Media And Political Bulletin – 08 May 2019

Media and Political Bulletin

08 May 2019

Media Summary

PSNC’s Future of Pharmacy animation

PSNC has developed an animation explaining how community pharmacy will fit into the NHS of the future.

The animation not only showcases the sector to stakeholders, but also describes the transformation that community pharmacy will undertake.

The animation can be viewed here.

Parliamentary Coverage

House of Commons, Oral Questions, 07 May 2019

Justin Madders, MP: What recent assessment he has made of the availability of prescription drugs.

Answered by Seema Kennedy: Over 2 million prescription items are successfully dispensed in England every day, and we have well-established procedures to deal with medicine supply issues should they occur. We work closely with all those involved in the supply chain to help ensure any risks to patients are minimised when supply issues arise.

Justin Madders, MP: I welcome the Minister to her place. She will know from written questions I have tabled that my constituents have real concerns about the availability of the epilepsy drug Sabril, which has been in short supply. She told me last month that supplies would be resolved by mid-April; she has now told me in a written answer that supplies will be resolved by mid-May. It seems there is a disconnect between what the Minister is saying and what is actually happening on the ground. When can she guarantee that this drug will be widely available again?

Answered by Seema Kennedy: I thank the hon. Gentleman for raising this issue again. We have expressed our great concern to the suppliers about this problem, and we are working alongside them to ensure that, although there is enough Sabril nationally, we get it in the right place at the right time. We will go back to them and express our concern again.

Chris Philp, MP: May I add my congratulations to my hon. Friend the Member for South Ribble (Seema Kennedy) on her appointment? I am sure the whole House wishes her well in her important work.

Related to the question of prescription drugs is that of vaccinations, where rates have been falling, partly driven by alarming and inaccurate material posted on social media, including Facebook. Will the Minister join me in calling on Facebook to remove material that deters people from vaccinating their children? If it refuses to do so, does she agree that legislation may be needed?

Answered by Seema Kennedy: I thank my hon. Friend for his question. As he will know, my right hon. Friend the Secretary of State met Facebook last week.

On the issue of vaccination broadly, in 2017 we met the 95% rate for vaccination. Immunisation for everybody is absolutely crucial, but some children cannot be immunised because they are too young and others because they are immune-suppressed; so everybody who can be immunised should be immunised.

Julie Cooper, MP: I also welcome the hon. Lady to her place. Close to 100 commonly prescribed medications are in seriously short supply, including painkillers, antibiotics and antidepressants. Worries about Brexit outcomes have led to the stockpiling of medications, which has undoubtedly exacerbated the problem, but I know from my own experience in community pharmacy that there have been concerns about the supply chain for several years, long before Brexit was ever dreamed of. The Government have, however, consistently turned a blind eye to these problems, which place additional pressures on GPs and pharmacists and are most certainly detrimental to patient care. Can the Minister assure me today that she understands the scale of the problem and outline the steps she is taking to resolve it?

Answered by Seema Kennedy: I thank the shadow Minister, my Lancashire neighbour, for her welcome. The Department takes this extremely seriously; we have a whole team working on it. There are about 12,500 prescribed medicines in this country, with only between 50 and 100 being looked at by the medicines supply team at any one time. There is no cause for complacency, though. In January this year, we took further steps to make it mandatory for pharmaceutical companies to report any supply issues to us as soon as possible.

Media and Political Bulletin

22 May 2018

Media Summary

Breaking: Pharmacy’s battle to overturn governments funding cuts resumes in court

PharmacyBusiness, Neil Trainis, 21 May 2018  

Pharmacy Business reports that community pharmacy’s battle to overturn the government’s funding cuts will resume today as appeals by two leading bodies against a judge’s verdict last year that ministers did not act unlawfully in imposing the measures is heard.

The National Pharmacy Association (NPA) and Pharmaceutical Services Negotiating Committee (PSNC) will have their cases heard at the Court of Appeal just over one year after Lord Justice Collins dismissed their judicial reviews of the decision to implement £320 million in cuts over a two-year period. The hearing is expected to last three days.

The PSNC’s original judicial review revolved around their belief that the government had failed to carry out a proper consultation on the cuts while the NPA’s argument was that ministers did not conduct an adequate impact assessment of the cuts on vulnerable groups such as the elderly, disabled and people living in deprived areas.

The PSNC said: “We do not expect the judges to make an immediate decision at the end of the hearing, which means that we may not know the outcome of the appeal cases for several weeks. It is not helpful to speculate on what the outcome may be at this stage.”

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

Breaking: Pharmacy’s battle to overturn governments funding cuts resumes in court

PharmacyBusiness, Neil Trainis, 21 May 2018  

 

Community pharmacy’s battle to overturn the government’s funding cuts will resume tomorrow as appeals by two leading bodies against a judge’s verdict last year that ministers did not act unlawfully in imposing the measures is heard.

The National Pharmacy Association (NPA) and Pharmaceutical Services Negotiating Committee (PSNC) will have their cases heard at the Court of Appeal just over one year after Lord Justice Collins dismissed their judicial reviews of the decision to implement £320 million in cuts over a two-year period. The hearing is expected to last three days.

The PSNC’s original judicial review revolved around their belief that the government had failed to carry out a proper consultation on the cuts while the NPA’s argument was that ministers did not conduct an adequate impact assessment of the cuts on vulnerable groups such as the elderly, disabled and people living in deprived areas.

The PSNC said: “We do not expect the judges to make an immediate decision at the end of the hearing, which means that we may not know the outcome of the appeal cases for several weeks. It is not helpful to speculate on what the outcome may be at this stage.”

Despite his decision not to quash the cuts last year, Lord Justice Collins was critical of the Department of Health’s (since renamed Department of Health and Social Care) consultation process which he said was unfair albeit not unlawful. The department had failed to disclose its use of a Companies House analysis which it claimed showed community pharmacies had an operating margin of 15%.

Lord Justice Collins also said the department did not understand the duty to reduce health inequalities when making decisions about the NHS and highlighted the range of services being delivered by community pharmacies to some of the most deprived areas of England.

