Media and Political Bulletin – 28 May 2020

Media and Political Bulletin

28 May 2020

Coronavirus (COVID-19): travellers exempt from UK border rules

UK Home Office, 22 May 2020

Last Friday Home Secretary Priti Patel announced new public health measures for all UK arrivals to guard against a second wave of coronavirus infections. Measures include 14 days’ self-isolation for anyone entering the UK, bar a short list of exemptions. Of particular importance to our sector, the below exemptions have been granted:

  • Qualified persons and responsible persons for human medicines, clinical trials and pharmacovigilance.
  • A worker with specialist technical skills, where those specialist technical skills are required for essential or emergency works or services (including commissioning, maintenance, and repairs and safety checks) to ensure the continued production, supply, movement, manufacture, storage or preservation of goods.

These arrangements are due to come into effect on 8 June, and measures will be subject to review every three weeks.

Media Summary

Government launches online portal to order PPE; setback to pharmacy as sector is left behind

Pharmacy Business, Pri Mandav, 27 May 2020

Pharmacy Business reports that pharmacy has not been allowed access to a new government online portal designed to help primary and social care providers to order critical PPE. During the current phase of the roll-out, GPs and small residential and domiciliary social care services will be invited to register on the portal.

Claire Anderson, Chair of the Royal Pharmaceutical Society said, “It’s really disappointing to see pharmacy being left behind in this phase of the roll-out”. She added: “People working on the frontline of COVID-19 should get the same support wherever they may be, including across the whole of primary care.”

The government said it was focusing on small care providers because “they seem to be less likely to be registered with wholesalers,” adding that its data shows that they account for half of all care provision.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Government launches online portal to order PPE; setback to pharmacy as sector is left behind

Pharmacy Business, Pri Mandav, 27 May 2020

In a major setback, pharmacy has not been allowed access to a new government online portal designed to help primary and social care providers to order critical personal protective equipment (PPE).

The PPE Portal, developed in collaboration with eBay, has been tested and is being scaled up nationally over the coming weeks.

During the current phase of the roll-out, GPs and small residential and domiciliary social care services will be invited to register on the portal.

RPS demands inclusion of pharmacy

Commenting on the news, Royal Pharmaceutical Society Chair Claire Anderson said: “It’s really disappointing to see pharmacy being left behind in this phase of the roll-out.

“Pharmacies are one of the last places keeping their doors open to the public without an appointment and yet seemingly an afterthought when it comes to sourcing PPE for staff.

“We’ve raised this repeatedly with the Government and have called for pharmacy to urgently being included in the PPE Portal.

“People working on the frontline of COVID-19 should get the same support wherever they may be, including across the whole of primary care.”

The government said it was focusing on small care providers because “they seem to be less likely to be registered with wholesalers,” adding that its data shows that they account for half of all care provision.

“It’s therefore important that they ensure that they have the option of quickly joining the portal should they need to.”

Significant boost to PPE supply

Government on Tuesday (May 27) announced “a significant boost” to PPE supplies across health and social care sectors, following deals with more than 100 new suppliers from around the world in a challenging global market, including securing a further 3.7 billion gloves to help meet the expected demand.

The government has also supported UK industry to significantly boost domestic production with companies signing contracts to manufacture over 2 billion items of PPE in the UK, including facemasks, visors, gowns and aprons.

Since the start of the outbreak, over 1.48 billion items of PPE have been delivered to the frontline in England, and tens of millions more items distributed in Scotland, Wales, and Northern Ireland, a government press release stated.

Health and Social Care Secretary Matt Hancock said: “Last month, I set a national challenge to ensure we continue to supply enough PPE to those on the frontline of this battle.

“We have now signed deals with over 100 suppliers across the world to secure more PPE, and at the same time we have ramped up domestic production. We have now ordered 2 billion pieces of PPE from homegrown firms which is also great news for jobs and the economy, and over 3 billion pieces from abroad.

“Worldwide demand for PPE has never been higher so I want to thank Paul [Lord Deighton] for his work in ensuring that PPE continues to be delivered to where it is needed.

The UK has worked with numerous international partners to procure additional PPE supplies throughout the pandemic. A new team has been established to secure new supply lines from across the world and will continue to strengthen and diversify the supply chain.

Domestic production is simultaneously being ramped up to unlock new avenues to get PPE to the frontline.

Lord Paul Deighton, who leads the government’s efforts to secure PPE, said: “As unprecedented demand for PPE continues around the world, British industry has stepped forward to strengthen the UK’s response and increase PPE supplies.

“We have already secured millions of PPE items through deals with British industry, and continue to work with hundreds of potential manufacturers to further bolster our domestic supply chain now and in the future.”

Media and Political Bulletin

04 May 2020

Media Summary

Contraceptive pills are listed on eBay by unregulated sellers as women struggle to access family planning services in lockdown but experts warn drugs could be fake and potentially ‘toxic’

Daily Mail, Emily Webber, 04 May 2020

The Daily Mail reports that contraceptive pills are being listed on eBay as women struggle to access family planning services during lockdown

Tracey Forsyth, the lead contraceptive nurse at British Pregnancy Advisory Service, said that women are “struggling to access contraception”, but that “medication purchased on sites like eBay might be fake [..] and could be unsafe.”

“Family planning clinics have closed or reduced hours, staff have been redeployed to the Covid-19 frontline, and as a result women cannot get appointments,” she explained.

Dr Diana Gall, online pharmacy Doctors4U, added that “counterfeit drugs carry the risk of containing toxic chemicals, and may not contain any of the active ingredients needed for the drug to be effective, and this poses serious threats to your health.”

SPECIAL REPORT: Pharma firms ensure continuity of medicines supply to pharmacy during pandemic

Pharmacy Business, Pri Mandav, 01 May 2020

Pharmacy Business reports that there are real concerns about the continued supply of medicines, with some countries having banned exports of vital drugs to protect their own interest, and the pandemic highlighting the interdependencies within the global pharma market.

If the virus refuses to burn out and the pandemic continues, stockpiles of medicines, APIs and other vital chemicals are bound to decrease – resulting in severe shortages. In an interview with The Financial Times on April 20, the EU Health Commissioner Stella Kyriakides said that Brussels would use its pharmaceuticals strategy to tackle supply chain problems revealed by the crisis, notably the bloc’s reliance on China and India for imports of crucial intensive care drugs.

In the UK though, the ABPI has said that there are “robust procedures in place” to manage the supply of medicines and companies are taking “all possible measures” to secure supply of medicines in line with government guidance. But while medicine shortages in the UK have so far been limited, the PSNC is concerned that shortages are becoming increasingly frequent.

Paracetamol and hand sanitiser top price complaints

P3 Pharmacy, Pharmacy Network News, 01 May 2020

P3 Pharmacy reports that paracetamol and hand sanitiser have shown the highest price increases among products cited in 430 complaints of unfair pricing raised with the Competition and Marketing Authority since 3 April.

The CMA’s Covid-19 Taskforce, set up to monitor competition and consumer problems arising from coronavirus, received almost 21,000 complaints between 10 March and 19 April. While the average price increase across all reports is 130 per cent, the largest price increase is for hand sanitiser, with a reported rise in price of 367 per cent, followed by paracetamol at around 230 per cent.

The CMA says the vast majority of businesses are behaving responsibly and fairly in the unprecedented circumstances created by the coronavirus outbreak. However, on 20 March the CMA wrote an open letter to the pharmaceutical sector saying it had received reports that a minority of firms were seeking to capitalise on the situation by charging unjustifiably high prices for essential goods or making misleading claims around their efficacy.

Please click here to view the HDA Statement regarding the availability of Public Health England-supplied PPE for community pharmacy.

 

Parliamentary Coverage

 

House of Commons – Written Question, 01 May 2020

Alexander Stafford (Rother Valley): To ask the Secretary of State for Health and Social Care, what plans he has for the future funding of community pharmacies

 

Full Coverage

Contraceptive pills are listed on eBay by unregulated sellers as women struggle to access family planning services in lockdown but experts warn drugs could be fake and potentially ‘toxic’

Daily Mail, Emily Webber, 04 May 2020

Contraceptive pills are being listed on eBay as women struggle to access family planning services during lockdown – but experts warn buying medication from the online site could lead to unwanted pregnancies.

Sellers across Europe are advertising various brands of the birth control pill, emergency contraception and even an IUD – also known as the coil – which requires insertion by a specially trained doctor or nurse.

One anonymous seller from Manchester has listed the combined oral contraceptive pill Femodene for £22, while another from London listed a non-hormonal copper coil at £28.98.

Tracey Forsyth, the lead contraceptive nurse at British Pregnancy Advisory Service, told FEMAIL that women are ‘struggling to access contraception’ but urged them to only purchase contraception ‘via regulated services’.

‘Family planning clinics have closed or reduced hours, staff have been redeployed to the Covid-19 frontline, and as a result women cannot get appointments,’ she explained.

‘Medication purchased on sites like eBay might be fake, may offer no protection against unplanned pregnancy, and could be unsafe.

‘If women are struggling to get their usual method through their usual route, they should seek help from online pharmacies.’

Dr Diana Gall, online pharmacy Doctors4U, added that buying contraception from unknown sources can cause adverse side effects and increase the risks of unwanted pregnancies.

The consultant said: ‘The biggest danger of buying contraception or any medicines on websites such as eBay is that you simply don’t know where it has come from.

‘If you don’t know where the drug has come from then there is no guarantee that the medicine is regulated or has gone through the same strict trials, or quality and safety checks as it would from a regulated, medical provider.

‘Counterfeit drugs carry the risk of containing toxic chemicals, and may not contain any of the active ingredients needed for the drug to be effective, and this poses serious threats to your health.’

Dr Gall advised that a routine check-up should be completed every three to six months when a patient is using contraception such as the combined pill or mini pill.

She also stressed how medicated contraception can cause adverse side effects even from a regulated source and people should be questioned about their health.

‘Medicines sold on eBay may not be prescribed by medical professionals and may not have the facility to check whether this medication is suitable for the buyer, or if they have had the necessary check-ups such as blood pressure monitoring,’ Dr Gall added.

‘Even if the contraception is from a regulated source, you should always be asked questions regarding your health and any other medications you may be taking before purchasing medicines online. This is something that may not be strictly enforced on these types of private seller websites.’

‘If you rely on counterfeit contraceptive medicines without using barrier methods of protection such as condoms, you’re not only risking your health, but you’re also risking an unwanted pregnancy as the contraception is not likely to be effective.

‘There is an increased risk of unwanted pregnancies when buying contraception from eBay. Likewise, condoms bought on eBay that aren’t from a regulated seller run the risk of being ineffective if they don’t meet standards of quality.

‘Any website offering prescription medication must be listed on the governments medicines sellers register and the website must display the logo clearly. If a website isn’t listed on this site then the chances are it’s not a legitimate website.’

An eBay seller from Bulgaria is advertising a special offer on the contraception Pharmatex, which is a locally applied medication that destroys sperm inside the vagina.

And it seems the promotions have seen a spike in sales, with the stockist selling 14 packets of Pharmatex – making £122.70 since lockdown began on March 23.

Despite sellers warning people to ‘consult your doctor or pharmacist before taking Pharmatex pessaries’, many are offering a discount on the original prices to entice shoppers to purchase multiple.

It comes after a study by the British Association for Sexual Health and HIV since the coronavirus outbreak found that 86 per cent of clinics could not offer long-acting reversible contraception options such as the coil or implant.

Speaking about access to the contraceptive pill, Ms Forsyth said: ‘While GPs are supplying prescriptions, there is a long wait for telephone appointments which can mean that there is a gap during which they are not protected against unplanned pregnancy.’

She added that GPs are advising women to seek advice from contraception and sexual health (CASH) clinics, but admitted the coronavirus pandemic is an ‘incredibly difficult’ time for women.

‘Emergency contraception is an important back-up method, but women with symptoms or who need to isolate during the pandemic cannot get to the pharmacy while observing government guidance on social distancing,’ she said.

‘Many women choose long-acting methods because, once fitted, they don’t need to remember to take a daily pill which can be a struggle at the best of times, let alone during these uncertain and worrying times.’

The leading contraceptive nurse added how online pharmacies ‘provide an excellent service’ enabling women to order a six-month supply of the contraceptive pill direct to their front door.

She said: ‘This is an important alternative to access via GPs and family planning clinics because it enables women to stay at home.

‘We know many women are worried about going to clinics and pharmacies in case they contract Covid-19 and spread the virus to their children and loved ones.

SPECIAL REPORT: Pharma firms ensure continuity of medicines supply to pharmacy during pandemic

Pharmacy Business, Pri Mandav, 01 May 2020

The world is heavily reliant on China for personal protective equipment, India for generic drugs and a host of other countries for critical parts to make reliable ventilators. There are real concerns about the continued supply of medicines because some countries have banned exports of vital drugs to protect their own interest.

India, the largest exporter of generic drugs, for instance, had temporarily banned the export of antimalarial drug hydroxychloroquine (HQC), amid media reports of a spike in global demand for HQC and another similar drug, chloroquine – despite a lack of solid scientific evidence that both the drugs actually work against the virus.

The pandemic has also highlighted the interdependencies within the global pharma market. If the virus refuses to burn out and the pandemic continues, stockpiles of medicines, active pharmaceutical ingredients (API) and other vital chemicals are bound to decrease – resulting in severe shortages.

Fast-tracking delivery

Pharmacy Business contacted five pharmaceutical companies in the UK to get a sense of how prepared they were in the face of potential drugs shortages.

Accord Healthcare said it was “speeding up delivery” of its medicines and raw chemicals from around the world to its manufacturing sites in the UK to ensure continuity of supply.

The company is one of the UK’s largest generic manufacturers and suppliers of critical medicines. Accord said it was “able to provide a secure supply chain of vital medicines” such as paracetamol and HCQ, as well as ICU medicines for ventilators (midazolam and cisatracurium) and anti-retroviral medicines like ritonavir and lopinavir, which are in high demand.

“Accord’s size, breadth and reach means that it has been able to swiftly speed up delivery of its medicines and raw chemicals from around the world to its manufacturing sites in the UK, where it has adapted its machinery and production lines to produce the range of vital medicines now being used by the UK healthcare professionals to fight Covid-19 and ensure continuity of supply,” the company said.

Teva-UK, meanwhile, has “mobilised to keep medicines moving to our customers and from there to patients.”

“We’ve been working to make sure we monitor and optimise our supply chain, in the midst of very difficult conditions,” it told Pharmacy Business.

Torrent Pharma said it was focussing its “efforts not only on the here and now situation but that of the forthcoming months where the supply disruption will most likely be seen; given the restrictions in our manufacturing countries

and transport networks.”

Sandoz, a division of pharma giant Novartis, said it wasn’t anticipating any “disruption at this time.”

“With our priorities being the supply of our medicines to NHS patients and the health and safety of our associates, we will continue to ensure supply of our medicines to patients in the UK.

“Sandoz supplies over 10 million packs per month, treating 450,000 patients. We are being flexible with our current supply, working closely with retailers and wholesalers.”

“We are making special provision for supplying some specific critical medicines which would be made immediately available for ITU usage and are working closely with the DHSC regarding the current and medium-term supply of these medicines to ITUs.

Zentiva is “doing everything in our power” to help patients beat the disease. The pan European pharmaceutical company said it was “working on a number of projects in Europe, and beyond, to ensure medicines’ supply.

“We have managed to quickly turn on UK supply of some critical products at our European-based manufacturing sites and our teams have embraced around the clock shift-working patterns to accommodate these changes.

The company added that “within just weeks” it had developed a hand sanitiser and was planning for a production for the UK market.

In Europe, around 90 per cent of APIs for generic medicines are sourced from India and China – which is a matter of deep concern for those tasked with making health policies.

In an interview with The Financial Times on April 20, the EU Health Commissioner Stella Kyriakides said that Brussels would use its pharmaceuticals strategy to tackle supply chain problems revealed by the crisis, notably the bloc’s reliance on China and India for imports of crucial intensive care drugs, including narcotic pain relievers, muscle relaxant ingredients and some older anaesthetics.

In the UK though, the Association of British Pharmaceutical Industry has said that there are “robust procedures in place” to manage the supply of medicines and companies are taking “all possible measures” to secure supply of medicines in line with government guidance.

While medicine shortages in the UK have so far been limited, the Pharmaceutical Services Negotiating Committee is concerned that shortages are becoming increasingly frequent.

Help for community pharmacy

When asked what the company was doing to help their community pharmacy customers, Torrent Pharma said: “We have been working hard to ensure ongoing supplies of our medicines to meet demand.”

It added the company has been working collaboratively “alongside our customers and with our industry body, the BGMA, to communicate and understand the major difficulties being faced by all parties.”

Zentiva said: “We have seen an increase in orders over the last few weeks, which has put pressure on our supply chain, but we are doing all we can to meet this demand. Consequently, we have implemented revised working patterns across our warehouses to ensure we get products, as swiftly as possible, to our customers and their patients.”

Teva-UK noted: “We’ve done some specific things, such as bringing forward rebate payments and supplying pharmacy support packages and resources – as well as continuing to work hard to maintain a stable supply of medicines for them.

“We’re always thinking about ways we can to make the lives of pharmacists easier, and any additional support we can provide.”

Accord said: “We are working closely with all elements of the supply chain, including pharmacists and wholesalers, and are actively exploring all solutions within our ability to help ensure the continued supply of high-quality, cost-effective medicines to patients.”

The company added that it was working closely with community pharmacists to consolidate the supply chain.

“We are in regular dialogue with our wholesaler partners and independent pharmacies to ensure that we are responding rapidly to their requests, and we have re-focused our sales teams on supporting pharmacists to locate much needed supplies.”

For its part, Sandoz said that it was “committed to keeping prices stable for a basket of essential medicines that may help in the treatment of coronavirus cases, specifically antivirals to reduce the impact of coronavirus and antibiotics to combat pneumonia.

“We are evaluating our existing products some of which have been rapidly progressed into clinical trials as candidates for the potential treatment of Covid-19.”

Paracetamol and hand sanitiser top price complaints

P3 Pharmacy, 01 May 2020

Paracetamol and hand sanitiser have shown the highest price increases among products cited in 430 complaints of unfair pricing raised with the Competition and Marketing Authority since 3 April.

While the average price increase across all reports is 130 per cent, the largest price increase is for hand sanitiser, with a reported rise in price of 367 per cent, followed by paracetamol at around 230 per cent.

The CMA’s Covid-19 Taskforce, set up to monitor competition and consumer problems arising from coronavirus received almost 21,000 complaints between 10 March and 19 April.

The profile of price increase complaints remained relatively stable over the period. Complaints about medication hovered around 4-8 per cent of the total, with the exception of a peak on 9 April which reflected a spike in complaints about paracetamol and ibuprofen.

The CMA says the vast majority of businesses are behaving responsibly and fairly in the unprecedented circumstances created by the coronavirus outbreak. However, on 20 March the CMA wrote an open letter to the pharmaceutical sector saying it had received reports that a minority of firms were seeking to capitalise on the situation by charging unjustifiably high prices for essential goods or making misleading claims around their efficacy.

