News

Media And Political Bulletin – 18 January 2019

Media and Political Bulletin

14 January 2019

Media Summary

Should pharmacies trade medicines between themselves?

Chemist and Druggist, Thomas Cox, 11 January 2019

 

Chemist and Druggist includes a comment from Martin Sawer, Executive Director of the HDA, about his views on PSNC’s suggestion that regulations should be relaxed to allow pharmacists to trade medicines after Brexit.

 

Martin Sawer said that the HDA would support the idea of pharmacies being able to trade between themselves, should medicines supply be impacted post-Brexit.

 

“Pharmacy-to-pharmacy trading is a good contingency [plan]. It means borrowing stock and paying it back – you return the same medicine when you get some more,” he said.

 

“These are sensible proposals that should reduce the time taken for alternatives to be provided to patients and make it easier for clinicians to deliver the appropriate treatment.”

 

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 11 January 2019

 

Wayne David, MP: To ask the Secretary of State for Health and Social Care, what consultation his Department has undertaken on proposals for the introduction of Serious Shortage Protocols for medicines.

 

Wayne David, MP: To ask the Secretary of State for Health and Social Care, what the timeframe is for the introduction of Serious Shortage Protocols for medicine.

 

Wayne David, MP: To ask the Secretary of State for Health and Social Care, what safeguards his Department has put in place to ensure that medical Serious Shortage Protocols do not pose risk to the well-being of patients.

 

Answered by Steve Brine: The Department engaged with a wide range of stakeholder representative bodies about the proposals and also conducted a written consultation. The Department received 47 responses to its written consultation including from industry, patients’, pharmacists’ and doctors’ representative bodies. The responses to the consultation were broadly supportive.

 

The Statutory Instrument is expected to be laid shortly and come into force before 29 March. Any serious shortage protocol would be developed with and signed off by clinicians. Only if clinicians deem it appropriate, an alternative quantity, strength, pharmaceutical form or medicine can be dispensed in line with the protocol.

 

A protocol is only one of the tools that can be used to manage shortages. The Department manages shortages in collaboration with manufacturers and suppliers, the National Health Service and the Medicines and Healthcare products Regulatory Agency and will continue to do so. A protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, taking account of the risks to and well-being of patients and after discussion with the manufacturer and/or marketing authorisation holder.

Any serious shortage would be time limited and the protocol itself would indicate the period during which it has effect.

Full Coverage

Should pharmacies trade medicines between themselves?

Chemist and Druggist, Thomas Cox, 11 January 2019

 

As PSNC suggests regulations should be relaxed to allow pharmacies to trade medicines after Brexit, C+D asks three contractors – and the wholesaler body – for their views

 

With just 77 days until the UK’s exit from the European Union, and Prime Minister Theresa May yet to secure parliament backing for her Brexit deal, the Department of Health and Social Care (DH) has ramped up its contingency planning.

 

As part of a raft of proposals suggested by the Pharmaceutical Services Negotiating Committee (PSNC) last month to ensure continuity of medicines supply post-Brexit – whether a deal is secured or not – it has called for the DH to “relax the restrictions on pharmacy-to-pharmacy wholesale dealing without wholesaler dealer licenses”, to allow pharmacies “to trade stock between them at a local level”.

 

This would “allow medicines to reach those patients who most need them, without regulatory barriers”, PSNC says.

 

Pharmacists were able to trade medicines under certain circumstances without a wholesaler licence until 2012, when the Medicines and Healthcare products Regulatory Agency revoked the legislation.

 

So, would pharmacies welcome the opportunity to swap stock between them once again? C+D asks three contractors and the head of the wholesaler’s body – the Healthcare Distribution Association (HDA) – for their thoughts.

 

“We don’t need any more pressure at this time”

Michael Lennox, chief officer of Somerset local pharmaceutical committee, tells C+D that he “would welcome the opportunity for the regulations to allow us to better support patients”.

 

“If Brexit were to have an impact, then I think we would need to change the framework,” he says. “We don’t need any more pressure at the minute.”

 

“Things will get worse”

Alan Kurtz, owner of Fishers Pharmacy in south London, says: “I don’t see any reason why we shouldn’t be able to help one another in order to be able to help patients.”

