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Australian cyclosporin therapeutic monitoring method survey: 1993
1Department of Clinical Pharmacology, Queen Elizabeth Hospital, Woodville South, South Australia.
Abstract:
A detailed questionnaire was distributed to the 30 Australian laboratories known to provide cyclosporin-A (CsA) therapeutic drug monitoring (TDM) services with a view to evaluating the range of approaches to such monitoring. Replies were received from all 30 laboratories. The data suggested there was a wide discordance in approaches to CsA TDM due to the fact that laboratories appeared to have adopted individual approaches to this service, both in method selection(s) and proposed therapeutic range(s). In many cases, patients served were shown to travel to more distant centers for their graft, returning to their home city/town for longer term management. Hence, services of several laboratories were involved during their clinical care. A strong mandate was received from respondents for development of national guidelines for the monitoring of CsA and other immunosuppressant drugs in order to avoid such discrepancies in the future. The approaches to external analytical quality assurance (QA) and, to a lesser extent, internal quality control (QC) were generally inadequate.
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Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