As of 19 April, it had written to 187 individual businesses expressing concern about unjustifiable price rises. Together, these businesses accounted for over 2,500 complaints – one in eight of all complaints.

The General Pharmaceutical Council reported a “significant rise” in Fitness to Practise concerns in papers released ahead of its council meeting on April 23, citing profiteering concerns as a main contributor.

Over 100 more FtP concerns were raised in March than would usually be seen in this period. “Many related to concerns about pricing and profiteering,” the GPhC said, though it added that it was “unlikely” the rise in complaints against registrants would lead to a rise in FtP hearings.

Concerns around pricing are generally considered to fall outside the regulator’s remit.

Media and Political Bulletin

01 May 2020

HDA Statement regarding the availability of Public Health England-supplied PPE for community pharmacy

The Healthcare Distribution Association would like the community pharmacy sector to be aware that the stocks of Public Health England (PHE) PPE masks recently supplied by the Association’s member wholesalers to pharmacies, for staff use only, have now almost completely run out.  HDA member companies are awaiting a new sale event to be announced by Public Health England.

In the meantime, the Department of Health & Social Care has told HDA:

“We have extended our PPE supply route to Local Resilience Forums (LRFs) to help distribute stock to organisations outside of the NHS supply chain who have the highest need clinically and other services that would have a high priority need for PPE including Pharmacists.

Over 7 million more items of PPE have been delivered over the last week to the LRFs identified as being in the highest need of resupply. We will continue to make drops of PPE for distribution by the LRFs to meet some priority need until the new e-commerce solution is operational.

We will continue to make releases to wholesalers when stocks permit.

If providers are unable to access PPE through these routes and have an urgent need, they should contact the National Supply Disruption Response (NSDR) helpline to request emergency support. The 24/7 freephone number is 0800 915 9964.”

This statement about PHE-supplied PPE masks excludes the fact that individual HDA wholesalers may be able to obtain some supplies of appropriately certified PPE masks from their own sources.

Media Summary

 

EXCLUSIVE: Facing the pandemic challenge together

Pharmacy Business, Jeremy Main, 01 May 2020

The HDA’s Chair, Jeremy Main, wrote an opinion piece in Pharmacy Business highlighting the vital role of certain sectors that have for years been under appreciated, and are now suddenly being called upon more than ever.

Jeremy Main notably puts a spotlight on the pharmacy sector, who he believes has long been a pillar of local communities yet often not given enough recognition and been desperately under- funded.

He explores the challenges faced up and down the medicines supply chain in these unprecedented times, and applauds the efforts of everybody involved in the supply of medicines, urging one and all to work together.

Wholesalers ‘almost completely out’ of government-supplied PPE, trade body warns

The Pharmaceutical Journal, Carolyn Wickware, 01 May 2020

The Pharmaceutical Journal reports that the HDA has said it is currently waiting for an announcement of further supplies from Public Health England, with pharmacies instead advised to contact their local resilience forum (LRF) for the recommended fluid-resistant (Type IIR) surgical masks.

The statement comes after a survey by the Royal Pharmaceutical Society revealed that one in three pharmacists have been unable to access continuous supplies of PPE.

Martin Sawer, executive director of the HDA, said the amount of PPE available to wholesalers from sources outside of PHE was “not huge volumes at all and it varies a lot by wholesaler”. When asked whether sourcing PPE in this way would meet demand, Sawer said: “The HDA does not believe so currently, but the situation is very fluid as production sites globally open up again.” However, he added: “I do believe that PHE and the DHSC, and others, are prioritising PPE procurement for the UK.”

Pharmacists can supply some CDs with no script if asked by DH

Chemist+Druggist, Valeria Fiore, 30 April 2020

Chemist+Druggist reports that the government passed legislation on April 29 permitting pharmacists in England, Wales and Scotland to supply medicines in schedule 2, 3 and part 1 of schedule 4, without a prescription “in a pandemic situation”.

The legislation states that the health secretary may activate the legislation by making “an announcement permitting pharmacists without prescribing rights” to issue the medicines patients need in cases where the patient has been prescribed the medication before.

The legislation will allow pharmacists to supply medicines in schedule 2 to part 1 of schedule 4 under a serious shortage protocol.

Parliamentary Coverage

 

VAT zero rating for personal protective equipment

HM Revenue & Customs, 30 April 2020

This is a new temporary zero rate that will apply to supplies of PPE as defined by Public Health England’s coronavirus (COVID-19) PPE guidance on 24 April 2020.

The policy objective of this relief is to relieve the burden of VAT on the price of purchasing PPE used for protection from coronavirus by front line workers. This will particularly aid sectors that cannot recover VAT on such goods due to their VAT exempt status, such as care homes, but will benefit all consumers.

The temporary relief is being introduced as an urgent response to the coronavirus emergency. The measure will take effect from 1 May to 31 July 2020.

Full Coverage

EXCLUSIVE: Facing the pandemic challenge together

Pharmacy Business, Jeremy Main, 01 May 2020

As the Covid-19 pandemic has swept across the world the vital role of certain sectors that have for years been under appreciated are now suddenly being called upon more than ever.

One great example of this is pharmacy.

Having long been a pillar of local communities, pharmacies and pharmacists sit at the heart of a well-functioning healthcare system. Yet, they are often taken for granted, especially by those in government – not given enough recognition and desperately under- funded. Suddenly pharmacy and medicines supply are in the spotlight.

What the coronavirus crisis has brought into sharp focus is how almost overnight the sustainability and resilience of pharmacy can be questioned and thrown into doubt. In the blink of an eye, not only is the financial security of community pharmacy being severely tested, but also the health and safety, of pharmacy staff.

It has, therefore, been imperative that community pharmacy’s partners rise to the challenge of providing support to a vital front-line cog in the anti-COVID machine.

Understandably, many patients are un- aware of how many partners sit behind and support pharmacy. From the manufacturers of active pharmaceutical ingredients (API) in India and China, to the air freight providers who are flying in finished medicines, the medicines supply chain is a long one. At a time like this, with both massive global and local disruption, it is even longer and more complex.

But, of course, ultimately all that matters to patients is whether the pharmacist is able to hand over their medicines when they need them. A task that became harder as the demand for medicines in primary care dramatically increases and as GPs change their prescribing habits in response to coronavirus. Given the nature of the medicines supply chain, such an increase in demand has a significant effect, dramatically impacting each complex moving component further up the chain.

The challenges

Take the healthcare distributors that the HDA represents. In many ways, they face a similar challenge to the supermarkets. We have all seen the images of empty shelves with no pasta and bread, eggs or toilet rolls as customers panic buy.

The supermarkets argue that the required food is in the country, they just can’t get it to their shops quick enough. Although patients can’t panic-buy prescription medicines the increase in prescription days written has meant massively increased volumes of medicines have had to arrive at pharmacies at the same time.

Broadly, in the initial few weeks of the surge in demand at community pharmacy, we have not seen a significant spike in the number of additional shortages that could be attributed to the Covid-related increase in the number of scripts. This, of course, has been a team effort. Pharmacists ordering accurately and on time; the pre-wholesalers moving vast quantities of medicines; and the pharmaceutical manufacturers reacting to changing market dynamics.

The level of detail that has been addressed to ensure continuity of medicines supply has been simply astounding. It is a reminder how complex and interdependent the supply chain is. Every stage must be functioning efficiently for patients to receive their medicines. And when every stage is being severely challenged as a result of Covid-19 then the potential for a breakdown is critically high.

The HDA is aligning with pharmacy bodies to identify and mitigate potential risk factors and working around the clock with the government departments to have them formally addressed by official guidance or by the short-term easing of certain less critical regulations.

Shared experiences

Like pharmacy, wholesalers have been facing many new challenges in the day to day operation of their businesses. Due to very strong personal commitment, staff absences have thankfully been lower than many have expected, but nonetheless normal ways of working have had to be flexed or re-designed. Many staff members have been redeployed to add extra capacity in service centres and extra hours and shifts are being worked across our members’ businesses.

For example, one member has moved from a 5.5-day week with 16-hour days to a 24×7 operation to serve customers in London and the South East. Wholesalers are dealing with an unprecedented volume of orders, high call volumes and emergency orders.

Alongside pharmacists and following sustained lobbying we were grateful that the government has classified pharmaceutical wholesalers as key workers, allowing our sector’s staff members to continue to send their children to school. Additionally, we now also have access to the government’s Covid-19 testing regime.

This will mean more team members can be on the warehouse floor to get pharmacy orders packed and out for delivery. Another issue is security. As with many pharmacies our members have also reported increased examples of criminal behaviour – some very serious – targeting medicines distribution. Incidents so far remain low, but extra measures have had to be implemented.

Working together

Our members have over 12,000 warehouse staff and delivery drivers, who alongside the hundreds of staff members in customer support, purchasing, finance, security, IT have been working day and night to support pharmacies in meeting the huge surge in demand for medicines. In many ways, medicines distribution is the hidden player in the supply chain.

Patients interact with their GPs and pharmacists and appreciate that their medicines have been manufactured somewhere in the world. But the 24/7, just in time delivery service provided by HDA members often goes unseen.

Across all our member companies there are numerous examples of teams working selflessly and tirelessly to ensure medicines are delivered safely and on time. It has been a time of unprecedented challenge – and as with other supply chains, of course, not everything has been perfect – but by and large the efforts of our members along with manufacturers and pharmacists have underpinned the overall successful operation of ensuring patients receive their medicines.

In an unprecedented time like this we are all in it together and need to continue working together in the coming weeks and months. Let’s applaud the efforts of everybody involved in the supply of medicines, recognise the challenges we all have and work constructively to solve them.

Wholesalers ‘almost completely out’ of government-supplied PPE, trade body warns

The Pharmaceutical Journal, Carolyn Wickware, 01 May 2020

Wholesalers have “almost completely run out” of the personal protective equipment (PPE) supplied by Public Health England (PHE) for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned.

In a statement published on 29 April 2020, the Healthcare Distribution Association (HDA) said it was waiting for an announcement of further supplies from PHE, with pharmacies instead advised to contact their local resilience forum (LRF) for the recommended fluid-resistant (Type IIR) surgical masks.

The statement comes after a survey by the Royal Pharmaceutical Society revealed that one in three pharmacists have been unable to access continuous supplies of PPE.

On 9 April 2020, three wholesalers — AAH Pharmaceuticals, Alliance Healthcare and Phoenix — received supplies of PPE from the government reserve.

However, AAH Pharmaceuticals, which said at that time it had received “limited stocks” of masks, told The Pharmaceutical Journal in a statement on 30 April 2020 that it has “run out of the [government] stock”.

“We are working with the HDA to understand when new stocks will be released, and how regularly thereafter, to ensure that all community pharmacies have access to the protective equipment that they need,” it said, adding that the company is sourcing masks through its own suppliers and expects these to be available “in the next couple of weeks”.

Alliance Healthcare said it also “does not have any of the PHE-supplied stock available” but added that it does have “limited stock available” from other sources, with further deliveries anticipated in May 2020.

The third wholesaler, Phoenix, would not comment on its current PPE supply.

The HDA’s statement said it wanted “the community pharmacy sector to be aware that the stocks of PHE PPE masks recently supplied by the association’s member wholesalers to pharmacies, for staff use only, have now almost completely run out”.

It added that the Department of Health and Social Care (DHSC) had advised the trade body that PPE supplies were directed to LRFs “to help distribute stock to organisations outside of the NHS supply chain who have the highest need clinically, and other services that would have a high priority need for PPE, including pharmacists”.

Martin Sawer, executive director of HDA, said the amount of PPE available to wholesalers from sources outside of PHE was “not huge volumes at all and it varies a lot by wholesaler”.

When asked whether sourcing PPE in this way would meet demand, Sawer said: “The HDA does not believe so currently, but the situation is very fluid as production sites globally open up again.”

However, he added: “I do believe that PHE and the DHSC, and others, are prioritising PPE procurement for the UK.”

In a statement on its website, the Pharmaceutical Services Negotiating Committee (PSNC) told community pharmacies that are running out of PPE to contact their LRF for more supplies.

Simon Dukes, chief executive of PSNC, said the HDA’s comments show “just how critical the national PPE situation is becoming”.

“It is putting the safety of community pharmacy staff at risk, which is quite simply unacceptable,” he said, adding that he would highlight to government “the absolute imperative that our staff are protected”.

Pharmacists can supply some CDs with no script if asked by DH

Chemist+Druggist, Valeria Fiore, 30 April 2020

New legislation will allow pharmacists to supply certain controlled drugs without a script to patients who have been prescribed them before when given the go ahead by government.

The government passed legislation yesterday (April 29) permitting pharmacists in England, Wales and Scotland to supply medicines in schedule 2, 3 and part 1 of schedule 4, without a prescription “in a pandemic situation”.

The legislation states that the health secretary may activate the legislation by making “an announcement permitting pharmacists without prescribing rights” to issue the medicines patients need in cases where the patient has been prescribed the medication before.

Before making an announcement that relates to Scotland or Wales, the health secretary “must consult” with the ministers in the respective countries, according to the legislation.

Pharmacists may also be allowed “to change the intervals in prescriptions for drugs specified in schedule 2 or 3” during the pandemic, following agreement with the prescriber or – if they are unavailable – a person chosen by the prescriber to “agree this type of change”.

The legislation will also allow pharmacists to supply medicines in schedule 2 to part 1 of schedule 4 under a serious shortage protocol. This applies when “to help manage a serious shortage” the pharmacists might need to “reduce the amount to be supplied” or offer a “different pharmaceutical form of the drug that was prescribed”. This may “not necessarily [be] in a pandemic situation”, the legislation said.

Limitations

The change in the law will apply only to “the area to which the announcement relates” and “during the period specified in the announcement”, according to the legislation – which was signed by home secretary Priti Patel. Earlier this month, Ms Patel consulted with the Advisory Council on the Misuse of Drugs and asked them to “advise on the potential harms or risks” of implementing the measures.

The period to which these measures apply “must initially not be for more than three months”. However, this could be extended for additional periods, “of not more than three months at a time”.

Commenting on the legislation, Royal Pharmaceutical Society President Sandra Gidley said the legislation will help patients “needing ongoing treatment for palliative care or substance misuse therapy” to continue to access their treatment “when the usual means of prescribing and accessing it are unavailable”.

“Now the legislation has been published, we will shortly provide professional guidance for pharmacists who may need to supply controlled drugs under the new measures,” she said.

Media and Political Bulletin

15 April 2020

Media Summary

Two arrested for illegally selling Covid-19 home testing kits

The Guardian, Jamie Grierson, 15 April 2020

The Guardian reports that a pharmacist and a surveyor have been arrested on suspicion of illegally selling coronavirus testing kits in two separate investigations by the National Crime Agency (NCA).

In another unrelated move, the NCA took down a website trying to fool victims into buying suspected non-existent personal protective equipment (PPE) through phishing emails.

Nikki Holland, NCA director of investigations, said: “Illegally selling testing kits completely undermines the nation’s collective response to the pandemic and actually endangers lives. Anyone thinking of trying to profit in this way should take note of these arrests and that bringing these offenders to justice and ceasing their activities is a key priority across law enforcement.”

Graeme Biggar, director general of the National Economic Crime Centre, added: “Covid-19 is increasingly being used as a hook to commit fraud – and we think these offences are likely to increase during the pandemic.”

This was also reported on by Sky News and the Express.

EMA task force established to co-ordinate rapid regulatory action for COVID-19 medicines

European Pharmaceutical Review, Hannah Balfour, 14 April 2020

European Pharmaceutical Review reports that the EMA has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF).

The task force was established as part of the agency’s health threat plan, to aid EU member states and the European Commission (EC) in dealing with the development, authorisation and safety monitoring of therapeutics and vaccines intended for treatment or prevention of COVID-19.

According to the EMA, COVID-ETF will enable a fast and coordinated response to the COVID-19 pandemic, by drawing on expertise from the European medicines regulatory network. In all its activities, the task force is accountable to the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Medicines supply notices

Dispensing Doctors’ Association, Ailsa Colquhoun, 14 April 2020

The Department of Health and Social Care has published the following medicines supply notices:

NHS not going to run out of drugs to treat patients, senior medics stress

Evening Express, Press Association, 12 April 2020

Evening Express reports that senior medics have said there will be enough drugs to treat critically ill patients in intensive care despite fears of drug shortages. But leaders in intensive care medicine and anaesthetics also warned that people should obey social distancing rules in order to reduce the burden on NHS resources.

Their comments come amid reports key medicines at some intensive care units were in short supply. Dr Alison Pittard, dean of the Faculty of Intensive Care Medicine, told PA news agency: “We are not going to run out of drugs to treat patients, that’s the bottom line. We may do things differently, but patient care won’t be compromised because we have to change the choice of drug.”

Her comments come as she released a joint statement with leaders of the Intensive Care Society, Association of Anaesthetists and Royal College of Anaesthetists.

Warwick Smith, director general of the BGMA, said manufacturers were working “extremely hard” to meet the unprecedented demand for intensive care medicines. He added: “We are currently seeing four-fold demand increases in some areas and so we are particularly focused on the supply of these critical products.”

This was also reported in Metro.

Britain’s supply chain of food and medicine could grind to a halt after nearly HALF of lorries are taken off road as hauliers struggle to stay afloat

Daily Mail, Jemma Carr, 12 April 2020

The Daily Mail reports that the Road Haulage Association (RHA) has warned it is reaching crisis point, with many transport firms on the brink of collapse. If they go under, the UK’s fleet of lorries which delivers essential goods such as food and medicine up and down Britain, will stand idle.

An RHA survey found that 46 per cent of trucks have been taken off the road since the COVID-19 crisis began. The main income for many independent hauliers is transporting equipment for large concerts and events, all of which have been cancelled due to coronavirus. Others have been hit by a lack of international imports after airports all but closed down due to the crisis.

Richard Burnett, RHA chief executive, warned many firms are in danger of going out of business permanently. He said they need immediate cash injections to stay afloat so they can continue to keep the UK economy moving.

Mr Burnett said: ‘The measures the Government have come up with simply don’t work.

This was also reported in the Express.

 

 

Parliamentary Coverage

House of Commons – Written Answers, Tuesday 14 April 2020

Asked by 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 steps he is taking to ensure that the NHS will not face a medicine shortage in the coming months.

Answered by Jo Churchill on 14 April 2020 (Holding answer received on 24 March 2020): The country is well prepared to deal with any impacts of COVID-19 and we have stockpiles of generic drugs, in the event of any supply issues or significant increases in demand.

The Department is working closely with industry, the National Health Service and others in the supply chain to help ensure patients can access the medicines they need, and precautions are in place to reduce the likelihood of future shortages.

The steps being taken to protect the United Kingdom’s supplies in response to the COVID-19 outbreak were set out in the Department’s press statement issued on 11 February 2020. This statement is available at the following: https://www.gov.uk/government/news/government-to-monitor-impact-of-coronavirus-on-uk-medicine-supply.

 

Asked by Taiwo Owatemi (Coventry North West): 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.

