HDA Media And Political Bulletin – 10 February 2016

New safety features to protect EU citizens from falsified medicines

The Pharma Letter, 9 February 2016


The Falsified Medicines Directive delegated regulation published yesterday by the European Commission will help tackle the health threats of falsified medicines. Adrian van den Hoven, director general of the European Generic and Biosimilar medicines Association (EGA) welcomed the delegated regulation.


Delegated act: clock starts ticking for safety feature compliance

Securing Industry, Phil Taylor, 9 February 2016


Pharmaceutical companies have three years, starting from the date of publication, to implement the safety features which will allow to guarantee the authenticity of medicines in the supply chain. Another aspect of the regulation is the introduction of the online pharmacy verification scheme to facilitate the sale and purchase of medicines online.


C+D letter spurs Labour MP into action on pharmacy cuts

C&D, Annabelle Collins, 9 February 2016


Labour MP John Mann launched an early day motion last week to draw MPs attention to the consequences of a 6% cut to community pharmacy funding. This support was sparked by the reception of several C&D letters. Alistair Burt responded to his written question stating that the government believes that efficiencies are possible without compromising the quality of pharmacy services.


Making the case for community pharmacy

The Pharmaceutical Journal, Julia Robinson, 9 February 2016


The Pharmaceutical Journal interviews Sandra Gidley, chair of the RPS English Pharmacy Board, on her thoughts on the community pharmacy funding cut. Sandra Gidley explains that moving forward the RPS will work to make the best of the integration fund and provide support to Pharmacy Voice and PSNC.


NHS England has not managed Cancer Drug Fund properly, MPs say

The Pharmaceutical Journal, Ingrid Torjesen, 9 February 2016


The Public Accounts Committee (PAC) released a report last week which finds that the Cancer Drugs Fund was not properly managed by the NHS and that the Department of Health had not been able to demonstrate impact on patient outcomes. The report outlines recommendations to reform the fund such as setting clear objectives.


NCSO/Price Concessions February 2016

PSNC, 9 February 2016


The Department of Health granted the following price concessions for  February 2016:

The price concession only applies to the month that it is granted.

No additional endorsements are required for price concessions.


Drug Pack size Price concession
Celiprolol 200mg tablets 28 £19.83
Celiprolol 400mg tablets 28 £39.65
Cimetidine 400mg tablets 60 £19.99
Clindamycin 150mg capsules 24 £11.30
Ferrous Sulfate 200mg tablets 28 £2.85
Lamotrigine 5mg dispersible tablets sugar free 28 £8.50
Lercanidipine 10mg tablets 28 £5.70
Lercandipine 20mg tablets 28 £9.00
Mefenamic acid 500mg tablets 28 £10.59
Pioglitazone 15mg tablets 28 £25.83
Pioglitazone 30mg tablets 28 £34.99
Pioglitazone 45mg tablets 28 £39.55
Procyclidine 5mg tablets 28 £14.00
Trazodone 50mg capsules 84 £36.80
Trazodone 100mg capsules 56 £41.99
Trazodone 150mg tablets 28 £35.25


If you have problems obtaining a Part VIII product or problems obtaining the product at the set Drug Tariff price, please report the issue to PSNC using the online feedback form on the PSNC Website. If you have been able to source the product, please provide full details of the supplier and price paid. PSNC will investigate the extent of the problem and if appropriate discuss the issue with the Department of Health. Please note that PSNC cannot provide details of generic products that are suspected of being affected by generic supply problems unless and until the Department of Health grants a concession. PSNC is in discussion with the Department of Health on a number of generic medicines in short supply.



Parliamentary Coverage

House of Commons Oral Answers, Community Pharmacies, 9 February 2016


Stephen Pound (Labour): What assessment he has made of the potential effects on public health of his Department’s proposals on the future of community pharmacies.


