HDA UK Media And Political Bulletin – 10 March 2017

Media Summary

PSNC: ‘Incomprehensible’ that budget bypasses pharmacy
Chemist and Druggist, Thomas Cox, 10 March 2017

The Pharmaceutical Services Negotiating Committee (PSNC) chief executive, Sue Sharpe, said it is “incomprehensible” that the NHS is directing more energy into GPs in hospitals than pharmacy. In the Spring Budget, Philip Hammond said that £100 million will be invested into A&E departments over the next year. With the NHS heavily strained, the PSNC highlighted that “With the right enablers, [pharmacies] could take on the 1.1m visits to emergency departments for patients with minor ailments without delay”.

‘People have swallowed the hub-and-spoke marketing brochure’
Chemist and Druggist, Anas Hassan, 10 March 2017

A National Pharmacy Association (NPA) board member has responded to claims that hub-and-spoke dispensing could work for independents. Mr Hewitson was responding to the positive messages on hub-and-spoke dispensing that came out of the Numark conference earlier this week. Rather than outright rebuttal, Mr Hewitson issued a note of caution that the technology is not yet available to support the dispensing model.

Parliamentary Coverage

House of Commons, Written Answers, Thursday 9 March 2017

Barry Sheerman, MP:

To ask the Secretary of State for Health, which specialised medicines, procedures and medical technologies are undergoing evaluation by NHS England Specialised Services for potential commissioning in 2017-18 and 2018-19.

Department of Health
David Mowat, MP:

NHS England is preparing this data set, which is currently in draft form. It will be published shortly.

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House of Commons, Written Answers, Thursday 9 March 2017

Barry Sheerman, MP: If he will publish details of the process by which NICE plans to create commissioning support documents on rare disease medicines for NHS England in 2017.

Department of Health
Nicola Blackwood, MP:

The National Institute for Health and Care Excellence (NICE) has advised that it has been commissioned by NHS England to support the development of clinical commissioning policies for licensed (or soon-to-be licensed) technologies that are directly commissioned by NHS England. NICE is working with NHS England to agree how this will be achieved and will publish full detail in due course.

Media Summary

Safer medical devices: Council adopts new EU rules

European Council, 7 March 2017

The Council has adopted new EU rules to improve the safety of medical devices. The rules encompass certain products which do not have a specifically medical purpose, such as coloured contact lenses. Accessibility and timeliness are key to these rules, as are follow-up guidelines to improve the availability of clinical data on devices. The European Parliament is expected to adopt the two regulations in April, when they will be published in the Official Journal.

Contractors, stop ‘covering your ears’ on hub-and-spoke

Chemist and Druggist, Annabelle Collins, 7 March 2017

At Numark’s conference in Cape Town, Steve Anderson said that contractors can either position themselves against hub-and-spoke, or they can see it as a way to benefit their business. Highlighting how different the current wholesale model is from previous years, Anderson said that wholesalers need to keep up with digital developments. He also stressed that in order to achieve profitable growth, a different type of collaboration is needed across the sector.

Web GPs shut down in CQC swoop

Dispensing Doctor, 8 March 2017

Two online GP and pharmacy providers have shut down following CQC urgent inspections.

The providers are MD Direct and HR Healthcare Ltd. Following an internal review of all 43 online services that are registered, CQC has brought forward a programme of inspections prioritising those it considers as presenting a significant risk to patients.

Parliamentary Coverage

House of Commons, Written Answers, Department of Health

Tuesday 7 March 2017

Kevin Hollinrake (MP):

What steps his Department is taking to regulate the online sale of (a) antibiotics and (b) other medicine.

Nicola Blackwood (MP):

In the United Kingdom, there are legal controls on the retail sale, supply and advertising of medicines which are set out in the Human Medicines Regulations 2012. These apply without distinction to medicines advertised, sold or supplied through the internet.

This means that Prescription Only (POM) and Pharmacy medicines (P) can only be sold or supplied at registered pharmacy premises by, or under the supervision of, a pharmacist. Furthermore, POMs can only be sold or supplied in accordance with a prescription from a doctor, dentist or relevant healthcare professional. POMs cannot be advertised to the general public.

The vast majority of antibiotics are only available as POM for supply only under the supervision of a suitably qualified healthcare professional.

Websites offering to supply POMs without a relevant prescription are in breach of UK legal requirements and the Medicines and Healthcare Products Regulatory Agency will investigate and take appropriate action including criminal investigation and prosecution.

Full Coverage

Safer medical devices: Council adopts new EU rules

European Council, 7 March 2017

On 7 March 2017, the Council adopted new EU rules improving the safety of medical devices for the benefit of patients while preserving a timely access to innovative healthcare solutions.

Medical devices and in vitro diagnostic medical devices help diagnose, prevent and treat or alleviate diseases. They cover a wide range of products, from sticking plasters to hip replacements and hearing aids, and from pregnancy tests to HIV tests.

The new rules keep pace with recent technical developments. Their scope has been extended to cover certain products which do not have a specifically medical purpose, such as coloured contact lenses. The experience of metal-on-metal artificial hips and faulty silicone breast implants also has been taken into account in the preparation of the new rules, in particular by requiring the systematic scrutiny of vital implants by medical experts.

“Medical devices play a crucial role in all our lives. We all regularly use sticking plasters or have dental fillings, and we know people who are still alive thanks to devices that have helped in the diagnosis and treatment of serious diseases. These new rules will do more to help save lives, by having more innovative and safer devices on the market” – Mr Christopher Fearne, Minister for Health of Malta and President of the Council.

The two new EU regulations:

  • provide a stronger mandate to independent notified bodies in their assessment of medical devices before they can be placed on the market, and strengthen the oversight of these bodies by national authorities; the new rules also ensure that notified bodies meet the same high safety standards throughout the EU; these measures will improve the safety of medical devices
  • improve the availability of clinical data on devices and clearly set out manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; this will allow manufacturers to react quickly in the event of concerns being raised and help them improve their devices continuously on the basis of actual data
  • improve the traceability of medical devices throughout the supply chain to the end-user or patient by using a unique identification number; this will allow fast and effective measures to be taken in the event of safety problems
  • set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; this will enable them to make better informed decisions

Next steps

The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.

Web GPs shut down in CQC swoop

Dispensing Doctor, 8 March 2017

Web GPs shut down in CQC swoop.

CQC slams providers where patients self-medicate.

Two online GP and pharmacy providers have shut down following CQC urgent inspections.

The providers are MD Direct (which had traded through the website assetchemist.co.uk and HR Healthcare Ltd (through the website treated.com).

CQC’s inspection of HR Healthcare Ltd was influenced by an investigation by Dr Faye Kirkland for BBC Radio 5 Live Investigates in October 2016, which looked at the online sale of antibiotics from this provider.

Immediately after the inspections, CQC suspended the registration of HR Healthcare Ltd. MD Direct responded to CQC’s concerns by voluntarily cancelling its registration. Both providers have stopped providing services to patients in England (assetchemist.co.uk now uses an alternative online GP provider for its prescription service).

Inspectors found that the two providers demonstrated significant clinical safety and organisational risk to patients, with widespread failings to provide safe care. Among the concerns which were identified:

No (or minimal) identity checks for patients.

No way of identifying whether or not patients lacked capacity to consent or understand their prescribed treatment or medical advice, or if there were any safeguarding concerns (and if they were identified, minimal structures in place to handle them).

No systems or processes to contact the patient’s regular GP, including when medication was prescribed that required monitoring or follow-up

Prescribing practice that did not take account of the patient’s clinical condition or consider differential diagnoses.

Inadequate medical history-taking to inform appropriate prescribing.

No assurances that clinicians had relevant skills or qualifications for the role they were performing.

