Media And Political Bulletin – 07 April 2020

Media and Political Bulletin

07 April 2020

Media Summary

Panic buying, trade curbs cause shortages of coronavirus drugs in EU

Reuters, Francesco Guarascio, 06 April 2020

Reuters reports that hospitals in the European Union are facing shortages of critical drugs to treat COVID-19 patients because of trade restrictions and excessive stockpiling by EU governments, EU and industry officials said on Monday.

Despite several calls for solidarity, many of the 27 EU nations have resorted to protectionist measures during the coronavirus outbreak, restricting sales of essential products, such as medicines, face masks and medical devices.

“Some EU member states have indicated that they are starting to see shortages of certain medicines used for patients with COVID-19 or are expecting such shortages to occur very soon,” the European Medicines Agency said in a statement.

Shortages mostly concern drugs used for patients with the most serious complications caused by the pandemic. These include medicines used in intensive care units such as anaesthetics, antibiotics and muscle relaxants that allow patients to receive breathing support from ventilators.

Birmingham pair given suspended prison sentences for selling medicines online illegally

MHRA, 06 April 2020

The MHRA reports that a man and a woman who sold breast cancer and erectile dysfunction medicines illegally online appeared at Birmingham Crown Court.

The sentencing on Friday 3 April followed a three-year investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) into the illegal sale of medicines through their website.

MHRA investigators along with officers from West Midlands Police, executed a number of search warrants in March 2017, seizing initially nearly 27,000 tablets and vials with a street value of more than £21,000.

Egle Bunkute, 31, and Edvinas Ivanauskas, 26, eventually admitted to supplying or intending to supply containing prescription only and unauthorised medicines after further investigations by the MHRA uncovered thousands of photographic records of the transactions.

This was reported on by P3 Pharmacy.

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Panic buying, trade curbs cause shortages of coronavirus drugs in EU

Reuters, Francesco Guarascio, 06 April 2020

Hospitals in the European Union are facing shortages of critical drugs to treat COVID-19 patients because of trade restrictions and excessive stockpiling by EU governments, EU and industry officials said on Monday.

Despite several calls for solidarity, many of the 27 EU nations have resorted to protectionist measures during the coronavirus outbreak, restricting sales of essential products, such as medicines, face masks and medical devices.

“Some EU member states have indicated that they are starting to see shortages of certain medicines used for patients with COVID-19 or are expecting such shortages to occur very soon,” the European Medicines Agency said in a statement.

Shortages mostly concern drugs used for patients with the most serious complications caused by the new coronavirus infection.

These include medicines used in intensive care units such as anaesthetics, antibiotics and muscle relaxants that allow patients to receive breathing support from ventilators.

Last week a group of large European hospitals, including Milan’s San Raffaele and Barcelona’s Vall d’Hebron, said they would shortly no longer be able to treat COVID-19 patients if restrictions on drug movements were not removed.

At the beginning of the outbreak, the bloc faced delays in the delivery of medicines caused by supply disruption in China and trade bans in India, but now the main hurdles to supplies are due to EU states themselves, industry officials said.

“Countries are building up stocks. This is a reasonable approach but stocks are sometimes too big and this will deprive countries in need to get them,” said Adrian van den Hoven, director of Medicines for Europe, a trade body for the EU generic drugs industry.

He said in one case that a drug order from a state, which he did not name, covered the yearly output of a manufacturer.

“This is not rationale, and is not limited to one country,” he said.

Austria and Portugal are among EU states that are excessively stockpiling, said Kasper Ernest, secretary general of Affordable Medicines Europe, the trade body for pharmaceutical wholesalers.

TRADE CURBS

Many countries have also restricted the export of drugs that are deemed essential during the epidemic. Under some of these curbs, only when national needs are fulfilled, medicines can be exported. The restrictions hit mostly distributors.

The European Commission, the EU executive arm, is probing the legality of measures adopted by France, Poland, Hungary, Romania and Slovakia, a spokeswoman for the EU commission said on Monday, adding that trade restrictions also apply to medical gear and devices.

“In a period when we are focused on saving lives, it is not the time to restrict exports of medicines and essential medical equipment, nor to let them expire rather than share,” EU health commissioner Stella Kyriakides said.

Trade restrictions imposed by Romania are for instance currently blocking a large shipment of heart medication which was meant to reach patients in Hungary and Montenegro, Ernest said, warning that the drugs will soon expire.

Birmingham pair given suspended prison sentences for selling medicines online illegally

MHRA, 06 April 2020

A man and a woman who sold breast cancer and erectile dysfunction medicines illegally online appeared at Birmingham Crown Court.

Egle Bunkute, 31, originally from Lithuania was sentenced to 14 months’ custody suspended for two years and ordered to complete 100 hours of unpaid work in the community.

Edvinas Ivanauskas, 26, also from Lithuania was sentenced to 44 weeks’ imprisonment suspended for two years and ordered to complete 100 hours of unpaid work.

The sentencing on Friday 3 April followed a three-year investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) into the illegal sale of medicines through their website.

MHRA investigators along with officers from West Midlands Police, executed a number of search warrants in March 2017, seizing initially nearly 27,000 tablets and vials with a street value of more than £21,000.

Bunkute and Ivanauskas eventually admitted to supplying or intending to supply containing prescription only and unauthorised medicines after further investigations by the MHRA uncovered thousands of photographic records of the transactions.

The medicines were sent illegally to addresses in the UK, EU, the USA, Canada and Australia. The postage costs for posting these medicines was in excess of £105,000.

Officers also found social media messages between the pair discussing the medicines and ways to avoid detection which clearly showed they knew they were involved in the illegal supply of the medicines.

The business at the centre of the illegal supply of medicines was operated through the website www.uk-rxcart.com which was shut down in 2017 by the MHRA.

The pair were selling Tadafil used for the treatment erectile dysfunction, Prolox and Dapoxetine (premature ejaculation treatments) and Nolvadex/Tamoxifen which are used to treat breast cancer.

Egle Bunkute was also sentenced for offering to supply Human Chorionic Gonadotrophin, a growth hormone and class C controlled drug.

They both pleaded guilty to the offences at earlier hearings.

Tariq Sarwar, Acting Head of MHRA Enforcement Group said:

“It is a serious criminal offence to sell prescription only medicines without a prescription and to sell unlicensed medicines, we will continue to work relentlessly with regulatory and law enforcement colleagues to identify and prosecute those involved.

“Those who sell medicines illegally are exploiting vulnerable people and have no regard for their health. Prescription-only medicines can be extremely strong and should only be taken under medical supervision as they may have potentially dangerous side effects

“Criminals selling medicines illegally show a blatant disregard for your health, and only care about making money.”

This was reported on by P3 Pharmacy.

Media and Political Bulletin

04 March 2020

Media Summary

Coronavirus: Drug shortage fears as India limits exports

BBC News, 04 March 2020

BBC News reports that there are fears of global shortages of some common drugs after India, the world’s biggest supplier of generic drugs, has restricted exports of 26 ingredients and the medicines made from them due to the coronavirus. The restricted drugs include Paracetamol, one of the world’s most widely-used pain relievers.

It comes as many drug ingredient makers in China remain shut or cut output. India’s drug makers rely on China for almost 70% of the active ingredients in their medicines, and industry experts have warned that they are likely to face shortages if the epidemic continues.

Oxford Economic’s lead economist Stephen Foreman told the BBC that there are indications that the scarcity of ingredients is already forcing up prices.

This was reported in a number of publications, including ReutersBloombergPMLiVE and European Pharmaceutical Review.

New figures show 3.5 million unlicensed erection pills seized in 2019

MHRA, 03 March 2020

According to new figures released by the MHRA, around 3.5 million unlicensed erection pills worth more than £10 million were seized in the UK in 2019.

The MHRA is warning people not to take a chance with fake medicines as it launches the next phase of its #FakeMeds campaign, this time focusing on fake erectile dysfunction (ED) medicines sold online.

More than half of all medicines and medical devices bought online are fake or counterfeit, highlighting the need for enforcement activity and public awareness to protect and improve the UK’s public health.

Mark Jackson, MHRA Head of Enforcement, said: “Any medication bought from an unregistered website may be fake and will not meet quality and safety standards. We encourage people not to take a chance with fake medicines – make sure you are buying from a legitimate source.”

 

 

Parliamentary Coverage

Commons Tabled Written Question – DH and Social Care

03 March 2020

Ms Harriet Harman (Camberwell and Peckham): To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that women in Camberwell and Peckham constituency have adequate access to Hormone Replacement Therapy (HRT); and if he makes an assessment of the adequacy of the medicine supply chain in relation to HRT.

Commons Second Reading – Medicines and Medical Devices Bill

02 March 2020

The Medicines and Medical Devices Bill has had its Second Reading in the House of Commons.

The Bill aimed to create a strong and nimble regulatory framework post-Brexit, with patient safety at its heart. The Bill would also increase the range of healthcare professionals who could prescribe medicines. The Opposition “broadly” supported the Bill and it passed without division.

 

Full Coverage

Coronavirus: Drug shortage fears as India limits exports

BBC News, 04 March 2020

There are fears of global shortages of some common drugs after India limited the export of certain medicines due to the coronavirus.

The world’s biggest supplier of generic drugs has restricted exports of 26 ingredients and the medicines made from them.

The restricted drugs include Paracetamol, one of the world’s most widely-used pain relievers.

It comes as many drug ingredient makers in China remain shut or cut output.

India’s drug makers rely on China for almost 70% of the active ingredients in their medicines, and industry experts have warned that they are likely to face shortages if the epidemic continues.

“Even drugs that aren’t produced in China get their base ingredients from China. Globally there could be a shortage if China and India both get hit,” warned analyst Shaun Rein from the China Market Research Group.

The list of ingredients and medicines accounts for 10% of all Indian pharmaceutical exports and includes several antibiotics, such as tinidazole and erythromycin, the hormone progesterone and Vitamin B12.

Oxford Economic’s lead economist Stephen Foreman told the BBC that there are indications that the scarcity of ingredients is already forcing up prices: “There are already signs that the reduction in supply to India has pushed up prices there considerably.”

The Indian government has urged calm over its announcement and said there were enough stocks to last for up to three months.

In 2018 Indian imports accounted for almost a quarter of US medicines and more than 30% of medicine ingredients, according to the US Food and Drug Administration (FDA).

FDA Commissioner Stephen Hahn told US senators on Tuesday that the agency is working to determine how the restrictions will affect America’s medical supply and its effect on essential medicines.

Major US pharmaceutical companies have said they are monitoring their supply chains.

Mylan warned last week that there could be drug shortages, while Eli Lilly said it does not expect the coronavirus outbreak to result in shortages for any of its therapies, including insulin products.

This was reported in a number of publications, including ReutersBloombergPMLiVE and European Pharmaceutical Review.

New figures show 3.5 million unlicensed erection pills seized in 2019

MHRA, 03 March 2020

Around 3.5 million unlicensed erection pills worth more than £10 million were seized in the UK in 2019 according to new figures released today by the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA is warning people not to take a chance with fake medicines as it launches the next phase of its #FakeMeds campaign, this time focusing on fake erectile dysfunction (ED) medicines sold online.

