HDA UK Media and Political Bulletin – 05 January 2021

Media Summary

Covid vaccine: How much supply does the UK have and what’s behind the shortage of dosages?

The Independent, Samuel Lovett, 04 January

With the UK now having licensed two coronavirus vaccines, the Independent reports that supply shortages have raised concerns over whether the government will be able to meet its vaccination target.

It has been reported that enough of the Oxford vaccine has been produced to provide 4 million doses, but some claim that the UK has not yet secured enough “fill and finish” supplies to scale up the rollout. Indeed, a lack of material such as vials and specialised bungs has hampered efforts to get the vaccine bottled up and distributed throughout the four nations.

Prime Minister Boris Johnson has also suggested a limiting factor in expanding the UK’s vaccine rollout is waiting for batches of the jab to be tested. He said: “It’s not so much a manufacturing issue although that’s part of it. Each batch needs to be properly approved and quality controlled.”

MHRA Chief Executive, Dr June Raine, added: “It’s a supply chain that goes right back from the manufacturer, right through to MHRA, and then on to the clinical bedside or where the vaccines are delivered, so we are a step on the road but our capacity is there, I’m very clear about that.”

 

Parliamentary Coverage

House of Commons, Written Answer, 24 December

Stephen Farry (Alliance, North Down): To ask the Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, whether the Draft unilateral declarations by the European Union and the United Kingdom of Great Britain and Northern Ireland in the Withdrawal Agreement Joint Committee on human and veterinary medicines cover medical devices.

Penny Mordaunt (Conservative, Portsmouth North): The Unilateral Declaration on Medicines allows for the phased implementation in Northern Ireland of relevant medicines regulation, and in particular the Falsified Medicines Directive. Medical devices are not subject to the Falsified Medicines Directive and are not in scope of the declaration. Businesses and authorities moving medical devices can make use of the Trade Support Service and the UK Trader Scheme. Full guidance on the regulatory requirements for medical devices are set out on gov.uk. Medical devices will be able to be moved smoothly between Great Britain and Northern Ireland from 1 January 2021.

 

Full Coverage

 

Covid vaccine: How much supply does the UK have and what’s behind the shortage of dosages?

The Independent, Samuel Lovett, 04 January

The UK has now licensed two coronavirus vaccines and has begun administering doses throughout the four nations.

Research has shown that the NHS will need to carry two 2 million vaccinations a week to prevent a third wave of Covid-19, but supply shortages have raised concerns over whether the government will be able to meet this target.

So, how many vaccine doses do we have on the way? And how much is ready to go?

Pre-ordered supplies

The UK’s vaccine taskforce has put together a portfolio of seven different candidates, securing a total of 357 million doses – enough to vaccinate the British population twice over.

So far, two of those seven vaccines have been approved for emergency use by the the Medicines and Healthcare products Regulatory Agency: the Pfizer-BioNTech and Oxford-AstraZeneca jabs. The other candidates remain in development.

Up to 40 million doses of the Pfizer-BioNTech vaccine have been ordered, while 100 million doses of the Oxford jab are set to be delivered to the UK.

Originally, the government said that 10 million doses of the Pfizer vaccine were due by the end of 2020 – a target which was missed.

For the Oxford vaccine, Downing Street said in May of last year that the country would have 30 million doses available by September in preparation for the national rollout.

That figure was later corrected by the vaccine taskforce to 4 million for the end of 2020. However, this target was also not met.

Last week, health secretary Matt Hancock said that the UK had just 530,000 doses of the Oxford for its nationwide rollout on 4 January.

How much vaccine is ready to go?

Pfizer said the number of doses it has now sent to the UK is “in the millions”, while the Department of Health and Social Care said the government had received 22 deliveries of the vaccine as of 25 December.

It is not clear how many doses of the Pfizer-BioNTech candidate are currently available to the population, or how much will be provided in the coming weeks.

Pascal Soriot, the Chief Executive of AstraZeneca, said last Wednesday that the manufacturer was able to produce “1 million doses and beyond” per week of the Oxford vaccine.

Although 530,000 doses are ready for use as of 4 January, the government has said this figure will rise to the “tens of millions” by the end of March.

What’s behind the lack of supplies?

According to reports, enough of the Oxford vaccine has been produced to provide 4 million doses. However, it’s claimed that UK has not yet secured enough “fill and finish” supplies to scale up the rollout.

A lack of material such as vials and specialised bungs has supposedly hampered efforts to get the vaccine bottled up and distributed throughout the four nations.

Professor Jonathan Van-Tam, Deputy Chief Medical Officer for England, said last month: “The only thing that is going to slow us down is batches of vaccines becoming available. Many of you know already that it’s not just about vaccine manufacture. It’s about fill and finish, which is a critically short resource across the globe.”

Prime Minister Boris Johnson has also suggested a limiting factor in expanding the UK’s vaccine rollout is waiting for batches of the jab to be tested.

Ministers have said the NHS has the capacity to deliver 2 million doses a week of the Oxford vaccine once it receives supplies from the manufacturers. But the PM said the issue is not supply or staff, but waiting for batch approval.

He explained: “We have the capacity, the issue is to do with supply of the vaccine.

“It’s not so much a manufacturing issue although that’s part of it.

“Each batch needs to be properly approved and quality controlled.”

The Medicines and Healthcare products Regulatory Agency (MHRA) said it had “scaled up” its review process for each vaccine batch.

“The MHRA is fully scaled up to do the batch testing that’s so important for confidence as the new products come through,” said Dr June Raine, Chief Executive of the agency.

“It’s a supply chain that goes right back from the manufacturer, right through to MHRA, and then on to the clinical bedside or where the vaccines are delivered, so we are a step on the road but our capacity is there, I’m very clear about that.”

How many people have been vaccinated so far?

As of 4 January, a total of 944,539 people across the UK had received their first vaccine dose.

The government says this figure will rapidly rise in the coming weeks and months once more batches from the different vaccine manufacturers have been quality checked.

It is hoped that all at-risk groups will have been vaccinated using the Oxford or BioNTech-Pfizer candidate by the end of April, helping to ease the strain on the NHS amid a deluge of hospitalisations driven in part by the new coronavirus variant.

Media and Political Bulletin

21 September 2020

Media Summary

EU must step up efforts to tackle medicine shortages, say MEPs

The Pharma Letter, 18 September 2020

The Pharma Letter reports that the European Parliament, at the Plenary session on 17 September 2020, called for the European Union to be more self-sufficient when it comes to medicines and medical equipment so that affordable treatments are available at any time.

Parliament welcomed the new EU health program EU4Health and asked the Commission to use the upcoming pharmaceutical strategy to ensure that safe medicines in Europe can be made available, accessible and affordable and to examine ways to restore pharmaceutical manufacturing in Europe.

Priority needs to be given to boosting domestic production of essential and strategic medicines as currently 40% of medicines marketed in the EU originate in non-EU countries, while 60%-80% of active pharmaceutical ingredients are produced in China and India, MEPs said.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

EU must step up efforts to tackle medicine shortages, say MEPs

The Pharma Letter, 18 September 2020

The European Parliament at yesterday’s Plenary session called for the European Union to be more self-sufficient when it comes to medicines and medical equipment so that affordable treatments are available at any time.

Parliament adopted by 663 votes to 23 and 10 abstention a resolution addressing the root causes of recent medicine shortages. MEPs called for an increased EU response to a problem that has been exacerbated by the COVID-19 health crisis across Europe with a direct negative impact on patients’ health, safety and the continuation of their treatment.

Parliament welcomed the new EU health program EU4Health and asked the Commission to use the upcoming pharmaceutical strategy to ensure that safe medicines in Europe can be made available, accessible and affordable and to examine ways to restore pharmaceutical manufacturing in Europe.

The resolution also calls on the Commission to propose a directive setting minimum standards for quality healthcare systems in member states.

Return to EU independence in the health sector

Priority needs to be given to boosting domestic production of essential and strategic medicines as currently 40% of medicines marketed in the EU originate in non-EU countries, while 60%-80% of active pharmaceutical ingredients are produced in China and India, MEPs said.

They also mentioned the need to screen foreign direct investment in pharmaceutical manufacturing plants, which are part of Europe’s critical health infrastructure and encourage the introduction of financial incentives to persuade companies to produce active pharmaceutical ingredients and medicines in Europe.

After the vote, the rapporteur Nathalie Colin Oesterle (EPP, FR) said: “Public health has become a geostrategic weapon that can bring a continent to its knees. Our dependence on non-EU countries has been exposed by the current pandemic. Certain types of production must be relocated, legislation must be harmonised and cooperation between member states must be strengthened in order to achieve greater solidarity and to regain our independence.”

EFPIA raises some issues

Speaking about the vote, European Federation of Pharmaceutical Industries and Associations (EFPIA) director general, Nathalie Moll said: “We are acutely aware of the impact medicine shortages can have on patients. Addressing them is a priority for the European research-based pharmaceutical industry, as was acutely exemplified industry’s frontline role over the past eight months to avoid any shortages of medicines during this pandemic.” She went on to say. “While some of the recommendations put forward by the European Parliament could have a positive impact in reducing medicines shortages, we are deeply concerned that other measures proposed not only fail to address the root causes of this emerging problem, but if implemented, could severely undermine the ability of our companies to innovate.”

While the Parliament has recognized patent protection as a key incentive for companies to invest in innovation, the EFPIA notes with concern that several suggestions made in the report, such as changes to EU intellectual property rules, as well as pricing and procurement policies, are disproportionate and unbalanced. Similarly, in calling for a number of regulatory reforms and sanctions for manufacturers, the European Parliament does not consider the extreme complexity of the issue, and the need to produce additional evidence and knowledge about the key drivers and extent of medicines shortages.

Media and Political Bulletin

15 September 2020

Media Summary

There was no media coverage today.

Parliamentary Coverage

The law must change to improve medicine shortages

The Royal Pharmaceutical Society, 14 September 2020

The Royal Pharmaceutical Society has joined together with the BMA, the Royal College of GPs and patient group National Voices to call on Health Secretary Matt Hancock to amend medicines legislation.

They are calling on the Government to amend legislation to enable all pharmacists to alter prescriptions in order to minimise the impact of medicine shortages on patient care. The letter asks for pharmacists to be able to provide a different quantity, strength, formulation or generic version of the same medicine on a prescription if it is in short supply.

President of the Royal Pharmaceutical Society Sandra Gidley said the change was urgently needed ahead of a second wave of COVID-19, flu season and a potential no-deal Brexit, which would place heavy demands of the medicines supply chain and primary care services.