Following an internal review of all 43 online services that are registered, CQC has brought forward a programme of inspections prioritising those services it considers as potentially presenting a significant risk to patients.

CQC chief inspector of GPs, professor Steve Field said: “We have found websites which in effect allow people to select their own medication, including medicines restricted as prescription only, with little or limited clinical oversight.”

Duncan Rudkin, chief executive of the General Pharmaceutical Council, said: “Where necessary, we are carrying out further inspections of the pharmacies linked to the online primary care services being inspected by the CQC, to assess whether they are meeting our standards and appropriately addressing the issues and risks linked with online prescribing and dispensing.”

Media Summary

Budget 2017: What to look out for in health and care

HSJ, Lawrence Dunhill, Shaun Lintern, 6 March 2017

With the unveiling of the Spring Budget on Wednesday, Philip Hammond has warned that there will be no “spending sprees”. Social care services are expected to receive additional funding; in the spending review in 2015, the government said an extra £1.5bn would be added to the better care fund by 2019-20, with around half of the increase coming in 2018-19. One option could be to bring these increases forward, coming into effect from 2017-18. Significant capital will be needed to fund the 44 STPs. The government may look to cushion the impact of rising business rates for hospitals and trusts, especially as many trusts are now claiming they are eligible for an 80 per cent discount on business rates because they should be classified as charities.

How hub-and-spoke dispensing could work for independents

Chemist and Druggist, Anabelle Collins, 6 March 2017

Numark’s managing director, Mr D’Arcy, spoke to C+D at the Numark conference in Cape Town yesterday on the subject of hub-and-spoke dispensing. He explained that while there is not a “legally workable solution” for independents just yet, an amended hub-and-spoke model could allow pharmacists to provide more “professional services”.

Parliamentary Coverage

There is no Parliamentary Coverage.

Full Coverage

Budget 2017: What to look out for in health and care

HSJ, Lawrence Dunhill, Shaun Lintern, 6 March 2017

Chancellor Philip Hammond has warned there will be no “spending sprees” in Wednesday’s budget, but there are several areas in which the government may look to support the NHS.

It will be a surprise if social care services do not receive some additional funding, following months of “crisis” headlines and calls for extra revenue.

In the spending review in 2015, the government said an extra £1.5bn would be added to the better care fund by 2019-20, with around half of the increase coming in 2018-19.

So one option would be to bring these increases forward, to come into effect from 2017-18.

Meanwhile, the use of any additional funds for social care is expected to be overseen by the Care Quality Commission, under measures intended to assure the Treasury that the money will deliver measurable improvements.

Significant capital resources will be needed to fund the 44 sustainability and transformation plans, and an announcement of extra investment would present a major opportunity to dispel the “cuts” narrative that has dominated the process.

However, Simon Stevens has warned not to expect additional capital funding in this budget, suggesting the autumn budget was a more likely juncture.

What we might see instead is what Jim Mackey has described as an “NHS bond”, which would be a new mechanism for allowing providers that want to sell assets to realise some of the capital before the sale goes through.

Proposals from Sir Robert Naylor’s review into the NHS’s estates strategy, which is due to be published soon, could also feature.

NHS trusts are due to be hit by increased business rates from April, following a revaluation process that has proved hugely controversial.

Law firm Gerald Eve has estimated that business rates for hospitals will rise from £328m this year to £418min 2021, with some trusts seeing their rates double.

With the rates increases for many small businesses proving hugely controversial, the government may look to cushion the impact.

Dozens of trusts are also claiming they are eligible for an 80 per cent discount on business rates because they should be classified as charities.

The trusts are seeking a tax rebate relating to the previous six years, which could result in a £1.5bn bill for local authorities. Could Mr Hammond seek to end this dispute?

The government could hand the NHS up to £1bn to cover increased costs from clinical negligence compensation.

Justice secretary Liz Truss has announced plans to end the discount rate used for compensation payments, which means the NHS will face higher payments at the outset of a case being concluded.

The government has said it will compensate the NHS for the increase but will the money go direct to NHS trusts to cover high NHS Litigation Authority premiums or will it go direct to the authority?

Public sector pensions continue to be a significant cost to the Treasury. Particularly as the NHS scheme is an “unfunded” scheme – in other words, paid for out of general tax revenue each year.

NHS employers have been made to increase their contributions to 14.3 per cent and this follows the controversial reforms to the pension scheme in 2012, which transferred staff to career average pensions and increased contributions.

Tax relief is a key area where there could be changes. The government has previously reduced the total lifetime allowance before tax relief ends to £1m, which has hit many NHS staff and added to the early retirement problems among some key groups such as senior leaders, consultant and senior nurses.

A further cut to the allowance could be bad news for staff and for those responsible for workforce planning.

In his autumn statement, Mr Hammond made clear the era of off-payroll senior staff working in the NHS was coming to an end, and new rules are due to be enforced by NHS Improvement along with its crackdown on medical locum costs.

However, costs have not fallen as fast as hoped. Jeremy Hunt has been clear that he wants to see senior pay reduced. Could the chancellor use his budget to reveal tougher measures?

In 2015, George Osborne delivered bad news for NHS staff, making clear that public sector pay restraint would last for at least another four years.

NHS staff on Agenda for Change and medical staff have seen their pay fall substantially in real terms under the coalition and Conservative governments and there are growing calls for Theresa May to lessen the pain.

Changes in pay could help the NHS to tackle workforce shortages, though it’s widely expected Me Hammond will disappoint those calling for an end to pay restraint.

It’s worth noting that the Five Year Forward View made the point that pay restraint needed to come to an end. Nuances within this issue include how the expected 1 per cent pay rise could be used.

The government has previously said it would allow the cash to be pooled and concentrated on staff groups particularly under pressure. This could include junior doctors and nurses, but the chances of this happening look slim. Also watch out for any hint of new contract reform for Agenda for Change staff and consultants.

All-Party Pharmacy Group calls for action on drug shortages

10 June 2016, The Pharmaceutical Journal

 

The Pharmaceutical Journal also reports on Sir Kevin Barron, chair of the APPG, calling for the Government to do more to tackle the issue of drug shortages in the UK. The group calls for the Department of Health, the MHRA and NHS England to establish a monitoring system to help reduce the impact of shortages on patients.

 

Shock news: The government may actually ‘consult’ the sector

10 June 2016, Chemist and Druggist, James Waldron

 

Chemist and Druggist comments on the Government’s decision to delay hub and spoke dispensing plans, to take more time to explore the responses to its consultation in more detail. It points out that the sector has often cited this change as a possible way to “level the playing field”, but has expressed concerns that automated dispensing would come to the expense of patient interactions. Ultimately, this delay demonstrates the necessity for the Department of Health to consult with the sector before implementing change.

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

All-Party Pharmacy Group calls for action on drug shortages

10 June 2016, The Pharmaceutical Journal

 

The All-Party Pharmacy Group (APPG) has repeated its call for more to be done to tackle medicines shortages, after over half of community pharmacists responding to a survey said they dealt with drug shortages on a daily basis.

 

In a letter to Alistair Burt, the minister for community and social care, the group calls for the Department of Health, NHS England and the Medicines and Healthcare products Regulatory Agency to establish an early warning system to monitor and detect drug shortages, to help reduce the impact of shortages on patients.

 

Sir Kevin Barron, APPG chair, says the amount of time healthcare professionals are having to spend on dealing with medicines shortages is “damaging”

 

“It’s clear that at a time when the NHS needs to be making the very best use of its valuable resources in order to maximise efficiency and productivity, the time healthcare professionals are having to spend on dealing with shortages is damaging,” says Sir Kevin Barron, chair of the APPG.

 

In the survey, 48% of community pharmacists said they spent 21–50 hours a month dealing with medicines shortages while 16% said they spent 51–75 hours; 5% were spending over 100 hours a month on medicines shortages.

