Medicines Management – losing its way

I am a great supporter of NICE. It makes reasonable decisions based on a level of uncertainty. When it has been misguided, I have even written a report for the ERG giving them more information and NICE responded.

I was looking at a product recommended by NICE for a common, but high impact on the individual condition. There is some uncertainty about comparable effectiveness to existing medicines, but some certainty about reduced risk of side effects. So NICE says, quite rightly, use it after older medicines unless you are worried about the potential side effects or the patient has experienced the side effects before and then use it first.

Bing, bang, boom – stick it in the formulary – word for word – and translate it into local guidelines – job done – move on. I am not too worried about this as it is actually LESS expensive that the market leader. As I look, it would seem that most of the Pharmacists out there do this – generally we are a very reasonable bunch.

But obviously not all medicines managers follow my lead.

The Medicines Optimisation Pharmacist notices that they use additional medicines to treat the side effects of the older products. So he promotes the product, reduces costs and starts to investigate within a pilot whether the new medicine would improve outcomes. He believes he can reduce cost within this class, reduce the use of additional medicines to deal with side effects, make life simpler for GPs and have a serious look at adherence and longer term outcomes for patients, adding quality to life and perhaps some large savings for the whole system, particularly community and social care. Damn I wish I thought of this!

The ‘not in my budget’ Medicines Manager puts a line in his formulary that says this newer medicine should be initiated by specialists only and they should continue prescribing for three months before transfer to general practice. Good plan, but this area now has three times the level of referrals for that speciality than the regional average and over 60% are single visits. I am sorry; I don’t see the point of paying for a referral to secondary care to get prescribed a cheaper, safer and easier to use medicine than the most commonly prescribed medicine in the area. My GP prescribing lead would have rightly cut my legs of for even suggesting this insult. I can hear his voice boom out ‘are you suggesting that a GP would not be able to prescribe and manage this medicine’. And of course he is right. I doubt that this is in the spirit of NICE, although I am sure they would argue that the recommended medicine was available.

The ‘life’s gone mad’ Medicines Manager puts an incentive scheme for GPs to prescribe the cheapest agent in class first. So GPs accept a payment to use a medicine that, personally, I wouldn’t use in my practice, nor would I want anyone in my family put on and incidentally didn’t have on my formulary. Knowing that more than 4 in 5 people discontinue this drug within 6 months must say something about it and the market leader and medicine that NICE recommends have two to three times this persistence rate. I can’t really get my head around this – life has gone mad. Is it legal? Was there a GP on the board that approved this? So there is a CCG out there that incentivises their GPs to use nasty cheap medicines that patients won’t take to save money in their prescribing budget.

I appreciate that the NHS is strapped for cash and has to make efficiency savings, but these should be made right across the board – the prescribing budget is just one point of expenditure.

Medicines optimisation – the creative use of medicines to improve outcomes for the individual patient is the way forward. There is a need for creative investment of the medicines budget to create savings right across the whole system because patients do better.

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NICE and the NHS constitution – failing guidance

I often write guidance. I often read guidance. But sometimes I’m shocked on the waste of NHS money to provide guidance that is neither required or palatably to the reader. Today is that day!

So the CCG has written guidance – ‘on the cost-effective use’ of medicines approved by NICE within TAGs. 14 pages with flow diagrams sent for consultation throughout the area and updated and reviewed several times. Must have cost tens of thousands of pounds to produce a guideline that the NHS has been expressly told not to produce.

NICE is the organisation that judges whether a medicine is cost-effective. The NHS should introduce all NICE recommended medicines ‘without further assessment’. Put the guidance in your formulary within 3 months and publish on-line. Make the money available to ‘fund and resource’ the implementation of the guidance within three months. Do not introduce ‘barriers’ to uptake and ensure existing barriers are overcome. Monitor uptake in line with the NICE costing template. Surely this is simple enough.

But obviously not. CCGs and CSUs continue to commission further reviews of NICE TAGs at considerable expense. They make recommendations that are clearly not in line with the NICE TAG and does not contain NICE wording. It is shocking that they can also make false claims and cherry pick data. They think that they can get away by saying at the end – ultimately it is the choice of the clinician and the patient – followed in bolt type with – we recommend xxxx over the NICE recommended medicines. So it is the responsibility of the clinician to do the right thing and it will be the clinician in the dock if something goes wrong.

