Mandatory reporting: New reporting rules give advance warning

On 1 January 2019, new laws will enforce the mandatory reporting scheme for medicine shortages – a welcome change.

It’s a very difficult conversation to have with a patient when you have to explain to them that the only medication that keeps them well, or the only medication that they can tolerate, isn’t available.

That’s why pharmacists support the recent amendment to the Therapeutic Goods Act 1989 introducing a mandatory reporting scheme for medicine shortages and decisions to permanently discontinue supply involving high-risk medicines in Australia. These measures will go some way to ensure continuity of supply, so that patients, carers, pharmacists and prescribers aren’t landed in the situation where there isn’t the lead time to be able to make those clinical considerations or to discuss with the patient and their carer what an appropriate substitute might be, how they might be able to access it and what it might mean for their care.

I have seen this myself, especially in my role as a mental health pharmacist in acute inpatient units, when a medication has been discontinued and the patient has less than a few weeks’ supply. They don’t know whether their only option might be to risk switching to a less-effective medication or to be admitted to hospital – not something that most mental health patients want. Understandably, that is quite distressing for all patients.

The PSA and others understand that medicine shortages occur worldwide for a variety of reasons. They have worked closely with the TGA and other stakeholders to help improve the response to shortages, but there are still significant gaps and problems in this procurement pathway in Australia. This legislation is a culmination of the working together with the sector to review the issues of medicine shortages in Australia. The partnership has developed a comprehensive protocol which will be implemented through this legislation, which will go some way to ensuring there is timely and relevant information available on the supply of medicines, which should assist patients, their doctors and other allied health professionals to manage their treatment plans so they receive uninterrupted care.

The scheme, beginning on 1 January 2019, will principally apply to prescription medicines; some of my former colleagues have said that they believe this watchlist should be expanded to include other medications that would have a critical impact. I’m sure that will be something that will be looked at over time. But I welcome the fact that this is now being made mandatory, because it’s evident that the current system has been broken.

On the shortage of critical impact drugs and the requirement to notify within two working days when it’s ‘reasonably known’, I’m sure that suppliers and manufacturers will enter into this in the spirit of it and notify as soon as possible, because sometimes two days is too long. With other shortages it’s within 10 working days.

Early in my career you didn’t see the shortages of common antibiotics and medications that you see now. There needs to be a wider look at this particular problem, but I welcome these new measures.

Emma McBride is the ALP Federal Member for Dobell, NSW. Prior to her election in 2016 she worked as the Chief Pharmacist at Wyong Hospital, and was the Deputy Director of Pharmacy for the Central Coast Local Health District.  

* This is an edited excerpt from a speech Ms McBride recently made in the House of Representatives.