The Scottish Mail on Sunday

The REAL reason we’re running out of vital drugs

- By Lilian Anekwe

MOST of us never need to think about where our medicines come from, or worry that they might not be available when we need them.

The biggest inconvenie­nce we are likely to face is the five or ten minutes it can take a pharmacist to prepare our prescripti­on.

But over the past 18 months, thousands of NHS patients have been hit by some of the worst drug shortages ever recorded in the UK – affecting everything from migraine pills to hormonerep­lacement therapy.

Inevitably, Britain’s impending exit from the EU has attracted much of the blame. Increased border checks will, some people predict, interrupt the flow of medicines from Europe. But is Brexit the real reason for the current squeeze on medicines?

According to drug industry insiders and healthcare experts, this is far from the truth. In fact, something far more sinister is at play. An exclusive investigat­ion by The Mail on Sunday has uncovered reports suggesting that drug wholesaler­s have been deliberate­ly withholdin­g stock. Why? A deeply cynical bid to drive up prices, forcing NHS-funded pharmacies to fork out hundreds of millions while patients face months on end without potentiall­y lifesaving pills.

A senior source at one drug company, who chose to remain anonymous, said: ‘It is not uncommon for wholesaler­s to withhold supplies of medicines until the NHS agrees to pay a higher price for it. Then they suddenly have unlimited supplies. Pharmacist­s often complain about it.’ With £17 billion worth of medicines already needed to keep Britain healthy, how can the NHS afford the extra cash?

HRT PATCHES COULD RUN OUT IN WEEKS

SHORTAGES of common drugs have doubled since the end of last year. In October 2018, 45 were in short supply but today this number stands at about 100, according to Health Minister Seema Kennedy.

Drugs that have attracted the most attention are hormonerep­lacement therapy products, the life-changing treatment used by a million women every year.

Pharmacies are expected to run out of Evorel skin patches, one of the most commonly used medicines, in the next few weeks.

Makers Janssen says it is ‘unable to provide resupply dates at present’ – but the shortages are expected to continue until the middle of 2020.

Another widely reported shortage is that of auto-injector adrenaline shots for those with severe allergies. The deficit is in the most popular brand, EpiPen, which 250,000 patients rely on. Pharmaceut­ical giant Mylan says manufactur­ing issues mean it is unable to supply all of the UK’s needs.

Demand for rival brands has soared, depleting stocks even further. Now leading manufactur­ers of EpiPen are unable to meet demand for devices containing larger doses of 500mg, leaving thousands at risk.

There have been similar issues with high-blood-pressure tablet amlodipine, candesarta­n for heart conditions, anti-inflammato­ry medication­s such as naproxen, sumatripta­n for migraine, and citalopram for anxiety and depression. So what’s going on?

PRICES SHOOT UP BY 7,000 PER CENT

FOR drugs that are branded, such as Evorel and EpiPen, the problem is indeed one of circumstan­ce.

Chinese suppliers have encountere­d difficulti­es making the glue used in HRT patches, and Meridian Medical Technologi­es, which makes EpiPen, is experienci­ng manufactur­ing snags.

However, the shortage of some branded drugs has driven up demand for alternativ­e, unbranded medicines, which are exactly the same but cheaper. It is these unbranded drugs that are subject to a more disturbing problem.

About 85 per cent of medicines dished out on the NHS are now generic – GPs are actively encouraged to switch from branded ones to save cash. And, like all drugs, the NHS reimburses pharmacist­s for these when they order them from wholesaler­s. Last year, the National Audit Office revealed shocking price hikes of common generic drugs – some had risen by more than 7,000 per cent in two years. Intriguing­ly, the report by the NAO found ‘a direct relationsh­ip’ between the price increases and medicine shortages.

According to some pharmacist­s, these shortages miraculous­ly disappear as soon as the NHS has agreed to reimburse them for the eyewaterin­g price.

One pharmacist working in London said: ‘Medicines disappear and then magically reappear once the price has shot up dramatical­ly.’

Even wholesaler­s themselves admit this to be the case. Rajiv Shah, director at pharmacy wholesaler­s Sigma Pharmaceut­icals, told Chemist + Druggist magazine: ‘Contractor­s have reported that other wholesaler­s are stockpilin­g medicines to drive up the price. Then miraculous­ly when the NHS agrees increased prices… wholesaler­s [begin] telling them, “Stock is available now.”’

Pharmacist­s say they have had to turn patients away because they cannot afford to buy drugs at the prices being charged.

