Anda di halaman 1dari 7

1

Nurses and midwives


Key legislative requirements

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.

Possession of Schedule 4 and Schedule 8 poisons


In the Drugs Poisons and Controlled Substances Regulations 2006, the term nurse means (a) a registered
nurse or (b) an enrolled nurse (other than an enrolled nurse who has a notation on his or her registration
indicating that he or she is not qualified to administer medication).
It is an offence to possess Schedule 4 poisons unless specifically authorised under the Act or the Regulations.
Nurses and midwives are authorised (under regulation 5(2)) to possess Schedule 4 and Schedule 8 poisons
that are necessary for administration to patients under their care, in accordance with any of the following points:

The instructions and authorisation of an authorised prescriber for a specific patient

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

Clarifying the terms administration and supply


For clarification of this issue and in no broader context, the terms administer and use mean to personally
introduce a medicine or personally observe its introduction to a patients body. The term supply means to
provide a medicine to a person for administration or use at a later time.
In the lawful practice of the profession, a nurse or midwife is authorised to administer or use scheduled
poisons, in accordance with the provisions of regulation 47 (see page 3) but is not authorised to supply or
prescribe scheduled poisons unless his/her registration has been endorsed to do so (see page 5).
Note:

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).

Where there is Health Services Permit (HSP)


An HSP is issued to an establishment (e.g. hospital, day procedure centre) to authorise the possession of
Schedule 4 and Schedule 8 poisons for the provision of health services.
Each HSP contains conditions that are specific to the type of health service provided, e.g. the conditions for a
hospital vary from those of a bush-nursing centre or an ambulance service.
Each HSP has a corresponding Poisons Control Plan (PCP), which describes the manner in which each
permit holder has undertaken to comply with legislative requirements.
Nurses and midwives employed by HSP holders (e.g. hospitals) will generally be required to comply with the
conditions of the HSP and the contents of the establishments PCP.
Note:

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.

Storage of Schedule 4 and Schedule 8 poisons


Schedule 8 poisons must be stored in a locked facility, fixed to the floor or wall, which provides not less
security than a (10 mm thick) mild steel drug cabinet. Schedule 8 poisons must not be stored with any other
items other than other drugs of dependence.

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).

Access to Schedule 4 and Schedule 8 poisons


Storage facilities for Schedule 4 and Schedule 8 poisons must be secured to prevent access by persons not
specifically authorised under the Act (including the conditions of a Health Services Permit) or Regulations.
Accordingly, keys and combination codes should not be accessible to unauthorised staff members.

Administration of Schedule 4 and Schedule 8 poisons


Regulation 47 requires a nurse or midwife to refer to authoritative instructions before administering Schedule 4
or Schedule 8 poisons, namely:

Written instructions of an authorised prescriber (the most common option)

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.

Destruction of Schedule 8 poisons


Regulation 51 authorises a medical practitioner, nurse practitioner, pharmacist or dentist to destroy a Schedule
8 poison in the presence of a medical practitioner, nurse practitioner, pharmacist, dentist, nurse or midwife.
Note: Although a nurse or midwife is authorised to act as the witness when a Schedule 8 poison is to be
destroyed, two nurses and/or midwives may not destroy Schedule 8 poisons.
To clarify the situation relating to an accepted practice, regulation 51 specifically authorises a nurse or midwife
to discard or destroy the remaining, unused contents of a previously sterile container (e.g. a partially used
ampoule) provided an appropriate record in made. Note: A witness is not mandated by the regulations
although many establishments have a policy that requires a witness when another nurse or midwife is available.

Starter packs (and professional sample packs) in hospitals


The term starter pack is commonly used to describe a small quantity of a Schedule 4 medicine that has been
provided by a pharmacist (or licensed manufacturer) so that an authorised prescriber can supply sufficient
medicine to enable a patient to commence treatment prior to obtaining a larger quantity on prescription.
Starter packs are commonly presented with the containers labelled in a manner that enables the authorised
prescriber to insert patient-specific information at the time of supply.
If a starter pack is supplied to a hospital by an external supplier or pharmacist (i.e. not from the hospitals
pharmacy department), supply is considered to have occurred when possession, control of or access to the
medicine is transferred to the permit holders staff. When/if a payment might occur is not relevant to the question
of when supply is said to have occurred.

Not to be supplied by nurses or midwives


Nurses and midwives are not generally authorised to supply Schedule 4 poisons. The decision to supply a
starter pack or professional sample pack of a Schedule 4 poison must be made by an authorised prescriber.

Supply by an authorised prescriber


The authorised prescriber (e.g. medical practitioner, nurse practitioner, authorised registered midwife) who
supplies a Schedule 4 medicine in a starter pack is responsible for ensuring that the container is labelled in
accordance with the provisions of regulation 29, plus Appendix L of the Standard for the Uniform Scheduling of
Medicines and Poisons (see below) and that a record of supply is made. This responsibility cannot be
delegated. Required components of a label include:

the name of the patient;

the date on which the transaction is recorded and/or a reference number that clearly shows the date;

the name, address and telephone number of the practitioner;

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;

the words KEEP OUT OF REACH OF CHILDREN in red on a white background;

adequate directions for use;

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.

Replacing a starter pack


If an authorised prescriber provides a prescription, which directs a pharmacist to supply further medicine to
the patient, the pharmacist must supply the quantity specified on the prescription; must label the
corresponding container in the manner described in regulation 29; and must make a record of the
transaction.
Note: It is not lawful to attach a dispensing label, which corresponds to the prescription, to the container that
was supplied previously.
Regulation 45 makes it an offence to administer drugs, obtained on prescription, to any person other than the
person named on the prescription. Hence, a container of medicine, obtained on prescription, must not be used
to replace a starter pack that was previously supplied.

For further information


Department of Health & Human Services (DHHS)
Drugs and Poisons Regulation
GPO Box 4057
Melbourne 3001
Tel: 1300 364 545
Fax: 1300 360 830
Email: dpcs@dhhs.vic.gov.au
Web: www.health.vic.gov.au/dpcs

Nurses and midwives with registration endorsements


Information relating to the additional legislative requirements for nurses and midwives, whose registrations have
been endorsed Nursing and Midwifery Board of Australia, are contained on the following documents or on the
departments website, as indicated below.

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

Other possible sources of information


Nursing and Midwifery Board of Australia
www.nursingmidwiferyboard.gov.au

Australian Health Practitioner Regulation Agency (AHPRA)


www.ahpra.gov.au

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

OxyContin tamper-resistant oxycodone tablets