Module information

Module details

Title
Vitamins, Trace Elements, Toxicology and Therapeutic Drug Monitoring
Type
Specialist
Module code
S-CB-S5
Credits
10
Phase
3
Requirement
Compulsory

Aim of this module

This module will provide trainees with an understanding of the issues which are particular to drug, vitamin and trace element analysis and interpretation. This will include both therapeutic drug monitoring and investigation of poisoning/overdose. This module will equip trainees with the skills and knowledge required to manage common clinical scenarios encountered in non-specialist laboratories, including such issues as paracetamol overdose, immunosuppressive drug monitoring and routine drugs of abuse screening. The trainee should also have an appreciation of the techniques used in specialist laboratories including issues relating to analyte stability and appropriate specimen collection.

The ability to interpret or advise on specialist toxicology screening assays is beyond the scope of this module and is not an intended outcome of this training.

Work-based content

Training activities

# Learning outcome Training activity Type Action
# 1 Learning outcome 1,2,4,6 Training activities

Select the appropriate diagnostic pathway for patients with a suspected diagnosis of the following conditions:

  • High anion gap metabolic acidosis
  • Paracetamol overdose
  • Drug overdose causing reduced level of consciousness
Type ETA Action View
# 2 Learning outcome 1 Training activities

Interpret results for the following vitamins:

  • Vitamin A
  • Vitamin D
  • Vitamin E
Type ETA Action View
# 3 Learning outcome 1,5 Training activities

Interpret results for one of the following pharmacogenetic tests:

  • Thiopurine methyltransferase (TPMT) activity and metabolites
  • Cholinesterase variants
Type DTA Action View
# 4 Learning outcome 1,2 Training activities

Perform and interpret assays for the following metals:

  • Copper
  • Zinc
  • Selenium
  • Lead
  • Aluminium
  • Chromium and cobalt
Type DTA Action View
# 5 Learning outcome 1,2,5,6 Training activities

Perform and interpret assays for the measurement of including chromatographic analysis:

  • Ethylene glycol
  • Ethanol
  • Methanol
Type DTA Action View
# 6 Learning outcome 1,2,3 Training activities

Perform and interpret assays for the detection of drugs of abuse in urine for the following:

  • Heroin
  • Morphine
  • Codeine
  • Methadone
  • Cannabis
  • Cocaine benzodiazepines (including diazepam),
  • Amphetamine
  • MDMA
Type DTA Action View
# 7 Learning outcome 1,2,3,4,5,6 Training activities

Perform vertical audit of a sample analysed for a ‘toxicology screen’

Type DTA Action View
# 8 Learning outcome 1,2,5,6 Training activities

Perform and interpret assays for the analysis for three of the following:

  • Methotrexate
  • Phenytoin
  • Theophylline
  • Gentamicin
  • Vancomycin
  • Digoxin
Type ETA Action View
# 9 Learning outcome 1,2,5,6 Training activities

Perform and interpret assays for the measurement of four of the following:

  • Lamotrigine
  • Levetiracetam
  • Clozapine
  • Tacrolimus
  • Ciclosporin
  • Infliximab
Type DTA Action View
# 10 Learning outcome 6,7 Training activities

Review the current protocol for with reference to best practice:

  • Processing samples in the cases of SUDIC
  • Release of clinical material/clinical information to an external party (i.e. police or HM coroner)
Type DTA Action View
# 11 Learning outcome 8 Training activities

Review a case in which biochemistry has contributed to the clinical care where the patient has nutritional deficit

Type DTA Action View

Assessments

Complete 2 Case-Based Discussions

Complete 2 DOPS or OCEs

Direct Observation of Practical Skills Titles

  • Perform maintenance on an LC-MS (LC-MS/MS, HR-MS etc) or GC-MS system, confirming adequate performance with system tests.
  • Perform maintenance on an ICP-MS/ICP-OES/AA system, confirming adequate performance with system tests.
  • Interpret five positive samples referencing significance of results for drugs of abuse testing.
  • Interpret five positive samples referencing significance of results for a comprehensive toxicology screen.
  • Interpret an EQA return for a drugs of abuse assay or similar screening assay.

Observed Clinical Event Titles

  • Advise a clinician on the appropriate time to take a sample.
  • Advise/collate clinical/situational details to inform a toxicology request.
  • Present two cases at departmental/ Duty Biochemist meeting.

Learning outcomes

# Learning outcome
1

Analyse drugs, vitamins and trace elements in various biological matrices via quantitative and qualitative assays using automated and manual methodologies.

