CSB601 Exam With Complete
Solution
What is the role of TGA? - Answer Regulation of the supply, import, export and
manufacturing of therapeautic goods in Aus.
What does the TGA classify as therapeutic goods? - Answer medications, supplments,
complementary meds, medicine devices, tests/diagnostic materials, vaccines, biolgic
products, sunscreen, surgical implants
Aust L is? - Answer low risk medicines: vitaminsm herbals, no evidence assessed
Aust R is ? - Answer registered meds, high risk
What is an active ingredient ? - Answer chemical in the medicine that has a therapeutic
effect, makes it work
What is a brand name? - Answer manufacturers use a memorable name
What is the original brand? - Answer first patented brand of medicine
What is bioequivalence ? - Answer the active ingredient is identical and the medicine is
manufactured to have the same effect in body
Are all generic medicines exactly the same? - Answer No, they have the same ingredient
but forms may change
What site do you use to find brand names ? - Answer MIM/AUSDI/AMH
Where can you confirm meds are registered in AUS? - Answer TGA
Drugs which have been taken by large number of pregnant women and women of
childbearing age without any proven increase in frequency of malformations or
direct/indirect harmful effects on fetus having been observed. - Answer Category A
Drugs which have been taken by a limited number of pregnant women, without an
increase in frequency of malformation effects on fetus . Studies in animals have NOT
shown evidence of an increased occurrence of fetal damage. - Answer Category B1
Drugs which have been taken by limited number of pregnant women without an increase
in frequency of malformation effects on fetus. Studies in animals are INADEQUATE but
available data show no evidence of an increased occurrence of fetal damage - Answer
Category B2
Drugs which have been taken by limited number of pregnant women without an increase
in frequency of malformation effects on fetus. Studies in animals HAVE shown evidence
of increased occurrence of fetal damage, significance is considered UNCERTAIN in
,humans. - Answer Category B3
Drugs which owing to pharmacological effects have caused or suspected of causing
harmful effects on fetus without causing malformations. Effects may be reversible. -
Answer Category C
Drugs which have caused an increased incidence of human fetal malformations or
irreversible damage. May also have adverse pharmacological effects. - Answer
Category D
Drugs which have such a high risk of causing permanent damage to fetus that they
should not be used in pregnancy where possible. - Answer Category X
Pharmacokinetics - Answer What the body does to the drug, how it
changes/absorbs/distributes/metabolises/eliminates it
Pharmacodynamics - Answer What the drug does to the body
Why do drugs adminsitered vie inhalation tend to have a faster onset than oral drugs ? -
Answer Inhalation drugs have a shorter journey to reach arterial circulation.
Which has a larger Tmax? Oral drugs or inhalation ? - Answer Orals have a larger Tmax
Four chambers of fluid in body that drugs may be distributed ? - Answer Blood, fat,
intracellular fluid and extracellular fluid
What is first pass metabolism? - Answer When a drug is metabolised by liver before it
reaches systemic circulation (oral drugs). The more it is broken down by first pass the
less of the active drug reaches systemic circulation and less effective.
First order elimination ? - Answer More drug in plasma the faster it is eliminated, no
enzyme saturation.
zero order elimination - Answer There IS an enzyme that is necessary for metabolism
and excretion that may be saturated and not able to clear drug as fast as it enters
plasma
Why are zero order elimination drugs more likely to be overdosed on? - Answer because
they aren't cleared faster if there is more if it in the body - builds up in body as the
enzymes become saturated
Why might someone need to wait 14 days before starting a new medication ? - Answer
Their original medication may have a very long half life. which means that it will stick
around in the body for longer after stopping it. If it is still in the system then it has
potential to interact.
5-6% incidence of DI if taking how many drugs ? - Answer 2
increased 56% DI if taking how many drugs ? - Answer 6
, DI chance is 100% if taking how many drugs ? - Answer 8
Poly-pharamcy pts, hepatic/renal disease, long term therapy for chronic disease,
intensive care pts, more than one prescriber, elderly, critically ill - Answer Susceptible
pts to DI
An interaction is said to occur when the effects of one drug changed by the presence of
: - Answer another drug, herbal meds, food/drink, medical condition,
environmental/chemical agent
Drugs which are often implicated in a clinically important DI include? - Answer Narrow
therapeutic index drugs and steep dose-response curve drugs
Narrow therapeutic index drug examples - Answer theophylline, lithium, digoxin,
warfarin
Steep dose-response curve drug examples - Answer verapamil, sulphonylurea,
levodopa
Drug/disease interactions:
Tricyclic antidepressant interacts with? - Answer Hx of postural hypotension
Drug/disease interactions:
long term use of NSAID for osteoarthritis ? - Answer Chronic renal failure
Vitamin K interacts with ? - Answer Warfarin
Dangerous DIs in long term care:
Warfarin and - Answer NSAIDS
Sulfa drugs
Macrolides
Quinolones
Phenytoin
Dangerous DIs in long term care:
ACE inhibitors - Answer Potassium supplements
Spironolactone
Dangerous DIs in long term care:
Digoxin - Answer Amiodarone
Verapamil
Solution
What is the role of TGA? - Answer Regulation of the supply, import, export and
manufacturing of therapeautic goods in Aus.