 

Additionally, 48% of community pharmacists reported that patients had needed additional medical treatment, time off work or been caused emotional distress in the prior six months as a result of medicines being unavailable. And GPs reported the same outcome in 36% of cases where medicines were unavailable.

 

“We appreciate that the reasons behind shortages are complex and some are not always preventable, but this survey shows that those on the front line believe – like us – that a system which highlights early warning would help to limit the damage the current situation is causing,” adds Barron.

 

The survey was carried out in collaboration with North of England Commissioning Support between October 2015 and January 2016. There were 206 respondents, including GPs, practice managers, community pharmacists, primary care pharmacists, hospital doctors and hospital pharmacists.

Government puts brakes on hub-and-spoke plans

7 June 2016, Chemist and Druggist, Annabelle Collins

 

Responding to a Parliamentary Question, Pharmacy Minister Alistair Burt announced that the Department of Health will delay its plans to allow independent pharmacists to legally operate automated dispensing hubs as a result of the consultation responses. Mr. Burt added that the proposals would be explored “in more details” with stakeholders.

 

Government postpones ‘hub and spoke’ plans

7 June 2016, PSNC

 

PSNC welcomed Alistair Burt’s statement that the Department of Health’s hub and spoke plans will be delayed. The Association further expressed its delight that the Government has acknowledged the issues and shortcomings of the proposals. PSNC Chief Executive Sue Sharpe commented explaining that the effect of the proposed legislation had not been made clear to the public.

 

The story was also reported by P3 Pharmacy and the NPA.

Parliamentary Coverage

House of Commons Questions, Pharmacy, 7 June 2016

 

Question

Stephen Pound, MP (Ealing North): To ask the Secretary of State for Health, if he will re-open the consultation on pharmacy dispensing models and displaying prices on medicines that closed on 17 May 2016 in order to allow respondents to take into account revised information on the safety profile of hub and spoke dispensing models.

 

Answer: Department of Health

Alistair Burt, MP: The consultation on changes to medicines legislation including on ‘hub and spoke’ dispensing did not rely on any specific safety profile of hub and spoke dispensing. Instead, the consultation document specifically asked consultees to provide evidence on the issue. Nevertheless, the responses to the consultation have raised issues around removing the bar on ‘hub and spoke’ dispensing between retail pharmacies that are not part of the same business that the Department would like to explore in more detail with stakeholders’ representatives before progressing any legislation. It does not now envisage changes to the legislation on this issue commencing on 1 October 2016.

 

Full Coverage

Government postpones ‘hub and spoke’ plans

7 June 2016, PSNC

 

Today (7th June) the Government has announced that it will further engage with PSNC and other stakeholders before making changes to medicines legislation on ‘hub and spoke’ dispensing.

 

Responding to a Parliamentary Question, minister Alistair Burt said the Department of Health would like to “explore in more detail with stakeholders’ representatives before progressing any legislation”. He said the Department did not now envisage changes to the legislation commencing on October 1st.

 

Mr Burt said the responses to the consultation had “raised issues” around removing the bar on ‘hub and spoke’ dispensing between retail pharmacies that are not part of the same business.

PSNC responded forcibly to the consultation, pointing out the many fundamental flaws in the proposals and consultation process; crucially, that the narrative of the consultation did not match the proposals in the draft legislation. We are delighted that the Government has acknowledged some of the issues and hope that in these further discussions it will recognise all of the shortcomings in its proposals.

 

PSNC Chief Executive Sue Sharpe said:

 

“The proposals in the ‘hub and spoke’ consultation have been ill thought out and the effect of the proposed legislation has not been made clear to pharmacy or the public.

 

We have seen a similar approach throughout the wider proposals laid out in the Government’s 17th December letter on ‘Community Pharmacy in 2016/17 and beyond’, but as yet there has been no indication from the Department of Health that it will be prepared to grapple with the real issues or acknowledge the failings of that wider consultation process.”

 

Government delays plans on hub and spoke

7 June 2016, P3 Pharmacy

 

Government proposals to change legislation on hub and spoke dispensing has been put on hold, allowing time for more discussion on the matter.

 

In answer to a written parliamentary question from Stephen Pound MP, the Pharmacy Minister, Alastair Burt, said that legislation on this issue will no longer commence on 1 October 2016. Instead, the Department of Health will enter into detailed talks with pharmacy representatives before progressing any legislation.

 

The National Pharmacy Association called the announcement “a victory for common sense” and said that “the news today shows the power of unity within the sector”.

 

The statement from Pharmacy Minister Alistair Burt said: “The consultation on changes to medicines legislation including on ‘hub and spoke’ dispensing did not rely on any specific safety profile of hub and spoke dispensing. Instead, the consultation document specifically asked consultees to provide evidence on the issue. Nevertheless, the responses to the consultation have raised issues around removing the bar on ‘hub and spoke’ dispensing between retail pharmacies that are not part of the same business that the Department would like to explore in more detail with stakeholders’ representatives before progressing any legislation. It does not now envisage changes to the legislation on this issue commencing on 1 October 2016.”

NPA Chairman Ian Strachan said that there was cause for celebration. “In no way is this the end of the matter. Nevertheless, I think we can allow ourselves to celebrate today.”

 

NPA welcomes Government re-think on hub and spoke

7 June 2016, NPA

 

The NPA has wholeheartedly welcomed the Government’s re-think on hub and spoke dispensing, which was announced in Parliament today (Tuesday 7 June).

 

In answer to a written parliamentary question from Stephen Pound MP, the Pharmacy Minister Alastair Burt stated that legislation on this issue will no longer commence on 1 October 2016.  Instead, the Department of Health will enter into detailed talks with pharmacy representatives before progressing any legislation.

 

Responding to the news, NPA Chairman Ian Strachan said today:

 

“The Department of Health has listened to the growing chorus of concern in and around the pharmacy sector on this issue.  The NPA has been at the forefront of the independent sector’s response and our detailed work on the issue has been key to achieving a unified position across the sector.

 

“So we are naturally delighted that the Department is going back to the drawing board, which has been our request from the outset.

 

“It’s to the credit of Ministers and officials that they have shifted the position in response to overwhelming evidence and reasoned arguments. We now hope that they will show the same degree of mature reflection in relation to other elements of their proposals.  The entire policy package foisted on the sector in December should now be sense checked in the light of this development.  At the very least, it surely calls into question the timing of the proposed funding cuts, which the DH has suggested could be absorbed because of the supposed cost savings from hub and spoke.

 

“Throughout, we have worked closely with our Pharmacy Voice and PSNC colleagues and pharmacy bodies elsewhere in the UK.  The news today shows the power of unity within the sector.

 

“We now look forward to being part of the detailed discussions, bringing the widespread and genuine concerns of the independent sector to the table.

 

“In no way is this the end of the matter.  Nevertheless, I think we can allow ourselves to celebrate today.  It is a vindication of our approach and a victory for common sense”.

 

The full statement from Alastair Burt reads:

 

“The consultation on changes to medicines legislation including on ‘hub and spoke’ dispensing did not rely on any specific safety profile of hub and spoke dispensing. Instead, the consultation document specifically asked consultees to provide evidence on the issue. Nevertheless, the responses to the consultation have raised issues around removing the bar on ‘hub and spoke’ dispensing between retail pharmacies that are not part of the same business that the Department would like to explore in more detail with stakeholders’ representatives before progressing any legislation. It does not now envisage changes to the legislation on this issue commencing on 1 October 2016.”

