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EU red tape fuelling UK’s drug shortages: No10 faces pressure to ditch bloc’s pharmacy sharing rule

Britain’s current drug shortages are partly being fuelled by EU red tape that blocks pharmacies from sharing in-stock medicines.

Industry bodies want No10 to ditch the rule so they can trade medications and help end the ‘postcode lottery’ for HRT, blood pressure drugs, antibiotics, and dozens of other medications plagued by supply issues, MailOnline can reveal.

Pharmacies were once allowed to sell up to 5 per cent of their stock to other stores without needing a special licence that costs almost £1,000 a year.

Known as the ‘5 per cent rule’, it enabled individual pharmacies to sell their supplies to ones experiencing high demand. But it was scrapped in 2012 to align the UK with Brussels’ regulations.

Despite the UK leaving the bloc officially at the end of 2020, the rule remains in place.  

Trade bodies argue the 5 per cent rule should be reintroduced immediately, even if it ends up barely making a dent on the current crisis.

Fears are growing that the UK could soon find itself short of painkillers, steroids, anti-depressants and blood pressure medications, too.

The crisis for HRT has left desperate women tipping each other off about pharmacies with supplies, swapping medications in car parks and paying eye-watering premiums online. 

Pharmacy industry groups are calling for No10 to reintroduce a rule allowing pharmacies to more freely share drug supplies that was scrapped to align with EU regulations 

The National Pharmacy Association (NPA), which represents community pharmacists, is one of those calling for the rule to be brought back now the country has left the EU. 

Jasmine Shah, its head of advice and support services, told MailOnline: ‘Pharmacies should also be able to share medicines with each other if one or more run short of a particular line.

‘This flexibility was available to pharmacies until a few years ago but it was curtailed to comply with an EU directive.  

The Mail’s manifesto to fix the HRT crisis 

1. Allow pharmacists to dispense substitutes if the prescribed HRT is out of stock

Currently, if an HRT product is unavailable, a pharmacist cannot substitute another product without consulting the prescribing GP, forcing patients to go back and forth between doctor and pharmacy. This could be avoided if pharmacists are allowed to alter prescriptions themselves. They should also be able to move stock between different pharmacies.

2. End the postcode lottery

Local areas all have different formularies – or lists – of approved HRT products, meaning women face a postcode lottery of treatments. A national list of all approved HRT products would ensure women have equal access, and that alternative treatments are available faster.

3. Immediately introduce the once-a-year payment for HRT medication

An annual prescription payment for HRT, which could save women up to £200 a year, is planned for April 2023. This must be implemented urgently, especially during the cost-of-living squeeze, so all women can afford treatment.

4. Bring forward mandatory requirement for medical students to be taught about the menopause

A curriculum change needs to be introduced sooner than January 2023, when it is planned. This will ensure all doctors have the training to recognise menopause symptoms, which will help reduce the rate of misdiagnoses.

5. Provide menopause information to women at their NHS health check

Everyone who doesn’t have a pre-existing medical condition is invited for a free check-up every five years between the ages of 40 and 74. Women should be given information at these health checks to raise awareness of the menopause and treatment options.

‘This should now be reintroduced.’

Labour MP Carolyn Harris, a co-chair of the UK menopause taskforce, also said she supported the reintroduction of pharmacy sharing.

‘In principle, as long as it is limited to 5 per cent, this is a good solution to a problem that thousands of people up and down the country are facing,’ she said.

‘It worked well in the past and would save patients the anxiety of travelling around different pharmacies trying to locate stock themselves.’

However, she added that products need to be available for pharmacies to share and therefore Britain needed to boost its HRT supplies first.

‘Shortage of supply countrywide will not be solved by allowing pharmacies to share medicines if they are simply not available anywhere in the first place,’ she said.

The 5 per cent rule enabled community pharmacies to transfer limited amounts of drugs between each other and other health care providers such as small hospitals without paying for a licence.

This allowed a pharmacy with excess stock of a particular medication to transfer it to other pharmacies that needed them.

However, this exemption was scrapped in 2012 to align with EU legislation which required anyone undertaking such transfers or sales to hold an authorisation to do so. 

With the NPA warning hundreds of community pharmacies are facing closure due to the financial impact of Covid, few can afford the cost of an annual licence.

Four drugs are classified as being in severe shortage by the Pharmaceutical Services Negotiating Committee (PSNC) which negotiates NHS deals with the Government.

Three of these are HRT medications, Oestrogel, Ovestin and Premique.

The other is a specific dosage of the antidepressant called fluoxetine, sold under the brand Prozac.

But 59 other medications are also considered to be in short supply by the PSNC and the Government.

These medications include treatments for hay fever, hypertension as well dosages of antibiotics and painkillers. 

Global demand for these drugs is so high that they have been added to a price concession list.

This list sets the the Government is willing to pay more for drugs prescribed to NHS patients when pharmacists cannot be purchased at the usual price. 

There were about 512,000 NHS prescriptions written for 'female sex hormones and their modulators' in England in February, the latest official data shows, compared to 265,000 in March 2017. Many of these will be HRT medications but some may include other female hormone drugs such as contraceptives

There were about 512,000 NHS prescriptions written for ‘female sex hormones and their modulators’ in England in February, the latest official data shows, compared to 265,000 in March 2017. Many of these will be HRT medications but some may include other female hormone drugs such as contraceptives

These price concessions can range from just 74p for skin creams to treat eczema to £146 per pack for some cancer medications.

