Media And Political Bulletin – 11 May 2020

Media and Political Bulletin

11 May 2020

Media Summary

Wholesaler body: Pharmacies not at risk of exceeding credit limit

Chemist+Druggist, Thomas Cox, 06 May 2020

In an exclusive podcast with Chemist+Druggist, Executive Director of the HDA Martin Sawer said that most pharmacies should not be at risk of being unable to dispense medicines after reaching their credit limit with wholesalers.

With some pharmacies having to buy so much medicine to meet demand that they have reached the credit limit on their wholesaler account, their ability to purchase drugs is potentially being imperilled.

But Sawer said that only a “small number” of pharmacies might have challenges with their credit limit with his members. “I have been told that there is a lot of flexibility being allowed on those caps. Wholesalers have put on extra customer service teams to try and deal with all those regular customers who have that issue,” he told C+D.

Shortage of intensive care drugs mean operations cannot be restarted, anesthetists warn

The Telegraph, Tom Morgan, 09 May 2020

The Telegraph reports that many hospitals believe they are “nowhere near” returning to operating at full capacity for non-emergency patients, because anaesthetic drugs remain low following the peak of the Covid-19 crisis.

A Department of Health and Social Care spokeswoman said: “We are aware there is an increase in demand for a number of intensive care drugs and we are working with the pharmaceutical industry to make additional supplies available. We are working closely with industry, the NHS and the relevant national expert groups to ensure precautions are in place to reduce the likelihood of shortages.”

Several theatres in the south west are understood to have been particularly short of muscle relaxants and propofol in recent weeks. However, a doctor said the situation was “rapidly changing” and NHS England sources said issues with anaesthetics were not being felt on a national scale.

Parliamentary Coverage

The Department of Health and Social Care has announced it is partnering with companies including Amazon, the Royal Mint, eBay and Jaguar Land Rover to increase supply of PPE to NHS and social care workers. This follows a call-to-action from the government for UK businesses to use their existing manufacturing power to meet demand.

The Local Government Association (LGA) has said some councils have recorded a 40% increase in reported scams since the start of the COVID-19 emergency, including the sale of fake coronavirus test kits and hand sanitisers, bogus medical products claiming to treat or prevent COVID-19 and false communications about how to claim school meals funding and government grants.

The Office for Product Safety and Standards (OPSS) Chief Executive Graham Russell said: We are committed to supporting legitimate businesses who are working hard to increase the supply of PPE to health and social care settings. But anyone setting out to supply unsafe PPE, with fake certification and false safety marks, needs to know we take a zero-tolerance approach.

We will use all necessary enforcement powers to make sure unsafe PPE does not enter the supply chain and will take action against importers who set out to flout important safety rules.

OPSS has seen a rise in intelligence relating to PPE products including sales of non-compliant or counterfeit face masks and hand sanitisers, being sold online, in shops and at markets.

300,000 items from the consignment have been cleared by OPSS personnel, actively protecting health workers against the pandemic. Unsafe PPE that cannot be re-worked or used safely in another setting will be quarantined or destroyed.

House of Commons Question, 07 May 2020

Alex Norris (Nottingham North): To ask the Secretary of State for Health and Social Care, what assessment he has made of the effect of the covid-19 outbreak on the supply line to community pharmacies.

Jo Churchill: As part of our concerted national efforts to respond to the COVID-19 outbreak, we are doing everything we can to ensure patients continue to access safe and effective medicines.

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

 

Full Coverage

 

Wholesaler body: Pharmacies not at risk of exceeding credit limit

Chemist+Druggist, Thomas Cox, 06 May 2020

Most pharmacies should not be at risk of being unable to dispense medicines after reaching their credit limit with wholesalers, according to the head of a wholesaler body.

The recent deluge of scripts, up to triple the usual volume, has pushed some pharmacies to breaking point during COVID-19. Some have had to buy so much medicine to meet demand that they have reached the credit limit on their wholesaler account, potentially imperilling their ability to purchase drugs.

But Martin Sawer, executive director of the Healthcare Distribution Association (HDA), says that only a “small number” of pharmacies might have challenges with their credit limit with his members.

“I have been told that there is a lot of flexibility being allowed on those caps. Wholesalers have put on extra customer service teams to try and deal with all those regular customers who have that issue,” Mr Sawer told C+D last Friday (May 1).

“If there are any issues with with any of my members, then please do pass them on.” HDA members include AAH, Alliance Healthcare, Lexon and Phoenix.

Listen to the podcast to hear about:

  • Demand from community pharmacy for medicines returning to normal
  • How contractors can deal with medicines price hikes
  • The ups and downs wholesalers experienced during COVID-19, resulting in them being offered army support

Shortage of intensive care drugs mean operations cannot be restarted, anesthetists warn

The Telegraph, Tom Morgan, 09 May 2020

Many hospitals believe they are “nowhere near” returning to operating at full capacity for non-emergency patients because anaesthetic drugs remain low following the peak of the Covid-19 crisis.

A group of doctors, speaking to the Sunday Telegraph on condition of anonymity, added that some NHS Trusts were also weeks away from getting infection control measures right to ensure normal surgeries can resume.

Several theatres in the south west are understood to have been particularly short of muscle relaxants and propofol in recent weeks. Another doctor said the situation was “rapidly changing”, however.

The Telegraph first reported last month how propofol, a commonly used anaesthetic, and alfentanil, an opioid painkiller, had been running low due to the increased pressure on intensive care units.

“If anything the situation has got worse in our hospitals,” said one senior doctor. “We are nowhere near a return to full capacity, and many other hospitals in a similar situation.”

The Royal College of Anaesthetists has developed a joint strategy document  on “Restarting planned surgery in the context of the COVID-19 pandemic” in which it makes clear that planned surgery should not resume until  “sufficient anaesthetic and critical care drug stocks have been secured”.

Professor Ravi Mahajan, president of the college, said on May 1 that it “is clear that the NHS cannot simply resume planned surgery services before sufficient resources are in place”. “As well as adequate PPE and drugs supplies, staff capacity will be key in resuming planned surgery, and I am conscious that anaesthetists and all healthcare staff have been working incredibly hard throughout the pandemic,” he added.

Letters were sent out the same week by the Government to hospitals urging them to make preparations to return to regular treatment. The request comes amid warnings that more than 2,000 cancer diagnosis a week were being missed as a result of Covid-19.

At the peak of the crisis over the Easter weekend, figures from the NHS operational dashboard showed that 40.9 per cent of acute beds were unoccupied – about four times the normal number. In the same week of 2019, some 90 per cent of critical care beds were occupied.

Clinicians, meanwhile, are getting increasingly concerned at the potentially fatal consequences of the public being fearful of attending accident and emergency wards.

