Over the past few years, drug shortages have become a regular reality in the NHS and a significant problem for pharmacists and patients
Back in May, a Community Pharmacy England report noted that drug shortages are now at critical levels with patients at risk of immediate harm and even death.
“This all causes worrying delays for patients, and in worst cases it can lead to a deterioration of their health: last year [2023] we surveyed people working in pharmacies and 87% told us that their patients’ health was being put at risk due to medicine supply issues.”
Pharmacists are increasingly having to issue “owings” to patients, whereby they dispense only part of the prescription and ask the patient to come back for the rest of it later, once the pharmacist has sourced the remainder.
A report by The Nuffield Trust in April 2024 found that there are now over double the number of notifications by drug companies warning of impending shortages than there were three years ago: in 2023 there were 1,634 such alerts issued, compared to 648 in 2020.
Charities working with patients have seen increases in helpline calls associated with particular shortages. The Nuffield report notes that Epilepsy Action reported five times as many calls in early 2024 as a year earlier, associated with worrying shortages of the key medications carbamazepine, sodium valproate, and lamotrigine.
The Cystic Fibrosis Trust has been continually updating its information on the shortages of Creon, a vital pancreatic enzyme replacement therapy used by those with CF. There have been issues with supplies across the UK since late 2023. Patients have sometimes had to travel to multiple pharmacies to find Creon and shortages have forced some to make changes to their diet and nutrition.
What happens when there is a shortage of a drug
Medicines supply problems are risk assessed by the DHSC and classified according to their potential impact into one of four ‘clinical escalation categories’, known as tiers.
- Tier 1 (low impact) and tier 2 (medium impact) supply problems can be managed locally, using existing stock, temporary supply controls or the provision of alternative medicines.
- Tier 3 (high impact) supply problems affect medicines with no or limited alternatives, where switching between medicines is difficult or requires monitoring, or where the affected patient group is considered vulnerable.
- Tier 4 (critical) supply problems are likely to have a life-threatening impact and require the support of other agencies.
In response to the Tier 2 category or above the DHSC issues a Serious Shortage Protocol (SSP). The SSP allows the supply of either an alternative quantity, strength, pharmaceutical form or medicine.
This means a pharmacist does not have to refer the patient back to the prescriber and can supply the patient in accordance with the SSP rather than as in the prescription.
In some cases, however, a patient requires a specific medicine. This is often the case for those with epilepsy, where therapeutic or generic equivalents are not suitable, or for treatment requiring biosimilar products, where the medicines would need to be prescribed by brand for clinical reasons. In such cases the pharmacist will have to refer the patient back to the prescriber.
It is sometimes the case that medicines are available, but community pharmacies are unable to source them at prices at or under the reimbursement rates (paid by the NHS). When this is the case the DHSC can offer price concessions, which are temporary increases to the reimbursement price of a medicine that ensures pharmacies can cover the costs of supplying it.
The government can respond to a medicine shortage or risk of shortage by placing restrictions on its export and hoarding (deliberately withholding the supply). In 2019 HRT products were banned from parallel exporting, whereby product is bought in the UK to be exported and sold in another market at a higher price. Multiple SSPs have been issued for HRT products from 2018 to 2023.
What drugs are in short supply?
In mid-August there were active SSPs for quetiapine, a treatment for schizophrenia, psychosis and major depressive disorder, the antibiotic cefalexin, ramipril for hypertension (high blood pressure), and Creon, a pancreatic enzyme replacement therapy.
There have also recently been medicine supply notifications for other products, where the supply situation has not reached the level for an SSP, but is still significant. These include the asthma treatment Flixotide (fluticasone), carbamazepine, for epilepsy and bipolar disorder, ipratropium bromide for asthma, and disopyramide for heart rhythm abnormalities.
Previous SSPs in recent months include a range of HRT products and antibiotics.
Why are there drug shortages?
Shortages of drugs have not been restricted to the UK, they have been a feature of health services across the globe. The reasons are complex, but include:
- manufacturing problems, including shortages of raw materials, issues with industrial capacity and flexibility, medicine recalls and product quality problems
- distribution or logistical problems, including capacity issues international trade barriers and excessive exporting or deliberately withholding the supply of medicines
- increased demand for medicines and/or changing prescribing patterns, in response to changing guidance or health needs, especially where this is unanticipated.
- changes in pricing and drug reimbursement arrangements for medicines.
