Published: 5 September 2019


Medsafe Files – Episode 11: Communicating medicines information

Prescriber Update 40(3): 49-50
September 2019

Key Messages

  • Medsafe provides information on the benefits and risks of harm of medicines so that you and your patients can make informed decisions about the use of medicines.
  • Visit the Medsafe website to find information on approved medicines.
  • You can subscribe to receive Prescriber Update, safety communications and regulatory updates.

An important part of Medsafe’s role as regulator of therapeutic products is to provide medicines information to healthcare professionals, consumers and the pharmaceutical industry. The Medsafe website plays a crucial part in ensuring that everyone can access this information.

We recently updated the design of the Medsafe website, and we hope you enjoy using it. You can still access the same information as before, including:

  • data sheets and consumer medicine information
  • Medsafe safety communications
  • Prescriber Update.

These resources are described in more detail below, along with how to stay informed.

Data sheets and consumer medicine information (CMI)

Information on the known benefits and risks of medicines is provided in data sheets for healthcare professionals and consumer medicine information (CMI) for patients.

You can search for data sheets and CMI here.

Pharmaceutical companies are responsible for the content of data sheets and CMI, including keeping the information up-to-date. Medsafe provides guidelines for pharmaceutical companies to follow and can request data sheet updates as new information becomes available.

Please contact the pharmaceutical company named as the sponsor in the data sheet or CMI if you have any questions about the information in these documents.

Data sheets

Data sheets are written for healthcare professionals and can help during discussions with patients about whether a medicine is appropriate for them. Data sheets must now follow a set format – the information is in the same order in all data sheets, with clinical information near the beginning.

Prescription medicines and pharmacist-only (restricted) medicines must have a data sheet. Data sheets are optional for pharmacy-only medicines and general sales medicines.

Consumer medicine information (CMI)

CMI is an interpretation of the data sheet, written for patients. It contains advice such as what the medicine is used for, how to take it, what side effects can occur, and what to do if a dose is missed.

CMI is not intended to reduce or replace advice from healthcare professionals.

Although there is no legal requirement for CMIs, Medsafe encourages pharmaceutical companies to provide CMIs for their products.

Medsafe safety communications

Medsafe uses safety communications to communicate important new safety information for medicines and devices.

There are two types of Medsafe safety communications: monitoring and alerts.

Monitoring communications

Monitoring communications provide information on newly identified potential safety concerns that are under review by Medsafe.

Monitoring communications may be used to seek further adverse reaction reports under the Medicines Monitoring scheme. These communications display this symbol:M2 Logo

No actions are generally recommended in monitoring communications, other than to follow the instructions provided with the medicine.

Alert communications

In contrast to monitoring communications, alerts are issued once Medsafe has completed a review of the safety concern.

Alert communications contain more information on the safety concern than monitoring communications and include specific advice on actions that healthcare professionals and consumers may need to take.

For further information on Medsafe safety communications, including communications issued in the last 12 months, visit the Medsafe website.

Prescriber Update

Prescriber Update is written for healthcare professionals to provide information on safety concerns with medicines and medical devices. It is published electronically four times a year.

Stay informed

You can subscribe to receive Prescriber Update and Medsafe safety communications.

You can also subscribe to receive weekly emails for new additions to the Medsafe website. These emails outline new and updated data sheets and CMI, plus other regulatory changes.

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