Answered by Jo Churchill on 14 April 2020 (Holding answer received on 24 March 2020): The Government has no plans to create facilities in the United Kingdom to manufacture further active pharmaceutical ingredients. There are 16,000 medicines on the market in the UK. Whilst some of these are manufactured in the UK, most are manufactured abroad. Where medicines are manufactured here, the active ingredients and excipients for those medicines may be manufactured abroad. It is not realistic to manufacture all 16,000 medicines and the active ingredients and excipients needed for these medicines in the UK.

The production of medicines is complex and highly regulated, and materials and processes must meet rigorous safety and quality standards. Supply problems can affect a wide range of medicines and can arise for various reasons, such as manufacturing issues, problems with the raw ingredients and batch failures. These problems arise regardless of where in the world the manufacture takes place.

 

Asked by Ms Angela Eagle (Wallasey): To ask the Secretary of State for Health and Social Care, whether his Department will take steps for pharmacists who are dealing with members of the public to be issued protective clothing and equipment.

Answered by Jo Churchill Answered on 14 April 2020 (Holding answer received on 24 March 2020): Packs of personal protective equipment (PPE) have now been delivered to community pharmacies by DPD. This began on 13 March 2020; and deliveries were completed on 17 March 2020. These packs are only for use by pharmacy staff in line with the standard operating procedure for community pharmacy, and contain masks, aprons and gloves.

If pharmacies have not received their PPE packs, or if the pack delivered is incomplete, they can contact the National Supply Disruption Service.

Should community pharmacies require further PPE supplies, they can order this through their wholesalers.

 

Full Coverage

Two arrested for illegally selling Covid-19 home testing kits

The Guardian, Jamie Grierson, 15 April 2020

A pharmacist and a surveyor have been arrested on suspicion of illegally selling coronavirus testing kits in two separate investigations by the National Crime Agency (NCA).

NCA officers arrested a 46-year-old pharmacist from Croydon on Saturday under the Fraud Act 2006 after he allegedly made false and misleading claims about tests’ capability. Two properties and a car linked to the suspect were searched. He was released on conditional bail.

In a separate investigation, a 39-year-old surveyor from Uxbridge, west London, was stopped while driving his car, in which 250 Covid-19 testing kits were found. He was arrested under the Fraud Act 2006 after making false and misleading claims about the capability of the tests, which he told investigators he was planning to sell to construction workers. He was released on conditional bail.

In another unrelated move, the NCA took down a website trying to fool victims into buying suspected non-existent personal protective equipment (PPE) through phishing emails.

Nikki Holland, NCA director of investigations, said: “Illegally selling testing kits completely undermines the nation’s collective response to the pandemic and actually endangers lives.

“Anyone thinking of trying to profit in this way should take note of these arrests and that bringing these offenders to justice and ceasing their activities is a key priority across law enforcement.”

Graeme Biggar, director general of the National Economic Crime Centre, added: “Covid-19 is increasingly being used as a hook to commit fraud – and we think these offences are likely to increase during the pandemic.”

Offenders are targeting people trying to buy medical supplies online and have been sending emails offering fake medical support and scamming people who may be vulnerable or isolated at home, the NCA said.

Frauds have been attempted by trying to lure victims with offers that look too good to be true such as high return investments, “healthcare opportunities” or appeals to support bogus charities.

Tariq Sarwar, head of operations for enforcement at the Medicines and Healthcare Products Regulatory Agency (MHRA), said: “The use of products for the diagnosis of coronavirus infection in community settings, such as pharmacies, for home use, is not at present advised by Public Health England.

“There are no CE-marked tests for home use, and it is illegal to supply such products. The safety, performance or quality of the products cannot be guaranteed and this poses a health risk.” He added: “Always make sure you are buying your medicines from a registered pharmacy or website and your medical devices from reputable retailers.”

This was also reported on by Sky News and the Express.

EMA task force established to co-ordinate rapid regulatory action for COVID-19 medicines

European Pharmaceutical Review, Hannah Balfour, 14 April 2020

The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.

The European Medicines Agency (EMA) has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF).

The task force was established as part of the agency’s health threat plan, to aid EU member states and the European Commission (EC) in dealing with the development, authorisation and safety monitoring of therapeutics and vaccines intended for treatment or prevention of COVID-19.

According to the EMA, COVID-ETF will enable a fast and coordinated response to the COVID-19 pandemic, by drawing on expertise from the European medicines regulatory network. In all its activities, the task force is accountable to the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The COVID-ETF is chaired by the EMA and composed of the chair and vice-chair of the CHMP, the agency’s safety committee (PRAC), the Paediatric Committee (PDCO) and relevant working parties, as well as the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and the Clinical Trials Facilitation and Co-ordination Group (CTFG). The agency said it will also include CHMP rapporteurs and co-rapporteurs for all COVID-19 medicines and vaccines, additional experts on an ‘as-needed’ basis and will invite additional observers on a case-by-case basis.

The COVID-ETF’s mandate states it will:

  • review the available scientific data on COVID-19 medicinal products and identify promising candidates
  • request data from developers and engage with them in preliminary discussions
  • offer scientific support in collaboration with the CTFG to facilitate clinical trials conducted in the EU for the most promising COVID-19 medicinal products
  • provide feedback on development plans of COVID-19 medicinal products when formal rapid scientific advice is not feasible
  • act as advisor to the Scientific Advice Working Party (SAWP) or the CHMP for formal scientific advice and product-related assessment and contribute to the PRAC activities on emerging safety issues related to COVID-19.

The EMA health threats plan describes how the agency and European medicines regulatory network intend to respond to and communicate about serious health threats like the COVID-19 pandemic. The plan is built on experience from the 2009 H1N1 influenza pandemic and other health emergencies since, including the Ebola outbreak in 2014-2016.

As part of this plan, specific expert groups such as the COVID-ETF and scientific advisory groups can be swiftly convened to assist the EMA’s scientific committees or take part in early scientific discussions and medicines’ reviews.

Medicines supply notices

Dispensing Doctors’ Association, Ailsa Colquhoun, 14 April 2020

The Department of Health and Social Care has published the following medicines supply notices:

Acetazolamide SR 250mg capsules

  • Out of stock until the end of July 2020
  • Acetazolamide immediate release 250mg tablets remain available
  • Unlicensed imports of acetazolamide SR 250mg capsules are available in limited quantities

Konakion Sol for Inj Amp 2mg/0.2ml (2mg Phytomenadionein 0.2ml).

  • Anticipated resupply date: end of May 2020.
  • Unlicensed imported Konakion 2mg is available

Konakion MM Paediatric

  • Out of stock until the end of May 2020
  • Unlicensed supplies available

NHS not going to run out of drugs to treat patients, senior medics stress

Evening Express, Press Association, 12 April 2020

There will be enough drugs to treat critically ill patients in intensive care despite fears of drug shortages, senior medics have said.

But leaders in intensive care medicine and anaesthetics also warned that people should obey social distancing rules in order to reduce the burden on NHS resources.

Their comments come amid reports key medicines at some intensive care units were in short supply.

But speaking at the daily Downing Street press conference on Sunday, Health Secretary Matt Hancock said the Government was working with pharmaceutical industry to ensure the right medicines were in place.

He added: “I can assure everyone that we’re working very closely with the pharmaceutical supply chain and hospital pharmacies so that the right medicines are there to treat people.

“And I’m glad to see the reassurances that have been provided today that everybody can have the medicines they need in order to get the care that they need.”

Intensive care consultant Dr Ron Daniels told the BBC that quality of care for all intensive care patients – not just coronavirus sufferers – will “likely be lower” as a result.

But Dr Alison Pittard, dean of the Faculty of Intensive Care Medicine, said that the NHS was not going to run out of medicines to treat patients and that care will not be compromised.

She told the PA news agency that medics have been issued new guidance telling them to use alternatives which were “perfectly safe for patients”.

Dr Pittard added: “We are not going to run out of drugs to treat patients, that’s the bottom line.

“We may do things differently, but patient care won’t be compromised because we have to change the choice of drug.

“I want to reassure the public – we know what we are doing, we are working together, we know what the situation is, and we are making sure they are our first priority.”

Her comments come as she released a joint statement with leaders of the Intensive Care Society, Association of Anaesthetists and Royal College of Anaesthetists.

In it, they said that while medics might not always be able to use their first choice drug, they expect them to be able to use an appropriate alternative drug.

Dr Pittard said: “There may be shortages of specific drugs but there are always alternatives in the same class that although staff will need to slightly modify their practice, they will be perfectly safe for patients.”

But the four leaders also stressed the public should continue to adhere to the Government’s guidance to stay at home.

They added: “By staying at home, not only will you significantly reduce the chance of being infected with Covid-19, but you will save lives by stopping the spread of this virus.

“Your compliant and considerate actions will help reduce the burden on NHS resources and staff who are working night and day to treat incredibly sick patients.”

The Department of Health and Social Care said it had banned the “parallel export” of more than 100 medicines to keep supplies in the UK.

A spokesman added: “As part of our concerted national efforts to respond to the coronavirus outbreak, we are doing everything we can to ensure patients continue to access the medicines they need.

“During this global pandemic there is in an increase in demand for a number of intensive care drugs and we are working with the pharmaceutical industry and NHS England to make additional supplies available and ensure they are managed fairly across the UK.”

Health Secretary Matt Hancock said earlier this month that the Government is “currently confident” that the UK has the supply of medicines needed.

Warwick Smith, director general of the British Generic Manufacturers Association (BGMA), said manufacturers were working “extremely hard” to meet the unprecedented demand for intensive care medicines.

He added: “The very significant increase in the number of patients requiring mechanical ventilation in intensive care as a result of Covid-19 has inevitably led to an unprecedented demand for the medicines required for that treatment.

“We are currently seeing four-fold demand increases in some areas and so we are particularly focused on the supply of these critical products.

“Increasing production and supply to unprecedented levels in some cases cannot be achieved instantly but manufacturers are working extremely hard to help ensure the highest levels of supply possible.”

This was also reported in Metro.

Britain’s supply chain of food and medicine could grind to a halt after nearly HALF of lorries are taken off road as hauliers struggle to stay afloat

Daily Mail, Jemma Carr, 12 April 2020

Britain’s vital supply chain could grind to a halt as nearly half of the country’s lorries have been taken off the road since the coronavirus crisis began, an industry body has warned.

The lorries are transporting essential goods such as food and medicine up and down Britain as the country continues to battle the pandemic.

Britain’s spiralling death toll hit 10,000 today with 737 new fatalities.

The Road Haulage Association warned it is reaching crisis point with many transport firms are on the brink of collapse.

If they go under, the UK’s fleet of lorries which deliver essentials will stand idle.

Multiple shops and factories rely on hundreds of small independent hauliers to ferry goods to them from distribution centres and ports.

But 46 per cent of the trucks have been taken off the road since the crisis began, an RHA survey found.

The main income for many independent hauliers is transporting equipment for large concerts and events, all of which have been cancelled due to coronavirus.

Others have been hit by a lack of international imports after airports all but closed down due to the crisis.

Richard Burnett, RHA chief executive, warned many firms are in danger of going out of business permanently.

He said they need immediate cash injections to stay afloat so they can continue to keep the UK economy moving.

Mr Burnett said: ‘The measures the Government have come up with simply don’t work.

‘An average haulier will make maybe 2 per cent margin, they’ll have two to three weeks cashflow within their business.

‘We’ve got hauliers at the moment who can’t even furlough their staff, because they have insufficient cash to pay those employees.

‘We need cash, we need grants, we need help to balance and normalise this cashflow problem, and the loan system simply doesn’t work at this point in time.

‘The Government will need to provide more radical financial support to ensure they survive.

‘The events and music world has been decimated with the cancellation of concert tours.

‘One major haulier has parked-up their 170-vehicle fleet and told their driving force nothing will be moving for at least two to three months with all revenue disappearing overnight.

‘Another is in the same situation having had concert tours worth millions cancelled.

‘Panic buying is creating artificial peaks with manufacturers working hard to supply retailers and volumes exceeding the normal Christmas peak.

‘What we’re seeing now, and have seen so far, is the tip of the iceberg.

‘While millions are now working from home we are still expecting truckers to be out there delivering goods like food and medicine. They are taken for granted and have been for years.’

Almost 50 per cent of the food consumed in Britain is imported with 29 per cent of that from Europe.

The RHA said the coronavirus epidemic has the potential to cause ‘catastrophic effects’ on haulage firms if supplies cannot cross borders.

Mr Burnett warned recently ‘Over the past six weeks we have seen container volume from China drop by between 70 and 80 per cent and we are now seeing issues with the flow of raw material, retail product and food from across Europe.

‘Air freight into Heathrow has more or less stopped.

‘It’s hard to know how much this volume will decrease from here as more borders are closed or restricted.

‘So far, road freight movements in Europe have been exempted from most restrictions and in many countries rules limiting or banning the movement of lorries at weekends have been suspended to create greater supply-chain resilience.

‘Any future lockdown of towns and cities and closure of food and retail outlets will suppress volumes further.

‘The main costs for most businesses are vehicles – which are often leased – plus fuel and wages.

‘Businesses are at massive risk from banks and fuel suppliers withdrawing credit and hauliers will collapse quickly if credit is not sustained and extended.

‘This problem is compounded by forthcoming regulatory change requiring companies to invest in new, low emission vehicles.

‘The measures we are calling for must start now. The industry usually starts planning for the mad panic of Christmas in August but this is beyond anything we have seen before.’

Jack Fleming, CEO of Chill-Chain, a cold chain logistics firm, said ‘Unless a company is one of the few that solely supplies supermarkets, you’re seeing fleets really struggling.

‘We’re seeing small and medium-sized haulage fleets struggling for work and that means drivers are being sent home.’

Natalie Chapman, head of urban policy at the Freight Transport Association, called on the Government to help.

‘We need to be protecting the businesses seeing a downturn in trade, while also ensuring that where we’re seeing big increases in demand, that as an industry we can fulfil that.’

The Department for Transport said ‘As the Chancellor announced, this Government will provide £330 billion of guarantees, including cash grants of up to £25,000 for several hundred thousand small businesses.

‘We will stand behind businesses small and large and will do everything we can to support businesses to get through this.

‘Ministers are engaging in weekly discussions with the Road Haulage Association to discuss the challenges facing the sector.’

This was also reported in the Express.

Media and Political Bulletin

26 March 2020

Media Summary

European Commission draws up plans to postpone MDR implementation

Med-Tech News, 26 March 2020

Med-Tech News reports that the European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.

The new regulation was due to come into force on 26th May this year but in light of the pandemic, and calls from trade bodies, the Commission has confirmed it is working on a proposal to postpone the application date.

The Commission said: “With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May, its deadline for entry into force. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the Coronavirus crisis.”

Medicine shortages: what’s going on?

Which?, Anna Studman, 25 March 2020

Paracetamol and ibuprofen are just some of the items that are increasingly hard to get hold of as people stock up on everyday essentials in the wake of the coronavirus crisis and UK government lockdown. But Which? reports that even before the pandemic hit, there were issues with prescription medicine shortages in the UK.

Which? members were surveyed in December 2019, and it was found that one in four people had experienced problems getting hold of the medicines they needed because of stock shortages in the past year.

The article explores some of the reasons behind these shortages.

India to set up $1.3bn pharma manufacturing fund, says report

European Pharmaceutical Review, Victoria Rees, 25 March 2020

European Pharmaceutical Review reports that, due to the COVID-19 outbreak, India has decided to invest $1.3 billion into its internal drug manufacturing capabilities, says a new report.

Published in Bloomberg, the report highlights that the disruptions to the supply chain because of the outbreak revealed the extent to which India relies on China for APIs and how easily medicine shortages could occur.

Reportedly, a government statement outlined that the funding will go towards infrastructure for drug manufacturing facilities and financial incentives of up to 20 percent incremental sales value over the next eight years.

COVID-19 update: Eli Lilly assures security of insulin supply

European Pharmaceutical Review, Hannah Balfour, 25 March 2020

European Pharmaceutical Review reports that, having become aware of insulin shortages in pharmacies, Eli Lilly has stated that its products are not backordered and should be available for delivery by wholesalers.

The company previously stated that it does not source any active pharmaceutical ingredients (APIs) for their approved medications from China. Therefore, it does not expect to be impacted by reduced manufacturing from the Asia Pacific market.

Lilly stated that it has a network of global manufacturing sites, and that at current, those producing insulin in Europe and the US are still operational, with increased precautions in place to protect the supply of medicine and the welfare of employees from COVID-19. The company say it is continually monitoring the situation for possible impact on the supply of their medicines.

Diamorphine 5mg and 10mg supply update

Dispensing Doctors’ Association, Ailsa Colquhoun, 25 March 2020

Dispensing Doctors’ Association reports that healthcare professionals are asked to plan for a permanent move to morphine sulphate injection as opioid of choice, where clinically appropriate, in place of diamorphine 5mg and 10mg.

Suppliers Wockhardt and Accord have indicated that full supply of these items are unlikely before Summer 2020. Manufacturers of diamorphine hydrochloride 30mg ,100mg, 500mg, which remain available, say they are unable to support an increase in demand on these strengths.

View the alert.

Contractors make urgent plea to chancellor on wholesale bills

P3 Pharmacy, Pharmacy Network News, 25 March 2020

P3 Pharmacy reports that community pharmacy contractors are warning the Government that they will be unable to keep providing vital medicines to patients unless they receive urgent funding assistance to help pay their wholesaler bills.

Amid an extraordinary period in which pharmacies throughout the UK have dispensed record numbers of scripts and contended with shortages and price fluctuations, many are in pressing financial straits.

Mark Lyonette, NPA chief executive told Pharmacy Network News: “We have already appealed to the Government for immediate support to help pharmacies remain operational. We’ve requested a number of emergency measures, including an advance payment scheme for NHS income. Many pharmacies are small businesses with existing cash-flow problems and COVID-19 is dramatically exacerbating this situation.  Above all, we need urgent, substantial new funding to keep pharmacies open.”

Coronavirus: harmonised standards for medical devices to respond to urgent needs

European Commission, 25 March 2020

Yesterday, the European Commission adopted decisions on harmonised standards which will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general. The standards will facilitate a faster and less expensive conformity assessment procedure.

The revised harmonised standards play a pivotal role in the current coronavirus pandemic because they relate to critical devices such as: medical face masks; surgical drapes, gowns and suits; washer-disinfectors and sterilization.

Stella Kyriakides, Commissioner for Health said: “With the measures we adopt today, we speed up the entry of safe, essential medical equipment and devices such as masks, gowns and suits in the EU market. This equipment is fundamental for our health professionals – the brave and resilient women and men at the front line – to keep saving lives”.

 

Parliamentary Coverage

House of Commons – Written Answer, 25 March 2020

James Murray (Ealing North): To ask the Secretary of State for Health and Social Care, if he will make it his policy to recognise the marketing authorisation by the European Medicines Agency of any coronavirus (2019-nCoV) vaccine to ensure there is no risk of delay in the UK acquiring the vaccine in comparison to countries in the EU.

