Medicines optimisation – failure to launch

 

Has medicines optimisation already failed?

This is a difficult question to answer, but my feeling is that, at the very least, it has stalled. The phrase ‘medicines optimisation’ did not appear once in the Community Pharmacy Call to Action document, making me wonder if the CPO and NHS England has dropped the language. This is despite their insistence that it is an important agenda – a view backed up by ministers and a host of others.

Where did it go wrong?

It was disappointing that there was no clear definition at the start. I said it was ‘all about achieving better outcomes for patients’, but perhaps the patient focus and the outcomes focus has been swamped by cost-containment and we haven’t fully communicated or embraced the need to think differently. I can’t say that the four guiding principles are particularly helpful and can make discussions rather difficult – trying to put our thoughts into four imperfect boxes. We should by now have ‘medicines optimisation indicators’, but rather than these measuring values and process, they seem to be altered medicines management performance indicators. How can we think differently if the framework is poor and the measures are not radically different?

Why it is still important?

There is still an issue with medicines out there. Medicines are too often the first port of call – it is too easy to prescribe something without ever considering that the patient is at the centre. It is not what you want and need it is what ‘they want and need’ to deliver the outcomes that ‘they would benefit from’. I can agree that there are too many prescribing errors, too many errors in taking medicines, inappropriate adherence, too much waste and too high a cost for the outcomes that are actually achieved. Polypharmacy seems on the increase. It is all as true today as it was when the initiative was launched with the exception of a few shining lights within the profession who might be making progress.

Putting it right

Three important starting points to putting it right:

  • Describing medicines optimisation as a part of a wider concept of treatment optimisation. We must recognise that medicines are not always the right answer and prescribing to early create a dependency that may lead to unhealthy choices.
  • The patient must be at the centre. It is simple to me that it is not my disease, not my outcome and not my life. Somehow we need to empower and support patients to make a decision that is right for them. Obviously there are limits on a healthcare professional’s agreement, but if you have no idea of the outcome that the patient wants you have no idea of the solution that is required.
  • Not all solutions for health and wellbeing fit within the health arena. The NHS Alliance, within their breaking boundaries manifesto, recognised that not all solutions to poor health and wellbeing fit within health and the need to integrate local authority solutions with all community healthcare providers. I note that some citizen’s advice bureaus have co-located within community pharmacy and medical practices – perhaps a way forward?

I do hope that the NICE short guideline on medicines optimisation will kick start the process again, but from the scoping, I am not sure that I will hold my breath on this one. They don’t have much heritage here.

 

Getting some of the framework right

  • Medicines optimisation as part of treatment optimisation is a cross cutting agenda that may be driven by pharmacists, but must be led by all professions who offer treatments (including medicines) to patients.
  • The well informed patient at the centre of decision making. I appreciate that some people simply feel that they want ‘an expert’ to lead them. This is OK, but where ever possible the patient must be well informed and encouraged to talk about what they want to achieve.
  • Outcome based decisions. Until you know what progress the patient wants to make, it is impossible to ‘prescribe’ the most appropriate treatment. I am so disappointed that medicines are still reviewed on the primary outcomes of clinical trials when they so often mean little to patients. They don’t always relate to the question – will I feel better – will I be free of pain – will I be able to go shopping – will I be able to play with my grandchild? So medicines should be properly assessed as to their ability to achieve the outcomes that patients want. Formulary processes and the general use of medicines need a real shake up to be fit for purpose.
  • Support to treatments and outcomes. Naturally community pharmacy has an important role in ensuring that patients continue to have access to the medicines that they need to achieve their outcomes. But even here we must think about things differently. The community pharmacist is often the first Healthcare Professional that recognises that something is wrong. It is sad that we pay the pharmacist to dispense the medicine, but not to chase the prescription that does not present for dispensing. It is good that the ‘call to action’ has arrived and it is time to radically rethink what we need community pharmacy to deliver.
  • I also talk about support groups for patients that could be primary care, particularly community pharmacy led, but charity or patient advocacy group run. What happened to the expert patient program? How many pain clubs are there? How many respiratory or diabetes clubs are there – particularly when we know the value of pulmonary rehabilitation, exercise and losing weight to achieving outcomes. I believe that medicines will achieve better outcomes if lifestyle choices and targeted support are improved.

I appreciate that medicine’s optimisation has not got off to a good start. But it is actually far too important an agenda to let die. Patients need it and the health service needs it.

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An interview with a formulary expert – transparency

I have heard you talking about transparency before.