Erectile problems in general affect up to 21% of men in the UK, which is equivalent to 4.3 million men in the UK. Despite this, it has been found that 44% of men with ED aged 40 and over have not sought medical help and may be buying fake products online.

Fake ED drugs can lead to more than just a let-down in the bedroom. There is no way of knowing what is in them nor the negative health effects they can have. Whilst it might seem appealing to skip the need for an assessment from a healthcare professional by buying medicines online, men with erectile problems may be putting their health at risk. Fake medicines may not contain any active ingredients, or worse, may contain toxic ingredients which could lead to serious health consequences.

The MHRA’s enforcement team has worked with UK Border Force to seize millions of unlicensed medicines at the border. Often illegal traders pose as legitimate suppliers, selling medications that are unlicensed for the UK market and offering tempting prices lower than the real deal. Since the launch of the #FakeMeds campaign in 2016, the MHRA has been continuing to crack down by closing illegally operating sites selling unlicensed products.

More than half of all medicines and medical devices bought online are fake or counterfeit, highlighting the need for enforcement activity and public awareness to protect and improve the UK’s public health.

With this new phase of #FakeMeds the agency is using the campaign to encourage people who buy medication online to make sure they are purchasing from safe and legitimate sources. It also encourages people to report suspected dodgy ED drugs, and any side effects experienced to the Yellow Card scheme.

Mark Jackson, MHRA Head of Enforcement, said:

Fake ED drugs might not give you the result you want or even make you ill. Any medication bought from an unregistered website may be fake and will not meet quality and safety standards. We encourage people not to take a chance with fake medicines – make sure you are buying from a legitimate source.

Visit the #FakeMeds website for tools and resources to help people purchase medication or medical devices safely online. If you have any questions about ED, please speak to a healthcare professional.

Ends

Notes to editor

  1. The #FakeMeds campaign is a public health campaign which aims to reduce the harm caused by purchasing fake, unlicensed or counterfeit medical products online. Phase 3 of the #FakeMeds campaign will focus on the issue of fake erectile dysfunction (ED) medicines and raise awareness of the prevalence of fake ED medicines online and encouraging audiences to buy from legitimate sources. Previous phases of the campaign have focused on dodgy diet pills and fake self-testing STI kits. Follow #FakeMeds on Twitter, Facebook and Instagram.
  2. The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
  3. The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC)and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health and Social Care.
  4. The Yellow Card scheme helps the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those that use them.
  5. Erectile problems in general affect up to 21% of men in the UK according to Kantar TNS Omnibus Survey Dec 2010 – in a survey of 1,033 men.
  6. 44% of men with erectile dysfunction (ED) aged 40 and over have not sought medical help according to Opinium for Pfizer: ED market research, February 2018.
BREAKING: PSNC CONSIDERING LEGAL ACTION AGAINST GOVERNMENT OVER CUTS
21 October 2016, Pharmacy Business, Neil Trainis

The Pharmaceutical Services Negotiating Committee (PSNC) is considering taking legal action against the Government following the announcement of cuts to community pharmacy funding. The Chief Executive of the PSNC, Sue Sharpe, has said that the PSNC is reviewing its position and examining options for a legal challenge. She stressed that whatever decision the PSNC makes will be what is best for contractors.

This was also reported by Chemist & Druggist

Community pharmacists ‘will need support’ after pharmacy cuts announcement, says RPS
21 October 2016, The Pharmaceutical Journal, Julia Robinson

The Royal Pharmaceutical Society (RPS) has pledged its support for their members. They have also called for widespread support from pharmacy organisations following the announcement of cuts to community pharmacy funding. The PRS expressed disappointment that the pharmacy integration fund (PhIF) is also losing funding from December 2016, in a statement made on 20 October 2016. The RPS also says it remains to be seen how effective the proposed Pharmacy Access Scheme (PAS) will be in preventing pharmacy closures.

The community pharmacy funding cuts were also reported in Pharmacy Business

The future of established payments was also reported in The Pharmaceutical Journal

The Governments Pharmacy Access Scheme was also reported in Chemist & Druggist and The Pharmaceutical Journal 

Pharmacy integration fund will total £42m over next two years
21 October 2016, The Pharmaceutical Journal

NHS England has announced that the pharmacy integration fund (PhIF) will total £42 million over the next two years. The scheme was proposed earlier in 2016, amounting to a total of £300 million by 2021. The aim of the PhIF is to assist the development of clinical pharmacy practices for a more integrated NHS primary care for patients. In order to decide how this funding will be spent Keith Ridge Chief Pharmaceutical Officer for England has commissioned an independent review of community pharmacy clinical services report, which is due at the end of 2016.

This was also reported by Pharmacy Business

What is the Falsified Medicines Directive?
20 October 2016, The Pharmaceutical Journal, Julia Robinson

The Falsified Medicines Directive (FMD) has been designed in response to concern about the increasing threat of counterfeit or ‘falsified’ medicines to public health and safety. The FMD will help to protect patients as it will minimise the chances of a counterfeit medicines entering Europe’s established supply chains. The FMD will introduce a Europe-wide system to track legitimate medicines from the manufacturer to the patient due to the obligatory safety features on each pack.

 

Parliamentary Coverage

There is no Parliamentary coverage today.

Full Coverage

BREAKING: PSNC CONSIDERING LEGAL ACTION AGAINST GOVERNMENT OVER CUTS

21 October 2016, Pharmacy Business, Neil Trainis

 

The PSNC is considering legal action against the government over its cuts to community pharmacy funding.

 

Sue Sharpe, the chief executive of the PSNC, told Pharmacy Business it was reviewing its position after the government said it would impose a 4% and 7.5% reduction in pharmacy funding in 2016-17 and 2017-18 respectively.

 

“PSNC will study the government’s imposition carefully to inform our decisions about next steps. Our decisions must be based on what is best now for contractors. PSNC will be examining the options for a legal challenge,” Sharpe (pictured) said.

 

“Over the coming months we will be working closely with LPCs and the other pharmacy organisations  to plan the next stages of the campaign, as well as to help the sector to adapt to the changes.

 

“We must also continue to build on the phenomenal support we now have among politicians from all parties and the general public to make the case for pharmacy’s long-term future.”

 

The government announced in its final funding package that community pharmacy will receive £2.687 billion for 2016/17 and £2.592 billion for 2017/18.

 

NPA to look into ‘legal avenues’ over pharmacy funding cuts

21 October 2016, Chemist & Druggist, Grace Lewis

 

The National Pharmacy Association (NPA) is “urgently” seeking safeguards against the impact of the cuts, after the government’s confirmation of a 12% drop in funding.

Chairman Ian Strachan vowed to carry on the lobby group’s anti-cuts fight “with renewed conviction”, in an emergency Facebook chat with members last night (October 20), as pharmacists came to terms with the government’s “modernisation” plans for the sector.

 

Mr Strachan reassured community pharmacists that the battle against the cuts “is far from over”. The NPA is considering “a range of options” for its next steps, including “legal avenues”, he said.

 

“The government has made its intentions clear; let’s make ours,” Mr Strachan said in the Facebook announcement. “We will continue to campaign because it is the right thing to do.”

 

Speaking to C+D today (October 21), NPA head of communications Stephen Fishwick said the association is “taking professional advice – including political, regulatory and legal – on all the options available to us.”

 

“We don’t want to show our hand just yet, but there are still things to play for and avenues to explore,” he stressed.

 

Mr Strachan said “the recent concession on hub and spoke dispensing showed that it is possible to get politicians to change course”. He added he is hopeful that with a “united front” from the sector, “there is still a chance to influence government thinking”.

 

‘Could have of been worse’

 

Many pharmacists contacted the NPA overnight, “angry” at the government’s announcement but also seeking “practical support” on what to do next, Mr Fishwick told C+D.

 

“Just think how much worse the situation could have been if we rolled over at the beginning and accepted all this nonsense,” he said. “The determined efforts of the sector and of patients has certainly been worthwhile and it is important to keep together and keep pushing back against this direction of travel.”

 

The NPA advised community pharmacists to “examine your numbers and review your wider business affairs, to make sure you are fit for the future”.

 

It will be producing a number of business “proposals and resources” to support the sector in the comming weeks.

 

The RPS response

 

In a statement yesterday, the Royal Pharmaceutical Society’s English pharmacy board chair Sandra Gidley said “we know that the profession needs more from us at this time”.

 

“It remains to be seen if the [pharmacy access scheme] will lessen the impact on opening hours and staffing levels in vital community pharmacies,” she added.

 

She added the society was “dismayed there is now less certainty about the long term status of [the pharmacy integration fund]”.

 

Ms Gidley said the RPS is making sure community pharmacists receive “practical support to plan for the change that will begin on December 1st”.

 

Community pharmacists ‘will need support’ after pharmacy cuts announcement, says RPS

21 October 2016, The Pharmaceutical Journal, Julia Robinson

 

Royal Pharmaceutical Society pledges to support its members throughout overhaul to community pharmacy framework, details of which were announced on 20 October 2016.

 

The Royal Pharmaceutical Society (RPS) says community pharmacists will need widespread support from pharmacy organisations after health minister David Mowat announced community pharmacy funding cuts will be implemented from 1 December 2016.

 

Speaking at the House of Commons on 20 October 2016, Mowat confirmed that funding for community pharmacy will be cut by 4% in 2016–2017 from 1 December 2016, and a further 3.4% will be slashed in 2017–2018.

 

Mowat’s announcement concludes months of discussions between government and pharmacy organisations, including: the Pharmaceutical Services Negotiating Committee, the negotiating body for community pharmacy contractors in England; Pharmacy Voice, a trade association which represents community pharmacy in England; and the RPS.

 

“The profession has spoken with one voice on this issue,” says the RPS in a statement, published on 20 October 2016. “We have consistently asked how the government’s aspiration for the future of community pharmacy to be at the heart of the NHS can be squared with large reductions in funding.

 

“We recognise the NHS is under huge financial pressure, with colleagues in public health and hospitals at the sharp end of squeezed budgets too. There is a broader case for all of us in health to make about investment in a service that is dealing with unprecedented demand and expectations.”

 

The RPS also expressed dismay that the pharmacy integration fund (PhIF), which aims to support the development and integration of clinical pharmacy practice in a wide range of primary care settings, has been reduced from £300m over five years to £42m over two years.

 

“We are committed to working with NHS England on the best use of this fund but are dismayed that there is now less certainly (sic) about the long-term status of this work,” the statement says.

 

In his speech, Mowat also described plans for a pharmacy access scheme, whereby additional funding will be made available for the 1,356 pharmacies in deprived areas across England to shield them from the impact of the cuts. However, the RPS says that it will take time to find out whether the scheme will lessen the impact on opening hours and staffing levels in these pharmacies.

 

“We know that many pharmacists, whether they own a pharmacy or work for a pharmacy business, will be hugely concerned about the future,” says the RPS. “We have been very clear about our opposition to funding reductions, but we know that the profession needs more from us at this time.

