Current Status of Therapeutic Drug Monitoring in Australia and New Zealand: A Need for Improved Assay Evaluation, Best Practice Guidelines, and Professional Development

Australian Centre for Paediatric Pharmacokinetics, Mater Pharmacy Services, South Brisbane, Queensland, Australia.
Therapeutic Drug Monitoring (Impact Factor: 2.38). 10/2010; 32(5):615-23. DOI: 10.1097/FTD.0b013e3181ea3e8a
Source: PubMed


The measurement of drug concentrations, for clinical purposes, occurs in many diagnostic laboratories throughout Australia and New Zealand. However, the provision of a comprehensive therapeutic drug monitoring (TDM) service requires the additional elements of pre- and postanalytical advice to ensure that concentrations reported are meaningful, interpretable, and clinically applicable to the individual patient. The aim of this project was to assess the status of TDM services in Australia and New Zealand. A range of professions involved in key aspects of TDM was surveyed by questionnaire in late 2007. Information gathered included: the list of drugs assayed; analytical methods used; interpretation services offered; interpretative methods used; and further monitoring advice provided. Fifty-seven responses were received, of which 42% were from hospitals (public and/or private); 11% a hospital (public and/or private) and pathology provider; and 47% a pathology provider only (public and/or private). Results showed that TDM is applied to a large number of different drugs. Poorly performing assay methods were used in some cases, even when published guidelines recommended alternative practices. Although there was a wide array of assays available, the evidence suggested a need for better selection of assay methods. In addition, only limited advice and/or interpretation of results was offered. Of concern, less than 50% of those providing advice on aminoglycoside dosing in adults used pharmacokinetic tools with six of 37 (16.2%) respondents using Bayesian pharmacokinetic tools, the method recommended in the Australian Therapeutic Guidelines: Antibiotic. In conclusion, the survey highlighted deficiencies in the provision of TDM services, in particular assay method selection and both quality and quantity of postanalytical advice. A range of recommendations, some of which may have international implications, are discussed. There is a need to include measures of impact on clinical decision-making when assessing assay methodologies. Best practice guidelines and professional standards of practice in TDM are needed, supported by an active program of professional development to ensure the benefits of TDM are realized. This will require significant partnerships between the various professions involved.

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    • "Interference from drug metabolite and other endogenous substances in patient samples has been highlighted with drug assays for cyclosporine and digoxin (Morris, 2000; Rogers et al., 2010). Despite recommendations from the literature (Morris et al., 2002), a large percentage of laboratories still employ poor performing immunoassays (Norris et al., 2010). We did not determine how the choice of drug assay was made by each hospital, although cost is probably a major determinant. "
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    ABSTRACT: In Malaysia, therapeutic drug monitoring (TDM) service was started in the 1980s. Since then, the number of hospitals that offer the service has increased. In this paper, we report the findings of a nationwide survey describing the practice of TDM in these hospitals. Questionnaires were mailed to 128 government hospitals. Data were collected for general characteristics of the hospitals, administrative, and laboratory activities related to TDM service. One hundred and twenty-one hospitals responded to the survey. Thirty-four hospitals (28.1%) provided the service with their own TDM laboratories, 44 hospitals (36.4%) provided the service using other hospitals' laboratories and 43 hospitals (35.5%) did not provide the service at all. TDM services were more likely to be offered in larger hospitals with various medical specialties. Since it is managed entirely by hospital pharmacists, these pharmacists assume an important role in ensuring optimum use of the TDM service.
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    • "The relative cost and requirement of specialized instrumentation also is another drawback compared with other techniques, such as immunochemical assays, which use cheaper, portable, and easy-to-use instrumentations [114]. Immunochemical assays have been used for other antibiotics for which routine TDM is well established, such as aminoglycosides and vancomycin [115,116]. However, the development of such techniques for beta-lactams has been a challenge [117,118]. "
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