You are here

Management and communication of medicine shortages and discontinuations in Australia

Guidance for sponsors and other stakeholder bodies

1 May 2019

Book pagination

Appendix 3: Example scenarios for sponsors

Please note that the following examples are only representative of possible scenarios involving reportable medicine shortages. These examples are not intended to be exhaustive or comprehensive.

Every potential medicine shortage needs to be assessed and managed based on its specific circumstances and in accordance with the requirements determined by the Act.

Example 1 - Manufacturing issues

Manufacturing issues are a major contributing factor to medicine shortages. For example, shortages may arise because the manufacturer ceases operation, or if there are problems sourcing the Active Pharmaceutical Ingredient (API).

If manufacturing issues occur, sponsors are required to perform an internal assessment prior to officially reporting a shortage to the TGA. Such a shortage might be current or anticipated in the near future. If the shortage is likely to occur within the next 6 months it must be reported. This internal assessment would include activities such as:

  • investigating availability from another manufacturer
  • assessing how long the issue will be present (duration of the resulting shortage)
  • level of stock affected and market share/usage (which helps to determine impact level).

Scenario: On 1 February 2019, a sponsor of a reportable medicine that is included in the Medicines Watch List becomes aware of possible manufacturing delays. On 5 February 2019, after investigating further and obtaining information from the manufacturer, the sponsor concludes that, although the stocks of the medicine in Australia will be sufficient to meet demand for the time being, the manufacturing delays will, by early April 2019, result in the supply of the medicine in Australia not meeting or not likely to meet demand.

Outcome: As the anticipated shortfall of supply falls within 6 months of 5 February 2019, on that date there is a reportable shortage of the medicine. As the medicine is included in the Medicines Watch List, the shortage is of critical impact and the sponsor therefore must notify the TGA as soon as possible or within 2 working days (in this case by 7 February 2019).

Example 2 - Unexpected increase in demand

Many medicine shortages arise due to an unexpected increase in demand, most commonly due to another sponsor of a medicine with the same active ingredient experiencing their own shortage.

When this occurs, there are a number of actions and steps that need to take place.

Scenario: Sponsor A has a 50% market share for a specific medicine, while Sponsor B and Sponsor C have 25% each. Sponsor A reports a shortage of that product to the TGA. The impact level is assessed by Sponsor A as being medium and they therefore notify the TGA within 10 days.

Outcome: The TGA reviews the information provided by Sponsor A. As Sponsor A has notified that they have a 50% market share, the TGA then contacts Sponsor B and Sponsor C individually to inform them of the shortage and collect information relating to their current supply status, market share and whether they anticipate any shortages in the next 6 months. Sponsor B expects a shortage due to the increased demand caused by Sponsor A's shortage. Sponsor C is unsure and is asked by the TGA to investigate further. Upon further investigation, Sponsor C also anticipates a shortage due to increased demand. This leads to additional medicine shortage notifications from Sponsor B and Sponsor C. This may result in the TGA negotiating with Sponsor A to reassess/increase their patient impact rating. A Medicines Shortages Action Group (comprising relevant experts engaged on a case-by-case basis) is consulted in regards to proposed management actions for the shortage. The TGA continues to liaise with each of the sponsors to assess currency of information on an ad hoc basis and monitor market signals from other sources of information, such as health professionals and consumers.

Example 3 - Discontinuation of a medicine

Discontinuation of a medicine, for example for commercial reasons, creates a medicine shortage that may be subject to mandatory reporting (if it's a prescription medicine or a reportable OTC medicine).

For any discontinuation, you should notify the TGA as soon as you are aware that a product is going to be discontinued. Consideration should be given to the information to be supplied to health professionals and consumers who may be impacted by the deletion of a product from the market.

Scenario: In March 2019, the global parent company decides to shut down Australian operations and subsequently to cease supplying the Australian market from October 2019. The medicine sponsor has three items registered on the Australian Register of Therapeutic Goods which will all be discontinued in 7 months' time.