Full Coverage

There was no media coverage today.

Media and Political Bulletin

01 June 2020

Media Summary

Thousands of pharmacies in deficit could close owing to COVID-19, trade body warns government

The Pharmaceutical Journal, Carolyn Wickware, 29 May 2020

In response to the letter, a Department of Health and Social Care (DHSC) spokesperson said that the DHSC was continuing to work with NHS England and the PSNC to assess the need for additional funding, beyond the £2.592bn promised in the ‘Community pharmacy contractual framework’, and for any further cash flow to support contractors in paying their drugs bills during the COVID-19 pandemic.

Record number of prescriptions issued as Britain entered lockdown

The Telegraph, Jack Hardy, 29 May 2020

The Telegraph reports that a record number of prescriptions were issued as Britain entered lockdown, fuelling fears of medication shortages as patients sought to stockpile.

New data from the NHS showed 93 million prescribed medicines were dispensed in March, a rise of more than seven million in the same month last year. It was said to have been the single busiest month for medicine supplies on record and came at a time panicked shoppers were clearing the shelves of supermarkets.

The Pharmaceutical Services Negotiating Committee said GPs had been “strongly recommended” not to allow patients to request longer duration prescriptions to avoid heaping further strain on the supply chain.

Last week the Telegraph revealed the price of one of the most widely prescribed antidepressants, sertraline, had rocketed more than 800 per cent in price amid a global shortage.

Parliamentary Coverage

There is no parliamentary coverage to report today.

Full Coverage

Thousands of pharmacies in deficit could close owing to COVID-19, trade body warns government

The Pharmaceutical Journal, Carolyn Wickware, 29 May 2020

Mark Lyonette, chief executive of the National Pharmacy Association, has written to prime minister Boris Johnson to request a “special COVID-19 payment” to help pharmacies stay open.

Thousands of pharmacies could close if they do not receive extra funding to cope with COVID-19 pressures, as around half were already in deficit at the start of the pandemic, the National Pharmacy Association (NPA) has told the government.

In a letter to prime minister Boris Johnson, seen by The Pharmaceutical Journal, Mark Lyonette, chief executive of the NPA, said the sector faced “trepidation” about having to repay the £300m advanced funding provided by the government.

The money is not extra to standard funding streams and the government has said it intends to recoup the sum.

The letter, dated 25 May 2020, said: “50% of pharmacies were already in deficit before the crisis began — forcing the repayment of these funds could cause thousands of pharmacies to go out of business.”

It added that pharmacies have “incurred considerable costs for staying open throughout the coronavirus crisis, including large increases in staff and medicine costs, outlays for security, [personal protective equipment] and deliveries”.

“A special COVID-19 payment to cover these exceptional costs would help provide the financial stability that we need to keep our doors open,” the letter continued.

The Pharmaceutical Services Negotiating Committee (PSNC) said on 15 May 2020 that its bid for extra funding for community pharmacies was with the government treasury for consideration.

The PSNC secured the £300m loan on 31 March 2020, after warning earlier that month that pharmacies were “teetering on the brink of collapse” as a result of pressures from COVID-19.

This was followed by a further £50m in advanced funding announced on 28 May 2020, which the NPA said loads new debt onto pharmacies, which many will be unable to pay back.

The NPA — along with other pharmacy bodies — previously said that the £300 loan was not enough and it was still worried about pharmacy closures, with some spending “many, many tens of millions of pounds” each month to stay open during the pandemic.

In response to the letter, a Department of Health and Social Care (DHSC) spokesperson said: “Community pharmacies carry out critical work to protect the health of the public and support the wider NHS, and we are backing them with £300m of advanced funding as we continue to assess the full additional impact of coronavirus.”

They added that the DHSC was continuing to work with NHS England and the PSNC to assess the need for additional funding, beyond the £2.592bn promised in the ‘Community pharmacy contractual framework’, and for any further cash flow to support contractors in paying their drugs bills during the COVID-19 pandemic.

Simon Dukes, chief executive of the PSNC, said the negotiators have “long sought to ensure the government and NHS are aware of the funding and capacity issues facing the community pharmacy sector”.

“As well as the rising cost of running a business, we have highlighted hidden costs, such as giving ad-hoc health advice and spending increasing amounts of time trying to source medicines,” he added.

“Many contractors were struggling to make efficiencies before this pandemic, and the COVID-19 outbreak has only exacerbated these issues.

“We are, therefore, working with the NPA and other pharmacy bodies to gather evidence of pharmacy’s contribution to public health during the pandemic, and we will use this to push for a full review of the contractual framework.”

Record number of prescriptions issued as Britain entered lockdown

The Telegraph, Jack Hardy, 29 May 2020

A record number of prescriptions were issued as Britain entered lockdown, fuelling fears of medication shortages as patients sought to stockpile.

New data from the NHS showed 93 million prescribed medicines were dispensed in March, a rise of more than seven million in the same month last year.

It was said to have been the single busiest month for medicine supplies on record and came at a time panicked shoppers were clearing the shelves of supermarkets.

The Pharmaceutical Services Negotiating Committee said GPs had been “strongly recommended” not to allow patients to request longer duration prescriptions to avoid heaping further strain on the supply chain.

Earlier this week the Telegraph revealed the price of one of the most widely prescribed antidepressants, sertraline, had rocketed more than 800 per cent in price amid a global shortage.

Figures published by the NHS Business Service Authority showed that 92,840,309 prescriptions were dispensed in March, up from 85,033,921 in March last year.

The Company Chemist Association (CCA), the trade body representing the big community pharmacies, said much of the medication was delivered before lockdown measures were put in place.

Malcolm Harrison, chief executive of the CCA, said: “There was a record increase in demand for medicines in March as people wanted supplies of their regular, and sometimes not so regular, medicines to have in stock at home.

He added: “We’d now like to see our community pharmacy sector get fair funding from the government for its work on the frontline of the NHS during the crisis.

“Pharmacies were already under significant financial pressures and now need immediate support from the government to allow them to continue to provide high quality healthcare on the high street.”

The soaring prices of medication such as sertraline left many pharmacies facing ruin, as it took several weeks before the Department of Health agreed to refund them at a level close to the inflated prices.

Media and Political Bulletin

22 May 2020

Media Summary

Boris Johnson wants self-sufficiency to end reliance on Chinese imports

The Times, Oliver Wright and Lucy Fisher, 22 May 2020

The Times reports that Boris Johnson has ordered civil servants to draw up plans codenamed Project Defend to end Britain’s reliance on China for vital medical supplies and other strategic imports in light of the coronavirus crisis.

Project Defend is assessing the national resilience of “essential supplies”. A source said it had been tasked with “planning for future events — no matter what they might be”. A second “capabilities” group is looking at where the government needs to support industry to “onshore” critical production such as pharmaceutical supplies.

Whitehall sources said there was obvious concern in particular about the future supply of medicines. Most drugs sold in Britain have a complicated multinational supply chain with about 70 per cent of active ingredients made in China and much of the manufacturing, especially of generic drugs, done in India. Overall between 80 to 90 per cent of the UK’s supply of generic medicines are imported.

77% of pharmacies experience medicines shortages due to COVID-19

Chemist+Druggist, Eliza Slawther, 21 May 2020

Chemist+Druggist reports that COVID-19 related medicines shortages have affected 77% of pharmacy professionals and are the biggest problem businesses have faced since the outbreak, a C+D survey can reveal.

The C+D survey, which ran from April 1 to May 10 and covered pharmacy teams in all four UK nations, asked respondents how their business had been affected by COVID-19, with almost eight in 10 flagging up medicines shortages as a key concern.

When asked about their concerns over the impact of COVID-19 on their pharmacy going forward, 85% of 962 respondents to the question said they were worried about becoming infected with the virus or passing it on to others. Medicines shortages were the second biggest concern for the future, with 75.5% selecting it.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Boris Johnson wants self-sufficiency to end reliance on Chinese imports

The Times, Oliver Wright and Lucy Fisher, 22 May 2020

Boris Johnson has ordered civil servants to draw up plans codenamed Project Defend to end Britain’s reliance on China for vital medical supplies and other strategic imports in light of the coronavirus crisis.

Officials across Whitehall have been asked to identify the country’s key economic vulnerabilities to potentially hostile foreign governments as part of a new approach to national security.

The initiative, led by Dominic Raab, the foreign secretary, could lead to the government intervening to support the “repatriation” of key manufacturing capabilities such as pharmaceuticals as part of a new national resilience framework. It is also looking at supply chain issues where critical UK businesses rely on components from abroad to make finished products.

The Times understands that two cross-departmental working groups have been set up as part of wider work being done across government to plan for the post-coronavirus economy.

Project Defend is assessing the national resilience of “essential supplies”. A source said it had been tasked with “planning for future events — no matter what they might be”. A second “capabilities” group is looking at where the government needs to support industry to “onshore” critical production such as pharmaceutical supplies.

One source suggested that these groups would feed into the government’s review of post-Brexit state aid rules to make them more flexible to support industries that were of strategic national importance to the UK.

The work carried out by officials was leading to a reassessment of what was considered to be in the national security interest, a source said. “We’re seeing resilience as a national security issue. If we are reliant on other states for particular things that is, in effect, a national security concern. The question is how can you mitigate that? You’ve got an awful lot of national security people working into these kinds of things.”

Another said: “It is about the diversification of supply lines so we are no longer dependent on individual countries for non-food essentials.”

Last week it emerged that the UK was strategically dependent on China for 71 critical goods categories. Active pharmaceutical ingredients needed to make painkillers, antibiotics and antiviral drugs are among the items for which Britain is a net importer and it relies on China for 50 per cent of its supplies. Industrial chemicals, certain metal products and consumer electronics including mobile phones and laptops are others, according to international trade data analysed by the Henry Jackson Society, a foreign policy think tank that takes a hawkish stance on China.

Whitehall sources said there was obvious concern in particular about the future supply of medicines. Most drugs sold in Britain have a complicated multinational supply chain with about 70 per cent of active ingredients made in China and much of the manufacturing, especially of generic drugs, done in India. Overall between 80 to 90 per cent of the UK’s supply of generic medicines are imported.

The government review is understood to include PPE and drugs but is looking at all areas of vulnerability particularly after the aggressive stance taken by China in response to international criticism of its initial handling of the Covid-19 crisis. “The way China has been acting has really alarmed people in Downing Street,” said one person familiar with their thinking.