PSNC director of operations and support Gordon Hockey said: “PSNC has always regretted very much that it became necessary to take the unprecedented step of seeking a judicial review. We have always sought to work constructively and collaboratively with the NHS and Department of Health and hope to begin substantive discussions with them on the future of community pharmacy very soon.”

NPA vice-chair Andrew Lane said: “Pharmacies are disproportionately located in deprived areas, a rare exception to the so-called inverse care law under which people with the highest needs have the least access to advice and treatment.

“The high court judgment vindicated our stance on health inequalities and we now want to see that flow through to a logical and fair conclusion. Had the Department of Health properly considered the impact of its cuts, it would have realised that the cuts will ultimately have a disproportionate effect on people living in the most deprived areas of England, where there is already a lack of NHS provision.”

Media and Political Bulletin

20 December 2017

Media Summary

PSNC announces antifraud CEO as replacement for Sue Sharpe

Chemist and Druggist, Grace Lewis, 18 December 2017

Chemist and Druggist reports that Simon Dukes, the current CEO of fraud prevention service Cifas, will be replacing Sue Sharpe as chief executive of the Pharmaceutical Services Negotiating Committee in May 2018.

According to PSNC chairman Mike Pitt, “a rigorous search and selection programme” was used to find Ms Sharpe’s replacement.

“The appointments panel was unanimous in agreeing that Simon had all the qualities we were seeking, and would be the right person to lead the work of PSNC in the demanding environment community pharmacy faces,” he said.

“The committee too approved the appointment unanimously, and we look forward to working with Simon.”

The news of Simon’s appointment was also reported in P3 Pharmacy and announced on the PSNC website.

Parliamentary Coverage

There is no parliamentary coverage today.

Full Coverage

PSNC announces antifraud CEO as replacement for Sue Sharpe

Chemist and Druggist, Grace Lewis, 18 December 2017

Simon Dukes, current CEO of fraud prevention service Cifas, will replace Sue Sharpe as chief executive of the Pharmaceutical Services Negotiating Committee (PSNC) in May 2018.

Mr Dukes joined Cifas in 2013 and previously worked for the UK government in a “variety of roles and specialisms”, covering counter-terrorism, cyber security and serious and organised crime investigations, according to the Cifas website.

Commenting on his new role, Mr Dukes said he is “looking forward” to developing the “community pharmacy service for the future”.

“Community pharmacies perform a vital role for the citizen, and I am very pleased indeed to have been selected as the new CEO for PSNC,” he added in a statement on the negotiator’s website this morning (December 18).

Ms Sharpe – who in May, announced she would leave PSNC at the end of 2017 – said Mr Dukes’ “experience and expertise from outside the health sector…will bring fresh thinking and strong leadership of the organisation”.

“Unanimous” decision

According to PSNC chairman Mike Pitt, “a rigorous search and selection programme” was used to find Ms Sharpe’s replacement.

“The appointments panel was unanimous in agreeing that Simon had all the qualities we were seeking, and would be the right person to lead the work of PSNC in the demanding environment community pharmacy faces,” he said.

“The committee too approved the appointment unanimously, and we look forward to working with Simon.

Network set up to study drug shortages across Europe

26 April 2016, The Pharmaceutical Journal

 

The European Union has launched a European Medicines Shortages Research Network to look at the causes of medicines shortages and their impact on patients. The Network aims to develop a set of principles that can be adopted across the EU to prevent shortages. Eighteen EU countries have so far signed up to the four-year programme.

 

Chemist and Druggist and The Pharmaceutical Journal report on the publication of a counter proposal by PSNC to the UK Government’s plan for the future of community pharmacy. This proposal offers recommendations for cost-saving measures rather than a funding cut.

 

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Parliamentary Coverage

 

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Full Coverage

Network set up to study drug shortages across Europe

26 April 2016, The Pharmaceutical Journal

 

The European Union has launched a European Medicines Shortages Research Network to look at the causes of medicines shortages and their impact on patients.

 

Eighteen EU countries have signed up so far to the four-year programme, an initiative of the European Cooperation in Science and Technology (CoST), which supports cooperation among researchers across Europe. More are expected to join and non-EU countries are able to attend meetings as observers.

 

The research network will explore the reasons for drug shortages in both primary and secondary care, including whether countries face similar or different issues, and it will then make recommendations on how medicines shortages can be prevented or minimised. The ultimate aim is to develop a set of principles that can be adopted across the EU.

 

Working groups have been set up to address a number of areas: the landscape of medicines shortages; manufacturing-related shortages; logistics-related shortages; therapeutic options and substitutions; and the impact of shortages on outcomes.

 

David Stead, former specialist procurement pharmacist at NHS South West, is chairing the logistics working group, supported by another UK representative Jane Nicholson, executive director of the European Industrial Pharmacists Group.

 

Stead said European countries procure medicines in different ways, so the initial focus will be on understanding the mechanisms in each country, so “we can identify whether the way that medicines are provided and procured actually creates problems”. Then the group will look at evidence based practice to make recommendations on how to prevent or minimise distribution problems and improve the clinical management of shortages.

 

The network is chaired by Helena Jenzer from the University of Bern, Switzerland, with Roberto Frontini, president of the European Association of Hospital Pharmacists (EAHP), as deputy chair.

 

 

Community pharmacists should be able to substitute cheaper drugs, says PSNC in proposals to counter government cuts

26 April 2016, The Pharmaceutical Journal

 

Giving community pharmacists more power to dispense cheaper generic alternatives to branded medicines or cheaper drugs of greater therapeutic benefit could save the NHS millions of pounds and prevent the need for planned government cuts of £170m from the community pharmacy budget in England, according to national negotiators.

 

Allowing pharmacists to dispense urgent medicine supplies routinely to patients out of hours without the need for a prescription from a GP, or following a pharmacy referral via the NHS 111 service, could also save money and offset the proposed cuts for 2016 and beyond, the Pharmaceutical Services Negotiating Committee (PSNC) is suggesting.

 

The negotiators have released a list of counter proposals, which they claim would meet the government budget cuts that are now at the centre of their confidential negotiations with ministers.

 

The PSNC’s counter proposals include a move to reduce medicines waste where pharmacists would not dispense repeat prescriptions for medicines or appliances to patients in cases where, following discussion, both sides agreed that they already had sufficient current stocks of drugs or other medical products.