 

Mr Kurtz explains that his pharmacy has been struggling with medicines shortages for “years”, which has been “very difficult”, and he has “no doubt things will get worse”.

 

“It worked well before”

Indira Panchal, owner of four pharmacies in Bedford, says while it is a “good time” for pharmacies to be able to trade medicines to help ease shortages, it is “short-sighted” that the change is only under consideration now.

 

Ms Panchal says owners of a single pharmacy would particularly benefit from PSNC’s proposal, as they are unlikely to have their own wholesaler’s license.

 

Wholesalers: “Good contingency planning”

 

HDA executive director Martin Sawer tells C+D that his organisation – which represents wholesalers – would also support the idea of pharmacies being able to trade between themselves, should medicines supply be impacted post-Brexit.

 

“Pharmacy-to-pharmacy trading is a good contingency [plan]. It means borrowing stock and paying it back – you return the same medicine when you get some more,” Mr Sawer explains.

 

“These are sensible proposals that should reduce the time taken for alternatives to be provided to patients and make it easier for clinicians to deliver the appropriate treatment.”

 

Serious shortage protocol

 

While PSNC continues to discuss the impact of Brexit with the DH via its Brexit forum, the DH expects to lay legislative changes for its “serious shortages protocol” before parliament this month.

 

The DH is seeking to amend the Human Medicines Regulations 2012 to enable pharmacists to dispense an alternative in accordance with the protocol, rather than the prescription, and without having to contact a GP, in the event of a serious medicines shortage.

 

The DH insists the regulations “will come into force before March, regardless of the situation with Brexit”, and told C+D it is still reviewing responses to its consultation.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Media and Political Bulletin

18 January 2019

Media Summary

DHSC to consult with pharmaceutical industry over generics price limiting powers

The Pharmaceutical Journal, Carolyn Wickware, 17 January 2019

The Pharmaceutical Journal reports that the Department of Health and Social Care will consult with the pharmaceutical industry over its plans to use new powers limiting the price of generics.

In a letter to the House of Commons Public Accounts Committee, Sir Chris Wormald, permanent secretary at the DHSC, said the Department was preparing “a framework for the use of its price-limiting powers” and it will consult on this with the industry.

His comments come in response to a PAC report on the rocketing prices of generic medicines in 2017, in which the committee said it was “not convinced that the department had a clear plan on how it would use the new powers”.

Pharmacists warn of a ‘surge’ in shortage of common medicines

BBC News, Catherine Burns, 18 January 2019

The BBC reports that pharmacists are saying that they are struggling to obtain many common medicines and paying ‘vastly increased’ prices for them. The article states that there are ‘a number of reasons why this has happened, but there are now concerns that uncertainty over Brexit will only make the situation worse.

The article also includes a comment from Martin Sawer, Executive Director of the HDA, who told the BBC ‘you can bet your bottom dollar people might be stockpiling…some businesses could be speculating on Brexit. That’s the nature of the market.’

Some common medicines `in short supply´

Daily Mail, 18 January 2019

The Daily Mail also reports on the fact that there has been a rise in the number of drugs on a ‘shortage of supply,’ and states that, according to the BBC, ‘there are 80 medicines in such short supply that the Department of Health and Social Care has agreed to pay a premium for them.

The article also includes a statement from Martin Sawer, who said that ‘some businesses could be speculating on Brexit…that’s the nature of the market.’

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 17 January 2019

Wes Streeting, MP: To ask the Secretary of State for Health and Social Care, whether his Department’s plans to ensure the supply of medicines in the event of the UK leaving the EU without a deal (a) have been or (b) will be subjected to an independent evaluation.  

Answered by Stephen Hammond: The Department’s plans to ensure the supply of medicines in the event of the United Kingdom leaving the European Union without a deal have been subject to scrutiny by a number of Parliamentary Committees, including the Public Accounts Committee, the Health and Social Care Committee, the EU Exit Committee and the House of Lords EU Home Affairs Sub-Committee. The Department is also working closely with suppliers, their supply chains, health services and devolved administrations to maintain the continuity of medicines supply in a ‘no deal’ EU exit scenario.

