Legislation

Question 1

Describe the types of advertising allowed for the different schedules.

Answer 1

Unscheduled - general public
S2 - general public
S3 - if in appendix H –> general public
- if NOT in appendix H –> only in genuine professional or trade journals.
S4 & S8 - only in professional or trade journals

Question 2

Who is allowed to sell or supply an S2 medication?

Answer 2

• pharmacist or an assistant under direction of pharmacist
• doctor, dentist, vet
• A person of the above professions may be granted a liscence to sell/supply S2 if:
• -> selling goods by retail
• -> more than 25km away from the nearest pharmacy.

Question 3

What are the 3 classifications of therapeutic goods?

Answer 3

1) EXEMPT–> do not need to be in the Australian Register of Therapeutic Goods (ARTG). (Eg. unscheduled antidandruff shampoos, experimental drugs)
2) LISTED –> unscheduled medicines that have a history of use eg. vitamins (Assessed for Quality & safety but NOT EFFICACY)
3) REGISTERED –> higher risk level. S2,3,4,8,9 (Assessed for quality, safety & efficacy)

Question 4

What can dentists prescribe?

Answer 4

S2, 3, 4, 8, 9 (ALL)

but CANNOT write repeats.

Question 5

What can Nurse Practitioners prescribe?

Answer 5

S2, 3, 4, 8, 9 (ALL) in their category of Nurse Practitioner (eg. primary care)

Question 6

What can Optometrists prescribe?

Answer 6

Only drugs for topical use in the eye.

S2, 3, 4

Question 7

What can Podiatrists prescribe?

Answer 7

Can prescribe specific list of S2, 3, 4

Question 8

What conditions must be met to prescribe, sell or supply S3 & S4 medicines?

Answer 8

1) Must be for medical treatment of person under practitioners care.
2) taken all reasonable steps to ensure a therapeutic need exists.

Question 9

What conditions must be met to prescribe, sell or supply S8 & DoD medicines?

Answer 9

1) Must be for medical treatment of person under practitioners care.
2) Taken all reasonable steps to ascertain the identity of that person.
3) Taken all reasonable steps to ensure a therapeutic need exists.

Question 10

DoD Prescription requires what to be handwritten on the script?

Answer 10

1) Name of substance
2) Strength
3) Quantity in BOTH words & figures
4) Directions
5) Number of repeats in BOTH words & figures

Question 11

What is the difference between Permits & Warrants?

Answer 11

Permit - PATIENT specific

Warrants - PRESCRIBER specific

Question 12

When is a warrant required?

Answer 12

For prescribing:
- ovulatory stimulants
- prostaglandins
- retinoids
-thalidomide
Warrant holder (& number if acting on doctor's instruction) must be included on prescription.

Question 13

What must you do if presented with a fraudulent script?

Answer 13

• notify police
• notify the Secretary (Department of Health Services)
• Inform practitioner that you believe it has been altered.

Question 14

What can you do if you cannot verify prescriber’s handwriting for S8/S9 script?

Answer 14

• Can supply UP to 2 days treatment
• remainder can be supplied once script verified.
• Pharmacist keeps script.

Question 15

When must you notify of similar supply?

Answer 15

If already supplied within the previous 8 weeks by another prescriber.
Notify most RECENT prescriber unless
- established GP/Specialist relationship
- prescribers work in the same practise
- locum working at practise of patient’s usual prescriber

Question 16

How long must prescriptions be retained for?

Answer 16

S8/S9 - 3 years
S4 - PBS for at least 1 year (private don’t need to but good practise)
Electronic transaction records must be readily retrievable for 3 years.
S8 must be recorded in a written drug register.

Question 17

What are the required representations of Vitamins?

Answer 17

One of the following must be included:

1) Vitamins can only be of assistance if the dietary vitamin intake is inadequate.
2) Vitamin supplements should not replace a balanced diet.

Question 18

What are the rules about Signal Headings on medicines?

Answer 18

• must be FIRST LINE of the main label. (Eg. PHARMACIST ONLY MEDICINE)
• S8 must include the additional statement immediately below signal heading: “POSSESSION WITHOUT AUTHORITY ILLEGAL”.
• KEEP OUT OF REACH OF CHILDREN must be included on ALL labels (directly below signal heading or below S8 caution line).

Question 19

What are the rules regarding labeling of poisons NOT for therapeutic use?

Answer 19

First Aid statements
- should be group together if multiple statements.
- Prefaced by “FIRST AID”
- Needs to be bold faced & capital letters.
S5 –> CAUTION signal heading
S6 –> POISON signal heading

Question 20

What can be done if no prescription is available?

Answer 20

Oral Instructions (Emergency Directions)
- normal supply allowed
- all schedules & prescribers
- written prescription must be provided ASAP.
Emergency Supply (S4 only)
- can give UP TO 3 days supply (or smallest commercially available pack)
Continued Dispensing
- oral contraceptives & Lipid modifying agents
- have been prescribed within last 12 months.
- give max quantity outlined in the Act (usually normal pack).
- must contact prescriber in writing within 24hrs.

Question 21

When is a permit required for a patient?

Answer 21

• Methadone
• S8 to drug dependent person (are exemptions)
• S8 to non-drug-dependent person for more than 8 weeks (exceptions)
• Specific stimulants
• S9 poison

Question 22

What exceptions do not require a permit?

Answer 22

General
- in-patient of hospital, aged care facility
- prisoner
- practitioner working in multiple practitioner clinic where someone else already holds a permit
Exemptions but must notify of treatment:
- Treating pain caused by cancer treatment
- Childhood ADHD
–> dexamphetamine/methylphenidate
–> Paediatrician or psychiatrist

Question 23

What specific stimulants require a permit?

Answer 23

Amphetamine
Dexamphetamine
Methylamphetamine
Methylphenidate
Lisdexamfetamine