HDA Media And Political Bulletin – 8 March 2016

Lawyers formally warn Burt about ‘legally flawed’ cuts

Chemist and Druggist, Samuel Horti, 7 March 2016

 

Law firm Charles Russell Speechlys sent a letter to the government with a warning that its planned cut to community pharmacy funding is flawed from a legal point of view. It has given a deadline of March 18 for the government to issue a response, depending on which its clients might launch legal action.

 

Pharmacy Biz also reported this news.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

CONSULTATION ON FUNDING CUTS COULD BE LEGALLY CHALLENGED

Pharmacy Biz, Neil Trainis, 7 March 2016

 

David Reissner, a partner at Charles Russell Speechlys, has suggested the government’s consultation on its cuts to pharmacy funding may have to be “restarted and conducted properly” if the pharmacy profession chooses to legally challenge its validity.

 

Speculation has been rife that community pharmacy will contest the validity of the consultation, which ends on March 24, in the high court. The consultation has been intensely criticised by heads of pharmacy organisations, although both Pharmacy Voice and the National Pharmacy Association both refused to confirm if they will instigate a legal challenge.

 

Ian Strachan, the chief executive of the NPA, has said the consultation is “short on detail” while Claire Ward, chair of Pharmacy Voice, has described it as “fundamentally flawed.”

 

“The consultation may have to be restarted and conducted properly,” Reissner, pictured at this year’s Sigma conference in Jamaica, told Pharmacy Business.

 

“It is not possible to say yet what will happen as a result of a proper consultation, because we do not know what information will be provided to support the Department of Health’s proposals.”

 

When asked if a legal challenge was likely to succeed, he said: “My clients have received a QC’s advice that a challenge to the consultation process would succeed unless the Department of Health complies with the requirements of a valid consultation.”

 

Reissner added: “(A) consultation is a legal requirement. The NHS Act says the Secretary of State cannot change remuneration without it.

 

“Consultation has a legal meaning and the Secretary of State must provide sufficient details of what is proposed, and keep an open mind about implementing remuneration and other changes until the consultation responses have been considered.”

 

A separate consultation is to be held on the government’s plan to introduce a hub and spoke dispensing model across community pharmacy.

PHARMACISTS WILL NOT TALK ABOUT STRIKING DURING MEETING WITH LEADERS

Pharmacy Biz, Neil Trainis, 8 February 2016

 

Pharmacy Business reports on a large meeting gathering more than 400 pharmacists and pharmacy representatives, including Sue Sharpe (PSNC) and Ian Strachan (NPA). The meeting aims to discuss a response to the 6% pharmacy funding cut and the progress in negotiations with government officials.

 

Government’s £4.2bn investment for NHS IT includes money for ‘click and collect’ prescription service

The Pharmaceutical Journal, 8 February 2016

 

UP to £4.2bn will be invested by the Government on NHS IT infrastructure and processes as part of its promise to make NHS England paperless by 2020.

 

 

Parliamentary Coverage

House of Commons Written Answers, Pharmacy, 8 February 2016

 

John Mann, MP: To ask the Secretary of State for Health, what assessment he has made of the effect of changes in funding for community pharmacies on the provision of pharmacy services; and what steps he is taking to ensure that busy community pharmacists are not forced to reduce their services.

 

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 are consulting the Pharmaceutical Services Negotiating Committee, other pharmacy bodies and patient and public representatives on our proposals.

 

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House of Commons Written Answers, Pharmacy, 8 February 2016

 

Paula Sherriff, MP: To ask the Secretary of State for Health, if he will make an assessment of the effect on patient care and safety of planned reductions in NHS funding for community pharmacies.

 

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 are consulting the Pharmaceutical Services Negotiating Committee, other pharmacy bodies and patient and public representatives on our proposals.

 

 

Full Coverage

PHARMACISTS WILL NOT TALK ABOUT STRIKING DURING MEETING WITH LEADERS

Pharmacy Biz, Neil Trainis, 8 February 2016

 

A large group of pharmacists and Local Pharmaceutical Committee members are to meet with pharmacy leaders this evening to discuss their response to the government’s cuts to community pharmacy’s funding, with one insider adamant talk of a strike will not be considered.

 

The meeting, which takes place at Chak 89 banquet hall in Mitcham, is expected to attract around 400 people including Sue Sharpe, chief executive of the PSNC, and Ian Strachan, chairman of the National Pharmacy Association, as well as officials from LPCs in the south west London area.

 

Prakash Daksha, a pharmacist from Sutton who is attending the meeting, said the talks will give pharmacists a chance to voice their thoughts and hear what plans the NPA and PSNC have to confront ministers overs the plans but denied that a community pharmacy strike would be on the agenda.

 

“I don’t think that is an option,” he told Pharmacy Business. “I hope they can highlight (the government’s funding cuts) to MPs and get some support from MPs. It will be interesting to hear what more (the NPA and PSNC) are going to be doing.

 

“They have been in a situation we’ve been accustomed to. They negotiate. But we have to formulate a response to the government. There has been very little detail.

 

“We will listen to the pharmacy leaders. We need action at a local level. We need our leaders to guide us.”

 

When asked if “action at a local level” meant the possibility of striking, he said: “Striking is not an option. Look at the junior doctors, they have not gained a lot by striking. But we need public support. Pharmacists have never gone on strike. I can’t see that happening.”

 

The PSNC has said it will not enter into further talks with NHS England until more details are disclosed about community pharmacy’s funding in the wake of concerns the government will slash more than the £170 million it has vowed to take in 2016-17. Strachan also recently said the NPA and its members “will not take this lying down.”

 

 

Government’s £4.2bn investment for NHS IT includes money for ‘click and collect’ prescription service

The Pharmaceutical Journal, 8 February 2016

 

The government is investing £4.2bn in NHS information technology (IT), including money that will facilitate pharmacists’ access to patients’ summary care records and to introduce a ‘click and collect’ service for prescriptions.

 

The announcement by health secretary Jeremy Hunt on 7 January 2016 forms part of the government’s promise to make the NHS in England paperless by 2020.

 

Some £1.8m will be spent on the abolition of paper patient records. IT systems will also be developed so that they work across organisations.

