HDA Media And Political Bulletin – 27 January 2016

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.

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

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