They fail to reference the NHS constitution which talks about patient’s rights to access NICE approved medicines if the clinician and the patient agree it is the right choice for them. But they go right ahead and suggest that clinicians should only offer a single medicine.

The guidelines clearly state that I the patient appear to be well controlled on their existing treatment then the clinician ‘must not consider’ a NICE recommended treatment even though it may be clinically advantageous to the patient  or the patient asks about it. That hardly sounds in line with the spirit of openness, transparency and the NHS Constitution.

There are other phrases that I just find insulting and condescending. Whoever uses the phrase ‘wilful non-compliance’ these days – what are they suggesting? Also ‘genuine needle phobia’, suggesting that some needle phobia is not genuine enough. And ‘genuine allergy’ – so what is the definition here. Oh and you need to have a ‘disability that causes difficulty in communication’ – so another judgement on an appropriate level of provable disability. What is the point of inserting the words wilful and genuine in these sentences?

Yes I know –patients will feign non-compliance, needle phobia, allergy and disability just to get access to an appropriate NICE recommended medicine in line with their legal rights under the NHS constitution. Why can’t they just ask?

What I can’t understand are the people who have been involved in the process – Consultants, GPs, Pharmacists, Commissioners, Managers and Patients. Not one of them have stood up and said ‘we should not be doing this’ or ‘don’t you think it is a little insulting to patients’ or shouldn’t we be supporting NICE and the NHS Constitution’. Even just shouldn’t we be open and transparent and explain why we are doing this to our population.

You should be ashamed of this guidance!

And NHS England should get off their butts and stamp it out.

Let’s support NICE and the NHS constitution and let’s trust well informed clinicians to do the right thing. Now there is a radical suggestion.

Tobacco harm reduction and community pharmacy

I would think that the publication of NICE public health guidance 45 would deliver an early test for the public health function in local authorities and the community pharmacy sector. One in five community pharmacies in England are contracted to deliver stop smoking services and these contracts have recently passed to the local authority. I could suggest that this number might be higher, but it might be better to just add that an eye-watering 1.8million people visit a community pharmacy every day, offering an unequalled opportunity to deliver positive public health messages.

The guidance recognises the value of reducing the impact smoking of those that find it difficult to stop in one go, wish to continue using nicotine or want to reduce the amount they smoke. The guidance makes a number of recommendations and community pharmacy have a significant role to play whether they deliver full stop smoking services or are simply part of the wider team that can raise awareness, communicate with smokers, advise, treat or refer.

The challenge is thrown out to Community Pharmacy to raise the issues with public health commissioners in the local authority. And be clear as to how they can help support this important agenda.

The role of public health commissioners is, however explained in the guidance:

  • Extend investment in harm reduction approaches that supports and extends the reach and impact of existing stop smoking services
  • Develop referral and treatment pathways
  • Ensure existing service providers offer people harm reduction approaches in line with the guidance
  • Develop activity and outcome measures around harm reduction services
  • Ensure service specifications allow for the long term supply of licenced NRT
  • Ensure service providers have appropriate training

So this NICE guidance produces the opportunity for community pharmacy and public health commissioners to work together to reduce the harmful effects of smoking.

Evidence based medicine -friend or foe?

Looking for evidence, I looked in the BMJ and in an article published in 1996 a rather tongue in cheek comment suggested that it was a ‘dangerous innovation perpetrated by the arrogant to serve cost cutters and suppress clinical freedom’.

 

Well I have sat in meetings – even in the hallowed grounds of NICE and felt that this is absolutely true. I have rigorously defended NICE in removing the word ‘affordability’ from a definition of evidence. I have listened to colleagues who add the word ‘evidence’ to the end of every sentence, perhaps hoping that it will give them some importance. I have been staggered by the arrogance of some who contend that everything is in the clinical paper and they gain nothing more from dialogue with the industry and other experts. And I have witnessed the suppression of innovative new medicines because of ‘cost’ and the shrinking of the investment in the UK.

 

Is EBM safe in the hands of medicines management – hell no! Will it be safe in the hands of medicines optimisation experts – only time will tell.

 

Wikipedia – that font of accurate knowledge actually helps – it defines it as – ‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients’.

