Curriculum standards

Knowledge guides

LG12: Foundations of clinical pharmacology

Epidemiology, pathophysiology, and clinical sciences

Advanced Trainees will have in-depth knowledge of the topics listed under each clinical sciences heading.

For the statistical and epidemiological concepts listed, trainees should be able to describe the underlying rationale, the indications for using one test or method over another, and the calculations required to generate descriptive statistics.

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Investigations, procedures, and clinical assessment tools

Advanced Trainees will know the scientific foundation of each investigation and procedure, including relevant anatomy and physiology. They will be able to interpret the reported results of each investigation or procedure.

Advanced Trainees will know how to explain the investigation or procedure to patients14, families, and carers, and be able to explain procedural risk and obtain informed consent where applicable.

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Important specific issues

Advanced will identify important specialty-specific issues and the impact of these on diagnosis, management and outcomes.

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Drug dependence

Classes of drugs involved, both legal and illegal
Legislative and regulatory controls for drugs of abuse
Principles of dependence, overdose, and tolerance, including receptor downregulation / internalisation

Drug discovery and development

Drug development principles, such as:
- considerations of using generic medicines, such as bioequivalence studies and drug patents
- delivery and formulation
- design and research, including lead generation and target identification and validation
- efficacy, quality, and safety of new drug applications
- opposing viewpoints and the pressures involved to market and subsidise new drugs
- role of the national regulatory authorities
Ethical aspects of drug-related research, including safety requirements of research subjects
Preclinical and clinical development principles, such as:
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidance
- phases of drug trials
- pre-clinical pharmacology and toxicology studies
- principles to determine the maximum safe starting dose and dose-escalation in first-in-human clinical trials, such as:
  - minimal anticipated biological effect level (MABEL)
  - no observed adverse effects level (NOAEL)
  - pharmacologically active dose (PAD)
- regulatory documents, such as:
  - Australian Public Assessment Reports (AusPAR)
  - European Public Assessment Reports (EPAR)
  - Food and Drug Administration (FDA)
- significant regulatory milestones
Principles of quality improvement methodology
Principles of research methodology, such as:
- awareness of more complex statistics, such as Mendelian randomisation (MR) and high-dimensional propensity score (hdPS) matching
- basic biostatistics, such as power analysis and survival analysis
- critical appraisal of a manuscript being submitted for publication
- hypothesis development and testing
- principles of good clinical research practice
- review of ethics application against national statement
- role of ethics, and ethics committees

Drug safety and toxicity

Adverse drug reactions (ADRs) and pharmacovigilance, such as:
- drug safety post-marketing
- mechanisms of toxicity
- monitoring adverse effects
Drug-drug interactions and contraindications

Multimorbidity

Clinical assessment, such as Charlson Comorbidity Index
Clinical guidelines and medications used in the treatment of common comorbidities
Conflicting therapeutic objectives
Contribution to polypharmacy and drug interactions
Definition
Epidemiology
Frailty as an effect modifier for medicines
Pathophysiology

Pharmacodynamics and drug mechanisms

Concentration-effect relationships, and factors that may alter these
Drug-receptor interactions, such as:
- agonists
- antagonists
- inverse agonists
- partial agonists
Enzyme activity in the presence of drugs
Ion channel function across various systems
Mechanisms of drug action, such as:
- biologicals
- gene therapy
- receptor pharmacology
Potency versus efficacy
Role of transport proteins in pharmacokinetics
Tolerance
Use of biomarkers in drug therapy monitoring
Variability in drug action

Pharmacoeconomics

Economic implications of drug therapy, such as:
- budget impact analyses
- cost-effectiveness analyses
- cost-minimisation analysis
- cost-utility analysis

Pharmacoepidemiology

Case control studies
Cohort studies
Cross-sectional studies
Data sources, such as electronic medical records (EMRs) and Pharmaceutical Benefits Scheme (PBS)
Repositories
Use and effects of drugs in large numbers of people, and how it can inform public health decisions

Pharmacogenomics

Databases available for pharmacogenomic research, including the Clinical Pharmacogenetics Implementation Consortium
Genetic variability of drug response and metabolism, such as:
- genetic variation of therapeutic targets
- polymorphisms of key drug metabolising enzymes and transporters
- race-associated pharmacogenetic variation
Ontogeny of expression and function of key pharmacodynamic and pharmacokinetic genes
Role in precision medicine
Tailoring drug therapies to individual genetic profiles

Pharmacokinetics

Basic pharmacokinetic equations
Gene therapy principles, such as:
- delivery vectors
- expression kinetics
- modalities
Principles of pharmacokinetics, such as:
- absorption, distribution, metabolism, and excretion (ADME)
- area under a plasma drug concentration-time curve (AUC)
- bioavailability and first-pass effect
- clearance, including extraction ratio and total body clearance
- drug behaviour in the body
- drug metabolism and elimination
- drug transport
- first- and zero-order processes, such as saturation kinetics
- half-life
- nonlinear kinetics
- plasma protein binding and free drug concentrations, considering the impact on parameters and effects
- receptor-mediated drug disposition
- volume of distribution
Principles of pharmacodynamics and pharmacokinetics in special circumstances, such as:
- extremes of size and age – development / senescence
- hepatic disease
- kidney failure
- lactation
- pharmacogenomics
Receptor concepts

