Practice Test Geeks(APC) Australian Pharmacy Council Practice Test
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Regulatory & Ethical Standards Flashcards

7 cards from real APC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Regulatory & Ethical Standards flashcards as text

  1. Under the Therapeutic Goods Act 1989, which category of medicines can be marketed in Australia without pre-market evaluation by the TGA?

    Answer: Listed medicines (ARTG listed)

    Listed medicines (e.g., low-risk complementary medicines) are entered on the ARTG based on a self-assessment of quality and safety without pre-market efficacy evaluation.

  2. A patient presents a prescription that appears to have been altered. The pharmacist's MOST appropriate action is to:

    Answer: Contact the prescriber to verify the prescription before dispensing

    Contacting the prescriber is the first verification step when prescription authenticity is in doubt, before any dispensing or reporting occurs.

  3. The concept of 'therapeutic substitution' in Australia refers to:

    Answer: Replacing a prescribed medicine with a pharmacologically different agent from the same therapeutic class

    Therapeutic substitution involves replacing one drug with a different chemical entity that has similar therapeutic effects, which generally requires prescriber approval in Australia.

  4. The mandatory reporting obligation under the Health Practitioner Regulation National Law requires a pharmacist to report a colleague who:

    Answer: Has a notifiable impairment that places the public at risk of harm

    Mandatory reporting applies to notifiable conduct including impairment that places the public at risk, sexual misconduct, and practice while intoxicated.

  5. What is the role of the Australian Pharmacy Council (APC) specifically within the pharmacy regulatory framework?

    Answer: Accrediting pharmacy programs and internship training

    The APC is the accreditation authority for pharmacy education programs and intern training programs, not the registration body.

  6. A pharmacist compounding a preparation that is not a registered therapeutic good must ensure compliance with:

    Answer: Relevant state/territory legislation and Pharmacy Board guidance on compounding

    Compounding pharmacists must comply with state/territory legislation and the Pharmacy Board's position statement on compounding, which incorporates quality standards.

  7. Which document provides the ethical framework guiding pharmacists' professional responsibilities in Australia?

    Answer: The Pharmaceutical Society of Australia's Code of Ethics for Pharmacists

    The PSA Code of Ethics for Pharmacists is the primary ethical framework articulating professional values, principles, and responsibilities for Australian pharmacists.