Format of prescriptions and administration orders

  • What is a “prescription”? What is an “administration order”? And what’s the difference between these?

    A prescription is a written instruction issued by a  prescriber and provided to a pharmacist  to prepare and supply a medicine for a patientso it can be taken away for the patient to use at a later time (for example, for the patient to use in their own home). In such a circumstance, the pharmacist must label the medicine with particular details as outlined in Appendix L of the Australian Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Such a label must include:

    • All letters being at least 1.5mm in height
    • The name of the patient
    • The date of supply
    • The name, address and telephone number of the place of supply
    • The name, strength, form and quantity of the medicine
    • The directions for use
    • The words “KEEP OUT OF REACH OF CHILDREN” in red with a white background and
    • If the medicine is for external use only, the words “POISON” or “FOR EXTERNAL USE ONLY” in red with a white background

    An administration order is an instruction for a health practitioner (normally a nurse) to administer a dose of a medicine to a patient (i.e. so the medicine would be used on the patient while the health practitioner is with the patient). Therefore, in such a circumstance, the medicine would not be supplied to the patient for use at a later time when the health practitioner is not with them. A medicine to be used for an administration order also does not need to be dispensed and labelled in accordance with Appendix L of the SUSMP (as described further above).

     
  • In what ways can prescriptions and administration orders be lawfully used for scheduled medicines in Victoria?

    The way in which prescriptions and administration orders may be lawfully used for scheduled medicines in Victoria are outlined in the table below.
    The table outlines some relevant key aspects of Victorian Drugs, Poisons and Controlled Substances (DPCS) legislation. However, these key aspects should not be read in isolation. The entirety of all DPCS legislation must be considered before using scheduled medicines in Victoria.

       Prescription  Administration order
    Hand-written on paper According to Regulation 24 According to Part 8 of the DPCS Regulations 2017 (e.g. Regulation 84 for medical practitioners providing administration orders)
    Computer generated, then produced on paper According to the relevant secretarial approval Including a signature in writing, according to Part 8 of the DPCS Regulations 2017 (e.g. Regulation 84 for medical practitioners providing administration orders). 
    Verbal Only in an emergency, according to Regulation 25 Only in an emergency, according to Part 8 of the DPCS Regulations 2017 (e.g. Regulation 84 for medical practitioners providing administration orders). 
    Faxed or scanned copy

    A pharmacist is only authorised to supply S4 and S8 poisons upon presentation of an original prescription. 

    A faxed or scanned copy of a prescription can only serve to provide confirmation of the details of a verbal authorisation from the prescriber. 

    The Department does not recommend this; however, refer to the following legal advice
    Electronic, not on paper According to the relevant secretarial approval Refer to the following advice

    Regulation 24: Required form for issuing prescriptions

    • A person who issues a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must write the prescription either
      • in the person's own handwriting; or
      • in a manner of writing approved by the Secretary under regulation 162(1).
    • A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must ensure that the prescription is written in a legible and durable form.
    • A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must sign the prescription.
    • A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must include in the prescription the following information
      • the name and address of, and a telephone number for, the person who wrote the prescription;
      • the following information for the person or animal for whom the prescription is issued
      • in the case of a person, the person's name and address;
        • in the case of an animal, the species, age, breed and sex of the animal, and the name and address of a person who owns or has custody or care of the animal;
      • the date on which the prescription was written;
      • full particulars of the poison to be supplied;
      • a statement of the quantity to be supplied;
      • directions for the precise dose or use and frequency of administration except in cases where
        • because of the complexity of the dosage regimen or use it is impracticable to do so and the prescriber has separately supplied the patient with written instruction; or
        • a variable dosage regimen is directed and a statement specifying a maximum frequency of administration is included; or
        • the administration of the poison is to be carried out by a registered medical practitioner, veterinary practitioner, pharmacist, dentist, authorized optometrist, authorised podiatrist, nurse or registered midwife;
      • in the case of a Schedule 8 poison, a monitored poison or a Schedule 9 poison if the prescription is for a person and not an animal, that person's date of birth;
      • in the case of a Schedule 8 poison or a Schedule 9 poison
        • if the poison may be supplied only once, a statement, using words and not just figures, that there is to be no repeat supply; and
        • a statement of quantity to be supplied, written in both words and figures;
      • subject to subregulations (4) and (5), the maximum number of times the poison may be supplied.
      • If the prescription is for a Schedule 8 poison or a Schedule 9 poison, the maximum number of times that the poison may be supplied must be stated in both words and figures.
      • If the prescription is for a Schedule 4 poison, the maximum number of times that the poison may be supplied need only be included if it is more than once.
      • A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must not include any information that the person knows is false or misleading.
      • A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must not write the prescription in a secret code or cipher.