The UK’s approach is being mirrored by other European countries. On Monday President Macron of France and Angela Merkel, the German chancellor, called for greater EU sovereignty on medical products.

The work is linked to separate government proposals to make it harder for foreign companies to buy up strategically important British companies that have lost value during the pandemic.

Mr Johnson told MPs on Wednesday he would introduce measures to “protect our technological base”.

The government said: “The coronavirus pandemic has demonstrated the importance of resilient supply chains to ensure the continued flow of essential items and keep global trade moving. That’s why we’re looking at what steps we can take to ensure we have diverse supply chains in place, to avoid shortages in the event of a future crisis.

77% of pharmacies experience medicines shortages due to COVID-19

Chemist+Druggist, Eliza Slawther, 21 May 2020

COVID-19 related medicines shortages have affected 77% of pharmacy professionals and are the biggest problem businesses have faced since the outbreak, a C+D survey can reveal.

Seventy-seven per cent of the 932 pharmacy professionals who responded to the survey’s question said they have experienced medicines shortages as a result of COVID-19.

The C+D survey, which ran from April 1 to May 10 and covered pharmacy teams in all four UK nations, asked respondents how their business had been affected by COVID-19, with almost eight in 10 flagging up medicines shortages as a key concern.

One respondent said that medicines shortages were “making life extremely difficult” and called for a “clearer price concession system” to mitigate against the dispensing losses they were incurring.

“Increased prescription volume and drug shortages have added to an already huge workload,” another respondent commented.

Two other respondents said trying to source alternative medicines for patients was time-consuming, and one commented that they were “continually having to contact prescribers for alternatives”. Several respondents said patients do not understand medicines shortages.

The question allowed multiple answers to be selected, with 54% of respondents highlighting a lack of protective equipment as an essential problem, 50% an absence of COVID-19 testing for staff and 48% less money from clinical services since the start of the outbreak.

Future problems

When asked about their concerns over the impact of COVID-19 on their pharmacy going forward, 85% of 962 respondents to the question said they were worried about becoming infected with the virus or passing it on to others.

Medicines shortages were the second biggest concern for the future, with 75.5% selecting it.

Other major concerns were a lack of personal protective equipment (55%), a lack of COVID-19 tests for staff (52%) having to close the business due to staff sickness (47%) and less money from clinical services (42%)

Several respondents commented about the price of medicines having risen above the drug tariff price, with one stating that an issue is “huge increases in generic prices”, for which pharmacies “will not be compensated”.

One respondent gave the example of sertraline tablets and explained that “low supply and high demand” of some “key medicines”, such as sertraline 50mg and 100mg has caused an overinflation of prices. A different person described sertraline as “extortionate”.

Media and Political Bulletin

17 April 2020

Media Summary

Accessing supplies of Personal Protective Equipment (PPE)

NHS England

There is unprecedented, global demand for personal protective equipment as a result of the COVID-19 pandemic. NHS England reports that the UK has released its pandemic influenza stockpiles, which included many types of PPE required for tackling COVID-19, and new logistics networks have been established to manage supply and demand across the UK, and to make sure appropriate PPE reaches those who need it.

A new online ordering site is being developed and will enable primary care, community care and social care providers to register their PPE requirements more easily. The site will be rolled out so that these providers can request critical PPE from a central inventory. Further details will be released on how to register directly to providers as part of a phased approach.

Any organisation running critically short of PPE, and having exhausted other supply routes, can phone the National Supply Distribution Response (NSDR) on 0800 915 9964 for an urgent delivery.

Coronavirus: Alert issued to hospitals as intensive care drugs run low

The Independent, Shaun Lintern, 17 April 2020

The Independent reports that doctors have been warned that crucial drugs used to help sedate and ventilate patients in intensive care are running out due to the demand caused by coronavirus, according to an alert to hospitals from NHS England today.

It’s said supplies of atracurium and cisatracurium were likely to be exhausted in coming days, and hospitals would need to switch to alternatives that were still available. As a result of the shortages, and to help maintain supplies, NHS England said it would now manage existing supplies “centrally”.

In recent weeks, doctors have warned of shortages of other key drugs such as propofol, a commonly used anaesthetic, and alfentanil, an opioid painkiller which is used in intensive care.

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Accessing supplies of Personal Protective Equipment (PPE)

NHS England

There is unprecedented, global demand for personal protective equipment as a result of this pandemic. The UK has released its pandemic influenza stockpiles, which included many types of PPE required for tackling COVID-19, and new logistics networks – including support from the army – have been established to manage supply and demand across the UK, and to make sure appropriate PPE reaches those who need it.

Information for NHS Trusts and Foundation Trusts

For acute, mental health, community, integrated care and ambulance trusts there is now a PPE dedicated supply channel delivering all core PPE products used for managing and treating patients with COVID-19 such as eye protection, aprons, gloves, gowns, hand sanitiser and masks.

This supply channel can also help Trusts and regional teams access information about how much PPE equipment has been delivered to each hospital, to help facilitate local mutual aid.

Information for primary care, hospices, social care and home care providers

There are a range of options available to primary care, hospices and home care providers to get of PPE equipment.

  • Additional supplies of PPE equipment continue to be made available to wholesalers that routinely supply to GPs, dentists, pharmacies, social care and hospices
  • Regional NHS leadership teams are working with individual trusts to support mutual aid and redistribution of supplies to meet greatest clinical need

Local Resilience Forums (LRFs) have received a push of PPE supplies to respond to local spikes in need, including those in social care and primary care, where there are current blockages in the supply chain. The PPE stock provided to LRFs is to support urgent need in vital services which are not linked to the NHS Supply Chain. This PPE is intended to support service providers which have exhausted their usual routes for PPE and there remains an urgent need for additional stock.

A new online ordering site is being developed and will enable primary care, community care and social care providers to register their PPE requirements more easily. The site will be rolled out so that these providers can request critical PPE from a central inventory. Further details will be released on how to register directly to providers as part of a phased approach. Orders will be managed in line with the published guidance from Public Health England and shipped directly via Royal Mail.

Accessing urgent supplies

Any organisation running critically short of PPE, and has exhausted other supply routes, can phone the National Supply Distribution Response (NSDR) on 0800 915 9964 for an urgent delivery.

Other information and resources

Pallet deliveries are being pushed out on a daily basis by Clipper Logistics. For more information about this service, daily manifests of what is being delivered, and how a customer service team can support enquiries visit the PPE Dedicated Supply Channel.

Coronavirus: Alert issued to hospitals as intensive care drugs run low

The Independent, Shaun Lintern, 17 April 2020

Doctors have been warned that crucial drugs used to help sedate and ventilate patients in intensive care are running out due to the demand caused by coronavirus.

An alert to hospitals from NHS England today said there were “limited supplies” of muscle relaxant drugs atracurium, cisatracurium and rocuronium, which are used during intubation when patients are sedated and paralysed with a ventilator used to help them breathe.

As a result of the shortages, and to help maintain supplies, NHS England said it would now manage existing supplies “centrally”.

It’s said supplies of atracurium and cisatracurium were likely to be exhausted in coming days, and hospitals would need to switch to alternatives that were still available.

In recent weeks, doctors have warned of shortages of other key drugs such as propofol, a commonly used anaesthetic, and alfentanil, an opioid painkiller which is used in intensive care.

A critical care nurse working in ICU in the south of England told The Independent they were already using alternatives but that this had to be used at different concentrations and run for longer to achieve the same sedation.

She said changes like this with staff overstretched could increase the likelihood of drug errors.

Drug shortages in the NHS and in intensive care are not unusual, and the Royal College of Anaesthetists said doctors were used to having to switch to different drugs.

The extra demand from coronavirus, which has seen thousands of extra patients admitted with Covid-19-related pneumonia and needing to be ventilated, has caused some drugs to run short.

NHS England said remaining stocks of atracurium and rocuronium would be allocated to hospitals based on modelling data and the number of patients in intensive care.

It added: “Stocks of cisatracurium in the supply chain are critically low and restock is not expected in the near future. Remaining stock is not at sufficient quantities to be centrally managed by allocations.”

It also said NHS England and the Department of Health and Social Care were working with suppliers and specialist importers to secure further supplies for the UK.

“We are also working with suppliers of other neuromuscular blocking agents to assess their supply position.”

The Royal College of Anaesthetists said intensive care staff were used to using alternative medicines adding: “It is important that NHS patients and the general public understand that drug demand-supply mismatch in anaesthesia and intensive care medicine are not unknown to us, even under normal circumstances.

“While we may not always be able to use our first choice drug, we expect to be able to use an appropriate alternative drug, therefore ensuring that all patients will receive effective medications.”

Media and Political Bulletin

06 April 2020

Media Summary

Virus delays put Brexit trade negotiations under threat

The Times, Stephen O’Brien, 05 April 2020

The Times reports that EU trade commissioner Phil Hogan said Britain will have to evaluate how the calendar for Brexit trade deal negotiations has changed, because the Covid-19 pandemic has reduced the already tight timeframe for talks.

The former Fine Gael minister, who is in his second European Commission term, said it was now certain that a comprehensive trade deal could not be concluded in time for Britain’s withdrawal from the union on December 31 this year.

He also fears that insufficient progress will be made on the individual sections of the withdrawal agreement that Britain and the EU had agreed to prioritise to facilitate that orderly exit.

UK medicines and medical devices regulator investigating 14 cases of fake or unlicensed COVID-19 medical products

MHRA, 04 April 2020

An increasing number of bogus medical products being sold through unauthorised websites claiming to treat or prevent COVID-19 are being investigated by the Medicines and Healthcare products Regulatory Agency (MHRA). These include self-testing kits, ‘miracle cures’, ‘antiviral misting sprays’, and unlicensed medicines.

At this time, there are currently no medicines licensed specifically for the treatment or prevention of COVID-19 and there are no CE marked self-testing kits approved for home use.

The MHRA has disabled 9 domain names and social media accounts selling fake or unauthorised COVID-19 products. This advice is part of the MHRA’s ongoing #FakeMeds campaign which aims to encourage people who buy medical products online to make sure they are purchasing from legitimate sources.

EU postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus pandemic

EU Today, Martin Banks, 04 April 2020

EU Today reports that the European Commission has adopted a plan to postpone by one year the date of application of the medical devices regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.

This decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable.

Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “Shortages or delays in getting key medical devices certified and on the market are not an option right now.”