 

A national therapeutic substitution service linked to a specific list of medicines with options for cheaper and more clinically effective alternative products is also being discussed.

 

The PSNC, in its briefing paper, says the list should also include specials where alternative licensed products could be dispensed instead.

 

A similar national list of generic alternative drugs would also be drawn up as part of the PSNC’s plans, which it says could mirror a scheme running in Ireland since 2013.

 

Other proposals include a community pharmacy-led review of prescribing in care homes.

 

The paper makes it clear that negotiators also oppose government plans to bring in a new pay system linked to a single fee for each prescription item supplied.

 

The new system, says the PSNC, is a backward step because it would incentivise pharmacists to increase medicine supplies. The negotiators suggest instead an alternative payment system that rewards pharmacies providing more clinical services.

The smoke starts to clear for hub and spoke dispensing

22 April 2016, The Pharmaceutical Journal

 

The Pharmaceutical Journal discusses the concerns over the hub-and-spoke consultation launched by the UK Government. Highlighting the confusions between hub-and-spoke and centralised dispensing, this editorial clarifies the distinction between the two models to outline the benefits and disadvantages of hub-and-spoke dispensing. While The Pharmaceutical Journal welcomes a technology which could assemble prescriptions more accurately and more quickly than a human for the benefit of patients, questions over its application are also raised.

 

PSNC publishes counter proposal

25 April 2016, PSNC

 

PSNC has published a summary of the counter proposal it has made to the Department of Health in response to the Government’s proposals for community pharmacy. The counter proposal sets out how community pharmacy could be used to generate savings to the NHS without a cut in pharmacy funding.

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Parliamentary Coverage

 

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Full Coverage

The smoke starts to clear for hub and spoke dispensing

22 April 2016, The Pharmaceutical Journal

The UK government’s push towards hub-and-spoke dispensing (as expressed in its community pharmacy reforms letter dated 17 December 2015) has caused concern, particularly among representatives of the independent community pharmacy sector. One of the challenges in the discussion lies in the definitions. The terms ‘hub and spoke’ and ‘centralised dispensing’ have been used interchangeably, including by The Pharmaceutical Journal, and this confusion is weakening the arguments on both sides.

Hub and spoke is a fairly clear concept. In a hub-and-spoke system, prescriptions are brought or sent to the spoke pharmacies, and the information is sent (generally electronically) to the hub pharmacy. The prescription is assembled at the hub, whether as boxes and packets of drugs in a bag or as individual tablets in a monitored dosage system (MDS) tray. The assembled prescriptions are delivered back to the spoke, where the pharmacist dispenses the drugs and offers advice to the patient or their representative. The definition of centralised dispensing is more ambiguous, and should perhaps be applied to the concept of prescriptions being assembled and dispensed at a hub and delivered to the patient by post or, potentially in the future, to a collection point such as a secure locker. Interactions take place online or over the telephone. It is this concept that has been referred to, somewhat disparagingly, as the ‘Amazonisation’ of pharmacy.

One of the drivers behind the government backing for hub-and-spoke dispensing is the idea that it will create major efficiencies and savings in community pharmacy. The Pharmaceutical Journal has given its support to the innovation behind hub-and-spoke dispensing in the past (2015;295:420). If a machine can assemble prescriptions more accurately and more quickly than a human then the technology should be exploited for the benefit of patients.

But questions remain and community pharmacists are right to be cautious. There is not enough evidence yet that the envisaged efficiencies will materialise. Hub-and-spoke dispensing will only be used for repeat prescriptions, and assembling these is not necessarily the most time consuming part of a pharmacist’s job. There are other important steps in the dispensing process, such as clinical and accuracy checks, which arguably take more time than picking the product off the shelf.

The process also may not be suitable for cold chain drugs and controlled substances, and automated systems struggle with liquids and with large or heavy items — but these problems should not be insurmountable. On account of the shipping time, turnaround will generally be around 48 hours, at least for now, so it cannot be used for short notice and emergency prescriptions. Pharmacists have also raised concerns about the security of data and medicines between the two sites, the costs of set up, and the validity of automated picking, as well as how hub and spoke can meet the terms of the forthcoming EU Falsified Medicines Directive.

Hub-and-spoke dispensing certainly has potential to improve reproducibility, particularly for repetitive manual processes such as creating MDS trays, and the automated systems have accuracy checks and traceability built in at each step of the process. The early proponents of the concept have also reported that it gives their pharmacists more time to be able to interact with their patients, and set up and support new services.

Automated hubs are still in their infancy and there are not enough data to assess the full impact of the technology. But if the benefits of speed and accuracy can be translated across the sector, opportunities will be created for greater not less interaction between pharmacists and patients.

 

PSNC publishes counter proposal

25 April 2016, PSNC

 

PSNC has today published a summary of the counter proposal it has made to the Department of Health in response to the Government’s proposals for community pharmacy in 2016/17 and beyond.

The counter proposal sets out how community pharmacy services, including an emergency supply of medicines service, could be used to generate the savings the NHS needs to make through pharmacy, without a cut in funding.

PSNC’s proposal includes plans that would enable pharmacies to make savings in the prescribing budget and to save on costs for out of hours GP services. PSNC has also proposed payments that would reward the provision of high quality pharmacy services, in response to the Department’s aim to alter community pharmacy funding distribution mechanisms.

Further details of the counter proposal are copied below.

Background

 

An important part of PSNC’s response to the letter of 17th December 2015 has been a counter proposal setting out how community pharmacy could use its unique skills, accessibility and contact with the public and patients to reduce NHS costs and improve quality.

PSNC’s proposal includes a number of possible community pharmacy services which, if implemented together, could lead to savings worth at least as much as the Government’s proposed £170m cut to community pharmacy funding. In this way community pharmacy could contribute to the efficiencies needed in the health service, as well as reducing the substantial levels of medicines waste, without the need for a blunt funding cut that will damage the services patients need and use.

PSNC’s counter proposal sets out how community pharmacy could generate savings in two areas:

The NHS prescribing budget; and

Costs of out of hours GP services.

