August 2014 CPN

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Community Pharmacy News – August 2014

Research proves value of NMS Service helps patients and brings economic benefits, evaluation concludes Endorsement factsheet | MPs back shortage concerns | Drug Tariff Q&A

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Official NMS evaluation confirms value of the service Report of the evaluation of the New Medicine Service (NMS) concludes that the service benefits patients and can save the NHS money The New Medicine Service (NMS) can significantly increase patients’ adherence to their new medicines and will save the NHS money through better patient outcomes at overall reduced costs, the evaluation of the service has concluded.

Published this month, the evaluation, which was led by researchers at Nottingham University, recommended that the service could be improved by expanding the range of conditions covered, improving training and engagement with GPs, and giving pharmacies access to GP records.

The conclusions followed a range of research and analysis, including a randomised controlled trial which tested whether patients who received the NMS after being prescribed new medicines were more adherent to their

medicines after ten weeks than those who received standard pharmacy advice. At Week 10 the researchers found that the NMS had increased adherence by about 10% and increased numbers of medicines problems had been identified and dealt with compared with standard current practice.

An economic analysis also suggested that the service saved money on each NHS patient, and the researchers concluded that implementation of the service provided positive clinical and economic benefits.

The evaluation did suggest some improvements to the service, such as through making it more patient focused and better integrating it into care pathways, and it concluded that the service should be commissioned in the future.

NMS Evaluation: your questions answered So will the NMS now be recommissioned?

The evaluation was carried out to inform decisions about the commissioning of the NMS, and at PSNC we will be using the outcomes to inform our ongoing negotiations with NHS Employers (who are acting on behalf of NHS England). Given the results we are of course optimistic about the future development of the service. We expect an announcement to be made when the whole funding package has been agreed.

So should we keep offering it to patients?

The report of the evaluation provides a sound basis from which we can continue our work to develop community pharmacy services, and we hope pharmacies will be encouraged by the results and will continue trying to recruit every patient possible to this important service.

And what about other services?

The evaluation confirms the positive difference that pharmacies can make to patients’ adherence to their medicines, benefitting both the patient and the NHS. It is our plan to build on that capability to see pharmacies delivering a whole range of care for patients, including longitudinal care for those with long-term conditions rather than just episodes of care as and when they meet certain criteria. We hope that in this way community pharmacies will play the lead role in medicines optimisation and will work in partnership with GPs offering full support to patients to help them to take care of themselves and to use their medicines appropriately. We are not there yet; but this evaluation is certainly a big step in the right direction.

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Reaction to the NMS Evaluation “As a pharmacist, contractor and member of PSNC I am delighted that this evaluation has drawn such positive conclusions about the NMS. This is a great reward for both the hard work that went into designing and negotiating the service, and for all the work pharmacies have been putting in since then to offer it to their patients. The authors note that more than 90% of community pharmacies have now offered the service and this is exceptional – it shows just how well the sector can respond when we are given the opportunity.”

Gary Warner, independent contractor and chair of PSNC’s Service Development Subcommittee “Obviously we are very pleased that the evaluation of the NMS has concluded that the service helps patients and makes sense economically; this is an excellent result and a testament to all the work pharmacies have been putting in to this service. It confirms what we have long heard from pharmacies: that the NMS is making a real difference to patients and is an asset to the health service as a whole.”

Sue Sharpe, PSNC Chief Executive

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Meet your new PSNC members Pharmacies may be aware that three independent contractors were elected to be new Regional Representatives on PSNC earlier this year. Here, the new members reflect on their first two meetings and the future.

Why did you want to be a PSNC member? I worked in industry for a number of years and during that time I worked with PSNC quite closely, however I had been on the outside looking in and I thought it would be good to be on the other side if I could be. It has been very revealing, having worked with PSNC for

so many years, I had no idea the huge amount of work that is done.

What advice would you give to pharmacies? We moved from being a supply only profession to a supply plus services profession in 2005 and services are a significant part of the way ahead.

We’re moving towards that different model of operation slowly but steadily, so I think at a local level contractors have

to work together to look for all the enhanced services and develop those where they can. So my message to contractors is although these are challenging times in the NHS and there is certainly considerable threat, there is also opportunity for us all to show what we can do, produce work which is patient centric, has good outcomes and produces solid evidence, which can benefit both colleagues and commissioners.

Ian Hunter owns a pharmacy in Kent and his election to PSNC follows 20 years as a contractor and a number of years working within the pharmaceutical industry

How were your first PSNC meetings?