“Restarting normal activity is already a major challenge,” the group of doctors added. “In addition to anaesthetic shortages in theatre, everything has to be done in PPE, and the PPE stocks are critically low. So we’re not sure if we can start operating again at full capacity, or see patients in clinic at full capacity, because we don’t have the supply. People will die as a result of not coming in for their planned operations.”

On April 2, four leading royal colleges and health organisations asked staff to “act immediately” and use alternatives to some “first line” medications in new guidance on changes to specific anaesthetic drugs facing “pandemic pressures”. However, government sources said medicines shortages have been an issue for many years prior to the Covid crisis.

More than 100 medicines commonly used to treat patients have been banned from parallel export out of the UK to help uninterrupted supply of medicines to the NHS and patients.

“It is important to understand that there are alternative drugs available if those normally used by anaesthetists and intensivists for a specific procedure are in short supply,” the source added.

The increased demand has been anticipated and the Royal College of Anaesthetists, the Association of Anaesthetists, the Faculty of Intensive Care Medicine and the Intensive Care Society, working closely with NHS England, were said to have “ensured that appropriate mitigating plans are being put in place”.

A Department of Health and Social Care spokeswoman said: “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 safe and effective medicines.

“We are aware there is an increase in demand for a number of intensive care drugs and we are working with the pharmaceutical industry to make additional supplies available.

“We are working closely with industry, the NHS and the relevant national expert groups to ensure precautions are in place to reduce the likelihood of shortages.”

NHS England sources said issues with anaesthetics were not being felt on a national scale.

Media and Political Bulletin

29 April 2020

Media Summary

Pandemic instalment prescribing rules announced

Dispensing Doctors’ Association, Ailsa Colquhoun, 29 April 2020

Dispensing Doctors’ Association reports that the Home Office has laid the foundations for COVID-19 emergency legislation to enable supply of controlled drugs.

The legislation will allow prescribers to vary the dispensing frequency of an instalment prescription, including for patients on courses of take-home Opioid Substitution Therapy. The proviso is that this legislation is used only in limited circumstances following an announcement by the Secretary of State and under conditions specified by the local health service.

Service providers should try to ensure that such patients have lock-boxes to store medicines and are provided with take-home naloxone. There should also be regular contact with the prescriber or prescribing service.

This was also reported in the Pharmaceutical Journal.

Call for action over medicine shortages exacerbated by COVID-19 outbreak

Euractiv, Natasha Foote, 28 April 2020

Euractiv reports that stakeholders across the EU are calling for action on medicine shortages, which they say pose severe threats to patient outcomes, patient safety and patient care.

The European Public Health Alliance (EPHA), alongside a number of its members representing patient and disease groups, published a report on Monday 27 April which they hope will help plug the gap. The report details new recommendations to tackle the EU medicine shortages crisis.

Similarly, the standing committee of European doctors (CPME) published their position on the topic earlier this month, in which they urged the European Commission to hold companies accountable and impose a public service obligation on providers of essential medicines.

They also highlighted the need to increase diversification of supply sources and become more independent from production sites outside Europe, notably for essential medicines.

In a statement, the European Medicine Agency (EMA) said that some member states have already indicated that they are starting to experience shortages of certain medicines that are used to treat infected patients, while others say they are expecting shortages to occur shortly.

Parliamentary Coverage

House of Commons – Written Answers, 28 April 2020

Adam Holloway (Gravesham):

  • To ask the Secretary of State for Health and Social Care, whether the Government is working with air freight companies to prioritise the supply of medical equipment for the treatment of covid-19 patients at an appropriate cost.
  • To ask the Secretary of State for Health and Social Care, whether his Department has had discussions with the Department for Transport on increasing the number of air freight transport routes in operation to minimise delays to the import of medical supplies

Edward Argar (answered on 28 April 2020, holding answer received on 27 April 2020): The Government has announced a range of measures to assist industry and companies are able to draw on this unprecedented package of economic measures. These measures have been designed to ensure that companies of any size, including airports, airlines and the wider supply chain, receive the help they need to get through this difficult time.

The Government recognises that air freight plays an important role in supply chains and the importance that essential goods can continue to be brought into and out of the United Kingdom without disruption. COVID-19 presents unique risks to the movement of goods.

Because of this, the Department for Transport is working with different sectors to help ensure that essential goods can continue to be transported into the UK. This includes working closely with the aviation sector to support it to ensure there is sufficient capacity to protect global travel routes, continue freight and maintain vital connectivity.

The Department of Health and Social Care is working closely with the Department for Transport, other Government Departments and industry to feed into this ongoing work as well as monitor the impact of COVID-19 on medical supply chains and manage identified risks. For example, the Department of Health and Social Care has mobilised an Express Freight Service to support the continuity of supply of medicines and medical products and ensure the continued prioritisation of critical products.

This is complemented by the current work of the Civil Aviation Authority and the Competition and Markets Authority. The Civil Aviation Authority oversees and regulates all aspects of civil aviation in the United Kingdom and is engaging airlines and airports to provide flexibility within the regulatory framework to help manage and mitigate COVID-19 impacts where appropriate. The Competition and Markets Authority, which has launched a COVID-19 pandemic taskforce to identify harmful pricing practices is advising the Government on the means of ensuring markets operate as well as possible.

Full Coverage

Pandemic instalment prescribing rules announced

Dispensing Doctors’ Association, Ailsa Colquhoun, 29 April 2020

The Home Office has laid the foundations for COVID-19 emergency legislation to enable supply of controlled drugs.

The legislation will allow prescribers to vary the dispensing frequency of an instalment prescription, including for patients on courses of take-home Opioid Substitution Therapy. The proviso is that this legislation is used only in limited circumstances following an announcement by the Secretary of State and under conditions specified by the local health service.

Service providers should try to ensure that such patients have lock-boxes to store medicines and are provided with take-home naloxone. There should also be regular contact with the prescriber or prescribing service.

The legislation also ensures that pharmacists vary the frequency of dispensing an instalment prescription only after consultation with a prescriber.

The aim is for health guidance to be aligned across the devolved UK health administrations.

This was also reported in the Pharmaceutical Journal.

Call for action over medicine shortages exacerbated by COVID-19 outbreak

Euractiv, Natasha Foote, 28 April 2020

Stakeholders across the EU are calling for action on medicine shortages, which they say pose severe threats to patient outcomes, patient safety and patient care. A new report released on Monday (27 April) hopes to help plug the gap.

The European Public Health Alliance (EPHA), alongside a number of its members representing patient and disease groups, has published a report detailing new recommendations to tackle the EU medicine shortages crisis, saying that patients “can’t wait any longer”.

They said that the virus outbreak has brought the issue of medicine shortages to a head.

Similarly, the standing committee of European doctors (CPME) published their position on the topic earlier this month, in which they urged the European Commission to hold companies accountable and impose a public service obligation on providers of essential medicines.