- Geopolitical factors, such as the Covid-19 pandemic and the war in Ukraine
These factors have caused direct interruptions to production or have led to companies abandoning certain markets due to a lack of profitability. The Nuffield Trust report also noted that there has been a concentration of generic production in India and China and a consequent reduction in the number of companies involved. The market has become generally less flexible with a limited ability to move quickly and for companies to fill in if manufacturers had issues.
In the UK there are additional issues associated with the UK approvals mechanism, drug policy and NHS decisions around reimbursement and pricing and particular changes in demand for certain drugs.
In January 2024, the British Generic Manufacturers Association blamed failures at the Medicines and Healthcare products Regulatory Agency (MHRA) for medicines shortages.
In a letter to the Guardian, the association’s Chief Executive claimed that the MHRA could take up to two-and-a-half years to approve “routine licensing changes”, preventing suppliers from adding stock to the market.
Prices
In terms of prices, the past few years have seen drug prices moving rapidly up as the drug ‘tariff’, the price list for reimbursing pharmacists, was raised during the Covid-19 pandemic (2020/21), when NHS budgets were less constrained. But this was followed by an attempt to squeeze prices back down in 2022/23 as the NHS in England saw its budget more closely controlled. This also coincided with global manufacturing and supply problems. The see-sawing in prices deterred suppliers, who prefer a stable, predictable market, particularly in the low-margin generics industry.
Added to this, the recent period of high inflation resulted in large clawbacks from suppliers of branded medicines under the 2019 voluntary scheme for branded medicines pricing and access (VPAS), agreed between government and industry, that ran until 2023. The VPAS meant that when branded medicine spending rose above an agreed level the DHSC clawed back a percentage of the companies’ profits. By 2023, as inflation pushed prices up, the proportion of the clawback reached 26.5%. This high level may have impacted on the willingness of companies to participate in the UK market.
Brexit
This has been a factor due to its contribution to lowering the value of sterling and removing the UK from EU supply chains. In the future when shortages occur, Brexit means that the UK is now on its own and is not part of the EU’s collective response to shortages. This includes the Critical Medicines Alliance and Voluntary Solidarity Mechanism, led by EU member states to protect themselves from the impact of shortages of medicines.
Awareness
Another factor in the UK was increased public knowledge and media interest in certain disorders and products that results in soaring demand.
In 2015, guidance from the National Institute for Health and Care Excellence (NICE) encouraged more GPs to prescribe HRT as first line treatment for patients. This move, coupled with increased public awareness of menopause symptoms, meant demand for HRT soared and led to widespread product shortages; the number of prescriptions dispensed for these products increased by 40% in the single financial year of 2021/22.
More recently media coverage of Novo-Nordisk’s anti-obesity drugs Ozempic/Wegovy (semaglutide) and its promotion by ‘influencers’ and celebrities has led to a shortage as doctors increased off-label prescribing (when medicines are prescribed to treat a condition or group of patients not named in its existing licence) for weight-loss.
In July 2023 and January 2024 DHSC issued national patient safety alerts in response to ongoing shortages of semaglutide and related drugs.
The alerts advise clinicians to avoid off-label prescribing and prescribing
‘excessive’ quantities of these medicines, to use alternatives in certain
circumstances, and to prioritise some patients who already use these drugs
In early August, the National Pharmacy Association (NPA) warned people not to buy fake Ozempic online. The NPA said people were risking their health by purchasing the drugs without proper checks.
Ozempic is available on the NHS for people with type two diabetes, while Wegovy can be prescribed for weight loss via specialist weight management services, with strict criteria around who can get the drugs.
Calls for changes to the current approach to shortages
The organisation Community Pharmacy England has called for “a full review of the medicines supply market”, including allowing pharmacists to be able to amend prescriptions, and on changes to medicines pricing and the price concessions system.
The Royal Pharmaceutical Society notes that it has had “consistent and widespread feedback” that suggests that SSPs are rarely used and when they are issued, they are “bureaucratic, professionally frustrating and inflexible.”
The RPS has also called for legislative changes that would allow pharmacists “to make minor amendments without a [SSP] protocol”. The society notes that “such substitutions are routine for pharmacists in both secondary care and general practice”, but not allowed for community pharmacists in England. In Scotland and Wales, community pharmacists already have more flexibility to make certain changes to prescriptions without contacting the prescriber.
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