PSNC is criticised heavily and I was one of the sceptics, but after two meetings I won’t be doing that again. It is unfortunate that because of the way the contract is negotiated we can’t inform contractors or LPCs about everything that we do, but PSNC are doing a lot of work, they have lots of experience in the committee, and a lot of the members are really working hard a lot of the time in their own time to achieve the desired results.

here is committed to c Everyone getting the best result for pharmacy So what would you like to tell pharmacies? The message I would give to contractors is that times are hard, not just for pharmacists but throughout the whole NHS, and we are working as hard as we can to get the best remuneration package possible. I can reassure you as a new

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member that everyone on this committee is fully committed to getting the best result for pharmacy that we can possibly get, but obviously the NHS haven’t got lots of cash that they can just throw out to pharmacy so we have to negotiate within the parameters we are set.

Anil Sharma owns eight pharmacies and is a member of Cambridgeshire and Peterborough LPC Do you have big ambitions for pharmacy? In my local work we’ve been able to get a number of services commissioned including minor ailments, sexual health services and we were one of the first LPCs to pilot flu vaccinations back in 2008. I think that is the future for pharmacy - there is a severe shortage of doctors and nurses and I think we need to make the national

leaders realise that pharmacy can plug those gaps. We should be there looking at medicines reviews and the wider picture of how medicines can be delivered safely to the general public, but also at how pharmacy can provide the stop gap things like flu vaccinations, immunisation, anti-coagulant testing.

What does the year ahead hold? The year ahead is certainly challenging for the simple reason that the government

is looking to the whole of the NHS to make a saving of £20 billion over the next two to three years, so we’re working in an environment whereby your costs are increasing, your profits are certainly diminishing, and you’ve got all the other challenges on top of that such as new local commissioners. But for those contractors who are able to innovate, and those contractors who are able to change, the future is there.

Prakash Patel is director of seven pharmacies in London. He’s owned a community pharmacy for 35 years, been an LPC member for 22, and worked as a PEC pharmacist psnc.org.uk 3

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Medicines shortages ‘far from solved’, MPs conclude MPs hear how community pharmacy teams’ efforts are minimising disruption for patients Pharmacies are still having to spend too much time sourcing hard to obtain medicines and managing patient needs and expectations, members of the All-Party Pharmacy Group (APPG) concluded last month.

In a roundtable discussion attended by PSNC and other pharmacy and supply chain representatives, the MPs heard about the work pharmacy teams are doing on a daily basis to cope with quotas and patient requirements, sometimes needing to ration medicines to manage demand.

PSNC continues to press for measures to ensure that all pharmacies can access the medicines they need to when they need them and we are working with wholesalers and dispensing doctors to raise the matter with politicians at the political party conferences in the autumn.

This month GPs also voiced concerns about medicines supply, with 93% of those responding to a survey by GP Magazine saying they had had to prescribe a second choice of drug because of shortages.

“It seems that the work that pharmacists do in minimising disruption to patients is giving the impression that the issue of shortages has lessoned to a lower level,” Sir Kevin Barron MP, Chair of the APPG said after the discussion. “But the problem remains – the supply chain is just getting better at managing it.”

The MPs called on the government to do more to address the issues and to recognise the work and time that pharmacies are having to put in to source medicines.

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PSNC Comment “Pharmacies are working incredibly hard to minimise the impact of shortages on our patients, but this has been going on for so long that for many of us the workload now feels normal. My goal as a member of PSNC is to ensure that pharmacies are fully funded for that, and it’s great to hear that we have the backing of MPs on this.

It is also not surprising to hear that many GPs are having to prescribe a second choice of drug for patients due to medicines shortages and that they feel that patient care is being compromised. Pharmacies have been seeing things like this for a long time. PSNC is continuing to raise these issues with the Department of Health, and adding the voice of GPs to pharmacy and MPs’ calls for solutions can only improve the case.

We know that in some cases LPCs and others have worked locally to alert prescribers to any major shortages, and formalisation of that process is something we have raised and would certainly welcome.”

Independent community pharmacy contractor and PSNC Regional Representative Mark Burdon

Public health news – have you seen the latest?

This month NHS organisations have published a number of updates that may be of interest to pharmacy contractors and teams. These are outlined below.

Emergency contraceptives update The European Medicines Agency (EMA) has concluded its review of emergency contraceptives to assess whether increased body weight/BMI reduces the efficacy of the medicines in preventing an unintended pregnancy. The EMA concluded that based on the data available the benefits of using emergency contraceptives containing levonorgestrel or ulipristal acetate remains positive and it cannot be concluded that body weight has an impact on their effectiveness.

C-card scheme guidance Public Health England and Brook have published updated guidance on the C-Card condom distribution scheme, and reiterated their view that access to condoms remains a central part of efforts to improve sexual and reproductive health.

