Prescription medicines overview

 What are prescription medications?

A prescription drug is one that can only be made available to a patient with the written permission of an authorised health practitioner. Prescription medications include blood pressure drugs, cancer treatments, and severe pain relievers.

 

All prescription medications are registered and can be identified by the AUST-R number on the label.

Why is a drug only available via prescription?

A medicine is designated as prescription only for a variety of reasons, including:

the risk that comes with its use
how it will be taken (for example, if it is going to be injected)
the potential for abuse.

How does the Therapeutic Goods Administration approve prescription drugs for use?

To supply a prescription medicine in Australia such as Opana tablets, norco, rohypnol etc, a drug manufacturer must first request for clearance from the TGA and give extensive evidence of the product's quality, safety, and efficacy.

This proof can take many years to collect, and it involves clinical studies to ensure that the treatment works as intended. Clinical trials also reveal potential hazards to the drug. You can learn more about clinical trials by visiting the Australian clinical trials website--external site.

Our technical specialists review all of the evidence provided and may seek additional information if necessary. If the overall benefit of the medicine is determined to outweigh the dangers when taken in acceptable circumstances, and quality is confirmed, the medicine will be approved.

Reviewing all of the medicine's information can take some time. Under our typical approval procedure, we can take up to 11 months to reach a decision. We do, however, provide fast track approval processes for certain prescription medications. These methods are intended to get some prescription drugs for critical and life-threatening diseases to patients sooner.

How can I know if my prescribed medication is safe?

We monitor the safety of prescription drugs after they have been approved. When a prescription medicine is first licenced and registered, clinical trials provide the majority of information concerning its safety and efficacy when administered to patients. Clinical studies include a restricted number of participants, so we may not have a complete picture of the medicine's safety. Some safety risks may be so rare that they must be discovered after thousands of people have used the medicine for an extended period of time. This is why we continue to collect information about the treatment after it has been approved and distributed.

How can I learn more about a prescribed medication?

The Consumer Medicine Information (CMI) provides additional information about a prescription medicine, such as its ingredients and potential side effects.

The CMI is designed for patients and contains information about a medicine's safety and efficacy, such as how it works, how much to take, adverse effects, and interactions with food or other medications.