 

A sum of £1bn has been earmarked for cyber security, IT infrastructure costs and achieving data consent. The development of “digital primary care”, which includes aspects related to medicines, has been allocated £750m and another £400m is earmarked for introducing free wireless internet access across the NHS and developing a new NHS website that will host approved smart phone apps. Some £250m has been set aside for the development of data for outcomes and research.

 

The expectation is that by March 2017 at least 10% of patients will use online systems or apps to access GP services and that by 2020 some 25% of patients with long-term conditions will monitor their health remotely and send real-time data to health professionals.

 

“The government is determined to learn the lessons from previous technology projects to ensure that IT solutions in place across the country are useable and beneficial to the clinical community,” says the Department of Health, which adds that it has already found £1bn towards the IT investment and is discussing with NHS England where the balance should come from. No details were given about the government’s plans for a ‘click and collect’ service for prescriptions, other than to say that the government is developing it.

 

The announcement coincides with the decision to appoint US IT expert Bob Wachter, chair of the department of medicine at the University of California, to review current NHS IT systems to ensure that the health service will be paperless by 2020.

One in four pharmacies on the high street face closure

27 January 2016, The Times, Chris Smyth

The £170 million community pharmacy funding cut announced for October was reported in the national press. The Times article highlights the social impact of the forecasted closure of 1,000 to 3,000 pharmacies. It also stresses the paradox of the Department of Health’s stance, which wants the pharmacy sector to play a larger patient facing role while requiring it to deliver more efficiencies.

 

Government wants to phase out pharmacy establishment payments  

26 January 2016, Pharmacy Biz, Neil Trainis

Pharmacy Biz reports that the Department of Health will gradually phase out the payment awarded to pharmacies dispensing 2,500 or more prescriptions each month. The aim of the DoH is to simplify a complex system in order to promote “efficient and high quality services”.

Neil Trainis responded to this new document in Pharmacy Biz stating “There is a flat and glaring contradiction in the Department of Health’s position”.

 

Petition against community pharmacy cuts close to 13,000 signatures

26 January 2016, The Pharmaceutical Journal

The petition launched in response to the community pharmacy funding cut has now reached 13,000 signatures. In response to the call for increased support of the community pharmacy services which save the NHS money, the government stated that the sector played a “vital role”.

 

Two-thirds of readers back strike action

26 January 2016, C&D, Beth Kennedy and Samuel Horti

A Chemist and Druggist poll reveals that two-thirds of readers would support strike action while 21% of the 464 respondents are against. Pharmacy Voice stated that the results testify of the deep concerns felt by the community pharmacy.

 

Refrigerated medicinal products, part 1: receipt and storage – some things to consider

26 January 2016, MHRA Blog, Steve Todd

This blog in two posts draws on learnings from Good Distribution Practice inspections, with patient safety as the end objective in mind.

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

One in four pharmacies on the high street face closure

27 January 2016, The Times, Chris Smyth

Up to a quarter of pharmacies will close as ministers slash funding in order to limit the number on each high street, The Times can reveal.

Local pharmacies rely on the NHS for 90 per cent of their income, receiving an average of £220,000, mainly through fees for handling prescriptions.

Ministers will impose a £170 million cut for high street stores in October.

Doctors said that the decision was extremely short-sighted and could deprive vulnerable patients of a trusted source of health advice. They claim that GP practices are already overwhelmed and could not cope with the extra influx of patients that in-house pharmacies would inevitably bring.

However, the government insists that many areas have “more pharmacies than are necessary to maintain good access”, pointing out that 40 per cent are part of clusters with at least three others within a ten-minute walk.

Alistair Burt, the health minister, told MPs on the all-party pharmacy group that “between 1,000 and 3,000” pharmacies out of 11,674 might close as the government eyes further budget reductions next year.

He said that the exact number would depend on how shop owners coped with cuts, but he conceded that big chains could be better placed to survive than smaller independent pharmacies.

Mr Burt promised money to keep pharmacies afloat in areas where closures would leave patients without help, according to minutes revealed by the journal Chemist and Druggist.

Sir Kevin Barron, chairman of the parliamentary group, warned that the government was engineering “a crisis situation where people are going bust because income is taken off them”.

He said there was “a clear intention to reduce the number of pharmacies . . . If that has to happen it should be done in a structured, organised way and not in in a chaotic way. We’re going to have closures by stealth.”

Encouraging patients to order prescriptions online raised questions around safety, quality and access, Sir Kevin added.

The move comes as rising surgery closures forced more patients to change GPs. Last year 206,269 patients had to find new doctors or travel further to keep their existing doctors because practices had shut or merged. This was up from 43,649 in 2013, according to figures seen by Pulse magazine. The Royal College of GPs said that a shortage of doctors was “a genuine danger to patient safety”.

To ease pressure on GPs, ministers also want pharmacists to do more in advising older people on taking medicines and dealing with coughs and colds.

At the same time, the government says that the pharmacy sector must “play its part in delivering the efficiencies required” to make £22 billion of savings by 2020. Ministers say there needs to be more centralisation and online “click and collect” prescribing.

Rob Darracott, chief executive of Pharmacy Voice, an industry group, said that it was unclear what the scale of closures would be: “We’re extremely concerned. It’s a massive shock to the sector. Some [pharmacies] are really going to be struggling. The network is a fantastic resource. It’s delivered in neighbourhoods where people live, work and shop. We think the government is underestimating the social value of that massively.”

Keith Ridge, the chief pharmaceutical officer said: “We are looking at ways to make greater use of the skills of pharmacists in GP surgeries, A&E, care homes and other settings, and make better use of technology. We also have a responsibility to make sure we get the best use from our resources.”

 

Q&A

How do pharmacies make money?

A typical pharmacy receives 90 per cent of its income from the NHS, an average of £220,000 each. Half of this annual £2.8 billion is fees for filling prescriptions; the rest is linked to schemes such as carrying out medicines reviews.

Why is the government cutting back?

In return for billions of pounds extra in the recent spending review, the Treasury is determined to squeeze efficiency out of the health service. The NHS’s own plan relies on £22 billion of savings by 2020.

