Pharmacy Legislation 1

Question 1

What happens when a pharmacist fails to comply with legislation?

Answer 1

Failure to comply with these requirements may result in a practitioner being reported to the pharmacy board of Australia and jeopardising their registration as a pharmacist.

Question 2

Describe the Posions Standard & The Poisons Schedule

Answer 2

The Poisons Standard refers to the requirements on how medicines are labelled, packaged and Scheduled.

The Poisons Schedule refers to how medications with different properties are classified into groups that require similar regulatory controls.

Scheduling determines the limitations on distribution and access of a medicine

A medicine can be in more than one Schedule. The most restrictive provision applies unless there is an indication otherwise.

Question 3

Who are authorized prescribers and what are the conditions of prescribing?

Answer 3

S4 PRESCRIBERS
Doctors, Dentists, Midwives, Optometrist, Podiatrists, Vets and Nurse Practitioners

S8 PRESCRIBERS
Doctors, Dentists, Midwives, Nurse Practitioners and Vets

S9 PRESCRIBERS
Doctors, Dentists and Vets

Dentists cannot issue Methadone Script

Question 4

3. Is self-prescribing permitted?

Answer 4

NO. A prescription must be for the medical treatment of a person other than the practitioner; and – CANT SELF PRESCRIBE

reg 105

Question 5

What is the style and the required particulars for a prescription?

Answer 5

FOR ALL S4, S8 and S9:
Script is legible in writing
• must sign the prescription.
• the name and address of, and a telephone number for prescriber
• the person’s name and address;
• in the case of an animal, the species, age, breed and sex of the animal, and the name and address of a person who owns or has custody or care of the animal;
• the date on which the prescription was written;
• full particulars of the poison to be supplied;
• a statement of the quantity to be supplied;
• directions for the precise dose/ use & frequency of administration
Date of Birth

FOR S8 and S9:
Quantity
Medication to be supplied
Whether or not there are repeats
Strength
Dose instructions

 MUST ALL BE WRITTEN IN handwritten words and figures.

Question 6

What is an emergency supply and under what circumstances can it be used?

Question 7

What conditions must be met for a pharmacist to supply in full quantities Schedule 8 poisons to a patient with a prescription?

Question 8

In what circumstances should a prescription not be filled? & What to do if they believe a person has obtained through them a S3 DoD, S4, S8 or S9 poison or a prescription for such a poison by false pretences?

Answer 8

REG (50)

• Expired Script (12 months for S4, 6 months for S8)
• Forged Script
• Altered in any way
• Illegible or defaced
• Already used or dispensed

Cannot dispense quantities, or instructions other than written by a practitioner.

If the script is under false pretence report to the Secretary:(as required by DPCSRs 2017, Reg 69) can be made by calling Medicines and Poisons Regulation (MPR) and asking to speak to the Duty Pharmacist (1300 364 545 during business hours).

Notify if they have had similar supply in the last 8 weeks.

Question 9

What obligations does Drugs, Poisons and Controlled Substances Act [DPCSA] 1981 (Vic), s.32A place upon pharmacists?

Answer 9

For the purposes of subsection (1), a reportable drug event is one or more of the following—

    (a) for a pharmacist, being requested or directed to sell, supply or dispense any drug of dependence, Schedule 8 poison, Schedule 9 poison or Schedule 4 poison for any person—
          (i) in greater quantities than appears to be reasonably necessary; or
          (ii) more frequently than appears to be reasonably necessary;
    (b) for a registered medical practitioner, having reason to believe that the practitioner's patient is a drug‑dependent person in circumstances where—
          (i) the patient requests or seeks prescription of a Schedule 9 poison; or
          (ii) the registered medical practitioner intends to treat or is treating the patient with a Schedule 9 poison;
    (c) any other event, or class of event, which the Secretary declares, under subsection (3), is a reportable drug event

Question 10

How long must a pharmacist retain a prescription for Schedule 8 or 9 poisons after the last supply is made? What if the prescription contains orders for other medications for which supplies can still be made?

Answer 10

• After the last supply is made retain the prescription for 3 years or, if other medicines on the prescription may still be supplied, mark the script clearly so further supplies are not allowed (usually done in practice with a red CANCELLED stamp)

Question 11

What rules must a pharmacist comply with when supplying Schedule 3 medications OTC? What restrictions on storage and display apply to S3 medications?