We are unable to publish the list of medicines requested. To reassure participating companies, we have committed to treating all information received confidentially, securely and to using it only for the purposes of the Department’s contingency programme. That means not introducing information about a specific company, medicine or supply route into the public domain.

On 23 August 2018, the Department wrote to all pharmaceutical companies that supply prescription-only and pharmacy medicines to the UK that come from, or via, the EU or European Economic Area (EEA), asking them to ensure a minimum of six weeks’ additional supply in the UK, over and above existing business-as-usual buffer stocks, by 29 March 2019. We recognise, however, that certain medicines with short shelf lives, including medical radioisotopes, cannot be reasonably stockpiled. Where these medicines are imported from the EU or EEA, we have asked that suppliers ensure in advance plans to air freight these medicines from the EU in the event of a ‘no deal’ exit.

Additionally, on 7 December 2018, the Department wrote to pharmaceutical companies that supply licensed medicines to the UK from or via the EU/EEA and/or manufacture medicines in the UK, informing them of the updated reasonable worst-case scenario border disruption planning assumptions and asking them about their current transportation routes and their ability to re-route their supply chains if they currently rely on Dover and/or Folkestone.

We have received very good engagement from industry who share our aims of ensuring continuity of medicines supply for patients is maintained and that suppliers are able to cope with any potential delays at the border that may arise in the short term in the event of a ‘no deal’ exit.

Full Coverage

DHSC to consult with pharmaceutical industry over generics price limiting powers

The Pharmaceutical Journal, Carolyn Wickware, 17 January 2019

The Department of Health and Social Care (DHSC) will consult with the pharmaceutical industry over its plans to use new powers limiting the price of generics, the department’s permanent secretary has said.

In a letter to the House of Commons Public Accounts Committee (PAC), Sir Chris Wormald, permanent secretary at the DHSC, said the Department was preparing “a framework for the use of its price-limiting powers” and it will consult on this with the industry.

His comments come in response to a PAC report on the rocketing prices of generic medicines in 2017, in which the committee said it was “not convinced that the department had a clear plan on how it would use the new powers”.

In July 2018, the DHSC was awarded new powers to instruct pharmaceutical companies to reduce the price of a generic medicine or introduce other controls on their branded products in cases where it thinks drug companies are charging unreasonable prices for generics.

However, the report found that the DHSC had “not yet set out how it will use its new powers, should similar price rises happen again” and recommended that the DHSC “write to the [PAC] to set out the full range of actions it can take to address rises in the price of generic medicines, and what skills and capacity it has put in place to use its new powers”.

In response, Sir Chris said the DHSC “is monitoring prices to determine where price increases have been sustained and where the market has corrected itself”.

But he added that the government’s “powers to limit prices can only be implemented following a consultation of the relevant industry bodies”.

He continued: “The department is therefore developing a framework for the use of its price limiting powers and is preparing an industry consultation to be released early 2019.

“The framework will set out what factors the department proposes to consider when setting the price of a generic medicine and what process the department will follow.”

The British Generic Manufacturers Association told The Pharmaceutical Journal that, as of 17 January 2019, it had yet to recieve a copy of the consultation.

Pharmacists warn of a ‘surge’ in shortage of common medicines

BBC News, Catherine Burns, 18 January 2019

Pharmacists say they are struggling to obtain many common medicines and paying “vastly increased” prices for them.

This is leaving patients complaining of delays in getting hold of drugs such as painkillers, anti-depressants and blood pressure medication.

The BBC has found there has been a big rise in the number of drugs on the “shortage of supply” list for England.

There are 80 medicines in such short supply that the Department of Health has agreed to pay a premium for them.

This is up from 45 in October.

There are a number of reasons why this has happened, but there are now concerns that uncertainty over Brexit will only make the situation worse.

The Royal Pharmaceutical Society said there was “a massive shortage and price spikes”.

What does this mean for patients?

Most people should be able to get their prescriptions filled as normal.

But if they need one of the drugs that is running short, they might not be so lucky.

Some pharmacists are sending patients back to their GPs to ask for a different medicine or dosage.

Others are giving as much of a drug as they can spare and sending people away with IOU notes for the remainder.

The best advice is to make sure you get prescriptions to your pharmacist in good time.