Department of Health


Alistair Burt,The Minister for Community and Social Care: It is my considerable honour, Mr Speaker, to respond to the hon. Gentleman in his victorious mode.


Community pharmacy is a vital part of the NHS and it plays a pivotal role in improving the public’s health in the community. We want a high-quality community pharmacy service that is properly integrated into primary care and public health. The proposed changes will help us, in conjunction with the pharmacy profession, to do just that.


Stephen Pound: I am very grateful to the Minister for that answer. There is always a place for him in our team next year, although we are running trials in the next few weeks.


Despite the generosity of the Minister’s response, does he not accept that community pharmacies are of great and growing importance to our constituents and provide an ever-increasing range of healthcare and advice in accessible high street locations? What message does he have for these dedicated professionals, who, frankly, now fear for the future due to the uncertainty arising from the announcement of a 6% cut in funding for the NHS pharmacy service?


Alistair Burt: I am grateful to the hon. Gentleman not only for his question but for the way he put it. The message is that community pharmacy does, and is doing, an extraordinary and important job, but it will change. In 2013, the Royal Pharmaceutical Society said in its publication, “Now or Never: Shaping pharmacy for the future”: “The traditional model of community pharmacy will be challenged” due to “economic austerity in the NHS , a crowded market of local pharmacies, increasing use of technicians and automated technology to undertake dispensing, and the use of online and e-prescribing”. It pointed to the massive potential of community pharmacists to do more and sees pharmacy as ideally placed “to play a crucial role in new models of…care.” All that is to come. We are negotiating with the pharmaceutical profession. A consultation is going on. There is a great future for pharmacy, but, like so much else, it will be different.




House of Commons Oral Answers, Pharmacy Budget, 9 February 2016



Mr Speaker: I am sorry, but demand is so high. Last but not least, I call Kevin Barron.


Kevin Barron, Labour: The 6% cut in the pharmacy budget will come in in October—halfway through the next financial year. Will the Minister tell us what the percentage cut will be in a full financial year?


Alistair BurtThe Minister for Community and Social Care: Negotiations are ongoing with the Pharmaceutical Services Negotiating Committee. The amounts that have been set out cover this financial year and the settlements are moved on from year to year, so the discussion is ongoing. The future for pharmacy is very good, although it will be different, as the profession has wanted for some time. Not only is there a great future for high-street shops in areas where we need them, but there will be an improvement in and enlargement of pharmacy services in healthcare settings, primary care settings and care homes around the country.


Several hon. Members  rose —


Mr Speaker:  Apologies to colleagues. I did stretch the envelope as far as I could, but we must move on.


Full Coverage

New safety features to protect EU citizens from falsified medicines

The Pharma Letter, 9 February 2016


Safety for medicines will be further reinforced with the introduction of new obligatory features like a unique identifier and an anti-tampering device, according to an announcement this morning from the European Commission.


Such safety features will protect European citizens against the health threat of falsified medicines, which may contain ingredients, including active ingredients of low quality or in the wrong dosage. The safety features will guarantee medicine authenticity for the benefit of patients and businesses, and will strengthen the security of the medicine supply chain – from manufacturers to distributors to pharmacies and hospitals.


The act in question, published today in the Official Journal, supplements the Falsified Medicines Directive (2011/62/EU), which aims to prevent falsified medicines to reach patients, to allow European Union citizens to buy medicines online through verified sources, and to ensure that only high quality ingredients are used for medicines in the EU. The delegated Regulation will enter into force three years after publication.


Commenting on the news, Adrian van den Hoven, director general of the European Generic and Biosimilar medicines Association (EGA), said: “We are confident that the implementation of the European Medicines Verification Blueprint System will be a major step forward for the fight against counterfeit medicines. To ensure that our industries continue to deliver access to high quality medicines and to improve patient safety, we plan to work closely with Member States to allow the industries to apply voluntarily the safety features when needed to increase patient safety even more.”