They also highlighted the need to increase diversification of supply sources and become more independent from production sites outside Europe, notably for essential medicines.

In a statement, the European Medicine Agency (EMA) said that some member states have already indicated that they are starting to experience shortages of certain medicines that are used to treat infected patients, while others say they are expecting shortages to occur shortly.

The EPHA say that these include medicines used in intensive care such as certain anaesthetics, antibiotics and muscle relaxants, as well as medicines that are used off-label for COVID-19.

The reasons given for such shortages include production and capacity issues or commercial decisions, adding that supply issues are now also occurring for medicines used to treat patients with COVID-19, including in ICU.

All European countries are affected by this issue, according to the EPHA, and the effects of shortages on patients and their families can be “life-changing”.

The report sets out a series of nine recommendations, which include a permanent system for monitoring medicine shortages in the EU to be established, as well as a new EU Joint Action on the issue.

They also call for a new EU study to assess the impact of shortages on patient health, treatment and care, as well as for the meaningful input from elected representatives in the European Parliament into the development of a new EU strategy to tackle the crisis.

Charlotte Roffiaen, of EPHA member France Assos Santé, said that medicine shortages have “gone out of control in most EU countries, with devastating effects on patient health.”

“We need increased European coordination and strong EU initiatives to fight this plague, as no member state is in a position to solve this crisis on its own,” she added.

The CPME concurs, saying that medicine shortages concern all EU countries and demand a common European response.

They emphasise that Europe needs member state to cooperate and to coordinate different measures in order to mitigate disruptions to the supply of medicines and ensure their equal availability for all EU citizens.

CPME President Professor Dr Frank Ulrich Montgomery said that medicine shortages can “severely limit doctors’ ability to provide appropriate treatment”.

“Today the situation is aggravated by the surge in demand due to the treatment of COVID-19 patients and additional interruptions in a globalised and fragile supply chain.”

“We must undertake immediate actions to prevent European hospitals from running out of essential medicines and, once the emergency is over, permanent measures must be put in place to ensure a stable supply of medicines to European citizens in the future,” he added.

Back at the beginning of April, Commission President Ursula von der Leyen recorded a video message on guidelines that are aimed at ensuring Europeans have access to affordable medicines during the crisis.

National governments have also been asked to lift any export bans on medicines and avoid stockpiling.

Most recently, on Tuesday (28 April) the Commission published more guidance on ensuring that clinical trials can continue taking place in the EU during the pandemic.

The aim is to mitigate the disruption of clinical research in Europe, including the distribution of medicines to patients in clinical trials.

Media and Political Bulletin

18 December 2017

Media Summary

Launch of new medicines in UK face two-year delay post-Brexit, MPs told

The Pharmaceutical Journal, 15 December 2017

 

The Pharmaceutical Journal underlines that, according to evidence presented to the House of Commons Health Committee, the launch of new medicines in the UK may be delayed by two years after Brexit as it is “relegated” in the global medicines market.

The predicted delay will also have a “significant” knock-on effect on the UK’s involvement in clinical trials. “If medicines are going to be delayed by two years, then standards of care will change. And if your comparator is unlikely to be available in the UK, why would you set up a clinical trial here?” Leslie Galloway, chair of the Ethical Medicines Industry Group, a trade association for life science companies, told MPs.

Galloway was giving evidence to the committee’s ongoing inquiry into the impact of Brexit on the medicines supply chain, and on medicines and devices regulation.

 

 

Drug shortages cost NHS £38m as patients struggle

The Times, Chris Smyth, 18 December 2017

 

The Times reports that medicine shortages cost the NHS £38 million last month, as officials say they are largely powerless to solve a problem that is leaving patients struggling to obtain essential drugs.

Attempts to force down prices have led pharmacists to warn that they cannot carry on supplying patients with drugs that lose them money. A total of 91 emergency price increases have been approved for November, but pharmacists have said that these are not enough to cover the cost of crucial cancer and anti-psychotic medicines.

Worsening shortages of medicines have cost the NHS more than £200 million since April, the publication reports, because it has had to approve a series of price rises of up to 4,000 per cent.

 

 

Contractors ‘sickened’ by final 53 November concessionary prices

Chemist and Druggist, Thomas Cox, 15 December 2017

 

Chemist and Druggist reports that contractors were unimpressed by the final 53 concessionary prices for November, announced by the Department of Health (DH) and National Assembly for Wales on Thursday.

While the Pharmaceutical Services Negotiating Committee (PSNC) chief executive Sue Sharpe said her organisation “is pleased that further November prices have finally been issued”, she stressed that “many are lower than we had sought, and some concessions we applied for have not been granted”.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

Launch of new medicines in UK face two-year delay post-Brexit, MPs told

The Pharmaceutical Journal, 15 December 2017

 

The launch of new medicines in the UK may be delayed by two years after Brexit as it is “relegated” in the global medicines market, MPs on the House of Commons Health Committee were told on 12 December.

The predicted delay will also have a “significant” knock-on effect on the UK’s involvement in clinical trials.

“If medicines are going to be delayed by two years, then standards of care will change. And if your comparator is unlikely to be available in the UK, why would you set up a clinical trial here?” Leslie Galloway, chair of the Ethical Medicines Industry Group, a trade association for life science companies, told MPs.

Galloway was giving evidence to the committee’s ongoing inquiry into the impact of Brexit on the medicines supply chain, and on medicines and devices regulation.

Galloway’s warnings were endorsed by Steve Bates, chief executive of the BioIndustry Association, the trade association for the sector. He said he was worried that, post-Brexit, the UK would no longer have access to new medicines — including generic products — which would have “implications for the NHS”.

Funding streams — from both the private and public sectors — essential to maintain a “vibrant life sciences sector” were also at risk, according to Bates.

Uncertainty over the future regulation of medical devices because of Brexit was creating anxiety in the sector, Suzanne Halliday, head of medical devices at the British Standards Institution, told MPs.

A no-deal Brexit would be “devastating for patients” in terms of access to new medical devices. “It could mean no access to any [new] medical devices after March 2019,” she admitted.

Some device manufacturers were already moving their manufacturing out of the UK to Switzerland and to Ireland, she revealed.

At the same time drug companies were also moving their marketing authorisation to “mainland Europe” because of Brexit, Galloway added. “They will not come back to the UK,” he warned MPs.

 

 

Drug shortages cost NHS £38m as patients struggle

The Times, Chris Smyth, 18 December 2017

 

Medicine shortages cost the NHS another £38 million last month, as officials say they are largely powerless to solve a problem that leaves patients struggling to obtain essential drugs.

Attempts to force down prices have led pharmacists to warn that they cannot carry on supplying patients with drugs that lose them money. A total of 91 emergency price increases have been approved for November, but pharmacists have said that these are not enough to cover the cost of crucial cancer and anti-psychotic medicines.