Emergency legislation could empower pharmacists to supply controlled drugs without a prescription

Pharmacy Business, Pri Mandav, 03 April 2020

Pharmacy Business reports that the Home Office has been proposing emergency legislation in the wake of the coronavirus crisis which could allow pharmacists to supply some controlled drugs without needing a prescription. In a letter dated 1st April Home Secretary Priti Patel asked Chair of the Advisory Council on the Misuse of Drugs Owen Bowden-Jones to respond to the proposals by Friday.

The new legislation, if enforced, would allow pharmacists to supply drugs in Schedules 2 and 3 and Part 1 of Schedule 4 of the Misuse of Drugs Regulations 2001, provided the patient receives them as part of their ongoing treatment. It would not affect Schedule 1 drugs.

Patel wrote that the proposed measures would “ensure patients continue to have access to medicines critical for ongoing treatment, build resilience and help relieve pressure elsewhere in the health system.”

This was also reported in P3 Pharmacy.

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Virus delays put Brexit trade negotiations under threat

The Times, Stephen O’Brien, 05 April 2020

Britain will have to evaluate how the calendar for Brexit trade deal negotiations has changed because the Covid-19 pandemic has reduced the already tight timeframe for talks, according to Phil Hogan, the EU trade commissioner.

The former Fine Gael minister, who is in his second European Commission term, said it was now certain that a comprehensive trade deal could not be concluded in time for Britain’s withdrawal from the union on December 31 this year.

He also fears that insufficient progress will be made on the individual sections of the withdrawal agreement that Britain and the EU had agreed to prioritise to facilitate that orderly exit.

“I don’t believe it is possible to have major improvements made in the negotiation of any of the [priority] chapters in such a short space of time that will give answers to all of the issues that arise at the end of the year, so I think that the United Kingdom will have to reflect on that calendar reality,” said Hogan.

“In every member state, including the UK I suspect, it is all hands on deck for the public servants and civil servants to deal with the Covid-19 crisis, and there aren’t [enough] people who are able to apply themselves to these intensive negotiations that are required to be concluded in such a short space of time.”

Asked whether he would welcome a British application to extend the Brexit deadline to allow for more negotiation, the trade commissioner said: “It is a matter for the United Kingdom to make up its mind on that issue. I am not going to pre-empt any decision they might make.

“The European Union side is ready to engage in this timeline or indeed any other timeline in order to reach agreement so really, this is a political call that has to be made by the UK, and the EU doesn’t have any control over it.

“There’s nothing like face-to-face negotiations in order to make a deal, and of course [the virus] has closed [them] down and we won’t have those opportunities for the duration of the crisis.”

In terms of the EU response to the coronavirus, Hogan acknowledged there were differences between governments on how to treat the debt that member states would run up in tackling the pandemic, but said several financial instruments were already in place, including a €750bn lending stream from the European Central Bank.

“How we treat the debt that will arise from this particular crisis is the subject of discussion in the eurogroup next week,” said Hogan.

A blanket of austerity measures would not be part of the response, he stressed.

“I believe that an agreement as soon as possible on the budget of the EU for the next seven years would give us new instruments and new opportunities to be able to help member states to overcome this problem,” he said. “Not every member state has the financial firepower to be able to deal with this crisis economically or from a health point of view.”

The former Carlow-Kilkenny TD and keen Kilkenny hurling supporter said he was confining himself to Brussels “for the time being at least”, but planned to be “back in Ireland for the first round of the championship, whenever that might be”.

He said he had spoken last week to his colleague Michel Barnier, the lead EU trade negotiator and one of the first high-profile figures to contract Covid-19 in Europe. He said Barnier, 69, had taken part in meetings since recovering and would be back at work next week.

Hogan said the European Commission had moved swiftly to stop some member states taking “unilateral action” to retain certain medical equipment and supplies within their own borders, but also to stop excessive exports of ventilators, test kits and personal protection equipment.

“We addressed that by introducing within a matter of days an export authorisation [requirement] to prevent product from going out of the EU in any distortive way that would have an impact on the capacity of the health authorities to have sufficient material in hospitals and healthcare facilities to deal with the virus for our own people,” he said.

UK medicines and medical devices regulator investigating 14 cases of fake or unlicensed COVID-19 medical products

MHRA, 04 April 2020

An increasing number of bogus medical products being sold through unauthorised websites claiming to treat or prevent COVID-19 are being investigated by the Medicines and Healthcare products Regulatory Agency (MHRA).

These include self-testing kits, ‘miracle cures’, ‘antiviral misting sprays’, and unlicensed medicines.

At this time, there are currently no medicines licensed specifically for the treatment or prevention of COVID-19 and there are no CE marked self-testing kits approved for home use.

The MHRA has disabled 9 domain names and social media accounts selling fake or unauthorised COVID-19 products.

Lynda Scammell, MHRA Enforcement Official said:

“Don’t be fooled by online offers for medical products to help prevent or treat COVID-19.

“There is no medicine licensed specifically to treat or prevent COVID-19, therefore any claiming to do so are not authorised and have not undergone regulatory approvals required for sale on the UK market. We cannot guarantee the safety or quality of the product and this poses a risk to your health.

“The risk of buying medicines and medical devices from unregulated websites are that you just don’t know what you will receive and could be putting your health at risk.

“We are working alongside other law enforcement agencies to combat this type of criminal activity.”

This advice is part of the MHRA’s ongoing #FakeMeds campaign which aims to encourage people who buy medical products online to make sure they are purchasing from legitimate sources.

To stay safe when buying medicines and medical devices online, the MHRA advises that you purchase from a registered pharmacy – either from the premises or online. Registered online suppliers can be found here. If people suspect they have a dodgy medicine or medical device they can report if via our safety monitoring system – the Yellow Card Scheme.

The National Fraud Intelligence Bureau is also seeing reports from victims who have lost money when they have tried to purchase PPE or self-testing kits online, from fraudulent websites, that simply do not exist. If you think you have been a victim of fraud, please report it to Action Fraud or by calling 0300 123 2040.

EU postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus pandemic

EU Today, Martin Banks, 04 April 2020

The European Commission has adopted a plan to postpone by one year the date of application of the medical devices regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.

This decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable.

Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “Shortages or delays in getting key medical devices certified and on the market are not an option right now.

“The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic. This shows once again that the European Union is leaving no stone unturned in our support to national public health systems in their hour of need.”

As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.

Today’s proposal therefore postpones, for exceptional reasons in the current context, the application of the Regulation by one year – until 26 May 2021.

Whilst the new Medical Devices Regulation is key to ensure patient safety and increase transparency on medical devices across the EU, the currently applicable rules will continue to guarantee the protection of public health.

In addition, the proposal also ensures that Member States and the Commission can address potential shortages of vitally important medical devices in the EU in a more effective manner through EU wide derogations.

The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.

The coronavirus pandemic and the associated public health crisis presents an unprecedented challenge to Member States and is a high burden for national authorities, health institutions and economic operators. The coronavirus crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices. None of this could reasonably have been anticipated at the time of adoption of the Medical Devices Regulation.

Those extraordinary circumstances have a significant impact on various areas covered by the Medical Devices Regulation. It is therefore very likely that Member States, health institutions, economic operators and other relevant parties would not have been in a position to ensure its proper implementation and application from the stipulated date of application on 26 May 2020.

To safeguard an effective regulatory framework for medical devices, it is also necessary to postpone the date of repeal of the directive on active implantable medical devices and the directive on medical devices by one year.

This proposal will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.

Emergency legislation could empower pharmacists to supply controlled drugs without a prescription

Pharmacy Business, Pri Mandav, 03 April 2020

The Home Office has been proposing emergency legislation in the wake of the coronavirus crisis which could allow pharmacists to supply some controlled drugs without needing a prescription.

In a letter dated Wednesday (April 1) Home Secretary Priti Patel has asked Chair of the Advisory Council on the Misuse of Drugs (ACMD) Owen Bowden-Jones to respond to the proposals by Friday.

The new legislation, if enforced, would allow pharmacists to supply drugs in Schedules 2 and 3 and Part 1 of Schedule 4 of the Misuse of Drugs Regulations 2001, provided the patient receives them as part of their ongoing treatment. It would not affect Schedule 1 drugs.

Patel wrote that the proposed measures would “help secure access to controlled drugs within the healthcare system in a pandemic and where there is a serious risk to human health. They will ensure patients continue to have access to medicines critical for ongoing treatment, build resilience and help relieve pressure elsewhere in the health system.”

The letter said since there was “a significant risk of supply shortages” due to the impact of Covid-19 on the supply chain, the proposals would also include supply of controlled drugs under a Serious Shortage Protocol (SSP).

“Pharmacists would only supply under an SSP at their professional discretion and in cases where they deem it reasonable and appropriate for the patient and would refer any complex cases back to a prescriber,” the stated.

This was also reported in P3 Pharmacy.

Media and Political Bulletin

03 April 2020

Media Summary

Coronavirus: European hospitals could run out of intensive care drugs ‘in days’

Sky News, Russell Hope, 02 April 2020

Sky News reports that the European University Hospital Alliance warned in a statement sent to national governments that hospitals across the continent could run out of stocks of muscle relaxants, sedatives and painkillers in less than two weeks. But at the hardest-hit hospitals, existing stocks might only last two days.

The group, which represents nine university hospitals in Austria, Britain, France, Germany, Italy, the Netherlands, Belgium, Sweden and Spain, said some governments were coping with the crisis by refusing to export to others. That could exacerbate current shortages, the alliance wrote.

It said: “No single country in Europe has the production facilities to provide all the drugs (or protective gear or ventilators) needed. Co-ordinated European action will be of vital importance.”

EU will avoid medicine shortage, industry chief says

Reuters, Matthias Blamont, 02 April 2020

Reuters reports that the European Union’s industry chief Thierry Breton said that countries will have access to the medicines they need to care for coronavirus sufferers, adding that pharmaceutical companies were doubling production to address shortages.

Hospital executives and doctors of nine European countries said in an open letter on Wednesday they only had up to two weeks’ worth of supplies of some medicines and urged greater European collaboration.

Many countries around the world rely on China, the source of the outbreak, for drug ingredients and now find themselves grappling with how to avoid shortages.

Asthma inhaler stocks low after COVID-19 linked demand spike, government says

The Pharmaceutical Journal, Carolyn Wickware and Julia Robinson, 02 April 2020

The Pharmaceutical Journal reveals that pharmacies are experiencing difficulties sourcing some commonly used asthma inhalers, following a surge in demand caused by the COVID-19 pandemic.