CHOOSE BREXIT AND MEDICINES SHORTAGES WILL BE ‘MUCH MORE ACUTE’ IN UK

26 May 2016, Pharmacy Biz, Neil Trainis

 

Pharmacy Biz reports that Martin Sawer, Executive Director of the HDA, said Brexit could result in exacerbated medicine shortages as well as extra costs of regulations that could be added over time to the NHS bill. He also predicted that negotiations to leave the EU could take a significant number of years, during which time members of the Association could face uncertainty on the supply front. Martin Sawer concluded the resilience and economic scale wholesalers and distributors benefit from being in the EU could be affected if the UK votes to leave.

 

Hub and spoke dispensing plans condemned for lack of evidence

26 May 2016, The Pharmaceutical Journal, Debbie Andalo

 

Pharmacy organisations have condemned Government plans to expand hub and spoke dispensing because of a lack of evidence that it will bring the benefits the minister expects. Pharmacy Voice shared its “significant concerns” about the proposal with chief executive Rob Darracott stating: ““It is a flawed assumption that hub and spoke dispensing must be more efficient, cost saving or safer and we do not recognise the validity of the assumptions which are proposed to form the basis of the impact assessment.” Similar concerns are shared by other pharmacy bodies including Numark, The Royal Pharmaceutical Society and The National Pharmacy Association.

 

Pharmacy minister, Alistair Burt, has backtracked on his prediction that up to 3,000 pharmacies could close as a result of the planned funding cuts. The full story was reported by C&D and Pharmacy Biz.

 

Dypiridamole 200mg/5ml oral suspension deleted from Part VIIIB of June Drug Tariff

26 May 2016, PSNC

 

Effective from 1st June 2016, Dypiridamole 200mg/5ml oral suspension has been deleted from Part VIIIB of the Drug Tariff. This is because a licenced alternative, Dypiridamole 200mg/5ml oral suspension sugar free, is now available and has been added to Part VIIIA of in June’s tariff.

 

Changes to the Drug Tariff impact on reimbursement so it’s important to take note when amendments are made to product listings.

 

Pharmacy staff are advised to take care in ensuring that any prescriptions dispensed in May are submitted for payment no later than the 5th June 2016 as per the rule for ‘Claims for Payment’ under Clause 5 of the tariff. Please note that if prescriptions were inadvertently submitted with your June bundle you would be reimbursed as per the June listing in Part VIIIA.

 

A full list of products and new reimbursement prices for Part VIIIB lines can be found on the NHSBSA website.

 

2016/17 Flu Plan published

26 May 2016, PSNC

 

Details have today been published outlining the influenza vaccination programme for winter 2016/17. The plan – published by the Department of Health, NHS England and Public Health England –  sets out a coordinated and evidence-based approach to planning for, and responding to, the demands of influenza across England.

 

The only change this year is the addition of the offer of the flu vaccination to children of school year 3. Also, as in previous years, there is an expectation for all frontline health workers to be offered flu vaccination by their employer.

 

A supporting letter for healthcare professionals, issued in conjunction with the Flu Plan, has also been published.

 

Flu plan: winter 2016 to 2017 (including the annual flu letter)

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

CHOOSE BREXIT AND MEDICINES SHORTAGES WILL BE ‘MUCH MORE ACUTE’ IN UK

26 May 2016, Pharmacy Biz, Neil Trainis

 

Martin Sawer, the executive director at the Healthcare Distribution Association, has warned that medicines shortages will become “much more acute” in the UK if it votes to leave the European Union.

 

As a June 23 referendum on the issue looms both remain and Brexit camps continue to boisterously make their cases.

 

The pharmacy industry is concerned that leaving the EU will inflate the manufacturing costs of generic medicines and deter pharmaceutical companies from investing in research and development in the UK.

 

Sawer (pictured) said opting for Brexit would hinder the supply of medicines into the UK and exacerbate the drugs shortages community pharmacists in the UK have contended with for several years.

 

“Supply shortage issues could become much more acute if the UK was to leave the EU, because the UK is, and always has been, a net parallel importer of medicines from the EU, providing medicines at short notice and at a reduced cost,” he told Pharmacy Business.

 

“The UK imports more medicines than any other EU country except for Germany. If we look across the pond at the United States, where parallel trade is not allowed, we can see shortages and sudden price hikes proliferating at times.

 

“We might expect the negotiations for Britain to leave the EU to take a significant number of years, during which time our Association member companies could face uncertainty on the supply front.

 

“Moreover, as the pharmaceutical supply chain is increasingly global, the less the number of differentiating markets, the better for patients. Many of our members source vital medicines from the EU for UK patients and it is made much easier by only having to comply with one over-arching set of European laws on Good Distribution Practice (GDP).

 

“Imagine the extra costs of regulation that could be added over time to the NHS drugs bill if there were different regulations in the UK, as compared with the EU in 10 or 20 years’ time. Regulators wherever they are, will want to add regulations over time, and if we leave the EU, the UK could expect to steadily get out of step.”

 

When asked what other impact Brexit might have on the UK pharmaceutical industry, Sawer said: “Our wholesalers and distributors benefit from being part of the EU to ensure a resilient UK supply chain, with direct access and leverage in the global market in generics.

 

“This resilience and economic scale could be affected in the medium to long term if the UK votes to leave. The NHS and UK patients could, in turn, be affected.”

 

Hub and spoke dispensing plans condemned for lack of evidence

26 May 2016, The Pharmaceutical Journal, Debbie Andalo

 

Government plans to expand hub and spoke dispensing across community pharmacies in the UK have been condemned by pharmacy organisations because of a lack of evidence that it will bring the benefits ministers expect.

 

Under current legislation, only pharmacies that are part of the same business can operate hub and spoke dispensing systems. But ministers believe that changing the law to allow pharmacies that do not have existing commercial ties to operate hub and spoke systems will create a level playing field and offer the profession more choice.

 

Pharmacy Voice, an association of community pharmacy trade bodies, says it has “significant concerns” about the proposal, which was out for consultation until 17 May 2016, and calls on the Department of Heath to produce the evidence to support the initiative.

 

Its chief executive, Rob Darracott, says: “It is a flawed assumption that hub and spoke dispensing must be more efficient, cost saving or safer and we do not recognise the validity of the assumptions which are proposed to form the basis of the impact assessment. Currently there are no hub and spoke dispensing models operating across different legal entities and therefore no data that could be used to extrapolate from. If the department has such data or hypotheses we call on them to publish it without delay.”

 

Numark, a buying group for independent pharmacies, echoes this view, saying that government assumptions that hub and spoke systems have the potential to save money and increase efficiency “is a significant over statement given the limited amount we know about [their] use in practice”.

 

The Royal Pharmaceutical Society (RPS) shares similar concerns: “Most of the evidence around this type of operation is from the United States but the health system they operate under is completely different and the efficiency savings are in what the patient pays for and are not real efficiencies within the overall system,” it says in its response.

 

“We are not aware of any other evidence available in the world for the type of hub and spoke model proposed in this consultation (inter-organisational) and we have concerns in relation to the hub and spoke model and the impact on patient safety.”

 

The RPS is also worried about the clinical governance process: “Clarity is required on several issues and to ensure patient safety,” it adds.

 

The National Pharmacy Association, a member organisation for independent community pharmacies, warns that the expansion of hub and spoke dispensing in England could have an impact on NHS funding and health strategies across the UK if the hub and spoke crossed borders.

 

“In Scotland and Northern Ireland there are particularly remote areas, such as the Highlands and the Islands, which can be particularly affected by extreme weather conditions. There appears to be a lack of appreciation of how delivery of medication from a hub that is situated in another part of the country, or indeed another country, such as England, will impact on patient care. For example, turnaround times for prescriptions may be excessive,” the NPA says.

 

Government proposals to display the price of medicines on packaging in England, which form part of the same consultation, have also failed to win the support from the sector.

 

The RPS opposes the move, arguing that the job of a medicine label is to provide information to the patient about the medicine. “We agree with the intent to make sure people take their medicines as prescribed and reduce medicines waste, however, this area is complex; people don’t take their medicines for many different reasons,” its response says. “Having the cost on labels could potentially have several different outcomes.”

