Home' Australian Pharmacist : Australian Pharmacist November 2016 Contents Australian Pharmacist November 2016 I ©Pharmaceutical Society of Australia Ltd.
Denise L Hope, BPharm, MMedRes, GradCertHigherEd;
Lecturer, School of Pharmacy, Griffith University,
Steven T Dickfos, BSc (Oceanography),
BPharmaceutSci, MPharm; Flight Lieutenant, Royal
Australian Air Force (RAAF), Canberra, Australia.
Michelle A King, BPharm, PhD (Med); Senior Lecturer,
Menzies Health Institute Queensland and School of
Pharmacy, Griffith University, Queensland, Australia.
*Corresponding author: email@example.com
» LEGAL GEMS
Legalities of generic
BY DENISE L HOPE, STEVEN DICKFOS & MICHELLE KING
Generic substitution of medicines saves consumers and the health system
The Therapeutic Goods Administration (TGA) provides overarching
guidance on generic substitution,
linked to the National Health Act 1953,
which only addresses the substitution of pharmaceutical benefits.3
The Acts and Regulations of New
South Wales, the Northern Territory,
South Australia, Tasmania, and Victoria
are silent on the issue of generic
Australian Capital Territory legislation
allows for prescribing, dispensing
and supplying a ‘bioequivalent
form’ of a medicine yet does not
state how bioequivalence is to be
Western Australia allows generic
substitution of any medicine in a
public hospital, regardless of prescriber
intention, and for other places of
practice any brand of the medicine may
be supplied, ‘unless the prescription
shows a contrary intention’.
The most restrictive state is Queensland,
where legislation allows unrestricted
generic substitution for S2, S3, S4 and S8
medicines in public hospitals. Outside
of public hospitals substitution is only
allowed if the medicine is listed on the
PBS, and if consistent with prescriber
6(s83, 195, 275) It is therefore illegal
in Queensland to brand substitute
medicines that are not listed on the PBS,
e.g. oral contraceptives such as Diane-ED.
The maximum fine for such action is
20 penalty units, currently valued at
6(s83, 195, 275)
1. McLachlan AJ, Ramzan I, Milne R. Frequently asked
questions about generic medicines. Aust Prescr. 2007;30(2).
2. Therapeutic Goods Administration. Geenric Prescription
Medicines: Fact Sheet. 2016; https://www.tga.gov.au/
Accessed 10 Oct 2016.
3. Australian Government. National Health Act 1953. 2016;
Accessed 10 Oct 2016.
4. Australian Capital Territory Government. Medicines, Poisons
and Therapeutic Goods Regulation 2008. 2016; http://www.
Accessed 10 Oct 2016.
5. Government of Western Australia. Poisons Regulations 1965.
main_mrtitle_1920_homepage.html. Accessed 10 Oct 2016.
6. Queensland Parliamentary Council. Health (Drugs and
Poisons) Regulation 1996 2016; https://www.legislation.qld.
10 Oct 2016.
Duty of care
In the event that an out of stock situation
or moral belief of a pharmacist leads to
the non-supply of a product or service, the
pharmacist must accept responsibility for
ensuring continuity of care – that is, timely
access to the required medicine or service.
EC may be requested for a future incident
of unprotected intercourse (advance
provision), e.g. where timely access might
not be possible. Advance provision has
not been shown to impact negatively on
sexual and reproductive health behaviours
and outcomes. Pharmacists should be
aware there may be a greater need to
provide written information regarding
appropriate use, proper storage and
awareness of the expiry date on the pack.
EC is safe for all women, regardless of age.
Information regarding age should only
be sought to fulfil the pharmacist’s own
professional obligations to the patient.
Supply to females under 16 years of age
requires consideration of state-based
Consider referral for patients <16 years
of age. The pharmacist’s duty of care
includes appropriate referral to a sexual
health or family planning clinic, children’s
hospital or medical practitioner of the
patient’s choice. Where timely referral is
not possible, the pharmacist needs to
• The patient is mature enough to
understand the advice and implications
• The patient is likely to begin or continue
to have sex with or without treatment
• The pharmacist has tried to persuade
the patient to inform her parents or to
allow the pharmacist to inform them
• The patient’s health would suffer
without treatment or advice
• The patient’s best interests require the
pharmacist to give treatment.
To access the full guidelines visit: http://www.
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