Adverse Reactions Policy 

 

At Shonelle Siegmann Naturopathy (with Wellness Pty Ltd), your health and safety are our top priorities. We exclusively partner with Australian manufacturers of complementary medicines who follow pharmaceutical Good Manufacturing Practice (GMP) standards. GMP is a rigorous system used in pharmaceutical production to ensure products are consistently made to the highest quality standards, thereby reducing risks associated with the manufacturing of both pharmaceutical and complementary medicines.

WHAT IS AN ADVERSE REACTION?

An adverse reaction refers to any unintended or harmful effects that may occur from using a therapeutic product, which includes medicines, vaccines, or medical devices. Adverse reactions can encompass side effects from medications and vaccines as well as complications or issues related to medical devices.

All therapeutic products—whether prescription medications, over-the-counter products, or complementary medicines—can potentially cause side effects or other adverse events. This includes:

  • Prescription medications

  • Over-the-counter medicines

  • Complementary medicines such as:

    • Herbal remedies

    • Naturopathic or homeopathic treatments

    • Nutritional supplements (e.g., vitamins and minerals)

Adverse reactions are sometimes known as idiosyncratic reactions. These are unexpected adverse effects that cannot be fully explained by the known mechanisms of the medicine. Such reactions do not occur at standard doses in most patients and are typically unpredictable. They arise from an individual’s unique biochemistry, which may make them more susceptible to certain reactions. Adverse reactions can happen with any substance, including food, supplements, pharmaceuticals, and complementary medicines.

If an adverse reaction occurs, we follow the necessary protocols to ensure the event is reported to the Therapeutic Goods Administration (TGA), Australia's regulatory body for medicines and therapeutic products. The TGA is responsible for ensuring the safety of therapeutic goods in Australia, and it offers a comprehensive system for monitoring and reporting adverse events.

For more information, visit TGA Adverse Event Reporting

When a therapeutic product is first introduced to Australia, its safety and effectiveness are typically based on data from clinical trials. While these trials identify many potential adverse events, they don’t always capture all risks because:

  • Clinical trials may not run long enough to detect delayed adverse events.

  • They may not involve a large enough sample size to identify rare events.

  • They may not include all demographic groups (e.g., older adults, children, pregnant individuals, or people with other medical conditions) who may be more vulnerable to certain reactions.

The TGA’s ongoing monitoring efforts help build a more complete understanding of the potential adverse events associated with products used beyond clinical trial conditions.

Consumer and healthcare professional reports are vital to the TGA’s safety monitoring program.

WHO CAN REPORT AN ADVERSE REACTION?

Anyone can report an adverse reaction.

Each year, the TGA receives a number of adverse event reports, which are published in annual statistics for medicines and medical devices. While most reports come from manufacturers (sponsors) such as pharmaceutical companies and medical device suppliers, health departments, hospitals, health professionals, and consumers also contribute valuable information.

If you suspect an adverse reaction, we recommend discussing your concerns with your healthcare provider.

Due to the unpredictable nature of adverse reactions or idiosyncratic events, Shonelle Siegmann Naturopathy (with Wellness Pty Ltd) does not offer refunds for affected products. If you wish to pursue a refund, please contact the relevant product sponsor (e.g., pharmaceutical manufacturer) directly to follow their specific reporting and refund procedures.

We have a clear TGA reporting process in place for all adverse reactions. If you experience an adverse reaction, please contact us immediately so we can initiate the reporting process with both the TGA and the manufacturer.

For further guidance, refer to the TGA’s AEMS Guidance for Health Professionals

OUR PROCESS FOR REPORTING ADVERSE REACTIONS

To report an adverse reaction, please reach out to us via email at hello@shonellesiegmann.com. We will support you throughout the TGA reporting process and provide you with the necessary guidelines.

Last update: 15/01/2025