 

“[We] will make sure we offer pharmacists practical support to plan for the change that will begin on 1 December 2016.”

 

PHARMACY SPITS BLOOD AT GOVERNMENT OVER FUNDING CUTS

21 October 2016, Pharmacy Business, Neil Trainis

 

The fall-out from the government’s cuts to community pharmacy funding continues with the profession spitting blood at ministers’ decision to reduce its budget over the next two years.

 

National Pharmacy Association chairman Ian Strachan described the government’s package, announced yesterday and which includes a 4% and 7.5% reduction in funding in 2016-17 and 2017-18 respectively, as a “slap in the face for hardworking pharmacy teams and for concerned patients.”

 

“The government’s approach shows a complete disregard for the community pharmacy sector and the wellbeing of patients,” he said.

 

“Millions of worried patients have asked the Department of Health to think again. Politicians from all parties are against the cuts. It is abundantly clear that the current policy approach is flawed and universally unpopular.

 

“Yet elements within government seem determined to press ahead with this damaging experiment, deaf to the nationwide protests. It is clear that they believe there are too many pharmacies and want closures.”

 

Strachan added: “But this is far from over. We will fight on in the light of (this) announcement. What gives us grounds for hope is the unprecedented level of public awareness and active political support that has been generated over the past months.

 

“This will form the basis of an ongoing effort to fundamentally shift the direction of government policy, so that pharmacies are seen as a solution to deep-seated problems in the NHS, not as a problem.

 

“Our most urgent task now is to defend against the most damaging potential consequences of the cuts.  We owe it to the millions of patients who have supported us to continue to safeguard the pharmacy services they rely on.”

 

Rob Darracott, the chief executive of Pharmacy Voice, said: “We have only just seen the government’s response to the PSNC but, on first inspection, it doesn’t appear that the Department of Health has been listening.

 

“We have spent the last 10 months explaining to them the value of community pharmacy, the pressure we take off other parts of the NHS and the money we save the Government by keeping patients out of GP surgeries and A&E.

 

“The public have made it clear to them that they expect their local pharmacies to expand their role in the community and MPs from every party have outlined how cuts will harm the interests of their constituents.

 

“Yet, despite this opposition, the government appears hell-bent on pressing ahead with this incoherent, self-defeating and wholly unacceptable policy and have replaced previous warm words with increasingly aggressive rhetoric.”

 

John D’Arcy, the managing director of Numark, said the cuts were “an outrage to the sector” and warned they “will have a devastating impact on pharmacies and the services they provide to their local community, especially on independent community pharmacies.”

 

“There is a real imbalance in government thinking here – funding is being cut, while at the same time pharmacies are being asked to do more,” he said.

 

“For example, the new NHS 111 service was put in place to take pressure off GP and accident and emergency departments, but this is looking increasingly likely to fail in light of these new cuts.

 

“It’s simply short-sighted for the government to make these cuts as they will hit areas with the greatest health inequalities the hardest.

 

“It’s estimated the cuts could also lead to many pharmacies being closed, causing huge job losses. In any other situation, imposing this sort of pay cut without any formal consultation would lead to an employment tribunal.

 

“The fear now of course is that not only will the livelihood of community pharmacy be affected, but so will patients and their ability to access essential healthcare services.”

 

D’Arcy said the government’s reward system for pharmacies providing a high quality service was “small relief from the cuts.” Up to £75 million will be made available for the quality scheme in 2017/18 and that will be funded from that year’s funding package of £2.592 billion.

 

“Sadly, announcement (of the cuts) flies in the face of public opinion as has been evidenced by the huge amount of public support and endorsement of community pharmacy through recent petitions,” D’Arcy said.

 

Norman Lamb, the Liberal Demoncrats health spokesperson, described the plans as “myopic” and accused the Conservatives of caring more about cutting costs than patient care.

 

“The government’s belief that cutting funding for community pharmacies will improve efficiency in the NHS is a complete false economy,” he said.

 

“These myopic plans will further increase pressure on GP surgeries and hospitals that are already buckling under the strain of limited resources and unprecedented demand for services.

 

“More people will be forced to take unnecessary trips to their GP and even A&E, which is completely counter to NHS England’s vision in the Five Year Forward View.

 

“If the government wants to ensure that health service is more efficient and focused on preventing ill health, then surely we should be investing more, not less, in pharmacies and other preventive services.

 

“This was the latest in a chain of fig-leaf consultations from the Conservative government, which is more concerned about cutting costs in a desperate attempt to make ends meet than creating an NHS that meets the needs of patients.”

 

Cormac Tobin, managing director of Celesio UK, accused the government of being “grossly disingenuous” over its intentions for community pharmacy.

 

“To say that the details of the final package are disappointing is a huge understatement,” he said.

 

“When the government’s intentions were first laid out at the start of the process, the proposed financial arrangements were couched as part of a wider plan to transform community pharmacy.

 

“The ambition for community pharmacy for 2016/17 and beyond all seems grossly disingenuous given that the only thing we’ve really got to show is a reduction in funding.

 

“With very little consultation undertaken and even less listening, proposals to save the NHS money dismissed out of hand and an apparent lack of consideration of the bigger picture, the stealthy and short-sighted manner in which the cuts have been handed down leaves a bitter taste for us all, and we must start to bear the impact and consider the future.”

 

The Royal Pharmaceutical Society, more measured in their response, said: “Community pharmacists will need support from RPS and other organisations following (the) announcement by the Department of Health that they will reduce total funding for community pharmacy, both this year and next.

 

“The profession has spoken with one voice on this issue. We have consistently asked how the government’s aspiration for the future of community pharmacy to be at the heart of the NHS can be squared with large reductions in funding.

 

“We recognise the NHS is under huge financial pressure, with colleagues in public health and hospitals at the sharp end of squeezed budgets too. There is a broader case for all of us in health to make about investment in a service that is dealing with unprecedented demand and expectations.”

 

The RPS added: “The pharmacy integration fund, originally set at £300 million over five years, has now been reduced to £42 million over two years, with years three, four and five yet to be confirmed.

 

“We are committed to working with NHS England on best use of this fund but are dismayed there is now less certainly about the long term status of this work.

 

“We know that many pharmacists, whether they own a pharmacy or work for a pharmacy business will be hugely concerned about the future. We have been very clear about our opposition to funding reductions, but we know that the profession needs more from us at this time.”

 

Pharmacy integration fund will total £42m over next two years

21 October 2016, The Pharmaceutical Journal

 

NHS England has announced that the pharmacy integration fund (PhIF), originally proposed in December 2015 as part of the government’s plans for community pharmacy, will total £42m over the next two years. This is substantially lower than the initial figure put forward earlier in 2016, which suggested the fund would amount to £300m by 2020–2021.

 

The aim of the PhIF is to support the development of clinical pharmacy practice in a wider range of primary care settings, resulting in more integrated and effective NHS primary care for patients.

 

“NHS England is making this extra money available to help modernise the pharmacy sector and make the most of pharmacists’ skills,” says Keith Ridge, chief pharmaceutical officer for England. “Everyone agrees that community pharmacy is being held back by an old-fashioned view of the pharmacist as someone who simply dispenses medicines at the back of the shop rather than as a trained clinical professional.

 

“We want to work with the profession to change that and, rather than increasing the burden on GPs, the aim is to allow community pharmacists to take a greater NHS role in helping patients.”

 

NHS England says the fund will be directed particularly towards the use of community pharmacists and pharmacy technicians in new, integrated local care models to improve access for patients and to relieve pressure on GPs and accident and emergency departments. Two workstreams already under the PhIF are aimed at integrating community pharmacy into the NHS’s national urgent care system through the urgent medicines supply service and the urgent minor illness care work with NHS 111, and these will run in parallel from December 2016 to April 2018.

 

To determine exactly how the fund will be spent over the next two years, Ridge has commissioned an ‘Independent review of community pharmacy clinical services’, which is due to report at the end of 2016.

 

NHS England Announces £42M Pharmacy Integration Fund

21 October 2016, Pharmacy Business, Neil Trainis

 

NHS England has launched the eagerly anticipated Pharmacy Integration Fund which will support community pharmacy’s development in the wake of swingeing government cuts to the sector’s funding between 2016 and 2018.

 

The Fund is worth £42 million over the next two years and is designed to drive forward clinical pharmacy practice in a range of primary care settings which NHS England hopes will result in a “more integrated and effective NHS primary care.”

 

There is a particular focus on making greater use of community pharmacists and pharmacy technicians in new, local, integrated care models through the Fund.

 

“This will improve access for patients, relieve the pressure on GPs and accident and emergency departments, ensure best use of medicines, drive better value and improve patient outcomes,” NHS England said.

 

Uncertainty persists over how the money will be spent over the next two years but an independent review commissioned by the chief pharmaceutical officer Dr Keith Ridge will report back on the issue by the end of the year.

 

The Fund is also a stark reminder to the pharmacy profession of the need to develop innovative new services through technology and digital platforms in line with a 21st century NHS.

 

“NHS England is making this extra money available to help modernise the pharmacy sector and make the most of pharmacists’ skills. We are not asking community pharmacy to do more, but to work with us over the next five years to develop how we can do things differently,” Dr Ridge said.

 

“There is no doubt that the community pharmacy profession will have to change how it works but we will be working closely with them to support and enable this process.

 

“Everyone agrees that community pharmacy is being held back by outdated working practices and an old-fashioned view of the pharmacist as someone who simply dispenses medicines at the back of the shop rather than as a trained clinical professional who provides specialist advice to patients and doctors from a professionally orientated clinical environment.

 

“We want to work with the profession to change that and rather than increasing the burden on GPs the aim is to allow community pharmacists to take a greater NHS role in helping patients.”

 

Two work streams designed to integrate community pharmacy into urgent care will run in parallel from December 2016 to April 2018; an urgent medicines supply service and urgent minor illness care work with NHS 111.

 

What is the Falsified Medicines Directive?

20 October 2016, The Pharmaceutical Journal, Julia Robinson

 

Aileen Bryson, practice and policy lead at RPS Scotland, speaks to Julia Robinson about the purpose of the Falsified Medicines Directive and how it will affect pharmacists in the UK when the final phase is rolled out in February 2019.

 

For several years, the European Union (EU) has been concerned about the increasing threat of counterfeit or ‘falsified’ medicines to public health and safety. In 2011, the European Commission (EC) started work to amend Directive 2001/83/EC to address these concerns under the Falsified Medicines Directive (FMD). The final phase of the FMD is due to be rolled out from 9 February 2019. But what does the FMD entail, how will it affect pharmacists in the UK and how is the Royal Pharmaceutical Society (RPS) involved? Julia Robinson talks to Aileen Bryson, RPS Scotland’s practice and policy lead, to find out.

 

What is the purpose of the FMD?

 

The FMD is designed to protect patients by minimising the chances of counterfeit medicines entering into the established medicines supply chain across Europe. It will enable manufacturers, wholesalers, distributors and everyone who supplies to patients to verify the authenticity of a medicinal product, identify individual packs, and check whether the outer packaging of medicines has been tampered with.