How will the cuts fall?

The details are still being worked out and officials stress that figures are only estimates. Funding for 2016-17 will fall by 6 per cent and more cuts could follow. The government wants to amalgamate prescriptions, potentially cutting pharmacists’ income.

Is it all about saving money?

Not entirely. The push to put more pharmacists in GP surgeries, hospitals and care homes is widely supported and ministers reasonably point out that resources will have to come from somewhere. They also believe that too many pharmacists cluster near each other, so closures would not affect care.

What about online prescriptions?

The government wants to make it easier for pharmacies to prepare prescriptions centrally before handing them out at local branches. It also wants more prescriptions handled online, which pharmacists say will make it harder to instruct patients in how to take their medicine.

 

Government wants to phase out pharmacy establishment payments  

26 January 2016, Pharmacy Biz, Neil Trainis

The government has set out its intention to phase out pharmacies’ establishment payments amounting to around £25,000 a year as it continues its search for efficiencies within pharmacy.

In what will be viewed as yet another kick in the teeth for the pharmacy profession, in the wake of swingeing funding cuts, the Department of Health said it would gradually remove the payment which is received by pharmacies dispensing 2,500 or more prescriptions each month.

Stating its intention to “simplify the NHS pharmacy remuneration payment system” in a consultation document outlining its vision for community pharmacy, the DoH said “the current system is complex and does not promote efficient and high quality services.”

Establishment payments, it said, “incentivises pharmacy business to open more NHS funded pharmacies, adding costs to the taxpayer. We therefore propose the establishment payment is phased out over a number of years.”

The DoH also reiterated its desire to introduce a hub and spoke model which it believes will “allow independent pharmacies to capture the efficiencies stemming from large-scale, automated dispensing, reduced stock holding and economies of scale in purchasing and delivery of stock to the hubs.”

The DoH added: “These efficiencies could help pharmacies lower their operating costs and enable pharmacists and their teams to provide more clinical services and to improve and support people’s health.”

Support for a hub and spoke model has been thin within community pharmacy. Ian Strachan, chairman of the National Pharmacy Association, last year said: “A roll-out (of hub and spoke) could bring with it serious risks to the pharmacy network and therefore ultimately patients and communities.”

The DoH also said it would encourage longer prescription durations “where clinically appropriate.”

 

Promoters of Government nonsense are blind or don’t care, slams NPA chairman

26 January 2016, Pharmacy Biz, Neil Trainis

Ian Strachan, the chairman of the National Pharmacy Association, has again vented his spleen at the government over its attempt to drive efficiencies within pharmacy, this time attacking a Department of Health document which proposes the removal of pharmacy establishment payments.

The DoH briefing document, ‘Comunnity pharmacy in 2016-17 and beyond,’ sets outs three central proposals; simplify the NHS pharmacy remuneration system, including phasing out £25,000-year establishment payments, encourage a hub and spoke model in community pharmacy and introduce longer prescription durations “where clinically appropriate.”

Strachan, who alongside PSNC chief executive Sue Sharpe has been one of the more voceriferous critics of the government’s cuts to pharmacy funding, accused “the promoters of this nonsense” of being “blind to the long term consequences or they see it perfectly clear and just don’t care.”

“There is a flat and glaring contradiction in the Department of Health’s position: it calls for community pharmacy to be at the heart of the NHS, then tells us how it plans to wrench the heart out of the sector,” he said.

“It’s appalling for pharmacy, appalling for patients and appalling for the NHS. That’s as clear as day to me. Maybe the view is different from an ivory tower.

“The promoters of this nonsense are either blind to the long term consequences, or they see it perfectly clear and just don’t care. Either way, we have to stand together and fight this every step of the way.”

Strachan added: “The document refers to ‘clinical pharmacists’ in GP practices, in care homes and at the end of a phone line. Never once does it acknowledge that there is any clinical capability in the community pharmacy setting. That is a slur, and I am personally offended by this unfavourable comparison.

“This is a jumble of proposals based on conjecture, not based on evidence and not grounded in the front line reality.”

 

Petition against community pharmacy cuts close to 13,000 signatures

26 January 2016, The Pharmaceutical Journal

The government has responded to an online petition protesting against the proposed cuts to England’s community pharmacy contract. By 26 January 2016, the petition had attracted 12,940 signatures*.

The e-petition can be found on the official government’s petition website and calls on ministers to scrap the proposed 6% cut and urges them to support community pharmacy services which save the NHS money.

Responding to the signatories, the government says that community pharmacy is “vital” to the NHS and could play a greater role.

The statement also says the government is consulting on its plans to introduce a pharmacy integration fund which it claims will help to transform how the profession fits in with its vision for the NHS over the next five years.

It goes on to reiterate the need for pharmacy to take its share of the £22bn NHS “efficiency savings” and that the cut to the contract can be achieved without damaging pharmacy services. And it highlights the need to modernise services with, for example, the expansion of ‘click-and-collect’ prescription services and the development of ‘hub-and-spoke’ automated dispensing.

When an e-petition reaches 10,000 signatures, the government issues a response. In this case, the statement comes just a week after community pharmacy national negotiators announced they were boycotting official talks over the proposed cuts until ministers give them more information.

The Pharmaceutical Services Negotiating Committee also voiced fears that even deeper cuts were coming in 2016–2017.

If the e-petition – which remains open until 29 June 2016 – reaches 100,000 signatures the government is obliged to hold a debate about the issue in the House of Commons.

*The number of signatures was correct at the time of publication.

 

Refrigerated medicinal products, part 1: receipt and storage – some things to consider

26 January 2016, MHRA Blog, Steve Todd

Patient safety is the end objective for manufacturers, wholesalers, distributors and those healthcare professionals administering to patients.

This blog is in 2 parts and draws on some of the findings from good distribution practice (GDP) inspections, references to the EU GDP Guidelines 2013, the Green Guide and an article I wrote for the Pharmaceutical Journal a few years ago.

Following manufacture, some medicinal products need to be stored and transported at lower than ambient temperatures to assure their quality and efficacy.