What does the TGA classify as therapeutic goods? - Answer medications, supplments,
complementary meds, medicine devices, tests/diagnostic materials, vaccines, biolgic
products, sunscreen, surgical implants
Aust L is? - Answer low risk medicines: vitaminsm herbals, no evidence assessed
Aust R is ? - Answer registered meds, high risk
What is an active ingredient ? - Answer chemical in the medicine that has a therapeutic
effect, makes it work
What is a brand name? - Answer manufacturers use a memorable name
What is the original brand? - Answer first patented brand of medicine
What is bioequivalence ? - Answer the active ingredient is identical and the medicine is
manufactured to have the same effect in body
Are all generic medicines exactly the same? - Answer No, they have the same ingredient
but forms may change
What site do you use to find brand names ? - Answer MIM/AUSDI/AMH
Where can you confirm meds are registered in AUS? - Answer TGA
Drugs which have been taken by large number of pregnant women and women of
childbearing age without any proven increase in frequency of malformations or
direct/indirect harmful effects on fetus having been observed. - Answer Category A
Drugs which have been taken by a limited number of pregnant women, without an
increase in frequency of malformation effects on fetus . Studies in animals have NOT
shown evidence of an increased occurrence of fetal damage. - Answer Category B1
Drugs which have been taken by limited number of pregnant women without an increase
in frequency of malformation effects on fetus. Studies in animals are INADEQUATE but
available data show no evidence of an increased occurrence of fetal damage - Answer
Category B2
Drugs which have been taken by limited number of pregnant women without an increase
in frequency of malformation effects on fetus. Studies in animals HAVE shown evidence
of increased occurrence of fetal damage, significance is considered UNCERTAIN in
,humans. - Answer Category B3
Drugs which owing to pharmacological effects have caused or suspected of causing
harmful effects on fetus without causing malformations. Effects may be reversible. -
Answer Category C
Drugs which have caused an increased incidence of human fetal malformations or
irreversible damage. May also have adverse pharmacological effects. - Answer
Category D
Drugs which have such a high risk of causing permanent damage to fetus that they
should not be used in pregnancy where possible. - Answer Category X
Pharmacokinetics - Answer What the body does to the drug, how it
changes/absorbs/distributes/metabolises/eliminates it
Pharmacodynamics - Answer What the drug does to the body
Why do drugs adminsitered vie inhalation tend to have a faster onset than oral drugs ? -
Answer Inhalation drugs have a shorter journey to reach arterial circulation.
Which has a larger Tmax? Oral drugs or inhalation ? - Answer Orals have a larger Tmax
Four chambers of fluid in body that drugs may be distributed ? - Answer Blood, fat,
intracellular fluid and extracellular fluid
What is first pass metabolism? - Answer When a drug is metabolised by liver before it
reaches systemic circulation (oral drugs). The more it is broken down by first pass the
less of the active drug reaches systemic circulation and less effective.
First order elimination ? - Answer More drug in plasma the faster it is eliminated, no
enzyme saturation.
zero order elimination - Answer There IS an enzyme that is necessary for metabolism
and excretion that may be saturated and not able to clear drug as fast as it enters
plasma
Why are zero order elimination drugs more likely to be overdosed on? - Answer because
they aren't cleared faster if there is more if it in the body - builds up in body as the
enzymes become saturated
Why might someone need to wait 14 days before starting a new medication ? - Answer
Their original medication may have a very long half life. which means that it will stick
around in the body for longer after stopping it. If it is still in the system then it has
potential to interact.
5-6% incidence of DI if taking how many drugs ? - Answer 2
increased 56% DI if taking how many drugs ? - Answer 6
, DI chance is 100% if taking how many drugs ? - Answer 8
Poly-pharamcy pts, hepatic/renal disease, long term therapy for chronic disease,
intensive care pts, more than one prescriber, elderly, critically ill - Answer Susceptible
pts to DI
An interaction is said to occur when the effects of one drug changed by the presence of
: - Answer another drug, herbal meds, food/drink, medical condition,
environmental/chemical agent
Drugs which are often implicated in a clinically important DI include? - Answer Narrow
therapeutic index drugs and steep dose-response curve drugs
Narrow therapeutic index drug examples - Answer theophylline, lithium, digoxin,
warfarin
Steep dose-response curve drug examples - Answer verapamil, sulphonylurea,
levodopa
Drug/disease interactions:
Tricyclic antidepressant interacts with? - Answer Hx of postural hypotension
Drug/disease interactions:
long term use of NSAID for osteoarthritis ? - Answer Chronic renal failure
Vitamin K interacts with ? - Answer Warfarin
Dangerous DIs in long term care:
Warfarin and - Answer NSAIDS
Sulfa drugs
Macrolides
Quinolones
Phenytoin
Dangerous DIs in long term care:
ACE inhibitors - Answer Potassium supplements
Spironolactone
Dangerous DIs in long term care:
Digoxin - Answer Amiodarone
Verapamil