Ms Nadine Dorries (answered on 25 March 2020, holding answer received on 23 March 2020): As of 31 January 2020, the United Kingdom is in the Transition Period. During this time the UK will continue to follow EU legislation which includes European Medicines Agency processes and decisions until 31 December 2020. As such any European Union centrally authorised medicines, including any COVID-19 vaccine, would also be authorised in the UK.

The UK is a world leader in preparing for and managing public health incidents and on 3 March the Government published its action plan to tackle the spread of coronavirus.

Both the EU and the UK are committed to agreeing a future partnership by the end of 2020 and are working to achieve this. The Government is working to ensure that UK patients can access the best and most innovative medicines, whatever the result of negotiations with the EU on our future relationship. It is in the interests of both the UK and the EU to agree a future partnership that keeps goods flowing, services being provided and business being done.

House of Commons – Written Answer, 25 March 2020

Chris Green (Bolton West): To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that all medical device businesses are re-certified so that they comply with the Medical Device Regulation before the May 2020 deadline.

Ms Nadine Dorries (answered on 25 March 2020): The new Medical Device Regulation (MDR), which will become United Kingdom law from 26 May 2020 as part of the European Union Withdrawal Act 2019, substantially strengthens the regulatory framework for medical devices and notified bodies and manufacturers are having to make significant changes to meet the enhanced requirements.

The Government recognises the importance of having competent notified bodies in place to ensure continuity of supply of products to the UK market. Therefore, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with UK industry and notified bodies on an ongoing basis to ensure that they are prepared for the implementation of the MDR.

There are also transitional provisions in place which enable existing CE marked devices to remain valid for sale until the date of expiry of that certificate. This means in practice that all devices on the UK market do not require immediate re-certification.

The MHRA will publish further guidance on how we intend to support businesses who may struggle to obtain certification under the MDR and to ensure continuity of supply of medical devices to UK patients.

House of Commons – Written Answer, 25 March 2020

Lord Roberts of Llandudno (asked on 19 March 2020): To ask Her Majesty’s Government what assessment they have made of whether the COVID-19 pandemic is likely to result in any medicine shortages.

Lord Bethell (answered on 25 March 2020): The country is well prepared to deal with any impacts of COVID-19 and we have stockpiles of generic drugs, in the event of any supply issues or significant increases in demand.

The Department is working closely with industry, the National Health Service and others in the supply chain to help ensure patients can access the medicines they need, and precautions are in place to reduce the likelihood of future shortages.

The steps being taken to protect United Kingdom supplies in response to the COVID-19 outbreak were set out in the Department’s press statement issued on 11 February 2020. These steps include asking suppliers to carry out risk assessments of the potential impacts of COVID-19 on their business and to retain any existing stockpiles of medical supplies from our previous European Union exit work. The statement also outlines that there is no need for the public or NHS to stockpile as this could aggravate problems elsewhere in the supply chain if they emerge.

 

Full Coverage

European Commission draws up plans to postpone MDR implementation

Med-Tech News, 26 March 2020

The European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.

The new regulation was due to come into force on 26th May this year but in light of the pandemic, and calls from trade bodies, the Commission has confirmed it is working on a proposal to postpone the application date.

The Commission said: “With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May, its deadline for entry into force. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the Coronavirus crisis.”

Trade association MedTech Europe, who called for the postponement of its implementation earlier this week, welcomed the Commission’s action, but said that a similar solution is need for In Vitro Diagnostic Regulation (IVDR) – which is due to come into force on 26 May 2022.

A statement from MedTech Europe read: “We welcome the announced intention of the European Commission to propose the postponement of the date of application for the Medical Devices Regulation by 12 months, and we also welcome the support that the European Parliament has expressed for this.

“Once adopted, this measure would enable healthcare stakeholders to maintain focus on fighting the COVID-19 pandemic while keeping healthcare systems running. Rest assured that our industry is putting all its efforts to deliver needed medical technologies to patients and healthcare professionals during these difficult weeks.

“For the In Vitro Diagnostic Regulation, we remain convinced that a similar solution is needed. Although this Regulation has a longer implementation time, diagnostic manufacturers and authorities alike must prepare for major changes and requirements to adapt to the new regulatory framework. Right now, their capacity is focused on the critical task of keeping diagnostic tests available, despite the challenges the pandemic is creating for their production and distribution. By providing the same solution for the in vitro diagnostics and medical devices sectors, the EU would be doing even more to keep health systems up running effectively in times of the COVID-19 pandemic.”

Medicine shortages: what’s going on?

Which?, Anna Studman, 25 March 2020

Paracetamol and ibuprofen are just some of the items that are increasingly hard to get hold of as people stock up on everyday essentials in the wake of the coronavirus crisis and UK government lockdown.

But even before the pandemic hit, there were issues with prescription medicine shortages in the UK.

We surveyed Which? members in December 2019 and found that one in four people had experienced problems getting hold of the medicines they needed because of stock shortages in the past year.

Pharmacy stocks have always been subject to fluctuations, but these appear to have become worse in the past six months, particularly, and the recent pressure on supplies due to people’s fears over coronavirus certainly hasn’t helped matters.

Coronavirus and paracetamol shortages

Paracetamol is the main form of relief available for the fever-like symptoms of COVID-19 if you’re self-isolating at home. It’s also an everyday household medicine that people are buying to prepare for self-isolation.

This increased demand has put stress on supplies – stocks are currently low or non-existent across pharmacies and supermarkets.

Painkillers such as paracetamol and ibuprofen are already subject to limits of how many you can buy in one go, but some stores are now putting even stricter limits in place in an attempt to regulate supply. Boots has now limited customers to just one paracetamol product.

But even so, a pharmacist we spoke to who works at a large Boots store said there were no paracetamol products in stock, and that they were on order but there was no promise of imminent delivery. We’ve been to several pharmacies and supermarkets and been greeted by empty shelves there too.

COVID-19 and increased global demand

Like hand sanitiser and other household essentials, paracetamol is increasingly hard to find. And there are some concerns about the scarcity of supply.

India, the world’s biggest supplier of generic drugs, recently introduced a limit on the export of medicines including paracetamol. The move came as factory shutdowns in China, attributed to the coronavirus lockdown, have fractured the supply chain (India gets most of its raw ingredients for medicines from China).

Will prices go up?

Drug wholesalers have passed on increased costs to high street retailers and pharmacies, but bigger chains can usually absorb these costs. Boots told us: ‘Customers can be reassured that the cost of their regular brands, including Boots own-brand Paracetamol, has not and will not go up.’

The Pharmaceutical Services Negotiating Committee (PSNC), a representative body for community pharmacists, said that it’s ‘keeping a close eye on generic medicines (including paracetamol) affected by recent price hikes and is making applications for price concessions [where pharmacies are reimbursed by the government for wholesale price hikes] in the usual way’.

UK government seeks to reassure consumers

Unsurprisingly, people are concerned about the shortages. We asked the Department of Health and Social Care (DHSC) for comment, and a spokesperson told us: ‘The country is well prepared to deal with any impacts of coronavirus and we have stockpiles of medicines such as paracetamol in the event of any supply issues or significant increases in demand.

‘We are working with suppliers of paracetamol to monitor and assess available supplies and demand, and will continue to do so. Suppliers have informed us that manufacture continues and deliveries are scheduled.’

The DHSC also said that the NHS has stockpiles of paracetamol reserved for use in hospitals.

What to do if you’re having problems getting hold of paracetamol

If you have a specific medical need for paracetamol and are struggling to find it in stores, speak to your GP or pharmacist to see if they can help you track it down and what options or alternatives are available.

Why do medicines shortages happen?

The current shortages of painkilling medication can be explained by the coronavirus impact: a toxic combination of massive increase in global demand, disruption to supply chains and people stocking up on things such as food, household products and medicines.

But what about the shortages of other medicines people were already experiencing?

A London GP told us their practice had faced a significant rise in workload because of daily medicine shortages: ‘In the past year, we’ve acquired three part-time pharmacists who are now “in-house” to share the load for finding alternatives to medicines in short supply.’

Another GP, based in Surrey, said shortages are affecting all sorts of medicines and they’re notified of new shortages almost daily, but with little advice on what to do about them.

It’s thought that a couple of different factors have led to the supply issues we’re seeing now. These are:

  • Manufacturing and distribution issues. If there’s an issue with a single ingredient or batch, this can affect the whole supply chain. There may then be a snowball effect as lots of people switch to an alternative, which is then in higher demand.
  • Pricing issues. Changes in wholesale prices, the drop in the value of the pound in recent years and what the NHS can afford to pay for some medicines can be another factor.
  • Parallel exports. Sometimes medicines on the market in the UK are bought by wholesalers and exported to another European Economic Area (EEA) country, which can also affect supply. It’s thought this may have become more attractive due to the drop in value of the pound.
  • Brexit. In a similar way to the COVID-19 impact, this may also have been a factor insofar as contingency planning and uncertainty about supplies could have exacerbated the situation.

The government has now banned parallel exports of some medicines which were experiencing shortages – including HRT treatments, some vaccines and adrenaline – in an attempt to make sure there’s enough for patients in the UK.

Responding to questions about increased demand for paracetamol due to coronavirus, the DHSC said: ‘Paracetamol is not on the list of products that can’t be parallel exported or hoarded, but we are keeping that list under review.’

Finding alternative medication

Pharmacists and GPs are constantly working to find substitutes for unavailable medicines.

Sometimes a medicine unavailable at one pharmacist will be stocked elsewhere or can be ordered in.

If your medicine is in low supply the pharmacist might dispense the prescription in stages – giving you some upfront and asking you to come back at a later date for the rest.

But a lot of the time, patients aren’t so lucky. One in five people we surveyed who faced a shortage had to take a break from their medicine until stock returned. One in four had substitute medication prescribed.

Getting used to a different formulation can create problems. One patient told us their substitute medication ‘had nasty side effects and caused more problems than it solved’.

What can patients do?

With the continuing spread of COVID-19 and global uncertainty, it’s now more important than ever to be responsible when buying medicine and only buy what you need.

That said, it’s worth anticipating when you might run out and ordering new supplies before this happens.

The PSNC advises patients to order any medicines that you need from your GP in good time (but no more than seven days before it’s due).

It also issued a reminder to only order medicines that you need. If you have unused medicines in your cupboard, use these first (remember to check the expiry date) and do not order extra medicines.

If you’re experiencing issues with any substitute medication you are prescribed, talk to your pharmacist.

India to set up $1.3bn pharma manufacturing fund, says report

European Pharmaceutical Review, Victoria Rees, 25 March 2020

Due to the COVID-19 outbreak, India has decided to invest $1.3 billion into its internal drug manufacturing capabilities, says a new report.

According to a new report, India will establish an almost 100-billion-rupee ($1.3 billion) fund to aid pharmaceutical companies in the manufacturing of active pharmaceutical ingredients (API).

Published in Bloomberg, the report highlights that the disruptions to the supply chain because of the COVID-19 coronavirus revealed the extent to which India relies on China for APIs and how easily medicine shortages could occur.

Reportedly, a government statement outlined that the funding will go towards infrastructure for drug manufacturing facilities and financial incentives of up to 20 percent incremental sales value over the next eight years.

As the outlet highlights, India imports almost 70 percent of its APIs from China, with many sourced from the Hubei province – the epicentre of the COVID-19 outbreak, leading to its decision to invest inwardly.

COVID-19 update: Eli Lilly assures security of insulin supply

European Pharmaceutical Review, Hannah Balfour, 25 March 2020

Having become aware of insulin shortages in pharmacies, the company has stated that its products are not backordered and should be available for delivery by wholesalers.

Eli Lilly has released an update about how the insulin supply chain is being affected by COVID-19. According to the company, they do not anticipate shortages and have set up resources to enable low- or no-income patients to access insulin during the coronavirus pandemic.

The company previously stated that it does not source any active pharmaceutical ingredients (APIs) for their approved medications from China. Therefore, it does not expect to be impacted by reduced manufacturing from the Asia Pacific market.

Lilly stated that it has a network of global manufacturing sites, at current, those producing insulin in Europe and the US are still operational, with increased precautions in place to protect the supply of medicine and the welfare of employees from COVID-19. The company say it is continually monitoring the situation for possible impact on the supply of their medicines.

According to the business, some US pharmacies have temporarily run out of stock of insulin products due to high demand. Lilly stated that, while some pharmacies have not had their orders fulfilled by wholesalers due to “manufacturer backorder”, they are not aware of any such problems and pharmacies should be able to secure orders for delivery in one or two days.

Lilly also advised that patients financially affected by COVID-19 can call the Lilly Diabetes Solution Center to access treatment options, including free insulin.

“COVID-19 is an unprecedented challenge for all of us, but Lilly has planned for such events,” said Mike Mason, president of Lilly Diabetes. “Our manufacturing facilities, supply chain and Lilly Diabetes Solution Center are designed to support those who rely on insulin. We are committed to providing a regular supply of safe insulin and our Solution Center can provide real insulin affordability assistance for people during this difficult time, including people whose jobs have gone away. If you need help, please call the Lilly Diabetes Solution Center.”

Diamorphine 5mg and 10mg supply update

Dispensing Doctors’ Association, Ailsa Colquhoun, 25 March 2020

Healthcare professionals are asked to plan for a permanent move to morphine sulphate injection as opioid of choice, where clinically appropriate, in place of diamorphine 5mg and 10mg.

Suppliers Wockhardt and Accord have indicated that full supply of these items are unlikely before Summer 2020. Manufacturers of diamorphine hydrochloride 30mg ,100mg, 500mg, which remain available, say they are unable to support an increase in demand on these strengths.

All healthcare professionals in primary care who prescribe, dispense or administer diamorphine hydrochloride injection 5mg and 10mg should:

  • identify a local lead within their organisation to manage the delivery of actions as advised in this document where possible
  • review and update guidelines and protocols, moving to morphine sulphate injection as opioid of choice, where clinically appropriate, in place of diamorphine 5mg and 10mg
  • identify and deliver required education and training to General Practice and community nursing teams to support the switch over to morphine;
  • ensure no new patients are started on diamorphine hydrochloride 5mg or 10mg injection
  • review patients currently receiving diamorphine 5mg or 10mg injection and manage the switch to an alternative opioid
  • not switch patients to higher strengths of diamorphine injection as there is insufficient stock to support increased use
  • consider morphine 10mg/ml injection as the first line opioid as supplies of alternative opioid agents are limited and these should be prescribed for patients where morphine is not clinically appropriate
  • place orders for morphine sulfate 10mg/1ml solution for injection ampoules (Ethypharm (Martindale) and Hameln) from major wholesalers.

View the alert.

Contractors make urgent plea to chancellor on wholesale bills

P3 Pharmacy, Pharmacy Network News, 25 March 2020

Community pharmacy contractors are warning the Government that they will be unable to keep providing vital medicines to patients unless they receive urgent funding assistance to help pay their wholesaler bills.

Amid an extraordinary period in which pharmacies throughout the UK have dispensed record numbers of scripts and contended with shortages and price fluctuations, many are in pressing financial straits.

Sutton contractor Reena Barai posted on social media today: “I’ve just had an email from my pharmaceutical wholesaler to say I’ve nearly reached my credit limit this month. We’ve run this pharmacy for 41 years and never had this situation.

“[Chancellor] Rishi Sunak, you’ve said you’ll do whatever it takes. If patients need access to meds, I need money to pay for them.”

Dorset contractor Mike Hewitson wrote: “We urgently need 10 Downing Street to put money into community pharmacies or we will run out of money to pay for drugs. Action needed now.”

Another contractor wrote: “This is exactly what we will all be facing before too long. Words are nice but those expensive drugs and extra hours don’t get paid for by words.”

Mark Lyonette, NPA chief executive told Pharmacy Network News this afternoon: “We have already appealed to the Government for immediate support to help pharmacies remain operational, both as frontline care providers and as businesses employing thousands of people.

“We’ve requested a number of emergency measures, including an advance payment scheme for NHS income. Many pharmacies are small businesses with existing cash-flow problems and COVID-19 is dramatically exacerbating this situation.  Above all, we need urgent, substantial new funding to keep pharmacies open.”

PSNC is currently in talks with Government on a number of COVID-19-related issues, including how contractors can be supported financially.

Coronavirus: harmonised standards for medical devices to respond to urgent needs

European Commission, 25 March 2020

Yesterday, the Commission adopted decisions on harmonised standards which will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general. The standards will facilitate a faster and less expensive conformity assessment procedure. The revised harmonised standards play a pivotal role in the current coronavirus pandemic because they relate to critical devices* such as:

  • medical face masks
  • surgical drapes, gowns and suits
  • washer-disinfectors
  • sterilisation

Stella Kyriakides, Commissioner for Health said: “We must not waste a second in our fight against the coronavirus. With the measures we adopt today, we speed up the entry of safe, essential medical equipment and devices such as masks, gowns and suits in the EU market. This equipment is fundamental for our health professionals – the brave and resilient women and men at the front line – to keep saving lives”.

Once implemented, the use of these standards will allow manufacturers of medical devices and other concerned economic operators, to comply with the health and safety requirements of the EU legislation, taking into account the most updated technical solutions. These standards, once referenced in the Official Journal of the European Union, grant conformity of devices with the requirements of the three Directives on medical devices.

The decision to adopt these harmonised standards for medical devices represents an additional measure taken by the Commission to respond to the coronavirus outbreak. Also upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in cooperation with their members made available a number of European standards for certain medical devices and personal protective equipment.

Background

European standards are an essential pillar of a fully functioning internal market. They reduce costs, promote innovation, ensure interoperability between different devices and services, and help companies to access markets.

To support EU product legislation, the Commission can request the development of European harmonised standards to facilitate compliance by manufacturers of the relevant requirements. Once agreed and referenced in the Official Journal of the European Union, these harmonised standards become part of EU law and allow companies an easy and direct access to the internal market for their products, while ensuring a high degree of safety for users and consumers.

European legislation for medical devices also relies on harmonised standards. In particular, under the three current directives on medical devices, there are about 300 harmonised standards conferring presumption of conformity with the legal essential requirements. The Commission and the concerned European standardisation organisations (CEN and CENELEC) continuously work together to update and improve the set of harmonised standards available to economic operators in the EU. In such a common effort to face the coronavirus pandemic, the Commission, CEN and CENELEC have agreed to make a number of harmonised standards for important medical protective equipment like face masks and single-use gloves freely available to those companies that are willing to start producing these items.

Useful links

Dedicated Commission webpage on the EU’s response to the COVID-19 outbreak

Medical device

Media and Political Bulletin

16 March 2020

Media Summary

‘Unprecedented demand’ for OTC painkillers as COVID-19 outbreak spreads

The Pharmaceutical Journal, Debbie Andalo, 13 March 2020

The Pharmaceutical Journal reports that pharmaceutical wholesalers are not ruling out supply issues in the near future as demand for medicine rises amid the outbreak.

Martin Sawer told The Pharmaceutical Journal that while there are currently no medicines shortages in the UK, there could be issues “around the corner”.

“The demand level for medicines across the board from community pharmacists, doctors and patients has gone up dramatically compared to what it usually is this time of year,” he said. However, he added that “there are not supply shortages”. Sawer added that wholesalers were using drugs from the stockpiles created for Brexit, but added “there could be a manufacturing issue around the corner.”

