News

Media And Political Bulletin – 8 November 2018

Media and Political Bulletin

8 November 2018

Media Summary

NHS is increasing fridge capacity to STOCKPILE medicines in case of no-deal Brexit

The Daily Express, Katie Weston, 8 November 2018

The Daily Express report that Health Secretary Matt Hancock has revealed the Government are increasing fridge capacity to stockpile medicines for the NHS.

Mr Hancock said: “Well we are building refrigerator capacity right now, even though we will get a deal and I’m confident we will get a deal.”

The Health Secretary asked the public not to stockpile medicine in the case of a no-deal Brexit, ensuring the Government will work with the pharmaceutical industry to meet demand.

Health Secretary Matt Hancock ensuring ‘more refrigerated capacity for medicines’ ahead of Brexit

ITV News, no author, 7 November 2018

ITV News reported that Health Secretary Matt Hancock has reiterated provisions are being made in the event of a no deal Brexit.

Speaking on Peston, he confirmed the Government is building refrigerated capacity: “Even though yes we think that we will get a deal and I’m confident we will get a deal, we are making sure that we have more refrigerated capacity for medicines.”

Mr Hancock also warned the public not to panic about securing prescriptions ahead of the UK leaving the European Union on 29 March 2019.

Health groups warn Brexit drugs supply risk at code ‘red’

Politico, Helen Collis, 7 November 2018

Politico reported that National Health Service providers, pharmaceutical companies and patient groups wrote to the government to warn that Britain is seriously unprepared to maintain access to medicines if there are border delays after Brexit.

In the leaked private letter to Health and Social Care Secretary Matt Hancock obtained by POLITICO, eight organizations said industry has done all it can in preparing for a cliff-edge Brexit — and that the government needed to take action to prevent widespread drug shortages.

Matt Hancock responded to shortage concerns during his appearance on ITV’s Peston on 7 November 2018: https://twitter.com/itvpeston/status/1060273662614417408.

DDA: hold fire on buying FMD tech

Dispensing Doctors’ Association, Ailsa Colquhoun, 7 November 2018

The Dispensing Doctors’ Association (DDA) is reiterating advice that dispensing practices should not commit to buying Falsified Medicines Directive (FMD) software until NHS England has finalised funding available from GP IT Futures.

Read the full presentation from Claymore Richardson, senior policy manager: pharmacy, Department of Health and Social Care.

Stock levels sufficient for at least two adrenaline auto-injectors per prescription

The Pharmaceutical Journal, no author, 7 November 2018

The Pharmaceutical Journal reported that according to a revised interim protocol issued by the Department of Health and Social Care (DHSC), patients presenting with a prescription can now be given at least two adrenaline 150 microgram auto-injectors that are either in date or have a formally extended expiry date.

The revised protocol, issued by the DHSC on 5 November 2018, says that while stock levels are now sufficient, supplies may be constrained until the end of 2018 owing to a backlog of patients requiring prescriptions. The existing dispenser and wholesaler prescription validation processes will continue for all adrenaline 150 microgram auto-injector prescriptions.

Parliamentary Coverage

An updated version of the MHRA’s document Medicines: new manufacturing and wholesale dealer licences has been uploaded.

A new version of the MHRA’s document Medicines: terminated and cancelled manufacturing and wholesale dealer licences has been uploaded.

Full Coverage

NHS is increasing fridge capacity to STOCKPILE medicines in case of no-deal Brexit

The Daily Express, Katie Weston, 8 November 2018

Health Secretary Matt Hancock confirmed the Government is increasing refrigerator capacity for medicines in anticipation of a no-deal Brexit.

The Government are increasing fridge capacity to stockpile medicines for the NHS, revealed Matt Hancock.

ITV’s Robert Peston said: “A lot of these medicines need to be refrigerated and they don’t even have the refrigerating capacity.”

Mr Hancock said: “Well we are building refrigerator capacity right now, even though we will get a deal and I’m confident we will get a deal.

“We are making sure we have more refrigerated capacity, we announced that last week.”

The Health Secretary asked the public not to stockpile medicine in the case of a no-deal Brexit, ensuring the Government will work with the pharmaceutical industry to meet demand.

He added: “Our goal is to ensure that in any Brexit deal, or no-deal, that people can get the unhindered access to our medicines that they need and that is what we’re going to achieve.

“We are working very closely with the pharmaceutical industry to make sure that happens. The argument is that if the delay is longer than the current six week assumption, then we’ll have to go about this through different ways.