Substance use disorders

Acute toxicity
Demographics
Mental health factors
Social factors
Tolerance
Withdrawal and abstinence syndromes of common substances, such as:
- antidepressants
- cannabis
- ethanol
- gabapentinoids
- nicotine
- opioids
- sedative hypnotics
- stimulants

Toxicology care

Anti-epileptic drugs
Common poisonings, such as:
- antibiotic
- anticoagulant and antiplatelet
- antihypertensive
- antipsychotic
- benzodiazepine
- beta blocker
- diuretic
- glucose-lowering medicine
- nonsteroidal anti-inflammatory drug (NSAIDs)
- opioid
- paracetamol
- salicylate
- steroid
Impact of specific interventions on the outcome
Novel psychoactive agents
Principles of toxicodynamics and toxicokinetics
Toxidromes, such as:
- anticholinergic, including antimuscarinic
- beta blocker
- calcium channel blocker
- cholinergic
- opioid
- sedative or hypnotic
- serotonergic
- sodium channel blocker
- sympathomimetic

AIM

Modelling and simulation, including physiologically based pharmacokinetic modelling (PBPK)
Principles of pharmacodynamics and pharmacokinetics in geriatric, lactating, and pregnant patients

PCH

Clinical and legislative issues relating to drugs of dependence / abuse, including adolescent substance misuse and neonatal abstinence syndromes
Consent and other ethical issues specific to paediatric age groups
Developmental changes in metabolic and kidney elimination pathways
Mechanisms of action, modelling, and simulation in relation to paediatric age groups
Paediatric drug trial principles, such as age-specific drug responses, and dosing and ethical challenges
Pharmacodynamics and pharmacokinetics in:
- adolescents
- children
- infants
- intrauterine environment
- lactation
- neonates
- preterm neonates

Drug development

Efficacy, quality, and safety of new drug applications in the paediatric age
Formulation development

Toxicology

Antenatal and perinatal toxicity of maternal medications
Clinically relevant human teratogens
Drug exposure and toxicity through breastfeeding
Principles of paediatric poisons exposures, such as intentional or accidental poisoning

Analytical methodologies, such as:
- immunoassays
- liquid chromatography
- mass spectrometry
Assays, such as:
- analysis of results
- common methodology
- performance principles
- quality control
Model-dependent analyses, such as compartmental models
Model-independent analyses
Nonlinear mixed effect modelling
Simulation of new dosing regimens

PCH

Assays in paediatric age groups

Impact on drug safety of digital health technologies, such as:
- apps for medication management
- digital therapeutics
- dose modification using predictive software
- electronic health records
- electronic medication management and ordering
- medical informatics and dashboards
- telehealth for patient consultations
Multidisciplinary approach to care, such as when treating complex cancer patients
National and local guidelines for the quality use of medicines
Opportunities to stay informed and up to date on advances in research and best practice clinical care, such as participating in journal club to learn about new drugs and devices

Quality use of medicines

Complementary and alternative medicine (CAM) benefits and limitations, including their side effects and interactions, and their prominence in the population
Drug information, such as:
- gaps between lay, paramedical, and medical understanding of research methodology and evidence
- levels of evidence
- principles of evidence-based medicine
- sources of drug information
Drug policy stakeholders, such as:
- competing factions, including:
  - drug companies
  - government regulatory committees
- drug committees
- formularies
Drug safety principles, such as:
- contribution of adverse drug reactions (ADRs) and drug error to morbidity and mortality
- difference between ADRs and adverse drug events (ADEs)
- importance of considering risks as well as benefits of drugs
- methods of evaluating and classifying ADEs, ADRs, and drug errors
- responsibility to contribute to the national database of ADRs
- role of post-marketing surveillance / pharmacovigilance / risk management plans
- sources of information on ADRs
Impact of drugs on broader society, such as:
- climate health
- eco-pharmacovigilance
- globalisation and its impacts on the drug manufacturing chain, such as supply shortages
- sustainability
Pharmaceutical, pharmacodynamic, and pharmacokinetic drug interactions as a cause of morbidity, mortality, and variability
Principles behind compliance and adherence with medicines, and methods to these, including the benefits of compliance aids
Principles of drug use evaluation, such as the audit loop, and the orphan drug designation
Therapeutic drug concentration principles, such as:
- indications, limitations, and usefulness of therapeutic drug monitoring in patient management
- therapeutic ranges for commonly assayed medications

PCH

Benefits, limitations, and extent of CAMs use in the paediatric age group
Drug information, such as:
- appropriate methods for extrapolating adult data to children, and the limitations of these methods
- sources of drug information for the paediatric age group, and the limitations of this information
Drug safety considerations, such as:
- detection of ADRs and ADEs in children
- errors in administration, dispensing, monitoring, and prescribing
Principles of administration of medicines to children
Role of neonatal / paediatric formularies in drug policies