The owner of LloydsPharmacy has said there is “unprecedented demand” for over-the-counter painkillers as a result of the COVID-19 pandemic. A statement released on 12 March 2020 from McKesson said it had put processes in place to “minimise” the impact of shortages of medicines and to continue to be able to provide a “consistent supply of critical products” from its stores.

Alliance Healthcare said it had faced similar pressures, while a spokesperson for Phoenix said it had seen a “considerable increase” in demand for medicines including paracetamol and Calpol.

Brexit threatens UK’s ability to respond to a future pandemic

The Guardian, Martin McKee, Anniek de Ruijter and Mark Flear, 14 March 2020

Martin McKee (professor of European public health at the London School of Hygiene and Tropical Medicine), Anniek de Ruijter (associate professor at Amsterdam Law School) and Mark Flear (reader in law at Queens University, Belfast) write in the Guardian that Brexit threatens the UK’s ability to respond to the novel coronavirus and future pandemics.

Media attention has already highlighted the damage that being outside the EMA will do to the British economy, however the consequences of being outside the EMA go much further. The UK now lies outside the EMA’s rapid authorisation mechanism for pandemic vaccines and medicines for treatment. Consequently, the UK could have to wait longer for these than EU member states.

In addition, they write, the UK has also withdrawn from the EU’s emergency bulk buying mechanism for vaccines and medicines, which allows EU member states to increase their market power and speed up access to vaccines and medicines during a crisis. Its exclusion could mean the UK will have to pay more to acquire these pandemic countermeasures.

This was reported on by The New European, the Independent, the Mirror and the Express.

Covid-19 presenting ‘increasing pressures’ on community pharmacies

ITV News, 14 March 2020

Cathy Harrison, Chief Pharmaceutical Officer at the Department of Health of Northern Ireland, told ITV News that the Covid-19 strain of Coronavirus is presenting ‘increasing pressures’ on community pharmacies.

Cathy Harrison says people needing medication should not stockpile and should continue to take their medication as normal, saying stockpiling could ‘disadvantage other patients’.

It comes as Northern Ireland saw its biggest spike in Coronavirus cases on Friday with 29 people diagnosed with the disease. Three cases came from community transmission.

Tackling COVID-19: EFPIA welcomes proactive and regular dialogue with Commissioners on the supply of medicines during the COVID-19 pandemic

EFPIA, 13 March 2020

Last week representatives from EFPIA joined a call with Health Commissioner Kyriakides, Commissioner Breton and Commissioner Lenarčič together with representatives from across the medicines and medical devices supply chain, to discuss the potential impact of the coronavirus on the supply of vaccines and medicines.

Speaking after the first of what will become weekly calls, EFPIA Director General Nathalie Moll said: “We welcome the proactive approach from the Commissioners and the opportunity for regular dialogue at this critical time. The biopharmaceutical industry in Europe remains fully committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks.”

EFPIA reiterates that the continuity of supply of medicines to patients remains of the highest priority, and that members have comprehensive business continuity and contingency plans in place. Companies are constantly monitoring global and market-specific demands for their products and take all inventory decisions carefully because supply disruptions can affect patients globally.

EFPIA is in constant dialogue with its members and authorities.

Fluoxetine 10mg tablet SSP published

Dispensing Doctors’ Association, Ailsa Colquhoun, 13 March 2020

Dispensing Doctors’ Association reports that a Serious Shortage Protocol (SSP) has been issued for fluoxetine 10mg tablets. This enables community pharmacists in England, Wales and Northern Ireland to supply patients with fluoxetine 10mg capsules.

Dispensers faced with shortages of fluoxetine 10mg tablets should request that the GP alters the prescription to fluoxetine 10mg capsules to enable the supply. This SSP will run until Friday 12 June.

This was also reported in C+D.

Current list of products under export ban due to national shortages

C+D, Eliza Slawther, 13 March 2020

C+D reports that hydroxychloroquine has been added to the list of medicines and products that cannot be exported from the UK as of March 14.

An initial 23 products were listed on October 4 last year, with more added and removed since. All the products are at “high risk of parallel export”, due to their prices increasing in EU countries, the Department of Health and Social Care (DH) told C+D in October.

By restricting wholesalers from exporting these products, the DH hopes “to tackle ongoing shortages and minimise the impact on patients”, it also said.

The list will be updated with each product that the DH subjects to export restrictions, and applies to all medicines containing the active ingredients, whether generic or branded.

GPhC launches guidance on getting medicines online

Pharmacy Business, Kiran Paul, 13 March 2020

Pharmacy Business reports that the GPhC, along with other healthcare regulators, has launched a new guide to help people access safe and right medicines or treatment online. The guide has a six-point check list for anyone going online for medicines or treatment.

“Online healthcare services and apps can bring real benefits for people, but there can also be significant risks, particularly if you use online services which are not regulated in the UK,” commented Duncan Rudkin, chief executive of the GPhC.

“We hope this advice will be particularly helpful during the coronavirus outbreak, when more people may be considering going online for medicines and when some unregulated websites may be offering fake medicines or false information”.

 

 

Parliamentary Coverage

There was no parliamentary coverage today. 

 

Full Coverage

‘Unprecedented demand’ for OTC painkillers as COVID-19 outbreak spreads

The Pharmaceutical Journal, Debbie Andalo, 13 March 2020

Pharmaceutical wholesalers are not ruling out supply issues in the near future as demand for medicine rises amid the outbreak.

The owner of LloydsPharmacy has said there is “unprecedented demand” for over-the-counter painkillers as a result of the COVID-19 pandemic.

A statement released on 12 March 2020 from McKesson said it had put processes in place to “minimise” the impact of shortages of medicines and to continue to be able to provide a “consistent supply of critical products” from its stores.

The statement added: “We are doing everything we can to ensure we provide a consistent supply of medicines. This includes sourcing from multiple providers, and putting commitments in place with manufacturers to secure supply.”

Meanwhile, Martin Sawer, executive director of the Healthcare Distribution Association — the membership organisation for UK wholesalers — told The Pharmaceutical Journal that while there are currently no medicines shortages in the UK, there could be issues “around the corner”.

“The demand level for medicines across the board from community pharmacists, doctors and patients has gone up dramatically compared to what it usually is this time of year,” he said.

However, he added that “there are not supply shortages”.

“There may be cases where deliveries into pharmacies may not be the [entire] amount they ordered because they are ordering a lot more than they would normally, so they are not getting the whole delivery the first time.

“The situation is just like supermarkets — they’ve got enough food but people are taking things off the shelves. We’ve got enough medicines.”

Sawer added that wholesalers were using drugs from the stockpiles created for Brexit, but added: “I wouldn’t say I’m not worried [about the impact of COVID-19]. The situation with the coronavirus changes quite quickly and supplies can change quickly but usually that is down to a manufacturing problem which we didn’t know about.

“We are managing at the moment and I feel confident, but there could be a manufacturing issue around the corner.”

A spokesperson for Phoenix, one of the UK’s largest pharmaceutical wholesalers, said it had seen a “considerable increase” in demand for medicines including paracetamol and Calpol.

“We have put in place some order restrictions for certain products to ensure equitable supply across the UK, but again emphasise that customers should only purchase according to need,” they said.

“Prices for some medicines have increased, but this is beyond the control of medicine distributors like Phoenix”.

Similarly, Alliance Healthcare said it had faced similar pressures.

A spokesperson for the wholesaler said: “There has been a significant increase in the demand for products such as paracetamol and ibuprofen over the last few weeks, which has caused some supply constraints.”

Gordon Hockey, director of operations and support at the Pharmaceutical Services Negotiation Committee (PSNC), said the government had already “approached medicine suppliers to assess the impact that COVID-19 could have on the supply chain”.

“The PSNC is keeping a close eye on the generic medicines, including paracetamol, affected by recent price hikes and is making applications to the Department of Health and Social Care (DHSC) for price concessions in the usual way,” he said.

“The PSNC has also commenced discussions with the DHSC on protection for pharmacies against sudden price rises and launched the Community Pharmacy COVID-19 Forum, providing an opportunity for information sharing with other pharmacy and supply chain bodies, DHSC and NHS England and NHS Improvement.”

Brexit threatens UK’s ability to respond to a future pandemic

The Guardian, Martin McKee, Anniek de Ruijter and Mark Flear, 14 March 2020

Brexit threatens the UK’s ability to respond to the novel coronavirus and future pandemics.

The coronavirus pandemic could not have come at a worse time for the UK and its citizens. Just as UK government ministers are digging in for the really difficult part of Brexit, the negotiations on future relationships with the EU and the rest of the world, a new virus comes out of China that reminds us of just why international co-operation is so important.

The obvious response, one might think, would be to do everything to safeguard those areas where the UK does collaborate, so as to reduce the threat of infectious disease. Instead, the UK has decided to isolate itself from European systems that have been built up over the past decade, many as a result of problems exposed by the 2009 swine flu pandemic.

The UK’s decision to leave the European Medicines Agency (EMA), an arm of the European Commission, has been discussed at length. The EMA is responsible for overseeing clinical trials for new vaccines and medicines for pandemics, and deciding on marketing authorisations for them that apply across the EU. Media attention has highlighted the damage that being outside the EMA will do to the British economy – both through lost activity among UK researchers and suppliers, and by making the UK a less attractive place for major pharmaceutical companies.

However, the consequences of being outside the EMA go much further. The UK now lies outside the EMA’s rapid authorisation mechanism for pandemic vaccines and medicines for treatment. Consequently, the UK could have to wait longer for these than EU member states. To make matters worse, the UK has also withdrawn from the EU’s emergency bulk buying mechanism for vaccines and medicines, which allows EU member states to increase their market power and speed up access to vaccines and medicines during a crisis. Its exclusion could mean the UK will have to pay more to acquire these pandemic countermeasures.

The government could, if it wished, go for a much closer alignment with the EU, a choice made by Norway, Liechtenstein, and Iceland, which form the European Economic Area (EEA). These countries are on the same footing as regulators in EU countries. However, the difference is that these countries are in the single market and have accepted its rules. Even Switzerland, which is outside the EEA, has bespoke arrangements with the EMA based on its alignment to EU rules.

A deal similar to the Ukrainian Association Agreement with the EU is another option. But each of these non-member states is outside the EU’s bulk buying mechanism for vaccines and medicines. In any case, all of these models seem unacceptable to the current UK government.

There other ways that the UK could mitigate the problems that come with being outside the EMA. One would be to copy Singapore, which has decided to automatically recognise EMA marketing authorisations, as well as those issued by the US Food and Drug Administration, subject to a 60-day Verification Route. However, this would be contrary to the UK government’s refusal to be a “rule taker”.

Finally, the UK could also, at least in theory, create its own rapid marketing authorisation mechanism. The slight problem is that this would almost certainly be impossible in the short term, not least because of the need to attract skilled staff. Many staff would have to be recruited internationally, and they may well be put off by the UK’s harsh, and extremely expensive, immigration regime. And even if a new UK mechanism did work, it would not necessarily ensure swift access to medicines as UK standards may diverge from those in the EU, a real threat given the upcoming implementation of the recent EU clinical trials regulation.

Concerns about UK divergence have been exacerbated by health secretary Matt Hancock, commenting that the UK’s medicines regulator could reduce bureaucracy, which signifies an intention to diverge. Clinical trials data and marketing authorisations in the UK, especially when made on the basis of that data, may not satisfy the EMA. Some pharmaceutical companies may therefore opt to base clinical trials in the EU, or in third countries that apply EU-compliant standards, so as to ensure they obtain marketing approval through the EMA for the EU market.

Pharmaceutical companies with UK manufacturing plants, including AstraZeneca, have already established batch control sites and pharmacovigilance teams in EU member states. This is to ensure they can continue to lawfully supply medicines in the EU. Pharmaceutical companies, facing the very large administrative burden involved in obtaining marketing authorisation, are likely to prioritise the EU’s single market over the UK’s far smaller market, as already happens with Switzerland and Canada.

It is a Canada-style trade deal that the UK is now pursuing, although it has not ruled out what it describes as an Australia-style deal, which is in effect code for no deal. Yet this could take upwards of eight years to agree, and EU negotiators are likely to drive a hard bargain. As with any deal with the US, itself very unlikely, this will demand that the UK make choices about who to align with.

For all of these reasons, if, as seems likely, a vaccine is developed against the 2019-nCoV virus, the UK is likely to have to join the queue for access with other countries, and to pay more than it otherwise would as an EU member state.

So while, in one respect, the timing of the pandemic could not have been worse for the UK, in another it could provide an opportunity to reflect on whether an isolationist ideology really is such a good idea. It has taken many years to build up the EU’s systems of defences against infectious disease. In an ever more uncertain and interconnected world, is it really a good idea to withdraw from them?

Martin McKee is professor of European public health at the London School of Hygiene and Tropical Medicine; Anniek de Ruijter is associate professor at Amsterdam Law School; Mark Flear is reader in law at Queens University, Belfast.

This was reported on by The New European, the Independent, the Mirror and the Express.

Covid-19 presenting ‘increasing pressures’ on community pharmacies

ITV News, 14 March 2020

The Covid-19 strain of Coronavirus is presenting ‘increasing pressures’ on community pharmacies, according to the Chief Pharmaceutical Officer.

Cathy Harrison says people needing medication should not stockpile and should continue to take their medication as normal.

It comes as Northern Ireland saw its biggest spike in Coronavirus cases on Friday with 29 people diagnosed with the disease. Three cases came from community transmission.

There have been 90 confirmed cases in the Republic of Ireland.

Retail premises have saw items such as toilet rolls and hygiene products being cleared from shelves.

The Chief Pharmaceutical Officer says stockpiling could ‘disadvantage other patients’.

“People should order prescriptions and take their medicines as normal,” said Harrison.

“Covid-19 is presenting increasing challenges for the dedicated staff working in our community pharmacies,” she continued.

“The Department is working to ensure that everyone continues to have access to their local community pharmacy. It is vital at this busy time that we are mindful of the pressure that community pharmacy staff are under.

“There is no need for you to do anything new or different when ordering or taking your medicines.”

She continued: “People should order prescriptions and take their medicines as normal.

“Extra supplies should not be ordered from your doctor.

“Stockpiling or purchasing medication that you do not need is completely unnecessary and could disadvantage other patients.

“There are no prescription medicine shortages as a result of Covid-19.”

Tackling COVID-19: EFPIA welcomes proactive and regular dialogue with Commissioners on the supply of medicines during the COVID-19 pandemic

EFPIA, 13 March 2020

Earlier today representatives from EFPIA joined a call with Health Commissioner Kyriakides, Commissioner Breton and Commissioner Lenarčič together with representatives from across the medicines and medical devices supply chain, to discuss the potential impact of the coronavirus on the supply of vaccines and medicines.

Speaking after the first of what will become weekly calls, EFPIA Director General Nathalie Moll said: “We welcome the proactive approach from the Commissioners and the opportunity for regular dialogue at this critical time. The biopharmaceutical industry in Europe remains fully committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks; through research into vaccines, diagnostics and treatments for COVID-19, through donations and in-kind support on the ground and by working to ensure the continued supply of medicines and vaccines.”

The continuity of supply of our medicines to patients has been, and remains, of the highest priority. EFPIA members have comprehensive business continuity and contingency plans in place. Companies are constantly monitoring global and market-specific demands for their products and take all inventory decisions carefully because supply disruptions can affect patients globally.

EFPIA is in constant dialogue with its members and authorities. From the latest information received, there is limited immediate risk that COVID-19 would impact manufacturing and supply of branded medicines in Europe in the short term. While supply and demand vary by product, EFPIA members are not aware of any significant near-term impacts on the availability of our medicines and vaccines. Companies have also assessed potential longer-term impacts. The situation is fluid, but at this point EFPIA members do not anticipate impacts to their supply chains unless disruption due to the COVID-19 outbreak is sustained over the next several months. We continue to monitor the situation closely and we will keep an open and constant dialogue with the European Medicines Agency and the European and National Authorities as important information becomes available.

The uncertainty with respect to the length and extent of the pandemic poses a challenge for everyone involved in the fight against COVID-19. We support the Commission in its goals to minimize any impacts to the quality of care for patients in Europe, including access to medicines and vaccines. We look forward to continuing to work in partnership with the Commission and EMA, the Member States, their Competent Authorities and our supply chain colleagues to address challenges as they arise with pragmatic approaches that put patient needs first. At the same time, researchers from across our member companies will continue the quest to find diagnostics, vaccines and treatments to address the crisis.

Fluoxetine 10mg tablet SSP published

Dispensing Doctors’ Association, Ailsa Colquhoun, 13 March 2020

A Serious Shortage Protocol (SSP) has been issued for fluoxetine 10mg tablets. This enables community pharmacists in England, Wales and Northern Ireland to supply patients with fluoxetine 10mg capsules.

Dispensers faced with shortages of fluoxetine 10mg tablets should request that the GP alters the prescription to fluoxetine 10mg capsules to enable the supply.

This SSP will run until Friday 12 June. For more information, visit the NHS Business Services Authority (BSA) website.

This was also reported in C+D.

Current list of products under export ban due to national shortages

C+D, Eliza Slawther, 13 March 2020

Hydroxychloroquine has been added to the list of medicines and products that cannot be exported from the UK as of March 14.

An initial 23 products were listed on October 4 last year, with more added and removed since.

All the products are at “high risk of parallel export”, due to their prices increasing in EU countries, the Department of Health and Social Care (DH) told C+D in October.

By restricting wholesalers from exporting these products, the DH hopes “to tackle ongoing shortages and minimise the impact on patients”, it also said.

The list will be updated with each product that the DH subjects to export restrictions, and applies to all medicines containing the active ingredients, whether generic or branded.

GPhC launches guidance on getting medicines online

Pharmacy Business, Kiran Paul, 13 March 2020

The General Pharmaceutical Council (GPhC), along with other healthcare regulators, today launched a new guide to help people access safe and right medicines or treatment online.

The guide has a six-point check list for anyone going online for medicines or treatment:

  1. Check if the online healthcare service and healthcare professionals working there are registered with UK regulators.
  2. Ask questions about how the service works
  3. Answer questions honestly about your health and medical history
  4. Find out your options for treatment and how to take any medicines you’re prescribed
  5. Expect to be asked for consent for information to be shared with other healthcare professionals involved in your care
  6. Check what after-care you will receive

“Online healthcare services and apps can bring real benefits for people, but there can also be significant risks, particularly if you use online services which are not regulated in the UK,” commented Duncan Rudkin, chief executive of the GPhC.

“We hope this advice will be particularly helpful during the coronavirus outbreak, when more people may be considering going online for medicines and when some unregulated websites may be offering fake medicines or false information”.

The guide also offers supporting information such as methods to check the regulatory status of the services and professionals.

In addition to the GPhC, the online guide is supported by Care Quality Commission, Healthcare Improvement Scotland, Healthcare Inspectorate Wales, General Medical Council, Medicines and Healthcare Products Regulatory Agency, Nursing and Midwifery Council, Pharmaceutical Society of Northern Ireland, Pharmacy Forum NI and the Royal Pharmaceutical Society.

