LECTURE 11: DRUG DEVELOPMENT AND SCHEDULING

Question 1

From idea to regulated product

Answer 1

Drug development -> Drug testing -> Drug registration and scheduling

Question 2

drug development

Answer 2

very expensive, long winded process undertaken by the drug company

Question 3

drug testing

Answer 3

huge financial investments to get drug to market
testing is done under the supervision of the body who will register the drug

Question 4

who registers drugs

Answer 4

therapeutic goods administration (TGA)

Question 5

scheduling of poisons depends on

Answer 5

• the risk of harm when used appropriately and inappropriately
• the risk of addiction e.g. heroin

Question 6

schedule 0

Answer 6

unscheduled products

paracetamol ≤ 500mg in packets containing ≤ 20 tablets/capsules

Question 7

schedule 1

Answer 7

“not in use”

no examples

Question 8

schedule 2

Answer 8

pharmacy medicine

aspirin (≤325mg, ≤500mg or ≤625mg*),

Question 9

schedule 3

Answer 9

pharmacist only medicine

ibuprofen (≤400mg),

Question 10

schedule 4

Answer 10

prescription only

codeine (≤30mg),

Question 11

schedule 5

Answer 11

caution - low potential for harm

ethylene glycol (radiator fluid)

Question 12

schedule 6

Answer 12

poison - moderate harm

arsenic (ant bait)

Question 13

schedule 7

Answer 13

dangerous poisons - high harm

strychnine

Question 14

schedule 8

Answer 14

controlled drug - pharmacist

ketamine

Question 15

S8 restrictions

Answer 15

 ingoings = outgoings
 every dose is signed off by a veterinarian, doctor or dentist
 inventory taken at least once a month
 up to date and ready for unannounced spot audit by WA Health Department

Question 16

the prohibited substances are

Answer 16

schedule 9 and 10

Question 17

schedule 9

Answer 17

prohibited substances

heroin

Question 18

schedule 10

Answer 18

dangerous to health

formaldehyde at >0.1% in oral hygiene products

Question 19

where do S10 drugs come from

Answer 19

illegal importation

Question 20

some exceptions to poison rules

Answer 20

industrial like mining

medical surgery

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