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The guidance is designed to give an introduction for health professionals who are interested in developing, reviewing or commissioning a C-Card scheme and it may be of interest to pharmacies providing or interested in providing such a scheme.

See psnc.org.uk/news Orchid View Review The Royal Pharmaceutical Society (RPS) has highlighted the publication of the Orchid View Serious Case Review which was seeking to learn lessons from the neglect, poor care and deaths at the Orchid View Care Home. The Society has asked pharmacy teams to remember the importance of raising the alert where they have concerns about the safe management and administration of medicines, and to consider their own whistleblowing processes to ensure any concerns are raised early on.

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Pharmacies could improve post-discharge care, PSNC tells HealthWatch England Special inquiry into poor care some patients receive after leaving hospital hears how pharmacies could make a difference Extending community pharmacy services and improving communications channels between pharmacies and hospitals would help to improve the care that patients receive after they leave hospital, PSNC has told England’s key patient representative group.

HealthWatch England, which works on behalf of NHS patients in England and has unique powers to advise commissioners and others leading the NHS, is holding a special inquiry into people’s experiences of leaving hospital.

In response to the inquiry PSNC wrote a report outlining how pharmacies could make a key difference in this area, highlighting in particular: • How targeted MURs and the New Medicine Service (NMS) can help patients to manage any new medicines they are prescribed in hospital; • A pharmacy reablement service that resulted in a 37% reduction in patients leaving hospital being readmitted, and a 67.5% reduction in hospital bed days following discharge and the service; • The need for improved communication between hospitals and pharmacies so that patients can receive the support they need following discharge in their communities; and • The potential to extend specialist pharmacy reablement services and to increase uptake of the NMS and MURs to ensure that all patients leaving hospital who might benefit from them can receive them.

The special inquiry is taking evidence from a range of different sources, seeking examples of best practice to inform its recommendations, and we look forward to seeing the outputs from it.

Psoriasis MUR toolkit now available Downloadable help for pharmacies follows Devon LPC’s successful diabetes MUR guide Devon LPC has this month published a downloadable toolkit to help pharmacists to deliver effective MURs to patients with psoriasis.

The toolkit, which was produced in association with the Psoriasis Association, MediaPharm, CPD Easy and PSNC, and with the support of a pharmacist with an interest in dermatology, a consultant dermatologist and a GP with a special interest in dermatology, includes: • A full briefing on the condition and its treatment and management to help pharmacists improve their knowledge and understanding; • A consultation guide including key questions and prompts for pharmacists carrying out the MURs; • A record form to be completed during the MUR and given to the patient; and • Ideas on lifestyle advice pharmacists could also give patients and places they could be signposted to for more information.

The toolkit is the second Devon LPC have worked on and follows

the success of similar diabetes MUR resources which are still available on the LPC’s website at devonlpc.org. The diabetes MURs were shown to benefit patients in an independent evaluation, and the toolkit for them has been downloaded by more than 2,500 pharmacists across the UK and beyond.

Both toolkits can be used by any pharmacies to help them to deliver their MURs.

Mark Stone, Devon LPC Project Pharmacist, who worked on both resources, said: “We know how hard pharmacies are working to deliver MURs that really benefit patients, and we wanted to help that process as much as we could. These toolkits have taken a lot of work, but it has been great to hear about how the diabetes resources have helped some pharmacists to make a difference to their patients. We’re looking forward to seeing this psoriasis toolkit do just the same!”

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PSNC support: updates on local commissioning and promoting pharmacy This month we are working on legal documents to help LPCs with local commissioning, and running a seminar to support local media management.

Many local pharmacy services are being commissioned in new ways following the demise of PCTs. For instance, local authorities are putting many public health services such as sexual health or substance misuse out to tender, and potential providers need to put in a bid to provide the service, competing with others.

These bids have caused some concern for pharmacy, because for most individual contractors responding to a large tender is not feasible. It had been suggested that the local representative body for contractors, the Local Pharmaceutical Committee (LPC), could put in bids for services to be delivered by groups of contractors, but this is not in fact possible because being a provider organisation is not legally within the remit of LPCs.

Memorandum and Articles of Association for a limited company to bid for and provide services locally. The work is now almost complete and the material should be available to LPCs in the next few weeks.

One solution is to form a limited company involving other contractors in the area giving the coverage and resources to provide a service over a wide area. To support this approach PSNC instructed lawyers to prepare template

With the support of contractors in the area an LPC will be able to facilitate the setting up of the company. As it is a body separate from the LPC, this will not breach the prohibition on LPCs themselves being a provider.

It will be for the LPC to decide if it wishes to pursue this option and careful consideration of all the responsibilities and duties for being a provider need to be assessed.