“You can’t have stockpiles for enormous lengths of delays, what you need is a different route, but all of this is doable, it is difficult, there’s a lot of work going on already to make it happen.”

It comes after Brexit Secretary Dominic Raab told a cross-party committee of MPs the end of negotiations are now “firmly in sight”.

Mr Raab said: “I would be happy to give evidence to the committee when a deal is finished and currently expect November 21 to be suitable.”

The Brexit Department has said there was “no set date” for the negotiations to conclude and said Mr Raab’s November 21 date related to the possibility of appearing before the Brexit Select Committee.

Shadow Brexit secretary Sir Keir Starmer tweeted: “This must be one of the quickest u-turns in political history.

Dominic Raab told MPs that a Brexit deal would be done by the end of November. Three hours later his own department was forced to correct the record. What a mess.”

Negotiations resumed in Brussels on Monday morning but it is unclear if progress has been made on the all-important backstop.

Today the EU27 gathered after it emerged Dublin was drawing up plans for a hard Brexit with increased patrols along the border and the revival of checkpoints not used since the dark days of the Troubles.

Ambassadors have been told to “expect an update” on the Irish backstop stalemate, Politico Europe reports.

Health Secretary Matt Hancock ensuring ‘more refrigerated capacity for medicines’ ahead of Brexit

ITV News, no author, 7 November 2018

The Health Secretary has reiterated provisions are being made in the event of a no deal Brexit.

Speaking on Peston, Matt Hancock confirmed the Government is building refrigerated capacity.

“Even though yes we think that we will get a deal and I’m confident we will get a deal, we are making sure that we have more refrigerated capacity for medicines.”

Mr Hancock also warned the public not to panic about securing prescriptions ahead of the UK leaving the European Union on 29 March 2019.

“It’s very important that people don’t go out of their way to have bigger personal stores because the NHS will be supplying unhindered flows of medicines to people in any scenario. That is our clear goal and we are working with the pharmaceutical industry to reach it.”

There has been growing calls for the Government to publish legal advice ensuring ministers are informed of all the facts.

Mr Hancock told ITV News Political Editor Robert Peston that is “not the normal approach”.

“We’ve got a brilliant Attorney General, who sets out the legal position… Well he can answer questions in the Commons, but it’s not normal to publish the legal advice. That’s a decision in exceptional circumstances for the Prime Minister.”

However, this is not a view shared by other Conservatives.

Jacob-Rees Mogg told Robert Peston “there is a concern the Cabinet is not being fully informed.”

“You hear of ministers getting 45 minutes to read crucial documents before Cabinet meetings – this is not a serious constitutional approach.”

Shadow Foreign Secretary Emily Thornberry was also on Peston talking about the Saudi Crown Prince following journalist Jamal Khashoggi’s killing.

She told Robert Peston: “I think because nobody stands up to him, he is out of control. What we would start by doing is we would, and I think the most important thing for us to do… is to stop selling arms to Saudi Arabia that can be used in the war in Yemen because while the murder of Khashoggi was absolutely appalling there are five million children on the verge of starvation in Yemen, their main port is besieged at the moment by the Saudis and we are supplying them with their arms.”

Health groups warn Brexit drugs supply risk at code ‘red’

Politico, Helen Collis, 7 November 2018

The U.K. government’s preparations for maintaining drug supplies in the event of a no-deal Brexit are so lacking that the warning level should be raised to “red,” a group of health organizations has said.

National Health Service providers, pharmaceutical companies and patient groups wrote to the government to warn that Britain is seriously unprepared to maintain access to medicines if there are border delays after Brexit.

In the leaked private letter to Health and Social Care Secretary Matt Hancock obtained by POLITICO, eight organizations said industry has done all it can in preparing for a cliff-edge Brexit — and that the government needed to take action to prevent widespread drug shortages.

“If this is the reality of U.K. government preparation for No Deal we do not believe that the current medicine supply plans will suffice, and we will have widespread shortages if we do not respond urgently,” the letter dated October 31 said.

Expressing support for Hancock’s “efforts to raise the warning level in Government,” the organizations said: “Only when we start to work through options will we all know where we are, but on medicines supply, on what we know and can glean from public information, we think we are at ‘red’.”

The groups called on the government to be more transparent “and reveal what cover we have by therapy area and where there are gaps,” so that the signatories can “find further creative solutions to shortages, but we need the data to engage.”

They also requested an urgent meeting in the form of a roundtable between ministers and industry.