 

Before any changes are made, the Society says the government should gather evidence to support its assumptions that displaying prices would help reduce medicines waste and encourage patients to take their medicines as prescribed.

 

Pharmacy Voice believes the move could compromise patient safety and discourage patients from taking their medicines properly.

 

“We do not believe there is substantiated evidence from the UK that it will improve quality or efficiency, or indeed have the effect the Secretary of State wants, which is to remind people that NHS services, including items which may be free at the point of use, are funded by taxpayers,” Darracott says.

 

The consultation ran from 22 March 2016 until 17 May 2016 and will require changes to be made to the Human Medicines Regulations 2012 and the Medicines Act 1968, which apply across the UK. However, it would be up to the UK’s devolved countries to decide whether to implement the changes the new legislation would allow.

PSNC responds to “Community pharmacy in 2016/17 and beyond” letter

24 May 2016, PSNC

 

PSNC responded yesterday to the UK Government’s letter from 17th December 2015 on Community pharmacy in 2016/17 and beyond. In this response, the pharmacy body argues that the proposals outlined in the letter are a major threat to the future availability of accessible healthcare, support and advice from community pharmacies. It is also concerned that there has been a lack of analysis of the consequences and costs of these policies for the public.  In its response, PSNC acknowledges that:

  • A reduced network of pharmacies would increase the difficulty of managing emergency supplies of medicines
  • There should be a careful assessment of the potential of the Hub and Spoke model to weaken the controls in place today to protect the supply chain of medicines from threats such as counterfeits

 

The full response is available here.

 

PSNC to launch second prescription analysis tool

24 May 2016, P3 Pharmacy

 

P3 Pharmacy reports that PSNC has launched a complimentary tool which allows pharmacies to interpret their Px prescription item report in a user-friendly way. This tool aims to help contractors understand their dispensing patterns in detail and has the potential to help highlight discrepancies. In addition, there is potential to help pharmacies with stock management and identifying generics dispensed as brands.

 

The launch of the new tool was also reported by Pharmacy Biz.

 

Brexit would delay patients’ access to drugs, regulators warn

24 May 2016, pharmaphorum, Richard Staines

 

According to GSK’s president of R&D, Patrick Vallance, splitting the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) from the European regulator, EMA, if Britain were to leave the EU, would mean delays getting drugs to market. The EMA, currently located in London, would have to move and the MHRA would have to grow in order to take on regulatory work currently performed by the EMA.

 

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PSNC responds to “Community pharmacy in 2016/17 and beyond” letter

24 May 2016, PSNC

 

PSNC has today published its response to the Government’s letter from 17th December 2015 entitled “Community pharmacy in 2016/17 and beyond”.

 

Within the response, PSNC makes clear that the proposals contained in the letter represent a major threat to the future availability of accessible healthcare, support and advice from community pharmacies. We are concerned that this threat has not been made clear to the public nor to their representatives, and that the policies underpinning the letter have not been based on analysis of the likely consequences or costs to the public as patients, members of our communities, or taxpayers.

 

The response also highlights that whilst PSNC is willing and keen to work collaboratively to achieve change, proper, informed negotiations between the Government and PSNC have been made impossible by the lack of clarity, detail or analysis of the issues raised by the letter.

 

PSNC’s response sets out the following key principles:

  • The interests of patients and patient care must underpin proposals;
  • Policies must be well-informed, using NHS resources effectively;
  • The ability of community pharmacy to offer much more to our communities has been largely neglected by policy makers. To meet the future health of our communities this must be properly addressed with urgency;
  • Remote supply and the benefits of automation are untested;
  • The interests of patient care must influence decisions about future pharmacy numbers and locations;
  • The NHS can make savings and improve patient care by developing patient services from pharmacies; and
  • The government must be honest, open and fair in implementing a major change of policy on community pharmacy.

 

PSNC to launch second prescription analysis tool

24 May 2016, P3 Pharmacy

 

PSNC has developed a new system, CheckRx, which allows pharmacies to interpret their Px prescription item report in a user-friendly way. While the report from the NHS Business Services Authority includes detailed information about the dispensed items that a contractor has been paid for, it has over 70 columns and a volume of data is difficult to manipulate, said pharmacist Patrick Grice, who helped develop the programme for PSNC.

 

CheckRx is a complementary tool to Check34, the programme launched last year that allows contractors to monitor monthly prescription payments from the monthly FP34.

 

CheckRx “turns the data into something more manageable,” said PSNC. Using the tool can help contractors understand their dispensing patterns in detail and has the potential to help highlight discrepancies, incorrect endorsement for example, by comparing with the FP34.

 

Users can recreate the FP34 through PRISM, view the top 20 products, focus on EPS scripts, Category M payments, expensive items, select particular categories or products and compare item numbers with local competitors.

 

“If you dispense a high proportion of Category M products, you may want to focus on how you buy these products,” suggested Mr Grice. The analysis can help pharmacies identify generics dispensed as brands, he said. It can also help with stock management.

 

The CheckRx programme, which has the same login for registered contractors as Check 34, will be offered for a separate fee of £144 per year when it goes live in June. The National Pharmacy Association says it is in discussions with PSNC about making CheckRx available to independents.

 

The system gives independent pharmacies “the same data processing capability as large head offices,” suggested Mr Grice. With Category M clawback underway, this is an additional tool to help communities pharmacies manage any financial fluctuations.

 

Brexit would delay patients’ access to drugs, regulators warn

24 May 2016, pharmaphorum, Richard Staines

 

Regulators and pharma have warned again that a “Brexit” would have dire consequences for the industry, delaying drug approvals in the UK and starving its regulator of cash.

 

The senior figures made their comments shortly before a poll by ORB showed the Remain campaign has a 13-point lead over the Leave campaign.

 

According to press reports, GlaxoSmithKline’s president of pharma R&D, Patrick Vallance, said splitting the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) from the European regulator would mean delays getting drugs to market.

 

The MHRA, which officially does not have a viewpoint on Brexit, has a close relationship with the European Medicines Agency and both regulators are based in London.

 

Vallance noted at a press conference in London that the Swiss regulator takes 157 days longer on average to approve drugs and Canada 140 days longer.

 

Sir Mike Rawlins, chairman of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) said at the conference he was “hoping and praying” that Britain would remain in the EU.

 

According to the Guardian, Rawlins said: “There is no question about it, if we were to leave the European Union, the EMA would go.”

 

He added that the MHRA would have to grow in order to take on regulatory work currently performed by the EMA. “Not only that, but I don’t know how it would be paid for,” he added.

 

MHRA board member Vincent Lawton told pharmaphorum earlier this month that the regulator would lose £12-15 million in annual funding from Europe in the event of a Brexit.

 

Rawlins added Brexit would mean Britain would be unable to access rapid alerts warning of dangers in drugs and healthcare devices.

 

The Daily Telegraph reported that Professor Bruce Campbell, non-executive director at the MHRA, said there are around “half a million” medical devices that will need to be regulated.

 

At the moment this work is covered by the EMA’s system of licensing and surveillance.

He said the UK would have difficulty dealing with the “sheer number” of such devices.

 

Campbell said: “If things went well we could continue to collaborate with other agencies but I think doing everything to do with medical devices alone would be very difficult.”

Drug wholesalers vent concerns about government’s hub and spoke plans

23 May 2016, The Pharmaceutical Journal

 

The Pharmaceutical Journal reports on the HDA’s response to the UK Government’s Human Medicines Regulations 2012 consultation. It details the Association’s concerns that drug distribution could be opened to new providers not required to match the standards mandated by the MHRA. The HDA also calls for the UK Government to further investigate issues raised by hub and spoke including the impact of the implementation of the EU Falsified Medicines Directive.