Contractors are advised to check their LPC website – which can be accessed from the PSNC website or at lpc-online.org.uk – for information about local commissioning and any plans for the setting up of local provider companies.

Promoting community pharmacy locally Often contact with local media comes when pharmacies or LPCs have to respond to a local issue or questions, but proactive positive engagement with local media is an inexpensive way of promoting community pharmacy to a wide audience.

PSNC regularly organises media training for LPCs to equip them with the skills to fire-fight if need be but also the ways to get positive promotion - perhaps highlighting the success of a new local pharmacy service, an MP visit to a pharmacy or other ways a pharmacy team has supported the local community. Getting such coverage needs a good understanding of the way the local media works, a good relationship with local journalists and the skills to write effective press releases and handle interviews.

To help LPCs to gain this understanding, we will be holding our next training on this topic in September. LPCs can find more information and book via the Events pages of the PSNC website. Any pharmacies who feel they have a story that could be of interest to the local media should contact their LPC as soon as possible.

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Are you submitting your EPS R2 prescriptions correctly?

Here are some FAQs & top tips which will help you to make sure you are not missing out on your claims!

Q. How do I declare the number of electronic items I have dispensed in my FP34C submission document?

A. At the end of the month, pharmacy contractors must declare the combined total of paper and electronic prescriptions, along with the total numbers of electronic and paper items, being submitted to the Pricing Authority for reimbursement on the FP34C submission document.

For paper prescriptions, the figures should relate to the total number of forms and items that are physically included in the prescription bundle (including returns).

For electronic prescriptions, the figures should relate to the total number of electronic forms and items that have been dispensed in the month being claimed and submitted to the Pricing Authority via an electronic claim message by midnight on the 5th of the following month.

For both paper and electronic prescriptions, the number of items declared should be adjusted to take into consideration any additional fees due (e.g. if an HRT product attracts 3 fees, it should be counted as 3 items).

Q. Do I have to submit all of my dispensing tokens for electronic prescriptions to the Pricing Authority?

A. Prescribing/dispensing tokens should be submitted to the Pricing Authority on a monthly basis where necessary e.g. where the patient is not age exempt and they are making an exemption declaration. Tokens must be submitted to the Pricing Authority in the same month that the corresponding electronic prescription has been submitted electronically. When tokens are submitted, the ‘ETP Token for non-payment’ box on the FP34C

submission document should be ticked.

Whilst each electronic prescription is electronically submitted with a paid/exemption category, some tokens also need to be submitted for audit purposes. These are those which are chargeable and those which are exempt for reasons other than age (i.e. any token requiring a patient signature).

Key pointers: • EPS R2 tokens should be secured into separate bundles and these bundles included at the top of the relevant groups (i.e. exempt or chargeable) along with your monthly submission of FP10 prescription forms.

• Although EPS R2 tokens need to be kept together separate from the main submission bundles, there is no requirement to sort these into prescriber order.

TOP TIPS for submitting your EPS R2 prescriptions 1. Don’t forget to mark every electronic prescription to indicate whether a prescription charge was levied, and where relevant indicate the prescription charge exemption category and whether evidence of exemption was seen.

2. Where the patient is not age exempt or has paid the prescription charge, the reverse of the corresponding token also needs to be completed and submitted to the Pricing Authority along with the monthly paper prescription submission.

3. The Pricing Authority base payment solely on information contained in the electronic prescription message, therefore it is essential that prescription charge exemption information is recorded accurately in the electronic message to ensure correct payment and prevent your prescription from being switched.

4. If you’re not sure of where or how the exemption should be completed on your PMR system contact your PMR provider for assistance and guidance.

Consultation on electronic prescriptions for controlled drugs The NHS Electronic Prescription Service in England enables prescribers (e.g. GPs) to send prescriptions electronically to a community pharmacy of the patient’s choice.

Currently Schedule 2 and 3 Controlled Drugs (CDs) cannot be prescribed electronically.

The Department of Health (DH) has published a consultation that seeks views on electronic prescribing of NHS prescriptions for these CDs. The DH is also asking whether these proposals should extend to private care.

Have your say at tinyurl.com/cdsineps

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July Hints & Tips

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The latest supply chain news

NHS Prescription Services (part of the NHS Business Services Authority) produces a quarterly newsletter called Hints & Tips.

There are two versions: one for dispensing contractors and one for information service users.

Pharmacy teams will no doubt be aware of a number of MHRA recalls in the past few months, and they may have needed to take action to deal with them.

We would particularly like to draw your attention to the latest edition (Issue 16) for dispensing contractors as it contains some really useful information and advice regarding dispensing unlicensed specials and imports, making handwritten endorsements, and additional product information on EPS release 2 prescription messages.