Delegated act: clock starts ticking for safety feature compliance

Securing Industry, Phil Taylor, 9 February 2016


The EU delegated act on safety features has been published today, giving pharmaceutical companies three years to add unique identifiers and anti-tampering features to medicine packs.


Announcing the publication, the European Commission said the addition of the safety features “will protect European citizens against the health threat of falsified medicines, which may contain ingredients, including active ingredients of low quality or in the wrong dosage.”


The safety features “will guarantee medicine authenticity for the benefit of patients and businesses, and will strengthen the security of the medicine supply chain – from manufacturers to distributors to pharmacies and hospitals,” it adds.


The publication in the Official Journal today means that the regulation will now enter into force on February 9, 2019. From that date, all medicine packs sold in the EU must carry a serialized unique identifier (UI) code within a 2D datamatrix barcode, an anti-tampering device on the outer packaging, and be verified at the point of dispensing to the patient.


It is one of the pillars of the Falsified Medicines Directive (2011/62/EU) which also included provisions to make it easier for EU consumers to buy medicines online safely – thanks to an online pharmacy verification scheme – and measures to ensure only safe and high-quality ingredients are used to make pharmaceutical products.


While many of the larger pharmaceutical companies are already well on the way to complying with the delegated act requirements, there have been concerns that smaller companies and contract manufacturers may leave it too late to come into compliance by the deadline.


Estimates are that making the necessary changes to packaging lines and IT systems to incorporate serialization – and verify that the systems are working properly – can take as long as two years from start to finish.


Companies must understand “the timescales … in place for EU member States [and] which products will be affected,” according to Craig Stobie of Domino Printing  Sciences, which recently became part of the Brother group.


Companies must develop “the capability to achieve onsite coding, reading and data management requirements in line with the new regulations,” he added.


Furthermore, although not explicitly stated in the delegated act, Stobie recommends that manufacturers look beyond 2019 in their planning to anticipate aggregation – in other words linking the individually coded packaging levels to cartons, cases and pallets used in shipping.


“While not currently mandated by the FMD, aggregation does form part of similar schemes elsewhere in the world and we believe it is the next logical step for the industry,” said Stobie.


“Building aggregation into planning now will ensure that when the time comes, manufacturers have a straightforward upgrade route.”


Meanwhile, the chief executive of Aegate – Mark De Simone – said that the publication of the delegated regulation means the work now starts “to ensure that the investment that manufacturers have already made in packaging, serialisation and tamper proofing is not wasted, or worse dwarfed by the costs of an authentication service that does not work.”


The publication comes just ahead of the annual Pharmapack Europe exhibition, which gets underway in Paris, France, tomorrow.


Making the case for community pharmacy

The Pharmaceutical Journal, Julia Robinson, 9 February 2016


Two months on from the announcement that the community pharmacy contractual framework will be cut by 6% in 2016, Sandra Gidley, chair of the RPS English Pharmacy Board, talks to Julia Robinson about her thoughts on the proposed changes and what the RPS is doing to support its members through them.


On 17 December 2015, a letter issued to Pharmaceutical Services Negotiating Committee (PSNC) chief executive Sue Sharpe revealed that funding for the community pharmacy contractual framework in England will be substantially reduced to £2.63bn from October 2016 – a cut of £170m – as part of efficiency savings in the NHS. Now, two months on, organisations such as the Royal Pharmaceutical Society (RPS) and the PSNC are developing their responses to the proposed reforms and establishing networks of support for those directly affected.


Why is the community pharmacy network needed to provide a clinical service?


The community pharmacy network is very accessible to the public. Apart from dispensing, community pharmacies provide a whole host of other services such as emergency contraception and public health advice, but they can do more. It’s therefore a concern that there are plans to cut the network when there’s a lot of services in the NHS that could be diverted cheaply and effectively to community pharmacists.

This is a top-down treasury cut and the community pharmacy network has been forced to think about working more efficiently.


