Published: 1 March 2018

The Medsafe Files — Episode Five: Pharmacovigilance

Prescriber Update 39(1): 6-7
March 2018

Key Messages

  • Pharmacovigilance aims to identify emerging safety issues related to the real world use of medicines and vaccines as early as possible.
  • By submitting reports of suspected adverse reactions, you are contributing to medicines safety in New Zealand.
  • Stay informed about medicines safety issues by continuing to read Prescriber Update and keeping an eye on the Medsafe website.

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. The main aim of pharmacovigilance is to identify emerging safety signals related to the use of medicines or vaccines or new information on known side effects.

What is pharmacovigilance?

Before a medicine is marketed, experience of its safety and efficacy is limited to its use in clinical trials. However, clinical trials do not always reflect the way a medicine or vaccine is used in real life. In addition, some populations such as pregnant women are not usually studied in clinical trials.

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

What does pharmacovigilance involve?

Pharmacovigilance involves:

Where does this information come from?

Information from many sources are used for pharmacovigilance including:

What are spontaneous suspected adverse reaction reports?

These are unsolicited case reports of suspected adverse reactions or adverse events that people have experienced while taking a medicine. Reports are collected by CARM in Dunedin.

Anyone can submit a report to CARM including healthcare professionals, consumers and pharmaceutical companies.

The advantages of these reports include that they are a very quick and effective way of finding potential safety signals with medicines and they can be used to monitor medicines safety in real life use over the lifetime of the medicine.

Limitations of spontaneous suspected adverse reaction reports include:

Due to these limitations, spontaneous reports are generally only used to detect safety signals and are not used to investigate or confirm them. Information obtained from spontaneous reports needs to be interpreted with caution.

What is a safety signal?

A safety signal is an indication that there may be a safety problem related to a medicine. A signal 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 reaction reports together with other information to determine if the safety signal is real. Medsafe seeks the advice of independent experts through the Medicines Adverse Reactions Committee (MARC) or may also form working groups of experts to provide advice.

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

The majority of safety signals that Medsafe investigates are not supported when all of the available information is closely examined. In this case, no action is considered necessary, although Medsafe may continue to closely monitor the issue.

A small number of safety signals are confirmed on close examination of the available information, and Medsafe takes appropriate action to improve the safe use of these medicines.

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

How does Medsafe communicate with healthcare professionals and consumers?

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

Medsafe provides information by:

You can subscribe to receive an electronic copy of Prescriber Update and alert communications on the Medsafe website (

Neither Medsafe nor CARM can say in individual cases that a medicine was the actual cause of a suspected adverse reaction. Any consumer who has concerns regarding medicines they are taking should discuss these with their healthcare professional.