Are we doing enough to identify and address current and potential problems with the supply of essential medicines?
This is one of many questions raised by a thought-provoking article in the current Medical Journal of Australia, titled A Pandora’s box: sustainable pharmaceutical supply (abstract only free).
One of the authors, Dr Simon Quilty, an Advanced Trainee in General Medicine at John Hunter Hospital at Newcastle, explores some of the issues in the article below for Croakey readers.
(Update, 10 Nov: The article was also co-authored by: Alison Jones, Dean of the Graduate School of Medicine, University of Wollongong, and Forbes McGain, intensive care physician at Western Health, Melbourne.)
Why the supply of medicines is a current and future concern
Simon Quilty writes:
Four weeks ago, for the first time in six decades benzylpenicillin disappeared from our hospital shelves.
Benzylpenicillin has a strong history here – it was invented in part by an Australian, and Australia was the first nation to commercially manufacture and provide its curative power to the civilian population.
The solution to the recent shortage was to find another supplier overseas. Manufacturing our way out of this problem was never a solution as it is no longer technically feasible – we now produce less than 5% of the medicines we use.
Luckily there were a number of other antibiotic substitutes to fill the gaps whilst the TGA managed to quickly source an alternative supplier. No lives were lost.
Benzylpenicillin isn’t the only medication in short supply.
At the moment, Pfizer has 14 medications including five chemotherapy drugs in short supply in their stock holdings. There are at least half a dozen other medications that are either in short supply or unavailable in Australian hospitals that we know of, and it is not currently possible to determine how many medicines are running low on distributors’ shelves.
This is an international problem – in the US, the American Society of Health System Pharmacists currently lists 207 medicines as being in short supply, with the total number of shortages to date this year being five times as many as in 2006.
There are no mechanisms of tracking or anticipating drug shortages in Australia but the trend is almost certainly the same, we are simply unaware of the problem because no-one is watching.
In a study that we have published this week in the Medical Journal of Australia, we have demonstrated that generally speaking, it is medicines used in acute settings such as antibiotics and intravenous fluids that are most vulnerable to unpredictable shortages.
Other vulnerable classes include anti-cancer chemotherapies, and it is these that are now running very low in the US as described in the New England Journal of Medicine last week.
The reasons for these shortages are complex – manufacturing problems, shortages of ingredients, increasing global demand from countries such as China where the population being able to afford such drugs is rapidly growing. Injectable drugs which require more sophisticated manufacturing processes are particularly vulnerable due to the complexities of setting up a plant and the subsequent disincentives for manufacturers to make them.
However, the forces driving global shortages of cheap generic drugs – those that are off-patent and have been available for decades – are of simple economics.
The less profitable a drug becomes the less attractive it is for pharmaceutical companies to make and the more likely it is to be mass-produced in factories in China and India where labour is cheap, demand is high and profits can be maximized. Essentially what is happening is a convergence of manufacturing of the cheapest but arguably most useful medicines to less than a few factories worldwide.
The end result is market failure, and the recent shortage of benzylpenicillin is a precursor of things to come. Any generic minimally profitable drug is vulnerable to suddenly disappearing from pharmacy shelves, and as it stands at the moment in Australia, also without any warning. Insulin, anti-epileptics, chemotherapies, vaccines, heart drugs and so on.
It’s not just drugs that could be in short supply in the near future.
If you are unfortunate enough today to cut your finger and require a single suture, when the hospital doctor opens a suture kit pre-packed in China, she will hold the wound with stainless steel forceps, guide the needle using stainless steel suture holders before cutting the nylon string with a perfect pair of stainless steel scissors. Then she’ll chuck everything, including the 150grams of barely bloodstained steel into the bin.
The simple economic argument behind this wasteful process of disposables in medicine is undeniable, but what this argument does not include are the unseen costs – the loss of investment in sterilization capacity in a hospital, the newfound reliance on manufacturers of these kits, and the significant increase in contaminated waste disposal that hospitals are struggling to control.
When we choose to import medicines or medical hardware to save money, it always comes with unforeseen costs, particularly when foreign manufacturers themselves make very small profits from these.
The most obvious costs are the uncertainty of supply of a minimally profitable good and the disinvestment in Australian industrial and technical capacity. These indirect costs are only recognized when markets fail and it is only at this point that the immense challenges of re-instituting local manufacture are realized.
The global market is a vast resource from which we all benefit, and self-sustainability is not only utterly unachievable but also undesirable.
However, Australia should recognize its vulnerabilities and invest in strategic ways to secure the essentials of healthcare for future generations.
In terms of drugs, we should have a national list of essential medicines to focus on secure supply of the most important and usually cheapest medical options.
Pharmaceutical companies and industries that make medical products within Australia should be supported with a longer-term objective of diversifying the international market.
And the medical profession itself needs to start investing in sustainability and how it wishes to hand the profession to the next generation of doctors and their patients – the ideal of curing all disease is much less realistic than the hope of sustaining current practice.