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This document has been prepared by Drugs and Poisons Regulation (DPR) to assist medical practitioners to understand key storage and recording relating to Schedule 4 and Schedule 8 poisons in general practice clinics. For simplicity of reading, this document does not refer to all legislative requirements; merely those that are relevant to the majority of general practice clinics. For full details, reference should be made to the Drugs Poisons and Controlled Substances Act 1981 and Drugs Poisons and Controlled Substances Regulations 2006 (at Documents dealing with other key legislative requirements, may be found on the DPR website (at

Storage requirements

Schedule 8 poisons(labelledControlled Drug) are drugs with strict legislative controls, including but not limited to morphine, pethidine, methadone and fentanyl.

  • When transported for use in another location, Schedule 8 poisons must be stored in a locked receptacle (e.g. doctor’s bag) in the doctor’s possession. If the receptacle is necessarily out of the medical practitioner’s immediate possession for a brief period, it should be secured, out of sight, in a lockable facility (e.g. lockable vehicle or cupboard) to prevent unauthorised access.
  • Schedule 8 poisons must otherwise be stored in a locked facility, fixed to the floor or wall, and providing not less security than a (10 mm thick) mild steel drug cabinet (see regulation 35(1) for details of minimum standards).
  • Exception: To enable clinics to hold a limited number of morphine ampoules for emergency use, without incurring the expense of a more substantial storage facility, up to 6 divided doses (e.g. morphine ampoules), for emergency use, may be stored in a locked facility that does not comply with regulation 35(1).

Schedule 4 poisons(labelled Prescription Only Medicine) include all other drugs for which prescriptions are generally required, e.g. oral contraceptives, antibiotics, some compound analgesics (e.g. Panadeine Forte®), pseudoephedrine, nitrous oxide and many others.

  • Schedule 4 poisons (including professional samples) must be stored in a lockable storage facility, e.g. cupboard, drawer, fridge, filing cabinet, treatment room, storeroom. There is no requirement for the lockable facility to be within a lockable facility - see page 2 for variations and issues relating to access.

‘Drugs of dependence’ is a term used to describe Schedule 8 poisons plus specified Schedule 4 poisons that are subject to misuse and trafficking, e.g. benzodiazepines, phentermine (Duromine®), testosterone and other anabolic steroids.

  • Schedule 4 drugs of dependence may be stored in the same manner as other Schedule 4 poisons or in the drug cabinet or safe with Schedule 8 poisons.

Schedule 2 and 3 poisons (labelledPharmacy Medicine or Pharmacist Only Medicine respectively) must only be supplied (in an open shop) by pharmacists.

  • Medical practitioners may supply Schedule 2 and Schedule 3 poisons in a similar manner to Schedule 4 poisons (i.e. for the treatment of patients under their care).To prevent unlawful supply, it is recommended that Schedule 2 and Schedule 3 poisons are stored and handled in a similar manner to Schedule 4 poisons.

Prescription pads and pages for computer-generated prescriptions

Prescription pads and pages for computer-generated prescriptions are known to be misappropriated by patients (sometimes by staff members and family members) and used to create fraudulent prescriptions for drugs of dependence. These items should not be stored in unlocked areas or left in printers, where they might be subject to opportunistic theft.

Access to Schedule 4 and Schedule 8 poisons

In clinics that do not hold a Health Services Permit (HSP), Schedule 4 and Schedule 8 poisons (including doctor’s bag emergency drugs and professional samples) are obtained on the authorisation of the medical practitioner(s) and unsupervised access must be limited to medical practitioners.

Access to Schedule 8 poisons

Storage facilities for Schedule 8 poisons must remain locked to prevent access to unauthorised persons at all times except when it is necessary to open it to carry out an essential operation. Keys & combinations must not be accessible to or known by unauthorised persons (e.g. staff other than medical practitioners).

Access to Schedule 4 poisons

A medical practitioner must take all reasonable steps to ensure that the storage facility remains locked and secured to prevent access by persons who are not authorised, under the Act or regulations, to possess Schedule 4 poisons. In many clinics, only medical practitioners will be authorised (see below for variations).

Variations:

1. Variations might be applicable where an HSP is held by the clinic (see page 3).

2.The storage facility may be unlocked when it is necessary to carry out an essential operation in connection with the Schedule 4 poisons stored therein; e.g. inventory checks, extraction of Schedule 4 poisons for lawful administration or supply (regulations 34(2) and 71).

3.To provide parity with Schedule 4 poisons stored by other registered health practitioners (e.g. pharmacists, veterinary practitioners), Schedule 4 poisons may be stored in a treatment room of the premises in which the medical practitioner carries out the lawful practice of his/her profession (regulation 34(3)) when themedical practitioner is present. This provision:

  • does not relieve the medical practitioner of the requirement to take all reasonable steps to restrict access; it merely acknowledges that the presence of the medical practitioner might fulfil this requirement
  • does not mean that the medical practitioner must be present in the treatment room, anymore than a pharmacist must remain in the dispensary area of a pharmacy
  • does not allow for Schedule 4 poisons to be stored in an unlocked treatment room merely because a medical practitioner is present on the premises; if medical practitioners are otherwise occupied for extended periods and are unable to observe persons entering or leaving the storage area, adequate security might not be achieved
  • allows medical practitioners to determine which reasonable steps are compatible with the practicality of continually locking and unlocking treatment rooms or storage facilities in their own clinics; if in doubt, it is recommended that Schedule 4 poisons are stored in lockable facilities that are locked when a medical practitioner is not readily able to provide personal supervision.