Worsening shortages of medicines have cost the NHS more than £200 million since April because it has had to approve a series of price rises of up to 4,000 per cent. Patients are still experiencing delays getting medication and have sometimes had to switch drugs.

The government has moved to setting temporary prices based on manufacturers’ selling prices, rather than those charged by wholesalers, in an effort to squeeze margins. Manufacturers have accused wholesalers of inflating prices, but wholesalers have denied that they are manipulating the market.

Sir Chris Wormald, the permanent secretary at the Department of Health, told MPs last week that government had limited powers to resolve this. “There isn’t an obvious solution because it is a question of supply and demand,” he said.

Despite temporary rises for 20 more drugs than the previous month, over-payments in November totalled £38 million, down from £56 million the month before. This is because the government reduced the excess prices it pays for some drugs. For example, it will pay pharmacists £27 for olanzapine tablets, an anti-psychotic, well above the usual price of £1, but down from £62 in October. Mark Burdon, a member of the Pharmaceutical Services Negotiating Committee, which makes requests for price rises, said the reaction of some colleagues was that officials were “having a laugh” because wholesale prices had not come down this much.

Ben Goldacre, whose University of Oxford data team produced the November estimates, said: “We have pharmacists issuing drugs to patients, which the pharmacies have purchased a price set by the market, but those pharmacists have no idea what the NHS will pay them for it . . . The entire system needs a rethink and an overhaul.”

 

 

Contractors ‘sickened’ by final 53 November concessionary prices

Chemist and Druggist, Thomas Cox, 15 December 2017

 

Contractors were unimpressed by the final 53 concessionary prices for November, announced by the Department of Health (DH) and National Assembly for Wales yesterday.

While Pharmaceutical Services Negotiating Committee (PSNC) chief executive Sue Sharpe said her organisation “is pleased that further November prices have finally been issued”, she stressed that “many are lower than we had sought, and some concessions we applied for have not been granted”.

PSNC revealed last week that it requested 67 price concessions in total – 14 more than have been granted (see table below).

C+D reported earlier this month that contractors in England were “highly stressed” waiting for concessionary prices for items including levetiracetam, amlodipine and felodipine – the latter of which did not make the list.

Responding to the latest concessionary prices, the superintendent pharmacist of Broadway Pharmacy in Preston, Michael Ball, tweeted: “I honestly feel like giving up. It’s just one blow after another, beyond sickening.

“I feel like I need to determine how substantial the loss is, but then I’ll just be even more depressed and not spending the time productively,” he continued. “[I’m] honestly flabbergasted. Scary times.”

Excluding felodipine was “a joke”

Contractor Nat Mitchell from Cockermouth, Cumbria said it was “a joke” that felodipine was not among the 53 items, and that bicalutamide’s concessionary price was as low as £4.99 for 28 150mg tablets. “I feel like I’m being defrauded,” he added.

Fellow Cumbria pharmacist Ben Merriman said one wholesaler had priced bicalutamide at £39.

Newcastle-upon-Tyne pharmacy manager Rani Rehan said “thankfully” her pharmacy does not have patients on felodipine or bicalutamide, but described her reaction to the £53.63 concessionary price for 60 tablets of quetiapine 300mg as: “Ouch.”

Contractor Tony Schofield – also based in Newcastle – said “all the major wholesalers” are offering quetiapine at £136, and “the best [price] we could get” occasionally is £73.

Supplying at a loss?

Contractor Suketu Patel from Cheshire said he will “have to seriously consider” whether to supply medicines not granted a concessionary price at “below actual purchasing price”, or not at all.

Reacting to the news, Wyvern Pharmacy contractor Andrew Grierson tweeted: “Show of hands how many small contractors didn’t submit items for fear of losing out on a crippling amount of money, and now have to wait with fingers crossed for December.”

PSNC’s Ms Sharpe said she hopes the DH will respond to requests for December price concessions – submitted earlier this month – in a “more timely manner”.

Media and Political Bulletin

8 December 2017

In response to the series of articles published in The Times on current medicines shortages and subsequent price rises, the HDA has sent a response to the paper, to view this response please follow this link.

Media Summary

NHS close to blowing entire winter fund on costly drugs

The Times, Billy Kenber and Chris Smyth, 8 December 2017

 

The Times reports that the NHS will burn through a £350 million emergency winter fund by the end of December because it has been overpaying for drugs. Supply problems affecting at least 100 drugs have led to the NHS approving temporary price rises of up to 4,000 per cent.

Ministers are now under pressure to protect patients and the NHS budget by getting to the root of worsening medicine shortages that have led to some cancer and mental health patients going without crucial drugs.

Manufacturers have accused wholesalers of increasing prices artificially. Martin Sawer, executive director of the Healthcare Distribution Association, has responded stating that any such accusation is an insult to the professionalism of his members and their legal obligation to maintain a continuous supply of medicine.

 

Drug Money

The Times, 7 December 2017

 

A leading article in The Times reiterates the publication’s concern of what it labels the ‘flawed pricing system’ that has led to excess spending by the NHS. Under agreed rules, recent shortages have triggered prices increases which are designed to ensure a continued supply of medication, but this increase has at times spiralled out of control, with one product that at one time cost the taxpayer £1.62 per unit, now costing £65.

The article continues that an agreement between the Department of Health and the pharmacist’s professional body, which allows for the price of hard-to-obtain drugs to be increased, is responsible for the recent increases despite a failure to restore supply.

 

 

 

Parliamentary Coverage

House of Commons Questions: NHS – Drugs, 7 December 2017 

Royston Smith, MP: To ask the Secretary of State for Health, what steps his Department is taking to ensure value for money on pharmaceutical procurement?

Steve Brine, MP: For unbranded generics the Government relies on completion to keep prices down which generally works well and has led to low prices of these medicines. We alert the Competition and Markets Authority (CMA) when we believe that competition does not work. In the case of liothyronine, the CMA is currently investigating Concordia’s potential abuse of its dominant position to overcharge the National Health Service for liothyronine.

In primary care community pharmacies are incentivised to source products at the lowest possible cost by allowing them to retain the medicines margin (the difference between what the NHS reimburses a pharmacy for a product and how much the pharmacy purchases it for) up to £800 million in England. In secondary care, competitive tenders ensure value-for-money to the NHS.

Full Coverage

NHS close to blowing entire winter fund on costly drugs

The Times, Billy Kenber and Chris Smyth, 8 December 2017

 

The NHS will burn through a £350 million emergency winter fund by the end of this month because it has to overpay for drugs, calculations show.

Ministers are under pressure to protect patients and the NHS budget by getting to the root of worsening medicine shortages that have led to cancer and mental health patients going without crucial drugs. Medicine wholesalers have been summoned to the Department of Health to explain their handling of the crisis. They denied that they had been manipulating the market.