It is almost always possible to come up with an alternative.

However, that can be more difficult with conditions like epilepsy, where patients need to be on specific drugs.

What would ‘no deal’ mean for food and medicine?

Public may have to stockpile drugs in no-deal Brexit

Is NHS already finding it hard to get medicines?

What is the scale of the problem?

It is hard to obtain a definitive tally of which medicines are running short.

But the industry in England uses a list from the Pharmaceutical Services Negotiating Committee (PSNC).

It shows which drugs are in such short supply and for which ones the NHS has agreed to temporarily pay a higher price.

The PSNC publishes monthly lists of these so-called concession prices.

The BBC has analysed this data and found that the number of medications on the list has grown six-fold in three years.

During this time period the peak was in November 2017, but there has been a recent surge and figures for December show it is approaching that level again.

What drugs are affected?

This is about prescriptions for generic medicines, rather than specific brand names.

For example, Nurofen is a common painkiller, but you can buy the same generic drug, ibuprofen.

Ash Soni, president of the Royal Pharmaceutical Society, says he has never seen so many common drugs affected by shortages.

He explains: “The items are out of stock and unavailable. Patients are having to wait.

“We’re having to send some patients back to the GP to get a different prescription, because we just can’t fill them.”

On December 2018’s concession list, 28 drugs, or about a third, were among the 500 most commonly prescribed.

For example, furosemide is used to treat high blood pressure and other cardiovascular problems.

It comes in various dosages, but one type, 40mg tablets, is the 23rd most commonly prescribed drug in England.

Other drugs on the list include fluoxetine, which treats depression, and naproxen, which is an anti-inflammatory.

Mr Soni says naproxen went “completely out of stock” recently.

“I didn’t have any on my shelf last week. I’ve got patients who are waiting for it.”

He did manage to track some down eventually, but it cost £6.49 a box. That is £2 more than the NHS last agreed to pay for it.

He says: “I’ve ordered 20 boxes today and that will last me about two or three days.

“We’re dispensing at a loss. We’re paying for patients to get their meds on the behalf of the NHS.”

What do drug companies say?

Warwick Smith, director general of the British Generic Manufacturers Association, says stock levels can fluctuate.

He prefers to call it a “tightening of supply” rather than a shortage.

“It’s normal for levels of availability to increase and decrease, which impacts prices,” he adds.

The government stresses that two million prescription items are dispensed in England every day, and the vast majority of medicines are not in short supply.

A Department of Health and Social Care spokesperson said: “We continue to work closely with industry and partners to ensure patients receive the medicines they need and pharmacies are reimbursed fairly.”

Why is this happening?

Industry figures all stress that there is no single, neat answer to explain such a complicated situation.

Suggestions for reasons behind the shortage include:

increased global demand

cost of raw materials

new regulatory requirements driving up costs

fluctuations in exchange rates

generic companies being unwilling to carry on selling unprofitable products.

Another possible explanation is that the NHS has done too good a job of driving down the prices it will pay for drugs.

The PSNC says this makes the UK a less attractive market for manufacturers.

Has Brexit had an impact?

The government has told manufacturers of both branded and generic drugs to stockpile six weeks’ worth of supplies, so that people would still get their medications if we have a no-deal Brexit.

Hospitals, distributors and patients have been told not to stockpile their own supplies.

Generic shortages started peaking in 2017, so it is not possible to say that this issue has arisen because we are so close to Brexit.

Former Liberal Democrat MP Sandra Gidley, a pharmacist who is chairwoman of the English Pharmacy Board at the Royal Pharmaceutical Society, said “Brexit is not a factor”.

She told BBC Radio 4’s Today programme: “Shortages have been a problem for some years. It’s a fluctuating problem. They are now worse than ever.

“The situation with Brexit is that the government have recognised that there could be potential supply problems and they have been asking manufacturers to keep in a buffer stock so that if there are freight problems, trouble with customs, patients will still get their drugs.

“Unfortunately what’s been happening on social media over Christmas is that people have been putting two and two together and assuming this is because of Brexit. The pharmaceutical supply chain is a very, very complex subject. There are global issues at play here.”