A spokesperson for the Department of Health and Social Care said in a statement: “The Government is confident of reaching a deal with the EU that benefits patients and the NHS. However, as a responsible Government we are also preparing for a range of potential outcomes in the unlikely event of a no deal.

“As part of our contingency planning, we continue to work closely with pharmaceutical companies and storage providers to ensure the continued supply of critical drug and medicine supplies,” the spokesperson said.

The letter to Hancock was backed by, among others, the Association of the British Pharmaceutical Industry (ABPI), the Association of British HealthTech Industries (ABHI), the BioIndustry Association and the Brexit Health Alliance — a conglomerate of NHS, medical research, industry, patients and public health groups.

“When an incredibly broad group of medical organizations and bodies are telling the government we are at warning level ‘red’, it shows the preparations government has made are both shockingly inadequate and woefully behind,” said Liberal Democrat Brexit spokesperson Tom Brake.

The government in August asked drugmakers to stockpile an extra six weeks-worth of drug supplies in preparation for delays in importing medicines, but companies have since warned storage will be a major hurdle.

Companies advising the government on how to maintain supplies after a no-deal Brexit have signed strict non-disclosure agreements (NDAs) barring them from revealing information.

Outlining the extent of potential disruptions at Britain’s borders, the letter cites reports that U.K. minister David Lidington told the Cabinet the Dover-Calais trade route could be limited to 12 percent of normal capacity for six months after Brexit.

The letter points to a recent report from the National Audit Office that concluded 11 out of 12 critical upgrades to IT systems at the border are at risk of not being delivered on time, and that there is a high risk of failure in the government departments’ border programs for “day one of no deal” due to their scale, complexity and urgency.

With much of the necessary infrastructure unable to be built before March, the timescale is too tight for companies to make the necessary changes, it added.

Matt Hancock responded to shortage concerns during his appearance on ITV’s Peston on 7 November 2018: https://twitter.com/itvpeston/status/1060273662614417408.

DDA: hold fire on buying FMD tech

Dispensing Doctors’ Association, Ailsa Colquhoun, 7 November 2018

The DDA is reiterating advice that dispensing practices should not commit to buying Falsified Medicines Directive (FMD) software until NHS England has finalised funding available from GP IT Futures.

In his presentation to the DDA 2018 conference, Claymore Richardson, senior policy manager: pharmacy, Department of Health and Social Care said that NHS England was “well aware that the FMD is necessary for GPs to fulfil NHS contract” and that conversations over central funding had started. But he said: “This will take some time to implement.”

In his presentation, Mr Richardson also revealed that some European member states have exempted GPs from the FMD decommissioning process. He said that as a result, the Department of Health and Social Care would examine its current position for England’s GPs using the FMD.

He said there was constructive discussion with the DDA to achieve a sensible approach to implementation, although he admitted that full FMD dispensing could be as far as five years away. He said: “There is a long tail in transition.” He could not say when firm implementation guidance would be available, but said that dispensers can sign up for end-user registration via the SecurMed UK Registration Portal.

He reminded delegates that FMD compliance is a regulatory obligation, and that genuine non-compliance could result in criminal sanctions.” Dispensaries need to have a plan in place that shows willingness to comply with the FMD.”

Read the full presentation from Claymore Richardson.

Read the related presentation from Takeda.

Stock levels sufficient for at least two adrenaline auto-injectors per prescription

The Pharmaceutical Journal, no author, 7 November 2018

Patients presenting with a prescription can now be given at least two adrenaline 150 microgram auto-injectors that are either in date or have a formally extended expiry date, according to a revised interim protocol issued by the Department of Health and Social Care (DHSC).

The revised protocol, issued by the DHSC on 5 November 2018, says that while stock levels are now sufficient, supplies may be constrained until the end of 2018 owing to a backlog of patients requiring prescriptions. The existing dispenser and wholesaler prescription validation processes will continue for all adrenaline 150 microgram auto-injector prescriptions.

Pharmacies are being advised to read the DHSC protocol, which also includes a revised flowchart of questions to ask patients aiming to ascertain those who are in most need of supply, and implement the protocol with immediate effect.

The shortage of EpiPens was first highlighted in May 2018 when the UK supplier Mylan identified shortcomings owing to manufacturing problems. Jext and Emerade 0.15mg adrenaline auto-injectors have now also been rapidly depleted as a knock-on effect of supply problems.

Media And Political Bulletin – 8 November 2018

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

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