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2015.1
This document has been prepared by Drugs and Poisons Regulation (DPR) to assist nurses and midwives to
understand key legislative requirements under the Drugs Poisons and Controlled Substances Act 1981 (Act) and Drugs
Poisons and Controlled Substances Regulations 2006 (Regulations). Reference should be made to the Act and
Regulations (at www.legislation.vic.gov.au) for full details.
Note: The registrations of some nurses and midwives have been endorsed to identify the nurses and midwives with
additional qualifications and specific expertise. Information relating to the additional legislative requirements for these
nurses and midwives are contained in other documents, as indicated on page 5.
For simplicity of reading and comprehension, this document focuses on general issues and issues that may be relevant
to the majority of nurses and midwives practising in hospitals and acute care facilities.
The conditions of a Health Services Permit (HSP) issued by the Department of Health & Human
Services (DHHS) (see page 2)
The approval of the Secretary (of the DHHS) in specified circumstances, e.g. nurse immuniser;
forensic nurse examiner; and registered midwife.
Under the provisions of regulation 5(3), the Secretary (of DHHS) has given approval in general for a registered
midwife employed at a hospital to possess and administer to a pregnant woman in labour, in an emergency if
unable to contact a medical practitioner, a single dose of morphine or pethidine if such practice is in accordance
with the written instructions of the medical practitioner under whose care the patient is, provided that the
practice has been approved by the governing body of the hospital concerned or a committee to which the
responsibility has been delegated by the governing body.
For information relating to approval by the Secretary for a nurse immuniser or a forensic nurse examiner,
please refer to the DPR website (www.health.vic.gov.au/dpcs/approve)
Note: Nurses can also be authorised to possess Schedule 4 and Schedule 8 poisons when acting in a role that
is not specifically limited to nurses, as specified in regulation 5(1); for example:
Possession and self-administration of medicines that were lawfully supplied to the nurse (as a patient)
Possession of medicines, which were lawfully supplied (e.g. on prescription) to a patient for whom the
nurse is caring, in the course of assisting that patient to administer their own medicines
This does not mean that a nurse or midwife cannot return or deliver a persons own medicines (e.g.
discharge medicine that has been lawfully supplied on prescription for a patient) if it is appropriate.
However, a nurse or midwife must not supply hospital ward stock or a starter pack (see page 4) to a
patient; making such a supply will generally require the personal involvement of a pharmacist, medical
practitioner, dentist, nurse practitioner or another nurse/midwife with an appropriate endorsement on
his/her registration (see page 5).
Key terms
Schedule 8 poisons (labelled Controlled Drug) are drugs with strict legislative controls, including opioid
analgesics and ketamine. Pethidine, fentanyl, morphine (MS-Contin , Kapanol), oxycodone (OxyContin,
Endone), methadone (Physeptone), buprenorphine (Suboxone, Subutex) and two benzodiazepines
(flunitrazepam and alprazolam) are other examples of Schedule 8 poisons.
Schedule 4 poisons (labelled Prescription Only Medicine) include most other drugs for which prescriptions are
required, e.g. local anaesthetics, antibiotics, vaccines, naloxone, strong analgesics (e.g. Panadeine Forte ) that
are not classified as Schedule 8 poisons and benzodiazepines (other than flunitrazepam and alprazolam; both
Schedule 8 poisons).
To avoid possible confusion, please note that, in Victoria, the term drug of dependence is used to describe
substances, listed in Schedule 11 to the Act, which are known to be subject to misuse and trafficking. It is not
limited to Schedule 8 poisons and includes some Schedule 4 poisons (e.g. benzodiazepines). However, most
regulations relate primarily to whether a drug is in Schedule 4 or Schedule 8 (rather than Schedule 11).
The following requirements for storage, administration, recording and destruction of Schedule 4 and
Schedule 8 poisons are those contained in the Drugs Poisons and Controlled Substances Regulations
2006.
In some establishments, the PCP includes requirements that are more stringent than those contained in
the Regulations.
