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Record linkage for pharmacoepidemiological studies in cancer patients.

https://arctichealth.org/en/permalink/ahliterature101314
Source
Pharmacoepidemiol Drug Saf. 2011 Aug 2;
Publication Type
Article
Date
Aug-2-2011
Author
Myrthe P P Herk-Sukel
Valery E P P Lemmens
Lonneke V Poll-Franse
Ron M C Herings
Jan Willem W Coebergh
Author Affiliation
PHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands. myrthe.van.herk@pharmo.nl.
Source
Pharmacoepidemiol Drug Saf. 2011 Aug 2;
Date
Aug-2-2011
Language
English
Publication Type
Article
Abstract
BACKGROUND: An increasing need has developed for the post-approval surveillance of (new) anti-cancer drugs by means of pharmacoepidemiology and outcomes research in the area of oncology. OBJECTIVES: To create an overview that makes researchers aware of the available database linkages in Northern America and Europe which facilitate pharmacoepidemiology and outcomes research in cancer patients. METHODS: In addition to our own database, i.e. the Eindhoven Cancer Registry (ECR) linked to the PHARMO Record Linkage System, we considered database linkages between a population-based cancer registry and an administrative healthcare database that at least contains information on drug use and offers a longitudinal perspective on healthcare utilization. Eligible database linkages were limited to those that had been used in multiple published articles in English language included in Pubmed. The HMO Cancer Research Network (CRN) in the US was excluded from this review, as an overview of the linked databases participating in the CRN is already provided elsewhere. Researchers who had worked with the data resources included in our review were contacted for additional information and verification of the data presented in the overview. RESULTS: The following database linkages were included: the Surveillance, Epidemiology, and End-Results-Medicare; cancer registry data linked to Medicaid; Canadian cancer registries linked to population-based drug databases; the Scottish cancer registry linked to the Tayside drug dispensing data; linked databases in the Nordic Countries of Europe: Norway, Sweden, Finland and Denmark; and the ECR-PHARMO linkage in the Netherlands. Descriptives of the included database linkages comprise population size, generalizability of the population, year of first data availability, contents of the cancer registry, contents of the administrative healthcare database, the possibility to select a cancer-free control cohort, and linkage to other healthcare databases. CONCLUSIONS: The linked databases offer a longitudinal perspective, allowing for observations of health care utilization before, during, and after cancer diagnosis. They create new powerful data resources for the monitoring of post-approval drug utilization, as well as a framework to explore the (cost-)effectiveness of new, often expensive, anti-cancer drugs as used in everyday practice. Copyright © 2011 John Wiley & Sons, Ltd.
PubMed ID
21812067 View in PubMed
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Rosuvastatin safety: a comprehensive, international pharmacoepidemiology programme.

https://arctichealth.org/en/permalink/ahliterature169103
Source
Pharmacoepidemiol Drug Saf. 2006 Jul;15(7):454-61
Publication Type
Article
Date
Jul-2006
Author
Saga Johansson
Eileen E Ming
Mari-Ann Wallander
Luis A García Rodríguez
Ron M C Herings
Wim G Goettsch
Antonio González-Pérez
Andrew T McAfee
Alexander M Walker
Author Affiliation
AstraZeneca R&D Mölndal, Sweden. Saga.Johansson@astrazeneca.com
Source
Pharmacoepidemiol Drug Saf. 2006 Jul;15(7):454-61
Date
Jul-2006
Language
English
Publication Type
Article
Keywords
Canada
Databases as Topic
Fluorobenzenes - adverse effects
Great Britain
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects
Netherlands
Pharmacoepidemiology
Pyrimidines - adverse effects
Randomized Controlled Trials as Topic
Safety
Sulfonamides - adverse effects
United States
Abstract
Results from clinical trials and clinical practice have shown statins to be generally well tolerated with a low frequency of clinically relevant side effects. Nevertheless, there are rare occasions when adverse events (AEs), sometimes serious, may occur. Rosuvastatin is the newest statin to be approved in the USA and many other countries. As part of the continued assessment of the benefit-risk profile of rosuvastatin, AstraZeneca has developed a progressive, comprehensive pharmacoepidemiology programme to complement safety data obtained from randomised clinical trials and spontaneous reporting systems, which have demonstrated that rosuvastatin has a safety profile in line with comparator statins. This programme comprises nine studies conducted in recognised centres of excellence assessing over 50,000 patients treated with rosuvastatin. It consists of three components: patient characteristics studies (four studies), safety evaluation studies (four studies); and review of data generated from the Prescription-Event Monitoring (PEM) study, designed and run by an independent third party. Patient characteristics studies are designed to describe the characteristics and drug utilisation patterns of new users of rosuvastatin compared with new users of other statins in automated databases. Safety evaluation studies will examine the rates of specific AEs in different cohorts of statin users and determine risk factors for these events using data recorded prospectively in automated databases with case adjudication via medical record review. The independent PEM study will monitor any significant events recorded by general practitioners since starting rosuvastatin treatment. This article is an overview of the rationale and methodology of the rosuvastatin pharmacoepidemiology programme.
PubMed ID
16733834 View in PubMed
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