L12 PHRM20001 - How do we control poisons?

Question 1

Therapeutic index (TI)

Answer 1

The therapeutic index (TI) (also referred to as therapeutic window or safety window or sometimes as therapeutic ratio) is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity

Question 2

Is a higher or lower TI better?

Answer 2

A higher therapeutic index is preferable to a lower one: a patient would have to take a much higher dose of such a drug to reach the toxic threshold than the dose taken to elicit the therapeutic effect.

Question 3

Therapeutic goods act 1989 (Section 4)

Answer 3

The object is: to provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods…

Question 4

What are “therapeutic goods”? – term Australia uses

Answer 4

It means medicines, devices, blood products, biologicals, individual ingredients, containers

Question 5

Registered Goods

Answer 5

Evaluated for safety, quality and efficacy. Licensed by TGA. Result is AUSTR and a number on the packaging.

Question 6

Listed Goods

Answer 6

Ingredients generally safe but not evaluated for efficacy. AUSTL followed by a number. Licensed by TGA. But not evaluated by TGA/

Question 7

Exempt Goods

Answer 7

• Are therapeutic by definition
• Not included in the Australian Register of Therapeutic Goods (ARTG)
• No licence needed to manufacture (e.g. sunscreens

Question 8

Orphan Drugs

Answer 8

Drug, vaccine or in vivo diagnostic agent must be intended to treat, prevent or diagnose a rare disease and NOT be commercially available to treat another disease
• “Rare disease” is a disease likely to affect not more than 2000 individuals in Australia at any one time
• If the drug is not approved on safety grounds in UK, USA, EU, Netherlands, Sweden or Canada, it is ineligible for consideration as an orphan drug in Australia
• Sponsor to apply to TGA for consideration
• “Designated Orphan Drugs” are gazetted
• Usual evaluation but no fees charged
• Included in the ARTG

Question 9

Can schedule 3 drugs be publicly advertised?

Answer 9

No, unless approval given by Advisory Committee on Medicines Scheduling

Question 10

Can schedule 4 drugs be publicly advertised?

Answer 10

No, only legal in NZ and US.

Question 11

What permit is needed to obtain schedule 7 drugs?

Answer 11

A permit from the Department of Health and Human Services.

Question 12

Sunscreens- therapeutic goods in AUS or EU?

Answer 12

AUS, cosmetics in EU.