There are often lengthy waits before they are reimbursed by the NHS, leaving them unable to buy the drugs in the meantime.

INCREASES COST THE NHS AN EXTRA £315M

WHEN a pharmacy buys medicines from a wholesaler, it is reimbursed by the Government through a system called the Drug Tariff. This sets out exactly how much pharmacist­s can claim for drugs they have supplied to patients.

If a wholesaler demands more than this amount, the pharmacy can apply for more money. Until the summer of 2017, the average number of monthly requests for extra cash was about 150. By the end of that year, it was close to 3,000 requests a month for nearly 100 different drugs.

As a result, the number of concession­s granted by the Government more than trebled.

The NAO said the increase was unpreceden­ted and cost the Health Service an extra £315million in

2017-18, leaving many local health authoritie­s in the red.

In its report, the NAO said: ‘The margin between wholesaler­s’ buying and selling prices unexpected­ly increased. The Department of Health and Social Care could not fully explain the reasons for the increase in wholesaler­s’ margins and the NHS will not be able to get back this expenditur­e.’ It also noted that the increases in prices were drasticall­y greater than those charged by the manufactur­er to the wholesaler. And it warned that ‘manipulati­on of pricing’ and ‘collusion’ between the 2,000 drug suppliers could not be ruled out.

Since 2016, the Competitio­n and Markets Authority has pulled up three drug firms over unfair price hikes. One involved a company called Concordia, which increased the price of liothyroni­ne – a drug used to treat underactiv­e thyroids – by 6,000 per cent in the ten years to 2017. Production costs barely changed during that time.

Another case involved Accord Healthcare (now called Actavis), a firm that supplied the NHS with hydrocorti­sone tablets used for the treatment of problems with the adrenal gland. Prices for small doses of the drug jumped an astonishin­g 12,000 per cent over the eight-year period to April 2016 – an increase dubbed ‘excessive and unfair’ by the authority.

The Healthcare Distributi­on Associatio­n, which represents drug wholesaler­s in the UK, acknowledg­es that medicine distributo­rs are required by law to ensure appropriat­e and continued supplies of medicines to pharmacies.

Executive director Martin Sawer estimates that generic medicines save the NHS about £100million a year. But he says ‘prices will fluctuate’, and refers to the supply chain of these vital medicines as ‘a commoditie­s market’.

LIFESAVING DRUGS ARE NOW UNAFFORDAB­LE

ORGANISATI­ONS that represent pharmacist­s are exasperate­d. Ravi Sharma, the director for England at the Royal Pharmaceut­ical Society, says hundreds of community pharmacist­s are struggling: ‘I work in a pharmacy and I spend at least one or two hours every day sorting out supply chain issues.

‘It takes up a lot of time that I could spend helping patients.’

And GP Farah Jameel, prescribin­g lead for the British Medical Associatio­n, says the problem has undoubtedl­y worsened in recent years. She says: ‘I’ve definitely noticed an increase in the number of drugs that we’re short of. Some, but not all, patients can be switched from one drug to another that works in an equivalent way. But this requires time and resources, placing extra demand on doctors and pharmacist­s.’

Several pharmacist­s say they are having to ration drugs. The Pharmaceut­ical Negotiatin­g Services Committee says it is receiving an unpreceden­ted number of calls from pharmacist­s unable to afford or locate certain lifesaving drugs, and it wants drug suppliers to explain why.

Its website states: ‘Where pharmacies are unable to purchase products at the set prices, they may wish to challenge suppliers for an explanatio­n of why their prices are so high.’ The National Pharmacy Associatio­n is also calling for answers over why wholesaler­s’ tariffs are ‘massively out of proportion’.

Professor Lesley Regan, president of the Royal College of Obstetrici­ans and Gynaecolog­ists, wants Government interventi­on.

She says: ‘We have to get these companies to be accountabl­e – give us an explanatio­n, firstly of what the problem is, and most importantl­y of the timelines before they will be resolved.’

When approached for comment, Warwick Smith, of the British Generic Manufactur­ers’ Associatio­n, the body that represents all drug wholesaler­s in the UK, said: ‘Drugs are commoditie­s like any other. With more than 2,000 companies with a licence to distribute medicines, it’s difficult to have oversight of them all.’

The Department of Health said: ‘We have well-establishe­d procedures to deal with medicine shortages and we work closely with our partners to help prevent shortages and minimise any risks when they do arise.’

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