UPDATED ACTUAL Exam Questions and
CORRECT Answers
What does TGA stand for? - CORRECT ANSWER - Therapeutic Goods Administration
What are the roles for TGA? - CORRECT ANSWER - Their purpose is to protect health and
safety by regulating therapeutic goods in Australia.
1. Regulate control medicines manufactures
2. Classify medicine based on level of risk
3. Monitoring (post-marketing survaliance)
What is AUST R? - CORRECT ANSWER - Higher level of risk
- prescription medicines and some non-prescription medicines
What is AUST L? - CORRECT ANSWER - Lower level of risk
- over the counter medicines
- sunscreens and vitamins etc.
What is AUST LA? - CORRECT ANSWER - New category
- Sites listed between low risk and high risk
- Complementary medicine
What does the TGA make risk categories based on? - CORRECT ANSWER - Ingredients
Standard of manufacturer
Dosage form
Therapeutic claims
,What is TGA apart of? - CORRECT ANSWER - The Department of Health
What process for scheduling medicine and poisons through? - CORRECT ANSWER -
Advisory committee on medicines scheduling (ACMS)
Advisory committee on chemicals scheduling (ACCS)
What schedules is therapeutic use? - CORRECT ANSWER - 2, 3, 4, 8
(pharmacy medicine, pharmacist only medicine, prescription only medicine and controlled
drugs)
What schedules is agricultural, domestic and industrial use? - CORRECT ANSWER - 5, 6, 7
(Caution, poison, dangerous poison)
What schedule is teaching, training and research use? - CORRECT ANSWER - 9 (prohibited
substances)
What schedule is prohibited form use? - CORRECT ANSWER - 10 (substances danger to
health)
What is in the SUSMP? - CORRECT ANSWER - Medicines and poisons are classified into
schedules required to protect public health and safety. Also contains provision for labelling,
containers, storage and possessions according to laws and requirements.
What is in the MPMR? - CORRECT ANSWER - Specifies who is authorised and what
dealings they may undertake with certain medicines.
What is the PBS? - CORRECT ANSWER - Lists all medicines available to be dispensed at a
government-subsidised price.
- Detailed CMI, payments and conditions of use
, Who is eligible for PBS items? - CORRECT ANSWER - - All Australian residents who carry
a medicare card.
- Eligible Veterans (see RPBS)
- All individuals from countried AUS has a reciprocal health care agreement.
- Pension concession card holders
- Health care card holders
- CVA white, gold or orange card
- PBS safety net card holders
- Closing the gap (CTG) - aboriginals and torres strait islanders.
What is unrestricted benefits? - CORRECT ANSWER - Drugs that have no restrictions on
their therapeutic use.
What us restricted benefits? - CORRECT ANSWER - Drugs that can only be prescribed for
specific therapeutic use.
What is authority required benefits? - CORRECT ANSWER - Drugs that meet authorised
requirements (have approval from Service Australia or the DVA.
What is the price for concession patients? - CORRECT ANSWER - $6.80 (may receive up to
$1.00 discount)
What is a premium? - CORRECT ANSWER - additional charges for specific brands/drugs.
- brand premium, therapeutic group premium and special patient contribution premium.
What is brand premium? - CORRECT ANSWER - The difference between alternative brands
of the same drug.
What is therapeutic group premium (TGP)? - CORRECT ANSWER - The difference in price
among drugs from the same therapeutic group.