Savings to the prescribing budget could be made through a not-dispensed scheme and a therapeutic substitution service, supplemented by generic substitution, a focus on reducing waste in care homes and a campaign and audit on unwanted medicines. Costs of out of hours services could be reduced by an Emergency Supply service. This briefing sets out more information on all of these proposed services.

Alongside these service developments, PSNC has also proposed the introduction of payments linked to quality. This would reward pharmacy contractors that provide a range of services in a high quality manner.

1. Proposals to generate savings in the NHS prescribing budget and to reduce medicines waste

 

Not-dispensed scheme

 

The objective of this scheme would be to reduce NHS expenditure on medicines and appliances through not dispensing prescription items where the pharmacy team determines with the patient that they already have sufficient stock of the medicine or appliance at home.

Following discussions with the patient regarding their repeat medication or appliance, contractors would mark any items not required by the patient at that time as not-dispensed in a way that can be easily identified by the Pricing Authority. For each non-dispensed item, contractors would receive the usual professional fees plus a small additional non-dispensing fee.

Therapeutic substitution service

 

The objective of this service would be to reduce NHS expenditure on medicines by community pharmacists recommending alternative products to prescribers following the dispensing of a product on a target list.

These suggested substitutions would be based on a list of ‘costly’ medicines with suitable alternatives, based on cost and efficacy grounds, to propose to the prescriber. The pharmacist would send GP practices proposals on alternative prescribing options for individual patients. Where the prescriber agreed to amend the patient’s prescription, the pharmacist would then clearly explain the reason for the change to the patient, providing reassurance on the change and advice on the use of the new product. This face to face discussion with patients would help to increase the likelihood of patient acceptance of the amendment and their subsequent adherence to the amended regimen.

The target list would be created nationally but could also be flexible to reflect local priorities.  It is envisaged that it would cover a range of areas for example:

Divested products, where prescribers may not be aware of the significant levels of price inflation that have occurred with individual products;

Therapeutic gains, where more effective treatments are available at equivalent or lower cost; and

Specials, where licensed alternative products may be available.

In the long-term this service could be developed to further support the work of local Medicines Optimisation teams to reduce inappropriate and inefficient prescribing.

Generic substitution service

 

The objective of this service would be to reduce NHS expenditure by allowing community pharmacists to dispense cheaper generic equivalents in the place of prescribed branded products. A list of medicines that could be generically substituted would be agreed at a national level, ensuring inclusion of only those products where it is safe and clinically appropriate to make a substitution.  The pharmacist would discuss the substitution with the patient at the point of dispensing, to ensure that they understand the reasons for the substitution. This conversation is vital to ensure patient acceptance of the substitution and their subsequent adherence to the amended regimen.

Development of the list of medicines would require consultation with interested parties, but it could be based on the list and approach to substitution which was implemented in Ireland in 2013; significant savings have been made since the introduction of the service.

Care homes

 

The objective of this service would be to reduce NHS expenditure on medicines and appliances by community pharmacists identifying excess prescribing and supply of medicines and dressings to care homes.  Pharmacists would need to conduct a regular review of the supplies to care homes and the stock being held at the home in order to identify excess stock. Pharmacists may also facilitate the use of bulk prescriptions for the supply of some commonly used ‘as required’ items and recommendations to prescribe potential alternatives to costlier products.

Unwanted medicines campaign and audit

 

The objective of this proposal would be to reduce NHS expenditure on medicines by raising the awareness of patients and prescribers about waste medicines through a campaign and audit of waste medicines returned to pharmacies. Each year community pharmacies would run a month-long campaign in which they would encourage patients to return any unwanted medicines to them. Pharmacy teams would then audit and report on the waste returned to them and share learnings with local prescribers to help them to minimise future medicines wastage.

2. Proposal to reduce NHS spend on out of hours services

 

Emergency supply of medicines service

 

The objective of this service would be to reduce NHS expenditure on out of hours GP services by allowing community pharmacies to make emergency supplies of medicines to patients at NHS expense. Patients requiring medicines could obtain supplies without the need for an urgent prescription, which during the out of hours period would save them visiting an out of hours GP. The service could also receive referrals of patients from NHS 111.

3. Proposals for payments linked to quality

 

As part of the proposals for community pharmacy in 2016/17 and beyond, the Department of Health set out an intention to alter the distribution of community pharmacy funding, replacing the current complex system of payments with a single activity fee for each prescription item supplied.

PSNC believes this proposal is a retrograde step, as it would incentivise pharmacies to maximise supply of prescriptions over the provision of other services to patients and combined with the cost pressures affecting the sector, even excluding the proposed cuts, this will lead to a reduction in services to patients, with consequential increases in demands on other NHS and care budgets. The DH proposal would also appear to be contrary to their statement that there is a need for a clinically focussed community pharmacy service that is better integrated with primary care.

PSNC wants to develop funding delivery systems that specifically target higher payments to pharmacies providing a range of high quality services. We have made initial proposals to DH setting out how such a quality payment might work. Suggestions of possible eligibility criteria for quality payments currently under consideration include:

  • Having a consultation room that meets MUR/NMS requirements;
  • Provision of Advanced Services (MUR, NMS and flu vaccination);
  • Maintenance of an up to date NHS Choices profile and NHS 111 Directory of Services listing;
  • Having a programme for the provision of public health interventions to meet local population needs
  • Training staff as health champions;
  • Making interventions on prescriptions as part of the therapeutic substitution and not-dispensed services (described above);
  • Participation in available locally commissioned services;
  • Access to the Summary Care Record; and
  • Participation in an annual medicines waste campaign and audit (as described above).
PSNC defends clinical vision in face of reader criticism

C&D, Annabelle Collins and Samuel Horti, 19 February 2016

Community pharmacists have criticized PSNC’s three-phase plan for the sector on the basis that it fails to consider forthcoming funding cuts and ignored pharmacists supply role. PSNC agreed that it would be “unaffordable” for contractors to offer all services to set out in the plan.

 

Further coverage on proposed Government reforms to community pharmacy can be found on C&D here and here.

