Issues | Information

Core CMI

Since 1993 pharmaceutical manufacturers have been providing Consumer Medicine Information (CMI) to help consumers better understand the medicines they take.

CMIs are typically made available to consumers by their doctors and pharmacists as part of their consultation and dispending services.

Most CMIs are available as an insert in the medicine package. Others are available on an electronic database, accessible by pharmacists, or as a leaflet given to the consumer by the pharmacist.

Although the CMI is prepared by the manufacturer, it has to be factual, contain no advertising material, and must comply with the requirements set down in the Commonwealth Therapeutic Goods Regulations.

A CMI includes:

  • The name of the medicine;
  • The active ingredients, as well as the inactive ingredients (excipients);
  • The dosage form of the medicine (eg tablet, injection or suppository);
  • What the medicine is used to treat and how it works;
  • Any warnings and precautions, such as when the medicine should not be taken;
  • Any interaction the medicine might have with food or other medicines;
  • How to use the medicine properly;
  • Side effects, if any;
  • What to do in the case of an overdose;
  • How to store the medicine properly;
  • The manufacturers/sponsors name and address; and
  • The date the CMI was last updated.

Including all of this information can make a CMI quite long. But all of it is important information. However, in a well-written CMI, a consumer should be able to follow the headings and subheading to easily find out what they need easily.

To ensure that CMIs are written in a manner easily understood by the consumer a Quality Assurance Reference Group was established.

The Quality Assurance Reference Group includes representatives from consumers, doctors, nurses, pharmacists, manufacturers, CMI writers and an expert in communications.

To assist manufacturers develop their CMIs, the Quality Assurance Reference Group has developed a set of templates for the common medicine groups. These templates called ‘Core CMIs’ can be found in the Consumer Medicines Information section of this website, under Core CMIs.

In addition, companies can reference the Writing About Medicines for People Guidelines that describe how to write CMIs in a way that will be most useful to, and easily read by consumers.

The Quality Assurance Group encourages contact from anyone who has a concern about a particular CMI, for example if they think it is unclear or confusing, or something important has been left out. The Quality Assurance Reference group can be contacted through its Chairman, Ms Deborah Monk, on 02 6282 6888 pr by writing c/- Medicines Australia, 16 Napier Close, Deakin ACT, 2600.

For more information on CMI’s go to http://www.health.gov.au/internet/main/publishing.nsf/Content/nmp-consumers-cmi.htm. This link goes to the government’s health site where it has some valuable information.

To assist manufacturers develop their CMIs, the Quality Assurance Reference Group has developed a set of templates for the common medicine groups. These templates called ‘Core CMIs’ can be found below:

Please contact Elizabeth de Somer on (02) 6122 8525 for more information.

 

 

Page updated: August 2011