A registered midwife is authorised to possess and administer Schedule 4 and 8 medicines in accordance with the provisions of regulation 5 and regulation 47, respectively.
Approved by the Secretary
Under the provisions of regulation 5(3), the Secretary (of the Department of Health and Human Services) 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.
Authorised registered midwives
The term 'authorised registered midwife' is defined in the Regulations as a registered midwife whose registration is endorsed under section 94 of the Health Practitioner Regulation National Law. For more details, refer to the Nursing and Midwifery Board of Australia website and the endorsement 'Eligible Midwife – Prescribe Scheduled Medicines'.
In addition to the authorisation applicable to other midwives, an authorised registered midwife is authorised to obtain, possess, use, supply or prescribe medicines in Schedules 2, 3, 4 or 8 that are ‘approved by the Minister’ (for Health) in the lawful practice of his or her profession as an authorised registered midwife (section 13 of the Act). This authorisation does not extend to:
- activities unrelated to his or her endorsed practice
- supplying medicines that have been prescribed by another registered health practitioner (e.g. for self, spouse or employees); that is the role of a pharmacist
- supplying scheduled poisons by wholesale, an activity that requires a wholesale licence.
An authorised registered midwife’s scope of practice will be supported by an employer’s clinical governance framework and will be guided by the Nursing and Midwifery Board of Australia’s professional practice framework, which details how professional decision-making within a sound risk management, professional, regulatory and legislative framework is to be managed.
In general, regulatory requirements are applicable to each authorised registered midwife but the circumstances of employment need to be considered to ensure compliance with the regulations.
Hospitals (and some other health services providers) are authorised to possess and use scheduled poisons in accordance with the conditions of a Health Services Permit (HSP) and in compliance with the contents of a Poisons Control Plan (PCP) that is specific to each permit holder and will contain details relating to the manner in which medicines are to be obtained, stored, used, recorded and destroyed.
In some cases, a PCP will contain requirements that are more specific or additional to regulatory requirements that relate, in general, to authorised registered midwives. The current version of the PCP, which is commonly controlled by the Director of Nursing or Director of Pharmacy, should be available for perusal by relevant staff; in some cases, it is available on a hospital’s intranet.
However, if an authorised registered midwife is not practising under the auspices of a health services provider, issues relating to the manner in which scheduled medicines are obtained, possessed, used, recorded and destroyed will be the sole responsibility of the authorised registered midwife to whom the medicines are supplied.
Approved List of scheduled medicines
The Minister (for Health) has approved a list of a Schedule 2, 3, 4 and 8 medicines for authorised registered midwives for the management of women and their infants in the prenatal, and post-natal stages of pregnancy and birth. Note: Some of the listed medicines are only approved for use for the purposes of an emergency or intrapartum purposes.
The Approved List, which identifies specific substances and classes of scheduled medicines, is located on the Drugs and Poisons Regulation website (at www.health.vic.gov.au/dpcs/prescriber/registered-midwives) under the 'Approved by the Minister' link.
Note: In the event of an inconsistency, between the Approved List and the Nursing and Midwifery Board of Australia’s prescribing formulary, the (gazetted) Approved List represents the lawful situation in Victoria.
Prescribing and supplying Schedule 4 and Schedule 8 medicines
Authorised registered midwives must not prescribe or supply Schedule 4 and Schedule 8 medicines other than for the medical treatment of persons under their care and then only after taking all reasonable steps to ensure that a therapeutic need exists (regulation 9B).
When writing prescriptions, the prescription must:
- contain the full details of the prescriber (including address and phone number)
- contain the patient’s name and address
- identify the medicine unambiguously
- show the quantity and number of repeats (in words and figures for Schedule 8 poisons)
- be signed and dated by the prescriber
- contain precise directions for the use (except where complex directions are provided separately in writing or if administration is to be carried out by the prescriber)
- be in the authorised registered midwife’s own handwriting or in a manner of writing approved by the departmental Secretary, for example, computer-generated prescriptions that comply with specified criteria.
When supplying Schedule 4 and Schedule 8 medicines, an authorised registered midwife must personally ensure that the correct medicine is selected and supplied in the required manner. This responsibility cannot be delegated to another person.
An authorised registered midwife is responsible for ensuring that the container is labelled in accordance with the provisions of regulation 29, plus Appendix L of the Poisons Standard (aka Standard for the Uniform Scheduling of Medicines and Poisons). 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 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.
Note: The roles of prescribing and supplying medicines have traditionally been separated, to allow a pharmacist to check for possible contraindications and to assess the safety and appropriateness of prescribed medicines.
Pharmacists have well defined standards, including the use of ancillary labels, to ensure that medicines are labelled in a manner that maximises the likelihood that the medicines will be administered in a safe and effective manner. Authorised registered midwives who choose to supply Schedule 4 or Schedule 8 medicines are advised to do so in a manner that is of a comparable standard to that required of pharmacists.
Self-administration and prescribing prohibited
Self-administration of Schedule 4 and Schedule 8 medicines is prohibited unless the medicines have been lawfully prescribed and supplied by a registered health practitioner (e.g. medical practitioner) or supplied by a pharmacist on a prescription from a registered health practitioner (regulation 48). Note: This does not mean that, where medicines have been prescribed by another registered health practitioner, an authorised registered midwife may continue the treatment with medicines obtained from an authorised supplier or prescribed by themselves for themselves.
Managing Schedule 4 and Schedule 8 medicines
Licensed wholesalers and pharmacists must only supply scheduled medicines to an authorised person (or permit holder) and must record the details of the person (e.g. authorised registered midwife) to whom supply is made, regardless of to whom an invoice for payment might be directed (e.g. a corporate entity or business name). The supplier might also require the provision of a written order before supply is made. The person to whom supply is made must thereafter be able to account for all transactions in the corresponding scheduled medicines.
Schedule 8 medicines 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 medicines 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 medicines that are being transported for use in another place and for small quantities (e.g. up to 6 ampoules of morphine) for use in an emergency.
Schedule 4 medicines (including professional samples) must be stored in a lockable storage facility (e.g. cupboard, drawer, fridge, filing cabinet).
Storage facilities for Schedule 4 and Schedule 8 medicines must be secured to prevent access by persons not specifically authorised under the Act (including the conditions of a Health Services Permit) or Regulations unless the authorised registered midwife is present. Accordingly, keys and combination codes should not be accessible to unauthorised staff members.
Records of transactions
An authorised registered midwife must make true and accurate records of all scheduled medicines administered or supplied, retain them for 3 years and produce them, 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 medicines
Regulation 51 authorises an authorised registered midwife to destroy a Schedule 8 medicines in the presence of a medical practitioner, nurse practitioner, pharmacist, dentist, nurse or midwife.
Regulation 51 specifically allows a Schedule 8 medicines to be discarded or destroyed without a witness in the case of the remaining, unused contents of a previously sterile container (e.g. a partially used ampoule) – provided an appropriate record in made. Note: Although a witness is not mandated by regulation, many establishments or their PCP require a witness when a suitably qualified person is available.
Schedule 2 and Schedule 3 medicines
Schedule 2 and 3 medicines (labelled 'Pharmacy Medicine' or 'Pharmacist Only Medicine', respectively), typically referred to as 'over-the-counter' medications, must only be supplied in an open shop by pharmacists.
However, authorised registered midwives may use, prescribe or supply Schedule 2 and Schedule 3 medicines that are specified in the Approved List in a similar manner to Schedule 4 medicines, i.e. for medical treatment, consistent with their scope of practice, of persons under their care. Schedule 2 and Schedule 3 medicines must not be supplied for any other purpose or to any other person.