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

 

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EXPECT MORE FUNDING CUTS, PSNC MEMBER WARNS COMMUNITY PHARMACY

Pharmacy Biz, Neil Trainis, 11 February 2016

There is an increasing concern amongst community pharmacy that budget reductions will go beyond the 6% funding cut the government has announced for 2016-17. Kirit Patel, from Day Lewis and a member of the PSNC negotiating team, stated that he was hopeful that the funding cut proposal would be revisited.

 

PSNC responds to funding cuts with ‘clinical’ vision

Chemist and Druggist, Annabelle Collins, 11 February 2016

In response to the announced 6% funding cut, PSNC has released a plan for community pharmacy which proposes to expand the clinical role of the sector. The proposal, rolled out in three phases, aims to paint a picture of the pharmacy service with 6% less funding.

You can review the full proposal here.

 

Bar codes to be added to medicines packaging

P3 Pharmacy, 11 February 2016

P3 Pharmacy reports on the introduction of safety features to be added on packaging following the publication of the Falsified Medicines Directive delegated regulation on Tuesday. These measures aim to tackle the threat of falsified medicines entering the supply chain.

 

Ministers scramble to introduce new NHS cancer drugs scheme

FT, Andrew Ward, 11 February 2016

The Financial Times discusses the future of the Cancer Drugs Fund as it is set to expire on March 31. The scheme, which aims to ensure access to the latest treatments, has come under scrutiny as the industry warns that the United Kingdom is a hostile environment for medical innovation and the country is lagging behind European counterparts in cancer treatment.

The ABPI has issued a statement calling on the government to seize the opportunity to transform patient access to cancer treatments in the UK.

 

Parliamentary Coverage

Medicines and Healthcare products Regulatory Agency: New rules to help fight falsified medicines

HM Government – Press Releases, 11 February 2016

 

New rules approved by the European Parliament will require safety features on the packaging of medicines at risk of falsification.

The European Parliament and Council has approved and published a Delegated Regulation (EU2016/161)  in the Official Journal of the European Union. This supplements the Falsified Medicines Directive (FMD) and introduces two mandatory safety features that will allow medicines to be verified and authenticated.

These safety features are:

• a unique identifier (a 2D data matrix code and human readable information) to be placed on medical products that can be scanned at fixed points along the supply chain

• tamper evident features on the pack

The delegated regulation comes into force in the UK in 2019. Marketing authorisation holders will be required to place the safety features on the packaging of medicines which fall within the remit of the delegated regulation no later than 9 February 2019.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health will continue to work with the European Commission and other Member States on implementation plans for the new regulation. We will also be working with stakeholders throughout the supply chain to secure implementation within the three years.

Further guidance will be published as it becomes available.

 

Full Coverage

EXPECT MORE FUNDING CUTS, PSNC MEMBER WARNS COMMUNITY PHARMACY

Pharmacy Biz, Neil Trainis, 11 February 2016

 

Kirit Patel, the chief executive of Day Lewis and a member of the PSNC negotiating team, has warned that community pharmacy is likely to suffer further cuts to its revenue on top of the £170 million the government has pledged to take out for 2016-17.

Fears that the government intends to take an even larger slice of money beyond the 6% reduction that has already been earmarked arose after Sue Sharpe, the chief executive of the PSNC, accused NHS England and the Department of Health last month of failing to meet her request for future funding figures for community pharmacy.

That vagueness generated apprehension within the ranks of the PSNC and concern that ministers will take a bigger slice of pharmacy revenue for 2017-18.

Patel reinforced those concerns by suggesting community pharmacists should expect further reductions. The figure he came up with was at least another £80 million taken out of community pharmacy over the next five years.

“The DH announced a 6% reduction in pharmacy remuneration in the year April 2016 to March 2017, the intention being that the whole 6% totalling £170 million would be taken out over six months from the beginning of October 2016,” he told Pharmacy Business.

“The letter (sent by NHS England to the PSNC in December explaining the funding cut) went on to say this was the maximum they would take out in the year, implying there would be more to follow. So let’s examine how much more is likely to be taken out.

“The NHS target of £22 billion in savings announced by Simon Stevens in the NHS forward plan was in a five-year plan and hence it’s safe to say that all the funds they intend to take out from pharmacy would be within five years.

“The clue lies in the rest of the three-page letter. The letter goes on to say that all establishment payments totalling £25,000 per pharmacy is to be phased out. With over 11,500 pharmacies this totals £270 million.

“So there is every likelihood of at least another £80 million being withdrawn from pharmacies over the next five years, bearing in mind £20 million is being put back for integration funds.

“On average that will work out at approximately £15,000 per pharmacy, going up to £25,000. This reduction in establishment payments will affect every single pharmacy in England.”

Patel added: “All the pharmacy bodies and the whole profession have united to fight back and many are confident that some of these proposals may be watered down and some revisited.

“I am hopeful that once the DH realises that pharmacy does far more for patient care than is obvious to the DH, they may not be so keen to throw out the baby with the bath water.”

He refused to say whether the community pharmacy profession should strike in protest at the cut or whether he would encourage Day Lewis pharmacies to strike.

Patel did, however, express his hope that the Pharmacy Integration Fund, set at £20 million for 2016-17 and described by chief pharmaceutical officer Keith Ridge as designed “to help transform how pharmacists, their teams and community pharmacy will operate in the NHS,” will specifically benefit community pharmacy. Sharpe has said the fund will be geared more towards pharmacists working in general practice.

“We should ensure that all this money does not go to GP surgery pharmacists alone and that hopefully a fair amount of it will end up back in community pharmacy,” Patel said.

“At Day Lewis we own 275 pharmacies and our reduction of revenue in the first year alone is £3.4 million, possibly rising to £5 million in the fifth year. I cannot see how we can recover from this loss of income and at the same time be expected to invest for the future.”

 

Bar codes to be added to medicines packaging

P3 Pharmacy, 11 February 2016

 

An implementation plan for the Europe-wide introduction of measures to protect patients from fake or “falsified” medicines has been released by The European Medicines Agency. Safety features to be added to medicines packaging include a 2-D barcode and an anti-tampering device.

Falsified medicines could contain ingredients, including active ingredients, which are of low quality or in the wrong dosage, and could potentially put patients’ health at risk, says the EMA. The measures are being taken to help prevent falsified medicines from entering the legal supply chain and posing a risk to patients and to ensure that any medicines bought online are supplied through verified sources.

