WEEK 6

Question 1

Basic steps of the basic drug evaluation and registration process

Answer 1

Application
Evaluation
Approval
Registration

Question 2

what is the TGA

Answer 2

A system which determines whether a medication can be sold in Australia.
Regulates how medications are sold, manufactured and advertised

Question 3

Some roles of the TGA

Answer 3

• Regulates therapeutic goods
• Evaluates and monitors therapeutic goods
• Ensures acceptable standards and manufacturing quality
• Regulates the imports and exports of medicines and medical devices
• Works with stakeholders to regulate emerging products to enable rapid scientific developments

Question 4

3 things the TGA doesn’t do

Answer 4

• Veterinary medicines
• Food regulations
• Cosmetic/chemical standards

Question 5

What is Aust L

Answer 5

Listed
Lower risk
Tested only for safety and quality
Claims not to assess for efficacy

Question 6

What is Aust R

Answer 6

Registered
Higher Risk
Prescription medications, not advertised to the public
Tested for safety, quality and effectiveness

Question 7

The drug evaluation commitee

Answer 7

An advisory committee on prescription medication ACPM

They play a role in providing independent, scientific advice on new drugs to the federal government

Advices and makes recommendations to the TGA on prescription medications

• Inclusion of prescription medicine on the ARTG
• Changes to an entry of a prescription medicine on the register
• Removal or retention of a prescription medication in the register.

Question 8

PBS aim

Answer 8

Aims to provide timely, reliable and affordable access to medications to all Australians
It subsides the cost of medications for most medical conditions. These are medications which are necessary to maintain the health of the community in a way that is cost effective

Question 9

PBS eligibility

Answer 9

• Available to all Australians residents who hold a Medicare card
• Also available to overseas citizens for some countries – including the UK, Italy, Sweden etc).

Question 10

safety net PBS

Answer 10

Once a threshold is reached, the cost of PBS medications is reduced for the remainder of the calendar

• General patient costs get reduced to concession rates
• Concession patient costs become free

Question 11

medicare what is it

and who is eligible

Answer 11

a commonwealth funded, compulsory, universal health insurance scheme

• Australian and NZ citizens
• People with a permanent visa
• People who have applied for a permanent visa

Question 12

aims of medicare

Answer 12

• Affordable healthcare for all Australian Citizens
• Provision of high-quality healthcare
• Access to health care services, with priority according to clinical need.

Question 13

medicare funding

Answer 13

3 ways

1. Taxation
2. Medicare levy (2%) medicare surcharge (1.5% after 30)
3. Medicare levy providers

Question 14

private health insurance

Answer 14

Voluntary insurance cover for people choosing to be treated as private patients in either private or public hospitals 
Includes: 
 Extras (e.g. dentistry) 
 Medications not on PBS
 Ambulance cover