 

PSNC responds to ‘Hub and Spoke’ consultation

23 May 2016, PSNC

 

Yesterday, the pharmacy body published its response to the UK Government’s Human Medicines Regulations 2012 consultation, otherwise known as the ‘Hub and Spoke’ consultation. Amongst the issues raised in response to the consultation, PSNC argues that ‘hub and spoke’ dispensing may not be able to comply with the Falsified Medicines Directive.

 

The full response is available here.

 

GIVE US EVIDENCE TO BACK UP HUB AND SPOKE, GOVERNMENT TOLD

23 May 2016, Pharmacy Biz, Neil Trainis

 

PSNC has called for the UK Government to make publically available evidence backing up the claims that a hub and spoke dispensing model would generate significant efficiencies.  Rob Darracott, chief executive of Pharmacy Voice, stated:  “Pharmacy Voice believes it is a flawed assumption that hub and spoke dispensing must be more efficient, cost-saving or safer and we do not recognise the validity of the assumptions which are proposed to form the basis of the impact assessment.”

 

The campaign against the community pharmacy funding cuts announced by the UK Government was further covered by The PharmacistPharmacy Biz and the NPA.

 

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Drug wholesalers vent concerns about government’s hub and spoke plans

23 May 2016, The Pharmaceutical Journal

 

A trade body representing drug wholesalers who distribute more than 92% of NHS medicines has warned that the full implications of hub and spoke technology have yet to be determined and its widescale implementation risks reducing the quality and safety of dispensing.

 

Responding to the UK government’s Human Medicines Regulations 2012 consultation, the Healthcare Distribution Association (HDA UK) – the former British Association of Pharmaceutical Wholesalers, which was rebranded in February 2016 – has agreed that independent pharmacies should be allowed the same access to hub and spoke technology as vertically integrated pharmacy chains.

 

Currently, section 10 of the Medicines Act 1968 only allows hub and spoke dispensing if the ‘hub’ and the ‘spoke’ pharmacy are both part of the same retail pharmacy business.

 

However, HDA UK warns that removing this legislative impediment could open drug distribution to new providers which may not be required to match the same standards mandated by the UK regulator, the Medicines and healthcare Regulatory Agency (MHRA).

 

It urges that the MHRA should be made responsible for inspecting hubs and ‘hub to spoke’ transportation to ensure they comply with European Union regulations for good distribution practice and that pharmacy regulations should be reviewed to take into account new requirements for storage and transportation prompted by hub and spoke systems.

 

HDA UK emphasises the need to discern between hub and spoke and centralised dispensing. It is crucial to maintain the patient-pharmacist relationship, it says, adding it does not support centralised dispensing, which sees prescriptions sent directly to patients. “It is a model that has been shown to be challenging and a substantial risk to patients receiving their medicines safely and in a timely manner.”

 

It admits that hub and spoke technology has the potential to free up spoke pharmacists’ time to deliver further patient-centric services, but says estimates that 45% of medicines will be dispensed through hub and spoke were on the “high side”.

 

HDA UK has also asked the UK government to look into additional issues raised by hub and spoke, including the impact on the implementation of the EU Falsified Medicines Directive, the need for contingency planning as a result of stock being centralised in large hubs, and any potential issues arising from any existing supply arrangements between drug manufacturers and wholesalers.

 

PSNC responds to ‘Hub and Spoke’ consultation

23 May 2016, PSNC

 

PSNC has today published its response to the consultation on ‘hub and spoke’ dispensing.

 

This follows discussion between PSNC and the Department of Health to clarify various concerns that PSNC had with the draft regulations.

 

The Department of Health has confirmed that the draft regulations, if implemented, would permit hub and spoke dispensing between “relevant clinical entities” which it is proposed would include hospitals and surgeries (premises at or from which primary medical services are provided as part of the health service), potentially bypassing registered pharmacy premises. There would still be pharmacist supervision of dispensing, but it is not clear if there would be pharmacist supervision of assembly or supply of the dispensed medicine at non-pharmacy relevant clinical settings.

 

While changes to the Medicines Act 1968 or Human Medicines Regulations 2012 do not change NHS provisions (and doctors have always been able to supply medicines to their patients), these changes, if implemented, would provide an entirely new legislative framework for the retail supply of medicines on which there has been no consultation.

 

Other issues PSNC raised in response to the consultation include:

  • the impossibility of creating a level playing field when independents must use and share patient lists with third party hubs;
  • the proposed unrestricted wholesale dealing between relevant clinical settings is arguably contrary to European legislation;
  • professional and legal issues and a change in legislative emphasis from pharmacies to pharmacists have not been considered and could lead to patient safety issues;
  • redesign of section 10 of the Medicines Act is unnecessary as a result of the Abcur judgment;
  • ‘hub and spoke’ dispensing may not be able to comply with the Falsified Medicines Directive;
  • that the alleged safety arguments are not evidenced and sharing the dispensing process between two legal entities could lead to quite the opposite effect; and
  • that the alleged economic efficacy arguments are not evidenced and arguably ‘hub and spoke’ dispensing could cost more overall.

 

GIVE US EVIDENCE TO BACK UP HUB AND SPOKE, GOVERNMENT TOLD

23 May 2016, Pharmacy Biz, Neil Trainis

 

Pharmacy Voice has urged the government to make public any evidence it has backing up its claims that a hub and spoke dispensing model in community pharmacy will generate significant efficiencies.

 

An extended consultation on ministers’ pharmacy efficiency plans concludes tomorrow but has done very little to placate the pharmacy profession which continues to battle huge funding cuts and other contentious measures including a hub and spoke dispensing model.

 

That model has been pushed forward enthusiastically by senior figures, notably the chief pharmaceutical officer Dr Keith Ridge, much to pharmacy’s chagrin since serious doubts persist over the benefits such a system would actually bring to patient care.

 

The pharmacy profession is infuriated by what it regards as a poorly conducted consultation on measures it regards as hugely counter-productive to the pharmacy profession and patient care.

 

There has been particular concern that the government has failed to reinforce its support for hub and spoke with concrete evidence.

 

“The proposed changes to enable hub and spoke dispensing were first announced against a backdrop of uncompromising and arbitrary funding cuts being imposed on the community pharmacy sector,” said Rob Darracott, chief executive of Pharmacy Voice.

 

“This subsequent consultation does not shed any further light on what basis the Department of Health believes the proposed changes to the (Human Medicines Regulations) HMR 2012 will make the dispensing process more efficient or how it will lower operating costs.

 

“Importantly, there is still no consistency in the terminology being used to describe what the government is trying to achieve, and there is no indication of how the consequent complex legal and professional issues will be resolved.

 

“The opportunity for constructive, informed policy engagement has been constrained by the rushed and poorly timed consultation.”

 

Darracott added: “Pharmacy Voice believes it is a flawed assumption that hub and spoke dispensing must be more efficient, cost-saving or safer and we do not recognise the validity of the assumptions which are proposed to form the basis of the impact assessment.

 

“Currently there are no ‘hub and spoke’ dispensing models operating across different legal entities and therefore no data that could be used to extrapolate from. If the Department (of Health) has such data or hypotheses we call on them to publish it without delay.”

HDA raises ‘fundamental’ concerns about hub and spoke with government

19 May 2016, Pharmacy Business, Neil Trainis

 

Pharmacy Biz reports on the HDA’s concerns about the government’s proposals for hub and spoke dispensing. The article explains the problems that the HDA has with hub and spoke dispensing and concludes by stating that “It is a model that has been shown to be challenging and a substantial risk to patients receiving their medicines safely and in a timely manner”.

 

Determining the social value of community pharmacy – we need your help!