 

How will it work?

 

The FMD will introduce a system to track legitimate medicines from manufacturers to patients. Manufacturers will be obliged to apply safety features to each pack: a tamper-proof security seal and a 2D barcode. The barcode enables each pack to be serialised with a unique randomised number, which will be authenticated before dispensing. This identification data will be stored in a database managed by the European Medicines Verification Organisation (EMVO), and supported at national level in the UK by the UK Medicines Verification Organisation (UKMVO), a not-for-profit organisation also known as SecurMedUk Ltd. Manufacturers will check packs into the database and they will be authenticated, decommissioned or “checked out” in the pharmacy by scanning the barcode. This sends a message to the database, which then considers the authenticity of that pack, sending confirmation back to the pharmacy.

 

What will happen to medicines already in the system?

 

The FMD is not going to be operational until February 2019 and manufacturers are already working on it, so there will be a long transitional period where packs without the barcode will be taken out of the system.

 

How will we know if there is a problem with a pack?

 

If the pack hasn’t been registered by the manufacturer or parallel importer for the UK, or if the system thinks the pack has already been decommissioned (i.e. it could be a counterfeit or faulty medicine or a pack that has been reported stolen) then a warning alert not to supply the pack will be issued. The Medicines and Healthcare products Regulatory Agency (MHRA) — the UK’s regulatory authority for medicines (the national competent authority) — will also be informed.

 

Will the FMD apply to all medicines?

 

In practice, almost all prescription medicines will require a barcode. There will be a few exceptions that will appear on a “white” list. Over the counter (OTC) medicines will only need to be scanned if there is evidence of them being subject to counterfeiting. In these circumstances they will appear on a “black” list. The MHRA will hold and monitor both lists.

 

Who will be affected by the FMD?

 

Operationally, the FMD will affect everyone along the supply chain because they will need to comply with the new legislation. If everything works well, patients should not be affected. But if a counterfeit is found just prior to dispensing there might be a delay in the patient obtaining their medicine. The FMD legislation is deliberately vague about the definition of “point of dispensing”, which it says should be as near to the patient receiving the pack as possible. But there is some flexibility — for example, you could have a two-stage process; scanning to authenticate when the stock comes into the pharmacy and then checking out when the pack is used. Different countries have different ways of doing things.

 

How much is it going to cost?

 

No idea. The manufacturers are only going to pay for the verification system up to the pharmacy door; who pays after that hasn’t been decided.

 

Do pharmacists need to prepare for the new legislation?

 

Pharmacists will need to have an awareness of the new legislation, as with any changes in the law, and they will have to become familiar with the new software. But I don’t envisage that being a heavy burden — some systems already use scanning technology. Whenever any new legislation comes in, the RPS looks at it to see how we can support pharmacists — this won’t be any different. Standard operating procedures (SOPs) will need to be revised to accommodate the new processes, including those for dispensing, reporting exceptional events, business continuity plans and staff training.

 

What other benefits do you think will come from the FMD?

 

The 2D barcode can hold more information than is required by the legislation, and the RPS has suggested that extra safety features could be added. For example, with electronic prescribing you could scan the pack and link it to a prescription as an extra accuracy check and as an expiry date check. There are also many innovative possibilities, such as having patient information videos on use of medicines built in.

 

What are the challenges associated with FMD?

 

The FMD will require changes to be made in the way pharmacists work. For example, there’s a ten-day window for re-entering packs back into the system; so if you scan a pack when a prescription is assembled but the patient doesn’t collect it within ten days you cannot re-enter it into the system. Whereas, if you scan the pack when the patient picks up their prescription you wouldn’t have that problem. There are also questions around how FMD will work with hub and spoke operations.

 

A lot of thought is going to have to be given to the practicalities of implementation to make sure that access to medicines is not hampered in any way for patients. If there are any gaps in the system that’s where the counterfeiting will take place.

 

The MHRA has been meeting with stakeholders to prepare for this. We understand that there’s going to be an impact assessment and a consultation in 2017.

 

Will Brexit have any effect on how the FMD works in the UK?

 

No. Coming out of Europe, we have questioned whether, longer term, we would need to comply with the FMD in exactly the way that we have to at the moment. But, as far as we can see, Brexit will not make any difference as the Directive is already in UK legislation. This is a pan-European system; if we don’t comply then we become a weak link within the system.

 

How has the RPS been involved?

 

The RPS has been engaged at UK and European level. We’ve responded to several consultations and engaged with all stakeholders. We’ve had an expert working group across sectors and spoken with European Commission staff in Brussels to try to ensure that the FMD will be fit for pharmacy practice in the UK — we’ve been successful in getting many changes to the legislation. One change related to the ten-day rule. We realise that having a ten-day window for re-entering packs back into the system is not ideal but, originally, they wanted the window to be 72 hours. This would have presented lots of challenges in practice, with potential for huge increases in NHS waste. The EC have also made allowances for the fact that we still split packs in the UK because pharmacies don’t do that in most other European countries.

 

On the industry side, we’ve worked with manufacturers to strengthen the security of prescription and patient data. No patient details will be stored in the UK hub, enabling links with patient medication record (PMR) systems. This will allow all processes related to dispensing to be operated through one workstation and to have all information in one barcode. We argued for safeguards for when IT systems fail so that normal dispensing isn’t adversely affected, including ensuring uploaded data doesn’t crash a system; the system does not slow down at peak periods; and that barcodes are stored until transmission is possible and packs have a human readable code for emergency use.

 

Establishment payments to be phased out in pharmacy funding overhaul

21 October 2016, The Pharmaceutical Journal, Ingrid Torjesen

 

The UK government has outlined further changes to fees and allowances for community pharmacies in proposals dubbed a “slap in the face” by industry bodies.

 

Establishment payments will be gradually phased out from December 2016, the Department of Health announced on 20 October 2016.

 

The end of the payments, which are worth around £25,000 per year and are paid to pharmacies provided they dispense a certain number of prescriptions, was revealed in documents, including a report entitled ‘Community pharmacy in 2016/17 and beyond: final package’.

 

This was published after health minister David Mowat delivered a statement to the House of Commons on 20 October 2016 confirming that community pharmacy funding will be cut by 4% in 2016–2017 to £2.687bn, and by a further 3.4% in 2017–2018 to £2.592bn.

 

The documents outline a range of changes to community pharmacy fees and allowances, which will be reflected in the Drug Tariff from 1 December 2016, the date that the budget cuts will be implemented.

 

From December 2016, establishment payments will be cut by 20% compared with 2015–2016 levels — equivalent to a 6.7% reduction in 2016–2017 as a whole. Then, on 1 April 2017, they will be cut by a further 20%.

 

As such, a pharmacy currently receiving the top level establishment, equivalent to £2,092 per month, can expect it to be cut to £1,673 per month in December 2016 and to £1,255 per month by April 2017. The payment will be phased out completely by the end of 2019–2020.

 

In his address to the House of Commons, Mowat said establishment payments were “an inefficient allocation of NHS funds when 40% of pharmacies are now in clusters of three or more which means two-fifths are within ten minutes walk of two or more other pharmacies”.

 

Also from 1 December 2016, a new single activity fee will be implemented as part of the overhaul. The fee will encompass the professional fee (dispensing fee), practice payment, repeat dispensing payment, and the monthly electronic prescription service (EPS) payment. It is anticipated this will be worth £1.13 per prescription item.

 

Additional fees paid for dispensing prescriptions for specific types of product, such as unlicensed medicines, appliances and controlled drugs, will remain, as will the one-off set-up payment for ‘EPS release 2’, the second phase of the transmission of electronic prescriptions, although this payment will cease from April 2017.

 

In addition, a new pharmacy access scheme will be introduced alongside the changes to protect the viability of pharmacies. Mowat reassured that the scheme will be put in place from December 2016 until March 2018, to protect patient access in areas of deprivation or where community pharmacy provision is sparse.

 

Furthermore, the proposals say that up to £75m of the £2.592bn community pharmacy budget for 2017–2018 will be allocated to a new quality payment scheme from April 2017. However, pharmacies will have to meet four criteria before they will be considered for the payment, including provision of least one specified advanced service and use of the electronic prescription service.

 

The quality payment scheme will be worth at least £6,400 per pharmacy per annum to stores that manage to meet all the criteria and possibly as much as up to £12,800 per pharmacy per annum, depending on how the sector performs as a whole. It is not expected that all pharmacies will meet all the criteria.

 

Also, NHS England’s £42m pharmacy integration fund (PhIF) has been set up to support the development of clinical pharmacy practice in a wider range of primary care settings over 2016–2018.

 

The PhIF is intended to support community pharmacy to develop new clinical pharmacy services, working practices and digital platforms during 2016–2017 and 2017–2018. It was announced on 14 October 2016 that the fund will support two pilot schemes — an urgent medicines supply service and urgent minor illness service — from December 2016 to April 2018. The schemes are being developed to take direct referrals from NHS 111.

 

The PhIF will also be used to support deployment of clinical pharmacists and pharmacy services in community and primary care settings, including groups of general practices, care homes and urgent care settings, such as NHS 111.

 

Responding to the announcements, Sue Sharpe, chief executive of the Pharmaceutical Services Negotiating Committee (PSNC), the body that represents pharmacy contractors, says: “The removal of establishment payments will target… the low dispensing volume pharmacies in areas with the highest health needs. [These pharmacies will] see fee income reduced by around 20% [in 2017], at a time when the NHS has said that efficiency targets of 4% are too high to be achievable, [but it] has reduced targets to 2%.”

 

Sharpe adds that although it is unlikely that pharmacies will close immediately as a result of the pharmacy funding cuts, pharmacy owners will be forced to take steps quickly to reduce costs.

 

“These are likely to include reducing opening hours and staffing, and stopping the provision of services which they are not obliged to provide, such as home delivery of medicines and the supply of medicines in compliance aids.

 

“As they are forced to review their operating costs and consider staff cuts, patients may find that they have to wait longer to receive advice that would previously have been readily available,” she adds.

 

Sharpe also warns that big policies could be railroaded by the community pharmacy proposals, “for instance if social care cannot cope with the increase in people left without support, there could for example, be a rise in hospital admissions”, she says.

 

The PSNC has published indicative income tables to help contractors to predict the impact on their businesses.

 

Ian Strachan, chair of the National Pharmacy Association, which represents independent pharmacies, says that the announcement is a “slap in the face” for hardworking pharmacy teams and for concerned patients.

 

“Millions of worried patients have asked the Department of Health to think again,” he says. “Politicians from all parties are against the cuts. It is abundantly clear that the current policy approach is flawed and universally unpopular,” he says.

 

“Elements within government seem determined to press ahead with this damaging experiment, deaf to the nationwide protests. It is clear that they believe there are too many pharmacies and want closures.”

 

Rob Darracott, chief executive of Pharmacy Voice, a pharmacy trade body, says: “We have spent the last ten months explaining to [the government] the value of community pharmacy, the pressure we take off other parts of the NHS and the money we save the government by keeping patients out of GP surgeries and A&E.