She admitted that as a former Liberal Democrat MP, she would “love to blame Brexit”, adding: “I’m sitting here saying this is not the case.”

But Gareth Jones, from the National Pharmacy Association, says: “Uncertainty over Brexit appears to be a significant factor.”

He says patients do not seem to be panicking about getting their medicines after a possible no-deal Brexit, but thinks there could be an element of “unconscious stockpiling”.

In other words, if people at every step of the supply chain hold on to extra medicines, it could have a significant impact on supplies.

Martin Sawer is executive director of the Healthcare Distribution Association, which circulates 92% of the medicines in the UK.

He says: “You can bet your bottom dollar people might be stockpiling.

“Some businesses could be speculating on Brexit. That’s the nature of the market.”

Some common medicines `in short supply´

Daily Mail, 18 January 2019

There has been a big rise in the number of drugs on a “shortage of supply” list for England, analysis shows.

There are 80 medicines in such short supply that the Department of Health and Social Care has agreed to pay a premium for them, according to data analysed by the BBC.

The figure is up from 45 in October.

Pharmacists said they were struggling to obtain some common medicines and are paying higher prices as a result.

While some experts said uncertainty over Brexit was making the situation worse, others said this was not the case.

Other reasons for the shortage may include increased global demand, cost of raw materials, new regulatory requirements driving up costs and fluctuations in exchange rates.

Another explanation is that the NHS has driven down the prices it will pay for drugs, which makes the UK less attractive to manufacturers.

Gareth Jones, from the National Pharmacy Association, told the BBC: “Uncertainty over Brexit appears to be a significant factor.”

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.”

Sandra Gidley, the former Liberal Democrat MP who is chairwoman of the English Pharmacy Board of the Royal Pharmaceutical Society, told BBC Radio 4’s Today that people should get their prescriptions to pharmacists in time, but should not stockpile.

She added: “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.

“Every day, there are items that are on a short-term supply problem, so you might have to wait two or three days for them to come in, but they do come in eventually.

“The message to patients is: ‘Please don’t leave picking up your medicines to the last minute at the moment’.”

Ms Gidley added: “Brexit isn’t a factor. Shortages have been a problem for some years. It’s a fluctuating problem. They are now worse then ever.

“The situation with Brexit is that the Government have recognised that there could be potential supply problems and they have been asking manufacturers to keep in a buffer stock so that if there are freight problems, trouble with customs, patients will still get their drugs.

“Unfortunately, what’s been happening on social media over Christmas is that people have been putting two and two together and assuming that this is because of Brexit.

“The pharmaceutical supply chain is a very complex subject. There are global issues at play here.”

The Royal Pharmaceutical Society told the BBC there was “a massive shortage and price spikes”.

A monthly list of drugs in short supply is managed by the Pharmaceutical Services Negotiating Committee (PSNC).

BBC analysis shows that the number of medications on the list has grown six-fold in three years.

During this time, the peak period peak was in November 2017, but there has been a recent rise.

Ash Soni, president of the Royal Pharmaceutical Society, said he had never seen so many common drugs affected by shortages.

He said: “The items are out of stock and unavailable. Patients are having to wait.

“We’re having to send some patients back to the GP to get a different prescription, because we just can’t fill them.”

Gareth Jones of the National Pharmacy Association told the BBC: “Certainly we would advise patients to order medicines in advance if they can do, in case there are any problems. It gives the pharmacist more time to deal with it.

“For the patient generally they can leave it to the pharmacist, who will do everything they can to source the supply.”

One drug on the list for December is furosemide, which is used to treat high blood pressure and other cardiovascular problems.

Other drugs on the list include fluoxetine, which treats depression, and the anti-inflammatory naproxen.

Mr Soni said naproxen went “completely out of stock” recently and he ended up paying £6.49 a box, £2 more than the NHS last agreed to pay for it.

A Department of Health and Social Care spokeswoman said: “The Department has 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.

“We continue to work closely with industry and partners to ensure patients receive the medicines they need and pharmacies are reimbursed fairly.

“The vast majority of medicines are not subject to supply problems and every day over two million prescription items are successfully dispensed in England.”

Media And Political Bulletin – 18 January 2019

From Factory to Pharmacy

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