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Medicine shortages: Information for sponsors (suppliers)
Information for sponsors
This web page provides guidance and other resources about mandatory reporting of medicine shortages in Australia. Information is also available for sponsors about supplying medicines during a shortage under section 19A of the Therapeutic Goods Act 1989.
From 1 January 2019, sponsors of 'reportable' prescription medicines and some over-the-counter medicines are required to report all shortages of those products to the TGA.
Shortages of reportable medicines with a critical patient impact must be reported to the TGA within 2 working days. At this time the sponsor must provide at least the minimum mandatory information about the shortage. The sponsor then has another 3 working days in which to provide the remaining required information on the shortage. All non-critical shortages need to be reported in full within 10 working days.
Reporting obligations for medicine shortages
To assist sponsors to understand their reporting obligations and timeframes, we have developed a decision tree tool:
- Decision tree - What is the patient impact of my medicine shortage and do I have to report it to the TGA?
Guidance documents on medicine shortages reporting
- Management and communication of medicine shortages in Australia - Guidance for sponsors and other stakeholder bodies
- Medicine shortages/discontinuations - Electronic notification form: User guide
- Publication of notified medicine shortages: Updated protocol
Medicine shortages resources
- Medicine Shortages in Australia: Reporting obligations and the TGA's compliance framework
- Webinar for sponsors - Medicine Shortages Mandatory Reporting Scheme: What you need to know
Question and answers
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.
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.
Medicine sponsors (the individual or company who is legally responsible for a therapeutic good) maintain continuity of medicine supply through demand forecasting, stock control, and backup supply routes. However, despite their best endeavours, situations may 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
In some cases a disruption of supply will have no impact on Australian consumers. However, where the volume of available product, or appropriate substitute medicine/therapeutic alternative is inadequate, the resulting shortage can have an impact on a consumer's medication regime.
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 supply of a prescription medicine or one of a small number of reportable over-the-counter medicines is likely to be affected by a shortage, reporting it is mandatory. If possible, the TGA can work with the sponsor to identify and authorise the supply of a suitable substitute medicine/therapeutic alternative.
The TGA also has a number of regulatory options to assist health professionals to obtain the medicines their patients 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. Medicines that have been approved for import and supply under s19A can be found on the searchable s19A database on the TGA website.
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.
The medicine shortage notification on the TGA website can provide a link to information about management actions for individual medicines that the TGA is undertaking; these may be in consultation with the medicine sponsor. These are contained within each notification.
Mandatory reporting shortages (including those arising from discontinuation of products) will facilitate more proactive, timely and transparent management and communication about medicine shortages for the benefit of Australian consumers and health professionals, as well as for medicine sponsors.
Improved communication will help consumers to be aware of medicine shortages that may affect them sooner, which will enable them to obtain timely advice and support from a health professional. In some situations, their health professional may be able to recommend alternative treatments or arrange supply of an alternative product.
It is important to note that sometimes disruptions to supply of a medicine cannot be avoided. Mandatory reporting of medicine shortages will not prevent these disruptions.
A reportable medicine is one that must be reported to the TGA if the medicine experiences a medicine shortage. Principally, these are:
- prescription medicines (schedule 4 and schedule 8)
- 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, salbutamol inhalers or adrenaline auto-injectors).
A shortage of a reportable medicine is automatically considered to have a critical patient impact if it is included in the Medicines Watch List, or if either of the following applies:
- at the time of the shortage or decision to permanently discontinue, there are no registered goods that could reasonably be used as a substitute for the medicine in question or, if there are, they would likely not be available in sufficient quantities to meet demand; or
- the shortage or discontinuation has the potential to have a life-threatening impact on, or a serious impact on the physical or mental health or functioning of, persons who take or who may need to take, the medicine in question.
The Medicines Watch List is a legislative instrument setting out a list of known critical medicine ingredients. It will help sponsors and the TGA to simplify and speed decision-making when deciding if a medicine shortage or permanent discontinuation may have a critical patient impact. Only ingredients from medicines that are included in the Australian Register of Therapeutic Goods (ARTG) are considered for the list.
The list of ingredients included in the Medicines Watch List has been derived from a consensus review of existing state hospital Emergency and Life Saving Drug Lists and the World Health Organization's Model List of Essential Medicines that are contained in the ARTG.
Yes. Shortages of medicines that are not on the Medicines Watch List can still be assessed as critical by the TGA. Sponsors are also required to self-assess according to the guidance to determine whether or not a shortage needs to be reported within 2 working days. That impact assessment will be reviewed by the TGA to confirm the status and determine what actions then should be taken (in accordance with the guidance).
Yes. As a legislative instrument, the Medicines Watch List could be amended by the Minister or a delegate of the Minister in the Department of Health. This would in most instances only occur after appropriate consultation has been undertaken. The TGA has also undertaken to review the Medicines Watch List on an annual basis to ensure it remains current and appropriate.
