Published: March 2011
Revised: 25 October 2013

Publications

Changes to the Medicines Regulations — what you need to know

Prescriber Update 32(1):6
March 2011

Revised: 25 October 2013

The Government has agreed to a suite of amendments to labelling, advertising, dispensing, and prescribing requirements under the Medicines Regulations 1984 and, to standing orders, under the Medicines (Standing Order) Regulations 2002.

The amendments are anticipated to come into effect in 2011.

Information on the changes to prescribing and dispensing requirements is outlined below.

Align prescribing rights

The requirements for dentists to prescribe prescription medicines for dental treatment only and for midwives to prescribe prescription medicines for antenatal, intra-partum or postnatal care only will be removed.

Regulations will stipulate that medical practitioners, dentists and midwives be required to prescribe within their scope of practice as defined by their responsible authorities established under the Health Practitioners Competence Assurance Act, for patients under their care.

Extend period of supply of prescription medicines

The maximum period of supply on a prescription will be extended from six months to 12 months for oral contraceptives, and from three months to six months for other prescription medicines (this amendment was deferred).

The 10 day limit on supply of a prescription medicine by a dentist will be removed; dentists will be able to prescribe the same quantities as medical practitioners and midwives, within their scope of practice.

Requirements for prescriptions

Regulations will be amended to require:

  • prescribers to include their physical street address and phone number, in addition to the current requirements (with an exemption for prescribers who do not have a fixed practice address, as long as alternative contact details are provided)
  • the given name(s) of the person for whose use the prescription is given
  • the prescriber to specify the total quantity of medicine or total period of supply.

Brand substitution

Pharmacists will be allowed to substitute an alternative brand of a prescribed medicine provided:

  • there are no clinical reasons why substitution should not occur
  • the prescriber has not marked the prescription with a statement such as 'no brand substitution permitted'
  • the pharmacist records details of the brand substitution on the prescription and informs the patient of the change of brand.

Dispensing requirements

Prescriptive dispensing requirements will be revoked and replaced with more flexible requirements which allow for electronic technologies and reflect current dispensing practice.

Sale of medicines through vending machines

The Director-General of Health will be able to specify medicines that may be sold by vending machine and place conditions on their supply (eg, pack size, location).

Countersigning standing orders

The issuer of a standing order will be able to specify the appropriate standing order arrangements (including when countersigning of administration and supply of the medicine is, and is not, required). Where countersigning is not required in every case, a documented monthly audit of a sample of the records of administration or supply under the standing order must be undertaken.

Definitions relating to pharmacy qualifications

Definitions will be updated and references to old legislation or superseded qualifications removed.

For further information see Proposed Amendments to Regulations under the Medicines Act 1981 - report of the analysis of submissions and final decisions.

 

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