Pharmacoepidemiology and drug safety
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Pharmacoepidemiol Drug Saf · Apr 2002
Utilization pattern of metamizole in northern Sweden and risk estimates of agranulocytosis.
This study was carried out in order to investigate the utilization pattern of metamizole to better estimate the quantitative risk of agranulocytosis since a cluster of such cases have been observed in Sweden. ⋯ This study indicates that in most inpatients the use of metamizole in northern Sweden was within the approved indications for the drug. However, a considerable number of outpatients received the drug for a longer time than recommended and this may carry an increased risk for developing agranulocytosis.
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To examine the effects of ketorolac, a non-aspirin non-steroidal anti-inflammatory drug (NANSAID) with antiplatelet properties, on the risk of in-hospital myocardial infarction (MI). ⋯ These results are consistent with a protective effect of ketorolac against MI. Future research that implements uniform screening for and independent validation of MIs as well as eliminates possible confounding by indication is the next logical step in confirming these findings.
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Pharmacoepidemiol Drug Saf · Jan 2002
How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.
It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. ⋯ But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated in this article, the reporting of ADRs via e-mail would cause real problems for the drug safety units. Finally, they consider that telephone call centres should be restricted to a specific communication problem such as crisis management or Dear Dr letters.
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Pharmacoepidemiol Drug Saf · Oct 2001
ReviewThe use of surrogate endpoints in clinical trials: focus on clinical trials in cardiovascular diseases.
Surrogate endpoints include a wide range of laboratory or physical measurements used in clinical trials as a substitute for meaningful clinical endpoints that directly assess effects of the intervention(s) tested on mortality and/or morbidity. These surrogate endpoints are frequently employed in clinical trials and when used judiciously, can accelerate and focus the study of new therapies and can greatly enhance our understanding of their mechanisms of action. The current review provides a definition of surrogate endpoints, proposes practical criteria for establishing their validity, outlines some of the advantages, disadvantages and specific statistical considerations associated with their use in clinical trials and attempts also to highlight drug approval issues associated with the use of these endpoints. A number of examples are also provided related to the use of surrogate endpoints in clinical trials with special emphasis on their use in cardiovascular medicine.
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Pharmacoepidemiol Drug Saf · Aug 2001
Databases for outcomes research: what has 10 years of experience taught us?
This paper describes how the mission of the Agency for Healthcare Research and Quality (AHRQ) is being executed through the many programs that it has developed and implemented. The Evidence-based Practice Center program was developed to provide systematic reviews on common and expensive conditions and health technologies and to ensure that this information is used to improve health care outcomes and costs. The National Guidelines Clearinghouse provides an internet-based source of clinical practice guidelines that are produced by clinical specialty organizations for the primary purpose of improving health care delivery and outcomes. ⋯ The Centers for Education and Research on Therapeutics (CERTs) program was developed to conduct real world evaluations to better understand the benefits and risks of single and combined therapy. Both programs further the mission of the AHRQ to improve the outcomes and quality of health care, with additional focus on the cost-effectiveness, patient safety, and increasing access to care for all. Information on programs developed by the AHRQ is available in more detail at the Agency Web site http://www.ahrq.gov.