 

“[Members of the] public have made it clear to [the government] that they expect their local pharmacies to expand their role in the community and MPs from every party have outlined how cuts will harm the interests of their constituents,” he adds.

 

In a statement, the Royal Pharmaceutical Society (RPS), the professional body for pharmacists, says: “We have consistently asked how the government’s aspiration for the future of community pharmacy to be at the heart of the NHS can be squared with large reductions in funding.

 

“We know that many pharmacists, whether they own a pharmacy or work for a pharmacy business will be hugely concerned about the future. We have been very clear about our opposition to funding reductions, but we know that the profession needs more from us at this time. The RPS will also make sure we offer pharmacists practical support to plan for the change that will begin on 1 December.”

 

Revealed: Which pharmacies will be protected from the cuts

21 October 2016, Chemist & Druggist, Annabelle Collins

 

A total of 1,356 pharmacies in England – around one in 10 – will receive money from the government’s “pharmacy access fund” to offset the worst of the incoming cut to funding.

 

A C+D analysis of the full list of these pharmacies – published by the Department of Health yesterday (October 20) – revealed that 312 (23%) of those listed belong to the three largest multiples.

 

This figure consists of 124 Boots branches, 56 Well branches, 107 Lloydspharmacy branches, as well as 25 Sainsbury’s branches – which transferred over to Lloyds last month.

 

A total of 36 Asda and Morrisons pharmacies will receive financial protection, as will 47 Rowlands branches and 37 Day Lewis pharmacies.

 

Distance-selling pharmacies were not eligible for the scheme, the DH said.

 

A full list can be found here.

 

Still expected to make efficiencies

 

The payment will amount to “roughly” £2,900 per month for 2016-17 and £1,500 per month for 2017-18, the DH said yesterday.

 

However, these pharmacies must still make efficiency savings of 1% in 2016-17 and 3% in 2017-18, it stressed.

 

To make it onto the list, pharmacies have to be more than a mile away from another pharmacy “by road” and not in the top 25% of pharmacies according to dispensing volume, the DH said.

 

It added: “Pharmacies that might have narrowly missed out on the access scheme through the distance criteria, but are in an area of high deprivation, will be eligible to ask for a review.”

 

“This will cover pharmacies that are located in the 20% most deprived areas in England and are 0.8 miles or more from another pharmacy, and are critical to access,” it added.

 

“Funding for successful reviews will be made available as required from outside of this package,” it added.

 

Government lists pharmacies that will be shielded from full effect of funding cuts

21 October 2016, The Pharmaceutical Journal, Ingrid Torjesen

 

Around 1,300 pharmacies in areas of deprivation or where community pharmacy provision is sparse will receive additional payments under the Pharmacy Access Scheme.

More than 1,300 pharmacies will receive additional payments to protect against the full effects of community pharmacy funding cuts in England. The additional payments will come from the total funding package being offered to the sector.

 

A total of 1,356 pharmacies have been identified as being in either an area of deprivation or an area where community pharmacy provision is sparse, according to a list published by the Department of Health (DH). The pharmacies listed meet three criteria: they are more than a mile away from another pharmacy by road; were on the pharmaceutical list on 1 September 2016; and are not high volume dispensing pharmacies (i.e. they are not dispensing 109,012 prescription items per year or more).

 

The named pharmacies will receive monthly payments under a pharmacy access scheme (PhAS) that will run from December 2016 until March 2018. There is no commitment to continue payments after this date. The average payment will be around £11,600 in 2016–2017 and £17,600 in 2017–2018. The exact payment will be based on the funding the pharmacy received in 2015­–2016, incorporating an efficiency saving of 1% in 2016–2017 and 3% in 2017–2018. This efficiency saving is smaller than the one being applied to the whole sector, which is 4.6% in 2016–2017 and 8.3% in 2017–2018.

 

“While efficiencies are being asked of community pharmacy, just as they are of other parts of the NHS, there is still sufficient funding to ensure there are accessible and convenient local NHS pharmacy services across England,” says Keith Ridge, chief pharmaceutical officer for England.

 

Pharmacies not on the list can apply to NHS England to have their case reviewed. Applications for review will be accepted from 1 November 2016 and must be made within three months of the start of the scheme (by the end of February 2017). NHS England will aim to complete the review process within six weeks.

 

Applications for review can be submitted if the pharmacy is believed to be more than one mile from the nearest pharmacy; if a semi-permanent road or bridge closure means that the nearest pharmacy is more than a mile away; or if the nearest pharmacy is less than a mile but the journey is particularly difficult.

 

Reviews of eligibility will also be granted to some pharmacies that may have narrowly missed out on the scheme through distance criteria (i.e. they are 0.8 miles or more from the nearest pharmacy). The near miss criteria will apply to pharmacies located in the 20% most deprived areas of England. To be successful in the review process, a pharmacy will need “to demonstrate that a local population relies on that pharmacy and would be materially affected by its closing”.

 

If a qualifying pharmacy subsequently increases the volume of prescription items it dispenses, the pharmacy will not lose entitlement to PhAS payments. “This is to ensure that pharmacies are not penalised for becoming more efficient, and seeking to grow their business,” the DH’s document says.

 

On funding beyond 2018, the DH states: “Funding levels and the PhAS beyond March 2018 will be subject to further consultation, which will include reviewing the PhAS and its effectiveness.”

 

In a statement issued on 20 October 2016, the Royal Pharmaceutical Society says: “Today we have heard more detail about the PhAS, with some additional funding for pharmacies in deprived communities. It remains to be seen if this scheme will lessen the impact on opening hours and staffing levels in these vital community pharmacies.”

Cost of Spain’s pharma industry to adapt production lines to medicines verification system
17 October 2016, The Pharma Letter

Spain’s pharmaceutical industry has plans to invest roughly 200 million Euros over the next two years into the adaption of its production lines. This investment is being used to incorporate the technical requirements of a new medicine verification system, as part of the European Falsified Medicines Directive and its delegated regulation. It is thought that in Spain this verifiable system will require an investment of 10 to 13 million Euros and annual support of between 5.5 and 8 million Euros.

Breaking: Just 1,380 pharmacies will be supported by Pharmacy Access Scheme
17 October 2016, Pharmacy Business, Neil Trainis

A leaked document from the Department of Health has revealed that the Government is intending to help 1 in 10 community pharmacies in England following the implementation of proposed cuts. The support will come through the Government’s Pharmacy Access Scheme which is designed to protect pharmacies from closure if they are situated in an area under-populated with community pharmacies. If a pharmacy qualifies for the scheme they will receive a top-up payment from the Government that will help ease the effect of the funding cuts. However, Labour MP Michael Dugher, believes that even with the Pharmacy Access Scheme there will be a large number of community pharmacies forced into closure if the proposed funding cuts are implemented.

This was also reported by Chemist & Druggist

You can follow the latest news and reactions to the pharmacy funding cuts at the Pharmaceutical Journal

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

Cost of Spain’s pharma industry to adapt production lines to medicines verification system

17 October 2016, The Pharma Letter

 

The pharmaceutical industry based in Spain will invest around 200 million euros ($220 million) over the next two years in order to adapt its production lines thus incorporating the technical requirements of the new system for the unitary verification of medicines.

These are the economic estimations of the sector, based on an average cost of 300,000 euros per line, according to an announcement by the Spanish trade group Farmaindustria, noting that this is an initial investment which only looks at the adequacy of the machinery and the start up process.

Unit verification of medicines in Europe is a requirement originating from the European Falsified Medicines Directive and its delegated Regulation. Its aim is to avoid the risk of falsified drugs entering the legitimate supply chain of medicines dispensed in pharmacies, further strengthening for the patient the full guarantee of medicines dispensed in pharmacies. Spain has adapted to this European regulation, even when the current manufacturing, distribution and dispensing system in our country today makes it barely impossible for falsified medicines to enter this legal channel.

Could amount to half a million euros

These investments in production lines are the first step in attaining the full operation of the verification system taking into account that, afterwards, companies will have to face a series of diverse expenses, such as the ones derived from the maintenance and printing of datamatrix and serialization, the latter representing a figure which could amount up to half a million euros per production center.

On the other hand, each laboratory will have to take on the appropriate fee in order to develop and maintain the Spanish Drugs Verification System (SEVeM), which should be at full capacity, as in other countries of the European Union from February 2019. Thus, the launch of the verifiable system requires between 10 and 13 million Euros of investment and an annual support of between 5.5 and 8 million Euros from this year.

According to European regulations, adaptation of the production lines will work in a way so that packaging will incorporate closures to allow for verification that it has not been tampered with, and a new two-dimensional code (Datamatrix) containing a unique and random serial number for each package. These serial numbers will be placed in a European repository and pharmacies, before dispensing the medication to the patient, will need to verify the authenticity of the package by a corresponding telecommunications link with the national repository, managed by the SEVeM.

During this adaptation period of these new requirements, it is expected that the Administration will regulate certain aspects that European legislation leaves at a purely national level. In this sense, Farmaindustria maintains a close relationship with the Spanish Agency for Medicines and Health Products (AEMPS) that will contribute to the industry allowing for them to adapt to the new requirements in an environment of ongoing dialogue.

However, the high costs involved for the production centers introducing technical requirements and maintenance derived from a system of drug verification, which responds to a request from a European character, would justify the adoption of measures supported by administrations.

In this sense, Farmaindustria says it is working on different proposals so that the economic impact of the verification system is acceptable, especially for small and medium-sized enterprises, because in some cases they will have serious difficulties in coping with the expenditure required to get it up and running.

 

BREAKING: JUST 1,380 PHARMACIES WILL BE SUPPORTED BY PHARMACY ACCESS SCHEME

17 October 2016, Pharmacy Business, Neil Trainis

 

A leaked ministerial document seen by Pharmacy Business has revealed the government intends to support just 1,380 community pharmacies in England through its Pharmacy Access Scheme despite promising to help pharmacy thrive through the initiative in the wake of swingeing funding cuts.

The document, originally obtained by the Labour MP Michael Dugher, uncovers the extent to which community pharmacy will benefit from the scheme, which was designed to protect pharmacies situated in areas that are not overpopulated by other pharmacies from closure as a result of the government’

The government was supposed to decide which pharmacies would benefit by creating a national formula identifying pharmacies which, geographically speaking, are most important for patient access.

Other factors were to be considered, including distance and travel times to pharmacies and population size and needs based on age, disability and deprivation. The government has been criticised by pharmacy bodies for a lack of clarity around the scheme’s formula.

The leaked document reveals that 1,380 pharmacies, equating to 11.8% or one in 10 of the total number of pharmacies in England, will receive support through the scheme.

In the document, the government says pharmacies one mile or more from another pharmacy “will be automatically eligible” and having assessed population travel times and needs, ministers say measures are in place to “ensure that no populations with high needs levels will slip through the net in terms of access.”

The document also said that pharmacies benefiting from the Access Scheme will receive a top-up payment taking them back to their 2015-16 remuneration levels minus a 3% efficiency saving.