In a statement, the DHSC told The Pharmaceutical Journal that there were delays in replenishment of stocks to wholesalers, although suppliers were continuing to make stock available. The statement comes as some wholesalers reported that several inhalers are out of stock.

Pharmacists said that panicked patients were ordering inhalers they did not immediately need.

A spokesperson for the DHSC said it was “working with suppliers to ensure supplies continue to remain available.”

Inhalers and insulin dominate new export ban products

P3 Pharmacy, Pharmacy Network News, 02 April 2020

P3 Pharmacy reports that asthma medications and insulin products make up the vast majority of the medicines newly added to the Department of Health And Social Care’s parallel export ban list.

On Tuesday 52 medicines were added to the list of products that cannot be exported because they are needed for UK patients, bringing the total number to 168 – a record high. Among the new medications on the list are 23 insulin products and 22 asthma medications.

There have been numerous reports of pharmacies struggling to source enough inhalers to meet patient demand since the Covid-19 pandemic hit Britain, in part because of some prescriptions being issued for a longer than normal period.

Codeine, doxycycline and diamorphine were some of the other medicines added to the ban list this week.

UK clinicians: revised PPE guidance must be backed by adequate supplies

The Guardian, Haroon Siddique, 02 April 2020

The Guardian reports that clinicians given the right to demand higher-specification personal protective equipment when dealing with coronavirus have warned that new guidance could count for little unless new supplies are made available.

The new guidance states that any clinician working in a hospital, primary care or community care setting within two metres of a suspected or confirmed coronavirus Covid-19 patient should wear an apron, gloves, surgical mask and eye protection “based on the risk”.

Employers and unions broadly welcomed the new guidance but warned that it must be backed by adequate supplies. Dr Chaand Nagpaul, chair of council at the British Medical Association (BMA), said that “what fundamentally matters is that doctors and healthcare workers get the adequate and appropriate supplies of PPE on the frontline.”

“Without these supplies, there is continued unacceptable danger to the health and lives of healthcare workers and their patients.”

Doctors’ Association UK agreed that adequate supplies were key.

Online price of cough medicine soars by 11% since UK lockdown

The Guardian, Phillip Inman, 02 April 2020

The Guardian reports that the price of cough and cold medicines bought online has jumped by almost 11% after an increase in demand during the coronavirus outbreak.

The Office for National Statistics said the cost of over-the-counter cough and cold treatments had increased by 10.7% between 16 and 29 March. The online price for a basket of “high-demand products” increased by 1.1% during the same period, an annual rate of inflation of more than 53% it said. Paracetamol and antibacterial hand wipes were among the products that rose the most – 2.8% and 0.9% respectively – as well as pet food, rice, flour and nappies.

The ONS said the products, which also included toilet rolls, handwash and long-life milk, were chosen using anecdotal evidence of goods for which there was increased demand from consumers during the early stage of the pandemic.

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Coronavirus: European hospitals could run out of intensive care drugs ‘in days’

Sky News, Russell Hope, 02 April 2020

European hospitals could run out of drugs being used to treat COVID-19 patients in intensive care within days, a hospitals body has warned.

The European University Hospital Alliance said in a statement sent to national governments that hospitals across the continent could run out of stocks of muscle relaxants, sedatives and painkillers in less than two weeks.

But at the hardest-hit hospitals, existing stocks might only last two days.

“The most urgent need now is for the drugs that are necessary for intensive care patients,” the alliance said, noting that shortages have led some hospitals to buy alternative drugs or try other doses on patients.

“It is extremely worrying that overworked and often less-experienced nurses and doctors-in-training, drafted to fill the gaps, have to use products and dosages that they are not used to.”

The group, which represents nine university hospitals in Austria, Britain, France, Germany, Italy, the Netherlands, Belgium, Sweden and Spain, said some governments were coping with the crisis by refusing to export to others.

That could exacerbate current shortages, the alliance wrote.

It said: “No single country in Europe has the production facilities to provide all the drugs (or protective gear or ventilators) needed. Co-ordinated European action will be of vital importance.”

Spain, the second-worst hit country in terms fatalities, passed a grim milestone on Thursday as it recorded its 10,000th death from the pandemic.

A new record 950 COVID-19 deaths were recorded on Thursday, although the growth in infections is waning, health ministry data showed.

Spain also lost nearly 900,000 jobs, although that figure is dwarfed by the US, where 6.6 million new unemployment claims were made last week.

In New York state, the number of deaths doubled in 72 hours to more than 1,900.

In the city, bodies were loaded on to refrigerated mortuary trucks outside overwhelmed hospitals.

New York Governor Andrew Cuomo said: “How does it end? And people want answers. I want answers. The answer is nobody knows for sure.”

In Italy, where the total of 13,915 deaths is the highest globally, another 760 deaths were reported on Thursday as mortuaries overflowed with bodies and coffins piled up in churches.

Experts drew hope that the spread was already slowing in the country.

Sky’s Sally Lockwood, in Rome, said the lockdown there could start to be lifted “incrementally, by generations, soon” although she warned that schools “might not go back until September”.

In Italy, “they have upscaled their ICUs”, she said, while in Spain “14% of healthcare staff are infected”, a third of hospitals are at full capacity in ICUs.

Close to 940,000 people around the world have contracted the virus, according to a tally from Johns Hopkins University, and more than 47,000 people have died.

In other developments:

  • Italy has the world’s highest death toll of 13,155 from more than 110,000 confirmed cases
  • Spain announced record unemployment with 898,822 people out of work since the pandemic began
  • Russia recorded 771 new cases, a 43% increase on the day before
  • Belgium’s total number of deaths has passed 1,000
  • The Canada government is looking into reports drug imports were diverted to the US
  • Australia’s government will offer parents free child care from next week
  • New Zealand says it plans to repatriate tens of thousands of tourists, including Brits

EU will avoid medicine shortage, industry chief says

Reuters, Matthias Blamont, 02 April 2020

European Union countries will have access to the medicines they need to care for coronavirus sufferers, the bloc’s industry chief Thierry Breton said on Thursday, adding pharmaceutical companies were doubling production to address shortages.

The coronavirus pandemic has placed a huge strain on hospitals in Italy, Spain, France, and elsewhere in Europe as intensive care units fill up with tens of thousands of patients suffering the same illness.

Hospital executives and doctors of nine European countries said in an open letter on Wednesday they only had up to two weeks’ worth of supplies of some medicines and urged greater European collaboration.

Breton said the European Commission had anticipated the supply crunch.

“We foresaw there would be tensions over a number of medicines, notably those associated to intensive care treatment,” Breton told France Inter radio.

“Industry players have been summoned. Today, they are doubling production and I think we’re going to be able to address the situation,” he said, without elaborating.

Many countries around the world rely on China, the source of the outbreak, for drug ingredients and now find themselves grappling with how to avoid shortages.

France has said 40% of its drug ingredients are imported from China, where the coronavirus forced the closure of factories early in the year. They are only now beginning to reopen.

EU documents show that barely a month before Europe scrambled to find masks, ventilators and testing kits, national governments were telling Brussels their healthcare systems were ready and there was no need to order more stocks.

Officials with the European federation of pharmaceutical industries (EFPIA) were not immediately reachable for comment.

Doctors in France, which became the fourth country to pass the 4,000 coronavirus deaths threshold on Wednesday, have said levels of morphine and antibiotics, among other drugs, are running alarmingly low.

France’s drug safety regulator said earlier this month stocks of anaesthetic drug Propofol, manufactured by Germany’s Fresenius (FREG.DE), were running low and new supplies would not be available in France until mid-April. French doctors have also cited Pfizer’s (PFE.N) curare as another drug they need more of.

The head of the World Health Organization voiced deep concern on Wednesday about the rapid escalation and global spread of COVID-19 cases from the new coronavirus, which has now reached 205 countries and territories.

Asthma inhaler stocks low after COVID-19 linked demand spike, government says

The Pharmaceutical Journal, Carolyn Wickware and Julia Robinson, 02 April 2020

Exclusive: Shortages of Chiesi’s Clenil and Fostair inhalers, along with inhalers from other brands, have been noticed by pharmacists as patients begin to panic-buy inhalers they potentially do not need.

Pharmacies are experiencing difficulties sourcing some commonly used asthma inhalers, following a surge in demand caused by the COVID-19 pandemic, The Pharmaceutical Journal can reveal.

In a statement, the Department of Health and Social Care (DHSC) told The Pharmaceutical Journal that there were delays in replenishment of stocks to wholesalers, although suppliers were continuing to make stock available.

The statement comes as some wholesalers reported that several inhalers are out of stock, including four strengths of Chiesi’s Clenil Modulite (beclometasone dipropionate) inhalers and three strengths of its Fostair (beclometasone dipropionate and formoterol fumarate dihydrate) inhaler product.

Some 9.3 million of these Clenil and Fostair inhalers were prescribed in 2018.

Pharmacists said there was a “loo-roll situation,” with panicked patients ordering inhalers they did not immediately need.

A spokesperson for the DHSC said manufacturers of inhalers are experiencing a significant increase in demand for their products “which is linked to the outbreak of COVID-19 in the UK”.

They added that it was “working with suppliers to ensure supplies continue to remain available” and that “healthcare professionals and patients are reminded to only prescribe and order what they need during this time, to ensure that all patients can continue to access their medicines.”

Chiesi confirmed in a statement on its website in March 2020 that it is experiencing a supply issue with its Clenil Modulite 100 microgram pressurised metered dose inhalers “as a result of a delay in component material supply”.

It added that “significant demand in the supply chain” for all Chiesi respiratory products has caused wholesalers to go out-of-stock on many lines.

The wholesaler AAH Pharmaceuticals placed 11 inhalers on its “out of stock” list on the 30 March 2020, with little guidance on when supplies would return.

Anna Murphy, consultant respiratory pharmacist at University Hospitals of Leicester NHS Trust, said the demand was caused by panic from some patients who have not used their inhalers in years, causing a “loo-roll situation” in response to the COVID-19 outbreak.

Some companies “have very little leeway if patients are switched from one inhaler to another,” she said, although other companies “had huge stocks because of Brexit, so that has been helpful to them in managing the demand”.

Darush Attar-Zadeh, a respiratory lead pharmacist at NHS Barnet Clinical Commissioning Group, confirmed that he is also seeing shortages of salbutamol, from some companies, in addition to the Clenil inhaler shortages.

“My concern is that there may be even more overuse of reliever treatments in asthma that can make symptoms worse, and underuse of inhaled preventer treatment, exacerbated possibly by stock issues — there’s a lot of panic out there,” he said.

