About Medsafe

COVID-19 Archive

Medicine Safety Monitoring Process

How will Medsafe monitor COVID-19 medicine safety?
Pharmacovigilance
Adverse drug reactions (ADRs) – side effects
Reporting adverse drug reactions
ADR eLearning module for healthcare professionals
More information

How will Medsafe monitor COVID-19 medicine safety?

Medsafe has not yet finalised all of the methods that we will use to monitor the safety of medicines approved to treat COVID-19 infection. However, we will base them on our usual safety monitoring methods as summarised below.

Pharmacovigilance

Medsafe uses a variety of methods to collect information on the safety of medicines after they have been approved for use. These methods, together with investigation of the information gathered and taking action when appropriate, are known as pharmacovigilance.

Pharmacovigilance involves:

monitoring the use of medicines in everyday practice to identify previously unrecognised adverse drug reactions (side effects) or changes in the patterns of adverse drug reactions
seeking other information on the safety of medicines
investigating whether the information gathered suggests there is a new or changed adverse drug reaction
assessing the risk of harm and benefits of medicines, and taking action when required to improve their safe use
providing information to healthcare professionals and consumers to promote the safe use of medicines
monitoring the impact of any action taken and assessing whether further action is required.

We use information from many sources for pharmacovigilance, including:

clinical and epidemiological studies
case reports
published medical literature
pharmaceutical companies
other regulatory authorities such as the Food and Drug Administration (USA), European Medicines Agency (Europe) and Therapeutic Goods Administration (Australia).

In addition, suspected adverse drug reactions (ADRs) to vaccines are reported to the Centre for Adverse Reactions Monitoring (CARM). The Ministry of Health (through Medsafe) contracts the collection of this information to CARM, based at the University of Otago in Dunedin. If CARM detects a possible safety problem with any vaccine, they will inform Medsafe and the Medicines Adverse Reactions Committee.

Adverse drug reactions (ADRs) – side effects

An adverse drug reaction (ADR) is an unexpected or unintended effect suspected to be caused by a medicine or vaccine. ADRs are more commonly known as side effects.

All medicines can cause ADRs in some people. Adverse drug reactions can range from headaches and upset stomach to more serious reactions such as liver or kidney injury. Some ADRs can be predicted, but some others occur unexpectedly once many people take the medicine (eg, severe allergy). Most people take medicines without suffering any serious adverse reactions.

The best way to know what the possible ADRs might be for your medicine is to read the medicine data sheet and/or consumer medicine information. We will publish this information on our website for any medicine that is approved in New Zealand to treat COVID-19.

Discuss possible ADRs, and what to do about them, with your healthcare professional.

Reporting adverse drug reactions

Anyone living in New Zealand who thinks they may have experienced an ADR can report this to the Centre for Adverse Reactions Monitoring (CARM). You do not need to be a healthcare professional to report an ADR.

Reporting is easiest online