the NHS is facing shortages of drugs relied on by hundreds of thousands of patients as companies supplying widely-used medications face “unprecedented pressure” with supply chains and red tape, a leading industry body has warned.
An investigation by i has established that manufacturers of dozens of the most commonly used drugs in Britain – known as generics – are struggling with a “perfect storm” of challenges from rocketing costs of raw materials supplied from China and India to claimed delays of up to 18 months to secure approvals from the UK’s medicines regulator.
The British Generic Manufacturers Association (BGMA), whose members supply the NHS with 2.2m packs of medicines per day, said there is a “real risk” that the health service and pharmacies will face further shortages in the coming months similar to the current crisis in the supply of some hormone replacement therapy (HRT) drugs. Some two thirds of pharmacists have already reported they face daily supply issues.
It emerged yesterday that supplies of hay fever medications, are running low in high street chemists because of a shortage of its active ingredient. There are also question marks over the availability of highly specialized compounds, including a drug used to treat eye conditions, a heart arrhythmia medication and a muscle relaxant used in anesthesia.
Some four out five medications used by the NHS are “generics” for which patent protection has expired, allowing the health service to save an estimated £15bn a year on its drugs bill through vastly reduced supply costs. But producers are warning a cocktail of factors is starting to affect the price and availability of pills routinely used by hundreds of thousands of patients.
Mark Samuels, chief executive of the BGMA, told i: “The generic supply chain is under unprecedented pressure. There is a cumulative impact of factors that is unhelpful for the resilience of the NHS supply chain and it does bring a risk of medicine shortages.
“We are in the middle of a HRT shortage at the moment but there are other medicines and other areas that are at risk of terrible shortage. Generic medicines have been taken for granted. It is a complex industry and it is under unprecedented pressure and that does bring a real risk of shortages at the moment.”
Data seen by i shows there are currently just under 50 generic medicines supplied to the NHS in a particular size or strength which are listed as having supply issues – a 25 per cent increase in the last month. Of these 49 drug format, 44 have no equivalent alternative, meaning patients must return to their GP for a fresh prescription from a GP before they can dispense an alternative where available.
A senior executive at one major UK generic manufacturer told i: “It is a perfect storm of supply chain problems and a failure to appreciate that there are very fine margins in a drug being viable to produce or not. We are having to look at our portfolio constantly to see where we can, or can’t, meet supply demands.”
Millions of Britons take at least one prescribed medication daily, meaning that any shortages have the potential to cause widespread disruption.
There is no evidence of a supply threat to the statins, the UK’s most popular class of medication, for which there are nearly 80m prescriptions annually.
However, some 65m prescriptions are given for the most popular type of blood pressure medication, known as renin-angiotensin drugs, while there are 40m prescriptions for the most widely-used class of anti-depressant. Non-opiod painkillers account for 34m prescriptions. There are potential shortages in these types of drugs, though it is impossible to yet know the scale or precise nature – such as medication strength or pack size – of any shortfall.
Separate figures produced by the Pharmaceutical Services Negotiating Committee (PSNC), which represents 11,000 NHS pharmacy contractors, showed 67 drugs were listed in March as medications for which the Government was willing to pay a higher price because of problems such as supply issues. The figure was the highest for any March since 2014. The PSNC revealed last month that 67 per cent of its members were experiencing instability in supply of medications, including painkillers and cancer drugs.
The BGMA said its members were facing swingeing price rises, including a tripling in the cost of precursor chemicals known as active pharmaceutical ingredients (APIs) sourced from abroad and a six-fold increase shipping costs.
Suppliers of a particular class of generic, accounting for ten per cent of all primary care medicines, have also been hit by the tripling of a government levy to 15 per cent of their sale price, threating to wipe out profit margins and make production unviable.
Mr Samuels cited the example of Brexit, where issues created by the Northern Ireland protocol led to pharmaceutical companies giving formal notice that they intended withdraw 2,000 drugs from the province, as an example of the way supply problems can quickly snowball. He said: “Thankfully, we are not in that position [in NI] any more but it does show things can go wrong if we don’t manage them carefully.”
The BGMA also raised concerns at what it said was “exceptional unreliability” in the length of time it was taking for Britain’s medicines watchdog, the Medicines and Healthcare products Regulatory Authority (MHRA), to approve the manufacture of generic drugs. The industry body claimed that in some cases it is taking 18 months to secure approval and questioned whether the MHRA has the resources to fulfill its remit.
The number of patients facing issues with obtaining medications is likely to be at least 500,000, according to another industry body. The Association of Independent Multiple Pharmacies (AIMP) said its members were having to dedicate increasing proportions of their time to trying to source medications.
Dr Leyla Hannbeck, chief executive of AIMP, said: “The pressure of sourcing drug supplies is becoming impossible and this is an issue that really needs to be looked at. Why is that we are getting to the hay fever season and suddenly find we have little supply of a popular medication?
“We are asking for better transparency in the supply chain and need to understand how we are getting into these situations because we don’t want to reach a point where there is a threat to an important medication and we are left facing a life-threatening issue.”
Health Secretary Sajid Javid has appointed Madelaine McTernan, the head of the Covid-19 vaccine task force, to spearhead efforts to tackle a shortage of four HRT drugs which has seen women resort to the black market to secure supplies after a sharp rise in demand. The Government did not immediately respond to a request to comment but it has previously insisted that it has long established procedures to deal with drug shortages and works to minimize disruption “on the few occasions” when they occur.
The MHRA, which is currently undergoing a restructuring, said it regularly accelerated its approval process where a product could be the subject of a shortage to avoid impacts on public health.
Laura Squire, the watchdog’s head of healthcare quality, said: “We will expedite the assessment of applications for new products and changes to existing products in cases where there is an actual or potential shortage of supply of a medicine.”