To mitigate shortages, the DHSC said NHS England wrote to healthcare professionals working in primary care on 31 March 2020, asking them not to overprescribe or over-order during this time, as this will create further pressures on the supply chain.

The British Thoracic Society also advised prescribers, in guidance published on 1 April 2020, that they “discuss with those patients who have not ordered a repeat prescription for an inhaler for more than four months if this is still clinically required”.

The advice also recommends prescribers “avoid switching between different types of inhalers unless essential to ensure continuity of patient treatment”.

“If an alternative inhaler is required … ensure patients are switched to alternative class of inhaler device (i.e aerosol (e.g [metered-dose inhalers], Easibreathe, Autohaler) or dry-powder inhalers),” it continued.

The Pharmaceutical Journal has approached AAH Pharmaceuticals for comment.

Inhalers and insulin dominate new export ban products

P3 Pharmacy, Pharmacy Network News, 02 April 2020

Asthma medications and insulin products make up the vast majority of the medicines newly added to the Department of Health And Social Care’s parallel export ban list, which is designed to help the UK cope with shortages.

On Tuesday 52 medicines were added to the list of products that cannot be exported because they are needed for UK patients, bringing the total number to 168 – a record high.

Among the new medications on the list are 23 insulin products and 22 asthma medications, including a number of salbutamol and/or beclometasone preparations.

There have been numerous reports of pharmacies struggling to source enough inhalers to meet patient demand since the Covid-19 pandemic hit Britain, in part because of some prescriptions being issued for a longer than normal period.

A Covid-19 survey of 449 pharmacists carried out last weekend by Pharmacy Magazine and Independent Community Pharmacist found that Clenil was the medicine that was second-worst affected by shortages after paracetamol, with 60 per cent of respondents saying they had struggled to source it in the previous two weeks.

Meanwhile, 40 per cent said they had struggled to source other inhalers.

Codeine, doxycycline and diamorphine were some of the other medicines added to the ban list this week.

UK clinicians: revised PPE guidance must be backed by adequate supplies

The Guardian, Haroon Siddique, 02 April 2020

Clinicians given the right to demand higher-specification personal protective equipment when dealing with coronavirus have warned that new guidance could count for little unless new supplies are made available.

New guidance, issued by the UK government, public health authorities and NHS England after criticism of previous guidelines, states that any clinician working in a hospital, primary care or community care setting within two metres of a suspected or confirmed coronavirus Covid-19 patient should wear an apron, gloves, surgical mask and eye protection “based on the risk”.

It was updated after fears that the existing rules were confusing and some healthcare professionals were not being adequately protected from the risk of contracting the virus and passing it on to others.

Employers and unions broadly welcomed the new guidance, issued on Thursday, which doubles the distance at which PPE is required, but warned that it must be backed by adequate supplies.

Dr Chaand Nagpaul, chair of council at the British Medical Association (BMA), said the doctors’ union had heard concerns from physicians in more than 30 hospital trusts about shortages. “What fundamentally matters is that doctors and healthcare workers get the adequate and appropriate supplies of PPE on the frontline,” he said. “Without these supplies, there is continued unacceptable danger to the health and lives of healthcare workers and their patients.”

Doctors’ Association UK agreed that adequate supplies were key and said the requirement for long-sleeve protective gowns should have been extended in place of “flimsy plastic aprons”.

Reports have been rife of shortages and large variations in the level of PPE available. Pictures of healthcare workers who have created their own makeshift protective equipment out of bin bags and other materials have proved embarrassing for the government and NHS leaders. Staff have also improvised masks out of snorkels, bought kit from hardware stores, and used school science goggles to protect themselves.

Last week, the president of the Royal College of Surgeons, Prof Derek Alderson, urged members not to risk their health, following widespread reports of shortages. He said the new guidance was an improvement, but so long as shortages remained, “my warning still holds true”.

Niall Dickson, chief executive of the NHS Confederation, said the guidance was straightforward for “staff to apply it to the clinical reality they face, whether they work in hospitals or the community. It means that if they think they need protective kit in a particular situation, they should be able to access it and wear it. But guidance is not the whole answer. Staff will need the right training and the right equipment, including for example ‘fit test’ kits to make sure the masks are effective.

“There have been real problems with distribution, we have been assured they are being addressed, and to be fair, in many places that is happening. But any remaining supply chain problems need to be dealt with without delay.”

Unite, which represents 100,000 NHS staff, said increasing supplies was “a national priority”.

The government said the new guidance “reflects the fact that coronavirus is now widespread in the community, meaning clinicians are more likely to see patients with the virus, some of whom may have minimal or no symptoms” and has the support of the World Health Organization (WHO).

The previous guidance recommended PPE outside high-risk procedures when healthcare workers were within one metre of a patients with suspected or confirmed Covid-19. The new guidelines makes them consistent with the two-metre social distancing rule.

Prof Chris Whitty, chief medical officer for England, said: “NHS England and the government are working hard to secure the supply lines in this challenging period so staff have the appropriate equipment.”

Online price of cough medicine soars by 11% since UK lockdown

The Guardian, Phillip Inman, 02 April 2020

The price of cough and cold medicines bought online has jumped by almost 11% after an increase in demand during the coronavirus outbreak.

The Office for National Statistics said the cost of over-the-counter cough and cold treatments had increased by 10.7% between 16 and 29 March.

The online price for a basket of “high-demand products” increased by 1.1% during the same period, an annual rate of inflation of more than 53%, the ONS said.

Paracetamol and antibacterial hand wipes were among the products that rose the most – 2.8% and 0.9% respectively – as well as pet food, rice, flour and nappies.

The ONS said the products, which also included toilet rolls, handwash and long-life milk, were chosen using anecdotal evidence of goods for which there was increased demand from consumers during the early stage of the pandemic. “Prices were scraped from a number of UK retailers,” it said.

Some products that sold quickly as the UK lockdown began were recorded by the ONS as falling in price, including dried pasta and antibacterial surface wipes.

Retailers have come under fire from consumer groups for increasing the cost of goods in high demand, though chemists and local shops are understood to have blamed distributors for some price increases, while producers have claimed they faced an increase in the cost of raw materials.

The report also showed that the virus was having a dramatic impact on the British labour market. More than a quarter of businesses told the ONS they were laying off staff after a collapse in revenues.

The independent statistics agency said 27% of 3,642 businesses surveyed between 9 and 22 March reduced staff levels in the short term, while 45% of businesses reported “lower-than-expected” revenues during the two-week period in March, as the virus continued to hammer the UK economy.

The employment figures, which were predominantly recorded before the lockdown, also show the pandemic affected trade at more than half of firms importing or exporting goods.

The ONS said 57% of importers reported that the outbreak had an impact on trade, while 59% of exporters were facing a financial hit from the virus.

The survey was part of a new fortnightly release of data related to the pandemic. The ONS said: “These are experimental statistics and have been developed to provide early indicators of the impact of Covid-19 in a timely way.”

Media and Political Bulletin

25 March 2020

Media Summary

Pharmacists urge UK drug firms to start manufacturing paracetamol in Britain – not overseas – as desperate shoppers strip shelves bare and retailers warn they will sell out by Saturday

Daily Mail, Connor Boyd, 25 March 2020

The Daily Mail reports that pharmacists are urging UK drug firms to manufacture paracetamol in Britain amid a nationwide shortage caused by panic buying and production lines drying up in Asia.

Britain relies heavily on India – the world’s biggest supplier of generic drugs – for the painkiller, but the South Asian nation has restricted exports of the painkiller after factories in China, where the ingredient is mainly made, ground to a halt. The move, combined with shoppers desperately stocking up, has left supermarket and chemist shelves stripped bare.

This comes a day after pharmacies were told they can split large packs of paracetamol and sell single strips to the public. The RPS called for stores not to not to profit off the crisis.

The Department of Health denies there is a shortage of paracetamol in the UK.

Amazon and eBay failing to stop Covid-19 profiteers, says Which?

The Guardian, Rebecca Smithers, 25 March 2020

The Guardian reports that the consumer group Which? has warned that online shopping platforms eBay and Amazon Marketplace are failing to crackdown on a surge in profiteering by sellers due to the coronavirus, after its investigation uncovered a wide range of products on sale at “extortionate” prices.

Which? found “consistent overpricing” of household items, including cleaning products, hand sanitiser, thermometers, baby formula and tampons, which have all been in high demand since the coronavirus outbreak but in short supply in supermarkets and pharmacies.

The CMA has set up a coronavirus taskforce to crackdown on companies that cash in during the outbreak, but the snapshot investigation suggests third-party sellers are still “brazenly” ripping-off consumers and using the current situation to list overpriced items that are difficult or impossible to find in local shops.

COVID-19: National medicines delivery service announced for England

C+D, Eliza Slawther, 24 March 2020

C+D reports that a national community pharmacy medicines delivery service for England is due to start “in the next few days”, the PSNC has said. As part of the new service commissioned by NHS England & NHS Improvement, community pharmacies will deliver medicines to self-isolating patients during the COVID-19 outbreak.

Up to 1.5 million people in the UK have been told to stay at home for 12 weeks – a process known as shielding. Shielded patients will be asked to have their medicines collected and delivered to them by “friends, family or a volunteer” before being directed to the pharmacy provided delivery service if this is not possible, the PSNC explained in a statement on Sunday.

“We anticipate the service will commence in the next few days,” it added.

MHRA issues FMD over HMS Wholesale Limited products

European Pharmaceutical Review, Hannah Balfour, 24 March 2020

The UK MHRA has announced that it is investigating how several medicines may have left the legal supply chain to be reintroduced via HMS Wholesale Limited. European Pharmaceutical Review reports that a Class 4 FMD has been issued.

According to the MHRA, the products seem to be legitimate with genuine batch numbers. However, since they may have been stolen in early 2019 and reintroduced later that same year, their efficacy and safety cannot be guaranteed. The company has now had its wholesale licence terminated.

The advice from the MHRA is that if suppliers or patients have received any of these batches from HMS Wholesale Limited after May to August 2019, stocks must be checked and any remaining affected products quarantined, before notifying the Defective Medicines Report Centre (DMRC) or the MHRA.

UK in talks with Amazon and others to deliver coronavirus tests

Financial Times, Pilita Clark, Jim Pickard and Dave Lee, 23 March 2020

This article is subject to copyright terms and conditions. Please access full article here.