    Secretarial Approval: Criteria for computer-generated prescriptions (An authorisation under Regulation 24) (19 April 2018)

    Regulation 24 of the Regulations enables a person who issues a prescription to write the prescription in a manner approved by the Secretary. The extent of the authorisation is set by the approval of the Secretary under Regulation 162.

    The Secretary has given approval in general for a person referred to in regulation 24(1) to issue computer-generated prescriptions under circumstances which satisfy the criteria set out below.

    • The computer program will restrict access to the prescription-printing module to persons authorised to issue prescriptions.
    • Prescriptions will be generated only by persons authorised to issue prescriptions.
    • The prescription will be either printed with the prescriber's name, address and contact telephone number or with the address and contact telephone number of the practice.
    • The prescription will be personalised to the prescriber by the addition at the time of printing of the name of the prescriber below the last prescribed item when the prescription is being generated.
    • The prescriber will sign, in his or her own handwriting, the prescription form beneath and as near as practicable to the last item prescribed on the form.
    • The prescription will not be pre-signed.
    • The total number of items prescribed on the prescription will be either stated on the prescription or the area on the prescription below the prescriber's signature will be scored, hatched or otherwise marked in some way to prevent any other item being printed in that area.
    • The particulars of any prescription issued will be included in the clinical or medication record of the person or animal for whom the prescription was generated.
    • The clinical or medication record of the person or animal for whom the prescription was issued will be preserved for at least one year from the date on which the prescription was generated and will be capable of being accessed when required.
    • Alterations will not be made to printed prescriptions. Where alteration is required a new printed prescription will be generated and the other prescription will be immediately destroyed.

    Drugs of dependence: In the case of drugs of dependence (which includes all Schedule 8 poisons and some Schedule 4 poisons), in addition to the printed particulars on the prescription, the prescriber will include in his/her own handwriting, the following particulars: 

    • the name of the substance or the proprietary product containing it
    • the strength where more than one strength is available
    • the quantity being prescribed (in both words and figures for Schedule 8 poisons)
    • the number of repeats authorised (in both words and figures for Schedule 8 poisons)
    • the software program will automatically indicate that such handwriting is required.

    Notes:

    • A computer-generated prescription must comply with the requirements of regulations 18(2)(e), 24(1A), 24(2), 24(3), 24(6) and 24(7).
    • The criteria for computer-generated prescriptions may vary in different states. Medical practitioners, veterinary practitioners, dentists, nurse practitioners, authorised midwives, authorised optometrists and authorised podiatrists are strongly advised to seek, prior to purchase, verification from the software supplier that their software enables compliance with the specified criteria.
    • As of 20 August 2009 for drugs of dependence it is no longer a criterion that only one item appears on a prescription. This approval supersedes the Secretary Approval Criteria for computer-generated prescriptions dated 20 August 2009.

    Regulation 25: Emergency directions to pharmacists regarding supply

    • A registered medical practitioner, veterinary practitioner or dentist may issue verbal instructions to a pharmacist to supply a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison if, in the opinion of the registered medical practitioner, veterinary practitioner or dentist, an emergency exists.
    • A nurse practitioner or an authorised midwife may issue verbal instructions to a pharmacist to supply a Schedule 4 poison or Schedule 8 poison if, in the opinion of the nurse practitioner or authorised midwife, an emergency exists.
    • An authorised optometrist or an authorized podiatrist may issue verbal instructions to a pharmacist to supply a Schedule 4 poison if, in the opinion of the authorised optometrist or the authorised podiatrist, an emergency exists.
    • A registered medical practitioner, veterinary practitioner, dentist, nurse practitioner, an authorised midwife, an authorised optometrist or an authorised podiatrist who issues verbal instructions pursuant to subregulation (1), (2) or (3), as the case requires, must as soon as practicable
      • write an instruction that indicates that it is in confirmation of the verbal instructions previously given; and
      • send that instruction to the pharmacist.
    • For the purposes of subregulation (4), the written instruction may be a prescription, a chart instruction, or a written instruction of another kind.

