Medicine Shortages Information: Questions and answers

26 May 2014

The following questions and answers are those that are most frequently asked and answered by the TGA about medicine shortages.

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General

A medicine shortage occurs when the supply of a medicine is not likely to meet the normal or projected consumer demand for the medicine within Australia for a period of time. Most of this shortage information is provided to us voluntarily by the sponsor of the prescription medicine.

The Medicine Shortages Information Initiative aims to improve the communication and management of medicine shortages in Australia. The information provided seeks to assist health professionals and consumers when there is a temporary or permanent disruption (discontinuation) to the supply of a medicine in Australia. The initiative is being led by a partnership between the TGA, Medicines Australia and Generic and Biosimilar Medicines Association.

The initiative includes a website, hosted by the TGA, where you can search for information about the nature, anticipated duration and status of prescription medicine shortages.

Sponsors can advise the TGA when anticipated or current medicine shortages are known and when a sponsor is going to discontinue the supply of a medicine. A risk assessment to determine the impact of the shortage on consumers is then undertaken which includes decisions about the most appropriate responses, including how information about the shortage will be shared. Please take the time to review the Protocol to learn more.
You can subscribe to receive email alerts or RSS notifications about new or updated medicine shortage information.

Medicine sponsors maintain continuity of medicine supply through demand forecasting, stock control, and backup supply routes. However, despite best endeavours, situations inevitably arise where the supply of a prescription medicine may be disrupted or discontinued.

Medicine disruptions occur for a range of reasons including:

  • manufacturing plants being moved, merged and or closed
  • changes in clinical practices, which can lead to a change in demand
  • wholesaler and pharmacy inventory practices
  • 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

Not all supply disruptions results in a medicine shortage. Sponsors utilise a range of strategies to respond to disruptions. However, from time to time, a disruption will mean the timing and volume of supply of the medicine will be less than the demand for it.

In many cases, the disruption of supply 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 a consumer's medication regime.

The website includes prescription medicines experiencing an anticipated or current supply disruption where the sponsor cannot supply to the wholesaler either temporarily or permanently and has notified the TGA.

The website does not include medicines that were not on the Australian Register of Therapeutic Goods (ARTG) at the time of notification.

The site is not a complete list and will only generally show details of medicines shortages that the TGA has been told about by the sponsor.

Prescriptions medicines authorised for marketing in Australia are entered on the Australian Register of Therapeutic Goods (ARTG). Entry on the ARTG can only occur following the assessment of an application made by a sponsor of the medicine. If the supply of a registered medicine is expected to be disrupted, the sponsor is able to contact the TGA about the impending shortage of the medicine as part of their communication and management plan. If necessary, the TGA will work with the sponsor to identify and authorise the supply of a suitable substitute medicine/therapeutic alternative.

The TGA has a number of regulatory options to assist consumers to obtain the medicines they need, such as the supply of a substitute medicine/therapeutic alternative through the Special Access Scheme, and where it is in the interests of public health the TGA can authorise the supply of an otherwise unapproved medicine using s19A of the Therapeutic Goods Act 1989.

If a medicine shortage is likely to have a significant impact on consumers, for example there are no appropriate substitute medicines approved for use in Australia, the TGA works with the sponsor, public health officials and other experts to provide information to health professionals, consumers and their carers about what to do.

When special arrangements are in place though use of the regulatory options the presentation of the substitute medicine may look very different. For example the label might be in a different language. It is important to talk with your doctor or pharmacist.

Sponsors of medicines are responsible for:

  • taking steps to prevent medicines shortages
  • communicating to health professionals and consumers, where appropriate, when a medicine shortage occurs.

Notifying the TGA and the publishing of the information on this website complements the ongoing communication activities the sponsor conducts when managing medicine shortages.

The TGA employs scientific and regulatory experts who are responsible for the coordination of TGA-based activities related to the communication and management of medicine shortages.
Yes, the information on the website can be searched either by brand (trade) name or by active ingredient name.

Information for consumers

You can check if there is short supply of your prescription medicines by searching this website. Medicines which are available over the counter are not on this page.

The information provided refers to the supply of prescription medicines to the overall Australian market, which does not necessarily mean that a particular medicine is not available at your pharmacy to fill your prescription.

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

See the General information to find out more about what medicines are included on the Medicine Shortages Information website.

You should ask your doctor or pharmacist to seek further information.

If you are still worried and have not been able to get the necessary information then you can contact the TGA.

You should always contact your doctor or pharmacist if you have any concerns about your medicines. Health professionals are experienced in determining suitable options for you when a medicine is in short supply or unavailable.

They may be able to:

  • supply you with a different brand or product which contains the same active ingredient (that 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.

Information for health professionals

The website includes information provided by sponsors to assist health professionals and consumers when there is a temporary or permanent disruption (discontinuation) to the supply of a medicine in Australia.

In most cases, information can be obtained by searching this website.

The website lists mostly information provided to the TGA by the sponsor, only on prescription medicines (Schedules 4 and 8).

The shortages information is specific to anticipated and current shortages of prescription medicines between manufacturers and wholesalers. Wholesalers may have enough available stock of the medicine to cover anticipated shortages.

Health professionals should contact the sponsor about shortages if there is no information on the TGA website.

The predicted shortage start and end dates are included on the website as soon as the TGA receives the information from the sponsor. In the majority of cases, this will be all that is required to help health professionals and consumers during a shortage period.

The website also contains the date the shortage commenced and when that particular entry was last updated. When the shortage is resolved it will be displayed in the 'Resolved' area for three months after the resolution.

Information for industry

In many cases, the supply of a specific medicine is made to meet the demand for that medicine in Australia and there is no impact on consumers who use the medicine. However, when this is not possible, timely and consistent communication about medicine shortages is critical. Health professionals and consumers need information when there is a temporary or permanent disruption to the supply of a medicine in Australia. Changes to the access of any medicine, even when a substitute medicine or therapeutic alternative is available, can have significant implications for the quality use of medicines by the consumer.

The Medicine Shortages Information website, hosted by the TGA, is the key tool for delivering consolidated information to support health professionals and consumers when there is a temporary or permanent disruption to the supply of a medicine in Australia.

The initiative has the goal of improving the communication and management of medicine shortages in Australia. The initiative does not alter or replace current responsibilities of sponsors in managing medicine shortages.

Read the Protocol for all Australian Sponsors and the Therapeutic Goods Administration, as well as the Business Specifications and Guidance Supplement (available on the eBusiness Services website).