New NICE guidance for local formularies requires them to include NICE-approved medicines within 90 days, and not to repeat or challenge NICE appraisals.

CCGs are also required to publish all local formulary information online in a way that is accessible and clear to patients and the public.

This guidance reflects the Government’s commitment to ending the ‘postcode lottery’ and ensuring that local prescribing makes innovative drugs available.

All CCGs are required to publish formularies by 1 April 2013, and the new NICE guidance aims to help them combine three priorities: meeting local needs, reducing variation in prescribing, and enabling rapid uptake of innovative therapies.

Until now there have been no standard guidelines for putting together a local formulary, and this has allowed wide variation in prescribing between locations.

According to the NICE good practice guide, local formularies must follow three rules to ensure they are fit for purpose and compliant with law:

• Medicines with a positive NICE appraisal must be included (where clinically appropriate and relevant to the services provided) within 90 days.

• There must be no local duplication of, or challenge to, a NICE appraisal.

• All relevant local formulary information must be published online in a clear and simple way accessible to patients, the public and stakeholders.

According to Professor Alan Silman, Chair of the Guidance Development Group, the new guidance “allows formularies to continue to respond to local needs and circumstances but also ensures that NICE’s decisions to approve an intervention and other appropriate inputs into formulary production are taken up in a timely and transparent manner.”

ABPI Chief Executive Stephen Whitehead said the guidance was “an important step forward”. However, he added, there needs to be “strong local implementation of this guidance” before the formularies are published.

NICE has backed moves by the Department of Health to make NHS organisations publish which of their technology appraisals are included in local formularies from April next year.

Research has found that certain PCTs are blacklisting expensive treatments recommended by NICE creating a postcode lottery for patients across England.

That led to NICE chair Sir Michael Rawlins calling for patients to sue trusts which do not provide access to treatments recommended by the regulator.

Sir David Nicholson, NHS Chief Executive, has since written to SHAs and PCTs saying that he “wants to see” which NICE technology appraisals are included on local formularies.

“Formularies have an important role in underpinning safe and effective use of medicines,” he said in his letter. “However, they should not duplicate NICE assessments or challenge an appraisal recommendation. Once in formularies, there should be no further barriers to the use or prescription of technologies or medicines.”

Professor Gillian Leng, Deputy Chief Executive of NICE, welcomed the instructions by Sir David and said NICE is now working on creating a best practice guide to developing local formularies.

“This will help ensure consistency in the way in which local formularies are produced, and ensure there is no local evaluation of drugs that have been positively appraised by NICE.

“NICE-approved drugs should not be excluded from local formularies on the grounds of cost. We want all patients to have access to medicines that we consider to be effective.”

NHS Chief Executive Sir David Nicholson will require CCGs to state which NICE-approved treatments are available on their formularies.

In a letter to all NHS organisations, Nicholson linked this requirement to the NICE ‘compliance regime’ outlined in the Government’s innovation strategy.

His response follows a public argument between NICE and the NHS Confederation over delays in the availability of NICE-approved drugs.

In an online article, NICE Chairman Sir Michael Rawlins criticised NHS trusts for “trying to pretend” that they were capable of rethinking NICE decisions.

David Stout, Chief Executive of the NHS Confederation, responded that “every NHS organisation has a finite amount of money available” and that the NHS needed to be “open” about the “trade-offs” forced on it by economic pressures.

Nicholson’s letter attempts to bring together both sides of the argument by stating that PCTs and CCGs must make a public, online statement of which drugs on their formularies are NICE-approved.

The letter noted that local formularies should not “duplicate NICE assessments or challenge an appraisal recommendation”, and that addressing variations in compliance with NICE recommendations was important for the NHS.

However, it stopped short of explicitly banning local commissioners from failing to make any NICE-approved drug available. This is already a legal requirement – but NHS rationing is a sensitive issue, given the current strict cost controls.

Local formularies will be required to include “clear, simple and transparent” online lists of their NICE-approved drugs by 1 April 2013.

NICE has produced a new ‘best practice guide’ to stop ‘postcode prescribing’ and ensure that medicines it has recommended are included in local formularies.

The guide, which covers the creation and review of local formularies, states that medicines approved by NICE should be “automatically incorporated” into lists of available drugs within 90 days.

