Shutterstock.com
Manufacturers reported the highest number of medicine shortages to the government in July 2022 for nearly two years, official data have revealed.
The 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.
In response to a freedom of information (FOI) request from The Pharmaceutical Journal, the Department of Health and Social Care (DHSC) said it had received a total of 2,401 notifications of shortages from drug manufacturers through its discontinuations and shortages (DaSH) portal, as of 31 August 2022.
This peaked in July 2022, when 206 reports of medicine shortages were made — the highest number of reported shortages since the DaSH portal opened in October 2020, following the enactment of the Health Service Products (Provision and Disclosure of Information) Regulations in July 2018.
The number of shortages reported to the portal subsequently decreased to 137 in August 2022 — the most recent monthly data provided by the DHSC.
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 the 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 revealed that 1,665 reports of medicine discontinuations were received through the DaSH portal between 1 October 2020 and 31 August 2022, with the highest number occurring in August 2021, when 673 medicines were reported to face discontinuation.
However, the DHSC clarified in its FOI response “that not all discontinuation notifications result in actual discontinuations and that, in some cases, the notifications are subsequently withdrawn”.
Mark Samuels, chief executive officer of the British Generic Manufacturers Association, told The Pharmaceutical Journal that some medicines are being preferentially sold to other countries, owing to the UK’s increasing taxation through the 2019 voluntary scheme for branded medicines pricing and access (VPAS).
The VPAS requires manufacturers to pay a tax on profits made on selling certain medicines to the NHS, including branded generics. In 2022, this tax increased to 15%, from 5% in 2021.
“So, if it’s a branded generic that’s subject to VPAS, and therefore the margin on that product in the UK is extremely slim, and there’s a finite amount of stock, then global headquarters of shareholder-owned companies are going to prioritise other countries over the UK if they make a negligible margin in the UK as a result of the VPAS rate,” said Samuels.
He added that, as of May 2022, profits are also being impacted by rising energy costs for manufacturers and an increase in shipping costs since 2021.
“That combination of factors all makes it a very unhelpful situation in terms of medicine supply for the UK,” he said.
Mike Dent, director of pharmacy funding at at the Pharmaceutical Services Negotiating Committee (PSNC), said the organisation “has been extremely concerned about the surge in medicine supply issues [in 2022]”.
“The DaSH data corresponds with a spike in the contractor reports we received about shortages over the summer. However, the medicines market was already fragile and there are a number of other issues also affecting the supply chain,” he said.
“It is encouraging that DHSC has more oversight of the medicines supply chain than ever before; however, pharmacies are often left having to explain the situation to frustrated patients.”
A spokesperson for the DHSC said that a notification on the DaSH portal does not always materialise into a problem with the supply of a medication, as the issue is frequently mitigated before it arises.
“We have well established procedures to deal with medicine supply issues and work closely with industry, the NHS and others to help prevent shortages so that patients continue to have access to the medicines they need,” they said.
However, more than half of pharmacists responding to The Pharmaceutical Journal’s annual salary and job satisfaction survey in July 2022 said that medicine shortages have put patients at risk “in the past six months”.
The spokesperson for the DHSC added that medicine supply problems can occur for several reasons, such as manufacturing difficulties, regulatory problems, problems with the supply of raw materials, sudden demand spikes, or from issues that are related to the distribution of the product.