There are important parts to this – ‘current knowledge’ clearly suggests that knowledge is a continuum and we are just at a single point in this. This is actually important when we consider the development of medicines and the registration process. The EMA and the FDA are usually involved in the process of trial design and agreement of end-points. I am currently working on the most amazing case where both the EMA and FDA asked for different endpoints from those developed by the company. Hence there is absolutely loads of primary and secondary endpoints and I am scratching my head – was that an original one, a FDA one or an EMA one. Fortunately the medicine seems to have hit every one – that’s a relief!

 

And then it mentions ‘the care of the individual patient’. Interesting that it doesn’t say the population! Committees should remember this point and consider which ‘individuals’ the medicine will give benefit to.

 

And then it is the ‘conscious, explicit and judicious use’. So obviously ingraining EBM in everything that we do. But what does judicious mean here? Yes it is all about judgement, wisdom, good-sense and discretion.

 

So here is a view on this. I ask for three things – the three kings of EBM

 

Should it – the science – I would because I am also a pharmacologist and I like to know the basis of things.

Does it – the clinical trial evidence – so when put in a contrived and controlled situation does it perform and hit endpoints that might be applicable to the patient in front of me

Did it – the experience of others who have used the medicine in a similar situation

 

Naturally for every situation there are risks and benefits, but patients come in all sorts of shapes and sizes and the risk benefit conundrum is down to agreement in which both the patient and the prescribing clinician are happy

I have seen treatments blocked – and when I say blocked I mean ‘not to be prescribed under any circumstance’ by evidence based boffins’ for a whole host of implausible and inaccurate reasons. This is medicines management.

 

Medicines management is dead – long live medicines optimisation.

 

And finally, in the words of Sir David Nicholson, we need to be a little less risk averse. We need to use evidence, support experience and drive change.

Interview with the pharmacist

An interview in the Christmas future (20th december 2013)

Tell me Alison how long have you been Head of Medicines Optimisation at the PCT?

Nearly 9 months and it has been both challenging and exciting.

What was the challenging parts of the job?

Well firstly getting my head around the changed agenda. The easiest way of explaining this is by saying that my salary is top-sliced from the commissioning budget. I know that everything is together in the allocation, but it helps to understand that the outcomes are measured in terms of referrals, admissions and episodes of care.

So you have no direct role in the management of the prescribing budget?

Of course I do, everyone does, it is a single allocation. But a lot of the direction comes from the medicines management QIPP lead at the CSU and is delivered through contracts placed by the practices.

So what are you focussed on?

Well I have two large projects that I am working on at the moment. Supporting medicines reconciliation and driving medication review.

Isn’t reconciliation something that the hospital does?

They have been active in the game for some time and we can support that through our contracts, but the bigger issue is reconciliation in primary care and linking this with the New Medicine Services in community pharmacy. When patients pass across interfaces we open ourselves up to considerable risk and we must do better. You only have to read the CQC report to understand how bad we are at it.

And medication review – is this something for community pharmacy?

They are part of the solution, but we have to put our camp in order first. In some of our practices 100% of medication reviews are not done face to face. I know – you can’t believe it, so we are making this better through better organisation of general practice, targeting care homes and the elderly and including it as part of the practice based contracts. I am working on MUR projects with community pharmacy, but I have tried to give this a different focus.

What do you mean a different focus – aren’t the community pharmacists upset about this?

No, not at all. We are driving groups of patients through MUR and directed MUR in a big way. The underlying principle here is that we are trying to promote self care and stop these patients from getting stuck in the system. Yes we do the usual things around asthma, COPD, diabetes and CVD, but this is discretely different.

What do you mean?

Well we have two program’s running, IBS and GORD. There are lots of patients with both of these conditions and they can get stuck in the merry go round system. So we have improved community pharmacy, introduced PGDs and are working with two charities to deliver this work. So far we have reduced referrals to hospital, reduced endoscopes and other investigations and the patient satisfaction has increased hugely – oh and we have reduced the use of long term PPIs.

This must have taken a huge effort in the education front. Yes but I have focussed on positive education and I have some support through a small contract with the MMP for that. One feedback from the GPs has been ‘stop telling me what not to do – tell me what I can do’. I have taken that comment to heart and we have worked with the pharmaceutical industry to drive our educational effort.

Thank you for your comments, we must take a break now, but I want to come back to the practice contracts for support.