These are often referred to as ‘cold chain products’ or ‘fridge lines’ and wholesale dealers are expected to store and distribute them in strict accordance with the product labelling requirements as stated in the EU GDP Guidelines – chapters 5.5 (Storage) and 9.2 (Transport) give more information.

The second part of this blog which will focus upon transportation, packing, temperature management, the use of third-party couriers and returns will be posted in the near future.

When cold chain products are delivered, it is important that they are checked in as a matter of priority and placed in a pharmaceutical refrigerator.

The person responsible for receiving the delivery must also satisfy themselves that the goods have been transported under appropriate conditions (eg there has been no direct contact between the products and gel or ice blocks or if the consignment is warm to the touch).

If it cannot be confirmed that the products have been transported under appropriate conditions and there is concern that their quality may have been compromised, the delivery should be quarantined in a suitable refrigerator while enquiries of the supplier are made.

Until the issue has been clarified the products in question should be considered as unsuitable and should not be supplied.

If, following enquiries, there is still doubt as to the quality of the medicines received, the delivery should not be accepted and should be returned to the supplier.

Storage of refrigerated products in a pharmaceutical refrigerator

A pharmaceutical refrigerator is required for the storage of refrigerated medicinal products.

The air within this type of refrigerator is circulated by a fan, which provides a uniform temperature profile and a rapid temperature pull down after the door has been opened.

Temperature monitoring is recorded by a calibrated electronic min/max thermometer, with an accuracy of ±0.5C, which can be read without opening the refrigerator door.

Additional benefits are that these refrigerators can be locked and some have the option of either an audio or visual alarm system to alert staff in the event of temperature deviations.

Many refrigerators have glass fronted doors giving greater visibility to stock levels, aiding stock management and also deterring the storage of non-medicinal products.

When purchasing a new refrigerator, factors to consider might also include how long the unit can maintain the required temperatures if the power is turned off and to what extent the temperature is affected by external ambient temperature variation, for example, in hot spells.

Temperature monitoring in a refrigerator

As is applicable for transportation, products stored in a refrigerator should be subject to daily temperature monitoring by a minimum and maximum calibrated device with a supporting appropriate calibration certificate.

Temperature records should identify any temperature deviations and give details of corrective actions taken as a result.

For instances where there has been a temperature deviation, best practice would be to take a further reading later the same day, to ensure that it was a transient deviation and show that the temperature was now back within prescribed parameters.

The Responsible Person should be informed of any deviations.

Temperature records are especially important in the event of a problem with a product and may be required as evidence of appropriate storage. With this in mind, they should be free from alterations or corrections and the person responsible for taking the readings each day should have a trained deputy to cover for absences.

The records should be routinely reviewed and signed off by the Responsible Person.

The following guidance on can be found in the Green Guide:

“In addition to temperature mapping and monitoring there should be safeguards to preserve appropriate storage conditions. Some small refrigerators are purported to be medical or pharmaceutical refrigerators but this on its own does not automatically render them suitable for wholesale use. The refrigerator should be capable of restoring the temperature quickly after the door has been opened and without danger of overshooting to extreme cold. This could be assisted by an internal fan and good shelf design which enables an efficient air flow. There should be no internal ice box and no internal temperature dials capable of being inadvertently knocked and adjusted.”

“Storage practices for using small refrigerators should include consideration of segregation of stock with different status, e.g. incoming, quarantine, returned and outgoing stock. Sufficient space should be maintained to permit adequate air circulation and product should not be stored in contact with the walls or on the floor of the refrigerator. If the refrigerator is filled to capacity the effect on temperature distribution should be investigated. Where non-refrigerated items are introduced to the refrigerator, such as non-conditioned gel packs, the impact of introducing these items should be assessed regarding the increase in temperature they cause”.

Large commercial refrigerators and walk-in cold rooms

“These should be of appropriate design, suitably sited and be constructed with appropriate materials. The design should ensure general principles of GDP can be maintained, such as segregation of stock.

Condensate from chillers should not be collected inside the unit and there should be a capability to carry out routine maintenance and service activities as much as possible from outside the unit.

The temperature should be monitored with an electronic temperature-recording device that measures load temperature in one or more locations depending on the size of the unit, and alarms should be fitted to indicate power outages and temperature excursions”.

Freezers

“The same general principles apply to freezers as apply to other cold chain storage units above. Walk-in freezers pose a significant operator health and safety risk, and the impact of ways of working should be reviewed with consideration of risk to causing temperature excursions”.

Short-term storage of medicinal products

MHRA have provided guidance on sites that handle (ambient) and refrigerated medicinal products for short periods of time.

Short-term storage of ambient and refrigerated medicinal products – requirements for a wholesale dealers authorisation (WDA)

The EU GDP Guidelines define wholesale distribution as;

“…all activities consisting of procuring, holding, supplying or exporting medicinal products…”

The Glossary of Terms defines holding as “storing medicinal products”.

Medicinal products should therefore only be stored on premises that are covered by a wholesale distribution authorisation.

However, there are certain cases where medicinal products are held for short periods of time during transportation and prior to onward shipment, eg in the transportation vehicle at motorway service stations or in overnight freight depots.

In such instances it has been determined that, as a matter of policy, a site does not have to be named on a licence where ambient products are stored for less than 36 hours.

Sites holding ambient products in excess of 36 hours must be licenced

This policy applies only where ownership of the products has not been transferred to the person carrying out the storage activities.

Where ownership has been transferred, this is supply and as such the receiving site must be licenced.

It is also important to note that, where wholesaling activities other than storage are being carried out, the site should be named on the relevant licence. This includes the handling of returned goods and where decisions are made regarding suitability for resale, as well as the usual activities of picking against orders.

Sites where refrigerated products are held, even when this is for less than 36 hours, must be licenced

The exception will be where these products are transported and stored overnight in continuously refrigerated vehicles.

The provisions of Chapter 9.2 of the EU GDP Guidelines must also be observed

As with any delivery, staff receiving goods should also be alert for the presence of falsified medicines.

Lastly for this blog… refrigerators – best practice

Whatever type of refrigerator or cold store is used, once a mapping exercise has taken place, products should be stored in an orderly fashion on shelves – not directly on the floor of the unit – to ensure air circulation and consistent temperatures throughout and facilitate cleaning.

