Requiem for a drug: undersupply of pharmaceuticals in the UK

Cas Gudgeon SciTech Editor

There have been increasing reports of significant shortages of pharmaceuticals in the UK and across the globe. A recent survey of 1,562 UK-based pharmacists found that 54% of respondents believed medicine shortages were pu ing patients at risk, and a further 25% of pharmacists felt unsure about the effects of such shortages. Last year, the UK government issued medicine supply notifications for a wide range of drugs, including specific formulations for medicines used to treat conditions such as bipolar disorder, prostate cancer, and endometriosis.

Among the many drugs which were reported to be affected by shortages, life-saving medications such as alendronic acid (used to treat osteoporosis) and semaglutide (a type 2 diabetes medication) featured prominently. In May 2022, the UK government also issued over a dozen serious shortage protocols for hormone replacement therapy (HRT) products, meaning that pharmacists were permi ed to restrict patients’ prescriptions, and make substitutions without first consulting with patients’ GPs.

One pharmacist, works in a hospital in England, explained that the shortages were affecting patients in palliative care. “There was no alternative for one patient who had to deal with an additional symptom in his last days of life due to lack of available treatment.”

Another GP pharmacist said they were “always firefighting”, adding: “Presently, hardly a week goes by without at least one pharmacy asking us to give an alternative. Such requests are often not easy to navigate and can sometimes be quite dangerous. It creates a lot of stress to both patients and professionals alike.”

Other notable examples of drugs affected by supply deficits included painkillers such as eletriptan, which is indicated for migraines, as well as epidural kits and the opioid remifentanil, both of which are used for pain management during childbirth.

The oral suspension of paroxetine (brand name Seroxat), an antidepressant, was also discontinued by GSK in 2022, resulting in more governmental medicine supply notifications. The discontinuation of the paroxetine product was met with frustration and ‘horror’ by patients, who noted the importance of the oral suspension in safely tapering off of the medication.

Sarah Tilley, in correspondence with The Pharmaceutical Journal, said “Many people trying to wean off Seroxat know how vital it is to get hold of the liquid version of the drug to help facilitate a safe and gradual taper [...] The decision to stop making liquid Seroxat is both concerning and hugely disruptive for those trying to come off.”

Another correspondent said that they had started taking Seroxat in their early twenties, and had been trying to taper off of the medication since 2004. “For my latest a empt to stop Seroxat, starting from 20 mg in 2018, I have used the oral suspension form to follow a hyperbolic taper. Doing so lets me precisely measure doses, avoids the risks of crushing tablets to make my own suspension, and is quicker and easier to order from my GP.”

Contractors are reporting problems obtaining more and more drugs

Just a few months after the announcement, The Economist published a piece titled, ‘Most people on antidepressants don’t need them’, citing a recent trial in Britain with 478 participants , which found that 44% of patients were able to discontinue antidepressant use without experiencing relapse within a year. The participants were longterm users of antidepressants (≥9 months of use), who had experienced multiple depressive episodes but felt well enough to consider stopping their medication. Though the claim is controversial, it’s clear that the abrupt withdrawal of these medications from the market poses a credible threat to patients who may wish to safely discontinue their use of antidepressant medications – and in the future one might reasonably expect more patients to turn away from antidepressants, given the growing uncertainty surrounding the widespread use of SSRIs to treat depression.

Across the pond, similar struggles have ensued in the US. Amoxicillin supplies are low in both the UK and the US, and the US Food and Drug Administration (FDA) has reported that 191 drugs – including antibiotics, cancer treatments, ADHD medications, and anaesthetics – are in short supply this month.

But what’s causing these shortages? And how long have they been going on?

In the UK, alarms began to sound over a year ago. In February of 2022, the Pharmaceutical Services Negotiating Commi ee (PSNC) raised the issue of drug procurement with the Department of Health and Social Care (DHSC). Mike Dent, the director of pharmacy funding at the PSNC, told The Pharmaceutical Journal, “Contractors are reporting problems obtaining more and more drugs, with a number of complex factors at play in the supply chain once again.”

In the US, these problems have been apparent since 2011, at least – for the past five years, the American Society of HealthSystem Pharmacists (ASHP) has reported that hundreds of drugs have been in undersupplied in every quarter.

Though Covid-19 contributed to these issues, these issues were prominent well before the pandemic years. Carolyn Wickware (Investigations Editor for The Pharmaceutical Journal) laid out several major factors which have contributed to shortages. One such factor is that the UK is an increasingly una ractive market for medicine manufacturers. For instance, manufacturers which signed up for the 2019 voluntary scheme for branded medicines pricing and access (VPAS) will have their tax rates increased to 26.5% this year. Just two years ago, the VPAS tax rate was 5%.

VPAS is designed to ensure that NHS medicine bills do not increase by more than 2% each year. But the UK is only a small component of the global drug market. Mark Samuels, chief executive of the British Generics Manufacturing Association (BGMA), explained: “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 shareholderowned 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.”

But removing these pricing controls could also have devastating results for the NHS. And the UK isn’t the only country to exert financial pressure on manufacturers. David Taylor, an emeritus professor of pharmaceutical and public health policy at UCL, says various medicine price controls exist across Europe. “It’s only really in [the United States] that you’ve got free pricing.” licenses are lost due to the delay in manufacturing – and even when applications are approved, a two-year delay means that in the meantime, there may be just one supplier for the medicine in question.

Beyond the red tape, an elaborate cocktail of supply chain issues looms over pharmacies. The PNSC a ributes supply issues to staff absence due to Covid-19, post-Brexit trade, and increased oil prices. The resulting shortages have driven up the cost of generics significantly.

A litany of other issues have been cited by pharmaceutical manufacturers and distributors, some of which are related to Covid-19. Samuels also stated, “There’s been a global shortage of shipping containers, and a challenge with shipping containers, not necessarily always being in the right parts of the world.”

“Medicines get no particular priority when it comes to shipping. There’s no preference to medicines over somebody shipping in a container full of socks.”

Marketing authorisation approvals for generic medicines are also a source of frustration for manufacturers. The Medicines and Healthcare Products Regulatory Agency (MHRA) has a ‘sunset clause’, which means that manufacturers will cease to have marketing authorisation for a medicine if the drug is not placed on the UK market for 3

When pharmacists are unable to obtain a generic medicine at its usual price, the NHS pays for more expensive versions of a generic medicine. OpenPrescribing, a project which analyses NHS prescribing data, estimates that over the last 12 months, NHS England spent £257,590,000 on pharmaceutical price concessions. This month, the projected spending for price concessions is £30.7 million. OpenPrescribing also estimates that the total cost of price concessions for the Claypath & University Medical Group in the last year came out to £70,038.

Moreover, price concessions don’t always mean that pharmacies are compensated for cost increases. A pack of temazepam, for example, may cost a pharmacy more than £20 – but the price concessions only subsidise pharmacies at roughly £16, meaning that pharmacies make a loss on certain medications.

A spokesperson for the DHSC said, “We have well established procedures to deal with medicine