Sandra Gidley, president of the RPS, said: “It is important to recognise there are benefits and risks to buying medicines online. Keeping patients safe is essential as there are many unregulated sites out there which look legitimate.

“The guidance builds on recommendations from across healthcare that will help people to avoid illegal sites and help protect patients from fake medicine or obtaining prescription-only medicines without a prescription.”

Media and Political Bulletin

15 August 2019

Media Summary

Industry and pharmacy bodies confirm signing government ‘gagging orders’ over no-deal Brexit plans

The Pharmaceutical Journal, Carolyn Wickware, 14 August 2019

The Pharmaceutical Journal reports that the Department of Health and Social Care says non-disclosure agreements have been signed “to protect the commercial interest of the government and its suppliers”.

The PSNC, BGMA, HDA and ABPI have now confirmed to The Pharmaceutical Journal that they are among other representative bodies to have signed these agreements preventing them from disclosing the UK government’s plans for a no-deal Brexit.

Martin Sawer said the no-deal Brexit planning discussions had to be held “in confidence because people then feel more comfortable discussing some scenarios and hypothetical situations, and it’s not all being held down and recorded”.

He added that the NDAs were signed by “all parts of the supply chain on the industry side” early in 2018, when the no-deal planning group was set up, “to enable government to float ideas … and we would respond to those ideas so the government would hopefully get the best possible advice and make the right decisions”.

UK throws veil of secrecy over no-deal Brexit plan

The Pharma Letter, 14 August 2019

The Pharma Letter reports that as the UK begins to make more extensive plans for an abrupt departure from the European Union, the country’s health ministry has confirmed that a number of pharma groups have signed non-disclosure agreements (NDA) concerning the preparations.

Pharma bodies such as the PSNC, BGMA, HDA and ABPI have now agreed to keep secret their ongoing work with the UK’s Department of Health and Social Care (DHSC).

A DHSC spokesperson said: “As part of any standard contract, in government or the private sector, we use these clauses to protect the commercial interests of government and its suppliers in a reasonable way.”

“By signing NDAs, the department can talk to the industry in confidence prior to making public statements and issuing advice. This means that when we go out to the whole industry we can be confident that any requests are clear, appropriate and deliverable.”

New service to deliver urgent medicines and medical products into UK

Department of Health and Social Care, 15 August 2019

The Department of Health and Social Care is strengthening its Brexit preparations with a £25 million contract to set up an express freight service to deliver medicines and medical products into the country.

The department is leading a procurement exercise for an express freight service as part of the government’s plans to support continuity of supply when the UK leaves the EU on 31 October.

The service is intended to deliver small parcels of medicines or medical products on a 24-hour basis, with additional provision to move larger pallet quantities on a 2- to 4-day basis. The service will be available to the whole of the UK.

While the majority of goods will be standard medicines and medical products, the express freight service can also deliver temperature-controlled products if needed.

The contract will run for 12 months, with a possible further 12-month extension.

This was reported on in the Financial TimesThe TelegraphThe Daily MailITV NewsThe Sun, and Dispensing Doctors’ Association.

Get ready to charge EU citizens under no-deal Brexit, NHS bosses told

The Times, Oliver Wright, 14 August 2019

The Times reports that EU citizens living in Britain will have to prove their right to free NHS care under a no-deal Brexit as part of new rules circulated to hospital managers.

In a directive to the NHS, the Department of Health said that trusts needed to prepare to charge EU citizens who had previously been eligible for free treatment “immediately after exit day”, which is scheduled for October 31.

But with only one million of the three million EU citizens living in Britain registered under the “settled status” programme, the move has led to accusations that ministers are creating a new “hostile environment” for immigrants.

This was also reported in The Daily MailThe IndependentThe Daily Express, and The Sun.

Jo Churchill appointed as new pharmacy minister

Chemist+Druggist, Eliza Slawther, 14 August 2019

Chemist+Druggist reports that Jo Churchill was appointed parliamentary under-secretary of state at the Department of Health and Social Care (DH) on July 26, following a cabinet reshuffle by new Prime Minister Boris Johnson which saw previous pharmacy minister Seema Kennedy moved to the Home Office.

The DH confirmed that Ms Churchill – who has been MP for Bury St Edmunds, Suffolk since 2015 – will be responsible for pharmacy as part of her new prevention, public health and primary care role. She previously held the role of assistant government whip from January 2018 to July 2019.

In a 2017 parliamentary debate about pharmacy and integrated healthcare in England, Ms Churchill said the British public “need to be made more aware of what pharmacies can do and how they can help people keep healthy”.

Ms Churchill was among 305 MPs who voted in favour of the pharmacy funding cuts in England in 2016. Only one Conservative MP voted against the cuts.

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Industry and pharmacy bodies confirm signing government ‘gagging orders’ over no-deal Brexit plans

The Pharmaceutical Journal, Carolyn Wickware, 14 August 2019

Exclusive: The Department of Health and Social Care says non-disclosure agreements have been signed “to protect the commercial interest of the government and its suppliers”.

The Pharmaceutical Services Negotiating Committee (PSNC) is one of several pharmacy bodies to have signed non-disclosure agreements (NDAs) preventing them from disclosing the UK government’s plans for a no-deal Brexit.

The Healthcare Distribution Association (HDA), the British Generic Manufacturers Association (BGMA) and the Association of the British Pharmaceutical Industry (ABPI) have also confirmed that they have signed NDAs issued by the Department of Health and Social Care (DHSC).

A spokesperson for the DHSC said the NDAs are used “to protect the commercial interests of the government and its suppliers”.

However, Warwick Smith, director general of the BGMA, said the agreements were hindering his organisation’s ability to give guidance to its own members.

In October 2018, the DHSC revealed that it had requested “a number of pharmaceutical industry representative bodies and manufacturers sign” NDAs so that advice then given to the whole industry on no-deal Brexit plans is “clear, appropriate and deliverable”.

The PSNC, BGMA, HDA and ABPI have now confirmed to The Pharmaceutical Journal that they are among other representative bodies to have signed these agreements.

But Warwick Smith, director general of the BGMA, criticised the government for publishing “lots of propaganda” when it “needs to be much more open about its planning assumptions”.

“Whilst those of us who have signed those infamous NDAs have a very good idea of what is going on, companies generally are not aware of the detail — there is an information gap and we need facts,” he added.

“We know a lot more than we’re allowed to tell our members,” he added.

“We are trying to give guidance to the members under [an NDA] so we can’t be fully open.”

However, Martin Sawer, executive director for the HDA, said the no-deal Brexit planning discussions had to be held “in confidence because people then feel more comfortable discussing some scenarios and hypothetical situations, and it’s not all being held down and recorded”.

He added that the NDAs were signed by “all parts of the supply chain on the industry side” early in 2018, when the no-deal planning group was set up, “to enable government to float ideas … and we would respond to those ideas so the government would hopefully get the best possible advice and make the right decisions”.

A spokesperson for the PSNC told The Pharmaceutical Journal that it signed an NDA “so that we could fully assist the DHSC in its contingency planning for the possibility of a no-deal Brexit”.

A spokesperson for the ABPI added: “Given the complexity of this planning — including commercially sensitive information shared between government and industry — an NDA was agreed to support effective planning for continued medicines supply in the event of a no-deal Brexit.”

“As part of any standard contract, in government or the private sector, we use these clauses to protect the commercial interests of government and its suppliers in a reasonable way,” a spokesperson for the DHSC said.

The Royal Pharmaceutical Society said has not signed a government NDA relating to no-deal Brexit preparations.

UK throws veil of secrecy over no-deal Brexit plan

The Pharma Letter, 14 August 2019

As the UK begins to make more extensive plans for an abrupt departure from the European Union, the country’s health ministry has confirmed that a number of pharma groups have signed non-disclosure agreements (NDA) concerning the preparations.

A so-called “no-deal Brexit” is widely believed to be more likely following the installment of hardliner Boris Johnson as Prime Minister.

Mr Johnson has said that the UK is “getting ready to come out on October the 31st, come what may,” and an additional £434 million ($523 million) has been made available to facilitate the importation of vital medicines in that eventuality.

Pharma bodies such as The Association of the British Pharmaceutical Industry (ABPI) have now agreed to keep secret its ongoing work with the UK’s Department of Health and Social Care (DHSC).

ABPI chief executive Mike Thompson said: “Given the complexity of this planning – including commercially sensitive information shared between Government and Industry – an NDA was agreed,” adding that “securing a deal remains the best way to protect patients and public health.”

Other groups reported to have agreed to gagging orders include the Pharmaceutical Services Negotiating Committee (PSNC), the Healthcare Distribution Association (HDA) and the British Generic Manufacturers Association (BGMA).

A DHSC spokesperson said: “As part of any standard contract, in government or the private sector, we use these clauses to protect the commercial interests of government and its suppliers in a reasonable way.”

“By signing NDAs, the department can talk to the industry in confidence prior to making public statements and issuing advice. This means that when we go out to the whole industry we can be confident that any requests are clear, appropriate and deliverable.”

New service to deliver urgent medicines and medical products into UK

Department of Health and Social Care, 15 August 2019

The Department of Health and Social Care is strengthening its Brexit preparations with a £25 million contract to set up an express freight service to deliver medicines and medical products into the country.

The department is leading a procurement exercise for an express freight service as part of the government’s plans to support continuity of supply when the UK leaves the EU on 31 October.

The service is intended to deliver small parcels of medicines or medical products on a 24-hour basis, with additional provision to move larger pallet quantities on a 2- to 4-day basis. The service will be available to the whole of the UK.

While the majority of goods will be standard medicines and medical products, the express freight service can also deliver temperature-controlled products if needed.

The contract will run for 12 months, with a possible further 12-month extension.

The contract notice has been published in the Official Journal of the European Union and potential bidders have until 21 August to submit proposals. The successful provider(s) are expected to be announced in September.

The taxpayer will only be liable for up to around £4 million of the total value of the contract, but it is expected to be much less than this.

The service will provide an additional level of contingency as part of necessary preparations to leave the EU on 31 October whatever the circumstances, supported by an additional £2 billion from the Treasury across government.

This money includes £434 million to help ensure continuity of vital medicines and medical products through freight capacity, warehousing and stockpiling.

The new service will support existing plans already in place, including:

  • building buffer stocks of medicines and medical products
  • changing or clarifying regulatory requirements so that companies can continue to sell their products in the UK if we have no deal
  • strengthening the process and resources used to deal with shortages
  • procuring additional warehouse capacity
  • supporting companies to improve the readiness of their logistics and supply chains to meet the new customs and border requirements for both import and export

Health Minister Chris Skidmore said:

“I want to ensure that when we leave the EU at the end of October, all appropriate steps have been taken to ensure frontline services are fully prepared.

“That’s why we are stepping up preparations and strengthening our already extremely resilient contingency plans.

“This express freight service sends a clear message to the public that our plans should ensure supply of medical goods remains uninterrupted as we leave the EU.”

This was reported on in the Financial TimesThe TelegraphThe Daily MailITV NewsThe Sun, and Dispensing Doctors’ Association.

Get ready to charge EU citizens under no-deal Brexit, NHS bosses told

The Times, Oliver Wright, 14 August 2019

EU citizens living in Britain will have to prove their right to free NHS care under a no-deal Brexit as part of new rules circulated to hospital managers.

In a directive to the NHS the Department of Health said that trusts needed to prepare to charge EU citizens who had previously been eligible for free treatment “immediately after exit day”, which is scheduled for October 31.

With only one million of the three million EU citizens living in Britain registered under the “settled status” programme, the move has led to accusations that ministers are creating a new “hostile environment” for immigrants.

Representatives of doctors and citizens’ rights groups have said that the “poorly planned” measure would place new burdens on hospitals to carry out immigration checks on thousands of patients who might not easily be able to prove a right to free care.

The Department of Health has confirmed that the checks would take place. “EU citizens living lawfully in the UK on the day of Brexit will be able to continue to use the NHS as long as they can demonstrate that they live in the UK on a lawful and property settled basis,” a spokesperson said.

“Such a move is discriminatory and outrageous,” said Maike Bohn, co-founder of the3million group, which campaigns for the rights of EU citizens living in the UK. “The new guidance is creating a hostile environment for millions of EU nationals who have the right to free healthcare in the UK but won’t be able to prove it. This outrageous decision spells chaos as the two groups of EU citizens will be indistinguishable to the NHS and we are running the risk of people being denied vital treatment they are fully entitled to.”

Dr David Wrigley, deputy chairman of the British Medical Association, said that the proposal was “another example of a chaotic, poorly planned result of a no-deal Brexit”. “This system would present hospitals with the mammoth task of determining where a patient was born, and, if they are from one of the 27 EU nations, whether they are eligible for free care,” he said. “With most people not carrying documentation to prove this — and the deadline to apply for settled status not until the end of December 2020 — it is a nigh-on impossible ask for any workforce, let alone overstretched NHS staff.”

The Conservative MP Alberto Costa, who has campaigned for the rights of British citizens in the EU and EU citizens in Britain, said: “In the referendum the Vote Leave campaign that is now running Downing Street pledged to protect the rights of EU citizens living in Britain. Making them have to prove their rights to use the NHS is injurious and a breach of that commitment.”

He added that it would have a knock-on effect on the more than one million British citizens living in the EU. “Such a move will make it harder to agree reciprocal healthcare arrangement to protect all citizens,” he said.

In March the government passed legislation that allowed ministers to strike reciprocal deals with EU member states that would allow citizens to be treated free of charge. Little progress has been made as this requires individual agreements with 27 countries.

If Britain leaves the EU without a deal the European Health Insurance Card (Ehic) will not be valid for British citizens and they will be expected to pay for their hospital treatment abroad.

The guidance states that in the event of a no-deal Brexit EU citizens who move to or visit the UK will not be eligible for free healthcare. “In the absence of a reciprocal healthcare agreement with an EU country after exit day new visitors from that country to the UK will be chargeable at the standard NHS tariff,” it says.

In advice to trusts the document adds: “The changes to the charging regulations will come into force immediately after exit day if there is a no-deal Brexit. You should make sure that any changes to your operational practices are implemented from that point forward. You should work closely with your organisation’s senior responsible officer for Brexit preparation and their teams, to make sure that you are operationally ready to implement the new charging regulations after exit day.”

Jonathan Ashworth, the shadow health secretary, said a no-deal Brexit would throw reciprocal healthcare arrangements “in the air” and that British holidaymakers and expats would “pay the price”. He added: “These arrangements allow patients with serious renal conditions to receive vital dialysis when in the EU. It’s simply not good enough for ministers to boast that they will be forcing hospitals to charge EU patients — they also now must be honest about what a no-deal Brexit means for UK citizens also.”

This was also reported in The Daily MailThe IndependentThe Daily Express, and The Sun.

Jo Churchill appointed as new pharmacy minister

Chemist+Druggist, Eliza Slawther, 14 August 2019

Jo Churchill is the new minister with responsibility for pharmacy, the government has confirmed.

Ms Churchill was appointed parliamentary under-secretary of state at the Department of Health and Social Care (DH) on July 26, following a cabinet reshuffle by new Prime Minister Boris Johnson which saw previous pharmacy minister Seema Kennedy moved to the Home Office.

The DH confirmed this afternoon (August 14) that Ms Churchill – who has been MP for Bury St Edmunds, Suffolk since 2015 – will be responsible for pharmacy as part of her new prevention, public health and primary care role. She previously held the role of assistant government whip from January 2018 to July 2019.

Ms Churchill was among 305 MPs who voted in favour of the pharmacy funding cuts in England in 2016. Only one Conservative MP voted against the cuts.

Past support for pharmacies

In a 2017 parliamentary debate about pharmacy and integrated healthcare in England, Ms Churchill said the British public “need to be made more aware of what pharmacies can do and how they can help people keep healthy”.

Ms Churchill also said the term “pharmacy-first culture” is a “good motto for everybody to live by”, and added that pharmacies are “often not used to their full value”.

In particular, Ms Churchill wanted to show both the “crucial role of community pharmacies”, and the “competition they face from high street providers”, as quoted in an article published on her website following the debate.

“Our independent pharmacies provide us with choice, often with bespoke services aimed towards the needs of local communities,” she continued.

Ms Churchill added that she is a “great supporter” of pharmacies being a first port-of-call for minor ailments, and stressed the importance of local pharmacies in delivering a ”smoother running and a more joined-up healthcare system”.

Pharmacy tweets

Ms Churchill’s Twitter account shows evidence of her commitment to community pharmacy over recent years.

In 2017, she tweeted an image of herself visiting Croasdales Chemist, an independent pharmacy in her constituency, to receive her flu jab.

Other tweets relating to community pharmacy include Ms Churchill’s visits to a branch of Day Lewis and Elmswell Pharmacy.

Media and Political Bulletin

30 April 2019

Media Summary

Scottish government announces £2.6m funding boost for community pharmacies

The Pharmaceutical Journal, Corrinne Burns, 29 April 2019

The Pharmaceutical Journal reports that community pharmacy in Scotland will receive an extra £2.6m in funding in the 2019/2020 financial year, matching the increase it was awarded in the previous year.

The Scottish government has announced that the global remuneration sum, which covers fees and allowances, for 2019/2020 will be £183.6 million and, with other forms of income, community pharmacies would be guaranteed remuneration of £224.7m in the 2019/2020 financial year.

The package also includes confirmation that the Pharmacy First scheme, which gives patients access to treatments for uncomplicated urinary tract infections and impetigo from a community pharmacy, has been integrated with the national minor ailments service. Funding for this element of the integrated service will remain at £1.1 million per year.

Opioid painkillers ‘must carry prominent warnings’

BBC News, 28 April 2019

BBC News reports that all opioid medicines in the UK will carry prominent warnings on their labels saying they can cause addiction, the health secretary has announced.

Matt Hancock acted after figures in England and Wales revealed a-more-than 60% increase in prescriptions for opioid painkillers in the last decade. People needed protection “from the darker side to painkillers,” he said.

Health experts welcomed the move, saying opioids can cause “life-altering and sometimes fatal addictions”.

This was also reported in PMLiVE and Pharmacy Business.

UK online pharmacies accused of ‘aggressive’ tactics to sell opiates

The Guardian, Sarah Marsh, 26 April 2019

A Guardian investigation revealed that online pharmacies have been accused of failing to carry out proper ID checks and using inappropriate marketing tactics to sell strong and addictive opiate drugs.

At least two major online pharmacies – registered with the UK regulator – are sending customers emails urging them to order drugs by claiming stocks are running out or telling them their “limit” has been removed and they can now buy more codeine pills.

There is growing concern internationally about the rising use of opioid drugs, such as morphine, fentanyl, oxycodone, tramadol and codeine. The regulator of pharmacies in England, Scotland and Wales recently introduced new rules to protect people from buying inappropriate drugs over the internet.

 

 

Parliamentary Coverage

House of Commons Tabled Written Questions – 29 April 2019

Bridget Phillipson (Houghton and Sunderland South):

  • To ask the Secretary of State for Health and Social Care, whether his Department plans to agree a multi-year funding commitment with community pharmacies to help ensure they can help achieve the goals of the NHS Long Term Plan.
  • To ask the Secretary of State for Health and Social Care, what plans his Department has to use community pharmacies to reduce pressure on urgent care services across England as part of the NHS Long Term Plan.