Calibrated temperature monitoring probes should be sited in a central location within the refrigerator and, preferably between the products.

Probes should not be placed in the door.

The refrigerator should be cleaned regularly (as part of a general cleaning rota) and serviced at least annually.

If the refrigerator is fitted with an audible or visual alarm, this should be routinely tested to confirm correct operation at specified appropriate temperatures.

The stock within the refrigerator should be subject to effective stock rotation based on first expiry, first out, (FEFO).

It should not be assumed that the most recent deliveries will have a longer expiry period.

Refrigerators containing medicinal products must not be used for the storage of food and drink or anything that might contaminate the medicinal products.

Minister highlights efficiency potential of 90-day scripts

26 January 2016, DDA, Ailsa Colquhoun

Dispensing Doctors’ Association reports on a shareholder information document published by the Department of Health reviewing potential areas for efficiencies such as the duration of a prescription. When questioned, pharmacy minister Alistair Burt explained that the government would not decide which pharmacies should close but that it would be their decision if they were viable after the funding cut.

Pharmacy Biz and Chemist and Druggist also report on the news here.

Further details on the document and update from PSNC can be found here.

 

Parliamentary Coverage

Regulatory fees for medicines: 2016 to 2017 and fees for online sellers of medicines

 

Thank you to all who responded to MHRA’s consultation on Medicines Licensing and Falsified Medicines Directive logo fees for 2016/17. The consultation response has now been published.

Full Coverage

Minister highlights efficiency potential of 90-day scripts

26 January 2016, DDA, Ailsa Colquhoun

Ninety day prescriptions are among the models being considered as part of the government’s drive to secure efficiencies from community pharmacies in England.

In a stakeholder information document, the Department states that many prescribers already prescribe 90-day repeat prescriptions where it is clinically appropriate. Where there is no clinical need for a 28-day repeat prescription, this represents inconvenience to the patient and an avoidable cost to the taxpayer. It says: “We will be looking at steps to encourage optimising prescription duration, balancing clinical need, patient safety, avoidance of medicine waste and greater convenience for patients.”

The effect of the measures on rural pharmacies has also been discussed. In a report from the All-Party Pharmacy Group, the minister is cited as saying that between 1,000-3,000 pharmacies could close, as a result of financial measures including the phased withdrawal of the establishment payment. This is worth around £25,000 per year to a pharmacy. And, when asked specifically about rural pharmacies, pharmacy minister Alistair Burt is quoted as saying: “The Pharmacy Access Scheme [funding] could apply to pharmacies after taking account of their location and local health needs”.

But, he also made clear that the government could not decide which pharmacies would close. A formula approach could have ‘hard edges’, and local decision-making may be more appropriate, he said. And, as for compensation, he added:  “Pharmacies would need to decide whether they were viable in light of the change to the funding level. Multiples are likely to have more resilience. Smaller pharmacies will be ‘squeezed’ and that was a matter of concern, so the government would look at that.”

The document, which is open for consultation until February 12, also reiterates Government support for ‘hub and spoke’ dispensing across different legal entities. The minister announced that there will be consultation on changing legislation intended to allow independent pharmacies to capture the efficiencies stemming from automated dispensing and reduced stock holding, and the economies of scale in purchasing and delivery of stock to the hubs. “These efficiencies could help pharmacies lower their operating costs and enable pharmacists and their teams to provide more clinical services and to improve and support people’s health,” the minister said.

The community pharmacy funding proposal, announced in December, looks to reduce pharmacy funding by 6% to a maximum of £2.63bn in 2016/17. Explaining the reduction, the minister said: “Efficiencies can be made without compromising the quality of services or public access to them because there are more pharmacies than are necessary to maintain good patient access. Most NHS funded pharmacies qualify for a complex range of fees, regardless of the quality of service and levels of efficiency of that provider.”

 

Between 1,000 and 3,000 pharmacies could close, Burt tells APPG

25 January 2016, Pharmacy Biz, Neil Trainis

Alistair Burt, the minister for community and social care, told the All-Party Pharmacy Group during a high-level meeting that between 1,000 and 3,000 pharmacies could close as a result of the government’s swingeing cuts to pharmacy funding.

Fears that many pharmacies will be forced to close in the wake of ministers’ decision to slash the pharmacy budget by £170 million, as indicated by the chief pharmaceutical offfcer Dr Keith Ridge following news of the revenue reduction, were exacerbated by Burt’s admission.

When asked by Paul Sherriff of the APPG whether he expected as many as 3,000 pharmacies to shut, Burt was reported by the APPG to have said during the meeting at the Department of Health that “between 1,000 and 3,000” could close but that “much would depend on the response of the multiples.”

“AB (Alistair Burt) noted that pharmacy numbers had increased by around 20% in the last 10 years. He could not be certain how many would close but suggested it could be between 1,000 and 3,000. Much would depend on the response of the multiples,” the APPG said.

Jeannette Howe from the DoH who was also at the meeting said because the government did not have access to the accounts of individual pharmacies, it “could not be sure about precise numbers of closures.”

Burt did however address the question of whether the government would use a formula to decide which pharmacies would survive by insisting the Pharmacy Access Scheme, which takes into consideration the location and local health needs of pharmacies, might serve such a function.

“(Burt) added that a formula approach could have ‘hard edges’ and that local decision-making may be more appropriate,” the APPG said.

“(APPG chair Kevin Barron) asked whether there would be compensation arrangements. (Burt) noted that the government could not decide which pharmacies would close.

“Pharmacies would need to decide whether they were viable in light of the change to the funding level. Multiples are likely to have more resilience. Smaller pharmacies will be ‘squeezed’ and that was a matter of concern, so the government would look at that.”

The APPG also said Howe confirmed there “would be further reductions in future years,” an unsurprising admission but one which will nonetheless cause great anxiety within community pharmacy.

“(Howe indicated) the October timing was intended to give pharmacies time to prepare. The government may be willing to consider phasing,” the APPG said.

“Paula Sherriff asked how the government had arrived at the figure of 6%. (Burt) replied that this was the figure that was settled upon after negotiations with the Treasury. He emphasised his earlier point that the government feels the market can withstand such change.”