This measure is intended to combat the growing trend of PCT clusters and CCGs placing more expensive new drugs on a ‘red list’ of products to be avoided in order to achieve spending cuts.

The recent DH report Innovation Health and Wealth highlighted the barriers to innovation at local level, where formularies often do not take account of recent NICE drug appraisals; in some cases, these appraisals are challenged by local bodies.

Refusal to provide more expensive drugs (such as cancer drugs) and over-dependence on the cheapest generics were both identified as issues.

The report said that there should be no barrier to the use of new NICE-approved drugs “beyond a clinical decision relating to an individual patient”.

Dr Gillian Leng, Deputy Chief Executive of NICE, commented on the best practice guide: “We want all patients to have access to medicines that we consider to be effective.”

NICE will publish details of any measures to be taken against local prescribers for ignoring the new guidance this autumn.

Dr Bill Beeby, Chairman of the prescribing subcommittee of the BMA’s GPs’ Committee, said that these measures were to be welcomed, but that more money had to be made available for prescription of more expensive drugs.

The new formulary guide is the first attempt to standardise the process of developing local formularies across the NHS in England. It reflects the complexity of seeking to give local prescribers more choice while imposing budget cuts.

Further plans outlined by the Innovation report include the introduction of a NICE Compliance Regime to drive rapid and consistent uptake of NICE-recommended products, and the establishment of a NICE Implementation Collaborative bringing NHS and DH organisations together with industry.

NICE has undertaken a review of NHS formularies in England to end local inequalities or ‘postcode prescribing’ of drugs.

The review will help the Department of Health to implement its new policy of ensuring that NICE guidelines are followed consistently across all regions.

While the NHS in England still has to cut £360 million from its drugs budget, NICE aims to ensure that high-cost medicines it has approved are not blocked.

Dr Gillian Leng (pictured), Deputy Chief Executive of NICE, said: “NICE will embark on a specific piece of work to look at how local formularies are put together. At the moment there is no standard process for them.

“NICE-approved drugs should not be excluded from local formularies on the grounds of cost,” she added. “We want all patients to have access to medicines that we consider to be effective.”

The disparities between local formularies have long been of major concern to the UK pharmaceutical industry as they make access to many drugs a regional variable, whereas NICE appraisals assume a national basis for decisions.

NICE said that some local NHS trusts are either repeating or challenging its appraisals, making their own decisions about which medicines are cost-effective.

A recent DH report attacked the idea of ‘postcode prescribing’ and recommended that local commissioners should incorporate new NICE recommendations into their formularies within 90 days.

This would mean an end to the ‘red lists’ currently drawn up by PCT clusters, recommending new and high-cost drugs for exclusion from local formularies even when they are recommended by NICE.

‘Red lists’ are a major strategy for helping NHS commissioners to work within current spending restrictions.

To help the new CCGs resolve this problem, NICE will develop a best-practice guide on the creation and review of local formularies. The guide will go out to consultation before being published in late autumn this year.

In the second of these articles we examine specific examples of actual prescribing incentives that have been used around the country and ask why this was done, and what is the impact to the pharmaceutical industry? Importantly, how does the pharmaceutical representative work within this climate?

Percentage drugs prescribed generically: Targets 70%-75%
Don’t think that there is not a region in the country that does not have this as the first and foremost incentive. This nation does indeed seem hell bent on generics despite the fact that we now know there has been significant delays in dropping of prices of generics and indeed maybe even some level of price control of generics. The generics situation has not been ideal for quite some time and the government has just announced a completely shocking statement regarding the prices of 4 named generic drugs. Remember that branded generics do not count as generic prescribing. Hence some PCTs have been recommending branded simvastatin – whilst this will drop the percentage generic prescribing rate, the perception is that it will reduce the cost of statin prescribing.

Percentage variation in statins: Target increase from baseline
Interesting twist on the above in that we are rewarding practices for increasing their statin use! But this will increase prescribing costs! So how will this work? Well there are incentives that are quality based. In fact, we need to put in some quality-based incentives for two reasons. Firstly to improve quality of prescribing. Secondly to ensure that our prescribing incentives are not thrown out for being purely cost motivated! In truth, increasing statin prescribing from baseline ensures us that certain NSF and NICE prescribing is being undertaken.