All published editions of the Hints & Tips newsletter can be found on the Prescription Services website: nhsbsa.nhs.uk/3191.aspx

We would like to draw your attention to the news pages of the PSNC website, which include all the latest recalls as they happen, and could be a useful source of information for teams. You can check the latest news from PSNC at psnc.org.uk/news.

Pharmacy teams can also sign up to our email newsletters to receive updates directly into email inboxes. The emails include weekly summaries of the latest community pharmacy news as well as urgent emails sent out as price concessions are agreed.

Is it allowed?

When pharmacies receive NHS prescriptions they must check whether the items prescribed are allowed on the NHS before dispensing. If they are not allowed, the pharmacy may not be paid for them.

Pharmacies can check whether medicinal products and medical devices are allowed using the Drug Tariff: Medicinal products: assuming the prescriber has the appropriate prescribing rights, any food, drug, toiletry or cosmetic may be prescribed on an NHS prescription unless the product is listed in Part XVIIIA of the Drug Tariff (the ‘blacklist’).

Medical devices: If a product has been registered as a medical device (also known as an appliance), it can only be prescribed on an NHS prescription if it is listed in Part IX of the Drug Tariff. Registered medical devices can be identified by a ‘CE’ mark on the product’s packaging.

Dispensers may wish to check PSNC’s Disallowed Appliance List (psnc.org.uk/disallowedappliances) for medical devices they are unsure about, and we have listed some products below that we have recently received queries about: Product

Does it have a ‘CE’ mark?

If no, is it in the blacklist?

Can it be dispensed on the NHS

Additional information

Build-up nutritious soup oral powder 49g (Nestle Health Science)

No

No

Yes

This item is not an appliance nor does it appear in Part XVIIIA of the Drug Tariff (the ‘blacklist’), therefore it can be dispensed against an FP10.

Please note: Build-up (Nestle Health Care) would not be passed for payment because it appears in the blacklist.

Nebuliser mask and tubing

Yes

n/a

No

Nebuliser masks are classified as appliances and, as they do not appear in Part IX of the Drug Tariff, they are not allowed to be prescribed on an NHS prescription.

Sharpsafe 1 litre

Yes

n/a

Yes

The 1 litre size of Sharpsafe is listed in Part IX of the Drug Tariff, so is therefore allowed to be dispensed against an FP10.

Please note: as only the 1 litre size is listed in the Drug Tariff, no other sizes can be prescribed on an NHS prescription.

Tena incontinence pants

Yes

n/a

No

Tena incontinence pants are classified as appliances and, as they do not appear in Part IX of the Drug Tariff, they are not allowed to be prescribed on an NHS prescription.

Please note: If the prescription is one of the following, pharmacies will need to check the relevant sections of the Drug Tariff/PSNC website: • FP10CN or FP10PN (community nurse prescriber) – Part XVIIB • FP10D (dental prescriber) – Part XVIIA • FP10MDA (instalment dispensing) – psnc.org.uk/mda

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Ask PSNC The PSNC Information Team can give pharmacies support and advice on a range of topics related to the Drug Tariff and reimbursement. Questions the team have been asked by pharmacies in recent months have included: 1. Can I claim Out of Pocket expenses for Dermacolor Fixing Powder?

Yes, in exceptional circumstances where the pharmacy has been unable to obtain the product without incurring additional expenses, this item is eligible for Out of Pocket (OOP) expense claims.

Products eligible for OOP expense claims are as follows: • Part VIIIA Category C • Readily available medicinal products outside of Part VIIIA • Part IXB • Part IXC For more information about OOP expenses, please visit psnc.org.uk/oop 2. How do I endorse a licensed medicine not in the Drug Tariff?

Endorse the quantity dispensed over the pack size used, and if the prescription has been issued generically, also endorse the brand name or the name of the supplier.

The Pricing Authority reimburses using the NHS-listed reimbursement price, but if this is not known by them (i.e. the supplier does not list the product/price on the NHS database, dm+d*) then they will need to use your endorsed price (N.B. the following must be included: the pack size, and total net price for

that pack before discount and ex VAT.) It is important to only include the necessary information in line with the endorsement requirement as any additional information could risk misinterpretation which could lead to an incorrect payment being made. *For more information on dm+d, please visit psnc.org.uk/dmd 3. Can I dispense Regaine for Men Extra Strength 5% scalp foam against an NHS prescription written as “Minoxidil 5% foam”?

Whilst the brand Regaine does appear in Part XVIIIA of the Drug Tariff (the ‘blacklist’), the generic description Minoxidil 5% foam has an Official Title (a rINN) and does not appear in the blacklist itself.