There have been concerns around the commissioning of community pharmacy services but Howe said the Pharmacy Integration Fund would help that process.

“Oliver Colvile (APPG vice-chair) asked how the government could speed up plans to increase the services that community pharmacies provide,” the APPG said.

“(Howe) replied that this was the government’s intention and that the Pharmacy Integration Fund, together with local commissioning, would assist. (Howe) confirmed that the Integration Fund would be £20 million in year one and was expected to rise to £100 million by year five.

“Asked about the value of the Access Scheme, (Howe) stated that this would be set at whatever value was necessary to meet ministers’ objectives.”

The Pharmacy Integration Fund however has not alleviated the anxieties of the PSNC, whose chief executive Sue Sharpe expressed her concern in a letter to NHS England and the DoH that it was not designed specifically for community pharmacy.

“Given the current drive to develop the role of pharmacists working in general practice we expect that this will overwhelmingly be directed towards increasing opportunities for those other than community pharmacies,” she wrote earlier this month.

PHARMA URGES GOVERNMENTS TO ACT IN DAVOS OVER ANTIMICROBIAL RESISTANCE

21 January 2016, Pharmacy Biz, Neil Trainis

At the World Economic Forum in Davos, 85 pharmaceutical companies in a joined up declaration urged governments across the world to work with them to develop funding sources for drug research and bolster efforts to fight against antimicrobial resistance. This declaration was also signed by 18 pharmaceutical industry associations including the ABPI.

 

The first cut is the deepest

20 January 2016, The Pharmaceutical Journal

This editorial recognizes that the announced funding cut, the first since the contractual framework was negotiated in 2005, will be damaging but was not unexpected. Alongside the funding cut, a consultation will investigate the possibility of a “pharmacy integration fund” to help change how community pharmacy and pharmacists operate within the NHS.

 

Independents better placed to cope with 6% funding cut

21 January 2016, Chemist and Druggist, Annabelle Collins

Chemist and Druggist reports that independent pharmacies would be in a better position to cope with the 6% funding cut, according to a finance expert. Independent contractors are more flexible, closer to operations on the ground and not constrained by a broader business model.

 

MHRA Drug Safey Update – January

21 January 2016, PSNC

The new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (Vol 9, Issue 6, January 2016) has been published and includes articles on:

  • Nicorandil (Ikorel): now second-line treatment for angina; risk of ulcer complications
  • Levonorgestrel-releasing intrauterine systems: prescribe by brand name

To see the latest MHRA Drug Safety Update in full visit the MHRA website.

 

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PHARMA URGES GOVERNMENTS TO ACT IN DAVOS OVER ANTIMICROBIAL RESISTANCE

21 January 2016, Pharmacy Biz, Neil Trainis

Eighty-five pharmaceutical companies used the World Economic Forum in Davos as a platform to urge governments across the world to work with them to find new ways of funding drug research and bloster the fight against antimicrobial resistance.

The companies, including GSK, Pfizer and Johnson & Johnson, issued their plea in Switzerland in a joint declaration from the pharmaceutical, biotechnology and dignostics industries which warned that “antibiotics are losing effectiveness faster than they are being replaced by new, innovative drugs, including both antibiotics and alternative non-antibiotic approaches to treating and preventing infections.”

“We call for governments to commit funding and support the development and implementation of transformational commercial models that (a) enhance conservation of new and existing antibiotics, while (b) improving financial and access-related predictability for both industry and health systems,” the declaration said.

Antimicrobial resistance remains a significant threat to humanity. An independent review in 2014 by the economist Jim O’Neill warned antimicrobial resistance could kill 10 million people worldwide each year by 2050.

“Antibiotic resistance is the sort of global healthcare challenge that this industry should be using its expertise to tackle,” said Sir Andrew Witty, chief executive of GSK.

“That’s why I’m so pleased to see such a broad range of companies committing to this declaration. I’m hopeful that today’s declaration will encourage governments to work with us on new economic models that can help to secure a new supply of antibiotics for the future.”

Ian Read, chairman and chief executive of Pfizer, said: “The growing problem of antimicrobial resistance requires new approaches and a heightened commitment to development of new treatments and vaccines.

“Pfizer applauds this declaration as a balanced and robust approach to stimulating R&D through market based incentives, and emphasising the importance of responsible stewardship.”

The declaration was also signed by nine industry associations in 18 different countries, including the Association of the British Pharmaceutical Industry.

 

Global pharmaceutical industry calls on Governments to work with them to beat the rising threat of drug resistance

21 January 2016, ABPI, Press Office

The ABPI has signed a declaration, in partnership with more than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as international and domestic industry bodies, to call on governments and industry to work in parallel in taking comprehensive action against drug-resistant infections.

The joint declaration​ launched at the World Economic Forum in Davos, Switzerland sets out, for the first time, how governments and the life sciences industry need to work together to support sustained investment in the new products needed to beat the challenges of rising drug resistance.

The declaration supports the ongoing work in the UK on tackling the challenges with AMR which included funding commitments in the most recent Spending Review. The ABPI continues to work closely with the AMR Review team and relevant government departments in England, Scotland, Wales and Northern Ireland to seek a strong and coherent response to AMR.​

Dr Virginia Acha, Executive Director for Research and Medical Innovation, said:

“When David Cameron announced the AMR Review work in July 2014, he called for ‘a stronger, more coherent global response, with nations, business and the world of science working together to up our game in the field of antibiotics’. With this global Declaration of Support for Combating AMR, industry has given that response. It is up to us all to make sure that delivers new solutions to address AMR for patients everywhere.”

 

The first cut is the deepest

20 January 2016, The Pharmaceutical Journal

It is hard for those working in community pharmacy not to see red after reading the recent open letter to the Pharmaceutical Services Negotiating Committee (PSNC) — which represents NHS pharmacy contractors — from the Department of Health and NHS England. It revealed that funding for the sector in England in 2016–2017 is set to be cut from £2.8bn to £2.63bn, a reduction of £170m, which is more than 6%.

