AMA advocacy on medicine shortages
BY A SSOCIATE PROFESSOR ANDREW C MILLER, CHAIR, AMA MEDICAL PRACTICE COMMITTEE
AMA members increasingly report that shortages of PBS medicines are impacting on the care of their patients.
We are all familiar with the scenario; patients turn up at their local pharmacy to be told that their current prescription for a long-standing condition cannot be filled. Usually alternative medicines can be prescribed, but these may not be subsidised under the PBS, or easily accessible themselves.
This situation is stressful, and sometimes expensive, for patients. It challenges the concept of stable chronic disease management, increases the risk of patient confusion resulting in medication errors and wastes the valuable time of patients and doctors.
Medicine supply shortage is not a new phenomenon, but it is becoming more frequent. Shortages are attributable to several factors, including the consolidation of suppliers in the US following changes in regulations; emerging markets in China and India that have also reduced the number of suppliers due to greater competition; and requirements to upgrade plants and processes following stricter quality controls and standards. With fewer suppliers worldwide, this means that a problem in production from one source may result in magnified impact across the globe, often impacting several brands.
For Australia, the impact is exacerbated: as the TGA points out, Australia has only two per cent of the world’s medicine usage and more than 90 per cent of prescription medicines are imported. Australia enjoys a relatively lowly place in ‘the queue’ for medicines in short supply. In addition our long supply lines complicate delivery of medicines requiring critical transport conditions, increasing the risk of in-transit spoilage, and reduce the capability of rapid resupply in any circumstance.
While medicine shortages are outside the direct control of governments, there is still considerable scope for regulatory bodies to take action to minimise the impact of shortages.
The AMA first started advocating for more proactive government interventions and regulatory solutions in 2012. The then AMA Vice-President, Professor Geoff Dobb, led the charge, meeting with and writing to Health Ministers, pharmaceutical industry representatives and the TGA. Subsequently, the TGA began working with industry stakeholders, the AMA and others to work out better ways of anticipating and managing shortages.
This ultimately led to the development in 2014 of a Medicine Shortages Protocol, an agreement signed by the TGA, Medicines Australia and the Generic and Biosimilar Medicines Association. The protocol established a voluntary regime for suppliers to notify the TGA of shortages in a timely manner as well as a public database of shortages activity.
Unfortunately, industry compliance has been patchy and as a consequence the TGA often becomes aware of shortages after they are impacting patients; and so before remedial action can be taken. This has rendered the shortages database next to useless.
COAG intervention led to a TGA review early last year. The AMA again contributed to the search for more effective solutions by participating in a stakeholder committee and providing feedback based on Medical Practice Committee advice.
It has become clear that, despite pharmaceutical industry opposition, a mandatory rather than voluntary reporting scheme is needed. The AMA fully supported the proposal that pharmaceutical companies must report all medicine shortages to the TGA within specific timeframes and that the TGA must also publish information about all shortages that have a critical patient impact.
The ‘mandatory notifications’ law was passed in Parliament last month and will come into effect on January 1 2019. Drafting of a new guide for pharmaceutical companies on their responsibilities is underway.
Will this fix the problem? It will certainly improve the ability of the TGA, health organisations and health practitioners to proactively manage shortages and to source alternatives.
However, a critical player in the continuum of medicine supply is not covered in the new legislation nor mentioned in the accompanying guide. In subsidising the supply of nearly all medicines prescribed in Australia, the PBS has a significant role to play in minimising the financial impact on patients of medicine shortages.
Where an alternative medicine may be available to patients, but not subsidised under the PBS, or subsidised but with restrictions which do not encompass the specific patient use a simple, a temporary change to the PBS authority restriction may provide needed relief. For example when there was a shortage earlier this year of norfloxacin, subsidised under the PBS to treat complicated urinary tract infection, ciprofloxacin – a good alternative – could not be prescribed under the PBS because its use does not extend to any form of UTI not due to pseudomonas (prostatitis only).
The voluntary notifications scheme may not have allowed the Department of Health to act in a timely way to effect temporary amendments, but there should be no excuse from next year.
The AMA has now raised this concern with the Department several times and been assured that timely shortages information would lead to a timely PBS response. The AMA will be watching closely.
You can find out more about accessing alternative medicines during a shortage on the TGA’s website.