Health Infoway. (2013b). Systematized nomenclature of medicine clinical terms (SNOMED CT). Retrieved from https://www.infoway-inforoute.ca/index.php/programs- services/standards-collaborative/pan-canadian-standards/systematized-nomenclature-of-medicine-clinical-terms-snomed-ct

Canadian Institute for Health Information. (2009). International statistical classification of diseases and related health problems: Volume one – Tabular list (Tenth Revision). Ottawa, ON: Canadian Institute for Health Information.

Coeira, E. (2003). A guide to health informatics. London, UK: Hodder Arnold.

Dormann, H., Muth-Selbach, U., Krebs, S., Criegee-Rieck, M., Tegeder, I., Schneider, H. T., . . . & Geisslinger, G. (2000). Incidence and costs of adverse drug reactions during hospitalisation: Computerised monitoring versus stimulated spontaneous reporting. Drug Safety: An International Journal of Medical Toxicology and Drug Experience, 22(2), 161-168. Retrieved from http:// link.springer.com/article/10.2165/00002018-200022020- 00007

Graham, T. A., Kushniruk, A. W., Bullard, M. J., Holroyd, B. R., Meurer, D. P., & Rowe, B. H. (2008). How usability of a web-based clinical decision support system has the potential to contribute to adverse medical events. AMIA: Annual Symposium Proceedings, 257-261. Retrieved from http://pubmedcentralcanada.ca/pmcc/articles/ PMC2655970/

Hazell, L., & Shakir, S. A. (2006). Under-reporting of adverse drug reactions: A systematic review. Drug Safety: An International Journal of Medical Toxicology and Drug Experience, 29(5), 385-396. doi: 10.2165/00002018- 200629050-00003

Health Canada. (2011a). Adverse reaction and incident reporting – 2010. Canadian Adverse Reaction Newsletter, 21(3). Retrieved fromhttp://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v21n3- eng.php#_Adverse_reaction_and

Health Canada. (2011b). Guidance document for industry
– Reporting adverse reactions to marketed health products. Retrieved from http://www.hc-sc.gc.ca/dhp-mps/ pubs/medeff/_guide/2011-guidance-directrice_reporting- -00003 notification/index-eng.php

Health Canada. (2012). Adverse Reaction Information. What is an adverse reaction (AR)? Retrieved from http://www.hc-sc.gc.ca/dhp-mps/medeff/advers-react- neg/index-eng.php#a1

Health Canada. (2014). Canadian adverse reaction newsletter. Retrieved from http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/index-eng.php

Héja, G., Surján, G., & Varga, P. (2008). Ontological analysis of SNOMED CT. BMC Medical Informatics and Decision Making, 8(Supp. 1), S8-S12. doi: 10.1186/1472-6947-8 -S1-S8

Hodge, J. G., Jr., Gostin, L. O., & Jacobson, P. D. (1999). Legal issues concerning electronic health information: Privacy, quality, and liability. JAMA: Journal of the Medical Journal Assocation, 282(15), 1466-1471. doi: 10.1001/ jama.282.15.1466

International Health Terminology Standards Development Organization. (2008). SNOMED clinical terms technical reference guide. Denmark: International Health Terminology Standards Development Organization.

Lopez-Gonzalez, E., Herdeiro, M. T., & Figueiras, A. (2009). Determinants of under-reporting of adverse drug reactions: A systematic review. Drug Safety: An International Journal of Medical Toxicology and Drug Experience, 32(1), 19-31. doi: 10.2165/00002018-200932010- 00002

Office of the Auditor General of Canada. (2010, April 20). Electronic health records in Canada: An overview of federal and provincial audit reports. Retrieved from http:// www.oag-bvg.gc.ca/internet/english/ parl_oag_201004_07_e_33720.html

Thürmann, P. A. (2001). Methods and systems to detect adverse drug reactions in hospitals. Drug Safety: An International Journal of Medical Toxicology and Drug Experience, 24(13), 961-968. doi: 10.2165/00002018-200124130

Tsang, C., Majeed, A., Banarsee, R., Gnani, S., & Aylin, P. (2010). Recording of adverse events in English general practice: Analysis of data from electronic patient rec- ords. Informatics in Primary Care, 18(2), 117-124.

University of Minnesota. (2010). Electronic primary care research network. Retrieved from http:// www.license.umn.edu/Products/Electronic-Primary-Care- ResearchNetwork__Z08118.aspx
Published
2016-03-10
Section
Articles