As Australia’s population ages, the use of pharmaceutical products rapidly increases; associated with this is the increased risk of medication errors. A study conducted in the early 1990’s, estimated that adverse medication events accounted for 80,000 hospitalisations per annum and cost the health system ~$350 million a year2. Amongst the most common causes of medication errors are poor communication between the patient and the health care professional (23%) and the patient’s lack of understanding of the medicine they have been prescribed (10%)3.

One of the key means of reducing the risk of medication error is by ensuring that the patient is adequately educated and informed about their medication through the use of Consumer Medicines Information leaflets (CMIs). CMIs were introduced following a recommendation made in the Baume Report, 1991. CMIs are provided at the point of dispensing to all patients receiving prescription medicines.

The CMI is based on the Product Information (PI) but is written specifically for consumers. The CMI is intended to provide information and instructions that will allow the patient to use their medicine safely and effectively. It is prepared according to specific guidelines that ensure the information is accurate, unbiased and easy to understand. CMI are available for most prescription and some non-prescription medicines.

The CMI provides the patient with important medicine information that they should consider before, during and after taking their medicine. The CMI will help them discuss with their doctor or pharmacist any questions or concerns they have about the medicine.

What a CMI contains
The CMI has a standard format that includes clear headings in a logical sequence. It contains simple instructions and straightforward explanations of what you need to do to get the best results from your medicine. The CMI is designed to help individual to locate the information they need easily, without having to search.

The content of the CMI is regulated under the Therapeutic Goods Regulations 1990, subregulation 9A Schedule 12 and 13.

A CMI includes:

• The name of the medicine
• The active ingredients
• 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
• The date the CMI was last updated

2 Second National Report on Patient Safety – Improving Medication Safety; Prepared by the Australian Council for Safety and Quality in Healthcare; July 2002

3 Alice L Bhasale, Graeme C Miller, Sharon E Reid and Helena C Britt; Analysing potential harm in Australian general practice: an incident-monitoring study; MJA 1998; 169: 73-76