Supply problems affecting at least 100 drugs have meant that the NHS has had to approve temporary price rises of up to 4,000 per cent, but even this has not prevented patients’ treatments being interrupted. Pharmacists report that hard-to-find drugs become immediately available when prices rise and Labour has called for a full investigation to make sure that the NHS is not being “taken for a ride”.

Mike Dent, director of pharmacy funding at the pharmaceutical services negotiating committee, said that it was “receiving unprecedented numbers of calls from community pharmacy teams who cannot get hold of certain medicines that patients need”. The National Pharmacy Association warned yesterday: “People could come to real harm if this continues.”

The Department of Health has a mechanism for granting temporary higher prices, known as price concessions, for drugs that are hard to obtain, with the aim of boosting supply. The NHS has spent £178 million in this way over six months, with the monthly cost rising from £2.5 million in April to £54 million in September.

An analysis of prescription data suggests that the government spent £56 million to cover cost rises in 81 drugs in October. This figure is expected to have risen further last month after concession requests for almost 100 drugs. The NHS has probably spent about £300 million because of drug shortages since April and will have spent about £350 million by the end of this month if the situation remains.

Ben Goldacre, who runs the Open Prescribing project at Oxford University, calculates that shortages of the migraine treatment sumatriptan and the antipsychotic drug olanzapine have cost more than £50 million in six months. He said: “The chancellor has pledged £350 million to help the NHS deal with the winter crisis. This may be entirely wiped out by the the excess costs from drugs going out of stock.”

Jonathan Ashworth, the shadow health secretary, said: “Ministers must hold a serious and open investigation into how drug prices are being set and, if there is evidence of market manipulations then ministers must make sure that companies are held to account. It is essential that the government step in to make sure that patients are able to access the medicines they need, when they need them, and that the NHS is not being taken for a ride on the costs.”

The government is investigating the cause of the shortages.

Manufacturers have accused wholesalers of increasing prices artificially. Martin Sawer, executive director of the Healthcare Distribution Association, which represents large wholesalers, said any such accusation was an insult to the professionalism of his members and their legal obligation to maintain a continuous supply of medicine.

Drug Money

The Times, 7 December 2017

 

It has become a cliché to say that the National Health Service will always need more cash than the Treasury can afford. Jeremy Hunt, the health secretary, said so recently. Insofar as the NHS is having to minister to an ageing population and pay for more and more exotic and expensive treatments, it is true that whatever money is made available for healthcare will never be enough.

All the more reason for the NHS to bear down on spending where it can. And yet, as we report today, the cost of many drugs used to treat several serious conditions is anything but under control. Recent figures suggest that in the six months to September, the health service paid out an extra £180 million to obtain medicines to combat prostate cancer, breast cancer and severe mental illness among other conditions.

The excess spending was caused by shortages of the necessary drugs. Under agreed rules, these shortages triggered price increases designed to ensure continued supply, but the increase spiralled out of control. In the most extreme cases they have been in the order of 4,000 per cent. One product that not long ago cost the taxpayer £1.62 a unit now costs £65. Such inflation in the price of a potentially lifesaving medicine is, to put it mildly, unfortunate. What shifts the situation from merely expensive to deeply problematic is that some suspect the shortages responsible for the price rises may have been deliberately caused by wholesalers in expectation of surplus profits. Pharmacists are mystified by a continuing difficulty in securing supplies of standard medicines manufactured by a variety of large companies. What is more troubling is that pharmacists say once the price has risen, these drugs sometimes magically become available.

The provision of pharmaceuticals is not like that of crops or coal or cod. There is no obvious variable involved in the mass production of drugs likely to create a sudden shortage and therefore a consequent spike in their cost.

Or maybe there is. A deal negotiated between the Department of Health and the pharmacist’s professional body allows for the price of hard-to-obtain drugs to be raised in extremis. This deal, which rejoices in the comically misleading name of a price concession agreement, is the mechanism that has enabled the recent increases even though they have signally failed to restore supply. Indeed, with pharmacists continuing to report unprecedented shortages, the system appears to encompass a poisonous cocktail of both irregularity and inefficiency.

Media and Political Bulletin

31 October 2017

Media Summary

Warnings of Brexit impact on medicines supply

P3 Pharmacy, 30 October 2017

P3 Pharmacy reports on the HDA’s submission to the Health Select Committee’s inquiry on Brexit. The article highlights the HDA’s concerns regarding price hikes on NHS medicines and an increase in red tape on imports which could have a serious effect on the post-Brexit UK medicines supply chain and put patient safety at risk. P3 Pharmacy reports that the HDA has called for both a transitional period during which the status quo is maintained and the formulation of a sustainable long-term approach.

 

BGMA: We are working with Department of Health to counter generic shortages

Pharmacy Business, Neil Trainis, 30 October 2017

Pharmacy Business reports that the British Generic Manufacturers Association has reassured community pharmacists who have struggled to source products in the wake of generic drug shortages that its members are working with the Department of Health to find solutions and ensure “any impact on patients is kept to an absolute minimum.”

When asked if he was aware of generic shortages at Bristol Labs and Dr. Reddy’s or any other of its members, BGMA director general Warwick Smith told Pharmacy Business: “A regulatory issue is currently limiting the supply of some medicines. The industry is working with the Department of Health to identify alternative sources of supply so that any impact on patients is kept to an absolute minimum”.

 

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Warnings of Brexit impact on medicines supply

P3 Pharmacy, 30 October 2017

Price hikes on NHS medicines and an increase in red tape on imports could have a serious effect on the post-Brexit UK medicines supply chain and put patient safety at risk, the Healthcare Distribution Association has said. The Association has called for both a transitional period during which the status quo is maintained and the formulation of a sustainable long-term approach.

The Association, which represents businesses that supply medicines, medical devices and healthcare services, was responding to the Health Select Committee’s Brexit inquiry.

Customs and tariffs

Answering the Committee’s question regarding the key considerations for companies, healthcare service and regulatory bodies, it outlined scenarios that could see changes to customs and tariffs affect the “timely and cost-effective supply of medicines to patients”, including prohibitive tariffs on imported medicines and significant increase in the administrative burden for imports before they reach the UK.

In addition, the loss of equivalence with EU legislation would make it difficult for manufacturers to bring products to the UK as quickly as happens currently, the HDA said, adding that “greater clarity on future regulatory and trading relations is required as soon as possible if patient safety is not to be put at risk.”

The HDA said: “The government must urgently agree not only a transitional arrangement with the EU for these issues, but a long-term and sustainable way forward that provides the medicines supply chain with the much-needed certainty that it requires to deliver the right medicine, in the right place at the right time for patients across the UK.”

