Poisons Control Plan
Poisons Control Plan for a Permit to Purchase or Obtain
Scheduled Poisons for the Provision of Health Services – Part One
Poisons Control Plan
A Poisons Control Plan must be submitted for registration in relation to all permits to indicate how the permit
holder proposes to comply with the Drugs, Poisons and Controlled Substances Act 1981 (the Act), the Drugs,
Poisons and Controlled Substances Regulations 2006 (the Regulations), the conditions of the permit and
relevant codes and standards.
The Act and Regulations are administered by the Department of Health, Drugs and Poisons Regulation
It is the responsibility of the permit holder to ensure compliance with the Act and Regulations.
Note:
• Please read all instructions and guidance carefully.
Responsible Person(s)
The permit will identify one or more Responsible Persons who have been nominated by the permit holder to
fulfil the following tasks:
• Ensure the maintenance, accuracy and currency of the registered Poisons Control Plan,
• Provide periodic confirmation (as required by the Department of Health, Drugs and Poisons Regulation) that
the permit holder is operating in a manner consistent with the registered Poisons Control Plan,
• Ensure that there is a periodic review (at least annually, such as at the time of permit renewal) of the permit
and the registered Poisons Control Plan to confirm that the permit holder continues to comply with the
conditions of the permit, the legislation and relevant codes and standards,
• Retain documentary records of the aforementioned reviews,
• Notify the Department of Health, Drugs and Poisons Regulation of any amendments which may be required
to the permit or the conditions of the permit (e.g. change of company name, change of address, change of
Responsible Person), and
• Submit any proposed amendments to the registered Poisons Control Plan to the Department of Health,
Drugs and Poisons Regulation for assessment.
Details of the permit to which this Poisons Control Plan relates: (Departmental Use ONLY)
Permit Holder:
Permit Number:
The registered version of the Poisons Control Plan contains
the Department of Health, Drugs and Poisons Regulation.
pages, each of which has been stamped by
Department of Health
1. The permit
A permit is required to purchase or obtain by wholesale poisons and controlled substances. These substances
are;
(a) poisons included in Schedules 2, 3, 4, 8 and 9 of the current edition (plus amendments) of the
Commonwealth Standard, the Standard for the Uniform Scheduling of Medicines and Poisons; and
(b) .Schedule 7 substances included in Chapter 1 Part 2 of the Poisons Code in the list of substances that are
not for general sale by retail (for example cyanide, arsenic and benzene)
http://www.health.vic.gov.au/dpu/poicode
These substances are collectively referred to as “scheduled poisons” in the Poisons Control Plan, or if
appropriate, “medications”.
The permit specifies which scheduled poisons may be purchased or obtained and the conditions that must be
observed by the permit holder.
Multiple campuses
A single permit may apply to multiple campuses, provided that:
•
all are in the same locality,
•
all are owned by the same legal entity, and
•
scheduled poisons are purchased and distributed only from the principal location.
Note: A separate permit is required for each location at which scheduled poisons are purchased or
obtained.
References
Current versions of the following source material may be accessed as indicated:
• The Act and Regulations http://www.legislation.vic.gov.au/
• The Department of Health website Drugs & Poisons Controls in Victoria contains application forms and
information relating to licence and permit requirements in Victoria http://www.health.vic.gov.au/dpu
• The Standard for the Uniform Scheduling of Medicines and Poisons, the source document for poisons
schedules and labelling and packaging requirements
http://www.tga.gov.au/industry/scheduling-poisons-standard.htm
Note: Key aspects of the preceding reference documents are addressed in this Poisons Control Plan. The
permit holder should refer to the source material for full details of requirements.
Location of documents
The permit and a copy of the registered Poisons Control Plan, which will be stamped and returned by the
Department of Health, Drugs and Poisons Regulation, must be readily available to relevant personnel.
1.1 Indicate where the permit document is to be located:
1.2 Indicate where the registered version of the Poisons Control Plan is to be located:
Page 2
Department of Health
1.3 Indicate the position (or role) of the person(s) to be responsible for the periodic review of the
registered Poisons Control Plan and the frequency with which the review is to occur:
1.4 Indicate the manner in which the review of the Poisons Control Plan is to be documented and where
the corresponding records are to be retained:
The permit holder should also have a Standard Operating Procedure for the storage, recording and use of
scheduled poisons. The Standard Operating Procedure should be readily available to relevant personnel and
should be a key component of staff training activities (see Section 8).
1.5 Indicate the manner in which the Standard Operating Procedure is to be retained and available for
use as a reference document:
Purpose for which scheduled poisons are required
1.6 Indicate the type(s) of health services for which the permitted scheduled poisons may be required:
2. Reference material
The Standard for the Uniform Scheduling of Medicines and Poisons is published annually, with additional
amendments during the year.