The Director of Pharmacy and/or the Director of Nursing commonly manage the HSP and PCP. In some
hospitals, the PCP may be examined on the intranet.
Note: Regulation 35 makes provision for alternative lockable facilities for storing Schedule 8 poisons
that are being transported for use in another place.
Schedule 4 poisons (including professional samples) must be stored in a lockable storage facility (e.g.
cupboard, drawer, fridge, filing cabinet).
Oral instructions of an authorised prescriber if, in the opinion of the authorised prescriber, an
emergency exists (e.g. telephone orders)
Written transcription (of emergency oral instructions) by the nurse or midwife who received those
instructions
Directions for use on a container supplied by an authorised prescriber or pharmacist (e.g. when
administering a persons own lawfully supplied medicine)
In accordance with the provisions of regulation 5(2), namely when administering under the conditions of
a Health Services Permit (e.g. the Standing Orders permit condition) or under an approval issued by the
Secretary of the Department of Health (e.g. nurse immunisers, midwives)
Some hospitals have a Health Services Permit with a condition authorising the hospital to generate Standing
Orders for the emergency administration of specified drugs in specified circumstances without prior reference
to an authorised prescriber. In such cases, the hospitals PCP will also contain details of the framework that has
been established to generate Standing Orders.
Nurse-initiated medicines
Nurse-initiated medicines are not to be confused with Standing Orders.
Some establishments have documented protocols which detail when a nurse or midwife may initiate treatment
with specified medicines other than Schedule 4 or Schedule 8 poisons. This is a matter of liability and policy
rather than of drugs and poisons legislation.
Records of transactions
A nurse or midwife must make true and accurate records of all Schedule 4 and Schedule 8 poisons that are
administered. Those records must be retained (typically by the HSP holder) for 3 years and produced, on
demand, to an authorised officer.
Patients treatment records (retained for at least 7 years to satisfy other legislative requirements) showing full
details of medicines administered or supplied may be sufficient for Schedule 4 poisons but for Schedule 8
poisons a separate record is almost certainly required.
Records for Schedule 8 poisons must be in a form that shows the true balance remaining after each transaction
and that cannot be altered without detection. Note: A computer spreadsheet is unlikely to comply with this
requirement; manual records, in a bound book with consecutively-numbered pages, are a common option.
the date on which the transaction is recorded and/or a reference number that clearly shows the date;
the name of the poison or controlled substance or a trade name that unambiguously identifies the
poison or controlled substance plus its strength, form (e.g. tablets) and quantity;
if the medicine is intended for external use only, the word POISON, or the words FOR EXTERNAL
USE ONLY, in red on a white background;
the mandatory sedation warning for drugs listed in Appendix K of the Standard for the Uniform
Scheduling of Medicines and Poisons, a link to which is located in the Related sites section of the
DPR website.
Containers must be impervious to the contents, sufficiently sturdy to prevent leakage and capable of being
securely re-closed.
For information relating to nurse practitioners, please refer to the corresponding document on the
DPR website at www.health.vic.gov.au/dpcs/reqhealth
For information relating to authorised registered midwives (aka Eligible Midwife Prescribe
Scheduled Medicines), please refer to the corresponding document on the DPR website at
www.health.vic.gov.au/dpcs/reqhealth
For information relating to authorised registered nurses (aka Registered Nurse Supply Scheduled
Medicines (rural and isolated practice)), please refer to the corresponding document on the DPR
website at www.health.vic.gov.au/dpcs/reqhealth
For more information, relating to endorsements of the registration of nurses and midwives, please refer
to the Nursing and Midwifery Board of Australia website at:
www.nursingmidwiferyboard.gov.au/Registration-Standards.aspx
For information relating to nurse immunisers, please refer to the DPR website and the section
Approved by the Secretary at www.health.vic.gov.au/dpcs/approve
To receive this publication in an accessible format contact Drugs and Poisons Regulation on 1300 364 545.
Authorised and published by the Victorian Government, 1 Treasury Place, Melbourne.
July 2015