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TGA medicine labelling and packaging review

Consultation

24 May 2012

Book pagination

Blister strip labelling

What is a blister strip?

A blister strip, or blister pack, is a sheet of plastic with pockets that contain the tablets or capsules. The blister strip is sealed with a thin sheet of aluminium foil. Blister strips are usually packed in an outer carton (primary packaging), which has more detailed labelling. For the purpose of this consultation, dose administration aids, such as Webster or calendar packs, that may be prepared for individual consumers by their health care professional are not considered blister strips.

For medicines packed in blister strips, each pocket usually contains a single tablet or capsule. Information about the medicine is usually printed on the foil backing.

What are the consumer health risks associated with insufficient information provided on the blister strip?

Often blister strips are stored away from their outer wrapping or packaging that contains the information about how to use the medicine safely. For example, it is not uncommon for people to carry a blister strip in their handbag, purse or travel bags without the primary container.

The blister strip does not always include all of the information that is provided on medicines labels to support the quality use of the medicine. Without this information there is a risk that the medicine may not be taken in accordance with the dosage instruction, or it may be taken with another medicine that contains the same active ingredient. Where a person is carrying more than one medicine in blister strips, there is the added risk of taking the wrong medicine. Issues may also arise in hospitals when a section of the blister strip is dispensed and the carer responsible for administering the medicine cannot tell what the medicine is, the strength or the expiry date.

These consumer health risks are compounded where blister strips that can be segmented do not repeat the information that they contain on each segment.

Figure 10: Illustration of how information should be presented on a blister strip under recommendation 6.1.

Proposed regulatory changes

For blister strips, other than those that have a "race track" blister strip format to facilitate the quality use of the medicine (such as oral contraceptives), the following requirements are proposed:

6.1 The brand name of the medicine, the active ingredient and amount of active ingredient, batch number and expiry date must be repeated at least once every two units.

6.2 Where strips can be segmented, the brand name, the active ingredient and amount of active ingredient, batch number and expiry date is to appear on each segment.

6.3 A maximum of 3 active ingredients should be listed on each segment / each 2 units of a blister strip for registered medicines.

6.4 Where there are more than 3 ingredients, for example multi-vitamins packaged this way, it may be sufficient to include a single list of active ingredients printed on the foil of each blister strip. Alternatively, the brand name, together with batch number and expiry date, should be repeated on the foil.

For oral contraceptives and other medicines that have a "race track" format to support their safe use, the TGA proposes the following requirement:

6.5 Blister strips that have a "race track format" must include the trade name, the active ingredient(s) and their amount(s), batch number and expiry date in a single location.

General question on the proposed regulatory changes for blister strip labelling

Do you think the proposed information for blister strips is sufficient?

What other changes would you like to see for this type of packaging?


Figures

Figure 10: Illustration of how information should be presented on a blister strip under recommendation 6.1

*Images shown are not actual medicines or brands.

Hypothetical blister strip - brand name, active ingredient, amount, expiry date, batch number repeated every 2 units; segmented strips have all the critical information

Book pagination