Formulary appeals

Knowing that you need a formal appeals process for formulary decisions, it should not be a real issue if you think this through.

The starting point is the establishment of a robust process. By this I mean that you write down clearly how you are going to manage any formulary application and decision.

Here are my suggestions on a process:

Application – obviously any stakeholder can submit an application for a non-NICE recommended medicine to the formulary. The form must be clear and a supporting guide to support the applicant.

Triage and Initial Review – a member of the formulary group should triage the application. Is it appropriate for this committee and within our terms of reference are we able to make a decision? Obviously this refers to the decision map that I have mentioned before. The review is a process of discovery where the applying clinician works with the formulary committee and other stakeholders to refine the application and insert supporting data.

Committee Review – the completed application and supporting data is presented to a group of stakeholders who complete the decision matrix (also described in a previous blog) and the committee approves the decision.

Communication – the decision must be appropriately communicated in a clear and transparent way that allows clinicians, patients and other stakeholders to understand.

Review – at this stage the clinicians or for that matter any stakeholder are able to ask the committee to review their decision. Despite the committee’s best efforts it is possible that they have made a mistake, not considered all of the available evidence, not appreciated the patient angle or made incorrect interpretations. It happens and the committee can be asked to review their decision.

The appeal comes in when someone feels that the committee has not followed their published process and have therefore been derelict of their duties. The appeal should go, in the first instance, to a senior member of staff – perhaps the medical director or a non-exec director. The appellant must demonstrate that due process has not been followed. The director, should they agree that there are grounds for appeal – ie there are deficiencies in process – then they must construct an appeal panel to hear the evidence.

So the lesson here. Write down the process and keep to it. People may not always agree with your decisions, but as long as you follow the process, then there will be no grounds to appeal.

For support in developing superb process contact Richard in the MMP.
 

NICE and 90 days.

This has always been an interpretation of NICE that I don’t understand and perhaps NICE does not understand either.

What I do understand is that there is a requirement to provide appropriate funding and resourcing for a NICE approved technology within three months or 90 days. This is a statutory requirement also underpinned by the NHS constitution. Just has to be done – no question. And the 90 days helps when resources need to be found (although PCTs and CCGs should plan for this) and resources to support implementation put in place. 

What I don’t understand is why NICE says that medicines with a positive nice technology appraisal (where did this term ‘positive’ come from?) should be included into the local formulary automatically – and then add the line ‘within 90 days’. I am sorry but my definition of automatically is not within 90 days.

We are further instructed not to duplicate evidence assessment or challenge an appraisal recommendation so why the delay? If we have nothing to discuss with reference to the formulary then what are we doing that takes 90 days?

I am pleased that there is some clarity around if clinically appropriate is now attached to relevant to the service. It should always have been obvious that, for example a mental health trust probably doesn’t need to list cancer drugs in their formulary. I have heard colleagues suggest that they consider that some decisions are not clinically appropriate in their area. Not relevant to their service – maybe – but not because NICE decisions are not clinically appropriate.

As I said, I don’t understand. If you want a simple solution well within 90 days with automaticity automatically included – contact Richard at the MMP – richard@themmp.co.uk

Medicines optimisation currency

I mentioned this earlier and thought it warranted a whole blog. If only the Chief Pharmacist had said this we might all understand a little more.

The currency for medicines optimisation is commissioning GBP – or to put more simply referrals, un-planned admissions and episodes of care. I would dearly like to factor in UK PLC (although I hate that term with a passion) but it does bring in employment, social care and the economic growth, but that is too far.

Pharmacists commissioned/employed to optimise medicines should believe that they are top-sliced from the commissioning budget and this should be their driver. They should think how the selection, use and experience with medicines can be improved to deliver better outcomes for patients, resulting in fewer referrals, fewer A&E attendances and shorter or less costly episodes of care.

So what might be important within this new currency. Obviously I am interested in reconciliation in primary care and secondary care linked to the New Medicines Service through community pharmacy. I am interested in safety. I am interested in the quality of medication review in primary care and nursing homes and linked to MUR. I am interested in the patient experience of medicines linked to compliance and wastage. I am interested in commissioning disease management schemes in primary care linking self-care to charities to community pharmacy. I am interested in patient outcomes and how they can be improved by the better use of medicines. I am going to change pathways through education and the better use of medicines in primary care. I will help GPs get the right information and help so they can improve outcomes for their patients.

