Standards of Practice Committee
Joint Chair of the committee: Professor Dr Christoph Hiemke (hiemke@mail.uni-mainz.de) & Dr Edgar P Spencer (Edgar.Spencer@gstt.nhs.uk) (Picture)
Recent documents:
- Interim report 1 2006
- Interim report 2 2006
- Proposal for workshop at the Nice meeting (accepted)
At the 5th International Congress of TDM-CT, November 10-14, 1997 in Vancouver, Canada, a new Committee was established, in order to address the future of TDM and to develop guidelines for International Standards of Best Practice in TDM-CT.
In 1997 a definition of TDM, as developed by the Joint C-TDM IATDMCT/IFCC Committee, was published: "TDM is a measurement made in a laboratory of a parameter which, with appropriate interpretation, will directly influence prescribing procedures. Commonly the measurement in a biological matrix is of a prescribed xenobiotic, but it may also be of an endogenous compound prescribed as a replacement therapy in an individual who is physiologically or pathologically deficient in that compound."
Although this definition is a general description of TDM, it does not provide a comprehensive outline of the best standard of practice in a TDM laboratory. It is clear to all the colleagues dealing with TDM for many years, that a successful therapeutic drug monitoring program can only be reached by an interdisciplinary approach. A close collaboration between the laboratory staff (clinical pharmacologist, clinical pharmacist, clinical biochemist, clinical pathologist) and physician and nursing staff, will allow improvement of patient care and reduce unnecessary costs.
For over 20 years clinicians have been using TDM as a way to monitor and regulate doses of drugs with narrow therapeutic ranges. The development of sensitive analytical methods (RIA, GLC, HPLC, EMIT, FPIA, MEIA) have enabled an understanding of pharmacokinetic principles for individualizing drug therapy, predicting drug toxicity and assessing drug compliance. The ability of a clinical laboratory to perform a drug concentration analysis is just one step in the whole process of TDM.
It is well established that results of tests reported as a "number only" are uninterpretable in many cases. Major reasons why TDM determinations are not interpretable include:
- blood samples not drawn at appropriate time in relation to dosing interval.
- poor documentation of drug-administration time in relation to sampling time, as well as dose, route, formulation of drug product and length of therapy.
- disease state and concurrent drugs the patient is receiving.
- improper specimen handling.
The director of a TDM service as well as the medical technologists performing the tests should be appropriately trained in order to be able to give the proper interpretation of the results obtained and to provide relevant advice to the physician. A successful TDM service is possible only when a cooperative effort of all the parties involved is present, including the laboratory, drug information centers, research into clinical problems identified by the TDM service and education of the staff and students in the medical sciences.
One of the goals of the Standards of Practice Committee will be to find common grounds of all the institutions providing comprehensive TDM services and to help to implement the activities that will allow better patient care.
An early document was published in 1995 by the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, with a description of best practice in a TDM service. The five sections of the document include:
- Clinical aspects (optimal interpretation of drug concentration results, effective liaison, clinical audit).
- Laboratory performance (accreditation of laboratories, quality controls and assurance, sample collection and report generation, standardization of ranges, method validation, staff selection and education).
- Information systems (provision of computer support, drug information services, access to statistical expertise, development and maintenance of records).
- Research and development (active targeting of areas in need of TDM, new methodologies, participation in externally funded studies).
- Education to instruct and promote understanding of TDM.
This document will serve as a basis to develop new guidelines for better standard of practice in TDM-CT and to help to establish new TDM services or to improve the existing ones.
There is also an urgent need to get established what a curriculum in practical pharmacokinetics and TDM-CT should be for training physicians, laboratory personnel and other professionals interested in this area.
Results of the second survey in the members' pages