Therefore the blacklisted brand can be dispensed against an FP10 prescription as long as the item has been prescribed generically.

4. Where can I obtain FP57 Refund and Receipt Forms?

If a patient is unsure whether they are entitled to free prescriptions, pharmacy staff should advise the patient to pay for their prescription and provide them with an FP57 Refund and Receipt Form with information on how to claim a refund at a later date.

It is the local Area Teams of NHS England who are responsible for issuing copies of these forms to pharmacies, on request. If you are unsure who your Area Team is, then use the database on NHS Choices to find out: tinyurl.com/areateamsearch

Look out for more frequently asked questions next month…

If you would like more information on any of the topics covered, the PSNC Information Team will be happy to help (0844 381 4180 or 0203 1220 810 or e-mail info@psnc.org.uk).

Revisions to SLS list (Drug Tariff Part XVIIIB) Changes to the SLS regulations, effective 1 August 2014, remove generic sildenafil from the list of medicines that may be prescribed only where they meet the SLS requirements. This means that generically written prescriptions for sildenafil no longer require the prescriber to annotate them with the letters “SLS”. However, Viagra has been added to the list, and so must be annotated “SLS” in order to be valid.

Avanafil is also added to the list of drugs used for the treatment of erectile dysfunction, and must be annotated “SLS”.

The generic drugs Apomorphine Hydrochloride, Moxisylyte Hydrochloride and Thymoxamine Hydrochloride are all removed from the list and can be prescribed in their generic form without annotating with the letters SLS.

All details correct at time of printing.

No part of this publication may be reproduced without the written permission of the PSNC. Produced for the PSNC by Communications International Group. ©. PSNC. Colour repro and printing by Truprint Media, Margate.

The publishers accept no responsibility for any statement made in signed contributions or in those reproduced from any other source.

Distributed for PSNC by:

Communications International Group Linen Hall, 162-168 Regent Street, London W1B 5TB Tel: 020 7434 1530 Fax: 020 7437 0915

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Drug Tariff Watch Your monthly summary of any additions, amendments and deletions being made to the Drug Tariff to help with dispensing and endorsements.

The first section of the Drug Tariff is the Preface. This contains valuable information relevant for both the current edition and the next. It lists additions, deletions and any other alterations to the Drug Tariff. The Preface should ideally be checked each month to identify products which are entering or being removed from the Tariff as well as those products changing between categories or in the case of Category C items, changes to the brand used for pricing.

It is especially important to note which items are Drug Tariff listed products as well as which category products are entering and the pack sizes being included in these entries, as reimbursement will be based on this classification and its endorsement requirements.

Incorrect endorsement can lead to incorrect payment for items.

It is also important to know the category of an item when claiming certain payments (e.g. OOP expenses) as these are not allowed in particular categories.

Below is a quick summary of the changes due to take place from September 2014.

Part VIIIA Additions There are no Part VIIIA additions this month.

Part VIIIA Amendments • Ampicillin 125mg/5ml oral suspension (100ml, item requiring reconstitution) is changing to Category C – Essential Generics Ltd • Chloramphenicol 5% ear drops (10ml, special container) is changing to Category C – Martindale Pharmaceuticals Ltd • Chlorpromazine 25mg/5ml oral solution (150ml) is changing to Category C – Rosemont Pharmaceuticals Ltd • Eprosartan 300mg tablets (28) is changing to Category C – Teveten • Ichthammol liquid (100g) is changing to Category C – J M Loveridge Ltd • Kaolin and Morphine mixture (200ml) is changing to Category C – Thornton & Ross Ltd • Liquorice liquid extract (500ml) is changing to Category C – J M Loveridge Ltd • Nicardipine 20mg capsules (56) is changing to Category C – Cardene • Peppermint water concentrated (100ml) is changing to Category C – J M Loveridge Ltd

Part VIIIA Deletions If a medicinal product has been removed from Part VIIIA and has no other pack sizes listed, it can continue to be dispensed, but it will need to be endorsed fully (i.e. brand/ manufacturer name and pack size) in future.

• Anise water concentrated (100ml) • Diamorphine hydrochloride powder (2g) • Zuclopenthixol acetate 100mg/2ml solution for injection ampoules (5) – Clopixol Acuphase Part IX Deletions It is important to take careful note of removals from Part IX because if you dispense a deleted product, prescriptions will be returned as disallowed and therefore payment will not be made for dispensing the item.