I am going to be positive and tell GPs and hospital Consultants what they can do and not what they can’t. When I review a medicine at a formulary, i will ask ‘ what can this medicine do for us’ rather than what does it cost. When I see a medicines approved by NICE, I will ask – how can we get this medicine offered to all appropriate patients quickly. I will drop into the shoes of a patient and ask – how do they feel about this. I will listen to then and try to understand their views. will tear up those silly health economic examples – you know if drug A cost £10 and was successful in 60% and drug B cost £5 and was successful in 40 % which one would I choose – and do what is best for the patient.

And could I live without a chart showing cost comparisons – absolutely. And when I see a Boston Matrix of prescribing cost vs clinical outcome, I will focus on the two boxes with poor outcomes and ignore the cost.

Can I hit the ground running to this agenda – you bet your life I can. And can I achieve? Well if I can save £8 for every £1 invested in the old currency why can’t I do it in the new.
Oh and I would probably commission someone to give advice in the cost effective use of medicines to GPs as managing the budget is their job now.

Another medicines strategy, another disappointment.

The tittle just about says everything. Same old – same old!
Having spent an hour or so reading a ‘hot of the press’ guide for GPs and GP commissioners I am truly disappointed in lack of innovation in the whole document. When leadership is needed the knowledgeable turn out a document defending all that is done today with the need to do extra things. Sooner or later someone will say ‘hold on a minute – who do they think they are kidding’.

The bit that sticks in my mind is ‘Many PCTs have historically used their prescribing budget to fund medicines management teams’ – so is this the thinking behind a document in which the first two bullet points in the introduction relates to the prescribing costs.

Two important reminders – the Chief Pharmacist has not fully clarified the medicines optimisation agenda, but this is the future I want and it is not focussed on saving money in the prescribing budget. The NAO report on prescribing costs in primary care is 5 years old – need I say more….

So here are a couple of thoughts:

Fund the medicines optimisation team through the commissioning budget. Change the focus from  saving money in prescribing to reducing referrals, reducing non-planned admissions and the cost of planned admissions. If you take this as the starting point the whole conversation changes and other things fit in. So is this clear – the currency is not £ prescribing spend – the currency is referral, admission, episode of care.

Scrap prescribing incentive schemes – they fundamentally wrong. Even NICE is taking it out of the QoF.

Stop talking about providing practice support – the idea of throwing good money after bad is dead. Set the standard and help practices employ their own practice support. There are some great examples around.

Truly believe that integration is essential and ensure that the prescribing agenda supports this. See my blog on ‘discovery’ for just one example.

If it is a statutory responsibility – just say – do it.

Rewrite the recommendations

Oh and I should say the only example that rocked my boat was from Croydon. A pilot scheme in nursing homes. But please don’t lead with drug costs down by £51,472 – just say hospital admissions down by 106 reducing expenditure by a mouthwatering £372,750. Medicines Optimisation at its best! Hmmm Barbara if that was you – hero of the week!

Getting the application right.

It is interesting to see the diversity in application forms. And in a way I have no problem with this. Local determination may mean that local health economies take a slightly different position on medicines and therefore they might ask slightly different questions. After all the application needs to be in line with three things:

  • The local commissioning framework
  • The local ethical framework
  • The formulary decision matrix

This seems obvious that to be able to offer a standardised decision that is compatible with both the ethical and commissioning frameworks then the application form needs to ask the right questions.

It is a little disappointing to see so few decision matrices used in committee and even more worrying when the application form does not ask the applicant a question related to every area of the matrix.

I always tell consultants – and it is usually consultants that apply – that the form is asking you to present a logical and compelling argument. However they so often answer it badly or refer it to the pharma industry to help. Sometimes there is a clinical pharmacist at the hospital that helps and then the form is usually great.

In the past I have actually earned money from training / presenting to clinicians on how to complete applications.

With the increased need for openness and transparency it is increasingly important to look at the process and ensure:

  • That the application form asks all the questions related to the decision matrix
  • The application is logical and sensible in its layout and flow.
  • That a guide is provided to clinicians to ensure that they understand what is required
  • That suitable support is available to ensure that the application is appropriate, accurate and complete

Remember – if the application is not right then you can’t make a decision in a consistent manner.