Outcome: The discontinuation will result in a shortage assessed as low patient impact. As such, the sponsor is required to report the discontinuation to the TGA at least 6 months before it is proposed to take effect (or as soon as practicable if that is not possible). If the medicine had been on the Medicines Watch List, or the shortage was assessed as being critical, it should be reported as soon as possible and at least 12 months in advance. The sponsor should begin the preparation of correspondence to relevant stakeholders, to be included in their notification to the TGA. In this scenario, the sponsor is not legally required to advise the TGA immediately, as the discontinuation is 7 months away. However, early notification is encouraged, as this gives health professionals and consumers more time to consider alternative treatment.

Example 4 - Shortage as a result of a recall

A recall of a product can result in a medicine shortage. The TGA will already be involved in the recall action, but a medicine shortage notification will also need to be made if it is a reportable medicine. Sponsor obligations pertaining to a recall are separate from sponsor obligation to report a medicine shortage.

Scenario: Through its standard quality assurance processes, a sponsor discovers that the majority of batches for one of its medicines are contaminated. This is reported to the TGA and advice provided recommends an immediate consumer-level product recall.

Outcome: In addition to the recall related activities, the sponsor also notifies the TGA that this will result in a shortage of that product for about 3 months. This is the period of time the sponsor estimates it will take to get alternative batches of stock into Australia.

Example 5 - Natural disaster

Natural disasters have been known to significantly affect the availability of medicines. For example, damage caused by Hurricane Maria in Puerto Rico in 2017 decreased global manufacturing productivity and led to worldwide medicine shortages for a number of lines.

Similar to instances in which a shortage is caused by a manufacturing quality issue, Australian medicine sponsors are required to perform an internal assessment confirming the likelihood of a shortage prior to officially reporting this to the TGA. Such a shortage might be current or anticipated in the near future. If the shortage is likely to occur within the next 6 months, it must be reported. This internal assessment would include activities such as:

  • investigating availability from another manufacturer
  • assessing how long the issue will be present (duration of the resulting shortage)
  • level of stock affected and market share/usage (which helps to determine impact level).

Scenario: On 15 November 2019, a sponsor of a reportable medicine that is included in the Reportable Medicines Determination List (OTC medicine) becomes aware of a typhoon that has affected a manufacturing plant in Japan. On 20 November 2019, after investigating further and obtaining information from the manufacturer, the sponsor concludes that, although the stocks of the medicine in Australia will be sufficient to meet demand for the time being, the damage from the typhoon and subsequent manufacturing delays will, by mid December 2019, result in the supply of the medicine in Australia not meeting or not likely to meet demand.

Outcome: As the anticipated shortfall of supply falls within 6 months of 20 November 2019, on that date there is a reportable shortage of the medicine. In this instance, as this medicine has no generic substitutes or any alternative available, the shortage is of critical impact and the sponsor therefore must notify the TGA as soon as possible or within 2 working days (in this case by 22 November 2019).

Example 6 - Local stock out issues

There may be instances in which a select population of individuals in Australia may not be able to access a certain medicine at a particular point in time. This could be due to a number of reasons including limitations in delivering to a particular region or cohort (for example, a town in which only a pharmacy depot exists or due to specialised commercial arrangements between wholesalers and pharmacies). It should be noted that unless these situations were to be universal in nature and affect all patients in Australia, they would not constitute a medicine shortage.

Scenario: A rural town in Victoria has only one pharmacy servicing it. Due to the pharmacy being a relatively small business compared to its regional and metropolitan counterparts, and the volume of business conducted, it does not have commercial arrangements with all of the major available suppliers. There is an instance of a specific product being available through a specific supplier. This pharmacy does not have a commercial agreement in place or any capacity to order stock from that supplier. As a result, patients in this population have to either drive to another town or visit another pharmacy to get their prescription for the product filled.

Outcome: This would represent an unavailability of a medicine at a particular location and would not constitute a medicine shortage as per the legal definition. No regulatory obligations would be imposed on the medicine sponsor in this instance.

Book pagination