Medicine shortages and discontinuations: Proposed changes to reporting requirements

Problem

We heard from consumers and health professionals that 6 months is not enough notice to plan for the discontinuation of some reportable medicines in Australia. Earlier notice of discontinuations is needed to support health professionals and patients in adapting to the change in available therapies, including potentially sourcing new medicines and/or updating clinical guidelines. We heard that earlier notice could also support industry processes in planning for and seeking registration and Pharmaceutical Benefits Scheme (PBS) listing approvals for replacement products.

The withdrawal of products from the market can negatively impact patients, especially where there are limited treatment options remaining. Although the mandatory reporting framework seeks to identify where a discontinuation may have a ‘critical impact’, this can be challenging for medicine sponsors to accurately predict, especially for products used by a small treatment population or with a particular place in therapy (e.g. use of colestyramine powder as a last line therapy for severe diarrhoea following ileal resection).

We heard from health professionals about the extensive and serious impact that the discontinuation of oral opioids had on patients in palliative care and the significant challenges in transitioning to appropriate treatment alternatives. This impact contrasts with the sponsor’s assessment of the discontinuation impact of oral morphine solution, which was reported as a medium impact on the basis that appropriate therapeutic alternatives were available in the Australian market at the time. This highlights the difficulties sponsors face in accurately assessing the impact of a medicine discontinuation and the risk of misalignment with clinical and patient experience.

We are also aware that the discontinuation of medicines used especially for niche indications can have a significant impact. For example, the discontinuation of lomustine capsules sparked significant concern from the Australian oncology community because there are very few alternatives available to treat glioblastoma, a rare and aggressive brain cancer.

Health professionals suggested that a minimum 12 months' notice period for these and other medicine discontinuations would assist in mitigating negative impacts on patients.

Current requirements

Sponsors must advise the TGA of any decision to permanently discontinue the supply of a reportable medicine in Australia either:

• 12 months before the discontinuation is proposed to occur if it is likely to be of critical impact - or as soon as practicable after the decision is made, or
• 6 months before the discontinuation is proposed to occur in all other cases - or as soon as practicable after the decision is made.

What do we mean by ‘critical impact’?

A decision to permanently discontinue a reportable medicine will be of ‘critical impact’ where either:

• the medicine is listed on the Medicines Watch List, signalling that a shortage or permanent discontinuation of the medicine could cause significant morbidity or death for patients in Australia; or
• at the particular time:
  • there are no registered goods that could reasonably be used as a substitute for the medicine or – that these substitutes are not likely to be available in sufficient quantities to meet the demand and
  • the 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. 

There are 96 medicines, plus vaccines listed in the National Immunisation Program Schedule (as at 1 July 2018), listed in the Medicines Watch List.

For medicines not listed in the Medicines Watch List, sponsors are required to assess the potential impact of a discontinuation to determine whether 6 or 12 months' notice of the discontinuation must be given to the TGA.

Options

1. Include additional medicines in the Medicines Watch List, such as oral opioids, to require sponsors of those medicines to notify the TGA of their permanent discontinuation at least 12 months’ before ceasing supply (or as soon as practicable after the decision is made).
    
2. TGA PROPOSAL: Update the Act to require sponsors of all reportable medicines to provide 12 months' notice of a decision to permanently discontinue the medicine (or as soon as practicable after the decision is made).
    
3. No changes to current mandatory periods for sponsors to notify the TGA of a decision to permanently discontinue a reportable medicine in Australia.

Justification

To support health professional and industry efforts in reducing the impact of discontinuations on patients, we propose to mandate a streamlined 12-month notice period for discontinuations of any reportable medicine included in the ARTG (Option 2). This proposal would reduce the complexity of the mandatory reporting framework, provide clarity for sponsors about their reporting obligations and remove the need for sponsors to assess whether a specific discontinuation would be of ‘critical impact’.

Due to factors outside of the sponsor’s control, there are situations where the 12-month discontinuation reporting timeframe may not be able to be met. Under Option 2, the TGA proposal would maintain the existing provision for reporting as soon as practicable after a discontinuation decision is made, to avoid an increase in regulatory burden for sponsors.

At this time, we are not proposing to add specific medicines to the Medicines Watch List (Option 1), such as those mentioned in responses to the recent consultation (e.g. oral opioid medicines), medicines included in specific PBS Schedules (e.g. palliative care medicines) or medicines used in diabetes management (e.g. insulin). The Medicines Watch List is a point in time legislative instrument and due to the dynamic nature of medicine supply, it cannot anticipate all situations where a discontinuation would result in a critical impact, especially for small treatment populations. It is likely that there are other medicines that were not mentioned in feedback to the recent consultation where a discontinuation would have a critical impact on a specific patient cohort. Option 1 would also increase the regulatory burden for affected sponsors due to the flow on requirements for reporting shortages within constricted timeframes (as soon as possible, but no later than 2 working days after becoming aware of the shortage compared to reporting shortages within 10 working days).

Instead, the TGA’s proposed approach (Option 2) seeks to provide a level playing field for sponsors in reporting medicine discontinuations, while supporting earlier information for health professionals to plan for alternative treatment options.