• CATHETERS, URINARY, URETHRAL – Nelaton Catheter – Wellspect HealthCare – Wellspect HealthCare LoFric Dila-Cath (891600/800) • HYPODERMIC EQUIPMENT – Reusable Pens – HumaPen Luxura 3.0ml • IRRIGATION SOLUTIONS – Sodium Chloride 0.9% irrigation solution, sterile – MiniVersol (all packs) • IRRIGATION SOLUTIONS – Water for irrigation, sterile – MiniVersol (all packs) • STOMA APPLIANCES – Two Piece Ostomy Systems – Hollister Ltd – Conform 2 – Drainable Pouch with Filter, anatomical shape, Beige (35mm size only)

For the latest guidance on endorsements and prescription submissions, visit

psnc.org.uk/dispensing-supply

PSNC website For up to date information and news on community pharmacy issues, visit the PSNC website at psnc.org.uk PSNC Community Pharmacy News is published by: The Pharmaceutical Services Negotiating Committee, Times House, 5 Bravingtons Walk, London N1 9AW Community Pharmacy News is edited by: Zoe Smeaton who can be contacted at the above address or by email at: zoe.smeaton@psnc.org.uk PSNC Office: 0844 381 4180 or 0203 122 0810

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Dispensing Factsheet: Unlicensed Specials and Imports The requirements for endorsing unlicensed specials and imports vary depending on whether the product is listed in Part VIIIB or not and how the product was sourced. Contained within this guide are examples of different products and how they should be endorsed.

What is an “unlicensed special”?

The Drug Tariff provides this definition of a special: “Specials are unlicensed medicinal products manufactured in the UK for human use which have been specially prepared to meet a prescription ordered for individual patients without the need for the manufacturer to hold a marketing authorisation for the medicinal product concerned.”

What is an “unlicensed import”?

This is a product which is manufactured and may hold a license in another country but it is not a licensed product in the UK. Please note: If a medicine does not meet either of the above descriptions, then the details contained in this factsheet do not apply.

Additional fees that can and cannot be claimed for unlicensed specials and imports

Type of claim

Broken bulk

Out of pocket expenses

Discount not given (also known as zero discount)

Costs incurred in obtaining the item

Part VIIIB products

Non-Part VIIIB products

(endorse ‘SP’ to claim the appropriate fixed fee instead)

(endorse ‘SP’ to claim the appropriate fixed fee instead)

(Part VIIIB prices include margin)

(no endorsement required as they are automatically recognised as discount not given lines)

(use ‘SP’ to claim a fixed fee of £20)

(use ‘SP’ to claim a fixed fee of £20)

Extemporaneously dispensed Part VIIIB products

(can be claimed on the ingredients used)

(endorse ‘ED’ to claim the appropriate fixed fee instead)

(no endorsement required as this is now an automated process for any eligible ingredients)

(use ‘ED’ to claim a fixed fee of £20)

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How and when to endorse unlicensed specials and imports 1. Is the unlicensed special or import listed in Part VIIIB of the Drug Tariff?

YES

The ONLY endorsement required is: 'SP' (where sourced through an MHRA specials or importers licence) or 'ED '(where extemporaneously dispensed) for costs incurred in obtaining the item

NO

2. Is the unlicensed product an import?

YES

Endorse: - Amount dispensed over pack size used - Price of pack used (minus discount/ rebates) & an indication of the pack size the cost relates to (e.g. “£30/pack”) - Supplier's MHRA importers licence number - Batch number of unlicensed product - SP

NO

3. Was the product extemporaneously dispensed?

NO

YES

Endorse: - The name, quantity & cost of each ingredient used - Broken bulk ('BB') can be claimed on the ingredients - ED

Endorse: - Amount dispensed over pack size used - Price of pack used (minus discount/ rebates) & an indication of the pack size the cost relates to (e.g. “£30/pack”) - Manufacturer's MHRA specials licence number - Batch number of unlicensed product - SP

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Endorsement and payment for Part VIIIB items Products listed in Part VIIIB, endorse ‘SP’ for products sourced under an MHRA specials license or importers license OR ‘ED’ for products prepared under the Section 10 exemption from the Medicines Act 1968 (see picture below).

Where a quantity is below or equal to the Part VIIIB listed minimum volume, reimbursement will be the price for the minimum volume. If the quantity prescribed is more than this minimum volume, reimbursement will be paid on that price plus the 1ml or 1g list price for every additional 1ml or 1g prescribed.

Worked example: • Total quantity prescribed – 200ml • Part VIIIB minimum volume listed – 100ml • Listed price for minimum volume – £100* • Listed price for each extra ml – £0.50* • Reimbursement calculation: 1x100ml + 100x1ml, which equals £100 + (100 x £0.50) or £100 + £50 = £150*

*All prices used are example prices only; please check Part VIIIB of the current Drug Tariff for the latest reimbursement information.