 

Full Coverage

Scottish government announces £2.6m funding boost for community pharmacies

The Pharmaceutical Journal, Corrinne Burns, 29 April 2019

The Scottish government has announced that community pharmacies will receive an additional £2.6m in funding in the 2019/2020 financial year.

Community pharmacy in Scotland will receive an extra £2.6m in funding in the 2019/2020 financial year, matching the increase it was awarded in the previous year.

The Scottish government has announced that the global remuneration sum, which covers fees and allowances, for 2019/2020 will be £183.6 million and, with other forms of income, community pharmacies would be guaranteed remuneration of £224.7m in the 2019/2020 financial year.

The package also includes confirmation that the Pharmacy First scheme, which gives patients access to treatments for uncomplicated urinary tract infections and impetigo from a community pharmacy, has been integrated with the national minor ailments service. Funding for this element of the integrated service will remain at £1.1 million per year. The Scottish government announced in September 2018 that it would be expanding its existing minor ailments service to make it available universally.

The funding decision was announced in a letter sent to NHS boards by Rose Marie Parr, chief pharmaceutical officer for Scotland, on 23 April 2019. Community Pharmacy Scotland (CPS), which has been negotiating the package with the government, said in a statement that “the package could not be accepted by the CPS board”.

Despite this, the CPS said “there are, nevertheless, many outputs within this package that CPS were willing to accept, and it particularly welcomed “the commitment to Pharmacy First through the introduction of funding into guaranteed streams”. It said it would work with the Scottish government to ensure that the extended minor ailments service would be up and running from April 2020.

Aileen Bryson, deputy director of the Royal Pharmaceutical Society (RPS) Scotland, also welcomed the increase in funding, and the further commitment to the national minor ailments service.

“The RPS supports the Scottish government’s vision for more people to use their community pharmacy as a first port of call and believes that the minor ailment service offers huge benefits to patients. We would like to see it offered to everyone across Scotland as a priority,” she said.

Rajshri Owen, head of professional and patient services at pharmacy wholesaler and community pharmacy membership company Numark, said although the funding announcement was welcome, “a longer period of funding assurance would have been favoured by Scottish contractors, particularly as we still remain uncertain how, when or even if Brexit will happen”.

Further details of the funding package are that the guaranteed minimum margin retained by contractors will be reduced from £100 million in 2018/2019 to £80m for 2019/2020. But the letter from Parr says that, “dependent on market conditions”, community pharmacy contractors will keep 100% of the first £10m earned above that minimum. Margin earned above £90 million will, the letter says, be shared on a 50:50 basis with NHS boards.

As with the 2018/2019 financial year, a sum of £20m will be set aside from the generic drugs tariff for guaranteed funding of an “agreed basket of targeted drugs”. This, the letter says, means that “the total amount of guaranteed remuneration in 2019/2020 will be £224.7m”.

The clawback on margin accumulated in 2018/2019 will between £18m and £20m, with the clawback rate set at 6% as of 1 April 2019.

Opioid painkillers ‘must carry prominent warnings’

BBC News, 28 April 2019

All opioid medicines in the UK will carry prominent warnings on their labels saying they can cause addiction, the health secretary has announced.

Matt Hancock acted after figures in England and Wales revealed a-more-than 60% increase in prescriptions for opioid painkillers in the last decade.

People needed protection “from the darker side to painkillers,” he said.

Health experts welcomed the move, saying opioids can cause “life-altering and sometimes fatal addictions”.

  • NHS accused of fuelling rise in opioid addiction
  • What are opioids and what are the risks?
  • Illicit and prescription drugs ‘played role in 10 deaths’ in NI

Opioids, such as morphine or fentanyl, can be highly effective for managing severe pain but they can also be highly addictive, the Department of Health (DoH) said.

It warned the number of prescriptions in England and Wales issued for these sorts of medicines had risen dramatically from more than 14 million in 2008 to 23 million last year.

The DoH added there are also some opioids available over the counter, such as codeine-based painkillers, which are weaker in strength but can also cause addiction.

From 2008 to 2018, the number of codeine-related deaths in England and Wales has more than doubled to more than 150, it said.

In Scotland, codeine-related deaths spiked at 43 in 2016, dropping to 27 in 2017, National Records of Scotland said.

In Northern Ireland, there were 16 codeine-related deaths in 2017.

What are opioids?

  • A large group of drugs used mainly to treat pain
  • Includes naturally occurring chemicals like morphine and codeine, as well as synthetic drugs
  • Codeine, morphine and methadone are among opioids judged by the World Health Organization as essential for treatment of pain and end-of-life care
  • Some opioid medications – methadone and buprenorphine – are used to help people break their addictions to stronger opioids like heroin

What are they used for?

  • Moderate and severe pain relief
  • Limited time treatment of pain that does not respond to standard painkillers like aspirin, ibuprofen and paracetamol
  • Usually used for acute pain – such as after surgery or terminally-ill cancer patients

Why are they dangerous?

  • They can be highly addictive
  • Pleasurable feeling that results from taking opioids can contribute to psychological dependence on the drugs
  • Higher doses can slow breathing and heart rate, which can lead to death
  • Mixing with alcohol or other sedatives such as benzodiazepines can also have serious consequences

Mr Hancock said: “I have been incredibly concerned by the recent increase in people addicted to opioid drugs.

“Painkillers were a major breakthrough in modern medicine and are hugely important to help people manage pain alongside their busy lives but they must be treated with caution.

“We know that too much of any painkiller can damage your health, and some opioids are highly addictive and can ruin lives like an illegal drug.

“Things are not as bad here as in America, but we must act now to protect people from the darker side to painkillers.”

‘Like thousands of insects inside your skin’

Lisa Peake, from London

I was prescribed painkillers for chronic neck pain after an accident in February 2014 but the pain didn’t go away.

I was taking codeine four to five times a day, tramadol as a top-up once a day, as well as naproxen and co-dydramol four or five times a day.

Opioids affect your mental capacity, you feel dizzy, you can’t concentrate and it’s hard for you to do your job.

I went on a three-week hospital pain management programme in October 2016 and they helped wean me off the meds and rely on other methods of pain control.

I had all the symptoms, albeit to a lesser extent, of a drug addict doing the same.

It feels like you’ve got thousands of insects inside your skin. You can’t find any comfort, you can’t sleep and your bowel movements are shot to pieces.

Professor Dame Sally Davies, the chief medical officer for England, has welcomed the government action.

She said: “We know that long-term use of painkillers can lead to life-altering and sometimes fatal addictions, so I am delighted to see measures put in place to raise awareness of the risks of codeine and prescribed drugs.

“It is vital that anyone who is prescribed strong painkillers takes them only as long as they are suffering from serious pain.

“As soon as the pain starts to alleviate, the drugs have done their job, and it is important to switch to over-the-counter medication like paracetamol which do not carry the same risk of addiction that comes with long term use.”

Analysis by Fergus Walsh, BBC medical correspondent

Until the late 90s in the UK, opioids were usually restricted to cancer patients and for those in acute pain following surgery, but then they began being increasingly prescribed for chronic pain.

As our population ages, the number of people living with low back or nerve pain is soaring. Opioids can be effective in the short term, but don’t work for pain that lasts for months or years.

The medicine packets already contain leaflets warning about potentially dangerous side-effects and the risks of addiction. Making these more prominent may encourage patients and their doctors to discuss alternatives such as physical and talking therapies.

The variation in prescribing rates between NHS regions shows that it is possible to limit their use.

Things have been getting worse here, but are nowhere near as bad as the US which has four times the rate of opioid prescriptions as the UK.

Public Health England is already undertaking a review into prescription medication addiction and is due to report its findings this year.

Under Mr Hancock’s plan, the Medicines and Healthcare products Regulatory Agency (MHRA) will have the power to enforce warnings on opioids packaging, following recommendations from the UK’s Commission on Human Medicines (CHM) Opioid expert working group.

Dr June Raine, director of the MHRA’s vigilance and risk management of medicines division, said: “This is an important first step to help minimise the risks of addiction associated with opioid medicines, while supporting patients to get the right information at the right time to support their care.”

UK online pharmacies accused of ‘aggressive’ tactics to sell opiates

The Guardian, Sarah Marsh, 26 April 2019

Online pharmacies have been accused of failing to carry out proper ID checks and using inappropriate marketing tactics to sell strong and addictive opiate drugs, a Guardian investigation can reveal.

At least two major online pharmacies – registered with the UK regulator – are sending customers emails urging them to order drugs by claiming stocks are running out or telling them their “limit” has been removed and they can now buy more codeine pills.

Online pharmacies have a limit on the amount of prescription drugs that can be ordered within a certain time period.

There is growing concern internationally about the rising use of opioid drugs, such as morphine, fentanyl, oxycodone, tramadol and codeine. The regulator of pharmacies in England, Scotland and Wales recently introduced new rules to protect people from buying inappropriate drugs over the internet.

The Doctor-4-U website contacted one customer about buying codeine, which costs £84.99 for 200 30mg tablets, writing: “What are you waiting for? … This item is going fast so grab them while you still can.”

Another online vendor, MyUKDoctor, alerted customers whenever they could order highly addictive opiate drugs again, saying their “limit” had been removed. “Please click here to reorder your medication again,” it said.

Ash Soni, the president of the Royal Pharmaceutical Society, said he was astounded by the marketing.

“That is, for me, something that should be firmly investigated by the regulators, that is appalling. That really is – to turn around and say ‘the restriction on that product has now been lifted if you want to buy some more please go and do so’. That is something you would never expect a reputable pharmacist to do.”

Dr Jane Quinlan, a consultant in anaesthesia and pain management at Oxford University hospitals NHS foundation trust, described the tactics as “really shocking”.

Both MyUKDoctor and Doctor-4-U are approved by the Medicines and Healthcare products regulatory agency, and both display the EU common logo with the message “click to verify if this website is operating legally”.

Yasir Abbasi, the clinical director for addiction services at Mersey Care NHS foundation trust, described the marketing as aggressive.

He said: “When it comes to opioid medications there should not be any direct marketing towards the consumer and if there is then there needs to be clear regulations and guidelines around that.”

A spokesperson for Doctor-4-U said the message was not a marketing email, rather, it was sent out when a person had placed an order but abandoned it before paying.

“This is not a marketing tactic and we would stress it is not possible to purchase any opioids through the website without a doctor’s approval,” the spokesperson said.

However, the company confirmed it would stop sending the message “in a bid to make our policy clearer on this matter”.

MyUKDoctor did not respond to the Guardian’s requests for comment.

Opioids tend to be prescribed for chronic lower back pain and arthritis, despite research showing the drugs are not the most effective way to treat such pain. There are concerns about growing prescription levels amid a rise in overdoses and an increasing problem of dependence and addiction to prescription drugs.

Codeine on its own is only available on prescription, with unauthorised possession being illegal. Small amounts of the drug are in some medicines that can be bought without prescription, but only in pharmacies.

Quinlan said: “We are trying to reduce the number of pain patients being prescribed opioids for chronic pain, as we know they don’t work for the majority of patients, and are trying to support those now dependent on high-dose opioids prescribed and taken in good faith.

“However, these online sales of opioids represent an invisible population of drug dependence, with what appears to be minimal checks and poor governance, risking patient safety.”

The Guardian was able to obtain 200 codeine tablets in two weeks by ordering 100 30mg tablets from the UK Meds website as “David Smith”, but with a card registered under a different name. A further 100 tablets were obtained from PillDoctor, using the same “David Smith” pseudonym and a payment card under another name. Random photos were uploaded instead of proof of ID and the proof of address. Both websites said customers should use their own name and card.

Abbasi said: “The method and governance around the way medication is ordered should raise a lot of concerns in the UK.”

PillDoctor, which is based in London but uses EU doctors to issue consultations and prescriptions, said the order went through by mistake due to “human error”.

“This does not reflect our practice … Human error has contributed to this and we have now taken swift measures to avoid such errors in the future,” a spokesperson said.

UK Meds, based in Nottingham, said its products were prescribed by General Medical Council-regulated doctors or other licensed prescribers and dispensed by a General Pharmaceutical Council-regulated pharmacy.

“The company acknowledges and is alive to the reality that the potential for abuse of the service is an ever-present risk that it needs to address. It continually strives to put in place rigorous procedures, operating in accordance with applicable legislation, which attempt to limit the potential for abuse of its service,” they said.

Prof Helen Stokes-Lampard, the chair of the Royal College of GPs, said the revelations were of great concern.

She added: “Codeine is an opioid and well-known to be highly addictive and so its use needs to be very carefully monitored. GPs are experts in prescribing and will be extremely cautious about starting a patient on opioids, but will also make sure they are closely monitored and regularly reviewed.”

One customer said she had obtained drugs for more than three years from different websites, citing the same condition each time. “I’ve been ordering from one website since citing the same condition every time (lying basically, saying that I’d had a pilonidal cyst removed) and they’ve never questioned it and just sent me the meds … This would be unheard of at any doctors’ surgery.”

The use of online pharmacies has increased rapidly in recent years, but issues have been raised about regulation.

Concern has also been raised about a legal loophole that allows people to buy strong painkillers from doctors based in Europe. It comes after the death of Jennifer Anne Lacey, 51, who was found dead in a Travelodge hotel in Morden, south London, last summer.

The coroner concluded (pdf) Lacey had killed herself after overdosing on tramadol and alcohol. She had taken 210 tablets, half of which she bought online.

The doctor who gave her 100 tablets of 50mg tramadol was based in Prague, Czech Republic. He had never seen her and had no access to her medical records, nor had he spoken to her GP. Lacey simply filled in an online form.

Concluding the inquest into her death, the coroner Fiona Wilcox said she was concerned such potentially dangerous and addictive drugs were so freely available online.

Media and Political Bulletin

28 February 2019

Media Summary

Wholesaler body proposes shortages information scheme to rebuild trust

C+D, Thomas Cox, 27 February 2019

C+D reports that Martin Sawer said last week at the Sigma conference that collating information on medicine shortages from manufacturers, wholesalers and pharmacies would rebuild trust across the supply chain.

“An information service [for] the supply chain – up to manufacturers and back down, particularly to community pharmacies – would be quite an achievement,” Mr Sawer said.

He admitted that sharing some data “is a challenge” because of commercial sensitivities, and any information shared “has to be handled properly”. However, exchanging information would help those in the supply chain understand each other better, and would improve trust between pharmacies, wholesalers and manufacturers, Mr Sawer said.

Medical Devices – Post-Brexit Supplies

Politico, Helen Collis, 28 February 2019

Politico reports that the U.K. will continue to accept medical devices safety-marked by EU notified bodies even if there’s a no-deal Brexit, the government confirmed in a new set of guidance. But that doesn’t mean manufacturers have nothing to prepare:

  • Device makers need to register their products with the MHRA by March 29 to place them on the U.K. market. However, depending on the type of device, the government is offering a grace period of four, six or 12 months after that deadline.
  • The U.K. is creating a new position, known as a “responsible person,” who will be physically on the ground in the U.K. to interact with the MHRA on behalf of manufacturers of products made outside the country.

But the European Commission said Wednesday there’s “no need for contingency measures” to keep the supply of devices flowing from the U.K. notified bodies after a no-deal Brexit.

Hydrocortisone shortages due to alleged supplier cartel, CMA concludes

Dispensing Doctors’ Association, Ailsa Colquhoun, 28 February 2019

Dispensing Doctors’ Association reports that the Competition and Markets Authority (CMA) has provisionally identified anti-competitive behaviour that could have led to hydrocortisone shortages between July 2011 and April 2015.

An investigation into suppliers Auden Mckenzie and Waymade has prompted the CMA to assert that Auden Mckenzie abused its dominant position by making monthly payments to Waymade not to enter the market.

As a result of this alleged anti-competitive behaviour, the CMA believes the NHS was denied a choice of suppliers and the potential savings resulting from increased competition.

NHS England updates no-deal Brexit advice

Dispensing Doctors’ Association, Ailsa Colquhoun, 27 February 2019

Dispensing Doctors’ Association reports that NHS England has published updated information on planning for continuity of supply of medicines in the case of a ‘no deal’ EU Exit. This information also includes supporting Q&As which may be helpful in any discussion with patients about their medicines and medical products.

The nhs.uk website has also been updated with some patient facing information on medicines supply.

In addition, Stephen Hammond MP, Minister of State for Health, has also written to, the NHS, Adult Social Care, Royal Colleges and Charities to provide an update on work to ensure the continuity of supply of medicines and medical products in the event the UK leaves the EU with no deal.

Drug shortages blamed on Brexit are ‘harming thousands of patients’ because GPs are being forced to dole out second-choice medicines

MailOnline, Sam Blanchard, 27 February 2019

MailOnline reports that patients are being harmed because drug shortages are forcing doctors to change their prescriptions, a survey has revealed. One in seven GPs say their patients have experienced negative side effects after they had to switch to second-choice drugs.

Shortages of medicines have this year been described as ‘worse than ever’ and there are concerns Brexit is contributing by causing patients and companies to stockpile.

More than a third of doctors say they ‘fairly often’ have to switch to less desirable drugs because of availability, while 16 per cent say they have to do it ‘very often’. In a survey of 586 GPs by the news website GP Online, nine out of 10 of them said they noticed their go-to medicines were becoming unavailable more often.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Wholesaler body proposes shortages information scheme to rebuild trust

C+D, Thomas Cox, 27 February 2019

Collating information on medicine shortages from manufacturers, wholesalers and pharmacies would rebuild trust across the supply chain, the wholesaler body has said.

Community pharmacies in particular would benefit from a tailored service that shows which medicines are experiencing supply disruptions, why, and when they are going to be available, Martin Sawer, head of the Healthcare Distribution Association (HDA) said last week (February 18).

The service would probably need a “third party of mutual engagement” such as the Department of Health and Social Care (DH), to oversee the sharing of supply data between pharmacies, wholesalers and manufacturers, Mr Sawer told C+D after his presentation at the Sigma conference in Muscat, Oman.

“An information service [for] the supply chain – up to manufacturers and back down, particularly to community pharmacies – would be quite an achievement,” Mr Sawer said.

Rebuilding trust

He admitted that sharing some data “is a challenge” because of commercial sensitivities, and any information shared “has to be handled properly”.

However, exchanging information would help those in the supply chain understand each other better, and would improve trust between pharmacies, wholesalers and manufacturers, Mr Sawer said.

“In some specific incidences, an accusation that’s been levelled [is that] wholesalers don’t always communicate why a product isn’t there and when it’s going to be there next. Sometimes we don’t actually know, that’s the trouble,” he told C+D.

“We need to tell a pharmacy that we don’t know – it’s just exchanging basic information. If that happened, there would be better trust established.”

“Getting hold of medicines is a huge challenge”

Mr Sawer would like to start developing the service later this year, he said. “I’ve mentioned it to a few pharmacy leaders and they’ve been supportive.