Where is the evidence that the community pharmacy network needs to work more efficiently?


There isn’t any evidence. This is a top-down treasury cut and the network has been forced to think about working more efficiently. There are concerns that smaller businesses will make those savings by cutting staff and hours, which seems perverse at a time when the government wants greater access to health services. If pharmacy staff are cut, existing staff will be under more pressure and be less able to provide the service they wish to provide.


Alistair Burt, minister of state for community and social care, has warned that one in four pharmacies could close – what are your thoughts about this?


In my hometown we have two pharmacies that belong to the same chain. It would make sense for them to merge into one, have longer opening hours and maybe provide extra services, but there are barriers to that happening at the moment. There are cases and situations where rationalisation could result in improved access to the public if funded properly, but we’re yet to see the details of how that could be engineered.


What do you think about the Pharmacy Integration Fund, particularly as it is not yet known how much money will be invested in community pharmacy?


The Pharmacy Integration Fund is far too small, but it’s an opportunity for the profession to shape its future if it wants to. If pharmacists from all sectors come up with working ideas of how to improve patient care and joint working, we’re likely to see more money attached to them. The government is not going to fund what we’re currently doing so we have to make sure there is a strong case for funding services of the future. Pharmacists are best placed to think about what they would really like to do so I would encourage groups of pharmacists to get together and think about how they can work with their local surgery. There are pots of money other than the community pharmacy funding and as a profession we need to be smarter at accessing them.


Where is the evidence that ‘hub-and-spoke’ dispensing will provide efficiencies?


I haven’t seen any evidence. All I can say if it were that good a model, large multiples would have rolled it out much more quickly. My understanding is that there are no cost efficiencies as such but it does free up time for pharmacists to do other things.

We have to devote our energies to making the best of the Pharmacy Integration Fund, pushing positive ideas forward and promoting pharmacists to do that too.


What are the RPS’s next steps?


It’s very difficult to fight the community pharmacy funding cuts because they have been imposed – the cuts will happen. We have to devote our energies to making the best of the integration fund, pushing positive ideas forward and promoting pharmacists to do that too. Our immediate priority is in putting forward the response to government. We’re working with Pharmacy Voice and Pharmaceutical Services Negotiating Committee (PSNC) and supporting each other as much as possible. It’s really important we focus on securing funding for new starter services and this could then lead to further funding if those services work. I have great concerns that there will be further cuts next year so, longer term, we’ll be doing as much as we can to make a positive case for services in the community pharmacy setting. Pharmacists in the community are ideally placed to take on patients managing long-term conditions.


How should community pharmacists prepare themselves over the following months?


Pharmacists should work with their local pharmaceutical committees to help them put together a case for pharmacy services, think about what support they need as a community pharmacist and how they can work together.


At the RPS, we have a role to provide pharmacists with training so they can confidently make a case for change. We are keen to work with Pharmacy Voice to try and deliver any support that is needed. But we have to be robust and make sure patients remain at the centre because that’s what the Department of Health wants. I think there is hope but it requires a change of thinking and that’s going to be difficult.


What about hospital pharmacies?


Hospital pharmacies are, in a sense, facing a similar challenge. The Lord Carter review outlines the desire to have 80% of the hospital pharmacy workforce delivering clinical services rather than infrastructure services. From this it’s clear that there is an aspiration for pharmacists to be delivering more patient-facing services. There’s also scope for community and hospital pharmacists to work more closely together and for community pharmacists to look at opportunities from the hospital sector if services are being outsourced. There seems to be a consistency of thinking that pharmacists are best placed in roles where they are using the skills that they learnt at university.


NHS England has not managed Cancer Drug Fund properly, MPs say

The Pharmaceutical Journal, Ingrid Torjesen, 9 February 2016


The Cancer Drugs Fund (CDF) has not been managed properly by NHS England and the Department of Health (DH), a committee of MPs says. The fund’s budget has been repeatedly overspent and there has been no assessment of what impact the fund has had on patient outcomes, according to the MPs.


