Drug Scheduling: Understanding the Basics

All medicines in Australia are categorised by how they are made accessible to the public. ‘Scheduling’ is the name given to this system. It is intended to protect the health and safety of the public.

As you would expect, medicines with a lower safety risk are generally less rigidly controlled than medicines that have a higher safety risk.

Some medicines have an inherently higher chance of causing harm than others, while other medicines are more likely to be misused because they have high rates of dependency or addiction (Healthdirect 2018).

Scheduled medicines are classified in descending order of legislative controls.

Each category has its own rules for how the medicine or poison should be labelled, sold, bought, stored and disposed of. These categories also inform whether a prescription is needed to buy that particular medicine (Healthdirect 2018).

Scheduled Medicines in Order

There are ten category ‘schedules’, arranged from least to most tightly controlled.

Schedule 1

Not currently in use.

Schedule 2

Pharmacy medicine: medicines that are available in pharmacies on the shelf.

Schedule 3

Pharmacist only medicine: medicines that are available from a pharmacist but do not require a prescription. These medicines are often behind the pharmacy counter.

Schedule 4

Prescription-only medicine: medicines which have to be prescribed by an authorised healthcare professional. They may be supplied in hospitals or purchased from a pharmacy with a prescription.

Schedule 5

Caution: chemicals that are unlikely to cause harm. They require appropriate packaging with simple, clear warnings and safety directions on the label.

Schedule 6

Poison: chemicals with a moderate risk of harm. They require appropriate packaging with a strong warning and safety directions on the label.

Schedule 7

Dangerous poison: chemicals that have a high risk of causing harm in low doses. They are only available to people who are capable of handling them safely. There are particular rules for selling, using or storing these chemicals.

Schedule 8

Controlled drug: medicines or chemicals which have special rules for producing, supplying, distributing, owning and using them. These may only be prescribed by an authorised healthcare professional, who may need a special prescribing permit.

Schedule 9

Prohibited substances: chemicals which may be abused or misused. They are illegal to produce, own, sell or use except if needed for medical or scientific research.

Schedule 10

Chemicals that are so dangerous they are banned.

(Healthdirect 2018, Health Vic n.d.)

Note that not all medicines are scheduled; these are categorised as 'not scheduled'. It is not considered necessary to limit access to these medicines. This does not mean that these medicines are considered harmless (Healthdirect 2018).

Is this System Australia-Wide or State and Territory Based?

Although the Schedule system is nationally based, the laws relating to the storage and supply of medicines are managed by the States and Territories.

While they are mostly very similar, there are some differences depending on the medicine Schedule.

(The Pharmacy Guild of Australia 2016)

The Poisons Standard

The Poisons Standard outlines the reasoning behind the classification of medicines and poisons into Schedules and how it relates to relevant legislation of the States and Territories.

The Poisons Standard also includes model provisions in terms of containers and labels, a list of products to be exempt from these provisions, and recommendations in terms of other controls on drugs and poisons.

It is intended to promote uniform scheduling of substances and uniform labelling and packaging requirements in Australia.

(TPA 2020)

Additional Resources

More information about scheduling can be found from the Therapeutic Goods Administration (TGA). The TGA is part of the Department of Health, responsible for regulating health products, https://www.tga.gov.au/

References

• Healthdirect 2018, Scheduling of Medicines and Poisons, Healthdirect, viewed 6 February 2020, https://www.healthdirect.gov.au/scheduling-of-medicines-and-poisons
• Health Vic n.d., Scheduling Medicines, Health Vic, viewed 6 February 2020, https://www2.health.vic.gov.au/public-health/drugs-and-poisons/scheduled-medicines
• Therapeutic Goods Administration n.d., Scheduling Basics, Therapeutic Goods Administration, viewed 6 February 2020, https://www.tga.gov.au/scheduling-basics
• The Pharmacy Guild of Australia 2016, Frequently Asked Questions about Medicine Scheduling, The Pharmacy of Guild of Australia, viewed 6 February 2020, https://www.guild.org.au/__data/assets/pdf_file/0024/5973/frequently-asked-questions-about-medicine-scheduling.pdf

(Answers: a, c, b)