The new measures must be introduced for all medicines for human use across Europe by February 2019 – three years time.

It has previously been suggested the pharmacies may be required to scan the 2-D barcode.

Martin Sawer, executive director of the UK’s Healthcare Distribution Association, representing organisations in the medicines supply chain, commented: “It is good news to finally see the publication of the Delegated Regulation that sets the clock ticking in the UK and other EU member states.”

He welcomed the model chosen for the initiative, after long debate in Europe. “Alternatives would have placed unnecessary burdens on the supply chain, including delays in being able to supply life-saving medicines speedily to patients,” he said.

 

Ministers scramble to introduce new NHS cancer drugs scheme

FT, Andrew Ward, 11 February 2016

 

Ministers have less than two months to thrash out a new system for financing cancer drugs in the NHS as the clock ticks towards expiry of a £340m-a-year fund set up by David Cameron to plug gaps in treatment.

A consultation on the future of the Cancer Drugs Fund, launched by the prime minister in 2010, closes at midnight on Thursday, seven weeks before the scheme is due to run out of money.

The government now faces a scramble to introduce a replacement scheme in the face of fierce lobbying from the pharmaceuticals industry, charities and patient groups over how it should work.

Erik Nordkamp, UK managing director for Pfizer, the US drugmaker, told the BBC on Thursday that the system for funding drugs in England was “really broken” and the country was a “hostile environment” for medical innovation.

The Cancer Drugs Fund was intended to ensure access to the latest treatments by paying for cancer medicines deemed too expensive under the usual criteria for assessing cost-effectiveness in the NHS.

However, the fund’s annual budget has soared from £200m to £340m and dozens of drugs have had funding removed in an attempt to control costs.

NHS England announced proposals in November for a system that would provide temporary funding for some new drugs while evidence was collected to decide whether they offered value for money in the long term.

Final details are due before the existing scheme expires on March 31 — although there will be a transition period before full implementation.

Sir Harpal Kumar, chief executive of Cancer Research UK, the charity, said he was hopeful of swifter access to breakthrough treatments. “The Cancer Drugs Fund hasn’t been fit for purpose for some time, so the proposed reforms are a promising step.”

However, the plans would involve tougher scrutiny of new drugs — with funding removed from those that fail to prove their cost-effectiveness during an initial trial period.

Mark Hicken, managing director of Johnson & Johnson’s UK pharma business, said the proposals would raise, rather than lower, barriers to market access. “This will have a significant impact on the availability of many new cancer medicines and we are very worried for patients in England.”

Drugmakers have become increasingly vociferous in their warnings that the NHS is falling behind the rest of Europe in cancer treatment.

Critics blame the industry for excessive pricing with some new cancer drugs costing thousands of pounds a month. The Association of the British Pharmaceuticals Industry said UK prices were among the lowest in Europe.

Under the NHS England proposals, new cancer medicines would be evaluated by the National Institute for Health and Care Excellence, the drug cost watchdog, within 90 days of regulatory approval. Those showing clear cost-effectiveness would be immediately recommended for use, while others would be granted temporary funding while further evidence was collected.

NHS England said: “For those drug companies willing to price their products affordably while sharing transparent information about ‘real world’ patient benefit, the new [fund] will offer a new fast-track route to NHS funding.”

Cancer drugs pose especially difficult economic and ethical dilemmas for the NHS because the most expensive ones are those usually used in the last few months of life — requiring pharma companies to recoup high development costs in relatively short periods of treatment. Some critics have questioned why cancer drugs — and patients — are given special funding unavailable for other conditions.

 

Cancer Drugs Fund consultation – an opportunity to introduce a sustainable, affordable solution that benefits patients and the economy

ABPI, 12 February 2016

 

As the consultation on the way forward for the Cancer Drugs Fund (CDF) closes, the Association of the British Pharmaceutical Industry (ABPI) urges the government to seize the opportunity and transform the way cancer medicines are assessed by the National Institute for Health and Care Excellence (NICE) and commissioned and funded by NHS England. If we do this, we can achieve a sustainable, affordable solution that will provide rapid access to new medicines for NHS patients.

​​​The role of the CDF has been to fund medicines while they are undergoing assessment, that have been rejected, or are not going to be assessed by NICE, in order to ensure that NHS patients have access to them as they do in other EU countries.

Everybody agrees that the current approach to the Cancer Drugs Fund is no longer workable. We need wholesale evolution of the medicines assessment process used by NICE to address this.

 

Dr Paul Catchpole, Director – Value and Access, said,

“We remain committed to working with the Department of Health, NHS England, NICE, charities and patient groups to evolve the way that NICE assesses innovative medicines so that they can be made more rapidly available to NHS patients. Compared to other EU countries, the UK has some of the lowest prices for medicines, and a unique national pricing scheme in place which, since 2014, has seen the pharmaceutical industry pay over £1billion to the NHS to support investment in the latest medicines.

“We want the best for all cancer patients so they can get sustainable and rapid access to new medicines. The aim needs to be to get the right medicines to the right patients at the right time, but significant revisions are needed to the current proposals to permit new medicines to fully deliver their potential in improving NHS cancer outcomes.”

PSNC announcement: government delivers financial blow to community pharmacy

PSNC, 17 December 2015

In a letter signed by the Director General, Innovation, Growth and Technology, Department of Health and the Chief Pharmaceutical Officer, the Government announced a funding cut for community pharmacy up to 6% in cash terms for 2016/17. Sue Sharpe issued a statement in response, deploring this decision which is bound to profoundly damage primary care and urgent care services. A meeting is scheduled in January to agree on a plan to deal with the funding cut.

 

The announcement and Sue Sharpe’s response were reported by Chemist and DruggistThe Pharmaceutical JournalP3 PharmacyDispensing Doctors’ Association and Health Service Journal.

 

Pharmacy Voice’s Chief Executive, Rob Darracott, also responded in an open letter to Alistair Burt acknowledging that the current situation is complex, with many items being discussed and consequences of these discussions yet unknown.