Parallel imports

Leaving the common trademarks system and the free movement (or ‘parallel trade’) of medicines this allows– a state of affairs that could be permanent in the event of a ‘hard Brexit’ – is also likely to increase the risk of medicines shortages, the HDA said, and could lead to price hikes for NHS medicines.

To avoid these harmful effects, the government “must consider sector-by-sector deals on IP rights, agreeing to mutually recognise certain products, such as pharmaceuticals,” the HDA said.

Stresses on the supply chain post-Brexit could affect the UK’s ability to implement the Falsified Medicines Directive by the February 2019 target date, the HDA added.

BGMA: We are working with Department of Health to counter generic shortages

Pharmacy Business, Neil Trainis, 30 October 2017

The British Generic Manufacturers Association has reassured community pharmacists who have struggled to source products in the wake of generic drug shortages that its members are working with the Department of Health to find solutions and ensure “any impact on patients is kept to an absolute minimum.”

The PSNC said last week it was in “urgent” talks with the DoH over “price concessions and wider concerns” following reports that contractors were enduring a shortage of generic drugs from Bristol Laboratories and Dr. Reddy’s.

When asked if he was aware of generic shortages at Bristol Labs and Dr. Reddy’s or any other of its members, BGMA director general Warwick Smith (pictured) told Pharmacy Business: “A regulatory issue is currently limiting the supply of some medicines.

“The industry is working with the Department of Health to identify alternative sources of supply so that any impact on patients is kept to an absolute minimum.

“Due to the multi-source nature of the UK generics market, when occasional supply issues of this kind arise, other manufacturers are usually able to increase production to mitigate any potential supply shortfall. Our focus and priority is on quality and security of supply.”

Rajiv Shah, a director at Sigma Pharmaceuticals, told the Avicenna conference in northern Cyprus in 2015 that generic drug shortages were costing independent pharmacists in England £10 million a year.

Media and Political Bulletin

16 October 2017

Media Summary

Drug Companies Fear Brexit Will Hit Medicine Trade

Bloomberg, John Lauerman, 16 October 2017

 

Bloomberg highlights that time is running short for a Brexit agreement that will allow the free movement of medicines through the U.K. and the rest of the European Union.

 

Alan Morrison, vice president of regulatory affairs international for Merck & Co., said in an interview in London last week that  a myriad of issues, including guidance on transferring product registration and drug testing in the region, are yet to be resolved. The problem is particularly acute for drug and biotech companies whose products sometimes take years to make, test and navigate through regulatory channels.

 

Concerns about a messy breakup are flaring after chief EU negotiator Michel Barnier said last week that discussions with the U.K. are “in a state of deadlock.”

 

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Drug Companies Fear Brexit Will Hit Medicine Trade

Bloomberg, John Lauerman, 16 October 2017

 

Time is running short for a Brexit agreement that will allow the free movement of medicines through the U.K. and the rest of the European Union.

 

A myriad of issues, including guidance on transferring product registration and drug testing in the region, are yet to be resolved, Alan Morrison, vice president of regulatory affairs international for Merck & Co., said in an interview in London. The problem is particularly acute for drug and biotech companies whose products sometimes take years to make, test and navigate through regulatory channels.

 

“Will we be able to do everything on time? Probably not,” Morrison said.

 

Concerns about a messy breakup are flaring after chief EU negotiator Michel Barnier said last week that discussions with the U.K. are “in a state of deadlock.” AstraZeneca Plc Chief Executive Officer Pascal Soriot warned last month that it was “impossible” for the government to forge new trade accords, establish a regulatory framework and develop new procedures for shipping products by the time the country exits the EU in 2019. Others echoed that sentiment, saying questions hang over a host of issues from duties and tariffs to the movement of products and people over borders.

 

“There could be some administrative delays to products being available in Europe,” Morrison said. Just changing registrations for medicines — which have to be filed in a EU member state to be recognized through the region — will be “a large logistical exercise in every company having to make the appropriate market transfer.”

 

Stale Lists

 

While Brexit leaders have suggested that the U.K. could revert to World Trade Organization rules, drugmakers counter that the WTO list of pharmaceuticals is far out of date. Products that aren’t on the list might be subject to tariffs for further restriction.

 

“The list hasn’t been updated since 2010,” David Boyd, Cambridge, England-based AstraZeneca’s director of European government affairs, said in an interview. Any drugs that the U.K.’s second-largest drugmaker has introduced over the past seven years wouldn’t be included, he said.

 

Pharma and biotech companies that depend on access to highly skilled employees are also concerned about Brexit’s impact. And those companies aren’t alone.

 

The top European drugs regulator, set to relocate from London following Brexit, could lose more than seven out of 10 employees, a survey of its staff showed. The exodus would trigger a “public health crisis,” the European Medicines Agency said last month.

 

Potential hires are increasingly concerned about their status following the U.K.’s move, Boyd said.

 

“There’s a lot of anxiety,” he said Friday in London.

Media and Political Bulletin

12 October 2017

Media Summary

Potential supply issues

MHRA Inspectorate Blog, Ian Jackson, 11 October 2017

 

The MHRA blog reports on the effect of the catastrophic weather conditions across the globe that have had a significant impact on the pharmaceutical supply chain in the last couple of months.

 

The blog highlights that the Inspectorate has already received reports of some manufacturing sites being affected and possible shortages occurring as a result.  Therefore, they are requesting that those companies that have sites within their supply chain that could be at risk due to recent weather events (such as those in Puerto Rico, Southern USA, India and Bangladesh) take steps to identify any potential supply issues.

 

The blog states that there is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to gmpinspectorate@mhra.gov.uk

 

Assurances that there are no issues would also be welcomed via the same email address.

 

NHS unprepared for no Brexit deal, says NHS England boss

Politico, Helen Collis, 11 October 2017

 

Politico reports on comments by the head of NHS England in a parliamentary health committee hearing on 11 October.  Simon Stevens highlighted that the U.K. government has not instructed the National Health Service to prepare for a Brexit “no deal” scenario, under which the citizenship rights of a significant proportion of the workforce would be in jeopardy.

 

Mr Stevens said that the system has a “superb contribution from staff who’ve trained and come from the rest of the European Union.” They account for over 9 percent of NHS doctors and about 5 percent of the 1.3 million NHS workforce.

 

Generic shortages: what can be done?

The Pharmaceutical Journal, Mark Burdon, 11 October 2017

 

The Pharmaceutical Journal publishes an opinion piece by Mark Burdon on potential solutions to generic shortages. Mr Burdon is an independent community pharmacy contractor and PSNC regional representative. The article highlights that the supply of generic medicines is vulnerable to the vicissitudes of market forces, with exchange rates fluctuating and manufacturers restricting distribution. Mr Burdon writes that the Department of Health needs to intervene to shield pharmacies from the impact of price spikes and ensure the resilience of the supply chain.