There has never been a cut in agreed funding since the introduction of the new contractual framework in 2005, let alone anything of this scale.

Unsurprisingly, pharmacy organisations have criticised the announcement. The recipients of the letter, the PSNC, labelled it “a damaging move” and “a destructive blow to the support community pharmacies can offer to patients and the public”. The National Pharmacy Association, the trade association for community pharmacies, called the proposals “misinformed” and accused the Department of Health (DH) and NHS England of using a questionable evidence base and giving an unbalanced opinion. The Royal Pharmaceutical Society’s English Pharmacy Board described the cuts as “shortsighted” and said there was cause for concern about the future of the profession.

The cuts are potentially damaging for community pharmacy, but they were not unexpected. The NHS ‘Five year forward view’, published in October 2014, described the need for greater efficiency and productivity, while in the November 2015 spending review, the government said it expects £22bn of efficiencies to be made within the NHS by 2020–2021. As a result, according to the DH and NHS England in the letter, “community pharmacy is a core part of NHS primary care” and it has “an important contribution to make” as the NHS continues to face financial challenges.

There is a (faint) silver lining. The DH will consult on how to introduce a “pharmacy integration fund” to help change how community pharmacy and pharmacists operate within the NHS. This is on the back of a recent initiative to employ pharmacists in GP practices. The fund is expected to be around £20m for 2016–2017, but it is unknown how much of this funding will go to community pharmacies.

The DH will also consult on the launch of a pharmacy access scheme, which would provide more NHS funds to certain pharmacies, considering factors such as location and the health needs of the population. But given the scrapping of the essential small pharmacy scheme in 2015, which was introduced in 2006 to provide additional funding to pharmacies that would be unviable without financial support, this seems to be a case of reinventing the wheel.

December has always been one of the busiest months for community pharmacists. Many pharmacists and pharmacy staff would have been organising patients’ repeat prescriptions to ensure they do not run out during the holiday period. Others would have been managing the increased volume of dispensing that happens as a result of patients travelling. Therefore, the letter could not have come at a worse time. It does nothing to boost morale for pharmacists and contractors working tirelessly for patients and their communities, and many will now be anxious about how the cuts will be implemented.

Community pharmacy already operates under a strong business model, so it is hard to see where such efficiency savings could come from, apart from staff reduction, which could have a negative impact on safety and user satisfaction. It is hard to see the rationale behind the DH and NHS England’s proposed cuts to an already efficient profession.

Given that this is likely to be the beginning of a series of efficiency savings by the government for years to come, pharmacy professional bodies must grasp the opportunity to limit the damage and make their — and their members’ — voices heard by the DH during the consultation period, which is expected to close on 24 March 2016.

BAPW expands membership beyond wholesalers

C&D, Beth Kennedy, 18 January 2016

In an exclusive interview with Chemist and Druggist, Martin Sawer explains that the rebranding of the BAPW as the Healthcare Distribution Association (HDA UK) aims to “better represent the future of medicines supply”. As part of this change, the Association will be opening up to non-wholesalers in the next month.

 

PSNC warns of ‘far larger’ funding cuts to come

C&D, Samuel Horti, 18 January 2016

Chemist and Druggist reports on PSNC chief executive, Sue Sharpe’s concerns that the Department of Health intends to close pharmacies with low dispensing volumes. Ms. Sharpe stated that the Department was withholding information and will not engage in negotiations until the full plans are provided.

This statement was also covered by Pharmacy BizThe Pharmaceutical Journal and Dispensing Doctors’ Association.

 

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PSNC THREATENS TO STOP TALKS WITH NHS ENGLAND OVER LACK OF DETAIL

Pharmacy Biz, Neil Trainis, 18 January 2016

The furore generated by the government’s plan to reduce community pharmacy funding threatens to boil over after PSNC chief executive Sue Sharpe accused NHS England of withholding information about the sector’s funding, sparking fears it intends to introduce even bigger cuts for 2017-18 and leading pharmacy’s negotiator to insist it will not commence talks until ministers reveal their true intentions for the sector.

In a strongly worded letter to Keith Ridge, chief pharmaceutical officer at NHS England, and Will Cavendish, director general, innovation, growth and technology at the Department of Health, Sharpe (pictured) underlined the negotiating body’s concerns over the government’s long-term plans for pharmacy, and lack of detail surrounding them, in unequivocal fashion.

In the letter she accused the government of “ignoring entirely the substantial evidence” of the value of commissioning community pharmacy services and said her request for pharmacy figures “in the NHS allocations for subsequent years” had fallen on deaf ears despite being told during a meeting on January 11 by NHS England and DoH officials that the request had been passed on to the Health Secretary Jeremy Hunt.

That meeting was attended by Ridge, Cavendish as well as Jeannette Howe and Liz Woodeson from the DoH and Deborah Jaines of NHS England.

The lack of a response, Sharpe wrote, led the PSNC to fear the government’s intention was to introduce a cut “far larger” than the £170 million for 2016-17 as outlined in a letter  signed by Ridge to Sharpe last month.

“You stated in the course of the meeting that the reason you decided to publish the letter was to make it clear that the figure for funding for 2016/17, a reduction of £170m, will not change,” Sharpe wrote.

“You raised my prior request for the community pharmacy figures in the NHS allocations for subsequent years and said you were seeking consent from the Secretary of State to making those figures available for PSNC’s meeting on January 12 and 13.

“We heard nothing subsequently, and as I anticipated, when it met PSNC felt it was being deprived of information essential for it to have a proper consultation.

“Contractors have noted your intention to implement the funding cuts from October 2016, ostensibly to give “pharmacies time to prepare for this change.” We fear you aim for a cut far larger than the 6% stated in the letter, in 2017/18.

“You will understand how this withholding of material highly relevant to our ability to consider and understand the government’s aims further erodes PSNC’s confidence, and that of the contractors we represent, in the process.”

Sharpe also expressed her concern that the government had not made clear how it intends to develop and cultivate a “clinically focused community pharmacy service” as described in the Ridge letter and cast doubt over the proposed Pharmacy Integration Fund which she suggested would not benefit community pharmacy.