    Secretarial Approval: Criteria for electronic prescriptions 9 April 2020

    For the purposes of this approval, a person who issues an electronic prescription must comply with the Criteria for Electronic Prescriptions, listed below in addition to any requirements under the National Health (Pharmaceutical Benefits) Regulations 2017 (Commonwealth Regulations), the Drugs, Poisons and Controlled Substances Act 1981 and the Regulations.

    1. The software used to issue or receive the prescription must be listed on the Register of Conformance by the Australian Digital Health Agency with a current conformance identifier, and must comply with the current version of the Australian Digital Health Agency Electronic Prescribing Participating Software Conformance Profile.
    2. The digital prescription message for each prescription must include:
      • the Healthcare Provider Identifier – Organisation (HPI-O) of the practice or organisation from which the prescription is issued (Electronic Prescribing Conformance Profile requirement PRES-18), and
      • the Healthcare Provider Identifier – Individual (HPI-I) (Electronic Prescribing Conformance Profile requirement PRES-19) or for an electronic prescription that is transmitted within a hospital a unique identifier that is managed and audited by that hospital, and
      • a unique prescription number (Electronic Prescribing Conformance Profile requirement PRES-18), and
      • the conformance identifier, except those electronic prescriptions that are transmitted within a hospital.
    3. The electronic prescription must include information that confirms the identity of the authorised prescriber.
    4. The software used to issue the prescription must:
      • manage defined roles with access rights that will only allow authorised persons to issue or receive electronic prescriptions for all medications, and
      • display the prescription and obtain a final approval from the prescriber prior to issuing a prescription for electronic distribution, and
      • utilise Electronic Prescribing Conformance Profile requirements to protect against fraud.
    5. The software audit requirements (Electronic Prescribing Conformance Profile requirements PRES-10, PRES-38, PRES-39) will be capable of being accessed when required and must be produced on demand to an authorised officer.
    6. The electronic prescription must comply with other requirements of the Drugs, Poisons and Controlled Substances Regulations 2017.

    Requirements for electronic prescriptions

    The requirements for electronic prescriptions are the same as those for paper prescriptions with some exceptions. Prescribers do not need to hand write or hand sign the prescription. Nor do prescribers need to hand write the quantity to be dispensed or number of repeats in words and figures for drugs of dependence.

    For an electronic prescription to be legally valid in Victoria, all systems participating in the prescribing, transmission and dispensing of the prescription must be listed on the Australian Digital Health Agency Electronic Prescribing Conformance Register with a Conformance Identifier.

    For an electronic prescription to be legally valid for supply in Victoria it must contain the information listed below.

    • Conformance ID of the system used to create the prescription (PRES-83)
    • Healthcare Provider Identifier – Organisation (HPI-O) of the practice or organisation from which the prescription is issued (PRES-18)
    • Healthcare Provider Identifier – Individual (HPI-I) of the prescriber (PRES-83)
    • unique prescription number for the prescription (PRES-83)
    • prescriber name, practice address and telephone number
    • date of issue
    • patient’s full name
    • patient's address
    • patient’s date of birth, in the case of a Schedule 8 poison, a monitored poison or a Schedule 9 poison
    • name, strength and form and quantity of the medicine
    • adequate directions for use
    • number of repeat supplies authorised, if any
    • the warrant number, when required
    • name of the registered medical practitioner holding the warrant number who gave the direction and warrant number, when required

    Regulation 84: How registered medical practitioner or dentist must authorise administration of Schedule 4, 8 or 9 poison

    • A registered medical practitioner or dentist who authorises the administration of a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison to a person
      • may, if the registered medical practitioner or dentist is of the opinion that an emergency exists, give that authorisation verbally to a nurse, registered midwife or pharmacist; and
      • otherwise, must
        • provide that authorisation in writing in a legible and durable form that names the person to whom the poison is to be administered; and
        • date and confirm that authorisation with the practitioner or dentist's signature.
      • A registered medical practitioner or dentist who gives an authorisation verbally as described in subregulation (1)(a), must as soon as practicable
        • confirm that verbal authorisation in writing; and
        • include the written confirmation of the verbal authorisation, or provide it for inclusion, in the treatment records of the person concerned.