Selling statins in this market
The statin market has become very unstable. A banned statin, a newly launched statin, a generic statin and the presence of a well-placed market leader statin has created unprecedented turbulence within the market. Being a pharma company selling within this arena is going to be fraught with significant local and regional political drivers. Certainly pharma companies are doing the following: working with NSF steering groups (diabetes and CHD), coordinating post-graduate education and local KOL meetings. But also, service delivery, practice nurses and audits and the striving to ‘aid’ in achieving ‘targets’ are also offered. Interestingly, whilst the industry pushes in one direction, you will see (or maybe hear on the grapevine) the PCT and NHS Trusts pushing in other directions. In fact PCTs have taken to ‘writing letters’ whereby ‘strong advice’ to use/not use/recommend/not recommend certain prescribed agents is widespread. It seems that both pharma companies and prescribing advisers are resorting to major ‘leaflet campaigns’ to get there agenda out en masse. Certainly if you have good relations with the PCT you may do the following: try and ascertain what are recommended agents, is there a ‘blacklist letter’ and what does it look like, what are the plans for short and medium term future. Looking at the effect of the combined generic incentive and increase statin incentive, GPs will probably be getting the message to increase statin prescribing of generic agents.

Percentage advised (named) antibiotics: Target 75%
It has already been mentioned that antibiotic prescribing is key on the government agenda. Hence I have seen significant numbers of PCTs link with the antibiotic policy of the Trust (working with the microbiologist) and then naming certain antibacterials with a view to encouraging GPs to use these products. Interestingly once an ‘antibiotic formulary or guidance’ is in place, we will pick probably 4-7 agents for the incentive scheme (usually generic alternatives to branded agents and usually agents that are being actively marketed). It seems that whilst we would want to encourage all GPs to roughly agree with our antibiotic formulary, we will name drugs that are in danger of being replaced by expensive brands of the same class, especially if there is active promotion during the particular quarter/half year.

Branded calcium channel blockers: Target 80% Branded Isosorbide Mononitrates: Target 80%
Whilst we want to increase generic prescribing, one area where we want branded generic prescribing is with calcium channel blockers of the dihydropyridine and benzthiazepine class (nifedipine and diltiazem). Hence there is prolific marketing of branded generics here and due to difference is bioavailability, the RPSGB and BMA recommend branded prescribing. Many deals are being struck for mass purchases.

Fluticasone actual cost / STARPU percentage total inhaled steroids
There are many inhaled steroids on the market. But this is the most ‘picked on’ from the point of view of prescribing incentives. Practices are penalised for spending too much on NIC fluticasone as a percentage of total spend on inhaled steroids. One could ask – what about outcomes? What about quality of life from using this agent. These are all relevant questions. The point is this. The presence of this agent on a number of prescribing incentives means those looking at budgets are wary. They don’t necessarily feel the drug is too expensive. It may come from the presumption it is being overused.

Working Reality of Prescribing Incentives
They are here and here to stay. What is interesting is that they are changing with the times. I have attested in the previous article as to ‘why’ they are created and ‘how’ they are created. But I am finding that with so many pressures these incentives are complicated and not always reflective of the overall picture. They are often created to ‘tackle’ an issue for a set time. It is a photo-picture problem of a dynamic situation. There are two points that must be made due to importance and urgency.

The most striking prescribing incentives seem to be created in response to very active marketing or a surged increase in the prescribing of a new/branded product. Essentially, a response to the marketing of the pharmaceutical industry.

If you have some form of relationship with your PA – why not ask them what is on their black list! Believe it or not – you may be able to help them. If they are trying to get rid of PPI 1 and you sell PPI 2 they may be supportive to you helping them with their messages. Kill two birds…

I am also seeing less complicated incentives developing. There are some areas that are moving away from set hurdles of restrictive prescribing and issuing the following edict: save what ever money you can from the prescribing budget and you can keep half that cash sum (the other half goes to the PCT)! Note this is JUST DRUG BUDGET MONEY. Not total expenditure.

Given that many pharma companies justify increased prescribing costs by offsetting costs in other areas of care, it is prudent to note that most prescribing incentives look purely at drug costs and drug costs in isolation.