“Taking all of these design elements together, we estimate that the scheme will support 1,380 pharmacies, at a cost of £12 million in 2016/17 and £27 million in 2017/18,” the document said.

“From our initial calculations, the vast majority of qualifying pharmacies will be opted in through the first rule (the ‘mile or more’ rule) and only a handful will be opted in through scoring highly on the index.

“As a rough indication, we would expect the estimated average payment per pharmacy to be £8,500 in 2016/17 and £19,500 in 2017/18.”

The document contradicts a promise made in December last year by Alistair Burt, the former minister responsible for pharmacy, who said: “Our aim is to ensure that those community pharmacies upon which people depend continue to thrive and so are consulting on the introduction of a Pharmacy Access Scheme, which will provide more NHS funds to certain pharmacies compared with others, considering factors such as location and the health needs of the local population.”

Dugher, who has campaigned vociferously against the cuts to pharmacy funding, accused the government of breaking its promise on the scheme.

“Ministers promised they would listen and consult widely on their planned cost-cutting, but the government is set to force through a brutal package of cuts that could leave many frail and vulnerable patients forced to walk a mile or more to get medicines they need,” he said.

“And we now find they are planning to arbitrarily impose a relief scheme that could still see the closure of many local pharmacies.

“These ill-judged cuts are bad for our communities and bad for our NHS because community pharmacies help to save money by providing free advice and dispensing medicine before patients head to their GP or A&E.

“Ministers must think again and recognise the vital role that community pharmacies play in frontline healthcare before they sound the death knell of thousands of local chemists.”

 

Only 1 in 10 pharmacies to benefit from cuts relief fund

17 October 2016, Chemist & Druggist, Annabelle Collins

 

Just one in 10 pharmacies will be given financial support as part of the government’s planned fund to provide relief from the cuts, a leaked document has revealed.

The Department of Health (DH) estimates its pharmacy access scheme – first proposed to ensure “geographically important” pharmacies are not forced to shut their doors as a result of a cut to the sector’s funding – will only support 1,380 of  the 11,674 in England, according to a leaked government document seen by C+D.

The document – obtained by Labour MP Michael Dugher and shared with C+D yesterday (October 16) – states that the scheme would cost a total of £12 million in 2016-17 and £27m in 2017-18.

It details two categories of eligibility for pharmacies to qualify for the funding. Pharmacies located a mile or more from another pharmacy will be “automatically eligible”, while a “handful” will also receive the funding if “population mapping” shows they are needed to provide care to a “high-need” patient group, according to the document.

The top 25% of pharmacies – based on dispensing volume – will be automatically excluded, as those with “greatest potential to remain viable” should not receive support, the DH stressed in the document.

It estimates that the average payment per pharmacy from the funding will be £8,500 in 2016-17 and £19,500 in 2017-18.

In January, the DH announced plans to “phase out” the current system of establishment payments completely “over a number of years”.

Efficiencies needed by all

According to the document, even pharmacies that are eligible for the fund will have to make efficiencies.

While the top-up payment is designed to bring the funding of eligible pharmacies back up to 2015-16 levels, they will still be required to make a 3% efficiency saving.

The DH said in the document that it “is keen” to discuss the proposals in further detail and called for the Pharmaceutical Services Negotiating Committee’s (PSNC) input.

Last week (October 13), PSNC outlined its 16 objections to the pharmacy access scheme in a letter to the DH’s head of pharmacy Jeannette Howe. The following day, the negotiator rejected the government’s plans to slash the sector’s funding by 12% from December.

The DH declined to comment on the leaked document.

Urgent need for clarity as government suspends pharmacy cut plans

27 September 2016, Pharmaphorum, Richard Staines

 

David Mowat, the Parliamentary Under Secretary of State for Community Health and Care, recently announced that the Government has suspended plans to cut funding for community pharmacy services. However, experts at an IMS Health webinar spoke about the urgent need for clarity. The panel also said the Government was attempting to re-engineer the pharmacy service, and was using the cuts as an opportunity to impose a ‘hub and spoke’ infrastructure. The Pharmacy Minister, Alistair Burt, announced that hub and spoke would not be introduced in October as previously planned, but an uncertainty over the future of these plans remains.

 

The global scourge of counterfeit medicines

29 September 2016, PMLive, Danny Buckland

 

The pharmaceutical industry and regulatory authorities are fighting back against falsified and counterfeit medicines that according to the European Commission cause approximately 100,000 deaths a year. The Alliance for Safe Online Pharmacy in the EU (ASOP EU) warns that 130 million people in Europe are risking their health by ordering medicines from illegal pharmacy websites. The implementation of the Falsified Medicines Directive (FMD) will ensure verification of drugs at manufacture, distribution and in pharmacies. Adrian van den Hoven, Medicines for Europe Director General believes that there is potential for major reputational damage from the sale of falsified medicines as persistent stories about dangerous medicines can breed mistrust.

 

Parliamentary Coverage

 

House of Commons Questions , Drugs, 27 September 2016

Department for Exiting the European Union

Andrew Gwynne: What discussions his Department has had to date with representatives of pharmaceutical companies on the UK voting to leave the EU.

Mr Robin Walker:

Ministers have met with the Association of The British Pharmaceutical Industry (ABPI), and The Secretary of State for Exiting the European Union will be attending the EU UK Life Science Steering Board. We will continue to consult with a broad range of stakeholders on the implications of the referendum result, including the pharmaceutical industry.

 

Full Coverage

Urgent need for clarity as government suspends pharmacy cut plans

27 September 2016, Pharmaphorum, Richard Staines

 

The government has suspended plans that would have put thousands of community pharmacies at risk of closure – but there is an urgent need for clarity, according to experts at a recent IMS Health webinar.

When David Mowat, the Parliamentary Under Secretary of State for Community Health and Care, announced at the beginning of the month that cuts to community pharmacy funding would not be implemented in October, the initial reaction from those affected was one of relief. However, this reaction may be short-lived, as the minister said the government has only decided to put on hold cuts that would probably lead to closure of thousands of pharmacies across the country, while the plans are reviewed.

Mowat’s announcement at the Royal Pharmaceutical Society conference in Birmingham that the government would “take some time” to ensure it is making the “right decision” followed a petition signed by more than two million people opposing the plans.

So the fight is on to secure the future of the small pharmacists that were threatened by the proposals, with one option being to increase their value within the community. Methods to achieve this include being the first point of care more frequently and offering a greater range of patient services, such as disease prevention education, adherence programme delivery and lifestyle advice.

At a recent webinar conducted by IMS Health, in collaboration with pharmaphorum (which took place prior to Mowat’s announcement), IMS Health estimated that proposed cuts of £170 million, from a pharmacy budget of £2.8 billion, could put 2,400 pharmacies at moderate-to-high risk of closure, with 269 of these deemed at very high risk.

John Carney, senior principal, supplier services at IMS Health said that the proposals could lead to “significant disruption” to between 110,000–600,000 people, assuming each pharmacy served around 4,500 people.

The webinar’s expert panel proposed that the government saw pharmacy as an easy target for efficiency savings, but made it clear that the cuts were not the only issue that caused them significant concern.

Hub and spoke

The panel said the government was also attempting to re-engineer the way pharmacies serve patients, and was using the cuts as an opportunity to impose a ‘hub and spoke’ infrastructure. This model is based around a central ‘hub’ where prescriptions are prepared – and patient-facing ‘spoke’ pharmacies that hand out treatments.

The system is already used by some larger chains and is seen by the government as a more efficient way to meet patients’ needs. But, although it works in some instances, this ‘one-size-fits-all’ approach may not be suitable for all areas and populations, and the panel warned it could result in serious reductions in the extra patient services provided by pharmacists that patients rely on, which frequently serve to relieve pressure on other areas of the NHS

In an announcement in July, pharmacy minister Alistair Burt said hub and spoke would not be introduced in October as planned – but the uncertainty over the direction of travel remains.

There are also fears that the government is attempting to introduce more online pharmacies through the back door – even though this does not suit the needs of many patients who rely on community pharmacists as a first port of call if they feel unwell.

Sandra Gidley, community pharmacist and chair of the Royal Pharmaceutical Society’s English Pharmacy Board, told the panel that she was concerned about the trajectory of governmental policy around community pharmacy. While the drive towards online services may suit some patients, those who are older and less likely to adopt new technology are the types of patient who need pharmacists the most, she argued.

Gidley said: “The depressing thing in all of this is that we see a drive to separate the supplies we make from the clinical services that pharmacists can deliver.”

Not just dispensing

Perhaps offering a crumb of comfort to Gidley, and those who have broader concerns about the wider role of pharmacists, Mowat in his speech said the pharmacy profession “rightly recognises that it needs to go further away from just doing dispensing into the service area.”

A Pharmacy Integration Fund, worth £20 million this year and rising to £300 million by 2020–21, was included in the government’s plans, and is intended to help pharmacists and their teams align more closely with GP practices. But details of whether this will still be implemented and, if so, how the scheme will work, are still unclear.

There are also concerns that the cuts to pharmacy will exacerbate problems caused by financial pressures on the NHS. Around three quarters of hospitals are operating in the red, and ran up a deficit of £461 million between April and June. Patient waiting times have increased, with 89.31% (vs. 95% target) of patients being seen within four hours in over-stretched A&E departments.

Services such as community pharmacies could, and should, become more important as hospitals and GP surgeries come under pressure, providing extra capacity that could deal with less serious illnesses.

John Smith, chief executive of the Proprietary Association of Great Britain (PAGB), said: “Our research shows that one-in-five visits to A&E and also to the GP are for conditions that could be self-treated.” The PAGB strongly backs raising the profile of pharmacists as expert healthcare providers. “We believe that, in the role of a high-street healthcare professional, not only will pharmacists enable people to obtain faster treatment but, in reducing the load on the NHS primary – and secondary – providers, they can also deliver savings to the taxpayer,” added Smith.

Changes needed, not cuts

The consensus seems to be that change – but not cuts – is needed to ensure pharmacy services meet patients’ needs and reduce pressure on the busiest NHS wards and A&E units. A recent poll by IMS Health found that 79% of respondents across industry and pharmacy said there was a need for an increased range of patient services in order for them to succeed in the changing environment.

Professor Rob Darracott, chief executive of the umbrella group Pharmacy Voice, said that “most innovation comes through interaction with patients” and argued that community pharmacists were well placed to question patients, identify other health problems and give public health advice, at no charge to the NHS.

Pharmacists already contribute with innovative services such as medicines optimisation, discussing ‘wellness packages’ and improving compliance with prescribed medication. Given that there are a billion transactions a year in community pharmacies, a relatively small change in practice across all pharmacies could yield significant results, Darracott argued.

However, pharmacy has been in turmoil since the government announced its plans in a letter to the industry’s negotiating body late last year.

Deliberations

The sector is awaiting Mowat’s conclusions following his period of deliberation. Although nothing has been officially announced, those involved with community pharmacy will listen intently during Theresa May’s first Autumn Statement, dedicated to NHS funding, for any news.