The CDF was established in 2010 to improve access to cancer drugs not routinely available on the NHS because they had yet to be recommended by the National Institute for Health and Care Excellence (NICE), and to address geographical variations in the availability of specific cancer drugs.


However, in a report published on 5 February 2016 MPs on the Public Accounts Committee (PAC) say that while about 80,000 people have received drugs through the fund, the DH has not been able to assess the impact on patient outcomes, such as extending patients’ lives, or demonstrate whether the fund is a good use of taxpayers’ money.


The PAC says it is unclear how far regional variations in access have been reduced, adding that “there is no assurance that the DH and NHS England are using their buying power effectively to pay a fair price for cancer drugs”.


“Half of the patients supported by the fund received drugs that had previously been appraised but not recommended by NICE because they did not meet its clinical and/or cost-effectiveness thresholds,” the report says. “In this respect the fund has cut across, rather than complemented, the work of NICE.”


The fund’s budget grew from £175m in 2012–2013 to £416m in 2014–2015, an increase of 138% in two years, with the fund’s budget for 2013–2014 and 2014–2015 being overspent by a total of £167m, the report says. However, NHS England did not start to take action to control the cost of the fund until November 2014.


Burgeoning costs mean that the fund is not sustainable, so NHS England and NICE are currently consulting on proposals to reform the fund from April 2016. The consultation closes on 11 February 2016.


“We expect NHS England… to take account of our recommendations and apply the clear lessons from the last five years to ensure that the new fund is managed better in the future,” the report says.


These recommendations include setting clear objectives for what the reformed fund aims to achieve; for NHS England to “be prepared to take tough decisions to ensure that the fund does not overspend”; and for the DH to “set out how it ensures that it pays a fair price for drugs”.


In terms of assessing the impact of the fund, the report says that NHS England should report back to the PAC by June 2016 “on what the available data indicate about the impact of the fund on patient outcomes”.


The PAC adds that the issue of whether NICE has the capacity to appraise all new cancer drugs within the proposed timeframes also needs to be addressed “as a matter of urgency”.


Meg Hillier, chair of the PAC and MP for Hackney South and Shoreditch, says: “There must be confidence that public money is being spent on the right medication, and at a fair price. We will be closely monitoring the progress made by the department and NHS England in the months ahead.”


Sir Andrew Dillon, pictured, chief executive at NICE, says that NICE has considered the effect of the proposed new arrangements on its workload and resources

Source: NICE


Sir Andrew Dillon, chief executive at the National Institute for Health and Care Excellence (NICE), says NICE has considered the effect of proposals for a reformed cancer drugs fund on the institute’s workload and resources


Responding to the report, Sir Andrew Dillon, chief executive at NICE, says the proposals being consulted on set clear objectives about how the fund will be managed and that NICE has considered the effect of the proposed new arrangements on its workload and resources. “Funding has been agreed with NHS England,” he says. “When these proposals are finalised NICE and NHS England will work together to put in place a new system to provide patients with promising medicines at a fair price.”


A spokesperson for NHS England welcomed the committee’s support for a redesigned fund, but says: “We hope their explicit call for cuts to cancer drugs prices charged to the CDF will be borne in mind as complex decisions on its future are taken in the next few months.”


Cancer charities also welcomed the report’s recommendations. Sally Greenbrook, policy manager at Breast Cancer Now, says it is “particularly pleasing” to see the report’s focus on price negotiations.


“[This is] something we feel has been missing from the current NICE and NHS England proposals,” she says, adding that the current proposals do not go far enough.


Mark Flannagan, chief executive of the charity Beating Bowel Cancer, says opportunities have been missed to collect data to demonstrate the impact of individual treatments on patients’ lives. “It’s vital that this is fixed.”

HDA Media And Political Bulletin – 10 February 2016

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