Managing drugs in general
practice clinics
Key legislative requirements in Victoria
2014.1
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 www.legislation.vic.gov.au). Documents dealing with other key
legislative requirements, may be found on the DPR website (at www.health.vic.gov.au/dpcs/reqhealth)
Storage requirements
Schedule 8 poisons (labelled Controlled 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 (labelled Pharmacy 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.
. Department of Health
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 the medical
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, any more 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.
Page 2
Department of Health
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 or pharmacist (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 (www.health.vic.gov.au/dpcs/approve.htm) 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 Plan for 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: http://www.health.vic.gov.au/dpcs/health.htm
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.
Page 3
Department of Health
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 http://www.health.vic.gov.au/dpcs/reqhealth.htm.
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: dpcs@health.vic.gov.au
Web: www.health.vic.gov.au/dpcs
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 dpcs@health.vic.gov.au
February 2014
Page 4
Department of Health