Page 1Department of Health

This document has been prepared by Drugs and Poisons Regulation (DPR) to assist registered dental practitioners, namely dentists, dental hygienists, dental therapists and oral health therapists to understand key legislative requirements. For simplicity of reading, this document does include the many options that are covered by the legislation; merely those that are relevant to the majority of dentists. For full details, reference should be made to the Drugs Poisons and Controlled Substances Act 1981 and Drugs Poisons and Controlled Substances Regulations 2006 (at www.legislation.vic.gov.au).

Drugs that require prescriptions

Note: The following lists are not exhaustive and show only some brand names (in brackets). There are other Schedule 4 and Schedule 8 poisons and there may be lesser-known brand names of the listed drugs.

Schedule 8 poisons (labelled Controlled Drug) have stricter legislative controls than other commonly available drugs, including but not limited to morphine (Kapanol®, MS-Contin®), pethidine, oxycodone (OxyContin®, OxyNorm®, Endone®), two benzodiazepines, alprazolam (from 1 February 2014) and flunitrazepam (Hypnodorm®) plus methadone (Physeptone®). Note: Dentists are not authorised to possess or prescribe methadone (Physeptone®).

Schedule 4 poisons (labelled Prescription Only Medicine) include other drugs for which prescriptions are usually required, e.g. diuretics, local anaesthetics, antibiotics, compound analgesics (e.g. Panadeine Forte®), and benzodiazepines (other than flunitrazepam and alprazolam).

Dentists

Dentists are authorised to obtain, possess, use or supply Schedule 4 or Schedule 8 poisons for the lawful practice of their profession (section 13 of the Act), i.e. for the dental treatment of persons under their care (regulation 10). A dentist’s authorisation does not extend to:

  • activities unrelated to dental treatment (e.g. the use of local anaesthetics for body piercing; administration of Botulinum Toxin where the Dental Board of Australia does not consider its use to be for dental treatment);
  • supplying drugs that have been prescribed by a medical practitioner (e.g. for self, spouse or employees); that is the role of a pharmacist;
  • supplying drugs or poisons by wholesale (including other dentists); this activity requires a wholesale licence.

Prescribing Schedule 4 and Schedule 8 poisons

Dentists must not prescribe or supply Schedule 4 and Schedule 8 poisons other than for the dental treatment of persons under their care and then only after taking all reasonable steps to ensure that a therapeutic need exists.

Note: The Pharmaceutical Benefits Scheme (PBS) is operated by Medicare Australia to subsidise the cost of listed medicines, The Drugs Poisons and Controlled Substances Act and Regulations govern the legality of prescribing and supplying medicines containing scheduled poisons in Victoria. Failure to comply with the legislation renders a person liable to prosecution regardless of whether a prescription is written under the PBS.

Prescriptions for Schedule 4 or Schedule 8 poisons

  • must contain full details of the prescriber (including address and phone number)
  • must contain the patient’s name and address
  • must identify the medication unambiguously
  • must show the quantity to be supplied (in words and figures for a Schedule 8 poison)
  • must not direct that a prescription be supplied more than once, i.e. no repeats (regulation 26(6))
  • must be signed and dated by the prescriber
  • must contain precise directions for use (except where complex directions are provided separately in writing - or if administration is to be carried out by the prescriber or a nurse)
  • must be in the registered dentist’s own handwriting or in a manner of writing approved by the Secretary (e.g. computer-generated prescriptions) - refer to the “Approved by the Secretary” section on the DPR website (http://www.health.vic.gov.au/dpcs/approve.htm#reg26) for criteria for computer-generated prescriptions.

Supplying Schedule 4 or Schedule 8 poisons

Dentists who supply Schedule 4 or Schedule 8 poisons must personally ensure that the correct medication is selected and supplied in the required manner. This responsibility cannot be delegated to another person.

A dentist 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). 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 medication 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.

Note: The roles of prescribing and supplying drugs have traditionally been separated, to allow a pharmacist to check for possible contraindications and to assess the safety and appropriateness of prescribed medications.

Pharmacists have well defined standards, including the use of numerous ancillary labels, to ensure that medications are labelled in a manner that maximises the likelihood that medications will be administered in a safe and effective manner. Dentists who choose to supply Schedule 4 or Schedule 8 poisons are advised to do so in a manner that is of a comparable standard to that required of pharmacists.

Other registered dental practitioners

Registered dental hygienists, dental therapists and oral health therapists are authorised to possess and have access to a limited range of specific Schedule 4 poisons that they require to provide dental care but they are not authorised to supply Schedule 4 poisons. The list of Schedule 4 poisons, approved by the Secretary, is available on the DPR website at www.health.vic.gov.au/dpcs/approve

Records of transactions in Schedule 4 & 8 poisons

Registered dental practitioners must make true and accurate records of all drugs 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 drugs administered or supplied may be sufficient for Schedule 4 poisons but for Schedule 8 poisons a separate record (almost certainly manually created) is also 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 drug register or administration book is usually available from pharmaceutical wholesalers. For limited use of Schedule 8 poisons, a smaller book may be available from the Royal Australian College of General Practitioners.

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 (e.g. money) other than other drugs of dependence.

  • Storage facilities for Schedule 8 poisons 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 (e.g. staff other than dentists).

Schedule 4 poisons (including professional samples) must be stored in a lockable storage facility (e.g. cupboard, drawer, fridge, filing cabinet).

  • Storage facilities for Schedule 4 poisons must be secured to prevent access by persons not specifically authorised under the legislation (i.e. staff other than dentists or other registered dental practitioners) unless the dentist is present. Keys must not be accessible to unauthorised staff members.

Note: In addition to the provisions for other registered dental practitioners, a dentist’s employee may possess medications that have been lawfully dispensed and labelled by the dentist for delivery to, or collection by a patient provided the drugs are in a package or container that clearly identifies the patient to whom they are to be supplied.

Self-administration

Self-administration of a Schedule 4 or Schedule 8 poison is prohibited unless the drug has 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 once a drug is prescribed by a registered health practitioner, a dentist may continue the treatment with drugs obtained from a wholesale supplier.

Over-the-counter medicines

Schedule 2 and 3 poisons (labelled Pharmacy Medicine or Pharmacist Only Medicine respectively) must only be supplied (in an open shop) by pharmacists.

Dentists may use or supply Schedule 2 and Schedule 3 poisons in a similar manner to Schedule 4 poisons, i.e. for the dental treatment of persons under their care. However, Schedule 2 and Schedule 3 poisons must not be supplied for any other purpose or to any other person.

For further information

Department of Health (DH)

Drugs and Poisons Regulation,

GPO Box 4541

Melbourne 3001

Tel: 1300 364 545

Fax: 1300 360 830

Email:

Web: www.health.vic.gov.au/dpcs

Note: Regulations 5,7,10,14,23,25-27,29,34,35,39-41,45,46,48,51,55,60,63 and 70 are regulations that relate to various dental practitioners. Current versions of the Drugs, Poisons and Controlled Substances Act and Regulations may be examined at www.legislation.vic.gov.au

Authorised and published by the Victorian Government, 50 Lonsdale St, Melbourne.
To receive this publication in an accessible format phone Drugs and Poisons Regulation on 1300 364 545 or forward an Email to
February 2014

Page 1Department of Health