Medicine shortages and discontinuations: Proposed changes to reporting requirements

Problem

Health professionals and the medicines industry told us that certain medicines considered essential to the health of Australian consumers are not currently captured in the shortages mandatory reporting framework. Currently, for these medicines, the TGA has limited power to require the pharmaceutical companies who supply them (sponsors) to provide detailed supply information when a possible shortage or supply disruption occurs.

Management of shortages of ‘non-reportable medicines’ is challenging for all stakeholders and can negatively affect health outcomes for consumers. For industry, health professionals and state and territory health departments, receiving too little or too late information about supply can prevent effective mitigation strategies from being put in place, and can impact diagnosis and treatment for consumers.

Shortages of non-reportable medicines that have impacted the Australian community include:

• Certain non-prescription medicines listed on the Pharmaceutical Benefits Scheme (PBS) (e.g. permethrin cream, a topical scabies treatment)
• Sterile intravenous (IV) fluids products
• Contrast agents for medical imaging
• Radiopharmaceuticals

When the TGA receives early warnings from consumers and health professionals about a possible supply chain disruption of a non-reportable medicine, there is a need for the TGA to be able to request and receive detailed supply data for that medicine from the sponsor. This information is essential to better inform the TGA’s response to the possible supply disruption, especially where it affects non-prescription medicines used alongside other treatments (e.g. analgesics such as paracetamol or ibuprofen or other non-prescription products on the PBS).

There is also a need to clarify that non-prescription medicines included in the Medicines Watch List are reportable within the medicine shortages framework. Medicines in the Watch List are those where a shortage or discontinuation is considered to be of ‘critical impact’, for example, non-prescription life-saving treatments such as phytomenadione (Vitamin K) injections.

Current requirements

Registered medicines are considered reportable under Section 30EH of the Therapeutic Goods Act 1989 (the Act) if they contain one or more Schedule 4 (Prescription Only Medicine) or Schedule 8 (Controlled Drug) substances, or if they are included in the Therapeutic Goods (Reportable Medicines) Determination 2018 (known as the Reportable Medicines Determination).

The Reportable Medicines Determination currently lists 11 reportable medicines that are non-prescription registered medicines considered critical to the health of Australians.

Sponsors of reportable medicines must report all shortages or discontinuations to the TGA. These details are then published on the TGA’s Medicine Shortage Reports Database.

For reportable medicines included in the Medicines Watch List, shortages and discontinuations are considered to have a ‘critical impact’ on Australians. The sponsor must report to the TGA within 2 working days of them becoming aware if supply of the medicine in Australia may not meet its demand at any time in the next 6 months. For a discontinuation of critical impact, sponsors must report at least 12 months before the discontinuation would occur or, if this is not possible, as soon as practicable after the sponsor's decision.

For non-reportable medicines on the Australian Register of Therapeutic Goods (ARTG), sponsors are not required to report shortages or discontinuations to the TGA. The TGA can request sponsors to provide information about whether the medicine is being supplied, imported into, or exported from Australia. However, the Act only provides a clear requirement for sponsors to provide more detailed data in relation to reportable medicines (e.g. data on the volume of products being imported, exported or supplied).

Options

1. Add all current registered non-prescription medicines on the ARTG into the Reportable Medicines Determination, which would require affected sponsors to report any shortage or discontinuation to the TGA.
    
2. TGA PROPOSAL: Balance regulatory burden on sponsors with the need to improve TGA’s monitoring of medicine shortages by:
    
   1. Adding 23 registered, non-prescription medicines that are critical to the health of patients in Australia, to the Reportable Medicines Determination (as outlined in Attachment A), and
       
   2. Including a provision in the Act to require sponsors of any approved medicine to provide the TGA, on request, with detailed supply information (i.e. not limited to reportable medicines).
3. No change to the current reporting requirements under the medicine shortages regulatory framework.

Justification

In the interests of public health, we propose to include 23 additional non-prescription medicines at Attachment A to the Reportable Medicines Determination (Option 2). These medicines are critical for the health of patients who need them and pose a high risk to care if a shortage or discontinuation was to occur. Sponsors would be required to notify the TGA of a shortage or discontinuation of these medicines and of any changes in duration or resolution of the shortage. Information about these shortages or discontinuations would be published on the TGA website.

The proposed medicines were identified from the TGA’s analysis of PBS medicines, the Medicines Watch List, previous shortages, and approvals of overseas alternative medicines where the registered medicines were unavailable or in short supply.

The TGA proposal would affect around 100 products registered on the ARTG and 23 sponsors. This proposal is not expected to significantly increase regulatory burden for most of these sponsors, as they already supply other reportable medicines and are familiar with the current framework.

There are also other medicines that are critical to the health of patients in Australia that we are not proposing to make reportable at this time. For example:

• Radiopharmaceuticals: specialised handling and transportation of these products is needed due to their radioactive nature, making it challenging for radiopharmaceutical sponsors to comply with the mandatory reporting timeframes for shortages when manufacturing or logistical issues arise.
• Contrast agents (other than barium sulfate): we have identified a high regulatory burden associated with reporting shortages for all contrast agents, without meaningful benefit, due to the large number of products (more than 150 products).

We are not proposing to include all registered medicines in the Reportable Medicines Determination (Option 1). Option 1 would affect almost 4000 ARTG entries and have a significant regulatory and administrative impact on industry with limited additional benefit. The significant increase in reporting would result in considerable additional processing load for TGA staff, delaying the publication of information and processing of shortage mitigation actions. The much larger number of lower-value shortage and discontinuation notifications published on the TGA Medicine Shortage Reports Database would make it more difficult for health professionals to find relevant shortage information that is critical to patient care.

Instead, under the TGA proposal (Option 2), for suspected shortages of non-reportable medicines, the TGA is exploring whether amendments could be made to the Act to require sponsors to provide the TGA with information relating to supply, shortages or discontinuations of any approved medicine, on request. The TGA’s proposed approach balances the regulatory burden of reporting on industry with the need for the TGA to have access to shortages information to act quickly and support informed treatment decisions.