In our featured interview this month, former deputy chief pharmaceutical officer Bruce Warner gave The Pharmaceutical Journal a rare glimpse of hope for the future of medicine shortages.
While the issue will never be eradicated, Warner says that the situation can be improved by implementing systems and processes that keep the impact on patients “reduced to the absolute minimum”.
Warner is leading on an upcoming report to be published on 26 November 2024 from the Royal Pharmaceutical Society (RPS), which promises a series of recommendations aimed to at least ease the burden of shortages on both patients and healthcare professionals.
The report will follow a similar one that was published by the British Generics Manufacturing Association (BGMA) on 1 October 2024. Titled ‘Solutions to medicines shortages’, the BGMA report focuses on recommendations around changes to the contractual arrangements made between NHS trusts and medicine manufacturers. It calls for suppliers to be scored based on their past performance with supply chain resilience and on “whether supply issues were reported with adequate notice”. Manufacturers that score well in these areas should be favoured to win medicine supply contracts tendered by the NHS.
However, suppliers are not always in control of how resilient their supply chain is. For example, manufacturers of pancreatic enzyme replacement therapies (PERT) — for patients with pancreatic exocrine insufficiency, commonly found in those with pancreatitis, pancreatic cancer and cystic fibrosis (CF) — are at the mercy of the pig farming industry. Pancreatic enzymes found in pigs are the closest in function to the enzymes found in humans. The pork industry is increasingly responding to consumer demands for leaner cuts of meat by producing leaner pigs, which have fewer enzymes available. Low enzyme supplies have led to a severe shortage of PERT products that is expected to last into 2026.
Mitigating actions either need to be taken on an international scale — or we need to isolate supply chains from global market forces
The impact of this shortage on patients has been colossal. Survey results published by the Cystic Fibrosis Trust in November 2024 revealed that one-fifth of people with CF have said they have lost weight owing to an inability to fulfil their PERT prescriptions.
This is just one example of how a medicine shortage has devolved into a patient safety concern amid circumstances out of the control of those working in the medicines supply chain. There are likely to be many others, as patient safety concerns linked to shortages increase. Our salary and job satisfaction survey for 2024 found that nearly seven in ten pharmacists believe medicine shortages are putting patients at risk — a 14-percentage point increase on The Pharmaceutical Journal’s 2022 survey, which revealed that 54% of pharmacists believed the same.
If, as Warner says in his interview, the crux of the growing problem lies in our exposure to a global market with influences outside of our control, then mitigating actions either need to be taken on an international scale — or we need to isolate supply chains from global market forces.
The former will be challenging post-Brexit. A report published by the Nuffield Trust in April 2024 says that, although Brexit has not caused a spike in medicine shortages, “it is likely to significantly weaken the UK’s ability to respond to them by splitting it from European supply chains, authorisations and collective efforts to respond to shortages”. The European Medicines Agency launched a ‘solidarity mechanism’ in October 2023, enabling EU countries experiencing a critical medicine shortage to request supplies from other EU countries. This means that other EU countries would likely benefit from measures taken by France, for example, to increase its own production of 50 medicines, including antibiotics, anaesthetics and cancer drugs — a process known as ‘reshoring’.
Reshoring is not a novel concept for the UK pharmaceutical industry, but it continues to be a contentious one. In 2020, Accord Healthcare announced plans to move production of hydroxychloroquine — which was being trialled as a COVID-19 treatment at the time — to the UK from abroad to combat potential shortages. The move coincided with evidence heard by House of Commons International Trade Committee from Sam Roscoe, senior lecturer in operations management at the University of Sussex, on the medicines supply chain. He posited the UK should consider “a parallel supply chain where we are able to develop manufacturing capacity to make critical drugs in the UK” in the event of a shortage.
While the UK may not have the market value to attract enough manufacturing business to reshore entire supply chains for certain products, even sheltering a proportion of the supply would provide a fail-safe in the event of a critical shortage
However, Rick Greville, distribution and supply director at the Association of the British Pharmaceutical Industry, argues that the UK market is too small to justify manufacturing within its own territory, unlike France, which has the market of the EU behind it. “The UK market is about 2.5% or 3.0% of the global market, so it isn’t that big in terms of decision-making in global companies,” says Greville.
The parallel supply chain that Roscoe put forward should be reviewed and reconsidered in the context of increasingly complicated market forces outside of industry control. While the UK may not have the market value to attract enough manufacturing business to reshore entire supply chains for certain products, even sheltering a proportion of the supply would provide a fail-safe in the event of a critical shortage.
With the number of medicine shortage alerts growing year-on-year, every avenue must be explored to meet Warner’s goal of ensuring that patient harm is “reduced to the absolute minimum”. PJ
