Ensuring lawful supply
Pharmacists are authorised, under the Drugs Poisons and Controlled Substances Act 1981 (the Act), to obtain, possess, use or supply scheduled poisons for the lawful practice of their profession at premises that have been approved by the Victorian Pharmacy Authority.
The Poisons Standard lists all scheduled poisons and contains standards with which pharmacists must comply, including the labelling requirements for dispensed medicines.
The Drugs Poisons and Controlled Substances Regulations 2017 contain the majority of regulatory requirements, relating to scheduled poisons, with which a pharmacist must comply.
This website contains a range of documents, in the section for Documents to print or download, which summarise the legislative requirements and issues that relate to pharmacists plus documents that relate to multiple categories of health practitioner. These documents include the following:
Key legislative requirements for pharmacists
Dispensing prescriptions, which includes information relating to:
- newly required components of a prescription
- how pharmacists might deal with non-compliant prescriptions
- exceptional circumstances in which pharmacists might vary from instructions on a prescription
- labelling requirements for dispensed medicines
- retaining prescriptions for Schedule 8 poisons
Management of Schedule 8 poisons, which includes information relating to:
- storage of Schedule 8 poisons
- records of transactions in Schedule 8 poisons
- examples of non-compliance
- discrepancies in Schedule 8 register
- responsibilities of individual pharmacists
- destruction of Schedule 8 poisons and the use of RUM bins
- misappropriation of drugs of dependence by pharmacists and employees
Issues relating to multiple categories of health practitioner, including:
- Schedule 8 permits
- Handwritten and computer-generated prescriptions
- All reasonable steps and other key terms
- Schedule 2 and 3 poisons
Ensuring safe and appropriate supply
In addition to the requirement to ensure lawful supply, pharmacists are required to meet professional standards that are contained in other legislation and that are determined by the Pharmacy Board of Australia.
Pharmacists should not dispense a prescription without satisfying themselves that it is safe, appropriate and lawful to supply the medication. Findings by VCAT and the Pharmacy Board have repeatedly expressed the view that this responsibility cannot be ignored simply because a prescription is presented.
The regulations require pharmacists to contact purported prescribers to:
- inform them that patients have obtained the same or a similar drug of dependence (Schedule 4 or Schedule 8) from another prescriber during the preceding eight weeks (Regulation 70)
- authenticate prescriptions for Schedule 8 poisons (Regulation 51).
In addition to complying with legislative requirements, pharmacists might need to contact prescribers to:
- check or confirm details or directions on prescriptions
- advise prescribers of contraindications and possible adverse reactions
- discuss the appropriateness of a particular course of treatment
- question the prescribed dosage or rate of administration.
While the vast majority of prescriptions do not require an intervention, pharmacists must remain vigilant and assess each prescription (critically) before determining whether it is to be dispensed. The knowledge and experience of a pharmacist might be the only barrier to undesirable outcomes (inadvertent or intentional) and dispensary assistants cannot be expected to identify issues that pharmacists are trained to identify.
Section 36 of the Act states that a pharmacist must notify DPR if called upon to dispense Schedule 4 or Schedule 8 poisons for any person in greater quantities or more frequently than appears to be reasonably necessary. This requirement is applicable regardless of whether a prescription is a PBS Authority script, private script or is funded by another agency (e.g. TAC).
Before notifying DPR, a pharmacist is expected to have communicated with the relevant prescriber/s to try to ascertain the reason for the apparently excessive prescribing but, regardless of information provided, if the prescribing appears greater or more frequent than reasonably necessary, a pharmacist must notify DPR and forward sufficient information to DPR to enable the noted prescribing to be adequately assessed, namely:
- a printout of the person's medication history for a relevant period (e.g. 3-6 months)
- the name, address and phone number of the prescriber/s
- any other relevant information (e.g. details of communications with the prescriber).
Other matters to be reported to DPR and/or police
Pharmacists are required to notify Victoria Police and/or DPR (as indicated below) when:
- a poison or controlled substance is lost by or stolen from them - notify police and DPR (regulation 152)
- a discrepancy in records of transaction (e.g. Schedule 8 poison register) remains unresolved after the discrepancy has been investigated - notify DPR only (regulation 112)
- records, required to be kept in relation to Schedule 4 or Schedule 8 poisons, are lost, stolen or destroyed - notify DPR only (regulation 113)
- a person is suspected to have obtained or attempted to obtain, by means of a false pretence (including the presentation of forged or fraudulently altered prescriptions), a Schedule 4 or Schedule 8- notify police and DPR (regulation 69).
How to notify DPR
Pharmacists are requested to submit an online form to report forged or fraudulent prescriptions to DPR; the form may be accessed on the DPR website in the section for 'Commonly used online forms'.
Pharmacists employed by the holder of a Health Services Permit (e.g. hospital pharmacy department) are requested to submit an online form to report lost or stolen Schedule 4 and Schedule 8 poisons or discrepancies in records to DPR; the form may be accessed on the DPR website in the section for 'Commonly used online forms'.
Pharmacists are otherwise requested to report matters to DPR by sending relevant details to the DPR email address (email@example.com).