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Reporting a problem with a medicine

4-minute read

Every medicine — even a ‘natural’ medicine — could potentially cause a problem in some people. It’s important that you report any problems you have with your medicine to a healthcare professional. It is also helpful if you report the problem directly to the Therapeutic Goods Administration (TGA) yourself.

Potential problems with a medicine

Adverse events

Sometimes a medicine or vaccine can cause an ‘adverse event’. This is an effect of the medicine that is not intended or wanted and could be a sign, symptom or disease.

Adverse events include side effects (also called adverse drug reactions or adverse effects) as well as problems with medical devices used to administer a medicine.

An adverse event may be caused by the way the medicine works. Information about this will usually be outlined in the Consumer Medicines Information (CMI) for each medicine.

However, in some cases, an adverse event may not be caused directly by the medicine. For example, it could be caused by:

  • an allergy you may have to the medicine
  • incorrect use of the medicine
  • the way a medicine's dose is started, then increased

It is also possible for your medicine to interact with another medicine you may be taking. This can affect the way either or both medicines work or how you react to them. A drug interaction with certain foods or drinks can also occur.

Packaging, handling or storage of medicine

Potential problems include any defects that may have occurred during the manufacture or distribution of a medicine. These defects could concern either a batch or a single package of the medicine.

Counterfeit medicines and questionable practices

Problems here include a medicine being sold without approval in Australia or a manufacturer illegally copying another medicine. The way a medicine is advertised and the claims a manufacturer makes about what it does are further issues.

What should I do if I have a problem with a medicine?

  • It's important to seek advice from a health professional such as your doctor or pharmacist.
  • If it's an emergency, call triple zero (000) for an ambulance.
  • If your problem is a suspected overdose or poisoning, call the Poisons Information Centre on 13 11 26 (24 hours a day).
  • You can also report a problem directly to the TGA yourself

Reporting problems with a medicine to a healthcare provider

Tell your doctor or pharmacist about any problem that you’re having with a medicine. If you are experiencing an adverse event, they may be able to help you.

It might be necessary to stop the medicine, change the dose, or switch to another medicine.

Your doctor or pharmacist may report the problem to the TGA (the organisation responsible for regulating medicines in Australia). If they do report the problem, your personal information will remain confidential and your privacy will be respected.

Reporting problems with a medicine to the TGA

The TGA monitors the safety of medicines, including any adverse events that a medicine may cause. The TGA can then ensure that this information is available to healthcare professionals and people taking the medicine. Reports of problems with medicines can come from anyone, including:

  • pharmaceutical companies who make and sell the medicines
  • doctors, pharmacists and other healthcare professionals
  • hospitals and health departments
  • people who take the medicine

By reporting a problem that you have with your medicine, you can play an important role in helping to monitor the safety of the medicine.

The types of medicines and equipment you can report on to the TGA include:

  • medicines prescribed by a doctor, including vaccines
  • medicines bought at a pharmacy or supermarket (‘over-the-counter’ medicines)
  • medicines that are complementary or ‘natural’, including vitamins and minerals
  • medical devices

How do I report a problem to the TGA?

  • If you experience an adverse event with a medicine, vaccine or medical device, call the Medicines Adverse Events line on 1300 134 237 or report it directly on the TGA website.
  • If you experience a problem with a medical device, call 1800 809 361 or report it on the TGA website.
  • If you think your medicine has a defect, call 1800 020 653 or report it on the TGA website.
  • If you think your medicine might not be approved, or there is a questionable manufacturing practice involved, report it on the TGA website.

The Black Triangle Scheme

The TGA has introduced the Black Triangle Scheme to monitor any problems that may occur with a newly-released medicine or a medicine that is being used in a different way. Occasionally, some adverse events do not occur during the product’s clinical trials and may only be noticed and monitored as the medicine is used by more people, once it has been released.

The TGA identifies these new medicines with an upside-down black triangle so that healthcare professionals and people who are taking the medicine will be encouraged to report any problems. If a medicine has a black triangle, you will find it in the medicine’s CMI.

More information

Find out more about reporting a problem with a medicine from:

Last reviewed: July 2018

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