C H A P T E R 1
Introduction to drugs
9
especially the nervous system, has led many healthcare
providers to recommend that no drug should be used
during pregnancy because of potential effects on the
developing fetus. In cases in which a drug is needed, it is
recommended that the drug of choice be one for which
the benefit outweighs the potential risk.
Drugs and poisons schedules
In 2003, the Australian Health Minister’s Advisory
Council established categories for ranking the abuse
potential of various drugs and management of poisons in
the Uniform Scheduling of Drugs and Poisons. There are
nine schedules under which drugs are classified. Box 1.2
contains descriptions of each category or schedule. Those
of specific relevance to nurses and midwives are sched-
ules 2, 3, 4, 8 and occasionally 9. It is important that all
health professionals involved in dispensing, prescribing
and administering medicines are aware of their responsi-
bilities in regard to each of the relevant schedules.
Each prescriber has a prescriber number, which
allows for monitoring of prescription patterns and
possible abuse. Nurses and midwives should be familiar
with not only the guidelines for controlled substances,
but also the local policies and procedures within their
state, territory or even their workplace, which might be
even more rigorous.
Generic drugs
When a drug receives approval for marketing from the
TGA, the drug formula is given a time-limited patent,
in much the same way as an invention is patented. The
length of time for which the patent is extant depends
on the type of chemical involved. When the patent runs
out on a brand-name drug, the drug can be produced
by other manufacturers.
Generic drugs
are chemicals
that are produced by companies involved solely in the
manufacturing of drugs. Because they do not have the
research, the advertising or, sometimes, the quality
control departments that pharmaceutical companies
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TABLE 1.4 Australian and New Zealand
legislation affecting the clinical use
of drugs
Commonwealth
of Australia
Therapeutic Goods Act 1989
Therapeutic Goods Regulation
National Health Act 1953
Narcotic Drugs Act 1967
Australian
Capital
Territory
Drugs of Dependence Act 1989
Drugs of Dependence Regulations
Poisons and Drugs Act 1978
Poisons Act 1933
Poisons Regulations
New South
Wales
Poisons andTherapeutic Goods Act
1966
Poisons andTherapeutic Goods
Regulation 2002
Northern
Territory
Poisons and Dangerous Drugs Act 2007
Poisons and Dangerous Drugs
Regulations
Queensland
Health Act 1937
Health (Drugs and Poisons) Regulation
1996
South Australia Controlled Substances Act 1984
Controlled Substances (Poisons)
Regulations 1996
Tasmania
Poisons Act 1971
Poisons Regulations
Victoria
Drugs, Poisons and Controlled
Substances Act 1981
Drugs, Poisons and Controlled
Substances Regulations 2006
Western
Australia
Poisons Act 1964
Poisons Regulations
New Zealand Medicines Act 1981
Medicines Act Amended 2005
Medicine Regulations 1984
Misuse of Drugs Act 1975
Misuse of Drugs Regulation
Category Description
A
These drugs have been taken by a large
number of pregnant women without
identified risk to the fetus.
B1
These drugs have been taken by limited
numbers of women without evidence of
increased fetal malformation. Animal
studies have not indicated a higher than
normal incidence of fetal impairment.
B2
These drugs have been taken by limited
numbers of women without evidence of
increased fetal malformation or other
harmful effect. Animal studies are
inadequate. There are no data to suggest
increased risk.
B3
These drugs have been taken by limited
numbers of women without evidence of
increased fetal malformation or other
harmful effect. Animal studies have shown
increased incidence of fetal effects.
C
These drugs have caused or been suspected
to cause fetal or neonatal effects, but
the effects are often reversible and not
congenital malformations.
D
These drugs have caused, or have been
suspected as causing, fetal malformation
or irreversible damage.
X
These drugs are not recommended for use
in pregnancy due to a high risk of causing
permanent damage to the fetus.
Taken from Dempsey et al. p.749
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BOX 1.1
Australian Drug Evaluation Committee
(ADEC) – Classification of drugs in
pregnancy