“The letter refers twice to the need for a ‘clinically focused community pharmacy service,’ but is entirely silent on how this would be achieved, and you have confirmed that there are no plans to consider further service development in 2016/17 that could make progress towards this ambition, which of course has been our aim for many years, and was integral to the structure of the CPCF in 2005,” she wrote.

“When we met you referred me to the two paragraphs in your letter, headed ‘Pharmacy at the heart of the NHS.’ I have re-read these and they contain nothing whatsoever that contributes positively to driving forward a clinically focused community pharmacy service.

“There is reference to the proposed Pharmacy Integration Fund. This will not be specifically for community pharmacy and given the current drive to develop the role of pharmacists working in general practice we expect that this will overwhelmingly be directed towards increasing opportunities for those other than community pharmacies.”

There was also grave concern about the government’s desire as set out in the Ridge letter to reduce the number of community pharmacies. Once again, Sharpe cited a lack of detail around the plans and accused the government of pressing ahead without evaluating the importance of the care provided by pharmacies.

“Neither you nor Jeannette or Deborah in previous meetings have been prepared to elaborate to allow us to understand your proposals or the rationale for them,” Sharpe wrote.

“You referred to analysis and modelling but have not made this available to us, so PSNC could not examine your plans. Nor will you state how many pharmacies you expect or intend will close.”

She added: “I have been able to elicit that the aim is to seek to reduce the number of low dispensing pharmacies and to reduce the number of pharmacies “in a cluster.” No evaluation of the care provided by a pharmacy should be based on such a crude measure as dispensing volume, but there has been nothing to suggest you have examined the levels of advice or other elements of the pharmacy service provided by these pharmacies, such as provision of compliance aid dispensing and support for self-care.

“It seems clear that you are proposing to drive ahead to radically change the market with a real paucity of knowledge essential for good decision-making.”

Echoing her criticisms last month in the wake of the Ridge letter, Sharpe said the government wanted to “drive patients to a commoditised supply service which bypasses the access to the support and advice available in their local pharmacy.”

Sharpe also questioned whether the government had assessed the impact of its proposal to increase the duration of prescriptions on “an increasingly fragile supply chain and the consequent risk to patients of pharmacies being unable to supply prescribed medicines.”

“If so, we would like to see it because we believe this is a very damaging consequence of this limb of your policy,” she wrote.

Sharpe’s letter pointed to a straining of relations between the PSNC and the government and that was fuelled by the PSNC chief executive’s closing remarks in which she insisted the collaboration “is challenged by what seems very clearly to be ill-informed policy driven by an equally ill-informed view that there is surplus funding that can be extracted from the sector.”

Sharpe added: “Following the PSNC meeting I advised Jeannette and Deborah that we cannot agree to commence negotiations before we have had an opportunity to understand fully your plans and the analysis underpinning them. We believe we are entitled to this material but it has not been forthcoming.”

 

PSNC refuses to negotiate until government shares plans for community pharmacy

The Pharmaceutical Journal, 18 January 2016

Community pharmacy negotiators are refusing to negotiate with the government over its planned 6% cut in community pharmacy funding in England until it has seen details of the government’s long-term plans and the evidence behind them.

The move comes as the Pharmaceutical Services Negotiating Committee (PSNC) voiced its fears that the government is deliberately keeping it in the dark about deeper cuts to come.

“We cannot agree to commence negotiations before we have had an opportunity to understand fully your plans and the analysis underpinning them,” says PSNC chief executive Sue Sharpe in a letter to England’s chief pharmaceutical officer on 15 January 2016. “We believe we are entitled to this material but it has not been forthcoming. The government appears to have a settled intention to proceed on a course of action that will run counter to its stated ambition to develop a clinically focused pharmacy service, and be damaging to patient care.”

She tells Keith Ridge that the PSNC is worried that the government is planning much deeper spending cuts in 2017–2018 than the 6% already planned for 2016, after the health secretary failed to provide the PSNC with details of contractual funding beyond 2016 in time for its January PSNC meeting.

Sharpe says the 6% cut will force pharmacies to cut staff and damage patient confidence in the profession; the PSNC is also suspicious of government plans to create more online pharmacy services.

The government policy is “ill-informed… driven by an equally ill-informed view that there is surplus funding that can be extracted from the sector”, she adds.

 

DH warned against ‘commoditised’ medicines supply

DDA, Ailsa Colquhoun, 19 January 2016

The Department of Health has been warned against creating a “commoditised medicines supply service”.

English pharmacy contract negotiator PSNC has voiced concerns that new pharmaceutical services policy could bypass access to community pharmacies, and reduce the viability of the current pharmacy network.

In a written response to the community pharmacy funding cuts announced before Christmas, PSNC criticises Government ambitions to reduce the number of low dispensing pharmacies and to reduce the number of ‘clustered’ pharmacies – despite the promise of a new Pharmacy Access Scheme. This proposes new funding for multiple hundreds of pharmacies that offer benefit due to their location and the local health needs.

The pharmacy contract negotiator also denounces proposals to increase the duration of prescriptions. It says rather than optimise prescription duration, longer prescribing periods “could encourage waste”. There are also implications for the supply chain, which PSNC describes as “increasingly fragile” with a consequent risk to patients “of pharmacies being unable to supply prescribed medicines”.

Dispensing practices concerned about the potential effect on GP dispensing services are advised to read this letter from DDA chairman Dr Richard West, published yesterday. This points out that the DDA is being consulted formally about these changes proposed for community pharmacy in England, even though it is not clear at this point whether the changes will affect dispensing practices. Practices are asked to be aware of the consultation taking place, and the DDA’s intention to shape the outcome in the best interests of our members and their patients.

PSNC’s letter also reveals its expectation that £20 million in ‘pharmacy integration’ funding will be used to develop the role of pharmacists working in general practice. PSNC has told pharmacists that the Department has no plans to consider further community pharmacy clinical service development in 2016/17 and that the assumption is “that the care, advice and support community pharmacies give to their patients can be provided by pharmacists in general practices”. PSNC adds: “This is wrong.” Pharmacists are also warned to expect funding cuts from 2017-18 that are “far larger than the 6% stated in the letter”.

From Factory to Pharmacy

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