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TGA medicine labelling and packaging review

Consultation

21 May 2012

Book pagination

Look-alike and sound-alike medicine brand names and look-alike packaging and branding

What do we mean by look-alike and sound-alike names and look-alike packaging?

Look-alike, sound-alike (LASA) names are medicine brand names that look or sound the same as other medicine brand names when written or spoken. Look-alike medicine packaging refers to medicine containers or primary packaging that looks like that of another medicine. There are also safety concerns with medicines packaging that looks like a toy or a food.

Look-alike medicine branding occurs when two or more products are marketed under the same brand name; this may also be known as brand extension.

What are the consumer health risks associated with LASA medicine names?

Key risks to consumers from LASA brand names result when they are accidentally given the wrong medicine by a pharmacist or health care professional or they select the wrong medicine themselves due to the similarity of the name or packaging of a medicine. The consequences to consumers range from being given a medicine that is ineffective for the condition from which they suffer to potentially fatal adverse reactions to a medicine that they were not prescribed.

The issue generally relates to brand names of medicines, but may also occur with active ingredient names. Examples (taken from the NSW Pharmaceutical Defence Limited error statistics, January 2009 - January 2011) where Australian consumers have been provided with the wrong prescription medicine due to LASA names are provided in the table below.

Intended Medicine Medicine Received

Aldactone 25mg (spironolactone)

To treat oedematous disorders (swelling with fluid), including congestive cardiac failure.

Aldomet 250mg (methyldopa)

Lowers high blood pressure.

Azopt (brinzolamide ophthalmic suspension)

For treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Atropt (atropine sulphate)

Used to dilate pupils.

Celepram (citalopram hydrobromide)

Used to treat depression.

Celebrex (celecoxib)

Used to relieve the symptoms of joint pain, tenderness, swelling and stiffness.

Deralin 10mg 1 bd (propranolol hydrochloride)

Used to treat various heart conditions.

Deptran 10mg 1 bd (doxepin)

Used to treat depression.

Losec (omeprazole magnesium)

Used to treat the symptoms of reflux oesophagitis or reflux disease.

Lasix (furosemide)

Used to treat swelling of the ankles, feet, legs or even the brain or lungs.

LASA brand names also pose a risk to consumers who are on complex medical treatments involving several different medicines or who self-medicate with several different non-prescription medicines. If the names of some of the medicines they are taking look similar to each other, there is a risk they will take or use the wrong medicine.

Look-alike medicine packaging also poses a risk to consumers from being given the wrong medicine.

In the case where the medicine container or primary packaging looks like a toy, as may be the case with some inhalers, or a food, there is a risk that children may be inadvertently exposed to the medicine.

What are the consumer health risks associated with look-alike medicine branding

Look-alike medicine branding results when an existing brand name is extended to include a product that has been produced to include an active ingredient that was not previously included in the brand product range. Consumers who take the medicine based on the brand name without checking the active ingredients may suffer from adverse reactions to the newly formulated medicine. If the consumer is taking another medicine that contains the new active ingredient, they may receive an overdose.

The extension of a well known brand name to new products with different active ingredients or indications is of particular concern, as consumers and health care professionals may have developed expectations about the active ingredients or intended use of the product based on the brand name.

Look-alike medicine branding also refers to the extension of a brand name to products that are designed to treat different conditions, as illustrated in Figure 5. Consumers who take the medicine based on the brand name without checking the active ingredients may take a medicine that does not provide the health benefit that the consumer is aiming to achieve and that may have a different safety profile.

Look-alike medicine branding can also arise when listed medicines are marketed under the same brand name as registered medicines, or vice versa. If a registered product is marketed under the same brand name as a listed medicine, consumers may not realise that the medicine they are taking may have an active ingredient with a different safety profile to the expected listed medicine active ingredient. In these cases there is also a risk of overdose if the consumer takes a product containing the same active ingredient but is marketed under a different name. Conversely, if a listed medicine is branded with the name of a registered product, there may be an expectation of a therapeutic benefit that is not achieved if the consumer does not realise that the two products contain different active ingredients.

Consumer health risks associated with look-alike medicine branding are generally associated with medicines that are selected by consumers, such as over-the-counter and general sale, pharmacy only and complementary medicines. However, issues may also be encountered with pharmacist only medicines and when health care professionals are selecting medications for patients.

Figure 5: An example of look-alike medicine branding.

Proposed regulatory changes - Look-alike sound-alike names and look-alike packaging

3.1 Sponsors of new medicines will be required to submit evidence of risk assessment of the proposed labelling and packaging. The TGA will work with industry to develop guidance for this assessment, which may include consumer testing or risk assessment checklists similar to those used in other countries. The TGA is investigating methods to electronically screen proposed brand names against already existing brand names to identify potential LASA names.

3.2 In relation to applications to include a new medicine in the Australian Register of Therapeutic Goods (ARTG), if the proposed medicine brand name differs from another product included in the ARTG by three letters or fewer, the presentation of the proposed medicine label and packaging must use colours and designs that contrast with the medicine label and packaging of the existing product. During the implementation of this change, the TGA will work with the medicines industry to develop guidelines to provide clarity about these proposed requirements.

3.3 In relation to applications to change the labelling and packaging of existing medicines, if the brand name of the medicine differs from another medicine included in the ARTG by less than three letters, the proposed changes must use colours and designs that contrast with the medicine label and packaging of the other medicine.

General question on the proposed regulatory changes for look-alike sound-alike names and look-alike packaging

Do you think the proposed changes to address LASA names and LA packaging will improve medicine safety? Why/why not?

Proposed regulatory changes - Look-alike medicine branding

To reduce the risk of consumer confusion and medication errors caused by look-alike medicine branding, the TGA proposes the following regulatory options:

3.4 Products that are listed on the ARTG cannot be marketed under the same name as a registered medicine.

3.5 Medicines that contain the same quantity of active ingredient(s) cannot be selectively differentiated or marketed for a subset of symptoms or uses, unless the medicine has specific characteristics that make it more suitable for a particular symptom.

For example: Products cannot be marketed as "BRAND headache", "BRAND backache", "BRAND joint pain" if they include the same active ingredients in the same quantity.

3.6 The same brand name cannot be applied to products that have different active ingredients or combinations of active ingredients unless all of the following conditions are met:

  1. The active ingredients are closely related (e.g. different salts of the same pharmaceutical chemical), and
  2. The safety profile, efficacy and dosage regimen are similar.

Examples of the application of the above requirements include:

A brand name that has historically been strongly associated with a particular anti-histamine would not be permitted to be used for a new product with a different type of active ingredient, such as a corticosteroid or a different anti-histamine.

A well known combination product that contains paracetamol under a particular umbrella brand name would not be able to use this same umbrella brand name for another combination product that also contains ibuprofen.

General questions on the proposed regulatory changes for look-alike medicine branding

What benefits, if any, do you think the proposed changes to address look-alike medicine branding will have for consumer safety?

Do you understand the proposed changes?

If you can read the labels and warnings clearly, will these changes reduce the potential for harm?


Figures

Figure 5: An example of look-alike medicine branding

*Images shown are not actual medicines or brands.

A range of hypothetical over-the-counter products depicting an example of umbrella branding. In this case all products have the same quantity of the same active ingredients. The products are only differentiated by the condition they are marketed to treat. Under recommendation 2.3 this range of products will no longer be allowed. The images also illustrate the warning statement proposed in recommendation 1.7 for products containing ibuprofen.

4 options Four hypothetical over the counter medicine boxes - front of box

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