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Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians: a model process

Whitstock, Margaret T., Pearce, Christopher M., Ridout, Stephen C. and Eckermann, Elizabeth J. 2011, Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians: a model process, BMC public health, vol. 11, pp. 1-11, doi: 10.1186/1471-2458-11-361.

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Title Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians: a model process
Author(s) Whitstock, Margaret T.
Pearce, Christopher M.
Ridout, Stephen C.
Eckermann, Elizabeth J.ORCID iD for Eckermann, Elizabeth J. orcid.org/0000-0002-4908-5629
Journal name BMC public health
Volume number 11
Start page 1
End page 11
Total pages 11
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2011
ISSN 1471-2458
Keyword(s) Aged
Aged, 80 and over
Comorbidity
Cyclooxygenase 2 Inhibitors
Drug-Related Side Effects and Adverse Reactions
Female
Humans
Lactones
Male
Medical Record Linkage
Medication Systems, hospital
Models, Theoretical
Pharmacy Service, Hospital
Polypharmacy
Retrospective Studies
Safety Management
Sulfones
Western Australia
Summary BACKGROUND: The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients. METHODS: The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug. RESULTS: Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug. CONCLUSIONS: Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest.Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term 'adverse drug event' (ADE).
Language eng
DOI 10.1186/1471-2458-11-361
Field of Research 169999 Studies in Human Society not elsewhere classified
111799 Public Health and Health Services not elsewhere classified
Socio Economic Objective 920502 Health Related to Ageing
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2011, BioMed Central
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30078036

Document type: Journal Article
Collections: School of History, Heritage and Society
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.