The panel of experts at the webinar concluded that the government must provide clarity on its plans. There is also a need for an end to the siloed thinking that has proposed swingeing cost cuts, with little thought about the wider implications for patients, the health service and society as a whole.

The PAGB’s John Smith concluded that the government must learn from the response to its proposals and the opposition from pharmacists and patient groups. He said: “We need a strategic approach to building the future between the sector, government and the NHS, which is aligned to the goals of the NHS, but does not leave implementation and delivery to chance.”

Ultimately, though, whatever the government’s next move is regarding these cuts – this is a clear message to the pharmacy sector that its role within the NHS must be more visible to patients and more extensive. As with many of the issues the UK health sector faces, a large part of the solution lies in stakeholder and patient collaboration/education and a clear, measured understanding of the value that the pharmacy sector brings to both the care pathway and the NHS budget.

 

The global scourge of counterfeit medicines

PMLive, 29 September 2016, Danny Buckland

 

The statistics are truly disturbing, with an annual death toll of around 100,000 from falsified and counterfeit medicines, according to the European Commission, and a criminal enterprise that the World Customs Organisation estimates could generate £1bn worth of illicit business in 2017.

But industry and regulatory authorities are fighting back with new measures to identify rogue shipments and coordinated action to disrupt the supply lines that criss-cross the globe.

The trend to seek medical aid online has made it easy for bogus medicines – containing anything from paint and antifreeze to brick dust and floor wax – to be mailed around the world. The Alliance for Safe Online Pharmacy in the EU (ASOP EU) warns that 130 million people in Europe are risking their health by ordering from the 30,000 illegal pharmacy websites that have flooded the Internet

Industry also has to consider the damage to its reputation from the corrosive impact of falsified and counterfeit medicines. ‘Fighting Counterfeit Medicines’ was debated at the recent Medicines for Europe conference (MFE) in Croatia, which drew together the leading voices in generic medicines.

A major concern is that generic medicines may be confused with substandard medicines peddled by criminals to a public struggling to understand the scale of the problem.

Delegates learned about increased safety features that will be implemented by February 2019 in the European Commission’s Falsified Medicines Directive (FMD) which boosts verification at manufacture, distribution and pharmacy. Its features include unique serial numbers and identification features on packs, tougher inspections, strengthened record-keeping and an EU logo to signify legal online pharmacies.

A key element is that the FMD will criminalise the acts of making and selling bogus medicines to create a credible deterrent.

The measures were further bolstered by a strategy meeting held at Google’s offices in Brussels, where campaigning groups and regulators joined forces to face the threat head-on. The group will meet again in September to share best practice and build on plans to address the ‘knowledge demand’ by raising public awareness, as market research reveals the public is largely ignorant to the dangers of buying medicines online.

The reputational damage is clear, according to Adrian van den Hoven, Medicines for Europe director general, because persistent stories about dan-gerous medicines can breed mistrust. Elke Grooten, an MFE board member told the conference: “It is important that we have these discussions in an international context because falsified medicines put patients and the general public at risk across the world – it is a crime against patients.[Industry must] repel the tide of dangerous internet medicines that operates outside the legitimate supply chains

“It is also an issue for healthcare providers caring about their patients because falsified medicines create mistrust in medicines and it is an issue for us as pharmaceutical companies developing and manufacturing high quality medicines – it affects all medicines.”

Van den Hoven highlighted that the new system, working in harmony with industry, will serialise 14 billion prescription drugs a year and enable pharmacies and hospitals to spot counterfeits.

“There have been serious issues. About a year ago there was a theft of empty vials and bottles from a hospital in Italy which were refilled with a liquid and exported to Austria and Germany in quite substantial amounts for serious treatments like cancer,” he said.

“There was an issue of trying to find those products because they disappeared and then reappeared in two different countries through completely illegal trading. They were found and to my knowledge didn’t reach patients but the investigation is still continuing and it was still a scare. The new system will make it extremely difficult for this to happen.”

Mike Isles, executive director of ASOP EU, believes the FMD clampdown must be matched by a twin effort to repel the tide of dangerous internet medicines that operates outside the normal and robust legitimate supply chain.

“It is a massive problem with 18% of the population going online to buy medicines and potentially endangering their lives,” he said. “These sites do not require a prescription and their medicines may have no active substance, too little or even too much. And they may contain toxic substances like floor wax, paint or antifreeze.

“Customers also risk having their credit card details stolen. The problem is that most people do not know these websites are operating illegally.”

He also feels industry, with its significant reach, can play an important role in educating healthcare professionals.

“The benefit is that it will help to prevent patients taking themselves out of their national health systems and potentially damaging their health. Industry is reacting well and has dedicated security people who are the first line who go into a country, compile the evidence and then pass it on to local law enforcement and customs, enabling Interpol or Europol to get involved.”

He added that Google is supporting information campaigns in Europe and the US to help educate patients to enable them to move away from bogus sites and is working on techniques to ensure only legitimate pharmacies are shown in online searches.

An educational campaign by ASOP EU and the European Alliance for Access to Safe Medicines, using Google AdWords to attract online buyers in Italy, revealed that 80% of people were unaware that the majority of online pharmacies operate illegally. A large majority said they would revert to their doctor or pharmacy after learning about the danger.

On the supply side, the task of catching the criminals is huge but Interpol, Europol, national customs’ forces, governments and credit card firms are engaging in the fight.

80% of people are unaware that the majority of online pharmacies operate illegally

An Interpol-led investigation earlier this year closed 4,932 sites and seized 12.2 million counterfeit drugs for cancer, depression, asthma and high cholesterol, along with slimming pills, infertility drugs and bodybuilding steroids. The crackdown across 103 countries resulted in 393 arrests.

Benoit Goyens, of the World Customs Organization (WCO), told the conference that the global value of illegally traded medicines could stretch to £1bn, adding: “The growth is exponential and we are not catching up.”

Research by ASOP EU highlighted that 65% of the public order online believing they are connecting with reputable pharmacies. The number of people using online sites for medical help is growing and ASOP estimated that some gangs haul in £1m in profit a month.

Pharmaceutical products now account for more than half of all goods seized, according to the WCO which reported that painkillers were the most frequently intercepted illicit drug at 36,324,200 in 2014. More than half of the 95,273,060 counterfeit medicines impounded last year came from India and China. Among the seizures was a supply of erectile dysfunction pills that contained a drug that could cause kidney failure.

Crime gangs are attracted to illicit drugs because the profits are high and sentences are rarely more than token fines.

The WCO has launched smart-phone technology to help identify and track shipments, and drugs firms, credit card companies and internet registers have pledged to disrupt the crime gangs’ deadly supply chain.

“This is a widespread and profitable criminal activity, and tackling it requires strong cooperation from all those involved in the pharmaceutical supply chain,” said Pierluigi Antonelli, head of the Western Europe region for Sandoz. “Falsified medicines are responsible for the deaths of thousands of people every year and risk the health and safety of many more.

“We support and drive a range of measures to increase patient awareness of the risks of falsified medicines, increase penalties and sanctions for counterfeiters, close illegal pharmacy websites, introduce serialisation of the legal distribution chain and increase regulatory actions to seize falsified medicines.

“We also strongly urge all concerned to avoid misleading and inaccurate comparisons between illegal falsified medicines and legally authorised, high-quality generic medicines produced by recognised pharmaceutical companies following loss of patent protection. Generic medicines account for 56% of all pharmaceutical prescriptions in Europe today, but only 22% of the cost.”

The fight is on for the health and safety of the public and the pharmaceutical industry’s reputation.

Be ready for EU scanning law 6 months early, warns Alliance

09 September 2016, Chemist & Druggist, Lilian Anekwe

 

Jeremy Main, the Managing Director of Alliance Healthcare has warned that pharmacies should be prepared for the EU falsified medicines directive (FMD) by September 2018, despite the law not coming into force until February 2019. Mr Main made it clear that the pharmaceutical sector cannot continue to put off the preparations for the legislation otherwise they may end up caught off guard by the Christmas and New Year’s rush.

 

Pharmacy will shoulder its share of efficiency savings, warns Mowat

09 September 2016, Pharmacy Business, Neil Trainis

 

The Community Health and Care Minister, David Mowat, has reminded the pharmacy sector that it will not be exempt from the governments bid to make £20 billion in efficiency saving. This warning comes after the announcement that the efficiency savings cuts to community pharmacy have been delayed. He emphasised that the NHS has to make major savings over the coming years and that this will need to be shared across all parts of the healthcare community.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

 

Be ready for EU scanning law 6 months early, warns Alliance

09 September 2016, Chemist & Druggist, Lilian Anekwe

 

Contractors must brace themselves for EU anti-counterfeiting legislation six months before it comes into effect, Alliance Healthcare’s managing director has warned.

When the falsified medicines directive (FMD) comes into force in February 2019, it will require every pharmacy in the UK to scan barcodes, check tamper-proof devices and decommission medicines to prevent them from being reused.

In an exclusive interview with C+D last week (August 31), Alliance Healthcare managing director Jeremy Main said pharmacies should be prepared for the EU law by September 2018, so they are not caught off-guard by the Christmas and New Year rush.

The sector can no longer afford to “bury its head in the sand” about the legislation, as it will have a “big impact” on community pharmacy, Mr Main said.

Two-year timeframe

“FMD is one of the big challenges we’ve got ahead,” he added. “It’s got to be implemented by February 2019, but we’ll really need to have done the work by September 2018, which is just two years away.”

Alliance Healthcare estimates that gearing up for the implementation of the legislation could cost millions, through buying new equipment – such as barcode scanners to track and trace medicines – and introducing new working practices for staff.

“We think we now fully understand what needs to be done, and we’re going to make sure that we implement the right solution to support our business and the whole industry,” Mr Main said.

Hub-and-spoke concerns

Mr Main also said plans to introduce more automation in the sector – by allowing independent pharmacies to legally operate automated dispensing hubs – appeared to be “in the long grass” for now.

While Alliance Healthcare has gained some experience of operating central dispensing hubs from Boots – also owned by parent company Walgreen Boots Alliance – Mr Main said he still has concerns that hub-and-spoke is “not yet proven”.

 

Pharmacy will shoulder its share of efficiency savings, warns Mowat

09 September 2016, Pharmacy Business, Neil Trainis

 

David Mowat, the community health and care minister, punctured any optimism community pharmacy might be feeling over a possible u-turn on cuts to its funding by reminding the profession it is not exempt from the government’s bid to make £20 billion in efficiency savings.

In what was a sobering nudge to pharmacy on a relative high after the government’s decision to delay its £170 million cut to pharmacy’s 2016-17 budget, Mowat (pictured) said hard times lay ahead for all sectors within the NHS.

“The message that I’m giving you is that we are looking at (the plans) but it is also true, and there is no getting away from this, that over the next few years in the NHS there is a need for something like £20 billion worth of productivity savings,” he said during the PSNC’s launch of a report which revealed pharmacy contributed £3 billion to the NHS, public sector and wider society last year.