2.1 Indicate whether a copy of the Standard for the Uniform Scheduling of Medicines and Poisons is
held and where it is to be located:
2.2 Indicate where the Act and Regulations are to be accessed or located:
3. Purchasing or obtaining scheduled poisons
The acquisition of the scheduled poisons to which the permit relates, must only occur in accordance with a
documented procedure or at the direction of the Responsible Person(s).
3.1 Indicate the position(s) or role(s) of the person(s) to be responsible for ordering scheduled poisons
from suppliers:
Page 3
Department of Health
3.2 Indicate what records are to be retained in relation to the acquisition of scheduled poisons:
Medications that are purchased or obtained on prescription (for administration or
supply)
In general, a prescription is a document intended to be presented to a pharmacist to authorise the supply of
medications for the treatment of the person named on the prescription.
A Patient Medication Chart is used to provide instructions for administration of medications to a patient.
Note: In most cases Patient Medication Charts do not fulfil the criteria required of a prescription and the terms
should not be considered to be interchangeable.
Although a permit is not required to purchase or obtain medications that are supplied on prescription for specific
patients, most of the following sections of the Poisons Control Plan are equally applicable to such medications.
3.3 Indicate the extent to which prescriptions are to be used to purchase or obtain medications for use
within the establishment, as distinct from medications that are purchased or obtained from other
sources:
4. Security
Where scheduled poisons are distributed from a primary storage area (e.g. pharmacy department, central
storage facility) to wards and units of an establishment, additional security provisions may be required. All
information relating to security and storage within the primary storage area is to be included in PART TWO of
the Poisons Control Plan.
4.1 Indicate the general security measures that are to be taken to prevent misappropriation of scheduled
poisons by external (e.g. burglars) or internal (e.g. staff, contractors) agents:
Storage and access to scheduled poisons
Specified storage requirements are required for Schedule 4 and Schedule 8 poisons, in order to prevent
unauthorised access and illegal diversion.
Schedule 8 poisons
4.2 Indicate how Schedule 8 poisons are to be stored:
A storage facility for Schedule 8 poisons must be locked and secured to prevent access by any unauthorised
person at all times, except when it is necessary to open it to carry out essential operations. Keys (or other
access methods e.g. combination codes, proximity cards) to storage facilities must be limited to the minimum
number required to provide essential access.
Page 4
Department of Health
4.3 Indicate how unauthorised or unsupervised access to Schedule 8 poisons is to be prevented:
Schedule 4 poisons
4.4 Indicate how Schedule 4 poisons are to be stored:
A storage facility for Schedule 4 poisons must be locked and secured to prevent access by any unauthorised
person at all times, except when it is necessary to open it to carry out essential operations. Keys (or other
access methods e.g. combination codes, proximity cards) to storage facilities must be limited to the minimum
number required to provide essential access.
4.5 Indicate how unauthorised or unsupervised access to Schedule 4 poisons is to be prevented:
Special storage facilities (e.g. emergency medications, medical gases)
4.6 Indicate what special storage facilities (if any) are to be used for specific scheduled poisons and,
where different from the previously stated methods, indicate what measures are used to prevent or
detect unauthorised access:
Schedule 2 and Schedule 3 poisons
4.7 Indicate how Schedule 2 and/or Schedule 3 poisons are to be stored:
5. Administration (or use) by a nurse or midwife
A 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.
A registered nurse means a person registered under the Health Practitioner Regulation National Law (a) to
practise in the nursing and midwifery profession as a nurse (other than as a midwife or as a student) and (b) in
the registered nurses division of that profession;
A midwife means a person registered under the Health Practitioner Regulation National Law (a) to practise in
the nursing and midwifery profession as a midwife (other than as a nurse or student); and (b) in the Register of
Midwives kept for that profession.
Administration (or use) is to personally introduce a medicine or personally observe its introduction to a
patient’s body. This is not to be confused with supply, which means to provide a medication for administration
at a later time.
For Administration (or use) by an authorised registered nurse – see Part Six.
Page 5
Department of Health
Unless otherwise authorised by the Act or Regulations, a nurse or midwife must not administer a Schedule 4 or
Schedule 8 poison other than in accordance with Regulation 47, i.e.:
•
On the written instruction of a medical practitioner (or other authorised practitioner),
•
On the oral instructions of a medical practitioner (or other authorised practitioner), provided to the nurse or
midwife, in an emergency situation,
•
On the written transcription, by another nurse or midwife, of the emergency oral instructions,
•
In accordance with the directions for use on a container supplied by a medical practitioner, pharmacist or
other authorised practitioner. This option is intended to specifically address the (rare) occasion where written
or verbal authorisation cannot be obtained.