Please note: Products which are classified as unlicensed specials are not recognised by the MHRA as having brand names.

For example, products such as Anoheal (Diltiazem hydrochloride 2% cream) and Epistatus (Midazolam 10mg/ml oral solution) are always paid on the price of the generic version as listed in Part VIIIB of the Drug Tariff.

Endorsement and payment of non-Part VIIIB items Please look at this worked example to see how to endorse items that are not listed in Part VIIIB and how this endorsement is used to calculate the reimbursement price.

Worked example: (see picture opposite) • Quantity dispensed – 15 capsules • Pack size – 30 capsules • Product should be endorsed with quantity dispensed over pack size used.

• Price should be the price per pack less any discount/rebates and not the total invoice price.

• Reimbursement calculation: One pack of 30 costs £30, so pro-rata the Pricing Authority will pay £15 for dispensing 15 (example price only) Additional endorsing requirements: • Special Manufacturer’s or Importer’s MHRA licence number • Batch Number of the product • Specials Procurement Fee (SP)

Record sending requirements for non-Part VIIIB items • At the end of each month, a copy of the endorsed Certificate of Analysis (COA)/ Conformity (COC) or invoice must be sent to the prescriber’s Area Team.

• Don’t forget to remove/black out any patient details before sending these to the Area Team.

• For specials not listed in Part VIIIB, stamp, date, initial and endorse the COA/COC with the invoice price paid per pack less any discount/rebates and the prescriber's details.

• For imports not listed in Part VIIIB, make every reasonable effort to obtain a COA/COC. Where one is available, endorse as above. Where one is not available, stamp, date, initial and endorse the invoice with the invoice price less discount and the prescriber's details.

• If you are unsure who to send the COC/COA form to at the Area Team, contact your LPC for further guidance.

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How NOT to endorse your unlicensed medicines You should ALWAYS endorse the price per pack size dispensed and make sure this is clear.

Opposite is an example of where the product price is unclear and may affect payment.

It is not clear whether the price endorsed relates to the quantity that has been dispensed or the pack size that was used.

Pharmacy staff should always endorse the price per pack size as shown above, i.e. price/pack size (£30/30 or £30/pack)* *NB. The invoice price endorsed on a prescription for a non-Part VIIIB special/ import MUST be the actual price paid per pack less any discounts/rebates.

For the most up to date information on unlicensed specials and imports, please visit the PSNC website: psnc.org.uk/specials

Unlicensed medicines: Frequently Asked Questions Q. I normally source my specials through a wholesaler – how will I be paid for (and how should I endorse) my specials?

Wholesalers typically categorise products as being either a “standard line” or “special obtain” item. Items classified as “special obtains” are those which the wholesaler may not have readily available in stock and has to “obtain specially” on a bespoke ad-hoc basis. Items which are obtained in this way are not automatically considered as a ‘special unlicensed medicine’, e.g. food products, stoma or incontinence appliances, or vitamin supplement products.

To identify an unlicensed special, pharmacy staff should look for the wholesaler’s MHRA specials licence number on the product packaging and invoice. For unlicensed imports, the invoice will state the wholesaler’s MHRA importers licence number.

Where the unlicensed special is listed in Part VIIIB, the contractor will be paid this price regardless of how the product was sourced. However, for those unlicensed specials and imports not listed in Part VIIIB, the contractor will be paid according to how the product was manufactured.

Where the product is manufactured under an MHRA specials licence, pharmacy contractors need to endorse: • the wholesaler’s invoice price less discount; • the pack size used to dispense from; • the manufacturer’s licence number; • the batch number of the product.

Where the product is manufactured under the section 10 exemption of the Medicines Act 1968 (when a product can be made on a pharmacy premises without the need for a licence), pharmacy contractors need to endorse the names, quantities and cost of the ingredients used in preparing the product.

Along with payment for the product, the contractor will also be paid the appropriate additional payment depending on whether the product was manufactured by an MHRA licensed specials manufacturer under their licence (they must endorse SP) or manufactured under the section 10 exemption by the contractor or by a 3rd party (they must endorse ED).

Q. What should I do with COCs/ COAs for prescriptions from other parts of the UK? For prescriptions for unlicensed specials and imports not in Part VIIIB originating from Wales, Scotland or Northern Ireland, the COCs and COAs should be retained for audit purposes, but there is no requirement for them to be sent to their health bodies.

Looking for more help sorting your monthly prescription bundles? psnc has produced a series of factsheets explaining exactly how to sort your bundles, with top tips to increase the chances of accurate pricing.

download them at psnc.org.uk/payment 14 Community Pharmacy News – August 2014