Training activity information
Details
Perform and interpret assays for the measurement of four of the following:
- Lamotrigine
- Levetiracetam
- Clozapine
- Tacrolimus
- Ciclosporin
- Infliximab
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Local and national training guidelines, standards and pathways
- Method selection, including pre-analytical issues, assay advantages and limitations, quality parameters, and interferences
- Equipment calibration and maintenance
- Quality control; EQA and IQC
- National and international guidelines
- Role of the duty biochemist
- Turnaround times and impact on patient care
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
- What is the clinical significance of therapeutic drug monitoring for these selected drugs? In what clinical scenarios are these measurements important?
- For the four drugs you will be analysing, what are the analytical methods used in your laboratory for their measurement (e.g., immunoassays, liquid chromatography-mass spectrometry)? What are the principles of these methods?
- What sample types are required for each drug assay? What are the correct sampling times in relation to drug administration?
- What are the therapeutic reference ranges for each of these drugs? What factors can influence these ranges (e.g., patient age, clinical condition, co-medications)?
- What are the basic pharmacokinetic principles (e.g., absorption, distribution, metabolism, excretion) relevant to these drugs and their monitoring?
- How are these drug assays quality controlled within the laboratory?
- How are the results of these therapeutic drug monitoring assays interpreted in relation to the patient’s clinical status and other relevant information?
- How will you gain practical experience in performing assays for these specific therapeutic drugs?
- How will you develop your ability to interpret the quantitative results in the context of therapeutic drug monitoring principles and patient information?
- What challenges do you anticipate in understanding the analytical methods, the timing of sample collection, or the interpretation of results in patients with complex medication regimens?
- How will this experience enhance your understanding of the application of pharmacokinetics in therapeutic drug monitoring?
- Review the Standard Operating Procedures (SOPs) for the measurement of these drugs, including sample preparation, instrument operation, calibration, and quality control procedures.
- Consider potential difficulties in understanding the assay principles or the clinical context of drug monitoring and think about how you might address them.
In action
- What is your involvement in performing the assays for the four chosen therapeutic drugs? What analytical techniques are being used for each drug (e.g., immunoassay, chromatography)? What are the key steps in each assay? Why are different techniques used for different drugs?
- How are you ensuring proper calibration of the instruments and accurate measurement of the analytes? How are you monitoring the quality control data?
- When interpreting the quantitative results for each drug, what are the typical therapeutic ranges? What factors might influence these ranges (e.g., indication, co-medications, patient factors)? How do you relate the measured concentration to the therapeutic range?
- How effectively are you performing the assays for each of the chosen drugs? Are you encountering any technical issues or challenges with specific assays? Are the quality control results within acceptable limits?
- When interpreting the results, how effectively are you able to determine if the drug concentrations are within the target therapeutic range, sub-therapeutic, or potentially toxic? Are you considering the analytical variability of the assays?
- If you encounter unexpected results or technical issues with an assay, what troubleshooting steps are you considering?
- If the interpreted drug concentrations seem inconsistent with the clinical picture (if available), what further information or steps might you consider? What support or guidance might you need from senior colleagues?
- Are you performing the assays and interpreting the results in accordance with the laboratory’s standard operating procedures and best practice guidelines for therapeutic drug monitoring?
On action
- Describe the therapeutic drug monitoring (TDM) assays you performed. Which four drugs did you measure? What analytical techniques were used? What quality control measures were in place during the assay performance? What were the results obtained for the TDM assays you performed? What patient information or clinical context did you consider when interpreting these results?
- What did you learn about the practical aspects of performing TDM assays for these specific drugs? How did this activity enhance your understanding of the pharmacokinetic principles underlying therapeutic drug monitoring?
- What did you learn about the target ranges and clinical significance of monitoring these drugs? Were there any challenges encountered during the performance or interpretation of the assays? What did you learn from these?
- How will you apply your understanding of TDM assays in your future practice? What considerations will you keep in mind regarding sampling time, patient factors, and interpretation of TDM results?
- Are there any aspects of the pharmacology or analysis of these drugs that you need to further investigate? What resources or guidelines will you refer to for performing and interpreting these TDM assays?
Beyond action
- Now that you have more experience with therapeutic drug monitoring (TDM), do you have a better understanding of the pharmacokinetic and pharmacodynamic principles that underpin the monitoring of these drugs?
- Reflect on any clinical cases you have encountered where the TDM of these drugs played a critical role in patient management. How does your initial experience with these assays relate to their clinical utility?
- Consider if you have learned about different analytical methods or platforms used for measuring these drugs. How does your initial experience compare to these other approaches?
- Has your hands-on experience with these TDM assays enhanced your understanding of the importance of appropriate sampling time and sample type? Has your initial interpretation of these assays made you more aware of the therapeutic ranges, potential toxicities, and the factors that can influence drug levels? Has this training activity influenced how you approach discussions with clinicians regarding TDM requests or the interpretation of results?
- If you are involved in developing or reviewing TDM guidelines or protocols, how will your initial practical and interpretative experience inform your contributions? Could the skills you developed in understanding analytical methods, pharmacokinetic principles, and clinical relevance be applied to the TDM of other drugs in the future?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Analyse drugs, vitamins and trace elements in various biological matrices via quantitative and qualitative assays using automated and manual methodologies. |
| # 2 |
Outcome
Apply the appropriate investigative strategy to clinical situations which may involve drugs or poisons, advising clinical teams on the appropriate course of action. |
| # 5 |
Outcome
Demonstrate the application of pharmacokinetics and pharmacogenomics in therapeutic drug monitoring. |
| # 6 |
Outcome
Illustrate how toxicology results are used in clinical practice and the legal consequences of drug testing in various settings. |