2012PHM - Pharmacy Practice II EOT Q&A
What does TGA stand for? - =Therapeutic Goods Administration
What are the roles for TGA? - =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? - =Higher level of risk
- prescription medicines and some non-prescription medicines
What is AUST L? - =Lower level of risk
- over the counter medicines
- sunscreens and vitamins etc.
What is AUST LA? - =New category
- Sites listed between low risk and high risk
- Complementary medicine
What does the TGA make risk categories based on? - =Ingredients
Standard of manufacturer
Dosage form
Therapeutic claims
What is TGA apart of? - =The Department of Health
,What process for scheduling medicine and poisons through? - =Advisory committee on
medicines scheduling (ACMS)
Advisory committee on chemicals scheduling (ACCS)
What schedules is therapeutic use? - =2, 3, 4, 8
(pharmacy medicine, pharmacist only medicine, prescription only medicine and controlled
drugs)
What schedules is agricultural, domestic and industrial use? - =5, 6, 7
(Caution, poison, dangerous poison)
What schedule is teaching, training and research use? - =9 (prohibited substances)
What schedule is prohibited form use? - =10 (substances danger to health)
What is in the SUSMP? - =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? - =Specifies who is authorised and what dealings they may undertake
with certain medicines.
What is the PBS? - =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? - =- 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? - =Drugs that have no restrictions on their therapeutic use.
What us restricted benefits? - =Drugs that can only be prescribed for specific therapeutic use.
What is authority required benefits? - =Drugs that meet authorised requirements (have approval
from Service Australia or the DVA.
What is the price for concession patients? - =$6.80 (may receive up to $1.00 discount)
What is a premium? - =additional charges for specific brands/drugs.
- brand premium, therapeutic group premium and special patient contribution premium.
What is brand premium? - =The difference between alternative brands of the same drug.
What is therapeutic group premium (TGP)? - =The difference in price among drugs from the
same therapeutic group.
What is special patient contribution premium (SPCP)? - =The difference between what the
manufacturer is charging and what the government is willing to cover.
What are the PBS requirements for a script (Rx)? - =Prescribers are required to write their Rx
using the active ingredient rather than brand name unless:
- handwritten Rx
- charts in residential aged care
- medicines that contain 4+ active ingredients
What does TGA stand for? - =Therapeutic Goods Administration
What are the roles for TGA? - =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? - =Higher level of risk
- prescription medicines and some non-prescription medicines
What is AUST L? - =Lower level of risk
- over the counter medicines
- sunscreens and vitamins etc.
What is AUST LA? - =New category
- Sites listed between low risk and high risk
- Complementary medicine
What does the TGA make risk categories based on? - =Ingredients
Standard of manufacturer
Dosage form
Therapeutic claims
What is TGA apart of? - =The Department of Health
,What process for scheduling medicine and poisons through? - =Advisory committee on
medicines scheduling (ACMS)
Advisory committee on chemicals scheduling (ACCS)
What schedules is therapeutic use? - =2, 3, 4, 8
(pharmacy medicine, pharmacist only medicine, prescription only medicine and controlled
drugs)
What schedules is agricultural, domestic and industrial use? - =5, 6, 7
(Caution, poison, dangerous poison)
What schedule is teaching, training and research use? - =9 (prohibited substances)
What schedule is prohibited form use? - =10 (substances danger to health)
What is in the SUSMP? - =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? - =Specifies who is authorised and what dealings they may undertake
with certain medicines.
What is the PBS? - =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? - =- 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? - =Drugs that have no restrictions on their therapeutic use.
What us restricted benefits? - =Drugs that can only be prescribed for specific therapeutic use.
What is authority required benefits? - =Drugs that meet authorised requirements (have approval
from Service Australia or the DVA.
What is the price for concession patients? - =$6.80 (may receive up to $1.00 discount)
What is a premium? - =additional charges for specific brands/drugs.
- brand premium, therapeutic group premium and special patient contribution premium.
What is brand premium? - =The difference between alternative brands of the same drug.
What is therapeutic group premium (TGP)? - =The difference in price among drugs from the
same therapeutic group.
What is special patient contribution premium (SPCP)? - =The difference between what the
manufacturer is charging and what the government is willing to cover.
What are the PBS requirements for a script (Rx)? - =Prescribers are required to write their Rx
using the active ingredient rather than brand name unless:
- handwritten Rx
- charts in residential aged care
- medicines that contain 4+ active ingredients