19 May 2016, PSNC

 

PwC is conducting an independent assessment of the social value of community pharmacy to provide a robust evidence base to use in the ongoing community pharmacy campaign. PSNC is encouraging community pharmacy teams to take part in the research to ensure an accurate picture of pharmacy services is given.

 

P3 Pharmacy also reports on PwC’s assessment of the social value of community pharmacy.

 

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HDA UK raises fundamental concerns on Government Hub and Spoke Proposals

19 May 2016, HDA

 

  • Hub and spoke technology is at a very early stage and its impact is unclear
  • Crucial to make distinction between hub and spoke and centralised dispensing
  • The MHRA should be responsible for regulating hub-to-spoke transportation

 

London: 19th May 2016: The Healthcare Distribution Association (HDA UK) has responded to the Government’s Human Medicines Regulations 2012 Consultation by agreeing that the hub and spoke playing field should be levelled to allow independent pharmacies access to the same technology as vertically integrated chains.

 

However, it has raised fundamental concerns regarding the Government’s proposals which do not recognise that hub and spoke technology is at a very early stage and the consequences of its introduction are not fully understood. Therefore, estimates that 45% of medicines will be dispensed through hub and spoke appear on the high side.

 

The HDA also has concerns that removing the current legislative impediment could open medicines distribution to new providers who might not be required to match the same high quality and safety standards, mandated by the MHRA, and provided by HDA member companies through their commitment to the MHRA-endorsed HDA Gold Standard of Good Distribution Practice. Although these new providers would be subject to GPhC pharmacy regulations, the distribution standards are not compatible with those currently in place for wholesale distribution. The HDA therefore argues that:

 

  • The MHRA should be responsible for inspecting hubs and hub-to-spoke transportation to ensure they comply with wholesaling levels of European Union regulations for Good Distribution Practice (GDP).
  • Pharmacy regulations for the appropriate storage and transportation of medicines should be reviewed to take into account the changes in pharmacy storage and transportation models prompted by hub and spoke.

 

It is also imperative that the distinction is made between hub and spoke and centralised dispensing. The HDA feels it is crucial that the patient-pharmacist relationship is maintained and therefore does not support centralised dispensing which sees prescriptions sent directly to patients. It is a model that has been shown to be challenging and a substantial risk to patients receiving their medicines safely and in a timely manner. However, hub and spoke technology does have the potential of freeing-up the time of ‘spoke’ pharmacists to deliver further patient-centric services.

 

Finally, the HDA has asked the Government to look into additional issues raised by the consultation, namely:

 

  • The impact from hub and spoke on the implementation of the EU Falsified Medicines Directive (FMD)
  • The need for contingency planning as a result of stock being centralised in large hubs
  • The potential disruption to the certainty of supply of medicines, which could be  caused through the challenging of any existing supply arrangements between pharmaceutical manufacturers and wholesalers

 

 

HDA raises ‘fundamental’ concerns about hub and spoke with government

19 May 2016, Pharmacy Business, Neil Trainis

 

The Healthcare Distribution Association has contacted the government to raise “fundamental” concerns about ministers’ plans to introduce a hub and spoke dispensing system across independent pharmacy.

 

In response to a government consultation the HDA said it had numerous problems with the proposals which Dr Keith Ridge, the chief pharmaceutical officer, has been particularly keen to see rolled out across community pharmacy.

 

One of those problems was the government’s failure to understand that hub and spoke technology is “at a very early stage and the consequences of its introduction are not fully understood.”

 

“Estimates that 45% of medicines will be dispensed through hub and spoke appear on the high side,” the HDA cautioned.

 

The organisation also has concerns over proposed changes to the law which would allow all community pharmacies to use hub and spoke dispensing even if they are not part of the same legal entity as the hub. That, the HDA said, might open the floodgates and allow new providers to operate unchecked.

 

“The HDA also has concerns that removing the current legislative impediment could open medicines distribution to new providers who might not be required to match the same high quality and safety standards, mandated by the MHRA, and provided by HDA member companies through their commitment to the MHRA-endorsed HDA Gold Standard of Good Distribution Practice,” it said.

 

“Although these new providers would be subject to GPhC pharmacy regulations, the distribution standards are not compatible with those currently in place for wholesale distribution.

 

“The HDA therefore argues that the MHRA should be responsible for inspecting hubs and hub-to-spoke transportation to ensure they comply with wholesaling levels of European Union regulations for Good Distribution Practice.

 

“(And) pharmacy regulations for the appropriate storage and transportation of medicines should be reviewed to take into account the changes in pharmacy storage and transportation models prompted by hub and spoke.”

 

The HDA said it did not support centralised dispensing because of the damage the system would do to the pharmacist’s relationship with the patient.

 

“It is also imperative that the distinction is made between hub and spoke and centralised dispensing. The HDA feels it is crucial that the patient-pharmacist relationship is maintained and therefore does not support centralised dispensing which sees prescriptions sent directly to patients,” it said.

 

“It is a model that has been shown to be challenging and a substantial risk to patients receiving their medicines safely and in a timely manner. However, hub and spoke technology does have the potential of freeing up the time of ‘spoke’ pharmacists to deliver further patient-centric services.”

 

The HDA also urged the government to examine hub and spoke in light of the Falsified Medicines Directive. David Reissner, a partner at Charles Russell Speechlys, told the law practice’s conference last month that hub and spoke’s impact on the Directive “doesn’t look like it’s been thought through by the Department of Health.”

 

The HDA added there was a “need for contingency planning as a result of stock being centralised in large hubs” and consideration given to “the potential disruption to the certainty of supply of medicines, which could be caused through the challenging of any existing supply arrangements between pharmaceutical manufacturers and wholesalers.”

 

Determining the social value of community pharmacy – we need your help!

19 May 2016, PSNC

 

PricewaterhouseCoopers (PwC) is conducting an independent assessment of the social value of community pharmacy for PSNC and we are calling on community pharmacy teams to get involved to make sure this work provides an accurate picture of the services that pharmacy teams provide up and down the country.

 

The work being undertaken by PwC will help the ongoing community pharmacy campaign by providing a robust evidence base to use in discussions with stakeholders and in future negotiations. We therefore strongly encourage all pharmacy teams to get involved in this work to help highlight the social value that your pharmacy brings to your community.

 

Pharmacy teams in England can get involved by assisting with two easy to complete activities:

 

Activity 1: Survey on additional activities relating to dispensing prescriptions

Participation in a short survey on the number of additional activities that your pharmacy team has provided in relation to dispensing prescriptions, for example, delivery of medicines and provision of monitored dosage systems. A survey form is available to collate this information, and your answers can then be submitted to PSNC and PwC via an online form on the PSNC website. Please submit your response to the survey by 5th June 2016.

 

Activity 2: Data collection on ‘advice on self-care or OTC medicines’

Completion of a simple data collection form over a seven-day period (from Wednesday 1st June to Tuesday 7th June) to record how many times advice on self-care or on the use of over-the-counter medicines has been provided. Once this data has been collected, we are asking that it is submitted to PSNC and PwC via an online form on the PSNC website

 

 

PSNC to assess the social value of community pharmacy

19 May 2016, P3 Pharmacy

 

PSNC is calling on pharmacy teams to take part in new research into the social value of the community pharmacy sector.

 

The independent assessment will be carried out by professional services network, PricewaterhouseCoopers (PwC), on behalf of PSNC, and aims to draw an accurate picture of the services pharmacy teams provide up and down the country.

 

It is hoped that the work will provide a robust evidence base to use in discussions with stakeholders and in future negotiations.

 

Pharmacy teams in England can get involved in two ways:

Firstly, they can participate in a short survey on the number of additional activities they provide in relation to dispensing prescriptions, such as medicines delivery or the provision of medicines dosage systems.

 

The second activity is a data collection on ‘advice on self care or OTC medicines’ over a seven-day period (from Wednesday 1st June to Tuesday 7th June). This research aims to record the number of times pharmacies provide advice on self care or on the use of OTC medicines.