Known medicine shortages of critical patient impact must be reported to the TGA within 2 working days. At this time the sponsor provides at least the minimum mandatory information about the shortage. The sponsor then has another 3 working days in which to provide the remaining required information on the shortage.
All non-critical shortages (those of low or medium patient impact) need to be reported in full within 10 working days.
All shortages will be published on the TGA website in the Medicine Shortages Information Initiative section. They will be listed under one of the following sub-categories: current, anticipated or discontinued. There will also be a list of resolved critical shortages.
You will also be able to switch the view to a consolidated list of shortages and discontinuations, which contains information about all shortages of low, medium and critical patient impact.
All of these notifications can be searched using either brand (trade) name or by active ingredient name.
In certain cases, further information may be published on the TGA website, including information on alternative products where appropriate. Links to other websites (sponsor, State and Territory, clinical college) will also be provided. Information on products approved to be imported under section 19A as alternative products to Australian-registered medicines that are experiencing a shortage are also available on the TGA website.
The website does not include medicines that were not on the Australian Register of Therapeutic Goods at the time of notification, such as medicines supplied under the Special Access Scheme or the Authorised Prescriber Scheme.
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 important.
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 shortage reports database 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. Publication of all information about medicine shortages is encouraged. The initiative does not alter or replace current responsibilities of sponsors in managing medicine shortages nor does it replace the sponsors PBS reporting responsibilities.
Read the Management and communication of medicine shortages in Australia - Guidance for sponsors and other stakeholders, as well as the Medicine shortages/discontinuations - Electronic notification form: User guide.
It is acknowledged that sponsors may require time to determine whether a particular circumstance will result in a shortage. Sponsors should undertake investigations as soon as possible to enable prompt reporting.
The patient impact of a medicine shortage is based on the availability of substitute medicines and affected patient population. The approach outlined in Table 1 - Impact assessment framework is to be used to assess the impact of the shortage. This can be found in the Guidance for sponsors and other stakeholder bodies.
Medicines included on the Medicines Watch List are automatically deemed to be of critical patient impact if in shortage.
A decision tree is available to help sponsors of medicines determine the patient impact level of a shortage (or an anticipated shortage) of one of their products and whether they need to report it to the TGA.
Below are types of information that are useful to health professionals and consumers in the event of a medicine shortage. As such, they should be considered (among other things) by a sponsor when developing communication strategies and activities, such as Dear Healthcare Professional letters, to assist in mitigating the effects of a medicine shortage.
- name of the medicine in shortage
- ARTG number of the medicine in shortage
- duration of the shortage/discontinuation
- contact phone number for the sponsor of the medicine in shortage
- alternative arrangements for supply during the shortage period, for example Special Access Scheme, section 19A
- if section 19A, direct the reader to the section 19A web page on the TGA website
- whether the sponsor has contacted and notified the TGA
- where can patients find further information, for example the TGA website, sponsor contact.
Information regarding medicine shortages provided by sponsors will be published on the medicine shortages website. The information provided by the sponsor that will be published will include:
- sponsors name
- sponsors nominated public contact details
- sponsors nominated website details*
- ARTG number
- ARTG Name of medicine (includes Name, active ingredient(s), strength, dosage form and container)
- active ingredient(s)
- therapeutic class description
- nature of the shortage
- impact of the shortage
- reason for the shortage
- estimated shortage dates for current or anticipated shortages
- deletion from market date for discontinued products
- supply information where appropriate.
*Sponsor website details will only be published if they contain information that relates to the management of medicine shortage.
The website will also include the shortage management actions being undertaken by the TGA to address the medicine shortage.
Information will remain on the TGA website for the following periods:
|Shortage||Time on Critical shortage list page||Time on consolidated (ALL Shortages) list page|
|Anticipated critical||Until made current or resolved||Until made current or resolved|
|Current critical||Duration of the shortage - until resolved or discontinued||Duration of the shortage - until resolved or discontinued|
|Resolved critical||For three months after the resolution of shortage||For three months after the resolution of shortage|
|Discontinuation of critical||From date of initial publication until one year after the Deletion from Market date||From date of initial publication date until one year after the Deletion from Market date|
|Anticipated medium/low||-||Until made current or resolved|
|Current medium/low||-||Duration of the shortage - until resolved or discontinued|
|Resolved medium/low||-||For three months after the resolution of shortage|
|Discontinuation of medium/low||-||From date of initial publication date until one year after the Deletion from Market date|
To submit a medicine shortages notification the sponsor must have access to the TGA eBusiness Services (TBS) portal. The Sponsor TBS Master Account Holder can create access profiles and assign log-in details as required. For further support and assistance Master Account Holders can contact the TBS helpdesk support via website (https://www.ebs.tga.gov.au), email (email@example.com) or phone (1800 010 624).