How do pharmaceutical advisers use prescribing incentives?

What is an incentive and how does it equate to improved prescribing?

Importantly – how does it relate to pharmaceutical industry activities?

PRESCRIBING INCENTIVES: WHAT ARE THEY?
Pharmaceutical Advisers are able to dip into the financial motivation of GPs to incentivise certain agendas. These incentives are called prescribing incentives. They are often talked about but usually within closed-door meetings.

WHY ARE THEY CREATED?
It seems a universal human trait – if you really want somebody to do something – pay them. This is the philosophy of the prescribing incentive. Sometimes good practice, patient follow-up, and quality prescribing is done from the good of the heart. Other times it is done for the worthy cause of an NSF target, or a NICE directive or on the basis of evidence from a large RCT. But there are occasions, when despite all these hooks – things do not get done. Or more importantly – do not get done the way we/the PCT/the formulary wants things to be done. So – we come up with the prescribing incentive!

FORMULARY PRESCRIBING
The PCTs are creating formularies at a rapid pace. Whilst we do not expect 100% concordance with the formulary, we are looking for 75%-80% concordance. Hence many prescribing incentives are based around POSITIVELY reinforcing one agent over another or NEGATIVELY punishing for non-formulary drugs

COST BASED INCENTIVES
• Generic prescribing rates % (drugs which have patent expiry)
• Antibiotic prescribing % (big move by government to reduce antibiotics across the board).I am seeing this as a significant pressure in both secondary & primary care. It does worry me slightly…
• Beta-blocker generic prescribing % (beta-blockers that have patent expiry are rewarded by these schemes
• NSAID: COX2 (some incentives look at %NIC and some give straight ratios. I have noticed others are simply blacklisting COX2 and either using ‘cost’ as an argument or ‘cost and efficacy’. Some are even banding around ‘safety’ issues around COX2 to reduce prescribing

QUALITY BASED INCENTIVES
Bendroflumethazide 2.5mg dose % of all bendroflumethazide dosing SABA: Inhaled steroids ratios in asthma Items / STAR-PU: identifying specific therapeutic groups (age/sex) prescribing units

EXAMPLES OF NATIONAL PRESCRIBING INCENTIVES
It is no secret that PCT Advisers use ‘incentives’ to control, police and enforce formularies. In fact the DoH is not only aware of it – they recommend it! So much so – the NHS Executive have given us a list of drugs to target on our prescribing incentives! These are shown below:
• Antibiotics (big move by the government to reduce antibiotics across the board)
• Encouraging simvastatin prescribing (sometimes incentivising for simva – sometimes negatively incentivising other statins)
• SSRIs – the government feel we are over using. There have been significant numbers of incentives to discourage SSRIs. The wake of negative media on these agents has only encouraged this move.
• ACE:A2A (ratios) : an unwritten 10:1 rule (ie) penalties if GP is using more than 10% sartans when compared to ACEI (despite the fact there is emerging data on the A2A molecules!!) Remember – when ACEI were new, prescribing advisers were telling GPs not to use ACEI. Now they are recommending ACEI instead of A2A! No doubt, when new RAAS molecules develop, we will be recommending sartans (which will have dropped in price!)

ARE PRESCRIBING INCENTIVES FOOL PROOF?
Not at all, but they can certainly help achieve cost-savings (in the short-medium term).

WHO DECIDES WHAT IS ON THE PRESCRIBING INCENTIVES?
Led by the pharmaceutical adviser but created by the prescribing team/PCT/pharmacy advisers, it is a collection of targets and hoops through which practices can earn extra money by achieving. Often incentives are linked. One example of a real incentive is given below.
• Generic prescribing 75% +
• Anti-obesity drugs prescribed within NICE guidance +
• NIC/DDD for PPI targets (ratio of what you are spending per dose on PPIs) +
• Reduction in antibiotics by x%

Now these 4 targets were linked. So either achieve all or none. But if all were achieved, significant funds were given to the GPs. If they achieved some or came close… tough. This may sound harsh.. But tell me. Does this ring a bell? Does not the pharmaceutical industry have targets (RSA / % market share / % growth of market)? Does not the industry reward a few who ‘top their targets’ with bonuses? And those who don’t achieve? Try harder next time…

THE PRESCRIBING ADVISERS in Primary care represent one of the industry’s biggest challenges. In the second part of this topic, Omar Ali explores some key aspects on the agendas of prescrib-ing advisers and how this affects interactions with the pharmaceutical industry. This article gives examples of The Good, The Bad and the Ugly, joint working, pharma relations and key agendas are explored. Omar also asks the question: Why do some pharmaceuti-cal advisers have a no-see policy ?