 

Parliamentary Coverage

House of Commons Question, 17 December 2015, NHS: Drugs  

 

Stephen Kinnock, MP:

What assessment his Department has made of the effect on trends in the number of medicines supplied to the NHS of each of the three options set out in its recent consultation, Changes to the Statutory Scheme to Control the Prices of Branded Health Service Medicines, published on 10 September 2015; and if he will make a statement.

 

Department of Health

George Freeman, MP:

Five companies have left the Pharmaceutical Price Regulation Scheme since January 2014 as follows:

– Derma November 2014;

– Genus (Thornton & Ross) November 2014;

– Vifor May 2015;

– Baxter October 2015; and

– Martindale October 2015

The Department estimates the financial effect to be a loss of around £10 million in 2015/16.

The Department’s consultation on options to amend the statutory scheme to control prices of branded health service medicines closed on 4 December 2015. The consultation was accompanied by an Impact Assessment which can be accessed:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/460011/Annex_C_Statutory_Scheme_2014_IA.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/460011/Annex_C_Statutory_Scheme_2014_IA.pdf

The Department’s analysis in the Impact Assessment concludes that the options would reduce National Health Service spending on drugs without affecting the use of those drugs in the NHS. The consultation sought views, comments and evidence on the potential impacts and operation of the options to revise the statutory branded prices scheme. The Department is considering the responses received and will respond to the consultation in early 2016.

 

Full Coverage

PSNC announcement: government delivers financial blow to community pharmacy

PSNC, 17 December 2015

In an open letter to PSNC, revealed at a meeting hosted by pharmacy minister Alistair Burt today (17th December), the government has announced that funding for community pharmacy in 2016/17 will be cut by £170m. The cut, from £2.8bn to £2.63bn, is a reduction of more than 6% in cash terms.

The letter is signed by the Director General, Innovation, Growth and Technology, Department of Health and the Chief Pharmaceutical Officer.

The decision to publish the letter is unprecedented, and in stark contrast to the secrecy that the NHS has always insisted on for negotiations in the past.

Read the Department of Health/ NHS England letter.

Sue Sharpe Statement

At a time when primary care and urgent care services are struggling to manage demand, this is a profoundly damaging move. It will deliver a destructive blow to the support community pharmacies can offer to patients and the public. Community pharmacies provide vital healthcare and advice which reduces the burden on GPs and urgent care services and helps the NHS to cope with winter pressures.

The letter speaks of the potential for far greater use of community pharmacy and pharmacists in prevention of ill health, support for healthy living and minor ailments, but almost inevitably the impact of the cuts will force pharmacies to reduce staffing levels and direct more people to GP or urgent care. We remain staggered at the decision by the NHS to abandon negotiations on a national minor ailments service over the summer, a move entirely inconsistent with exploiting the potential identified in the letter.

Pharmacy owners, whose funding has been under pressure and who have been absorbing efficiencies over the last few years, will be incredulous that the Government:

“Believes those efficiencies can be made within community pharmacy without compromising the quality of services or patient access to them.”

There are many excellent business owners in the pharmacy sector, who are incentivised to run their businesses as efficiently and effectively as possible, meeting the needs of their patients and providing support to them, whilst delivering massive savings to the NHS by reducing drug costs.  They will be sceptical about the expertise within the Government that underpins its assertion.

For some months PSNC has been awaiting news from the NHS and we had expected that it would not be positive. In a speech at the Royal Pharmaceutical Society Annual Conference in September the Chief Pharmaceutical Officer set out his view that large centralised dispensing facilities could be used to dispense up to two thirds of dispensing volume.

The letter includes a jumble of proposed measures, including centralised dispensing and online services. Reflecting the view of the Chief Pharmaceutical Officer that there are too many pharmacies, the letter says:

“In some parts of the country there are more pharmacies than are necessary to maintain good access.”

The threat to the network is clear but the letter is very short on detail on how the NHS will manage this “clustering” of pharmacies.

The only context in which patient choice is mentioned is to give patients the option of online services. The letter states that the Department will consult on the introduction of a scheme to provide additional funds to ensure that “those community pharmacies upon which people depend continue to thrive”. Following the shambles of the ESPLPS this promise will give little comfort to pharmacy contractors.

PSNC will meet in early January to agree how to deal with this.

 

Community pharmacy faces £170m cut to contractual funding

The Pharmaceutical Journal, 17 December 2015

Community pharmacy contractual funding in England in 2016–2017 is set to be cut by £170m as part of wider efficiency savings in the NHS.

The Department of Health (DH) announced on 17 December 2015 that funding for the community pharmacy contractual framework in 2016–2017 will be no higher than £2.63bn — 6.1% lower than the £2.8bn for this financial year. The reductions are expected to take effect from October 2016.

Details were revealed in a letter to Pharmaceutical Services Negotiating Committee (PSNC) chief executive Sue Sharpe. The DH will consult with the PSNC and other bodies over the next three months.

The government also plans to launch a new Pharmacy Integration Fund “to help transform how pharmacists and community pharmacy will operate in the NHS”, building on clinically focused pharmacy initiatives such as the pilot of pharmacists working in GP surgeries.

In the letter, chief pharmaceutical officer Keith Ridge and Will Cavendish, director general of innovation, growth and technology at the DH, say community pharmacy “has to play its part in delivering the efficiencies” set out in the government’s spending review and the NHS ‘Five year forward view’.

In addition, the government will consult on changes to how community pharmacies operate, with the aim of driving efficiencies and expanding clinical roles for pharmacists.

The letter said that in some parts of England there were “more pharmacies than are necessary to maintain good access”, identifying the 40% of pharmacies in a cluster of three or more within ten minutes’ walk.

As well as the previously announced consultation on widening use of centralised dispensing — known as ‘hub and spoke’ — the DH will consult on new models of ordering and collecting prescription medicines, including online ordering and home delivery.

The government will also consult on a new pharmacy access scheme that would increase funding to pharmacies in some rural or deprived areas.

 

Financial blow dealt to community pharmacy says PSNC

P3 Pharmacy, Sam Healey, 17 December 2015

Community pharmacy has been dealt a “financial blow” says the PSNC. A letter from chief pharmaceutical officer Keith Ridge to PSNC and the director general, innovation, growth and technology, Department of Health detailed cuts to pharmacy funding of 6% for 2016/2017, to £2.63 billion.

