FANZCA Industry Regulations 2 — Questions and Answers
Question 1: Which Australian government body is responsible for regulating therapeutic goods including anaesthetic drugs?
- AHPRA
- TGA (Correct answer)
- ACCC
- APVMA
Correct answer: TGA
The Therapeutic Goods Administration (TGA) regulates therapeutic goods including medications, medical devices, and anaesthetic agents in Australia.
Question 2: Under ANZCA Professional Document PS18, minimum monitoring during general anaesthesia must include which parameter at all times?
- Invasive arterial pressure
- Pulse oximetry (Correct answer)
- Bispectral index
- End-tidal CO2 only
Correct answer: Pulse oximetry
ANZCA PS18 mandates continuous pulse oximetry as a minimum monitoring standard throughout general anaesthesia.
Question 3: The ANZCA document that defines the standards for the anaesthesia workplace (machine check, equipment) is designated as:
- PS04
- PS28 (Correct answer)
- PS31
- PS54
Correct answer: PS28
ANZCA PS28 outlines the standards for anaesthesia workstations, including pre-use checks and equipment requirements.
Question 4: In Australia, Schedule 8 (S8) controlled drugs such as fentanyl must be stored in a manner that complies with which type of security requirement?
- A locked cupboard of any material
- A locked steel safe or cabinet of specified construction (Correct answer)
- A refrigerated unit with electronic lock
- A standard medication room with keypad access
Correct answer: A locked steel safe or cabinet of specified construction
S8 drugs must be stored in a specifically constructed locked steel cabinet meeting state/territory poison regulations for controlled substance security.
Question 5: ANZCA's PS15 professional document pertains to which aspect of anaesthesia practice?
- Minimum standards for intrahospital transport
- Recommendations for the pre-anaesthesia consultation (Correct answer)
- Standards for procedural sedation
- Management of difficult airways
Correct answer: Recommendations for the pre-anaesthesia consultation
ANZCA PS15 provides recommendations for the pre-anaesthesia consultation, detailing what the anaesthetist must assess before administering anaesthesia.
Question 6: Which regulatory requirement specifically governs anaesthetist-to-patient ratios and supervision levels for trainees in Australia?
- ANZCA PS08 (Correct answer)
- AHPRA Medical Board supervision guidelines
- Fair Work Act staffing provisions
- TGA clinical trial regulations
Correct answer: ANZCA PS08
ANZCA PS08 outlines the supervision requirements for anaesthesia trainees, specifying appropriate supervision levels based on trainee stage.
Question 7: Mandatory reporting obligations for impaired or incompetent registered medical practitioners in Australia are governed primarily by which legislation?
- Work Health and Safety Act 2011
- Health Practitioner Regulation National Law (Correct answer)
- Privacy Act 1988
- Therapeutic Goods Act 1989
Correct answer: Health Practitioner Regulation National Law
The Health Practitioner Regulation National Law (enacted in each state/territory) contains mandatory reporting obligations for health practitioners regarding impairment or misconduct.
FANZCA Industry Regulations 2
Which Australian government body is responsible for regulating therapeutic goods including anaesthetic drugs?