Answer 11

 Don’t draw undue attention to the medicines on S3
 Don’t be displayed in a way that allows self-selection for customers
 Must counsel them on the medicine
 Offer directions on how to use it.
 Must put label that identifies the supplier (pharmacy label)

Question 12

Are pharmacists required to keep records of transactions of poisons, and if so, what schedule of poisons? For how long must records be kept? What schedule(s) of poisons require records to be kept when destroyed?

Question 13

Who is authorised to destroy S8 or S9 poisons? Who else must be present to witness the destruction of S8 or S9 poisons? What details of the destruction must be recorded?

Answer 13

Reg 74 essentially requires all S8 and S9 poisons to be stored in a lockable storage facility of certain minimum specifications (i.e. a drug safe). This must remain locked at all times except when necessary to open it to carry out an essential operation

Question 14

14. Which medications require warrants?

Question 15

What must a pharmacist do in Verifying S8 and S9 scripts?

Answer 15

• pharmacist must not sell or supply a Schedule 8
  poison in a quantity that allows for more than
  2 days’ treatment unless—
  (a) the prescription is handwritten and—
  (i) the pharmacist is familiar with the
  purported prescriber’s handwriting; and
  (ii) the writing on the prescription is
  comparable to the usual writing of the
  purported prescriber; or
  (b) the pharmacist has taken all reasonable steps
  to verify that the prescription was written by
  the purported prescriber

Question 16

What is an emergency supply? when can it be used? Types of Emergency supply?

Answer 16

1). Emergency directions (verbal) reg 25- must
(a) write an instruction that indicates that it is in confirmation of the verbal instructions
previously given; and
(b) send that instruction to the pharmacist.

2). Emergency supply (3 days supply)

3). Continued Dispense- S4 not S8. Only the S4s listed in National Health (Continued Dispensing) Determination 2012
Once yearly pre CoVid now monthly.

Question 17

Factors that influence scheduling

Answer 17

The classification process takes into account a substance's:
•	toxicity profile
•	pattern of use
•	Indications
•	product formulation and dosage
•	potential for abuse
•	need for access

Question 18

What is the ARTG? Types of Therapeutic Goods?

Answer 18

• The ARTG is a computer data base of all the medicines/medical devices approved for use & supply within Australia.
• TGs divided broadly into two classes: medicines and medical devices.
• Unless exempt, TGs must be entered as either ‘registered’ or ‘listed’ goods before they may be supplied in, or exported from, Australia.
• Exempt goods include Section 19 approval or authority goods that deal with certain special and experimental uses. Like other exempt goods, these are not entered into the ARTG.

Question 19

Repeats: S4, S8, and S9?

Answer 19

DENTISTS- cannot do repeats. The prescription provides only for a single supply of the poison. (reg 17-23)

Question 20

What must be fulfilled in order to administer, prescribe, sell or supply S3, s4, or S8 and DoD?

Answer 20

1. The patient is under their care
2. If it is a drug of addiction, they must take steps to ensure the identity of the person to be treated. Person must be named in prescription.
3. Ensure that a therapeutic need exists for the medication (SAME FOR PHARMACISTS)

Question 21

Authority? Number of medicines per prescription?

Answer 21

1. All PBS prescribers (with the exception of dentists) can write authority PBS prescriptions.
2. Authority PBS prescriptions cannot have retrospective approval.
3. PBS authority medicines must be on their own script not with other medicines
4. Two types of authority: (a) Streamlined and (b) Authority required.

Question 22

The Schedules and Headings

Answer 22

Schedule 2-Pharmacy Medicine
Schedule 3- Pharmacist only Medicine
Schedule 4- Prescription Medicines
Schedule 8-Controlled Drug
Schedule 9- Prohibited Substance

Question 23

Emergency 3 day Supply

Answer 23

A pharmacist can give only if:

NOT FOR S8 OR S9. ONLY S4.
NO EMERGENCY SUPPLY FOR ANIMALS

o the pharmacist considers that the sale or supply is necessary to ensure continuity of treatment;

o (i) there is an immediate need for the poison and it is impracticable for the patient to obtain a prescription in time to meet that need;

o treatment with the poison has previously been provided for by a prescription issued, or a chart instruction written for the patient by a registered practitioner

o the patient, or an agent of the patient, is aware of the appropriate dose of that poison for that patient;

o (c) the quantity supplied does not exceed— (i) 3 days’ supply; or (ii) if it is not practical to supply a quantity required for 3 days, the smallest commercially available pack; and (d) the sale or supply would not continue treatment that has already been continued by the pharmacist selling or supplying the poison to the patient under this regulation.