Legislative requirements for pharmacists

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:

• Prescribing
• 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 medicine. Findings by VCAT and the Pharmacy Board have repeatedly expressed the view that this responsibility cannot be ignored simply because a prescription is presented.

Interventions

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.

Excessive supply

Section 32A, of the Act, requires a pharmacist to notify the Secretary (i.e. Medicine and Poisons Regulation branch), as soon as practicable of a reportable drug event. This includes 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

• in greater quantities than appears to be reasonably necessary; or
• more frequently than appears to be reasonably necessary

This requirement is applicable regardless of whether a prescription is a PBS Authority prescription, private prescription funded by another agency (e.g. TAC) or any other type of supply (e.g. supply on an order).

Before notifying MPR, 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 MPR and forward sufficient information to MPR to enable the noted prescribing to be adequately assessed.

Other matters to be reported to MPR and/or police

Pharmacists are required to notify Victoria Police and/or MPR (as indicated below) when:

• a poison or controlled substance is lost by or stolen from them - notify police and MPR (regulation 152)
• a discrepancy in records of transaction (e.g. Schedule 8 poison register) remains unresolved after the discrepancy has been investigated - notify MPR only (regulation 112)
• records, required to be kept in relation to Schedule 4 or Schedule 8 poisons, are lost, stolen or destroyed - notify MPR 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 poison - notify police and MPR (regulation 69).

How to notify MPR

Notification forms to notify MPR online can be accessed on the MPR website in the section for ‘Commonly used online forms’; the full list of online forms includes the following:

• Reportable drug event (s.32A): Notifications and records to be submitted to Drugs and Poisons Regulation (for pharmacists to complete) – Form no. 7 on the list
• Notification of forged or altered prescription (for pharmacists to complete) – Form no. 8 on the list
• Make a notification of lost scheduled substance (for organisations to complete) – Form no. 11 on the list
  • Note: This form is intended only for pharmacists employed by the holder of a Health Services Permit (e.g. hospital pharmacy department) to report discrepancies or lost or stolen Schedule 4 and Schedule 8 poisons
  • Pharmacists in community pharmacies are requested to report discrepancies or lost or stolen Schedule 4 and Schedule 8 poisons by sending relevant details to the MPR email address (dpcs@dhhs.vic.gov.au).