Shortage of Neo-Mercazole (carbimazole)

Related information

1 November 2013

The TGA has been advised that the alternative product will be supplied to pharmacies from 20 November 2013. Please read the update in the related information before deciding if you wish to follow the steps outlined below.

 information

Key facts

  • There is a global shortage of Neo-Mercazole (carbimazole), which is often prescribed to people with an overactive thyroid (hyperthyroidism).
  • If you want to obtain carbimazole before 20 November 2013 a doctor must use the TGA's Special Access Scheme to allow supply.
  • Supplies can be obtained by a pharmacist by contacting Link Healthcare after either approval from the TGA under SAS Category B has been obtained or by providing a completed SAS Category A notification form.
  • From 20 November, Link Healthcare will be supplying to pharmacies a different carbimazole product, Carbimazole ARISTO 5mg. When it becomes available the need to use the SAS process will stop.
  • The TGA will be updating its website when this alternative becomes available. If you want to receive an email please subscribe to TGA Safety Information email list.

Information for consumers

Many Australian pharmacies have run out of Neo-Mercazole (carbimazole).

Carbimazole is used by people with an overactive thyroid. If you regularly take Neo-Mercazole (carbimazole):

  1. Count and make a note of the number of tablets that you have left, so that you can give your doctor this information. (A full container contains 100 tablets.)
  2. Work out the number of days supply you have by dividing the number of tablets you have by the number of tablets you take each day.
  3. Arrange an appointment with your doctor. This appointment needs to be at least two weeks before you run out of tablets.
  4. Print this web statement and show it to your doctor.

Information for health professionals

Carbimazole is currently only available in Australia through the Special Access Scheme (SAS).

There will be no need to use the SAS after mid-November, when Link Healthcare will be supplying an alternative carbimazole product (Carbimazole ARISTO 5 mg).

Carbimazole ARISTO has been authorised by the TGA to be supplied temporarily in lieu of Neo-Mercazole.

This page will be updated when the use of SAS is no longer required.

The SAS has two processes depending on the doctor's assessment of the appropriate category for their patient - Category A and Category B.

SAS Category A - seriously ill patient with short life expectancy

Category A applies for persons who are seriously ill and for whom one of the following is true:

  • death is reasonably likely to occur within a matter of months, or
  • premature death is reasonably likely to occur in the absence of early treatment.

Carbimazole is available from Link Healthcare immediately upon receipt of an SAS Category A form.

For Category A patients:

  1. informed consent is provided by the patient or the patient's legal representative
  2. the SAS Category A form is filled out by a registered medical practitioner, being the treating doctor - this completed form constitutes the legal authority for an Australian sponsor to supply the specified product - a copy of the completed form must be sent to the TGA within 28 days
  3. a pharmacist is given a copy of the completed form and a prescription
  4. the concessional status (see price of carbimazole) of the patient is determined by the pharmacist and concessional status is clearly identified on the SAS form
  5. the named sponsor (Link Healthcare) is sent copies of the form and the prescription by the pharmacist, which allows the product to be supplied to the pharmacist
  6. the patient returns to the pharmacy to purchase the medicine.

The basis for these arrangements is that responsibility for prescribing an unapproved therapeutic good appropriately rests with a Category A patient's medical practitioner and the patient.

SAS Category B - all other patients

For all patients other than Category A patients, pre-approval from the TGA is required before supply is authorised.

Approval is currently taking up to ten working days, because of the large number of SAS applications.

For category B patients:

  1. informed consent is provided by the patient or the patient's legal representative
  2. the SAS Category B form is filled out by a registered medical practitioner, preferably the treating doctor
  3. if you wish the approval letter to be faxed as well as posted, this needs to be clearly stated on the form
  4. the TGA is sent the SAS Category B form
  5. the TGA considers the application (currently taking close to ten working days) and decides whether to grant an approval letter
  6. an approval letter is sent to the medical practitioner (by post, unless fax is specifically requested) by the TGA if approval is granted
  7. a pharmacist is given a copy of the approval letter and a prescription
  8. the concessional status (see price of carbimazole) of the patient is determined by the pharmacist and concessional status is clearly identified on the approval letter
  9. the named sponsor (Link Healthcare) is sent copies of the form and the prescription by the pharmacist, which allows the product to be supplied to the pharmacist
  10. the patient returns to the pharmacy to purchase the medicine.

Price of carbimazole

Link Healthcare has stated that if it is clearly written on the SAS form or approval letter that the patient has concessional status, then they will provide carbimazole at a price such that the usual concessional payment of $5.90 is maintained.

Medicines accessed through the Special Access Scheme are not subsidised through the Pharmaceutical Benefit Scheme (PBS).

The Special Access Scheme: a temporary measure

The use of the Special Access Scheme for the supply of carbimazole is a temporary measure pending availability of the alternative product, Aristo.

Use of carbimazole in animals

If your pet takes carbimazole, contact your vet, who should contact the Australian Pesticides and Veterinary Medicines Authority (APVMA).

Further information

Neo-Mercazole is the only medicine containing carbimazole that is registered in Australia.

Link Healthcare (the sponsor of Neo-Mercazole) apologises for the disruption in supply and has managed to source an overseas generic carbimazole product.

Once Link Healthcare has received the Category A form or the TGA approval letter for Category B, then they have legal authority to supply carbimazole for that patient's use.

An alternative product is expected to become available in Australian pharmacies on 20 November.

More information about the Special Access Scheme is available from the TGA: Access to unapproved therapeutic goods via the Special Access Scheme

Contact details

For questions about getting supplies contact Link Healthcare customer service:

For questions about using the SAS contact the TGA:

  • general enquiries: info@tga.gov.au
  • general enquiries telephone: 1800 020 653
  • email address for SAS forms: eps@tga.gov.au
  • fax: 02 6232 8112
  • tel: 02 6232 8111

For questions from vets about using carbimazole in pets, contact the APVMA:

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