About Consumer Medicine Information Documents
As Australia's population ages, the use of pharmaceutical products rapidly increases and, with that, the risk of medication errors.
A study conducted in the early 1990s estimated that each year adverse medication events accounted for 80,000 hospitalisation
Among the most common causes of medication errors are:
- poor communication between patient and health care professional (23%)
- patients' lack of understanding of the medicines prescribed (10%)3
A key means of reducing the risk of medication error is ensuring patients are adequately educated and informed through Consumer Medicines Information leaflets (CMIs). CMIs, introduced following a Baume Report (1991) recommendation, are provided at the point of dispensing to all patients receiving prescription medicines.
The CMI is based on the Product Information (PI) but written specifically for consumers. It intends to provide information and instructions which allow patients to use their medicines safely and effectively.
The CMI is prepared according to specific guidelines so that the information is accurate, unbiased and easy to understand.
What a CMI contains
- has a standard format that includes clear headings in a logical sequence
- contains simple instructions and straightforward explanations of what patients need to do to get the best results from their medicine
- is designed to help individuals easily locate the information they need without having to search
The content of the CMI is regulated under the Therapeutic Goods Regulations 1990, subregulation 9A Schedule 12 and 13 and 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 name and address of the manufacturer/sp
- 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-monito
ring study; MJA 1998; 169: 73-76