Key Agendas
Pharmaceutical Advisers broadly speaking have three agendas that drive their main activities:

• Prescribing Cost – Containment within the Drug Budget
• Evidence Based Prescribing
• Clinical Risk Management in Prescribing

Whilst each of the agendas are driven from key-government documents, the cost-containment is the direct measure of the Prescribing Adviser’s abil-ity to exert control, influence and accountability of his/her activities. Let’s take a closer look at each agenda…

AGENDA 1: Prescribing Cost – Containment within the Drug Budget
ACTIVITIES DRIVEN BY AGENDA 1
• Financial planning of drug budget
• Listing and targeting Top 10 expenditures (absolute cost terms) Listing and targeting Top 10 rate of increasing expenditures (in cost relative terms)
• Horizon Scanning of New Drugs & Managed Entry of Molecules at Launch (often in an attempt to pre-empt or neutralise marketing campaigns)
• Therapeutic Swaps of given classes (PPIs, CCBs, Inhaled Steroids) where it is felt significant patient numbers may be treated with a differ-ent agent within a class at a significant cost reduction.
• Scanning therapeutic classes which are under national priority for cost-reduction or improved cost-effective prescribing (ie) The DoH website encourages Prescribing Advisers to nationally target and prevent overuse of : antibiotics, SSRIs, Sartans:ACEI ratio, PPIs
• Securing Funding for NICE drugs. Rejecting funding for NICE drugs not being used within NICE guidance (ie) monoclonal antibodies, tenecteplase

AGENDA 2: Evidence Based Prescribing
ACTIVITIES DRIVEN BY AGENDA 2
• As there is much prescribing that is NOT evidence based, and given the fact there are not many pharmacists per PCT, to try and keep all prescribing evidence based is almost impossible
• SO – we target evidence based prescribing in those areas which are EXPENSIVE !
• Example : ALLHAT STUDY : Reinforcing bendrofluazide is 16x cheaper than amlodipine. The company line is that amlodipine is as effec-tive as bendrofluzide. Data is the same. Message is different.

Example : INHALED STEROIDS : Reinforcing BTS Guidelines and that combined steroids/beta-agonist is not step 1 or 2! Company lines vary but there is a feeling (right or wrong) that some companies encourage combination products earlier in disease and also that high dose steroids are over marketed. Probably not true but the perception is there without question.

• Practice Guidelines : PCT Formularies are rife now, with incentives and guidance and even some very heavy handed clinical governance rods to beat the GPs with!

AGENDA 3: Clinical Risk Management in Prescribing
ACTIVITIES DRIVEN BY AGENDA 3
• Even the most evidence based cost effective drugs will have elements of clinical risk

Example : infliximab requires concurrent treat-ment with methotrexate. In many cases, the methotrexate is not being monitored, neither is the liver function or the full blood counts. Consultants are too busy to recall them and GPs complain it is too specialised to follow up. Interestingly, a new agent from Abbott Labora-tories may be the answer for these rheumatoid patients…

Example: The glitazones have been well promoted, understood and are being prescribed. However, GPs are generally reluctant to initiate therapy. So despite prescribing power in primary care and all the budgets based at the PCT, unless diabetologists are starting, monitoring and following up patients, only those GPs with specialist interest in glitazones are initiating therapy. As they cost £27-£57 per patient per month you may find prescribing advisers toler-ating their use but they certainly won’t be encouraging their GPs to use them. Here the PCT adviser may use an evidence based argu-ment to stop the use of an expensive drug

