Taking medicines and undergoing medical procedures, such as blood tests, can put people's lives at risk if the products used to diagnose and treat their conditions haven't passed the approval of the TGA.
So, what exactly is the role of the TGA in the life of a health practitioner? The Therapeutic Goods Administration is the arm of the Department of Health which regulates therapeutic goods that are supplied and distributed in Australia to ensure that these meet the safety standards set by the Australian government.
Every health practitioner, whether they practise complementary therapies or conventional medicine, is expected to prescribe only therapeutic products that have passed the rigorous inspection, review and testing methods of the TGA. If a patient wants to use an unapproved drug, it is the practitioner's responsibility to inform them straight out of its potential health risks.
What are Therapeutic Goods?
Anything that is used to diagnose or treat an ailment, medical condition or injury is classified as therapeutic goods. Products that are used to modify physiological processes, conduct medical testing procedures and support, or control, pregnancy can be found in this category, such as the following:
- Prescription medicines
- Vaccines
- Biological drugs
- Blood and tissue products
- Over-the-counter medicines
- Complementary medicines
- Medical devices including those used for in vitro diagnostic tests
How Does the TGA Regulate Therapeutic Goods?
The TGA follows a rigorous system to ensure manufacturers comply with the standards that have been set for the production of goods. Their job involves reviewing the manufacturing process each product goes through, testing biological medicines and medical devices, as well as evaluating advertising materials.
These steps help them weigh the benefits, risks and possible adverse effects associated with the use of each product before giving the green light to distribute it. Once the products are out in the market, they shift to the task of monitoring and acting immediately on any evident anomalies or illegal activities, like the production of counterfeit drugs.
Getting Approved Therapeutic Goods Out in the Market
All therapeutic goods that have passed the safety and quality standards of the TGA should be entered into the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. Health practitioners can refer to the ARTG database for the complete information about the products they are prescribing.
Vitamins, herbal supplements and other therapeutic products that have low-risk ingredients bear an AUST L number on the label. On the other hand, prescription medicines and painkillers are marked higher risk medicines and have an AUST R number on the label.
Exemption of Some Complementary Medicines
While they meticulously inspect every medication that wishes to make its way into the homes of consumers, the TGA has set some exemptions which are applicable to complementary medicines. Products that are merely used as starting materials for manufacturing therapeutic goods aren't required to meet the standards of the TGA before inclusion in the ARTG. Some examples of these include:
- Herbs or essential oils extracted from plants
- Homeopathic medicines
- Certain anti-dandruff shampoos
- Medicine prepared for a particular person after consulting with that person
All health practitioners want nothing less than the best treatment for their patients, and to see them up and about again. Knowing which therapeutic goods to use is key to achieving that goal. And what better way to ensure the efficacy of a medicine, and the absence of any potential side effects, than by relying on the grading system of the TGA.
Originally published on Aug 31, 2020
