Definition of medicines
Medicines are substances that help our bodies – physically or mentally – to prevent, treat or cure diseases.
The term ‘medicine’ is different to what we refer to as:
- drugs, which is a broader term that includes medicines, alcohol, tobacco and illicit substances
- medical devices, which include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, prostheses and stoma appliances.
Benefits of medicines
Medicines help to:
- avoid illness
- get healthy when you’re sick
- keep chronic conditions in check
- improve quality of life
- prolong life.
They can also lower the cost of the wider health system, by helping to prevent serious conditions from developing. This can reduce hospital stays and other demands on health services.
Before most medicines are approved for sale in Australia, the Therapeutic Goods Administration (TGA) confirms they are of acceptable safety, quality and efficacy (that is, they do what they claim).
The TGA classifies medicines according to risk and potential for misuse in schedules, which specify whether the medicine is available:
- only when prescribed by specific health practitioners who might need a permit under strict conditions
- only when prescribed by a health practitioner
- only from a pharmacy after talking to the pharmacist
- only on the shelves of a pharmacy
- freely in shops.
Medicines approved for sale in Australia are included in the Australian Register of Therapeutic Goods (ARTG) as either:
- registered medicines, which include all prescription and over-the-counter medicines and some complementary medicines – these are individually pre-market evaluated for safety, quality and efficacy
- listed medicines, which include most complementary medicines and sunscreens – these are not pre-market evaluated, but the safety and quality of the ingredients used in these medicines are pre-market evaluated (and included in a list of listed medicines permissible ingredients). These medicines are also subject to post-market regulatory compliance reviews, which include evaluating their efficacy.
Unapproved medicines, such as some medicinal cannabis products, are not included in the ARTG, but may be accessible in other ways.
Read more about how the TGA classifies medicines.
You can search every medicine by brand or active ingredients to find out what it does, how to take it, what side effects it might have and other information.
The use of some medicines requires oversight from a health practitioner, so you need a prescription to get them. This might be because:
- your health practitioner needs to assess your condition to determine the most appropriate medicine
- the medicine is for a serious condition
- the way you take the medicine is not straightforward (for example, as an injection)
- the medicine can be addictive or misused.
Your health practitioner will give you a prescription. A pharmacist will dispense the medicine to you, after making sure it is appropriate and discussing potential risks or interactions with other medicines you take.
Pharmacists legally can’t dispense prescription medicines without checking that your prescription is valid.
Read more about how prescriptions work.
Over-the-counter medicines don’t need a prescription. How you can access those depends on their level of risk:
- Some can only be supplied by a pharmacist. These are usually ones that have some risk of side effects or might affect other medicines you take.
- Some can only be accessed at a pharmacy, but you don’t need to speak to a pharmacist.
- Low-risk medicines that treat mild conditions, including complementary medicines, are available off the shelf at pharmacies, supermarkets and health food shops.
Some medicines have a generic equivalent, which comes on the market after the patent for the brand medicine expires.
Generic medicines contain the same active ingredients as the brand medicines, but sometimes use different inactive ingredients. They are subject to the same strict standards of quality and safety as the original brand, and must be shown to be equally effective.
Vaccines protect you from a specific infectious disease and its immediate or long-term complications.
The National Immunisation Program provides free vaccines against various diseases, to increase national immunisation rates and reduce vaccine preventable disease.
Biological medicines contain substances made with genetically modified living cells or organisms. The genes are changed in the cell to produce the active ingredients for the medicine. They work like the natural proteins in the body, resolving symptoms and preventing or slowing the progression of the disease.
Biological medicines are often administered by an injection at home or an infusion in a hospital or clinic.
Some of the conditions they treat include:
- inflammatory arthritis
- inflammatory bowel diseases
- severe psoriasis
- multiple sclerosis
- kidney disease.
- hormones for hormone deficiencies (such as insulin and growth hormones)
- monoclonal antibodies to treat autoimmune diseases and cancers
- blood products (for example, to treat haemophilia)
- medicines that regulate the immune system (for example, to treat multiple sclerosis)
- enzymes (for example, to remove blood clots).
Some pharmaceutical companies make medicines that are very similar to the original, or ‘reference’, brand of a biological medicine. These are known as biosimilar brands of medicine.
See a list of all the biological medicines that the PBS subsidises.
Biosimilar medicines are highly similar versions of the original, or ‘reference’, brand of a biological medicine. They are subject to the same regulatory standards and are equally safe and effective at treating the same diseases as the original biological medicine.
No two batches of a biological medicine are ever the same, even from the same manufacturer, due to natural variability in the manufacturing process. This variation is very small and does not result in clinically meaningful differences.
Biosimilar brands of medicine come onto the market after the patent for the equivalent reference brand of a biological medicine has expired. They provide more brand options for the same clinical results, and introduce competition into the medicines market. They have been in use internationally for more than 15 years.
If you are already taking a reference brand of a biological medicine, you can change to a biosimilar brand of equivalent form and strength (or vice versa). This is considered as providing the same ongoing treatment.
A biosimilar medicine is not the same as a generic medicine, which uses the same active ingredients as the original medicine. Due to the complex process of making biological medicines, it is impossible to create an exact copy of the original.
No 2 batches of a biological medicine are ever the same, even from the same manufacturer, due to natural variability in the manufacturing process. This variation is very small and does not result in clinically meaningful differences.