 

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Potential supply issues

MHRA Inspectorate Blog, Ian Jackson, 11 October 2017

 

The last couple of months have seen some catastrophic weather conditions across the globe.  These can have a significant impact upon the pharmaceutical supply chain.

 

We have already received reports of some manufacturing sites being affected and possible shortages occurring as a result.  Therefore, we request those companies that have sites within their supply chain that could be at risk due to recent weather events (such as those in Puerto Rico, Southern USA, India and Bangladesh) take steps to identify any potential supply issues.

 

We are also liaising with our international regulatory partners in order to gain additional information on potential supply issues and support plans to ensure continued supply of products to patients.

 

You can play a big part by providing relevant information to help with this process.

 

Notifying MHRA

 

There is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to gmpinspectorate@mhra.gov.uk

 

Assurances that there are no issues would also be welcomed via the same email address.

 

NHS unprepared for no Brexit deal, says NHS England boss

Politico, Helen Collis, 11 October 2017

 

The U.K. government has not instructed the National Health Service to prepare for a Brexit “no deal” scenario, under which the citizenship rights of a significant proportion of the workforce would be in jeopardy.

 

Speaking to the parliamentary health committee today, Simon Stevens, head of NHS England, said the system has a “superb contribution from staff who’ve trained and come from the rest of the European Union.” They account for over 9 percent of NHS doctors and about 5 percent of the 1.3 million NHS workforce.

 

Pressed by Labour committee member Ben Bradshaw if he’d been asked to prepare for a no-deal scenario “which is what the Prime Minister [Theresa May] was talking about yesterday,” Stevens responded: “We have not.”

 

Stevens said he remained confident the U.K. government would ensure the health service can continue to employ EU workers after Brexit. “I don’t detect any disagreement with the proposition that … we will continue to rely on our international staff,” he said.

 

Interviewed today on LBC radio station, May said the message to EU citizens was “we want you to be able to stay” but that there were no guarantees if negotiations collapsed without agreement.

 

After the meeting, Bradshaw told anti-hard Brexit movement Open Britain it was “shockingly irresponsible” for May to “repeatedly threaten a no-deal Brexit” without asking the head of the NHS to prepare for the consequences.

 

“Theresa May and the hard Brexiters in Cabinet are putting our NHS at risk,” he said.

 

Generic shortages: what can be done?

The Pharmaceutical Journal, Mark Burdon, 11 October 2017

The supply of generic medicines is vulnerable to the vicissitudes of market forces, with exchange rates fluctuating and manufacturers restricting distribution. The Department of Health needs to intervene to shield pharmacies from the impact of price spikes and ensure the resilience of the supply chain.

Way back in 2012, before funding cuts and Brexit and countless other of today’s challenges were on the horizon, one problem was already coming to light. In fact, the voices of community pharmacy had grown so loud warning about the problem that the All-Party Pharmacy Group (APPG) — a group of MPs across all parties, with an interest in pharmacy — decided to hold an inquiry into it. Their verdict? Medicines stock shortages are a problem; sort them out.

But fast-forward half a decade and if you’re working in a community pharmacy it won’t feel like much has changed. We are still spending hours every week trying to get hold of the medicines our patients need; and things seem to be getting worse, rather than better.

Medicines sources limited

There are many factors currently affecting the supply of medicines to pharmacies and causing these problems. The restricted distribution models implemented by many manufacturers — whereby they only allow a few selected pharmacy wholesalers to stock their medicines — certainly had an impact. They have limited the places from which we can source medicines and diluted competition in the market. This makes the market less resilient, so when things go wrong — a power outage at a major wholesaler, for instance — it can be chaos for pharmacies who have to borrow medicines from one another to meet patient needs.

For many years the UK could import drugs cheaply, but exchange rates mean importing is often no longer a good way to source reasonably priced medicines

A second factor is the global nature of the market for medicines. For many years this benefited the UK as we could import drugs cheaply, but exchange rates mean importing is often no longer a good way to source reasonably priced medicines. In fact, generics prices in the UK are now so low that it is not difficult to imagine why the UK market might not appeal to generics manufacturers at all — why would any business want to sell at lower prices when they could fetch higher ones elsewhere?

Manufacturing plant closures

Another recent and unprecedented problem has been the inspections by regulatory authorities which led to the closures of manufacturing plants owned by two major generics companies. Inevitably, a plant closure means fewer medicines can be produced, prompting potential worldwide shortages of some medicines.

But alongside issues like these which can create real physical shortages of some medicines, a whole host of other market factors come into play and can affect our ability to source medicines. Pricing is a major worry; when medicines are in short supply they tend to become more expensive, and sometimes we simply cannot obtain medicines for anywhere near the Drug Tariff (which sets out how much we will be reimbursed for medicines) prices.

Manipulation of the market can make it very difficult for pharmacy contractors to purchase medicines and can lead to price distortions

Generics pricing is complicated at the best of times, because prices are adjusted regularly to try to set the amount of margin that pharmacy contractors can make on the medicines (this margin forms part of our core funding). But when shortages come into play the market can be even more volatile. There can also be manipulation of the market, which can make it very difficult for pharmacy contractors to purchase medicines as they usually would.

Branded generics distort prices

One example of this is when local NHS commissioners ask GPs to prescribe medicines called ‘branded generics’. Branded generics are produced by manufacturers and priced at levels below the Drug Tariff levels, making them attractive locally because they bring down local drugs bills. But nationally, because generic medicines are priced at a level designed to assure delivery of our core funding, this does not lead to savings. And in fact the local distortions of pricing can mean that pharmacies are not able to earn core parts of their funding, which is a problem.

So what can we do about all of this? Well some things we are already doing. Every month a huge amount of work goes into assessing market prices for any medicines known to be in short supply, to ensure that ‘concessions’ are granted. These mean pharmacies can purchase and be reimbursed for the medicines at the higher market prices. But this system takes a lot of work, and pharmacies often have to go for long periods without knowing whether they will be granted a concession price.

The PSNC is seeking urgent intervention from the Department of Health to ensure the resilience of the medicines supply chain

The Pharmaceutical Services Negotiating Committee (PSNC) would like to see a simpler process, with the Department of Health making speedy adjustments to address the impact of high price rises like the ones we are now seeing. With so many medicines lines currently affected we are also seeking urgent intervention from the Department of Health to ensure the resilience of the medicines supply chain. Unfortunately, there is no simple answer in such a complex market — if there were, they would have done it.

So in the meantime, for community pharmacies the job remains pretty much the same as back when the MPs investigated in 2012. Keep pushing your wholesalers for the best possible deal; keep telling us about the problems; and keep explaining to patients that you are doing all you can, but that sometimes the supply problems are national, and simply out of your control.

