What would you do in the event of someone experiencing an adverse reaction to a medication?
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CKS content is produced by Clarity Informatics Ltd (trading as Agilio Software | Primary Care). It is available to users outside the UK via subscription from the Agilio | Prodigy website.  If you believe you are seeing this page in error please contact us. 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 medicineAdverse eventsSometimes 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:
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 medicinePotential 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 practicesProblems 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?
Reporting problems with a medicine to a healthcare providerTell 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. 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 TGAThe 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:
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:
How do I report a problem to the TGA?
The Black Triangle SchemeThe 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 informationFind out more about reporting a problem with a medicine from:
Why are adverse drug reactions so important?As a leading cause of illness and death in the United States, the importance cannot be overstated. Any prescription or over-the-counter drug, as well as nutritional supplements, has the potential to cause adverse reactions. An adverse drug reaction is defined as an unintended effect of a medication that is harmful or unpleasant.
What to do in case of adverse reaction to a drug?What to do in case of adverse reaction. If you or someone you are with is suffering a serious adverse event, seek immediate help from your local poison center or hospital.
Is it normal to have an adverse reaction to medication?However, all medicines have some risks associated with their use and so a small number of people may experience an adverse reaction (also known as a side effect). What is an adverse reaction (side effect)?
What is an adverse drug event?Adverse drugs events are one of the most common preventable adverse events in all settings of care, mostly because of the widespread use of prescription and nonprescription medications.
What should you do if a patient has adverse drug reaction?How should I manage a person with a suspected adverse drug reaction?. Arrange emergency hospital admission if the adverse drug reaction (ADR) is serious or life threatening.. Assess whether the ADR can be managed in primary care.. Consider seeking specialist advice.. What is an adverse reaction to medication and how should it be reported?An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use, which is suspected to be related to the drug. The reaction may be a known side effect of the drug or it may be new and previously unrecognised.
Who can advise you if you are concerned about an adverse reaction to a medication?It is important that you also contact your doctor or pharmacist if you think you may have experienced a side effect after using a medicine. They will tell you if you need any medical care. They will also consider if you need to change your treatment or if you need a different treatment.
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