Yes transparency is a requirement for formularies and formulary processes. The MMP have been offering advice on this subject for some time now and are currently working with some forming CCGs to make sure that this is done…

…But it is not new is it?

No it is not new, but while decisions were made behind closed doors and often not written down, it hasn’t been important.

So how have things changed?

Well there is a requirement to publish on your formulary internet site all decisions to allow stakeholders including patients and members of the public to understand the decisions that have been made and the reasons behind them. This is very important if you expect prescribers to be able to explain why they are not using certain medicines.

So were decisions bad?

No certainly not, but some were made without a structured reference to the ethical framework and commissioning framework and many were hardly inclusive and very few actually had patient or public involvement. And some decisions have been presented in a poor way.

Do you have examples of these?

Yes lots, here is one as an example. It is a letter written to the consultant that made the application.

And what is wrong with it?

On its simplest level it hasn’t described the medicine properly. It is here as SR where it is a PR product.

But that is a minor error?

Agreed, but for me, it is a matter of professional pride. If you can’t describe the product correctly then what trust can I put in the rest.

Are there any other issues?

Numerous – a claim about license that is incorrect, a suggestion that in-patients would react to a medicine differently from the general population, a statement about lack of evidence in a specific hospital population and a claim that it would be difficult for a specialist in this area to ‘determine a tight cohort of patients’. So generally incorrect and frankly insulting. It shows a complete lack of understanding of concept of evidence based medicine. And a complete lack of understanding of the licensing process and the development of evidence in the UK.

So it makes them look silly?

I would probably say incompetent, but there is more. A statement that the CCG would be unwilling to recommend it as a product for GP continuation.

But that is fair isn’t it?

It would be if there was evidence in the public domain that confirmed that the CCG had in deed made that recommendation, but there is not. And this leads to the  ‘he said, she said’ culture that we can see which generates a lack of trust. And worse a feeling of collusion to refuse patients access to a medicine that might actually help. In this case there is no real credible alternative that they could offer in its place.

I see what you mean. I notice the final paragraph.

Yes – now that is what makes them look silly. Fancy suggesting that the consultant, an expert in her own field, should approach the company  and ask them to sponsor a small in-house trial. Frankly it beggars belief. I don’t know what they are thinking here. Perhaps that are actually trying to make the consultant look like a fool.

So there is a lot of work to do?

Yes – a lot of work. The NICE Best Practice Guidance does help, but some of the meaning and implementation must be carefully thought through and it needs to be executed with total transparency.

For help and support in any issues related to the blog, please contact Richard at…….. Richard@themmp.co.uk

Formulary as an inclusive process

When I have spoken to clinicians about formularies and the formulary process, they all describe it as a secret society. That is strange and when you ask GPs they say it is a process which tells them what to do. And when you speak to pharmacists that say it is a well defined process which ensures that evidence based decisions are made. I am sure that when you ask the pharmaceutical industry they describe it as a hurdle that they struggle to influence in order to get a fair hearing for their medicine. Patients probably say that it is a mechanism for denying them access to medicines that might help.

How can everyone have such a different view? That is easy – few of them are actively involved. A comment heard a couple of weeks ago – the decision was made by a ‘couple of pharmacists and a tame GP’. I think that the comment was grossly unfair, but I would wouldn’t I, I was one of the pharmacists.

It had me thinking. Actually, although the membership of the committee may be 30, there was rarely more than 10 attending and there only needed 4 to be quorate. So they were wrong – two pharmacists, a consultant and a GP made it quorate and able to make a decision. A decision that affected 1,000 clinicians.
When CCGs share services it is possible that a committee covers 4m populations and affects 5,000 clinicians

In the new world of CCGs there are several important features:

  • The GPs are in charge
  • There should be greater inclusion of stakeholders
  • The CCG should be more responsive to patients/careers and members of the public.

So what it the right number of people to be involved in the decision?

There must be a better way? There is – talk to Richard at the MMP richard@themmp.co.uk
 

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

Formulary transparency

So we need to publish all relevant local formulary decisions on line in a clear, simple and transparent way so that patients, the public and stakeholders can easily understand it.

A simple requirement you might think, but it asks several questions that must be thought through.

What constitutes ‘all relevant local formulary decisions’. There would seem to be two components to this:

  • decisions on how the formulary process operates 
  • decisions on individual medicines.

We already know that the terms of reference, the formulary process, the application form and the decision matrix should be available. I would assume any decision that affects the way that the committee is formed or how it carries out its business.

And then there are decisions related to individual medicines which need to be simple, clear and transparent so that patients, public and stakeholders can easily understand. Wow now that really is a task.

