McKenna's Pharmacology, 2e

9

C H A P T E R 1  Introduction to drugs

■■ TABLE 1.4 Australian and New Zealand

■■ BOX 1.1  Australian Drug Evaluation Committee (ADEC) – Classification of drugs in pregnancy

legislation affecting the clinical use of drugs

Commonwealth of Australia

Therapeutic Goods Act 1989 Therapeutic Goods Regulation

Category Description A

National Health Act 1953 Narcotic Drugs Act 1967

These drugs have been taken by a large number of pregnant women without identified risk to the fetus. 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. 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. 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. These drugs have caused or been suspected to cause fetal or neonatal effects, but the effects are often reversible and not congenital malformations. These drugs have caused, or have been suspected as causing, fetal malformation or irreversible damage. These drugs are not recommended for use in pregnancy due to a high risk of causing permanent damage to the fetus.

Australian Capital Territory

Drugs of Dependence Act 1989 Drugs of Dependence Regulations Poisons and Drugs Act 1978 Poisons Act 1933 Poisons Regulations Poisons andTherapeutic Goods Act 1966 Poisons andTherapeutic Goods Regulation 2002 Poisons and Dangerous Drugs Act 2007 Poisons and Dangerous Drugs Regulations Health Act 1937 Health (Drugs and Poisons) Regulation 1996

B1

New South Wales

B2

Northern Territory

Queensland

B3

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

C

D

Drugs, Poisons and Controlled Substances Regulations 2006

Western Poisons Act 1964 Poisons Regulations New Zealand Medicines Act 1981 Australia

X

Medicines Act Amended 2005 Medicine Regulations 1984 Misuse of Drugs Act 1975 Misuse of Drugs Regulation

Taken from Dempsey et al. p.749

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

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.