5.1 Indicate what steps are to be taken to obtain verbal instructions from a medical practitioner (or other
authorised practitioner) when written instructions are not available:
5.2 Indicate the circumstances under which a nurse or midwife might be required to administer a
Schedule 4 or Schedule 8 poison in accordance with the directions for use on a container:
A medication, obtained on prescription, must not be administered to a person other than the person named on
the prescription.
5.3 Indicate the steps to be taken to ensure that a medication, obtained on prescription, is not
administered to a person other than the person named on the prescription:
6. Administration (or use) by a person other than a nurse or midwife
•
A medical practitioner must not administer a Schedule 4 or Schedule 8 poison, other than for the medical
treatment of a patient under his or her care.
•
Other authorised practitioners (e.g. dentist, nurse practitioner, authorised optometrist or authorised
podiatrist) must not administer a Schedule 4 or Schedule 8 poison, other than for the treatment (that they are
authorised to provide) of a patient under their care, in respect of a medication that they are authorised to
administer.
•
A pharmacist must not administer a Schedule 4 or Schedule 8 poison other than on the original written
authorisation of a medical practitioner or other authorised practitioner.
•
Other persons (e.g. ambulance officers) must not administer a Schedule 4 or Schedule 8 poison, other than
to the extent and for the purpose specified in the permit to which this Poisons Control Plan applies.
6.1 Indicate under what circumstances a person other than a nurse or a midwife may be required to
administer Schedule 4 or Schedule 8 poisons within the establishment:
Page 6
Department of Health
7. Records of transactions
The definition of a "transaction" includes the preparation, use, transfer within and between premises,
administration, disposal or destruction of a Schedule 4, Schedule 8 or Schedule 9 poison.
Details of all transactions, in scheduled poisons to which the permit relates, must be kept for at least 3 years
and produced on demand to an Authorised Officer of the Department of Health.
Details of records for scheduled poisons that are distributed from a primary storage area (e.g. pharmacy
department) to other areas of an establishment are to be included in PART TWO.
7.1 Indicate how records of transactions are to be retained:
The Regulations specify the details required to be contained in records of transactions involving Schedule 8
poisons. All records of transactions must be retrievable by drug name.
Records of transactions involving Schedule 8 poisons must not be able to be altered, obliterated, deleted or
removed without detection and must show the true and accurate balance remaining after each transaction.
Exception – The true and accurate balance is not required to be kept in residential aged care services where
the Schedule 8 poison has been supplied, on prescription for a specific person, in tamper-evident compartments
of suitably labelled dose administration containers.
7.2 Indicate how records of transactions for Schedule 8 poisons are to be secured and validated:
7.3 Indicate what records are to be made in relation to internal stock transfers (e.g. between wards, from
emergency after-hours store):
8. Staff training
The permit holder should ensure that all personnel, who may have access to permitted scheduled poisons, are
fully aware of their responsibilities, as detailed in the Act and Regulations and the Standard Operating
Procedures of the establishment.
8.1 Indicate how staff training is to be implemented and reviewed:
Loss and misappropriation of scheduled poisons and other incidents
Appropriate record keeping procedures should detect and/or deter the misappropriation of scheduled poisons.
It is essential that relevant personnel are aware of the need to identify and report behaviour that might indicate
such activity.
There should also be Standard Operating Procedures for dealing with noted discrepancies as well as unusual or
untoward incidents (e.g. incorrect administration of medication or possible excessive usage).
Page 7
Department of Health
8.2 Identify key areas or substances (if any), where there may be a greater risk and/or a greater
vulnerability to loss or pilferage:
8.3 Indicate how relevant personnel are to be supervised and/or periodically re-trained to be aware of
and to address identified risks:
The permit holder should have a protocol, included in the Standard Operating Procedures for the establishment,
which clearly documents the form of Incident Reporting, the position (or role) of the person to whom such
reports must be submitted and the form of Response(s) required.
The Standard Operating Procedures should also detail the manner in which Incident Reports and Response(s)
are to be retained and reviewed to enable patterns or trends to be distinguished from isolated incidents.
8.4 Indicate the manner in which Incident Reports and Responses are to be documented, retained and
reviewed:
In circumstances where discrepancies or incidents are not adequately resolved (e.g. confirmed or suspected
misappropriation of scheduled poisons), the matter must be reported to Victoria Police and in writing to the
Department of Health, Drugs and Poisons Regulation.