Dispensing errors and automated dispensing research

12 May 2016, PSNC

 

PSNC has published a paper examining the research around dispensing errors and automated dispensing in pharmacy. The paper found that the research used to inform the government proposals was conducted prior to the introduction of the Electronic Prescription Service (EPS). As the majority of the labelling errors identified in the research will now be prevented by the EPS, PSNC concludes that automated dispensing systems are unlikely to further reduce the error rates.

 

Questions raised over DH hub and spoke proposals

12 May 2016, P3 Pharmacy

 

P3 Pharmacy also reports on the validity of the data used to inform the government’s proposals for hub-and-spoke dispensing. NPA public affairs manager, Gareth Jones, stated that the data presented by the Department of Health was misleading and flawed, and stressed there must be a fair representation of error rates.

 

EU exit will jeopardise drug research and development, warns ABPI

12 May 2016, Pharmacy Biz, Neil Trainis

 

The ABPI has warned that drug research and development in the UK may be compromised if the country leaves the UK due to a lack of EU funding and a breakdown in international collaboration. The ABPI has also warned that licensing difficulties will jeopardise rapid access to new medicines.

 

ABPI welcomes Office for Life Sciences publication of Early Access to medicines Scheme report

12 May 2016, ABPI

 

The ABPI has welcomed the publication of ‘Early access to medicines scheme: (EAMS) how the scheme works’. The publication provides further detail about how EAMS fits into healthcare, and will assist stakeholders in navigating through the EAMS process.

 

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House of Commons, Written Answers, Drugs: Wholesale Trade, 12 May 2016

 

Asked by Charlotte Leslie (MP): If he will take steps to increase competition in the pharmaceutical wholesale market.

 

Department of Health

 

Answered by George Freeman (MP): The United Kingdom has an active and diverse licensed wholesale dealing market for medicinal products for human use which is regulated by the Medicines and Healthcare products Regulatory Agency. It is up to individual companies to submit such licence applications.

If there is concern with anti-competiveness, this should be referred to the Competition and Markets Authority.

 

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Dispensing errors and automated dispensing research

12 May 2016, PSNC

 

PSNC has today published a paper examining the research around dispensing errors and automated dispensing in pharmacy.

 

The paper highlights statistics produced from the research and comments on their validity in assessing the impact of automation on reducing dispensing errors.

 

Dispensing errors and automated dispensing in community pharmacy

 

PSNC wrote this paper in response to comments made by the Chief Pharmaceutical Officer, Dr Keith Ridge, during an evidence session of the All-Party Pharmacy Group (APPG) held on 16th March 2016. The APPG reported that Dr Ridge noted dispensing errors in community pharmacy occur in around 3% of all items dispensed, whilst large-scale automated dispensing would reduce the error rate to 0.00001%.

 

PSNC welcomes a recent clarification of these comments from Dr Ridge in which further detail is given about where he acquired his figures and he acknowledges that it was not appropriate to draw a direct comparison between the two.

 

 

Questions raised over DH hub and spoke proposals

12 May 2016, P3 Pharmacy

 

Questions have been raised over data on dispensing errors used by the Department of Health as the basis for an argument for the wider use of hub and spoke dispensing.

 

England’s chief pharmaceutical officer Dr Keith Ridge has offered a “clarification on comments he made during the meeting on dispensing error rates in community pharmacy vs. automated systems”, says the All Party Pharmacy Group, referring to a statement from Dr Ridge posted on their website.

 

In the response to questions raised at a recent APPG meeting, Dr Ridge says in the clarification that revisiting evidence presented for dispensing error rates in pharmacy, including a study from Sweden where hub and spoke is used, has made him ask “further questions”. “Now that I know the error rate from Sweden is determined by reporting, it is not appropriate draw a direct comparison… I apologise for inadvertently misleading the committee and for any subsequent confusion,” he said. “However, I do remain of the view that automated centralised dispensing, underpinned by a robust quality assurance and regulatory system, resilient and implemented carefully, will improve safety and quality of patient care.”

 

The DH proposals are “unravelling” says the National Pharmacy Association. Commenting on the development, Gareth Jones, public affairs manager at the NPA, said that the original data presented was misleading and “flawed”, with further investigation now urgently needed. “We understand that the chief pharmaceutical officer has accepted that he misled the All-Party Pharmacy Group in relation to safety data for hub and spoke models. The Department of Health’s hub and spoke proposal is flawed – and this is just one of many claims that are unravelling. But he still needs to go further in order to ensure that the APPG and anyone planning to respond to the consultation has a fair representation of the error rate literature.”

 

A consultation on the potential for the wider adoption of the hub and spoke model is due to close on 17 May.

 

 

EU exit will jeopardise drug research and development, warns ABPI

12 May 2016, Pharmacy Biz, Neil Trainis

 

The Association of the British Pharmaceutical Industry has warned that drug research and development in the UK and rapid access to new medicines will be jeopardised if the country votes to leave the European Union.

 

There is growing momentum behind a stay-in-the-EU campaign within pharmacy, marked recently by an article distributed by Sigma Pharmaceuticals and written by Pharmacy Voice chair Claire Ward and Sigma director Bhavin Shah warning of the dangers posed to community pharmacy and patient health if the UK votes to leave on June 23.

 

Mike Thompson, the chief executive of the ABPI, waded into the debate, arguing that an exit would result in the UK losing EU funding which in turn could hamper the development of critical medicines.

 

“Our members are overwhelmingly supportive of remaining in the EU. We believe that staying in the EU will mean that patients in the UK will be more likely to get faster access to new medicines than if we left,” he said.

 

“With the European Medicines Agency, pharmaceutical companies have a one-stop shop for centralised licensing of new medicines and treatments across Europe. If we left the EU this would mean that the licensing of new medicines would have to be handled by a UK agency as well as a European agency.

 

“Our members have confirmed that the applications for UK licence would come after the European licence due to the smaller patient population in the UK.

 

“The UK also currently holds an enviable position as one of the premier European destinations for ground-breaking research and clinical trials. An EU exit risks the breakdown of international collaboration between scientists, doctors and industry which could slow down access to new drugs for patients in the UK.

 

“As a nation we benefit hugely from EU funding for research and development, more than any other EU country, and this has helped drive medicines research across a whole range of diseases, including cancer, dementia and diabetes.

 

“An EU exit would create a funding gap which would need to be filled if the UK is to continue punching above its weight globally in research and development of new treatments.”

 

Thompson added: “We believe that staying in the EU will also encourage global pharmaceutical companies to continue to invest, employ, research, manufacture and export in the UK, rather than elsewhere.”

 

 

ABPI welcomes Office for Life Sciences publication of Early Access to medicines Scheme report

12 May 2016, ABPI

 

The Association of the British Pharmaceutical Industry (ABPI) welcomes the publication of ‘Early access to medicines scheme : how the scheme works’ on the Office for Life Sciences webpages.

 

​​The Association of the British Pharmaceutical Industry (ABPI) welcomes the publication of ‘Early access to medicines scheme : how the scheme works’ on the Office for Life Sciences webpages.

 

Commenting on the release of the Dr Paul Catchpole, Value & Access Director, said, “ABPI welcomes the publication by the Office for Life Sciences of operational guidance and principles to support the Early Access to Medicines Scheme (EAMS).   Providing further detail and signposting about how EAMS fits across the entire patient access pathway spanning the Medicines and Healthcare Products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence( NICE) and NHS England will help stakeholders navigate through the EAMS process and helps further clarify the benefits of participating in EAMS.

 

“We look forward to further dialogue around EAMS when the Accelerated Access Review is published, including the review team’s consideration of the PwC independent EAMS review already published as part of this work”

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