 

Parliamentary Coverage

House of Commons – Written Answer, 24 March 2020

Taiwo Owatemi (Coventry North West):

  • To ask the Secretary of State for Health and Social Care, what plans he has to apply stress tests to the NHS medicine supply in response to the covid-19 outbreak.
  • To ask the Secretary of State for Health and Social Care, what plans he has to manufacture more active pharmaceutical ingredients in the UK to prevent medicine shortages.
  • To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that the NHS will not face a medicine shortage in the coming months.

Jo Churchill (answered on 24 March 2020): The Department of Health and Social Care has indicated that it will not be possible to answer this question within the usual time period. An answer is being prepared and will be provided as soon as it is available.

House of Commons – Written Question Tabled, 24 March 2020

Judith Cummins (Bradford South): To ask the Secretary of State for Health and Social Care, what steps are being taken to help community pharmacies handle increased patient walk-ins as a result of the covid-19 outbreak.

 

Full Coverage

Pharmacists urge UK drug firms to start manufacturing paracetamol in Britain – not overseas – as desperate shoppers strip shelves bare and retailers warn they will sell out by Saturday

Daily Mail, Connor Boyd, 25 March 2020

Pharmacists are urging UK drug firms to manufacture paracetamol in Britain amid a nationwide shortage caused by panic buying and production lines drying up in Asia amid the coronavirus crisis.

Britain relies heavily on India – the world’s biggest supplier of generic drugs – for the painkiller, but the South Asian nation has restricted exports of the painkiller after factories in China, where the ingredient is mainly made, ground to a halt.

The move, combined with shoppers desperately stocking up, has left supermarket and chemist shelves stripped bare.

The NHS advises coronavirus patients take paracetamol for their symptoms, after the Government urged infected Brits to steer clear of ibuprofen.

UK manufacturers now need to step up and start making the painkiller in Britain to prevent the ‘grim reality’ of COVID-19 patients not being able to get pain relief, pharmacists say.

Consulting pharmacist Shamir Patel, of online service Doctor-4-U, told MailOnline: ‘We are seeing a huge spike in the demand for medicines such as paracetamol due to the ongoing coronavirus crisis, due to a perfect storm of high demand for those worried about availability and the fact the raw ingredients come from China.

‘This is obviously very worrying for many people in the UK and a situation which should not be allowed to happen.

‘As well as asking people to reduce the amount of paracetamol they are buying to a normal level, UK pharmaceutical companies need to put in place a system whereby medicines such as paracetamol can be manufactured in the UK rather than relying on overseas exports.

‘The advice we are giving to people who are showing the symptoms of COVID-19 is to take paracetamol in order to try to manage their fever and reduce their temperature.

‘But if the supplies run out, which some reports are suggesting could happen in the UK by this weekend, it will further add to the grim reality of the coronavirus crisis.’

It comes a day after pharmacies were told they can split large packs of paracetamol and sell single strips to the public.

The General Pharmaceutical Council said the individual strips, which would come in repackaged boxes, should not be placed on open shelves.

Instead, it said stores should put up notices to tell patients paracetamol supplies are available at the counter.

The GPC, which is the independent regulator for all pharmacists in Britain, did not say how much the tablets should be priced at.

It said: ‘Pharmacies may be experiencing difficulties in obtaining over-the-counter pack sizes of paracetamol from wholesalers at this time.

‘Pharmacies may break down larger packs of paracetamol to prepare smaller packs for people, and the public, who need them.’

The Royal Pharmaceutical Society, which is the professional membership body for pharmacists, called for stores not to not to profit off the crisis.

It said: ‘Charge a reasonable price for the medicine. It’s not professional to charge excessive prices and we do not support this.’

Trade news publication Chemist and Druggist reported pharmacists had struggled to get hold of paracetamol because of the coronavirus outbreak.

The Department of Health and Social Care said it had ‘stockpiles of generic drugs like paracetamol in the event of any supply issues or increases in demand’.

Officials have already banned companies from exporting dozens of different drugs, including paracetamol, to keep a solid supply of medication in the UK.

The Department of Health denies there is a shortage of paracetamol in the UK.

Paracetamol is used in other branded drugs, such as Calpol. The firm has already warned of the potential for shortages because of the increase in demand.

By Saturday, Boots expects to have run out of paracetamol and has introduced measure to ration how much customers can buy.

A Boots spokesman said: ‘We have seen an increase in customers looking to buy paracetamol in our stores, and we’re sorry if there may have been limited occasions where we have sold out.

‘We have been working closely with all of our suppliers and have more stock arriving in stores every day.

‘To ensure we can support as many people as possible, there is currently a limit of two units per customer on hand sanitisers, soap and hand wash, pain relief products, cough and cold, all children’s medicines, thermometers, tissues and hand wipes, baby milks, baby sterilising and antibacterial products, and hand creams.

‘There is also a limit of one unit per customer for products containing paracetamol.’

India, the world’s biggest supplier of generic drugs, has already restricted the export of paracetamol – the main chemical in the drug – and 25 other pharmaceutical ingredients.

It relies on China for almost 70 per cent of the ingredients in its drugs but production has dried up in China because of the pandemic, with millions ordered to stay inside.

India’s Pharmaceuticals Export Promotion Council of India said some chemicals ‘may face shortages for the next couple of months’.

British paracetamol manufacturer Aspar Pharmaceuticals has already warned it was struggling because supply of ingredients was drying up.

The Royal Pharmaceutical Society’s chief scientist admitted that most of the generic drugs are made in India and China.

Pharmaceutical Journal reports that up to 90 per cent of medicines used in the NHS are imported, with the majority of those from India.

It is unclear how many other UK drug firms make paracetamol. But because it is a generic there is much less profit available for makers.

It comes after the Government’s chief scientific adviser warned earlier this month that Britons with coronavirus should no longer take ibuprofen.

Sir Patrick Vallance admitted the ‘sensible thing to do’ would be to avoid the over-the-counter painkiller amid fears it could worsen the infection.

The NHS also pulled its advice that told patients to take ibuprofen for symptoms of the deadly infection.

Before, its advice named paracetamol and ibuprofen as two painkillers that could fight off a fever and cough. Its help page now only advises paracetamol.

French health minister Olivier Véran prompted questions over the NHS advice when he said anti-inflammatories could ‘aggravate the infection’.

Other leading medics echoed his concerns, admitting the drug could dampen the immune system and even slow down recovery.

And parents of a four-year-old girl with tell-tale coronavirus symptoms claimed that ibuprofen caused her to become seriously ill.

Amelia Milner’s temperature spiked, she began shaking, panting and couldn’t keep her eyes open. She also vomited on herself.

Amazon and eBay failing to stop Covid-19 profiteers, says Which?

The Guardian, Rebecca Smithers, 25 March 2020

The online shopping platforms eBay and Amazon Marketplace are failing to crackdown on a surge in profiteering by sellers due to the coronavirus, a consumer group has warned, after its investigation uncovered a wide range of products on sale at “extortionate” prices.

Which? found “consistent overpricing” of household items, including cleaning products, hand sanitiser, thermometers, baby formula and tampons, which have all been in high demand since the coronavirus outbreak but in short supply in supermarkets and pharmacies.

The Competition and Markets Authority (CMA) has set up a coronavirus taskforce to crackdown on companies that cash in during the outbreak and has already contacted traders and online trading platforms about excessive pricing of some products.

But the snapshot investigation by Which? suggests third-party sellers are still “brazenly” ripping-off consumers and using the current situation to list overpriced items that are difficult or impossible to find in local shops.

It found active listings and auctions for dramatically overpriced items, including a thermometer that would usually retail for £40 priced at £300 on eBay and £150 on Amazon. A £3 bottle of disinfectant was on sale for £29.99 on eBay.

On eBay’s auction site, a flurry of bids sent the price for a bundle of three bottles of Dettol spray and three packets of antibacterial wipes soaring to £210. A 50ml bottle of Carex antibacterial hand gel was being sold for more than £100 by multiple sellers on eBay, despite usually costing about £1.50.

Last week the Guardian found one UK-based eBay user selling a 72-pack of Andrex toilet roll for £84.99 – triple its retail price.

Sue Davies, the head of consumer protection at Which?, said: “Online marketplaces have taken some action against coronavirus price gouging, but our investigation shows unscrupulous sellers are still cashing in on people’s fears by selling essential items at extortionate prices on eBay and Amazon.

“These companies must make good on their pledges to stamp out coronavirus profiteering, and the CMA must be ready to take strong enforcement action.”

An eBay spokesperson said: “All the items flagged by Which? have been removed and enforcement action has been taken against the sellers. We announced on Friday additional measures to tackle coronavirus-related price gouging. This is a continuation of aggressive action … which has included suspending hundreds of accounts, removing hundreds of thousands of listings, and suspending scores of bad seller accounts.”

Amazon said: “We are disappointed that bad actors are attempting to artificially raise prices on basic-need products during a global health crisis and, in line with our long-standing policy, have recently blocked or removed tens of thousands of offers. In addition to removing these offers, we are terminating accounts.”

COVID-19: National medicines delivery service announced for England

C+D, Eliza Slawther, 24 March 2020

A national community pharmacy medicines delivery service for England is due to start “in the next few days”, the Pharmaceutical Services Negotiating Committee (PSNC) has said.

As part of the new service commissioned by NHS England & NHS Improvement, community pharmacies will deliver medicines to self-isolating patients during the COVID-19 outbreak.

Up to 1.5 million people in the UK have been told to stay at home for 12 weeks – a process known as shielding – as they are at the “highest risk of being hospitalised by the virus”, housing secretary Robert Jenrick said at a daily press briefing from 10 Downing Street on March 22.

Shielded patients will be asked to have their medicines collected and delivered to them by “friends, family or a volunteer” before being directed to the pharmacy provided delivery service if this is not possible, the PSNC explained in a statement on Sunday.

“We anticipate the service will commence in the next few days,” it added.

Contractors will be able to “request support from volunteers to undertake deliveries of prescriptions to any patient, not just those that are being shielded,” it added.

The volunteers are part of a national network being mobilised in response to the epidemic, and patients will also be able to request support from them.

The PSNC said it will “issue full guidance” to contractors as soon as it is able to.

AIMp: Funding “essential”

Leyla Hannbeck, Association of Independent Multiple Pharmacies (AIMp) chief executive officer, said it is “essential there is funding available to cover these deliveries”, as community pharmacy is “cash-starved after many years of funding cuts”.

“We are playing a big role in the supply of medicines to patients who are worried, vulnerable and now those who need to self-isolate. The efforts of this sector need to be recognised and applauded,” she added.

