Getting Shorty – Meeting your obligations for Reporting Medicines Shortages in Australia
Ensuring adequate medicine supply to satisfy market demand is a complex business. Many products can have multinational supply chains using different suppliers of raw materials and ingredients and utilise manufacturers who provide medicines to multiple markets. Whilst most of the time, with accurate forecasting and/or established supply and demand patterns, medicine continuity of supply is not a problem. However, there are a number of factors that can impact supply, particularly so in times of market disruption and this can present a challenge for individuals and companies to navigate.
What is a Medicines Shortage exactly?
A medicine shortage is defined in the Therapeutic Goods Act 1989 as:
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.
More simply put, 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. Examples of events which may cause a medicines shortage include:
- Unavailability of ingredients and/or manufacturing quality issues
- Unplanned increases in demand due to competitor out-of-stock scenarios
- Unforeseen purchasing activity in times of health crisis
How are Medicines Shortages managed in Australia?
The current Medicines Shortage framework is administered by the Therapeutic Goods Administration (TGA) within the Australian Department of Health. This requires sponsors (marketing authorisation holders) to report shortages to improve awareness and enable early action to minimise their impact. The mandatory reporting framework was introduced in Australia on 1 January 2019, through amendment to the Therapeutic Goods Act 1989.
What kind of products does this apply to?
Mandatory Medicine Shortage reporting applies for the following products in Australia:
- ALL registered prescription medicines (schedule 4 and schedule 8 products)
- A limited number of OTC medicines (schedule 3) which are considered critical to the ongoing health of the patient. These are specifically listed in the relevant legislative instrument, and currently includes adrenaline autoinjector, glucagon injection, glyceryl trinitrate sublingual, levonorgestrel, monobasic sodium phosphate, naloxone injection, naloxone nasal spray, salbutamol inhalers, terbutaline inhaler, ulipristal.
Collectively these medicines are referred to as reportable medicines.
Who is responsible for reporting Medicines Shortages and how long do they have to report it?
Whilst the TGA, Healthcare Professionals and Consumers all have a role to play, the legal responsibility for medicines shortage reporting sits with the TGA sponsor of the medicine. Sponsors must actively monitor the supply of their medicines and report any anticipated shortages within the legislated reporting timeframes using the electronic notification form provided by the TGA.
Shortages of reportable medicines with a critical patient impact must be reported to the TGA within two working days. At this time the sponsor must provide at least the minimum mandatory information about the shortage. The sponsor then has another three 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.
The TGA actively liaises with sponsors of affected medicines and publishes information about all current and anticipated medicine shortages of critical impact on the Medicine Shortages Information Initiative (MSII) website. Within the TGA these activities are principally undertaken by the Medicine Shortages Section.
How do I know if my reportable medicine has a critical patient impact?
The Medicines Watch List is a legislative instrument used to streamline decision-making when determining the impact of a shortage. Any shortage of a medicine listed on the Medicines Watch List is automatically considered to have a critical patient impact. The Medicines Watch List includes the following categories of products: Antimicrobial Agents, Anticoagulants, Antivenoms, Antidotes/Treatments for poisoning, Emergency and Critical care products, Obstetrics, Selected Schedule 3 Medicines and Vaccines
Shortages of medicines that are not on the Medicines Watch List can still be assessed as critical by the TGA. Shortages of other medicines are also considered to have a critical patient impact if:
- at the time of the shortage, there are no products on the ARTG that could be used as a substitute, or if an appropriate substitute product is unlikely to be available in sufficient quantities to meet demand, and
- the shortage has the potential to have a life threatening or serious impact on the health of people who take, or who may need to take, the medicine.
Shortages of reportable medicines with a critical patient impact must be reported to the TGA within two working days. All other (non-critical) shortages need to be reported in full within 10 working days.
How do I report a Medicine Shortage and what do I need to report?
Sponsors need to report the shortage through the TGA’s Business Services (eBS) portal. The electronic notification form collects details of the shortage, including information to assist the TGA in assessing the patient impact of the shortage, the reasons for the shortage, the potential effects on supply of other medicines and the sponsor’s proposed approach to managing the shortage.
An assessment framework identifies the potential impact of any shortage by applying a mechanism that assesses the impact on the size of patient populations affected through measures of the prevalence of use in the population alongside the availability of alternatives.
The TGA’s Medicines Shortage section will review all Medicines Shortage Notifications submitted by sponsors. For Critical Medicines Shortages input may also be sought from a Medicine Shortages Action Group which includes the TGA and medical and pharmaceutical professional groups as appropriate.
Anything else I need to know?
Yes! The Medicines Shortage reporting framework also applies for Product Discontinuations. A discontinuation refers to a medicine no longer being available in the marketplace; it does not refer to the cancellation of the Australian Register of Therapeutic Goods (ARTG) entry from the Register. A Product discontinuation is treated like a ‘Permanent Shortage’ and information about discontinuations will be visible on the Medicines Shortage Information Initiative website for a limited time period (12 months from the deletion from market date provided by the sponsor). Where the discontinuation is likely to be of ‘critical impact’, the sponsor must report the discontinuation at least 12 months before the discontinuation is proposed to occur. If the sponsor is unable to comply with this timeframe, then it must be reported as soon as practicable after the decision to discontinue is made. Where the discontinuation is not likely to be of ‘critical impact’, the sponsor must report the discontinuation at least 6 months before the discontinuation is proposed to occur. If the sponsor is unable to comply with this timeframe, it must be reported as soon as practicable after the decision is made.
If you need assistance meeting your responsibilities for mandatory reporting for medicines shortages, contact Brandwood CKC today.
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
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