“In the Spending Review the Government re-affirmed the need for the NHS to deliver £22 billion in efficiency savings by 2020/21. Community pharmacy is a core part of NHS primary care and has an important contribution to make as the NHS rises to all of these challenges,” says the open letter.

“As well as providing more effective patient and public friendly services, community pharmacy also has to play its part in delivering the efficiencies required by the Government’s recently published Spending Review and to support the need for greater efficiency and productivity as outlined in the Five Year Forward View. “This will involve reductions in NHS funding for community pharmacies in England.

For 2015/16, the funding commitment for pharmacies in England is £2.8 billion under the community pharmacy contractual framework (essential and advanced services). In 2016/17 this funding will be no higher than £2.63 billion. We anticipate that the funding reductions will take effect from October 2016, giving community pharmacies time to prepare for this change.

“These consultation processes are an important opportunity to help further develop the proposals and inform the decisions taken by Department of Health Ministers, which will shape community pharmacy’s role in the NHS in future. We look forward to working together to transform community pharmacy for 2016/17 and beyond, to the benefit of patients and the public.”

Response from Sue Sharpe, PSNC

As part of her response Sue Sharpe said: “At a time when primary care and urgent care services are struggling to manage demand, this is a profoundly damaging move. It will deliver a destructive blow to the support community pharmacies can offer to patients and the public. Community pharmacies provide vital healthcare and advice which reduces the burden on GPs and urgent care services and helps the NHS to cope with winter pressures.

Pharmacy owners, whose funding has been under pressure and who have been absorbing efficiencies over the last few years, will be incredulous that the Government: “Believes those efficiencies can be made within community pharmacy without compromising the quality of services or patient access to them.”

“The letter speaks of the potential for far greater use of community pharmacy and pharmacists in prevention of ill health, support for healthy living and minor ailments, but almost inevitably the impact of the cuts will force pharmacies to reduce staffing levels and direct more people to GP or urgent care. We remain staggered at the decision by the NHS to abandon negotiations on a national minor ailments service over the summer, a move entirely inconsistent with exploiting the potential identified in the letter.

“The letter includes a jumble of proposed measures, including centralised dispensing and online services. Reflecting the view of the Chief Pharmaceutical Officer that there are too many pharmacies, the letter says: “In some parts of the country there are more pharmacies than are necessary to maintain good access.”

“The threat to the network is clear but the letter is very short on detail on how the NHS will manage this “clustering” of pharmacies.”

PSNC will meet in early January to agree how to deal with the issue, says Mrs Sharpe.

 

DDA to scruitinse effect of pharmacy funding cuts

Dispensing Doctors’ Association, Ailsa Colquhoun, 18 December 2015

The DDA is already in contact with the Department of Health over the surprise announcement yesterday that pharmacy funding will be cut by 6% from 2016-17.

The letter, which is signed by the director general, Innovation, Growth and Technology, Department of Health and the chief pharmaceutical officer, also signals a clear intention to reduce the number of community pharmacies.

It says: “In some parts of the country there are more pharmacies than are necessary to maintain good access. 40% of pharmacies are in a cluster where there are three or more pharmacies within ten minutes’ walk. ” PSNC has described the threat to the network as “clear”.

The announcement, made late yesterday afternoon, imposes a cut of £170 million in the funding for community pharmacy in England in 2016-17. This reduces the global sum from £2.8bn to £2.63bn – a cut of more than 6% in cash terms.

Dispensing practices are not specifically mentioned in the letter, but the fear is that funding for medicines supply (reimbursement) in England and Wales will also be affected by the move – as pharmacies and dispensing practices share the same Drug Tariff.

Commenting, DDA chairman Dr Richard West said: “Any changes to dispensing doctors’ contracts must be subject to formal consultation and negotiation between NHS England, the DDA and the BMA.   To date, we have not been made aware that there is any intention to change the contract for dispensing doctors.

“Please be assured that we are already in touch with the Department of Health and NHS England about the implications of this letter for dispensing practices.  As soon as we have more information, we will share it with the membership.”

To assure patient access to pharmacies, the letter points to additional funding for “those community pharmacies upon which people depend”. Stated replacements for the bricks and mortar pharmacy network include developing online services including ‘click and collect’ models, and hub and spoke dispensing.

PSNC has described the shock news as “unprecedented, and in stark contrast to the secrecy that the NHS has always insisted on for negotiations in the past”. CEO Sue Sharpe said: “At a time when primary care and urgent care services are struggling to manage demand, this is a profoundly damaging move. The impact of the cuts will force pharmacies to reduce staffing levels and direct more people to GP or urgent care.

“[The Government] believes efficiencies can be made within community pharmacy without compromising the quality of services or patient access to them. [Pharmacists] will be sceptical about the expertise within the Government that underpins its assertion.”

 

Pharmacy Voice responds to Government’s ‘Putting community pharmacy at the heart of the NHS’ letter

Pharmacy Voice, Rob Darracott, 17 December 2015

Rob Darracott, chief executive of Pharmacy Voice, has responded to an open letter from Government, revealed today at a meeting with pharmacy minister Alistair Burt:

“Announcing a 6% funding cut to community pharmacy from next October over six months is certain to hurt the sector. Many contractors, currently in the midst of the Christmas rush, will be rightly anxious as to how this £170m cut will affect their patients, their businesses, their livelihoods and those of their pharmacy teams and other employees.

“It is a complex picture and there are many items being discussed from hub and spoke dispensing, the role for clinical pharmacy to pharmacy numbers. At this stage we do not have the detail of how these elements can affect the bottom line. What we do know is that the expertise and knowledge of how to achieve change is within the sector, rather than in Whitehall. Community pharmacy has already delivered 4% efficiency savings to the NHS which is proof that we already play a highly efficient part in NHS service delivery.

“We will be working with our member organisations to agree how we best deal with these very challenging decisions. As recognised in the letter, we think it is a constructive step that, for the first time, Pharmacy Voice and other organisations will have the opportunity to engage in this process as statutory consultees. We will work with colleagues across the community pharmacy sector to ensure that the value of the network is retained and that negative, unintended consequences are avoided.”

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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