Schedule 8 medicines
When transported for use in another location, Schedule 8 medicines must be stored in a locked receptacle (such as a 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 (such as a lockable vehicle or cupboard) to prevent unauthorised access.
Schedule 8 medicines must otherwise be stored in a locked facility that is fixed to the floor or wall and provides not less security than a 10-mm thick mild steel drug cabinet (see r. 35(1) of the Drugs, Poisons and Controlled Substances Regulations 2006 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 six divided doses (for example, morphine ampoules), for emergency use, may be stored in a locked facility that does not comply with r. 35(1).
Schedule 4 medicines
Schedule 4 medicines (including professional samples) must be stored in a lockable storage facility (such as a cupboard, drawer, fridge, filing cabinet, treatment room or storeroom). There is no requirement for the lockable facility to be within a lockable facility.
Schedule 4 drugs of dependence may be stored in the same manner as other Schedule 4 medicines, or in the drug cabinet or safe with Schedule 8 medicines.
Schedule 2 and 3 medicines
Schedule 2 and 3 medicines may only be supplied (in an open shop) by pharmacists.
Medical practitioners may supply Schedule 2 and Schedule 3 medicines in a similar manner to Schedule 4 medicines (that is, for the treatment of patients under their care).To prevent unlawful supply, Schedule 2 and Schedule 3 medicines should be stored and handled in a similar manner to Schedule 4 medicines.
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 by patients, employees or others.
Access to storage facilities
In clinics that do not hold a Health Services Permit (HSP), Schedule 4 and Schedule 8 medicines (including doctor's bag emergency drugs and professional samples) are obtained on the authorisation of the medical practitioner(s) and unsupervised access must usually be limited to medical practitioners.
Schedule 8 medicines
The storage facility for Schedule 8 medicines 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 and combinations must not be accessible to, or known by, unauthorised persons (including staff other than medical practitioners).
Schedule 4 medicines
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 Drugs, Poisons and Controlled Substances Act 1981 or the Regulations, to possess Schedule 4 medicines. In many clinics, only medical practitioners will be authorised.
1. The storage facility may be unlocked when it is necessary to carry out an essential operation in connection with the Schedule 4 medicines stored therein, such as inventory checks, or extraction of Schedule 4 medicines for lawful administration or supply (rr. 34(2) and 71).
2. To provide parity with Schedule 4 medicines stored by other registered health practitioners (such as pharmacists or veterinary practitioners), Schedule 4 medicinesmay be stored in a treatment room of the premises (r. 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 medicines 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, security may be inadequate
- 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, Schedule 4 medicines should be stored in lockable facilities that are locked when a medical practitioner is not readily able to provide personal supervision.
Note: In any event, if the medical practitioner is absent from the premises, the storage facility for Schedule 4 medicines must be locked.
3. Other variations might be applicable where a Health Services Permit (HSP) is held by the clinic – as indicated in the next passage.
Health Services Permits
An HSP does not remove the responsibility of medical practitioners to be able to account personally for Schedule 8 medicines that are supplied in their names, such as doctor’s bag supplies subsidised by the Pharmaceutical Benefits Scheme plus any other Schedule 8 medicines supplied in the name of the medical practitioner.
However, 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 medicines when a medical practitioner is not present.
Details relating to each HSP holder will be contained in the Poisons control plan for each HSP.
Possession and access by nurses
A nurse is authorised to possess Schedule 4 medicines 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 medicines in other circumstances. An HSP is required for broader access and possession to be lawful.
Special provisions apply in the case of nurse immunisers.
Nurse administration of Schedule 4 and Schedule 8 medicines
Unless an HSP or other authorisation exists, r. 47 requires a nurse to refer to authoritative instructions before administering Schedule 4 or Schedule 8 medicines, 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 (such as administration of a person’s own lawfully supplied medication).
Nurses who administer Schedule 4 and Schedule 8 medicines must ensure that relevant details of the administration are recorded in an appropriate manner.
Vaccines — 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 and Human Services 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 medicines necessary for the treatment of anaphylactic reactions to the vaccines. Nurse immunisers should familiarise themselves with relevant legislation.
Recording and other requirements
Records of all transactions (including administration by medical practitioners and nurses) in Schedule 4 and Schedule 8 medicines must be retained in a readily retrievable form for 3 years and produced, on demand, in writing to an authorised departmental officer (r. 40).
For Schedule 8 medicines, 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 (r. 41). Loose-leaf books are not acceptable.
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 medicines supplied to them.
Destruction of Schedule 8 medicines
If a medical practitioner wishes to destroy expired or unwanted Schedule 8 medicines, 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
Victoria Police and the department must be notified when:
- medicines or records relating to Schedule 4 and Schedule 8 medicines are lost or stolen
- a medical practitioner has reason to believe a person has obtained Schedule 8 or Schedule 4 poisons (or prescriptions) under false pretences.
The department should also be notified about the loss or theft of prescription pads or pages.
Compliance with other standards
Compliance with the Drugs, Poisons and Controlled Substances Act and the 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.