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Media And Political Bulletin – 18 October 2018

Media and Political Bulletin

18 October 2018

Media Summary

NHS cannot be ‘confident’ about medicine supplies after a no-deal Brexit, senior official admits

The Independent, Rob Merrick, 17 October 2018

The Independent reports that Sir Chris Wormald, Permanent Secretary to the Department of Health, has warned that maintaining supplies would be ‘very complex’ if the UK crashes out of the EU, stating that ‘I never use words like confident.’

Sir Chris warned that there were also major concerns about staff shortages and the treatment of British travelers to the EU after Brexit.

‘Those are the three things that keep me awake on this subject,’ he said – telling the inquiry that was the case whether the UK and the EU strike a withdrawal deal or not.

The comments came despite Theresa May, a few hours later, insisting the department was working to ensure ‘we have plans in place’ to keep medicines flowing, even in the absence of a deal.

Pharmacies to ‘validate’ which patients get adrenaline auto-injectors

Chemist and Druggist, Grace Lewis, 17 October 2018

Chemist and Druggist reports that pharmacies are being asked to ‘validate’ whether patients are in urgent need of adrenaline 150 microgram auto-injectors as England faces a ‘critical supply issue.’

The article reports that in joint guidance from the Department of Health and Social Care and NHS England published earlier this week pharmacists have been told they ‘must’ follow its flow chart of questions – ‘unless there is an immediate clinical need’ – to decide whether ‘the prescription should be fulfilled, partially fulfilled, or [the] supply delayed.’

Mylan has been affected by manufacturing issues of its EpiPens ‘for several months’, the DH said. The manufacturer initially warned of supply issues with its 300 microgram EpiPen in May.

However, the supply issues are now ‘most acute’ for the EpiPen Junior 150 microgram device, and Mylan is ‘currently out of stock’. Further supplies are not expected until the end of October, the DH warned.

Pregabalin and gabapentin to be reclassified as controlled drugs

Chemist and Druggist, Isabel Finch, 16 October 2018

Chemist and Druggist also reports on the fact that the Home Office has announced that Pregabalin and gabapentin will be reclassified as class C controlled substances in April 2019.

The drugs – used to treat anxiety, nerve pain and epilepsy – will be placed in schedule 3 under the Misuse of Drugs Regulations 2001, but will be excluded from the requirement to be stored in a safe, the Home Office said.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

NHS cannot be ‘confident’ about medicine supplies after a no-deal Brexit, senior official admits

The Independent, Rob Merrick, 17 October 2018

England’s most senior health official says he cannot be “confident” that essential medicines will still be available after a no-deal Brexit – describing the task as “extremely difficult”.

Maintaining supplies would be “very complex” if the UK crashes out of the EU, Sir Chris Wormald told MPs, adding: “I never use words like confident.”

Sir Chris, the department of health’s permanent secretary, warned there were also major concerns about staff shortages and the treatment of British travellers to the EU after Brexit.

“Those are the three things that keep me awake on this subject,” he said – telling the inquiry that was the case whether the UK and the EU strike a withdrawal deal or not.

The comments came despite Theresa May, a few hours later, insisting the department was working to ensure “we have plans in place” to keep medicines flowing, even in the absence of a deal.

At the same inquiry, the boss of HM Customs and Revenue also warned he “can’t tell you it will all be fine” at Britain’s borders if no Brexit agreement is reached.

Jon Thompson said his French counterparts would not speak to him about the checks they would introduce – with knock-on delays and queues at UK ports – because all negotiations go through Brussels.

It was revealed in July that the government had asked drug firms, to stockpile six weeks of extra supplies, although Dominic Raab, the Brexit secretary, insisted that should not “scare people”.

At the meeting of the Commons Brexit committee, Sir Chris was asked whether he was “confident that the supply of essential medicines will be maintained in the event of no deal”.

After declining to say he was, Sir Chris said his department was “pleased” with the response of pharmaceutical firms, but added: “It’s a very complex market and a very complex supply chain

“As no-one can really predict exactly what will happen, there will be decisions we will have to make along the way.”

Sir Chris added that it would be “extremely difficult” to guarantee that all supplies would be fully maintained.

Meanwhile, Mr Thompson confirmed that the UK would, in the short-term, keep its borders open, because there was “no reason to believe there were different risks from French wine or Spanish tomatoes”.

But he admitted the UK was “in the hands of the French”, who would decide whether to introduce checks at Calais and other ports – inevitably triggering tailbacks on the English side of the Channel.

“We don’t know how Calais might behave,” Mr Thomson said, adding: “They won’t have a conversation at all.”