To achieve this we do need to think about the way that we run the process. A standard format agenda and minutes would help when these are published on the Internet, but we can now just say that a medicine has been added or removed without offering an explanation that a member of the public could understand.

The application form, completed and with supporting information is required for stakeholders to understand the decision that was requested and the information used. This is important when you consider the usual quality of the application form and the way that the supporting/competing information is presented. Now more than ever the application process should be an iterative process in which the application and the supportive information is melded into one. (See a previous blog on discovery and on the evidence pit.)

So we all need to work together to present an adult and cohesive approach to this. It does beg the question as to whether more formulary applications should be proactive and initiated by the formulary pharmacist, but that is another discussion. The process should filter out the poor applications at the ‘triage’ stage of the process and the consultant/applicant should feel happy that their application form is going to be published on the Internet along with a range of information which obviously either backs the application or not as the case may be. We mustn’t show the public anything other than reasonable people considering what is best for patients. I must admit that in a previous life as a secretary of a drugs and therapeutics committee about half of the applications got to committee stage – I have seem a wide range of specialists say ‘they aren’t going to approve this’ and then the application is either changed or withdrawn – and the committee had a high pass rate – just how it should be!

The final question is how we present the decision. Obviously to standardise the decision and to make sure it complies with the ethical and commissioning frameworks and our agreed priorities we are using a decision matrix. So the answers need to either be ‘compliance’ or a score which we can add us and present as a joint decision.

Then the only tricky bit is when we explain that the decision matrix is only an average of 6 responders – four pharmacists and two GPs. Ask Richard at the MMP for a solution to this problem.

The evidence pit

I have come across something I call the ‘evidence pit’ over the last few years, but it seems to be getting worse. I am not sure whether it is driven by the NHS or the pharmaceutical industry or just a general misunderstanding. I think I know what causes it – the financial pressures in the NHS.

 So the argument – here is the need, here’s a drug, here’s its license, here’s its data, this is where it fits and this is the price is lost in the fear that a new medicine is just too expensive for the NHS to bear.

So who changes the game? Who decides that the NHS can’t afford the new medicine and changes the way that the medicine is presented in the NHS? Who dreams up the positioning squeezing a new medicine into a gap in the market.

Quite honestly it hacks me off. A niche position in a group of patients or a place in a pathway that is not supported by the evidence.

Are you all mad!

How can I approve a medicine for a group of patients or a position in a pathway that are not clearly defined in the trials?

Why would you want your medicine used in a group of patients more severe than the trial and the likelihood of success is low.

Just because there is a medical treatment gap you don’t have to shoehorn a new medicine into it.

So here is how I see it.

The prescribing budget has performed well. Some good fortune and some good management. We know that some new medicines may create cost pressure and we will deal with it.

Present the medicines in line with licence and evidence – straight down the line

I like to approve medicines in line with their licence and in a group of patients compatible with those entering the clinical trials – simple

I don’t like approving medicines in positions not supported by evidence even though it may be in line with license. So to do this make sure that there is either evidence, experience or both supporting the medicine in that patient group and that place in the pathway showing effectiveness and safety and value. 

Give the medicine a chance – don’t fall in the ‘evidence pit’

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.

Is the Pharmaceutical Industry a stakeholder in the formulary process.

This is a question that has often taxed both the pharmaceutical industry and the NHS. Well should they? 

Should the manufacturer of the medicine in question be a stakeholder to the review process? I almost feel silly asking the question, but at an important meeting recently most attendees said no and I felt that I needed to back down.

I probably wouldn’t have said much about this except for five recent experiences:

  1. I found a drugs and therapeutics committee application form with the words ‘not to be shared with the pharmaceutical industry’ written on the top in very big and conspicuous writing – yes you probably know who you are
  2. I heard a senior medicines manager complaining that the pharmaceutical industry help consultants to fill in the applications – often the times that I had a well completed form – but the view was that the forms were ‘tainted’
  3. I was shown a decision made by a committee where it was obvious that they had the wrong medicine and the wrong information – actually embarrassing
  4. I almost don’t want to mention the fourth, but I had a discussion with a representative that he was searching for a specialist to make an application for a primary care drug. Have you ever had an application from a consultant who said – I want this drug on the formulary, but I am unlikely to use it – actually I want the GP to try this medicine before referring the patient to me.
  5. We share the common ground of compliance. If the patient doesn’t take the medicine properly, we get poor outcomes and the manufacturer gets poor sales.

