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TGA medicine labelling and packaging review
Dispensing label space
The dispensing label is the label that the pharmacist attaches to a prescription medicine. The information contained on dispensing labels or how it is presented is not regulated by the TGA. Some of these requirements are specified in the Poisons Standard and made mandatory by State and Territory legislation.
The standard size of the label used in Australia is 80 x 40 mm. Generally, information provided on the dispensing label includes the name of the patient and prescribing health care practitioner, medicine brand name, active ingredient and strength (amount of active ingredient in each dose), instructions from the doctor, the pharmacist's details and other information relating to the prescription.
What are the consumer health risks associated with not providing sufficient space on medicine packaging for dispensing labels?
Some prescription medicines are provided to consumers in the primary packaging produced by the manufacturer. When a dispensing label is attached to this packaging, it is possible that important information is covered by the dispensing label, such as dosage instructions, instructions for appropriate storage or additional warnings. Without access to this information, there is a risk that the consumer may not use the medicine appropriately, which may result in an adverse event or the desired health benefit not being achieved. This risk is potentially increased when labels are applied to small containers, such as eye drops where all the information may be covered.
5.1 A designated space of 70 x 30 mm, consistent with international best practice11, must be provided to accommodate the dispensing label.
5.2 Where a clear space is not practical due to constraints from packaging size and shape, the information should be arranged so that information that is likely to be obscured is the same as the information repeated on the label. The area for placement of the sticker should be illustrated by corner placement marks on the packaging.
5.3 For small containers, for example eye drops and ointments, where a designated space of 70 x 30 mm is impractical, a clear space should be provided to affix the edges of a folded dispensing label.
General question on the proposed regulatory changes for dispensing label space
Do you support a designated space for the dispensing label on prescription medicines? Why/why not?
- Design for patient safety: A guide to the graphic design of medication packaging, 2nd Edition; National Patient Safety Agency, 2007.
*Images shown are not actual medicines or brands.
A hypothetical prescription medicine box illustrating the dispending label space.