LEWIS HOUGHTON/SCIENCE PHOTO LIBRARY
The number of times manufacturers alerted the government to potential medicine supply problems increased by 67% between 2021 and 2023, official data have shown.
In response to a freedom of information (FOI) request from The Pharmaceutical Journal, the Department of Health and Social Care (DHSC) said it logged an average of 137 notifications of potential shortages per month from medicines manufacturers during 2023, compared with 82 on average per month in 2021.
The reports were made through the government’s discontinuations and shortages (DaSH) portal, which opened in October 2020, following the introduction of the Health Service Products (Provision and Disclosure of Information) Regulations in July 2018.
Under the 2018 regulations, manufacturers are required to provide information to the health and social care secretary about the purchase, supply, price and availability of medicinal products, including whether there are any shortages or discontinuations of medicines.
A review of the legislation, published by the DHSC on 12 August 2022, said DaSH was set up to “improve the process by which marketing authorisation holders of relevant products notify DHSC of potential shortages and discontinuations which may affect the supply of their medicines marketed in the UK”.
The data obtained from the DHSC also showed that 135 notifications of shortages were logged on average per month through the portal in 2022.
The Pharmaceutical Journal revealed in October 2022 that manufacturers had reported 210 medicine shortages during July 2022 — which remains the highest number of reports for any month since the portal opened.
The July 2022 shortages were reported in the same month that pharmacy negotiators warned the government that they were becoming “increasingly concerned” about sustained pressures on medicines supply, and a month before the government granted a record number of price concessions for community pharmacy.
While the monthly average number of supply issues has increased year on year, the data also show that the number of notifications made ahead of discontinuing a medicine decreased by 71% between 2021 and 2023.
In 2021, the portal included 109 reports of discontinuations on average each month from manufacturers, compared with an average of 32 each month in 2023.
Commenting on the increase in shortage reports, Mark Samuels, chief executive of the British Generic Manufacturers Association, said the data are “consistent” with its own data on medicine shortages obtained from the DHSC.
“The number of shortages is roughly double what it was a year ago, so there has been a steady increase,” he said.
“The underlying symptom is that we need a more supportive policy environment for generic medicines in the UK. That ranges from making sure that the [Medicines and Healthcare products Regulatory Agency] is licensing new biosimilar and generic medicines without the immense delay that we have now, all the way through to things like domestic manufacturing, where the Trade and Cooperation Agreement that we have with the EU is a big disincentive to manufacturing in the UK.”
Explaining the agreement with the EU, Samuels said: “At the moment, if you manufacture a medicine in the EU, you can export it to the UK, but if you manufacture it in the UK, you can’t export it to the EU — that disincentivises anyone from investing in domestic manufacturing in the UK, which reduces our agility and ability to supply medicines when there’s a shortage.”
He added that, since the agreement was signed in December 2020, there have been “7,000 job losses across medicine manufacturing as a whole in the UK”.
Claire Anderson, president of the Royal Pharmaceutical Society, said the increase in number of reports “reflects our members’ experiences”.
“Pharmacists are increasingly spending valuable time sourcing medicines, when their time could be better spent with patients. We understand the health implications and patient anxiety when medicines are unavailable or in short supply,” she said.
“Whilst work is being done to mitigate medicine shortages, we want to see a change in the law in England and Wales to help ease some medicine shortages. Enabling community pharmacists to adjust prescriptions, providing patients with different quantities, strengths, or formulations of medicine – such as switching capsules to tablets – without requiring prescriber involvement, will improve timely access to medicines, aligning with hospital pharmacy practices.”
Rick Greville, director of distribution supply chain at the Association of the British Pharmaceutical Industry, said: “Companies take their responsibilities very seriously and are accountable to UK regulators should supplies of their products become unavailable. When shortages happen, companies notify the DHSC as a priority, and DHSC then works with stakeholders to resolve the issue.
“The DaSH portal is an important tool for monitoring and mitigating potential shortages, but we must be careful about how we interpret the data it provides. While this data does show a gradual increase in issues reported over time, this could indicate an escalation in the prospect of shortages — or could just signify an improvement in the use of the tool.
The DaSH portal data follows several high-impact medicine shortages in 2023, including drugs to treat ADHD and GLP-1 receptor agonists.
The Pharmaceutical Journal hosted a roundtable in April 2023 to discuss contributing factors to medicines shortages and potential solutions to the problem.
In June 2023, a survey of 1,578 UK pharmacists by The Pharmaceutical Journal revealed that 57% felt medicines shortages had put patients at risk in the previous six months.