“That will need to be shared across all parts of the healthcare community. There’s a new government, a new Prime Minister and a new Chancellor of the Exchequer and we are taking a look at the way forward.”

Mowat did not say how long the government would take to review its plan to cut pharmacy funding or what the chances are that it might reverse its decision, saying only that they would “be coming back with proposals as soon as possible.”

Mowat’s remarks came as the PSNC unveiled a report highlighting the value of community pharmacy, a study that appeared to impress the pharmacy minister. He also praised Pharmacy Voice’s Community Pharmacy Forward View and even found time to inject a touch of humour into proceedings.

“I discovered my daughter-in-law’s sister is a pharmacist so there’s another lobbying mechanism,” he said to the backdrop of laughs.

Falsified medicines directive: the clock is ticking

30 August 2016, Chemist & Druggist, Jeremy Main

 

The implementation of the falsified medicines directive (FMD) is quickly approaching, despite some beliefs that Brexit may halt it or prevent FMD from happening, it is already entrenched into UK legislation and is certain to go ahead. This means that the countdown is on for the pharmaceutical industry to comply with the enhanced security requirements. There is a collective responsibility in the industry and it is important that all the manufacturers, wholesalers and distributers have an aligned approach for the FMD’s implementation. Jeremy Main the Chair of the HDA wants to encourage the pharmaceutical industry to begin the preparations now rather than leave it too late.

 

Shortages force GPs to prescribe second choice drug and causes harm

30 August 2016, Pharmacy Business, Neil Trainis

 

A survey of 441 GPs run by GPOnline found that 82% of them have been forced to prescribe a second choice drug to patients due to shortages. A further 18% of these GPs said that their patients experienced negative effects of these second choice drugs, including harm or slower recovery. Dr Andrew Green, Chairman of the GPC Clinical and Prescribing Subcommittee believes that informing GPs about drug shortages is a very key issue and he feels they would be open to some form of central system to alert them about shortages.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

 

Falsified medicines directive: the clock is ticking

30 August 2016, Chemist & Druggist, Jeremy Main

 

Whilst proposals for a hub-and-spoke prescription fulfillment model appear to have been pushed onto the back burner, the implementation of the falsified medicines directive (FMD) is really starting to cook on gas.

This affects everyone within the pharmaceutical supply chain and is a transformational change to current systems and processes.

You may be tempted to believe FMD will disappear following the EU referendum, but no one should bury their head in the sand; FMD is already incorporated into UK legislation and is certain to happen.

With the legislation becoming effective from February 9, 2019, the countdown is on for the pharmaceutical industry to comply with the enhanced security requirements. With increasing fears, concerns and instances of counterfeit medicines entering the pharmaceutical supply chain, these changes should be welcomed even if they don’t come cheaply.

Collective Responsibility

Previously, I’ve encouraged all parties to take a holistic view of the industry. FMD is a prime example of an issue affecting all stakeholders and needs to be considered by manufacturers, wholesalers and dispensers with an aligned approach.

The legislation requires prescription medicines for sale to carry a unique and randomised serial number encoded in a 2D-barcode and a visible anti-tampering device.

Manufacturers will be responsible for uploading the serial numbers to a system of national databases linked by a European hub, and country-based national data repositories will allow verification at different times and final decommissioning when each pack is dispensed to a patient.

At each stage of the supply chain, the product will be inspected to ensure it hasn’t been tampered with, has not previously been dispensed and that the packaging is intact. Additionally, goods distribution practice (GDP) guidelines will require the individual product to be scanned to record the batch number and expiry date. This check will indicate whether the product is authentic and bring up information such as whether the product has been subject to a recall.

These actions, to be carried out across the pharmaceutical supply chain, are vital to its integrity and minimise the opportunity for the original product to be replaced with a counterfeit.

FMD to increase patient safety

I wholeheartedly support the objective of FMD to implement end-to-end verification of the medicines supply chain for all prescription medicines, to not only enhance patient safety, but also provide greater confidence in the integrity and quality of medicines prescribed.

To ensure its successful implementation, FMD will require significant investment both in financial terms and a commitment of time and resource.

As one of the UK’s leading pharmaceutical wholesalers, we’ll continue to work with regulators, stakeholder bodies, our manufacturer partners and pharmacy customers to ensure all participants in the medicines supply chain are ready to safely implement the processes for medicines authentication in time.

Transformational change

February 2019 may seem a long way off, but don’t underestimate the scale of change required and, in reality, we have less than two years to be ready and to develop, test and input new systems and working practices. I’d encourage everyone to familiarise themselves with the requirements and start collective discussions with stakeholders now!

I have no doubt the change will be difficult and will come at a price, but I believe the long-term benefits far outweigh the short-term challenges. Given that all of us either take some form of medicine or have family or friends who are dependent on medication, it may be in our best interests to deliver this solution for the benefit of all.

 

Shortages force GPs to prescribe second choice drug and causes harm

30 August 2016, Pharmacy Business, Neil Trainis

 

An online survey of GPs has reignited concerns that drug shortages continue to blight patient care across the UK.

The survey, run by GPonline, found that 82% of 441 GPs who took part were forced to prescribe a second choice drug in the last year because of a shortage.

Of great concern was 18% of those GPs who said patients went on to experience “negative effects…including harm or slower recovery.” That conflicted sharply with Earl Howe’s infamous insistence to an All-Party Pharmacy Group inquiry in 2012 that there was no firm evidence that drugs shortages caused patient harm.

“The issue of secure drug supply is an on-going problem that no one has been able to adequately address. Sometimes problems can be very localised, so you can have difficulties in one part of the country and not in others. That makes informing GPs really quite a difficult task to do,” Dr Andrew Green, chairman of the GPC clinical and prescribing subcommittee, told GPonline.

“That’s an absolutely key issue. The first thing a GP knows about a drug shortage is when a patient returns disgruntled from the community pharmacy saying that the chemist can’t get hold of a particular medicine.

“And even when that happens, you can’t be sure if it’s a problem that’s widespread or limited instead to that particular pharmacy chain. I think that GPs would welcome some sort of central system of alerting, but it doesn’t help patients who are on a regular medication.

“There’s no doubt patients find changes in medication inconvenient, and whenever you change a patient from a medication on which they are settled there’s always a chance of introducing new adverse drug reactions.”

Doubts over hub-and-spoke as government fails to think plan through

13 April 2016, Pharmacy Biz, Neil Trainis

 

Pharmacy biz reports that David Reissner, a partner at legal firm Charles Russell Speechlys, stated he had doubts about the UK Government’s claims that the hub-and-spoke dispensing model will generate efficiency savings, due to the lack of evidence provided. He added he had concerns over how this model would work in light of the Falsified Medicines Directive.

 

Parliamentary Coverage

House of Commons, Written Answers; Pharmaceutical Services Negotiating Committee

 

Royston Smith (MP): What recent discussions he has had with the Pharmaceutical Services Negotiating Committee?

 

Department of Health

 

Alistair Burt (MP): Community pharmacy is a vital part of the National Health Service and can play an even greater role. In the Spending Review, the Government re-affirmed the need for the NHS to deliver £22 billion in efficiency savings by 2020/21 as set out in the NHS’s own plan, the Five Year Forward View. Community pharmacy is a core part of NHS primary care and has an important contribution to make as the NHS rises to these challenges. The Government believes efficiencies can be made without compromising the quality of services or public access to them. Our aim is to ensure that those community pharmacies upon which people depend continue to thrive and so we are consulting on the introduction of a Pharmacy Access Scheme, which will provide more NHS funds to certain pharmacies compared to others, considering factors such as location and the health needs of the local population.

The Government’s vision is for a more efficient, modern system that will free up pharmacists to spend more time delivering clinical and public health services to the benefit of patients and the public.

We have been in detailed discussions with the Pharmaceutical Services Negotiating Committee (PSNC) since December 2015 regarding the Government’s proposals for community pharmacy in 2016/17 and beyond, including the proposal for a Pharmacy Access Scheme. In parallel, we also want to hear views on our proposals from across the sector and from patient groups. We published our open letter to the PSNC on 17 December 2015 and on 27 January 2016 we published a set of slides setting out the proposals with a foreword by the Chief Pharmaceutical Officer.

We announced on 16 March 2016 that the consultation period was to be extended to allow more time to develop the proposed changes with the PSNC and others. It will now close on 24 May 2016.

Once we have carefully considered the outcomes from the consultation, we are looking to communicate final decisions as soon as possible, so that pharmacy contractors are fully informed some months before the funding reduction starts from October 2016.

The role of the general practice pharmacist is distinct from the role of the pharmacist in a community setting. However, they are synergistic. Pharmacists working in general practice will, in the main, work with patients who have long term conditions to support them with their medicines and self-management of their condition by helping with the development and review of individual care plans. These patients will not generally be those with minor illnesses which can be treated by seeing a pharmacist in a community setting and for whom community pharmacy will remain the first, and most appropriate, option.

 

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Doubts over hub-and-spoke as government fails to think plan through

13 April 2016, Pharmacy Biz, Neil Trainis

 

David Reissner, a partner at Charles Russell Speechlys, told the law practice’s conference in London today that he has doubts over the government’s claim that a hub and spoke dispensing model across pharmacy will generate significant efficiency savings and accused ministers of failing to justify the assertion with evidence.

 

Criticising the government over its plans for a widespread hub and spoke system, which have been met with a backlash from the community pharmacy profession, Reissner (pictured) said: “One of the key features of the Department of Health’s letter to the PSNC on December 17 last year, my impression is that the government thinks that if all pharmacies used hub and spoke dispensing models you’ll save a lot of money and that will somehow justify (it).

 

“I haven’t see anything to justify that or if the government has the figures to justify that. Many of you will have your own views about whether it’s realistic to expect community pharmacies to take up hub and spoke dispensing and make large savings. That seems doubtful to me.”

 

Plans for a hub and spoke model have been driven forward by the health minister Alistair Burt and Keith Ridge, the chief pharmaceutical officer.

 

It is not the first time Reissner has criticised the government over its pharmacy efficiency plans. Last month he said ministers had “not satisfactorily addressed” issues over the validity of its consultation on proposals to slash pharmacy funding by £170 million. Eight clients belonging to Charles Russell Speechlys indicated they were prepared to take the government to court over the validity of the consultation, which ends on May 24.

 

Reissner also said he had concerns about how a hub and spoke dispensing model would work in light of the Falsified Medicines Directive.

 

Under the Directive pharmacists will be required to scan the barcodes of medicines at the point of dispensing from 2019. Reissner accused the government of failing to thoroughly consider the practicalities of hub and spoke.

 

“It also impacts on the Falsified Medicines Directive because if a product has to be scanned and decommissioned at the time of supply, does that mean that the hub doesn’t do that even though it’s the hub that is doing the dispensing?” Reissner said.

 

“I’m not sure how practical that is going to be because if, for example, the hub (has) the original pack in order to make a supply, then the spoke is not going to have the original pack with the barcode. So that at the moment doesn’t look like it’s been thought through by the Department of Health.”

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.”

From Factory to Pharmacy

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