In any event, if the medical practitioner is absent from the premises, the storage facility for Schedule 4 poisons must be locked.

Note: Medical practitioners are reminded that they are personally responsible and must be able to account for all Schedule 4 and Schedule 8 poisons that are supplied to a clinic on the basis of their authorisation.

Possession and access by nurses

A nurse is authorised to possess Schedule 4 poisons that are necessary for administration to a specific patient under the care of the nurse, in accordance with the instructions of a medical practitioner in relation to that patient (or patients).

This does not mean that nurses in medical clinics may have unsupervised access to Schedule 4 poisons in other circumstances. An HSP (see below) is required for broader access and possession to be lawful.

Special provisions apply in the case of Nurse Immunisers (see below).

Nurse administration of Schedule 4 and Schedule 8 poisons

Unless an HSP or other authorisation exists, regulation 47 requires a nurse to refer to authoritative instructions before administering Schedule 4 or Schedule 8 poisons, namely:

  • written instructions of a medical practitioner
  • oral instructions of a medical practitioner if, in the opinion of the medical practitioner, an emergency exists
  • written transcription (of emergency oral instructions) by the nurse who received those instructions
  • directions for use on a container supplied by a medical practitioner orpharmacist (e.g. administration of a person’s own lawfully supplied medication).

Nurses who administer Schedule 4 and Schedule 8 poisons must ensure that relevant details of the administration are recorded in an appropriate manner (see page 4).

Nurse immunisers

Schedule 4 vaccines, which require refrigeration, must be secured in a lockable container or in a lockable refrigerator, unless the refrigerator is secured within a lockable room.

Nurse immunisers (operating under the Department of Health Secretary Approval –Nurse Immunisers),who are employed or contracted by medical practitioners, may have access to vaccines that are listed in Appendix 1 of the approval and to other Schedule 4 poisons necessary for the treatment of anaphylactic reactions to the vaccines. Please refer to the DPR website ( for further information and the list of vaccines. Nurse immunisers should familiarise themselves with legislative issues that are applicable to their situation.

Where there is a Health Services Permit (HSP)

In medical clinics that hold a current HSP, nurses may be designated as the persons responsible for ensuring compliance with purchase and storage requirements and may be authorised to have access to Schedule 4 and Schedule 8 poisons when a medical practitioner is not present. Details relating to each HSP holder will be contained in the Poisons Control Planfor each HSP.

There is a category of HSP, which would be applicable to a medical clinic, for which application and annual fees are lower than for other health services. However, the vast majority of medical clinics do not need and choose not to have an HSP.

All relevant application forms, details of fees plus instructions of how to make application are available on the DPR website at:

Note: An HSP does not remove the responsibility of medical practitioners to be able to account personally for Schedule 8 poisons that are supplied in their names, e.g. doctors’ bag supplies subsidised by the Pharmaceutical Benefit Scheme plus any other Schedule 8 poisons supplied in the name of the medical practitioner.

Recording and other requirements

Records of all transactions (including administration by medical practitioners and nurses) in Schedule 4 and Schedule 8 poisons must be retained in a readily retrievable form for 3 years and produced, on demand, in writing to an authorised officer of DPR (see regulation 40 for details of the information that must be recorded).

For Schedule 8 poisons, a separate record (usually a drug register or administration book) is required, in a form that shows the true and accurate balance remaining after each transaction and that cannot be altered without detection (regulation 41). Loose-leaf books are not acceptable.

Note: One drug register may be used to manage the purchase, storage and record keeping on behalf of all medical practitioners at a clinic but it is recommended that each medical practitioner maintains a separate register to account for Schedule 8 poisons supplied to him or her.

Destruction of Schedule 8 poisons

If a medical practitioner wishes to destroy expired or unwanted Schedule 8 poisons, the destruction must be witnessed by a pharmacist, dentist, veterinary practitioner, nurse, nurse practitioner or another medical practitioner. Two nurses are not authorised to perform the task unless the principal person is a nurse practitioner. Both participants in the destruction must sign the corresponding record book.

Matters to be reported to DPR

Victoria Police and DPR must be notified when:

  • drugs or records are lost or stolen
  • a medical practitioner has reason to believe a person has obtained Schedule 8 or Schedule 4 poisons (or prescriptions) by false pretences.

DPR should also be notified of the loss or theft of prescription pads; a notification form is available on the DPR website at

Compliance with other standards

Compliance with the Drugs Poisons and Controlled Substances Act and Regulations does not ensure compliance with other professional standards. The fact that a clinic is accredited does not ensure compliance with the legislation. However, failure to comply with the legislation renders a person liable to prosecution.

For further information

Department of Health (DH)

Drugs and Poisons Regulation,

GPO Box 4541

Melbourne 3001

Tel: 1300 364 545

Fax: 1300 360 830

Email:

Web:

Authorised and published by the Victorian Government, 50 Lonsdale St, Melbourne.
To receive this publication in an accessible format phone Drugs and Poisons Regulation on 1300 364 545 or forward an Email to
February 2014

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