Drug shortages are on the agenda once again. Heavyweight measures from the Government in recent weeks have included the issue of the first ‘serious shortage protocol’ (SSP) – which allows pharmacists to change fluoxetine formulations without GP involvement – and a ban on exports of 24 drugs (see box, below).
Shortages have been exacerbated by Brexit and concerns over future supply change. But they are not a new phenomenon. Figures from the NHS Specialist Pharmacy Service show that more than 900 formulations have been in short supply in the UK at some point since 2014.
A briefing document issued by the Royal Pharmaceutical Society in Scotland to MSPs at the start of October identified several causes, such as manufacturing problems, the unavailability of key ingredients, global demand, consolidation of drug manufacturers and fluctuation in exchange rates.
The 24 medicines banned from UK export
• Adrenaline autoinjectors
• Three conjugated oestrogen combinations, including formulations with bazedoxifene and medroxypro-gesterone
• 10 oestradiol and oestradiol combination products
• Oestriol • Hepatitis B (rDNA) suspension
• Levonorgestrel • Medroxypro-gesterone
• Oseltamivir • Ospemifene
• Prazosin • Progesterone
• Rivaroxaban • Tibolone
The shortages are also not a uniquely British headache, with countries around the world reporting extensive lists of drugs they are struggling to source.
Yet in the UK we are in the midst of a particularly challenging episode. Drugs already in short supply include HRT, oral contraceptives, epilepsy medicines, NSAIDs, antihypertensives and calcium channel blockers.
And in a recent poll of community pharmacists by Chemist and Druggist, 50% of respondents said they had been struggling to get hold of supplies of painkilling creams and patches.
There doesn’t seem to be any system for warning us in advance about drug shortages
Professor Azeem Majeed
This has a real effect on GPs. Professor Azeem Majeed, head of primary care at Imperial College London, stresses: ‘The first we generally hear about a shortage is when a pharmacy contacts us to say they can’t issue a prescription. This is inconvenient for patients and creates more work for pharmacies and general practices.
‘There doesn’t seem to be any system for warning us in advance about drug shortages.’
GPs bear the brunt
Yet GPs are left with the responsibility of supporting patients when there are shortages. Dr Richard Cook, a GP in Hurstpierpoint, West Sussex, says he now has patients who are on their third or fourth switch of HRT preparation.
He says: ‘You used to get the odd medicine that was occasionally unavailable, but now it’s a daily problem and what seems to be available one week isn’t available the next.
‘HRT and fluoxetine are still problematic but so are many other everyday items such as ear drops and naproxen and certain doses of some ACE inhibitors.’
HRT and fluoxetine are still problematic but so are many other items such as ear drops and naproxen
Dr Richard Cook
He says this is costing GPs valuable time: ‘Each time the pharmacy cannot get hold of something, I would estimate it takes up approximately 10 minutes of practice time and is a real drag for patients.’
Drug shortages have been increasing for a long time. In 2018, the National Audit Office (NAO) found there had been an ‘unprecedented increase in the number of requests from pharmacies for concessionary prices’ in the previous year – which happens when wholesalers increase prices because of drug shortages. Before May 2017 there were fewer than 150 a month, but in November 2017 they peaked at 3,000 a month.
Following the NAO report, new regulations came into force in July 2018, making it mandatory for drug companies to notify the Government if they expect a supply shortage.
But an inquiry by MPs on the Public Accounts Committee warned the law ‘only applies if a company itself judges that its actions will affect patients’ and that it ‘does not give the Department of Health and Social Care any control over which medicines companies notify it’.
The monthly price concession list, which logs medicines the Department of Health and Social Care has agreed to pay more for because of stock problems in England, can provide an indication of which drugs will be difficult to source.
In September, 45 drugs were listed. But fluoxetine did not appear. Yet at the end of the month the DHSC asked GPs to contact patients taking fluoxetine because there were shortages of 10mg, 30mg and 40mg capsules.
It can be distressing to change brands of a product every month
A week later the first SSP was issued – following a legal amendment during the summer – enabling pharmacists to change formulations for fluoxetine without referring the patient back to their GP. Today (25 October), this was removed for the 10mg formulations but it remains for 30mg and 40mg formulations.
GP practices say they welcome such measures, but fear they could result in confusion.
Tom Gregory, a GP pharmacist in Somerset, says: ‘I think patients are finding it difficult. It can be distressing to change brands of a product every month or so, and could quite easily cause confusion.’
It is not only patients who are confused – practice staff are also unclear about the details of shortages.
Mr Gregory says: ‘The lack of information and understanding is probably the hardest thing. We can’t advise people what may happen when we have no idea ourselves.’
He adds: ‘I’m pleased the SSP exists, but I question the wisdom of choosing something like fluoxetine, which is relatively straightforward given the available options. Where was this last year when naproxen was widely unavailable?’
The SSP – which has now been removed for 10mg fluoxetine tablets – was brought in as part of a range of measures to be deployed in the event of a no-deal Brexit and there are likely to be problems in the coming months. In the Government’s no-deal preparation document Operation Yellowhammer, dated 2 August and leaked mid-September, it was noted that medicines are ‘particularly vulnerable to severe extended delays’.
With an estimated 37 million packets of medicine entering the UK from the EU every month, mostly coming through ports on the south coast, there have been huge concerns in recent months about the additional chaos Brexit may bring.
In the worst-case scenario set out by Yellowhammer, checks at the French-English border would delay lorries by a couple of days, potentially causing severe problems for three months in winter, and disruption for a further six months.
An NAO report on the DHSC’s preparations for a no-deal Brexit, published at the end of September – just weeks before the UK’s scheduled 31 October departure date – also highlighted problems.
It said the DHSC ‘at present has incomplete information about the level of stockpiles’. By mid-October, the Government confirmed 96% of medicine suppliers had sent information on stockpiling.
I think it is almost inevitable Brexit will cause disruption
Dr Samuel Finnikin
Regardless of what happens in the coming months, these warnings have already had an effect.
The UK’s biggest supplier of insulin Novo Nordisk opened two new shipping routes between Denmark and the Netherlands and the north of England and said it would use air routes if needed.
Ministers have also tasked pharmaceutical companies with boosting their usual reserves by six weeks – although this has only been done for 82% of products. The Government itself has ordered 400,000 adult flu vaccinations for stockpiling. Meanwhile there are still concerns patients have been stockpiling medicines themselves, despite (or because of) Government warnings not to.
These Armageddon scenarios may never transpire (or so it seems, based on the direction of travel for the moment) but any flavour of Brexit is likely to affect the supply chain.
Birmingham Dr Samuel Finnikin says GPs will just have to deal with whatever happens: ‘I think it is almost inevitable Brexit will cause disruption – we just don’t know what it will look like. As always, we’ll have to adapt and hope we can mitigate any effect on patients.’
How to manage supply problems
• Ask your LMC to work with the Local Pharmaceutical Committee (LPC) to obtain regular updates on supply problems. This can highlight the reason for the shortage, what alternatives are available and their cost, and when stocks will return to normal.
• Ask your CCG’s medicines management team what steps it is taking and stay up to date on supply disruption.
• Consider appointing a pharmacist. They can make a big difference to medication reviews and optimisation, and liaise with local pharmacies about supply problems.
Professor Azeem Majeed is a GP and professor of primary care at Imperial College