8.5 Indicate the position (or role) of the person who is to be responsible for notifying the authorities and
how this person is to be aware of the action required of him/her:
9. Supply of medications
The entirety of Item 9 relates to the supply of medications purchased or obtained under this permit by this
permit holder. It does NOT relate to administration of medications and does NOT relate to the activities of
community pharmacies or health service providers other than this permit holder.
For Supply by an authorised registered nurse – see Part Six.
Supply by medical practitioners or other authorised practitioners
•
Medical practitioners may supply medications for the medical treatment of patients under their care in the
lawful practice of their profession.
•
Other authorised practitioners (e.g. dentists, nurse practitioners, authorised optometrists or authorised
podiatrists) may supply medications for treatment (that they are authorised to provide) of patients under their
care in respect of medications that they are authorised to supply.
9.1 Indicate under what circumstances medical practitioners or other authorised practitioners may be
required to supply medications:
Page 8
Department of Health
Supplied medications must be labelled and packaged in accordance with the Regulations.
9.2 Indicate how such medications are to be labelled and packaged:
The permit holder must ensure that all supplies are recorded in accordance with the Regulations.
9.3 Indicate what records are to be made in relation to the supply of medications by medical
practitioners and/or other authorised practitioners;
Supply by pharmacists of medications purchased or obtained by the permit holder
Pharmacists may supply medications upon receipt of the original written authorisation (e.g. prescription), or the
oral instructions (in an emergency situation), of a medical practitioner or other authorised practitioner.
9.4 Indicate under what circumstances pharmacists may be required to supply medications to patients:
Involvement by a nurse or midwife (other than an authorised registered nurse) in the
supply of medications to patients
Nurses and midwives (other than authorised registered nurses) are authorised to administer but are NOT
authorised to supply medications containing poisons in Schedules 2, 3, 4, 8 and 9.
Where a scheduled poison has been lawfully supplied and correctly labelled for the specified patient by a
medical practitioner or other authorised practitioner (for the treatment of a person under his/her care), a nurse or
midwife may issue or deliver that medication, in its original container, to the patient.
9.5 Indicate under what circumstances a nurse or midwife (other than an authorised registered nurse)
may be involved in the supply of medications to patients:
Supply to members of staff
The supply (if any) of medications to staff members within the establishment is likely to be restricted to supply
by pharmacists in a pharmacy department (with prescriptions required for S4 and S8 poisons) or to supply by
medical practitioners or other authorised practitioners (for the treatment of a person under their care).
9.6 Indicate what steps are to be taken to ensure that staff members are not supplied with scheduled
poisons in a manner that is contrary to the legislation:
Page 9
Department of Health
10. Waste Disposal
Waste material (including expired medications) containing scheduled poisons, must be disposed of in an
appropriate manner and must not be disposed of via normal waste collection agencies (e.g. rubbish collection).
10.1 Indicate the likely means of disposal of such waste material:
Destruction of Schedule 8 or Schedule 9 poisons
The Regulations allow the destruction of a Schedule 8 poison or a Schedule 9 poison by a registered
medical practitioner, pharmacist, veterinary practitioner or dentist, in the presence of another person who is a
registered medical practitioner, pharmacist, veterinary practitioner, dentist, nurse or midwife, provided that
records are kept of the name, strength and quantity of each poison destroyed, the method and place of
destruction, and the names of the persons involved. The records must comply with the requirements of the
Regulations.
The Regulations allow the destruction of a Schedule 8 poison by a nurse practitioner, in the presence of
another person who is a medical practitioner, pharmacist, veterinary practitioner, dentist, nurse or midwife,
provided that records are kept of the name, strength and quantity of each poison destroyed, the method and
place of destruction, and the names of the persons involved. The records must comply with the requirements of
the Regulations.
The Regulations allow the destruction of the unused contents of a previously sterile container containing a
Schedule 8 poison or a Schedule 9 poison that are not required for administration to a patient, by a
registered medical practitioner, pharmacist, veterinary practitioner, dentist, nurse or midwife, provided that
records are kept of the name, strength and quantity of each poison destroyed, the method and place of
destruction, and the name of the person involved. The records must comply with the requirements of the
Regulations.
A similar allowance exists for an operational staff member of an ambulance service in relation to a Schedule 8
poison that has been obtained under the health services permit of that ambulance service. The records must
comply with the requirements of the Regulations.
10.2 Indicate how Schedule 8 poisons are to be destroyed:
Note: Parts Two through Six of the Poisons Control Plan are applicable only to permits that relate to the
activities of each permit holder (or applicant) and may otherwise be discarded.
Authorised by the Victorian Government, Melbourne. To receive this publication in an accessible format phone
1300 364 545 Drugs and Poisons Regulation.
Page 10
Department of Health