Ms Hannbeck said AIMp encourages “more engagement with community pharmacy early on in the process”, and emphasised the important role pharmacies play in the community.

“We are doing whatever it takes to fight this outbreak,” she added.

MHRA issues FMD over HMS Wholesale Limited products

European Pharmaceutical Review, Hannah Balfour, 24 March 2020

A Class 4 falsified medicines directive (FMD) has been issued by the MHRA because medicines may have left the legal supply chain to be reintroduced later through HMS Wholesale Limited.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it is investigating how several medicines may have left the legal supply chain to be reintroduced via HMS Wholesale Limited. The company has now had its wholesale licence terminated.

According to the MHRA, the products seem to be legitimate with genuine batch numbers. However, since they may have been stolen in early 2019 and reintroduced later that same year, their efficacy and safety cannot be guaranteed. The agency stated that this is because they may have been transported or stored incorrectly during this time.

The advice from the MHRA is that if suppliers or patients have received any of these batches from HMS Wholesale Limited after May to August 2019, stocks must be checked and any remaining affected products quarantined, before notifying the Defective Medicines Report Centre (DMRC) or the MHRA.

UK in talks with Amazon and others to deliver coronavirus tests

Financial Times, Pilita Clark, Jim Pickard and Dave Lee, 23 March 2020

This article is subject to copyright terms and conditions. Please access full article here.

Media and Political Bulletin

20 March 2020

Media Summary

COVID-19 LATEST: Healthcare workers and ‘medicines distributers’ included on key worker list

The Pharmaceutical Journal, 20 March 2020

The Pharmaceutical Journal reports that the list of key workers who are able to still send their children to school has been published. Employees working in medicines wholesaling and distribution ARE included as key workers. Click here for the full list.

Although the list does not mention pharmacists directly, it specifies that front-line health and social care workers and “producers and distributers of medicines” are included. The RPS has published a letter that pharmacy teams can use when communicating with schools – a copy is here.

COVID-19: CMA approach to essential business cooperation

Competition and Markets Authority, 19 March 2020

The CMA reports that it is very conscious of concerns that competition law enforcement could impede necessary cooperation between businesses to deal with the current crisis and ensure security of supplies of essential products and services. That’s why the CMA welcomes the Government’s announcement today to relax some elements of competition law to help supermarkets work together.

Where agreements are not covered by that legal relaxation, the CMA is offering the following reassurance: the CMA has no intention of taking competition law enforcement action against cooperation between businesses or rationing of products to the extent that this is necessary to protect consumers – for example, by ensuring security of supplies.

At the same time, the CMA will not tolerate unscrupulous businesses exploiting the crisis as a ‘cover’ for non-essential collusion. This includes exchanging information on longer-term pricing or business strategies, where this is not necessary to meet the needs of the current situation. More guidance on this will follow from the CMA in due course.

COVID-19: ‘No medicine shortages due to virus’

Pharmacy Business, Pri Mandav, 19 March 2020

Pharmacy Business reports that NHS bosses have reassured the community pharmacy sector that there are no medicine shortages in the country as a result of COVID-19. This was stated in a joint letter sent to community pharmacists yesterday by Dr Keith Ridge, chief pharmaceutical officer for England, and Ed Waller, director, Primary Care Strategy and NHS Contracts.

The letter stated that the country was “well prepared to deal with any impacts of the coronavirus” and added that the Government was “working with manufacturers and suppliers to ensure people can continue to access the medicines they need.”

Furthermore, it said the Department of Health and Social Care has asked UK medicines suppliers to carry out a risk assessment on the impact of the virus on their businesses for all medicines. The letter stressed that patients and the public should not “seek to stockpile medicines” for the same reason.

Fake coronavirus ‘medicines’ and masks conning panic buyers online

Metro, Joe Roberts, 19 March 2020

Metro reports that British health authorities have joined a global crackdown on fake and unlicensed medicines amid a ‘disturbing trend’ of criminals exploiting the coronavirus outbreak. The MHRA said authorities had ‘identified a disturbing trend of criminals who are taking advantage of the Covid-19 outbreak by exploiting the high market demand for personal protection and hygiene products’.

The operation uncovered 2,000 coronavirus-related adverts online. Items claiming to be ‘corona spray’, ‘coronavirus medicines’ or ‘coronaviruses packages’ were seized by authorities, the UK’s MHRA revealed. Counterfeit face masks and unauthorised antiviral medication were also seized.

Elsewhere under the operation in the UK, the MHRA’s enforcement team, working with UK Border Force, found 871,616 doses of unlicensed medicines with a value of £2.6 million. It also took down 294 websites and removed 1,031 online social media adverts offering medicines illegally.

Esmya licence suspension

Dispensing Doctors’ Association, MHRA, 19 March 2020

Dispensing Doctors’ Association reports that healthcare professionals are asked to contact patients taking Esmya (ulipristal acetate) for uterine fibroids as soon as possible to stop treatment and advise on alternatives. Recent users should be told to seek immediate medical attention if they develop signs and symptoms of liver injury (nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia or jaundice). In addition:

  • No patients should be started on Esmya
  • Practices should perform liver function tests 2–4 weeks after stopping Esmya

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

COVID-19 LATEST: Healthcare workers and ‘medicines distributers’ included on key worker list

The Pharmaceutical Journal, 20 March 2020

The list of key workers who are able to still send their children to school has been published. Click here for the full list. Although the list does not mention pharmacists directly, it specifies that front-line health and social care workers and “producers and distributers of medicines” are included. This description has not gone down well with some pharmacists on social media, but the RPS has published a letter that pharmacy teams can use when communicating with schools – a copy is here.

COVID-19: CMA approach to essential business cooperation

Competition and Markets Authority, 19 March 2020

The CMA is very conscious of concerns that competition law enforcement could impede necessary cooperation between businesses to deal with the current crisis and ensure security of supplies of essential products and services, such as groceries.

That’s why the CMA welcomes the Government’s announcement today to relax some elements of competition law to help supermarkets work together.

Where agreements are not covered by that legal relaxation, the CMA can offer the following reassurance: the CMA has no intention of taking competition law enforcement action against cooperation between businesses or rationing of products to the extent that this is necessary to protect consumers – for example, by ensuring security of supplies.

At the same time, the CMA will not tolerate unscrupulous businesses exploiting the crisis as a ‘cover’ for non-essential collusion. This includes exchanging information on longer-term pricing or business strategies, where this is not necessary to meet the needs of the current situation. More guidance on this will follow from the CMA in due course.

The CMA trusts that these announcements will reassure businesses, which it knows are doing their best in difficult circumstances to meet the needs of the public.  Businesses must still be aware that any assurance given by the CMA cannot protect against competition litigation by private parties, but wants to offer comfort on its own approach.

COVID-19: ‘No medicine shortages due to virus’

Pharmacy Business, Pri Mandav, 19 March 2020

NHS bosses have reassured the community pharmacy sector that there are no medicine shortages in the country as a result of COVID-19.

This was stated in a joint letter sent to community pharmacists today by Dr Keith Ridge, chief pharmaceutical officer for England, and Ed Waller, director, Primary Care Strategy and NHS Contracts.

The letter stated that the country was “well prepared to deal with any impacts of the coronavirus” and added that the Government was “working with manufacturers and suppliers to ensure people can continue to access the medicines they need.”

Furthermore, it said the Department of Health and Social Care has asked UK medicines suppliers to carry out a risk assessment on the impact of the virus on their businesses for all medicines, including Prescription Only Medicines (POMs), Pharmacy only (P) meds and General Sales List (GSL), irrespective of where they have originated from.

Stating that precautions were “in place to reduce the likelihood of future shortages,” the two NHS leaders have advised GPs not to “issue prescriptions for a longer duration” and asked pharmacies against ordering larger quantities “as this behaviour could put the supply chain at risk.”

The letter stressed that patients and the public should not “seek to stockpile medicines” for the same reason.

Fake coronavirus ‘medicines’ and masks conning panic buyers online

Metro, Joe Roberts, 19 March 2020

British health authorities have joined a global crackdown on fake and unlicensed medicines amid a ‘disturbing trend’ of criminals exploiting the coronavirus outbreak.

The operation uncovered 2,000 coronavirus-related adverts online. Items claiming to be ‘corona spray’, ‘coronavirus medicines’ or ‘coronaviruses packages’ were seized by authorities, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) revealed.

Counterfeit face masks and unauthorised antiviral medication were also seized. The MHRA, which regulates medicines in the UK, added that no coronavirus-related products reached the UK’s borders.

It said authorities had ‘identified a disturbing trend of criminals who are taking advantage of the Covid-19 outbreak by exploiting the high market demand for personal protection and hygiene products’.

Elsewhere under the operation in the UK, the MHRA’s enforcement team, working with UK Border Force, found 871,616 doses of unlicensed medicines with a value of £2.6 million.

It also took down 294 websites and removed 1,031 online social media adverts offering medicines illegally.

Seven warrants were issued, leading to two arrests, as part of investigations linked to the illegal online sale of medicines and resulting in the seizure of anti-anxiety, sedatives and weight loss products.

Fake medicines seized by authorities included anti-depressants, erectile dysfunction tablets, painkillers and anabolic steroids.

A total of 611,888 unlicensed copies of erectile dysfunction medication were seized in the operation, as well as 88,160 doses of medicines to treat insomnia, and 26,005 doses of pain relief medication.

MHRA’s head of enforcement Mark Jackson said: ‘Criminals who sell medicines and devices illegally are not only breaking the law but have no regard for your health and will take advantage of a major public health crisis to make a profit.

‘Taking fake or unlicensed medicines and using a non-compliant medical device could put your health and safety in danger and may lead to serious health issues.’

The MHRA urges people to take care when purchasing medicines online by using legitimate sources and avoiding sites that might, for example, illegally offer prescription medicines without the need for a prescription.

People are also warned of the dangers of self-diagnosis and self-medication and should contact their GP if concerned about their health.

Esmya licence suspension

Dispensing Doctors’ Association, MHRA, 19 March 2020

Healthcare professionals are asked to contact patients taking Esmya (ulipristal acetate) for uterine fibroids as soon as possible to stop treatment and advise on alternatives.

Recent users should be told to seek immediate medical attention if they develop signs and symptoms of liver injury (nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia or jaundice).

In addition:

  • No patients should be started on Esmya
  • Practices should perform liver function tests 2–4 weeks after stopping Esmya

Please note there are no concerns with emergency contraceptive ellaOne (ulipristal acetate 30mg single dose) at this time.

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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