“The information supply is one thing – once that’s sorted, we need to move to how we sort out [shortages of] individual medicines,” he continued.

“Getting hold of medicines is a huge challenge, but if the information exchange allows an understanding of the level of demand and concern, then maybe medicines can be moved around if they’re in the wrong place, and supply can be added to more quickly.

“It will be on a case-by-case basis, medicine-by-medicine, because there’s different reasons for shortages,” Mr Sawer explained.

Watch Mr Sawer explain the proposals in more detail.

Medical Devices – Post-Brexit Supplies

Politico, Helen Collis, 28 February 2019

The U.K. will continue to accept medical devices safety-marked by EU notified bodies even if there’s a no-deal Brexit, the government confirmed in a new set of guidance. But that doesn’t mean manufacturers have nothing to prepare.

— Device makers need to register their products with the Medicines and the Healthcare products Regulatory Agency (MHRA) by March 29 to place them on the U.K. market. However, depending on the type of device, the government is offering a grace period of four, six or 12 months after that deadline.

— The U.K. is creating a new position, known as a “responsible person,” who will be physically on the ground in the U.K. to interact with the MHRA on behalf of manufacturers of products made outside the country. (It’s essentially the same role as an “authorized representative,” an official position within the EU’s device rules, who’s supposed to be on the ground in EU countries on behalf of manufacturers from the U.S., China, etc.)

EU declines to reciprocate: The European Commission said Wednesday there’s “no need for contingency measures” to keep the supply of devices flowing from the U.K. notified bodies after a no-deal Brexit.

Transparency wars: The appearance of DG GROW officials at a hearing in the European Parliament’s Environment, Public Health and Food Safety Committee turned into a heated debate about how much information on problems should be shared with the public in the EU’s new medtech database. Scroll down for the full article.

Lords talk: James O’Shaughnessy’s debate on the safety of medical devices was up in the House of Lords this morning.

Hydrocortisone shortages due to alleged supplier cartel, CMA concludes

Dispensing Doctors’ Association, Ailsa Colquhoun, 28 February 2019

The Competition and Markets Authority (CMA) has provisionally identified anti-competitive behaviour that could have led to hydrocortisone shortages between July 2011 and April 2015.

An investigation into suppliers Auden Mckenzie and Waymade has prompted the CMA to assert that Auden Mckenzie abused its dominant position by making monthly payments to Waymade not to enter the market.

As a result of this alleged anti-competitive behaviour, the CMA believes the NHS was denied a choice of suppliers and the potential savings resulting from increased competition.

From 2011 to 2015, while Auden Mckenzie remained the sole supplier of 20 mg hydrocortisone tablets, charges to the NHS rose from around £46 to £90 for a pack of 30 tablets, increasing the annual costs incurred by the NHS for the medicine from £1.7 million to £3.7m.

The CMA provisionally finds that in May 2011, Waymade was ready to enter the market for 20 mg hydrocortisone tablets, but then failed to do so until July 2015. Instead, it froze its own stock and agreed a deal with Auden Mckenzie under which it received monthly payments aimed at delaying its entry as a competitor in the market.

Waymade also obtained a licence to sell 10 mg hydrocortisone tablets in September 2012. In exchange for Waymade not entering the market and competing with its own tablets, the CMA alleges that Auden Mckenzie significantly lowered the price it charged Waymade from the market rate of around £32 per pack to £1.

This is a provisional finding. The companies now have the chance to make representations to the CMA before a final decision is reached. This will be made by a case decision group, which is separate from the case investigation team and was not involved in the decision to issue the statement of objections.

A final decision against the companies could result in a financial penalty of up to 10 per cent of annual worldwide group turnover.

For more information see the hydrocortisone tablets: alleged anti-competitive agreements and conduct case page.

NHS England updates no-deal Brexit advice

Dispensing Doctors’ Association, Ailsa Colquhoun, 27 February 2019

NHS England has published updated information on planning for continuity of supply of medicines in the case of a ‘no deal’ EU Exit. This information also includes supporting Q&As which may be helpful in any discussion with patients about their medicines and medical products.

The nhs.uk website has also been updated with some patient facing information on medicines supply.

In addition, Stephen Hammond MP, Minister of State for Health, has also written to, the NHS, Adult Social Care, Royal Colleges and Charities to provide an update on work to ensure the continuity of supply of medicines and medical products in the event the UK leaves the EU with no deal.

Drug shortages blamed on Brexit are ‘harming thousands of patients’ because GPs are being forced to dole out second-choice medicines

MailOnline, Sam Blanchard, 27 February 2019

Patients are being harmed because drug shortages are forcing doctors to change their prescriptions, a survey has revealed.

One in seven GPs say their patients have experienced negative side effects after they had to switch to second-choice drugs.

Shortages of medicines have this year been described as ‘worse than ever’ and there are concerns Brexit is contributing by causing patients and companies to stockpile.

More than a third of doctors say they ‘fairly often’ have to switch to less desirable drugs because of availability, while 16 per cent say they have to do it ‘very often’.

In a survey of 586 GPs by the news website GP Online, nine out of 10 of them said they noticed their go-to medicines were becoming unavailable more often.

Figures last month revealed the Government was in December paying over the odds for 80 drugs because they were hard to get hold of – this has dropped to 61 so far for February.

‘Shortages do affect patient management tremendously as second line medications are not always ideal and in rare cases not as effective,’ said one anonymous GP in the survey.

Another said anti-inflammatory painkillers, such as ibuprofen, high-strength aspirin and naproxen, pose a particular problem.

They wrote: ‘It is a particular nuisance for the anti-inflammatories. Patients are having to take stronger or unequal doses which is causing harm.’

And one said it was ‘terrifying’ to think about what might happen ‘if Brexit goes ahead’.

There have been concerns patients will try to stash medicines out of fear they won’t be able to get prescriptions filled if Britain leaves the EU next month.

International supply lines may also be disrupted if there are no agreements put in place before Brexit – even the Dutch government has admitted it is trying to secure access to ‘vital’ medicines out of fear European supplies will dry up.

And the country’s health minister, Bruno Bruins, said he wouldn’t reveal which medicines they were concerned about in case other countries tried to take them.

There has been disagreement over whether Brexit is the real cause, and the Government denies the link.

In January, chair of the English Pharmacy Board at the Royal Pharmaceutical Society, Sandra Gidley, said: ‘This has been a problem for some time.

‘There was a group set up by the Department of Health in 2010 to look at these shortages. But it is fair to say that recently the shortages have been worse than ever.’

Gareth Jones, from the National Pharmacy Association, told the BBC at the time: ‘Uncertainty over Brexit appears to be a significant factor.’

And Martin Sawer, executive director of the Healthcare Distribution Association, said people might be stockpiling medicines.

‘Some businesses could be speculating on Brexit,’ he added. ‘That’s the nature of the market.’

The Government has this month passed rules on ‘serious shortage protocols’, which will allow pharmacists to give a patient drugs different to what is on their prescription if supplies run out.

A Department of Health and Social Care spokesperson told GP Online: ‘There is no hard evidence to date to suggest current medicine supply issues are increasing as a result of EU exit.

‘Our number one priority is to ensure the continued supply of medicines and we are working closely with industry and partners in the health system to help prevent disruption, including increasing UK buffer stocks.

‘We are confident that, if everyone does what they need to do, the supply of medicines should be uninterrupted in the event of a no deal.

‘We have well-established processes to manage and mitigate the small number of supply problems that may arise at any one time due to manufacturing or distribution issues and this has always been the case – every day over 2m prescription items are successfully dispensed in England.’

How the NHS is planning for a no-deal Brexit

The Week, 27 February 2019

All forms of Brexit will negatively impact the NHS but a no-deal scenario could prove disastrous, according to a new health policy review.

The study, by leading experts in public health and law, found that leaving the EU without a deal would have negative repercussions on the NHS workforce and financing, and would also adversely affect the availability of medicines and vaccines, and the sharing of information and medical research.

“Our analysis shows that a no-deal Brexit is substantially worse for the NHS than a future involving the Withdrawal Agreement, which provides certainty and continuity in legal relations while the Political Declaration on the Future Relationship is negotiated and put into legal form,” says the paper, published in The Lancet.

Freedom of Information disclosures and board papers uncovered by Sky News reveal that hospitals around the UK are preparing for “shortages of medicines and staff” in the event of a no-deal Brexit. The London North West University Healthcare Trust is reportedly considering increasing security at its pharmacy “because of fears of break-ins” by people attempting to steal supplies.

The pharmaceutical industry has reportedly told the Government that it should “act to prevent medicine stockpiles being depleted by middle-men cashing in on a fall in the pound by selling no-deal supplies to European distributors”.

The Guardian reports that the government has already created a “logistics hub in Belgium” where “vital medical supplies will be stockpiled to stop the NHS running short of equipment if there is a no-deal Brexit”.

The paper adds that the Department of Health and Social Care has “arranged to get NHS supplies – including drugs – into Britain using seven new ferry routes” in order to “bypass the chaos that is widely expected in and around Dover in the event of no deal”.

A number of hospitals and trusts have also stated that they may be forced to cancel or postpone operations and other medical procedures in the event of no deal.

The Dudley Group NHS Foundation Trust said a no-deal Brexit would “adversely affect” supply chains, making it necessary for the trust to consider “prioritisation of key services and cancellation of non-critical services”.

Prime Minister Theresa May said yesterday that the UK would only leave the EU without a deal with the explicit consent of parliament, but insisted that the option had not been taken off the table.

Media and Political Bulletin

 14 February 2019

Media Summary

The ‘life-threatening’ reality no-deal Brexit poses for patients and their medical supplies

ITV News, Emily Morgan, 13 February 2019

ITV News’ Health Correspondent Emily Morgan undertakes a video report on the potential impact of a no-deal Brexit on patients and their medical supplies. She speaks to Matt Hancock; Wockhardt’s Managing Director, Sirjiwan Singh; Georgina Tankard, a patient suffering from breast cancer; Dr Jeanette Dickson, Vice Chair of the Royal College of Radiologists; and senior oncologist, Clive Peedell.

The full footage of the video report can be accessed here.

Diazepam diversion to criminal market down by 73 percent

Pharmacy Business, Lakshmi PS, 13 February 2019

Pharmacy Business reports that the Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued an organised crime update and it indicates that trading of Diazepam from the legal supply chain to the criminal market is now down by 73 percent.

Recent figures into bulk orders of diverted medicines also record a drop in the trading of Nitrazepam by 30 percent, top strength Temazepam by 18 percent and Zolpidem by 18 percent.

The MHRA launched a key investigation into the diversion of medicines from the legal supply chain in 2016, estimated to be worth up to £200 million.

WHO warns of falsified leukaemia drugs made from paracetamol

Pharmacy Business, Lakshmi PS, 13 February 2019

Pharmacy Business reports that the WHO has issued a medical product alert notifying patients, pharmacists and doctors of falsified versions of Iclusig 15 mg and Iclusig 45 mg circulating across Europe and the United States.

Genuine Iclusig contains Ponatinib Hydrochloride as the active pharmaceutical ingredient and it is used to treat different forms of leukaemia. The drug is priced at around £5,000 a pack in the UK in 2017. It is confirmed that the fake products do not contain Ponatinib but instead have paracetamol.

With medicine tracking operational, what does this mean for industry?

In-PharmaTechnologist.com, Ben Hargreaves, 13 February 2019

Hugh Pullen, EMVO’s president, explains what the launching of the EMVS means for the industry, and details how a potential no-deal Brexit will impact the system.

This content is copyright protected. The full article can be accessed here.

 

Parliamentary Coverage

Commons Tabled Written Questions – 13 February 2019

Bambos Charalambous (Enfield, Southgate): To ask the Secretary of State for Health and Social Care, what plans he has in place to (a) (i) monitor and (ii) identify gaps in the medicines being stockpiled by pharmaceutical companies and (b) protect the supply of medicines not being stockpiled by pharmaceutical companies.

Kevin Brennan (Cardiff West): To ask the Secretary of State for Health and Social Care, what assessment he has made of the effect of the UK leaving the EU on 29 March 2019on the supply of medicines to the UK for NHS use.

House of Lords Question – 13 February 2019

Lord Taylor of Warwick – asked on: 30 January 2019 to the Department for Exiting the European Union: To ask Her Majesty’s Government whether they intend to prioritise imports of medicine in their post-Brexit trading arrangements, in the event of a no-deal scenario.

Lord Callanan – answered on 13 February 2019: DHSC are working closely with life sciences industry and the NHS to make detailed plans to ensure continued access to medicines and devices in all scenarios.

We are working with industry to reroute supplies that make use of freight capacity acquired by Government. Medicines and medical products will be prioritised within this additional capacity to ensure that the flow of all these products will continue unimpeded after 29 March 2019. In addition, we are working with pharmaceutical companies to ensure that there is a minimum of six weeks additional supply of medicines in the UK, over and above existing business-as-usual buffer stocks.

 

Full Coverage

The ‘life-threatening’ reality no-deal Brexit poses for patients and their medical supplies

ITV News, Emily Morgan, 13 February 2019

Video report by ITV News Health Correspondent Emily Morgan

An awful lot has been written about what would happen if we crash out of the EU with no-deal.

So much so, that many are accusing the doomsayers of scaremongering and undoubtedly there may be some.

But in one area, medicine, there is a strong belief that the warnings aren’t scaremongering but reasoned and legitimate concerns.

A few months ago the Department of Health and Social Care recommended all pharmaceutical companies stockpile six weeks worth of medicine.

They have made it very clear everything is being done to ensure medication doesn’t run out and they have plans in place to honour that.

The problem is the oncologists we have spoken to want more detail.

They have cancer patients due to start radiotherapy and, would you believe it, all the isotopes used in certain treatments come from Europe.

Will flights carrying the nuclear medicine still be allowed in?

And crucially, if they are, will they get held up at customs?

Radioactive medicine loses effectiveness overtime so every minute counts.

Granted, this might affect a small number of patients, but they are patients none the less, who need this treatment and thus, need more detail on how the supply chain will continue unhindered.

Responding to the concerns, Health Secretary Matt Hancock told ITV News that he has ordered planes to be on standby to deliver time-sensitive supplies – such as medical radioisotopes – if lorries are held up.

“I’m confident if everybody does what they need to do – that includes resolving those transport issues – there will be that unhindered supply that everybody wants to see,” he said.

“We are doing the hard work now, whatever the scenario, to make sure the NHS will be strong and secure.”

Of course, it’s not just fear about isotopes but all medication.

Cancer drugs, insulin, medical equipment, even as we heard at the weekend, body bags, are all being stockpiled.

Wockhardt is one of the largest generic pharmaceutical companies in the world.

With over 350 products, the company supplies its own brands to hospitals, supermarkets, pharmacies and retailers.

On Wednesday, they let us film inside one of their warehouses where they are stockpiling medicine.

It’s the first time a pharmaceutical company has allowed TV cameras in, to see their stockpiles and it suddenly brought home what is going on.

The company’s Managing Director, Sirjiwan Singh, says it’s a prudent measure because it makes business sense but also because he doesn’t want to see patients lose out on their drugs.

Their warehouse has double the amount of drugs it usually holds, costing Mr Singh an extra £10 million pounds which he doesn’t expect to get back.

There are strict restrictions on drug prices so he won’t be passing the costs on.

Mr Singh has about four months worth of antibiotics, anti-diabetic drugs, bovine insulin and many more.

He’s taking no chances and says he’d be surprised if other firms weren’t doing the same.

Such measures are only partly reassuring for Georgina Tankard.

She has breast cancer and not only needs radiotherapy in a few weeks time but will also need hormone treatment drugs afterwards.

She wants to know why patients like herself should suffer because politicians can’t exit the EU in an orderly manner.

Ms Tankard says it is shameful there is uncertainty around the cancer drugs she needs, since she didn’t ask for Brexit, or indeed cancer.

She wants to know what will happen after the six weeks if stockpiled medicines run out, and nothing is resolved?

It’s a legitimate question.

Patients are being told that if there is a supply problem with their medication, pharmacists will be allowed to prescribe a different treatment.

But that doesn’t mean there isn’t anxiety.

Dr Jeanette Dickson, Vice Chair of the Royal College of Radiologists, is not convinced the Government will be able to solve the problems a no-deal Brexit could create in the time frame.

Senior oncologist, Clive Peedell, goes further.

He told us lives will be put at risk if there’s a no-deal.

Any delays at borders to radio-pharmaceutical agents could be life-threatening to patients.

He says this isn’t scaremongering, it’s a reality.

Diazepam diversion to criminal market down by 73 percent

Pharmacy Business, Lakshmi PS, 13 February 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued an organised crime update and it indicates that trading of Diazepam from the legal supply chain to the criminal market is now down by 73 percent.

Recent figures into bulk orders of diverted medicines also record a drop in the trading of Nitrazepam by 30 percent, top strength Temazepam by 18 percent and Zolpidem by 18 percent.

“Selling medicines outside of the supply chain is a serious criminal offence and the latest figures and the reduction is in diversion shows our determination to protect public health,” Alastair Jeffrey, MHRA Head of Enforcement, said.

As of February 2019, 32 investigations have been initiated and 86 suspects have been either arrested or interviewed under caution. 13 wholesale dealers have had their licenses discontinued or terminated and the General Pharmaceutical Council have suspended 8 pharmacists.

“The expansion of our operation shows we will continue to track down and prosecute those recklessly endangering public safety by illegally selling prescription medicines,” Jeffrey added.

MHRA launched a key investigation into the diversion of medicines from the legal supply chain in 2016, estimated to be worth up to £200 million.

WHO warns of falsified leukaemia drugs made from paracetamol

Pharmacy Business, Lakshmi PS, 13 February 2019

The World Health Organisation (WHO) has issued a medical product alert notifying patients, pharmacists and doctors of falsified versions of Iclusig 15 mg and Iclusig 45 mg circulating across Europe and the United States.

Genuine Iclusig contains Ponatinib Hydrochloride as the active pharmaceutical ingredient and it is used to treat different forms of leukaemia. The drug is priced at around £5,000 a pack in the UK in 2017.

It is confirmed that the fake products do not contain Ponatinib but instead have paracetamol.

The pharmaceutical companies Takeda and Incyte are the genuine manufacturers or market authorization holders for Iclusig in the regions which the above fake versions have been discovered to date. Both the companies confirmed to WHO that they did not manufacture or supply these products. Batch numbers PR072875 and 25A19E09 do not correspond to genuine manufacturing records.

“If you have taken this falsified product, or if you suffer an adverse event or an unexpected lack of efficacy, please seek immediate advice from a qualified healthcare professional, and ensure they report the incident to your local Ministry of Health/National Medicines Regulatory Authorities/National Pharmacovigilance Centre,” WHO directed through an alert.

National health authorities are asked to immediately notify WHO if these falsified products are discovered.

With medicine tracking operational, what does this mean for industry?

In-PharmaTechnologist.com, Ben Hargreaves, 13 February 2019

Hugh Pullen, EMVO’s president, explains what the launching of the EMVS means for the industry, and details how a potential no-deal Brexit will impact the system.

This content is copyright protected. The full article can be accessed here.

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

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?