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Medicine shortages reporting

2 January 2019

The TGA publishes information about shortages of prescription medicines and some important over-the-counter medicines. We publish notifications about all medicine shortages that have a critical patient impact. Critical impact shortages are those that are likely to have a serious or life-threatening impact or for which there are no products registered in Australia that could be used as a substitute. We also publish information about lower impact shortages where appropriate.

Medicine shortages are published on the TGA website

You can search the current database of medicine shortages notifications on our website, which includes estimates of how long shortages will last.

You can view just critical impact shortages or switch the view to a consolidated list that contains all medicine shortage notifications (including low and medium impact shortages).

Further information may be provided in the medicine shortage notification, such as details of potential alternative products and links to other information.

Not all medicine shortages are required to be reported to us, including most shortages of over-the-counter products. It is possible that details of a shortage of a product that you use may not be included in our database.

Seek advice from a health professional if there is a medicine shortage

If there is a shortage of a medicine that you need, speak to your doctor or pharmacist. Even if there is a shortage, a medicine may still be available from your pharmacy. In some situations, your doctor or pharmacist may be able to recommend an alternative medicine or treatment.

Medicine shortages can be hard to avoid

The companies who are responsible for suppling medicines in Australia (medicine sponsors) do their best to maintain medicine supply through demand forecasting, stock control and backup supply routes. However, sometimes medicine shortages cannot be prevented. These shortages may arise for many reasons, ranging from shortages of raw materials to natural disasters.

Reporting medicine shortages does not prevent them from occurring, but early awareness can help you and your prescribing doctor or pharmacist manage the impact of the shortage.

Reporting medicine shortages is mandatory

As of 1 January 2019, reporting medicine shortages is mandatory in Australia. Depending on the impact of the shortage, medicine sponsors must tell the TGA about shortages of prescription medicines and some important over-the-counter medicines within 2-10 days.

Mandatory reporting and improved communication about shortages help you to be aware of medicine shortages that affect you sooner, which means you can obtain timely advice and support from your doctor and pharmacist. They can then help minimise the effects of the shortage on your health and wellbeing.

Question and answers

A medicine shortage occurs when the supply of a medicine in Australia is not likely to meet normal or projected consumer demand.

The legal definition is as follows:

There is a shortage of a medicine in Australia at a particular time if, at any time in the 6 months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.

Sponsors (the individuals or companies who are legally responsible for therapeutic goods) maintain continuity of medicine supply through a number of activities, including demand forecasting, stock control and backup supply routes. However, despite their best endeavours, situations sometimes arise where a disruption to the supply of a medicine cannot be avoided.

Medicine disruptions occur for a range of reasons including:

  • manufacturing plants being moved, merged, repaired and or closed
  • changes in clinical practices, which can lead to a change in demand
  • wholesaler and pharmacy inventory practices
  • availability of raw material shortages
  • changes to the contract arrangements that hospitals and pharmacies have with suppliers and wholesalers
  • individual company decisions to discontinue specific medicines
  • natural disasters
  • manufacturing and/or transportation challenges—locally or from overseas
  • unexpected quality issues that lead to a product recall.

Not all supply disruptions result in a medicine shortage, and in some cases, a supply disruption has no impact on Australian consumers. However, where the volume of available product (or appropriate substitute medicine/therapeutic alternative) is inadequate, the shortage can have an impact on consumers.

Shortages of the following medicines must be reported to the TGA:

  • prescription medicines
  • other medicines determined in a legislative instrument by the Minister, provided the Minister is satisfied that they are critical to the health of Australian patients or that the reporting of any shortage or permanent discontinuation of them would be in the interests of public health (for example, ventolin inhalers or adrenaline auto-injectors).

If you suspect that a medicine you or a member of your family takes is in shortage, you should check the TGA's medicine shortages database. Please note that while all shortages of critical patient impact are published, some low or medium impact shortages may not be published, including shortages of most over-the-counter medicines.

The information provided in the database relates to the supply of reportable medicines to the Australian market as a whole. Even if a medicine is not available at your pharmacy, it may not be in shortage generally, and even if a medicine is in shortage, it may still be available at your pharmacy.

If you have any questions or concerns about the supply of your medicine, you should ask your pharmacist or doctor.

You should always contact your doctor or pharmacist if you have any concerns about your medicines. Your health professionals are experienced in determining suitable options for you when a medicine is in short supply or unavailable. The TGA is not able to provide clinical advice to patients.

Your health professionals may be able to:

  • supply you with a different brand or product that contains the same active ingredient (which may not be the same dose form or strength)
  • prescribe a similar medicine to treat your condition
  • recommend a new treatment option, which suits your individual circumstances.

If there is a change in your medicine, you can get information to help you use your medicine safely from your doctor, your pharmacist and on the NPS website.

You should ask your doctor or pharmacist to seek further information. The TGA is not able to provide clinical advice to patients.

If you are still worried and have not been able to get the necessary information about the management of the shortage, you can contact the Medicine Shortages Section at the TGA. The Medicine Shortages team can be contacted via email at medicine.shortages@health.gov.au.

Further information