2

Apply the appropriate investigative strategy to clinical situations which may involve drugs or poisons, advising clinical teams on the appropriate course of action.

3

Appraise the methods in routine use for ‘drugs of abuse’ screening and advise on the interpretation of common analytes.

4

Summarise the limitations of comprehensive toxicology screening in clinical practice.

5

Demonstrate the application of pharmacokinetics and pharmacogenomics in therapeutic drug monitoring.

6

Illustrate how toxicology results are used in clinical practice and the legal consequences of drug testing in various settings.

7

Apply protocols for sample processing and documentation required in the cases of sudden unexpected death of an infant/child (SUDIC) and coroner’s investigation.

8

Illustrate how biochemistry results are used to support the management of patients who require nutritional support.

Clinical experiences

Clinical experiences help you to develop insight into your practice and a greater understanding of your specialty's impact on patient care. Clinical experiences should be included in your training plan and you may be asked to help organise your experiences. Reflections and observations from your experiences may help you to advance your practice and can be used to develop evidence to demonstrate your awareness and appreciation of your specialty.

Activities

  1. Speak to a clinical team (e.g. midwifery) regarding drugs of abuse screening results, consider the relevance of results and reasons for presence of drugs.
  2. Attend a nutrition ward round to appreciate how many trace element results are used.
  3. Shadow a ward-based microbiology pharmacist to appreciate the follow up to antibiotic results by clinical teams.
  4. Attend liaison meetings between laboratory and a clinical team (e.g. drug treatment teams).
  5. Speak to the coroner officer regarding collection of ante-mortem samples required for a post-mortem investigation to appreciate the local guidelines which guide sample collection.

Academic content (MSc in Clinical Science)

Important information

The academic parts of this module will be detailed and communicated to you by your university. Please contact them if you have questions regarding this module and its assessments. The module titles in your MSc may not be exactly identical to the work-based modules shown in the e-portfolio. Your modules will be aligned, however, to ensure that your academic and work-based learning are complimentary.

Learning outcomes

On successful completion of this module the trainee will be able to:

  1. Explain the fundamental principles of pharmacokinetics, pharmacodynamics and pharmacogenetics.
  2. Plan and discuss the investigation of a suspected drug poisoning, related clinical conditions and chain of custody.
  3. Justify the appropriate sampling time and sample type for a range of therapeutically monitored drugs.
  4. Apply integrative knowledge of the role of pharmacogenomics in therapeutic drug monitoring.
  5. Critically evaluate the design, operation and performance of appropriate analytical methods for the detection of drugs, vitamins and trace elements in different biological fluids.
  6. Discuss and assess laboratory test results in the clinical interpretation of drug results.
  7. Evaluate the need for macro-and micronutrients for normal health, growth, repair and reproduction.
  8. Explain the role of clinical biochemistry in the assessment of trace element and vitamin status in health and disease.

Indicative content

  • Basic pharmacology, including the mechanism of action of different classes of drugs and an overview of renal/liver pathways of drug metabolism.
  • Pharmacokinetics including an understanding of drug half-life and dosage prediction.
  • Pharmacogenomics including impact on drug dosage and currently used clinical tests.
  • Therapeutic drug monitoring of digoxin, lithium, anti-epileptics, theophylline, methotrexate, immunosuppressive drugs and antibiotics.
  • Metabolic effects of ethanol and toxic alcohols.
  • Investigation and metabolic effects of overdose including salicylate, paracetamol, barbiturates and tricyclic antidepressants.
  • Investigating patients addicted to drugs including alcohol, opiates, amphetamines, benzodiazepines, cocaine and cannabis.
  • Metabolic effects and laboratory investigation of poisoning including carbon monoxide, lead, mercury, aluminium, iron, ethylene glycol, methanol and other organic alcohols, and organophosphates.
  • Laboratory investigation of the unconscious or deceased poisoned patient.
  • Laboratory methods for the measurement of therapeutic and toxic drugs from screening to confirmation.
  • Medicolegal considerations during drug testing.
  • The role of vitamins and trace elements in health and disease, including syndromes of vitamin deficiency and excess.
  • Methods of measurement of trace elements and vitamins in biological samples, including ICP-MS.

Module assigned to

Specialties

Specialty code Specialty title Action
Specialty code SLS1-1-22 Specialty title Clinical Biochemistry [2022] Action View
Specialty code SLS1-1-23 Specialty title Clinical Biochemistry [2023] Action View
Specialty code SLS1-1-24 Specialty title Clinical Biochemistry [2024] Action View