Media Summary

BGMA: We are working with Department of Health to counter generic shortages

Pharmacy Business, Neil Trainis, 26 September 2017

 

Pharmacy Business highlights the BGMA assurances to community pharmacists that it is working with the Department of Health to find solutions to the generic shortages. Many community pharmacists have struggled to source products in the wake of the generic drug shortages and the BGMA has reported that it is working with the DoH to find solutions and ensure that “any impact on patients is kept to an absolute minimum.”

 

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BGMA: We are working with Department of Health to counter generic shortages

Pharmacy Business, Neil Trainis, 26 September 2017

 

The British Generic Manufacturers Association has reassured community pharmacists who have struggled to source products in the wake of generic drug shortages that its members are working with the Department of Health to find solutions and ensure “any impact on patients is kept to an absolute minimum.”

 

The PSNC said last week it was in “urgent” talks with the DoH over “price concessions and wider concerns” following reports that contractors were enduring a shortage of generic drugs from Bristol Laboratories and Dr. Reddy’s.

 

When asked if he was aware of generic shortages at Bristol Labs and Dr. Reddy’s or any other of its members, BGMA director general Warwick Smith (pictured) told Pharmacy Business: “A regulatory issue is currently limiting the supply of some medicines.

 

“The industry is working with the Department of Health to identify alternative sources of supply so that any impact on patients is kept to an absolute minimum.

 

“Due to the multi-source nature of the UK generics market, when occasional supply issues of this kind arise, other manufacturers are usually able to increase production to mitigate any potential supply shortfall. Our focus and priority is on quality and security of supply.”

 

Rajiv Shah, a director at Sigma Pharmaceuticals, told the Avicenna conference in northern Cyprus in 2015 that generic drug shortages were costing independent pharmacists in England £10 million a year.

Applications are open for the Procurement and Distribution Interest Group’s Autumn Symposium. The symposium will be held on Thursday 2nd November at the “Hilton Birmingham Metropole Hotel, NEC, Birmingham. Application forms can be found here.

 

MEDIA SUMMARY 

 

Report your generic shortages
Dispensing Doctors’ Association, Ailsa Colquhoun, 25th September 2017The DDA reports on the Pharmaceutical Services Negotiating Committee’s invitation to dispensing GPs to contribute reports on generic shortages, via its website. These reports will then form a very important basis on which price concessions are agreed.The PSNC has told pharmacists that it is in “urgent discussions with the Department of Health regarding price concessions”, something which also applies to dispensing GPs.Following inspections at Bristol Laboratories and Dr Reddy’s, the PSNC has said it is aware of the very great difficulties that contractors are having sourcing a large number of products, with both shortage and pricing issues playing a part. This is having a huge impact on workload and a catastrophic impact on cash flow for contractors.

 

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Report your generic shortages
Dispensing Doctors’ Association, Ailsa Colquhoun, 25th September 2017Factors including branded generic prescribing to blame for current shortages.Pharmacy negotiators the Pharmaceutical Services Negotiating Committee has told pharmacists that it is in “urgent discussions with the Department of Health regarding price concessions”, which also apply to dispensing GPs.Following inspections at Bristol Laboratories and Dr Reddy’s, PSNC is aware of the very great difficulties that contractors are having sourcing a large number of products, with both shortage and pricing issues playing a part. This is having a huge impact on workload and a catastrophic impact on cash flow.PSNC invites dispensing GPs to contribute reports on generic shortages, via its website, as these reports form a very important basis on which price concessions are agreed.

As soon as any price concessions are agreed, the DDA website will be updated for the benefit of DDA members.

PSNC says it is “deeply frustrated and alarmed by the current medicines supply situation”, which it says it caused by factors such as the increasing use of branded generics by CCGs.  The DDA has identified this as a current issue for dispensing practices.

Media Summary

PSNC in ‘urgent’ talks with DH over ‘catastrophic’ generics shortages

Chemist and Druggist, Grace Lewis and Jennifer Offord, 22nd September 2017

 

Chemist and Druggist reports on the urgent discussions underway between The Pharmaceutical Services Negotiating Committee (PSNC) and the Department of Health (DH) about the “catastrophic” effect of generics shortages.

 

The PSNC is seeking “immediate action” from the DH following inspections by the European Medicines Agency (EMA), which found last month that a Bristol Laboratories manufacturing site in Luton, and a Dr Reddy’s site in India, did not “comply with good manufacturing practice”. This failure to comply has led to a huge supply shortage.

 

The supply shortage and pricing of a “large number of products” is having a “catastrophic impact on [contractors’] cash flow”, the PSNC said in a statement on Friday. The PSNC also said that it is “aware of the very great difficulties” and “numerous market issues that pharmacy contractors and teams are facing” and alerted the DH as soon as the extent of the issues became clear.

 

Also published in Pharmacy Biz.

 

Response to Prime Minister Theresa May’s speech in Florence

ABPI, 22nd September 2017

 

The Association of the British Pharmaceutical Industry (ABPI) responded to Theresa May’s speech on the future of the UK’s relationship with the European Union (EU) on Friday at Santa Maria Novella, Florence, Italy.

 

The ABPI’s Chief Executive Mike Thompson commented:

 

“We hope that today’s intervention delivers sufficient progress to start negotiations about issues at stake for our sector and move everyone on to thinking about how we ensure Britain has a smooth and orderly exit from the EU.

 

The Prime Minister’s speech is a welcome recognition of the importance of allowing reasonable time for industries like ours to plan and manage complicated changes in our supply chain and regulatory arrangements so that for patients across Europe, Brexit does not mean a break in their treatments.”

 

 

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Response to Prime Minister Theresa May’s speech in Florence

ABPI, 22nd September 2017

 

The Association of the British Pharmaceutical Industry (ABPI) have responded to today’s speech on the future of the UK’s relationship with the European Union (EU) by UK Prime Minister Theresa May at Santa Maria Novella, Florence, Italy.

 

​​​​Following the speech, The ABPI’s Chief Executive Mike Thompson commented:

 

“We hope that today’s intervention delivers sufficient progress to start negotiations about issues at stake for our sector and move everyone on to thinking about how we ensure Britain has a smooth and orderly exit from the EU.

 

The Prime Minister’s speech is a welcome recognition of the importance of allowing reasonable time for industries like ours to plan and manage complicated changes in our supply chain and regulatory arrangements so that for patients across Europe, Brexit does not mean a break in their treatments.

 

The Life Sciences sector needs not only sufficient time to reorganise our work, but also sufficient clarity about our new trading and working relationship. We need a clearly defined goal to move to in one single step in order to avoid unnecessary delay and duplication.

 

Cooperation and alignment between the UK and the EU underpins many of the achievements that our industry continues to deliver for patients across Europe. We should not let the UK’s withdrawal from the EU disrupt this work.”

From Factory to Pharmacy

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

See the Infographic

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