 

So perhaps we should reconsider the role of the pharmaceutical industry in the whole process:

It is now common for the medicines reviewing bodies in the NHS – not just NICE and the SMC – but NETAG, LNDG and the UKMI to offer their reviews to the manufacturer for comment. This is a good process to ensure that the statements are factual, the interpretation appropriate and the evidence complete. This is probably now standard practice and about time.

At a local level, applications from consultants sometimes are not in line with the full licenced indications – perhaps a particular group of patients or a particular point in a pathway. Here more than ever we should work with the industry to explore these requests. They may have access to data that has been presented rather than published and may be able to point us to clinicians who have experience in this use.

Let’s consider opening up the application process – it is all about securing rapid access to the right medicines to achieve the best outcomes. Consultants are busy people so let the pharmaceutical industry help with the completion of forms – actually give them instruction on what we need to see.

I know that it is radical, but have we ever considered allowing the pharmaceutical industry apply? If they think that their argument is strong – bring it on!

If we reject a medicine then they have the right to see our decisions and to present data or interpretation that we have missed. I always assume that I am not fallible and there is a possibility that I could get it wrong. The worse thing is that some patients suffer because we get things wrong.

Let’s also acknowledge that we are slow to introduce new medicines – it is not a sin – we usually just don’t have the time and resource. And when a medicine is prescribed we all win if it is taken correctly. Then consider ways in which the industry can help educate clinicians and patients to improve outcomes under our watchful eye.

 

At the end of the day we just need to grow up a little. They make the medicines – they should have a say in our review. If we use the right medicines in the right patients at the right time and get the best outcome, then it is a win-win-win.

When traffic lights go wrong. A little story of a private conversation

Last week up in Birmingham speaking to a group of very eminent sleep specialists – brains like planets. Pleased that things were going well.

 Outside the meeting one asked me to explain shared care and the traffic light system. Easy, I thought, home ground! And I suspected that they might be asking with reference to Oxybate which came up earlier.

Well it depends on how you answer three questions:

·         Is the condition difficult to diagnose or complex to manage with co-morbidities etc

·         Is the treatment uncommon, tricky to initiate, requires titration, stabilisation and/or require background tests that are difficult to interpret

·         Is the treatment tricky to maintain, requiring regular review and/or specialist tests.

It is all about clinical risk, bearing in mind that the clinician signing the prescription is responsible and whether the specialist or the generalist is the most appropriate clinician to safely  manage that situation.

In a flow – so stupidly carried on. You can use Oxybate as an example

·         So a condition like cataplexy in narcolepsy is a condition that needs a specialist to diagnose – that is your job.

·         Oxybate for example is a medicine that requires titration by someone who is familiar with the disease and treatment – that is also your job.

·         But once titrated and stabilised there is an argument that things become easier and as long as the specialist can be at hand, a GP might be happy to take over the prescribing – so I personally I would see that either a specialist or a generalist should continue treatment.

 There might be an argument here for Oxybate to be considered red and for specialist diagnosis, initiation and maintenance, I said, but I would suggest that this could be an amber drug with a shared care agreement in place.

Oh My God – there are times you realise you should just shut up!

In my opinion, where ever possible, prescribing responsibility should be held in one place. I don’t like it when one group of medicines are prescribed by the GP and another set is prescribed by a specialist. The risk is high that one clinician will not have the full picture. So I am an advocate of shared care whenever possible. 

There – breath – and feel comfortable that a reasonable explanation had been delivered.

And then he said – yes I understand all of that, but I was interested why Circadin had been given a red category. Afterall, he said, insomnia is a common and simple condition to diagnose, a single dose before bedtime treatment is not difficult to initiate and you only give it for 13 weeks. Also it is much safer than the other hypnotics that you could use, particularly in the over 55s where this drug is licensed.

I have had a few referrals for patients with a diagnosis of insomnia for assessment and initiation of Circadin. They are quite straightforward, but the PPCT pays a £260 first appointment, I treat and review in four weeks for a further £69 and then bring them back to offer up to 13 weeks for another £69. I worked out the economics of all this – nearly £400 in referral costs to manage a course of treatment that is simple and costs £45.

Well – he does have a point – and the correct answer…. Stop applying inappropriate traffic lights. 

On a serious point, traffic lights are a mechanism to reduce clinical risk. This is important and a central role for formulary and associated committees. And where was the GP, insulted that someone suggested that they were unable to diagnose primary insomnia in the over 55s, make a clinical choice between Circadin and other hypnotics, initiate treatment, review treatment and stop at a maximum of 13 weeks.Probably sitting in the back not getting involved. Well on April 1st it will be your money that is being wasted.