Module 2 - Legal, clinical and ethical responsibilities Flashcards

1
Q

What is involved in state legislation?

A

Authorisation of prescribers
Poison classification and restriction
Requirements for prescribing and dispensing
Administration of poisons

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2
Q

What is involved in commonwealth legislation?

A

Funding (PBS)
Registration of medicines and poisons (TGA)
National classification uniformity (SUSMP)
Practitioner registration (AHPRA)

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3
Q

What does SUSMP stand for?

A

Standard uniform for scheduling of medicines and poisons?

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4
Q

What is the role of the SUSMP?

A

Controls availability and accessibility of substances
Signifies the degree of control recommended

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5
Q

What is the state legislation for the ACT?

A

Medicines, Poisons and Therapeutic Goods regulation 2008

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6
Q

What does the Medicines, Poisons and Therapeutic Goods regulation cover?

A

Substances and goods to which the act applies
Medicines and poisons standard

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7
Q

What are the four legal and professional requirements of a valid prescription?

A

Name, address and phone of prescriber
PBS prescriber number
Name and address of patient
Date of prescribing

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8
Q

Who are the health professionals in Australia who can prescribe medications?

A

Medical practitioner
Nurse practitioner
Midwife
Optometrist
Dentist

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9
Q

What are schedule 2 medicines?

A

Pharmacy medicines

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10
Q

What are schedule 3 medicines?

A

Pharmacist ONLY medicines

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11
Q

What are schedule 4 medicines?

A

Prescription ONLY medicines

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12
Q

What are schedule 4d medicines?

A

Prescription RESTRICTED medicines

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13
Q

What are schedule 5 medicines?

A

Caution (low potential for causing harm)

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14
Q

What are schedule 6 medicines?

A

Poison (more dangerous chemicals with moderate potential for harm)

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15
Q

What are schedule 7 medicines?

A

Dangerous poison (high potential for causing harm)

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16
Q

What are schedule 8 medicines?

A

Controlled drugs (highly addictive)

17
Q

What are schedule 9 medicines?

A

Prohibited substances

18
Q

What is TGA?

A

Therapeutic Goods Administration

19
Q

What is the role of the therapeutic goods act?

A

Regulates therapeutic goods for use in humans for preventing, treating or diagnosing a disease

20
Q

What is the role of the TGA?

A

Evaluates a product (pre-marketing) for quality, safety, efficacy and cost-effectiveness

21
Q

What other provisions does the therapeutic good act cover?

A

Licenses for manufactures
Supply, wholesaling and retailing
Possession
Advertising
Prescribing and dispensing
Packaging and labelling
Administration
Storage and destruction
Testing of drugs

22
Q

What are orphan drugs?

A

Agent that is intended to treat, prevent or diagnose a rare disease