And Bernadette Kelly, permanent secretary at the department for transport, refused to echo Chris Grayling’s “categorical assurance” that flights will not be grounded – saying only that the chances were “very low”.

Asked if contracts had been signed for portable toilets for lorry drivers held up on motorways in the south east, she told MPs “necessary arrangements” were being made.

Pharmacies to ‘validate’ which patients get adrenaline auto-injectors

Chemist and Druggist, Grace Lewis, 17 October 2018

Pharmacies are being asked to “validate” whether patients are in urgent need of adrenaline 150 microgram auto-injectors as England faces a “critical supply issue”.

In joint guidance from the Department of Health and Social Care (DH) and NHS England published yesterday (October 16), pharmacists have been told they “must” follow its flow chart of questions – “unless there is an immediate clinical need” – to decide whether “the prescription should be fulfilled, partially fulfilled, or [the] supply delayed”.

The DH’s “dispenser validation protocol” advises conserving supplies to dispense to “children weighing 25kg or less, with the greatest short-term need”, but stresses that “all patients need to have access to a minimum of two 150 microgram adrenaline auto-injectors”.

Pharmacists are advised to delay supply to patients under 25kg who already have two or more auto-injectors – “not including at school or nursery”.

“The purpose of the validation is to ensure that every eligible patient has at least one in-date device and that a situation is avoided where some patients have two in-date devices, whilst others have none,” the DH explained.

“This can only be achieved by restricting issue of new devices until further notice,” it added.

Delays until the end of the year

Mylan has been affected by manufacturing issues of its EpiPens “for several months”, the DH said. The manufacturer initially warned of supply issues with its 300 microgram EpiPen in May.

However, the supply issues are now “most acute” for the EpiPen Junior 150 microgram device, and Mylan is “currently out of stock”. Further supplies are not expected until the end of October, the DH warned.

Manufacturers Bausch and Lomb, and ALK, are “working with their supply chains to increase supplies” of their alternative junior auto-injectors, Emerade 150 microgram and Jext 150 microgram, the DH added.

However, the extra supplies issued to UK wholesalers this week will not be “sufficient to fulfil normal demand”.

“In addition, it is anticipated that there will be a backlog of patients with prescriptions to be dispensed from August and September”, which means “there may be ongoing constraints until the end of the year”, the DH warned.

See the Pharmaceutical Services Negotiating Committee website for its advice on the patient validation protocol.

Pregabalin and gabapentin to be reclassified as controlled drugs

Chemist and Druggist, Isabel Finch, 16 October 2018

Pregabalin and gabapentin will be reclassified as class C controlled substances in April 2019, the Home Office has announced.

The drugs – used to treat anxiety, nerve pain and epilepsy – will be placed in schedule 3 under the Misuse of Drugs Regulations 2001, but will be excluded from the requirement to be stored in a safe, the Home Office said yesterday (October 15).

As controlled drugs, pharmacies will only be able to accept physically-signed prescriptions – rather than electronic copies. Pharmacies must also dispense the drugs within 28 days of the prescription being written, the Home Office stressed.

The decision follows the results of a consultation, which the Home Office launched in November after the Advisory Council on Misuse of Drugs raised concerns.

Victoria Atkins, minister for crime, safeguarding and vulnerability, said: “We accepted expert advice and will now change the law to help prevent misuse of pregabalin.”

Regulations implementing the law change will be laid before parliament tomorrow, ready for the reclassification of both medicines in April 2019, the Home Office added.

Costs of safes “considerable”

The Home Office acknowledged that its original “preferred option” to require reclassified pregabalin and gabapentin to be stored in safes, “would be disproportionate and result in considerable costs, owing to the need to buy and install new controlled drug cabinets in many organisations”.

By removing the “safe custody requirements”, the extra cost for pharmacies to implement the reclassification is “negligible”, as measures would be the same for other medicines such as tramadol, it said.

“It is assumed that it will take health professionals five minutes to acquaint themselves with the new classification of the drugs,” it said.

RPS: “Positive step”

Royal Pharmaceutical Society (RPS) president Ash Soni said the reclassification would be regarded as a “positive step” by pharmacists, as the dispensing restrictions are designed to improve patient safety.

“It is likely there will be some reduction in the prescribing of these drugs and pharmacies will need support in managing their stock holding to ensure they meet patient demand, but not end up with significant stocks that go out of date,” Mr Soni said.

“The fact that this is being notified in advance will help with this, but it will be important for all health professionals to be aware of the change and to start to support patients in understanding the changes,” he added.

Media And Political Bulletin – 18 October 2018

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