    Legal advice regarding using a facsimile transmission or a scanned version transmitted by email/text message for an administration order

    The Department does not recommend using a facsimile transmission or a scanned version transmitted by email/text message to provide an administration order. However, these methods could be used to verify a verbal order (provided in compliance with Part 8 of the DPCS Regulations 2017).
    Despite this recommendation, legal advice indicates that:

    • An administration order received by facsimile transmission is a valid order, as long as it is written, dated and signed in accordance with the DPCS Regulations 2017. That is, when a nurse refers to a facsimile transmission of a medical practitioner’s order to administer a Schedule 4 or 8 poison, the nurse may comply with Regulation 96 and/or 97 and a facsimile has the required legal standing as a medical practitioner’s written instruction as required by Sub-regulation 84(1)(b).
    • While advice indicates that the use of facsimile transmissions is legal, it is important to recognise the risks associated with the use of facsimile transmissions. In particular, frequently the facsimile transmission is not a true and accurate copy of the original with lines or other artefacts commonly appearing and text varying in appearance. (these include unwanted visible effects in the picture created by disturbances in the transmission or image processing, such as 'edge crawl' or 'hanging dots' in analog pictures, or 'pixelation' in digital pictures). Thus, it is advised that facsimile transmissions are used in conjunction with verbal instructions from the prescribing medical practitioner or written in such a way that artefacts are easily detected (e.g, including doses, strengths and quantities in words).

    The concept of providing an administration order electronically (i.e. not on paper)

    Aside from the guidance provided in Part 8 of the DPCS Regulations 2017, there is nothing in DPCS legislation that specifically broaches the concept of providing an administration order entirely electronically (i.e. not on paper).

    Part 8 of the DPCS Regulations 2017 indicates that health practitioners that provide administration orders must: 

    • provide that authorisation in writing in a legible and durable form that names the person to whom the poison is to be administered; and
    • date and confirm that authorisation with the practitioner’s signature.

    If a health practitioner were to consider providing an administration order entirely electronically (i.e. not on paper), then the Department would advise that he/she ensures that all of the same criteria that is required for e-Prescriptions is satisfied. The following is the criteria under the Secretarial Approval for e-Prescriptions where the word “prescription” is replaced with the word “administration order”:

    • The software issuing electronic administration orders will have the relevant roles defined, with access rights that will only allow authorised persons to generate electronic administration orders for all medications.
    • The digital signature of the authorized practitioner that provides the administration order must be included in the electronic administration order’s content. The generation of the digital signature for an electronic administration order must follow the following criteria:
      • The practitioner that provides the administration order must possess a credential (private key) that asserts the identity of this practitioner.
      • The software must display the administration order and obtain a final approval from the practitioner that provides the order prior to generating an administration order for electronic distribution.
      • The prescribing software must re-authenticate the credentials of the practitioner that provides the order at the point at which an electronic administration order for any medication, including drugs of dependence (which includes all Schedule 8 poisons and some Schedule 4 poisons), is generated. 
    • Electronic administration orders generated by the administration order software will produce the order information in an electronic format that is aligned with national medications messaging standards or related Australian Technical Specifications. The standards must include secure messaging (such as encryption), and application level acknowledgement, indicating positive or negative receipt of this information.
    • The electronic transfer of an administration order must use national standards for clinical information, terminology and medications in both the organisation that may provide the administration order, and that which may carry out the administration. The exchange of an electronic administration order detail should include the following capabilities:
      • It will provide an indirect communication path between the practitioner(s) that provide the administration order and the practitioner(s) that carry out the administration in which the practitioner(s) that carries out the administration can be selected by the individual (or their agent) at any time after the administration order is created.
      • It will provide a single point of control for each administration order that allows the practitioner that provides the administration order to electronically cancel an electronic administration order. From the time of cancellation, the system of the practitioner(s) and carry out administration will inactivate carrying out administration of any administration order items that have not been actioned. 
      • It will manage the security of the electronic administration order records that are distributed, including taking reasonable measures to apply current and future principles to:
        • Prevent the disclosure of information in the administration order record to unauthorised parties.
        • Ensure that the view of the administration order in both the systems of the practitioner that provides the order, and the practitioner that carries out the administration is consistent.
        • Protect against fraudulent electronic administration orders.
      • The particulars of any electronic administration order issued will be included in the clinical or medication record of the person or animal for whom the electronic administration order was generated.
      • The clinical or medication record of the person or animal for whom the administration order was issued will be preserved for at least one year from the date on which the administration order was generated and will be capable of being accessed when required.