Safety Information

How Does Medsafe Monitor Medicine Safety?

What is pharmacovigilance?
What are spontaneous suspected adverse reaction reports?
What is an adverse event?
What is an adverse reaction?
What are the advantages and limitations of spontaneous suspected adverse reaction reports?
What is a safety signal?
What does Medsafe do with this information?
What action can Medsafe take if a safety concern is confirmed?
How does Medsafe communication with healthcare professionals and patients?
Further information

Medsafe uses a variety of methods to collect information on the safety and quality of medicines and vaccines after they have been approved. These activities are known as pharmacovigilance.

What is pharmacovigilance?

Before a medicine or vaccine is marketed any experience of its safety and efficacy is limited to its use in clinical trials. However, clinical trials do not always reflect the actual use of a medicine or vaccine in real life. For example, a medicine or vaccine may only have been tested in a relatively small number of people for a limited length of time.

Although Medsafe may receive extensive information from clinical trials for a specific medicine or vaccine, some adverse reactions are rare and may not be seen until a very large number of people have taken the medicine or vaccine. For this reason, it is very important to monitor all medicines and vaccines after they have been approved.

Pharmacovigilance involves:

monitoring the use of medicines and vaccines in everyday practice to identify previously unrecognised adverse effects or changes in the patterns of adverse effects
assessing the risk of harm and benefits of medicines and vaccines to determine if action is required to improve their safe use
providing information to healthcare professionals and consumers to promote the safe use of medicines and vaccines
monitoring the impact of any action taken and assessing whether further action is required.

Information from many sources is used for pharmacovigilance, including:

clinical and observational studies
published medical literature
pharmaceutical companies
other regulatory authorities such as the FDA (USA), EMA (Europe) and TGA (Australia)
spontaneous suspected adverse reaction reports submitted to the Centre for Adverse Reactions Monitoring (CARM).

The main aim of pharmacovigilance is to identity safety signals of a possible problem.

What are spontaneous suspected adverse reaction reports?

Spontaneous suspected adverse reaction reports are case reports of suspected adverse reactions or adverse events that people have experienced while taking a medicine or vaccine. The Ministry of Health (through Medsafe) contracts the collection of this information to the New Zealand Pharmacovigilance Centre at the University of Otago in Dunedin.

Healthcare professionals and consumers are encouraged to report any suspected adverse reaction to a medicine or vaccine to the Centre for Adverse Reactions Monitoring (CARM, part of the New Zealand Pharmacovigilance Centre). Pharmaceutical companies also submit adverse reaction reports associated with the use of their products to CARM in Dunedin.

How do I report a problem to the Centre for Adverse Reactions Monitoring (CARM)?

What is an adverse event?

Adverse events are unwanted and sometime harmful outcomes which happen after taking a medicine or vaccine. An adverse event does not mean that the medicine or vaccine was the cause of the event. Adverse events include adverse reactions (side effects).

What is an adverse reaction?

Adverse reactions are known undesirable effects to medicines or vaccines.

Whilst some reactions may occur when a medicine is used at higher than recommended doses, adverse reactions may also occur when normal doses are used.

Reactions may be evident within minutes or years after exposure to the medicine or vaccine and may range from minor reactions like a skin rash to serious and life-threatening events such as a heart attack or liver damage.

More information on adverse reactions can be found in the consumer medicine information (CMI), on the package labelling, in the medicine or vaccine data sheet, or by asking your healthcare professional.

Find consumer medicine information (CMI) or a medicine data sheet.

Further information on adverse reactions to medicines.

What are the advantages and limitations of spontaneous suspected adverse reaction reports?

Spontaneous suspected adverse reaction reports have been shown to be a very quick and effective way of finding potential or possible safety signals with medicines and vaccines. They can be used to monitor the safety of medicines and vaccines in real life, over the life-time of the medicine or vaccine, and for all types of people.

The limitations of using spontaneous suspected adverse reaction reports include:

under-reporting (ie, some cases may not be reported)
a lack of reliable information on the number of people taking the medicine
incomplete information on diagnosis and history of the patient.

Spontaneous reports are also not very effective at detecting adverse reactions that occur a long time after starting the medicine. For this reason, spontaneous suspected adverse reaction reports are only used to detect safety signals and are not used to investigate or confirm them.

Information obtained from spontaneous reports need to be interpreted with caution.

Can I search for suspected medicine adverse reactions reported in New Zealand?

What is a safety signal?

A safety signal is an indication that there may be a safety problem related to a medicine or vaccine. This could be a previously unknown adverse reaction or a change in the frequency or severity of a known side effect.

What does Medsafe do with this information?

Medsafe analyses adverse reactions reports in conjunction with other information to determine if the safety signal is real. Medsafe seeks the advice of independent experts, via the Medicines Adverse Reactions Committee (MARC) or may also form working groups of experts to provide advice. Medsafe also works closely with other regulatory authorities from around the world.

Medsafe undertakes a risk-benefit assessment on safety signals to assess if action is required.

The majority of safety signals are not supported by any additional information and no action is taken although Medsafe may continue to closely monitor the issue.

A small number of possible safety signals are confirmed to be real. In these cases, Medsafe takes appropriate action to ensure the safe use of these medicines is improved.

What action can Medsafe take if a safety concern is confirmed?

Provide information directly to healthcare professionals and consumers on medicine safety related issues.
Require changes to warnings in the product information or on the product label.
Restrict the conditions that the medicine or vaccine can be used for.
Recommend that the legal status of a medicine or vaccine is changed. For example, change from over-the-counter to prescription-only.
Ask the pharmaceutical company to commission a clinical study to investigate a particular safety concern.
In rare circumstances, Medsafe can recommend removal of the medicine from the market.

How does Medsafe communication with healthcare professionals and patients?

Communication with healthcare professionals and consumers is one of the best ways to provide information about adverse effects and the safe use of medicines and vaccines.

Medsafe provides information by:

requesting pharmaceutical companies to update medicine data sheets and consumer medicine information (CMI)
sending letters to doctors or pharmacists by post or electronically to highlight urgent warnings about medicines
publishing safety information in Medsafe's safety bulletin Prescriber Update (this bulletin is published four times a year and is designed to inform healthcare professionals of medicine-related safety issues)
publishing safety alerts, media releases and consumer recalls on the Medsafe website
asking the pharmaceutical company to send letters to healthcare professionals (Dear Healthcare Professional letters).

Medsafe can also instruct other organisations to provide information to healthcare professionals or consumers.

Neither Medsafe nor the Centre for Adverse Reactions Monitoring (CARM) can say in individual cases that a medicine or vaccine was the actual cause of a suspected adverse reaction. Any consumer who has concerns regarding medicines they are taking should discuss these with their GP.

Can I search for safety concerns from Medsafe’s Prescriber Update?

What recent safety communications have Medsafe issued?

Are dear healthcare professional letters published on the Medsafe website?