It allows pharmacies — which actually do the buying — to claim the additional cost of procuring drugs back when they provide the prescribed medications to patients.

Hormone Replacement Therapy Q&A 

How does HRT work?

Hormone replacement therapy eases symptoms including brain fog, disturbed sleep and hot flushes by replacing hormones that are at a lower level as women approach the menopause. HRT can come in the form of patches, tablets or gels which are available on prescription through the NHS.

How much does it cost?

A single NHS prescription charge costs £9.35, or £18.70 if a woman needs two types of hormones. This is often provided on a short-term basis, meaning regular payments – once a month, or every three. The Government has pledged to make annual prescriptions available, but this won’t be implemented until next April. Many have now resorted to buying HRT for up to eight times the NHS price online.

Why is there a crisis?

NHS England data shows that prescriptions for HRT have more than doubled in five years following an increase in campaigning and media coverage. Besins Healthcare – which makes Oestrogel, used by 30,000 women in the UK – has expressed ‘regrets’ that ‘extraordinary demand’ has led to shortages. Other products have been affected as women switch to alternatives.

What can be done?

The British Menopause Society has advised women struggling to find Oestrogel to discuss other products with their GP. However, some experts have noted that women are often on a particular HRT regime that is specifically tailored to their needs.

Can the pharmacist help?

If a pharmacy is out of stock, a patient must first be referred back to their GP to be given a prescription for an alternative. The Royal Pharmaceutical Society has called for pharmacists to be able to make minor changes to a prescription to provide a suitable alternative. In addition, patients face a postcode lottery as pharmacies often cannot share stock with each other.

Is it dangerous to swap your HRT medicine?

Medical professionals have warned that sharing or swapping HRT products could lead to ‘serious side effects’ that can be debilitating, not least because different products will have different dosages. Trading with others also could mean accidentally using out-of-date medicine.

When will the crisis end?

Besins has said it is doing ‘everything we can’ to increase supplies to wholesalers and pharmacies across the country. The company said it is on track to meet growing demand in June.

What are ministers doing?

The Health Secretary has appointed an HRT tsar to help tackle the crisis. Madelaine McTernan, the woman responsible for securing Covid vaccines for the UK, will lead efforts to address shortages. Sajid Javid said he will leave ‘no stone unturned’ to make sure women get the HRT they need.

This list ballooned to 67 medications in March, one shy of the highest ever recorded number which was 68 in January this year.

While the number of medications on the list, updated monthly, has now dropped to 59 for April, the figure is still above the average over the past decade.

Ms Shah said worsening global drug supply issues were driving the rising number of medications on the list.

‘Supply issues have been escalating year on year and worsening,’ she said.

‘Various factors have increased the fragility of the generic medicines market, such as the consolidation of production of generic medicines at just one or two global manufacturing units,’ she said.

Britain imports many ingredients for medicines from China and India, the former of which has been hit by a number of draconic lockdowns as part of Zero Covid policy that has devastated both its manufacturing and shipping industries.

Manufacturers of dozens of the UK’s most commonly used drugs, such as blood pressure pills, painkillers and anti-depressants, have also reported struggling with a rising costs of raw materials.

Some have also accused No10 of being too fixated with Covid to listen to warning about drug supplies like those used for HRT.

This week the Association of Independent Multiple Pharmacies said the number of patients facing issues with obtaining medications is likely to be at least 500,000.

Ms Shah added the ongoing supply issues meant pharmacists were spending extra time to source medications at permitted prices, and sometimes even being forced to take a gamble on if a drug would later be added to the list.

‘In addition to the increases in workload, the situation has put immense financial pressure on pharmacies that have been forced to purchase medicines at inflated prices without knowing whether they will be adequately reimbursed,’ she said.

‘Pharmacies have displayed great professionalism and put patients first by continuing to supply medicines to patients in good faith, despite knowing that they may be doing so at a loss.’

She also warned that the situation could get worse with consequences for both patients and the taxpayer.

‘If adequate steps are not taken and generic medicine shortages and price increases continue as they are, then there could be detrimental ramifications for community pharmacies, patients, the NHS, taxpayers and the public,’ she said. 

Royal Pharmaceutical Society president, Professor Claire Anderson, is also calling for the rules governing restricting pharmacists to be changed.

‘We spend hours tracking down stock and working together to help patients, but would rather be talking to patients about their health than managing supply problems,’ she said.

One rule she was particularly keen to see changed was for pharmacists to be able to make minor changes to prescriptions if a medication is out of stock.

The current system means if a particular brand or dosage of a drug is unavailable a pharmacist cannot substitute it for another product, without consulting the prescribing GP.

This, as has been the case with some women battling to get HRT, has forced patients to go back-and-forth between their doctor and pharmacist multiple times.

On rising drug shortages a Department of Health and Social Care spokesperson said: ‘The UK has some of the cheapest generic medicines in Europe and good continuity of supply.’

The Government did not respond to pharmacy industry pleas to scrap the EU trade limiting directive.

Health minister Sajid Javid has continually promised action on Britain’s HRT crisis.

Earlier this month he appointed a new HRT tsar Madelaine McTernan who is reportedly working to secure menopause medications from countries with excess supplies in Europe and North America.

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