Log in to TBS and the user portal will be displayed. In the TBS Navigator there is a link to create a new medicine shortages notification. Complete the notification form, attach any documents you wish to include with your notification (for example, Dear Healthcare Professional letter, letter to wholesalers, letter to hospitals) and submit to the TGA. If your submission has been successful you will receive a message stating your submission has been successfully submitted to the TGA. Detailed instructions can be found in the Medicine shortages/discontinuations - Electronic notification form: User guide.
If you are trying to create a new medicine shortage notification for a product that was previously the subject of a medicine shortage, was subsequently resolved and is now predicted to be in shortage again, you are not able to reuse the previous notification, that is, you cannot vary a notification which has been resolved.
You will be required to create a new medicine shortage notification.
If your previous notification is still published on the Medicine Shortages Information Initiative website under the resolved tab you will need to contact the Medicine Shortages team (email firstname.lastname@example.org or phone 02 6289 4646) to unpublish and archive the previous notification. The information will be unpublished immediately but the archiving process is carried out overnight. Therefore you will not be able to create or submit your new medicine shortage notification until the next day.
If you have a medicine shortage that you think is of critical patient impact and you are not able to create a medicine shortage notification immediately because there is still a published resolved notification, you will need to contact the TGA as soon as possible using the above contact details. Medicine Shortages Section will take action to archive the notification immediately. This immediate archiving will enable the sponsor to be able to create and submit a new notification within 2 hours of notifying the Medicine Shortages Section.
In some situations the amount of product held at a distribution centre, considered in conjunction with what the sponsor has in stock, can affect whether or not there is a reportable medicine shortage.
For example, where a distribution centre has one months' supply of product but the sponsor has no product and is not going to have any product for another three months, the sponsor should submit an anticipated shortage to begin in one month's time for a period of two months. This is because the distribution centre has stock for one month of the three months that the sponsor will have no stock. Once the sponsor receives stock, it can supply the distribution centre and the shortage will be resolved.
In another example, a sponsor has run out of stock and will not be getting any more for one month. However, the distribution centre is holding 6 months stock. In this situation there is no shortage to be reported, as there is plenty of stock to cover the one month that the sponsor is without stock. At the end of the month the distribution centre will still have five months' supply of stock and the sponsor will be restocked.
There are a number of potential scenarios that could arise as a result of a sponsor discontinuing one product with the intention of replacing it with another product. The specific circumstance of each situation will determine what the sponsor is required to do.
For example, a product is discontinued in 6 months' time. The sponsor has a new product that has been registered but is not yet manufactured. The new manufacturer has had a delay and the new product will not be available for another nine months. As the second product has not been supplied to the market, there is no shortage of this product and therefore there is no requirement for a shortage notification for it. However, a discontinuation notification should be submitted for the first product, noting the actual deletion from market date. In this situation there will be three months where there is effectively no registered product available. The sponsor can do a couple of things in this situation:
- supply an unapproved product subject to application/notification made by a prescriber through the Special Access Scheme for the interim
- publish information on their website and supply the URL to the TGA for publication on the TGA website so that health professionals and consumers can be made aware of the alternative arrangements.
In another example, there will be no delay in the manufacture of the second product and therefore there will be no shortage of the active ingredient during the transition. As the first product is being discontinued, there is a requirement for a discontinuation notification to be submitted. When submitting this notification, the sponsor should include in the supplementary information that the second product is replacing it. The TGA will then be able to publish that information to inform customers of the current status of the goods. The sponsor can also inform health professionals and consumers by creating Dear Healthcare Professional/consumer letter(s) and advising of the change.
In a third example, the replacement product retains the Aust R number of the first product but manufacture has been delayed for nine months. As both products have the same Aust R number, an anticipated shortage notification should be submitted for the second product for a period of three months with the shortage period beginning in 6 months.
Compliance measures in relation to these reporting obligations are outlined in the Medicine Shortages in Australia - Reporting obligations and the TGA's compliance framework, which is in accordance with the TGA's Regulatory Compliance Framework.
The TGA takes a risk-based approach to compliance and has developed appropriate strategies to prevent non-compliance, including activities to raise awareness and understanding of mandatory reporting. This allows the TGA to respond proportionally to the varied types of non-compliant behaviour.
Regulatory measures now available to the TGA under the Act can be used to address breaches. These measures range from publishing the names of sponsors who do not comply with the requirements (in accordance with s61 of the Act), to issuing infringement notices and, in the most serious cases or where there is repeated non-compliance, initiating civil penalty proceedings. Civil penalties can result in maximum fines of 100 penalty units for a body corporate.
In most cases, civil penalty action would only be used where other steps, such as awareness raising and warnings, have previously been used and there is a history of repeated non-compliance.
In some case, to facilitate access to an alternative product, a sponsor can apply to the TGA for permission to supply an unapproved medicine under section 19A of the Therapeutic Goods Act 1989 (the Act).
Other avenues are available for health professionals to access unapproved goods to be used while a registered product is unavailable. These include the Special Access Scheme (approvals on an individual patient basis) and the Authorised Prescriber scheme (approvals based on a class of patients with a particular medical condition).
Mandatory reporting statistics
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