WHY DON’T SOME PHARMACEUTICAL ADVISERS SEE REPRESENTATIVES FROM THE INDUSTRY?
REASONS THEY WILL GIVE…
• “The data supplied by a representative is biased.” It is a company’s job to promote its product in the best light.
• “I haven’t got time.” Representatives must remember that they are paid to see customers. I am not paid to see members of the industry. So my ‘job description’ and ‘timetable’ will not allow for this unless I decide to do so.
• “The industry is just in it for the money.” Many companies are tailoring their activities with the intention of really looking at the NHS and what is required with a view to joint part-nerships. Having said that, most representatives are not bonused on relationships with customers but are bonused on sales (RSA, Market Share, % target)
• “Decision Makers are best kept at an arms distance from the Drug Industry.” Current debate of the day. Please read NO FREE LUNCHES BMJ May 2003. The whole issue is dedicated to this statement. It seems the USA, UK and much of Europe is asking this same question in different ways …

THE REAL REASONS WE DO NOT SEE REPRESENTATIVES !!!
As a prescribing adviser, if I look down on my PCT with a helicopter view, how do I see the Pharma-cuetical Industry? If they were all radioactively labelled, I would see hundreds of little ‘green ants’ running around from practice to practice, seeing GPs and telling them ‘what to prescribe’.

As a prescribing adviser, if I look with my own PCT what is MY JOB? I am effectively a lone ant (with 1 or 2 helper ants), running around from practice to practice, seeing GPs and telling them ‘what to pre-scribe’

CAN YOU SEE THE PROBLEM? WE DO THE SAME THING, WE ARE COMPETING DIRECTLY
This is different from your relationships with any of your other customers, and it is why Pharmaceutical Advisers and Pharmaceutical Representatives will always have a tenuous relationship.

A Trust comprising of 3 hospitals were under considerable ‘bombardment’ from COX2 companies pushing considerable data and marketing materials. One company managed to involve pharmacy in the review. The rest tried but for a number reasons did not gain access. Furthermore, this company managed to get a lead rheumatologist to apply for the drug to the D&T. Significant letters were also written from a pain consultant, a consultant in general medicine, a pain consultant and a care of the elderly consultant. All requested this same COX2 agent for formulary acceptance! This had never happened before…

At the D&T meeting the rheumatologist put forward the COX2 for application. The feedback from the directorate pharmacists revealed that the consultants who had also supported this drug were in fact using it off-formulary and prescribing the agent in outpatients.

A debacle followed.
The drug was thrown out. The consultant was furious. Pharmacy was displeased with the outpatient prescribing. The rep had reportedly told the consultants that pharmacy was supporting the drug. The pharmacy was told that the consultant was keen on their COX2. The whole thing was a mess!!!

The consultant in question wanted the drug for himself or for none at all. That is the case within the trust in question (unnamed) to this day. COX2 are banned. None on the formulary and there has been a broad sweep to abandon them for some while.

The consultant was quite indignant that other doctors were dabbling within ‘his’ specialised area…There was no drug to be evaluated.

Analysis
Remember all pharmacists maintain contact with each other. We may not always know of some practice directly, but a little probing will often lead us to the right answer

Don’t Don’t Don’t tell pharmacists that a ‘consultant wants to use your drug’. Why? Because of 3 things

1. So what – just because a consultant wants to use it in itself means nothing. An intention to bring to D&T is another.
2. What if the consultant is lying to you? They tell reps things for a number of reasons. Sometimes to get rid of them!! Analysis
3. Has it occurred to you that some consultants tell all their reps ‘yes I like your drug’

• Care if you have loads and loads of fans at the D&T. Especially if you have one champion. Care for upsetting people
• Have you seen the directorate pharmacist for your area – they supply true therapeutic intent of consultants. See them as they will tell you how likely you may be received by people like me and people like consultants
• If your drug is in paediatrics and you haven’t seen the paediatric pharmacist, you may get on formulary but you will have lots of difficulties after that
• If your drug is in medicine and you haven’t seen the medical pharmacist you probably will have difficulty before you get going
• Don’t tell all your customers that everyone wants to use your drug. If you want support be very precise and specific…. Who wants to support your drug and in which patients and how often. Don’t just say – Mr X wants our drug – you had better put it on the formulary!!
• See the drug information pharmacist – they supply much info to the D&T committee
• If your drug fails – start again. Though wait a while. Presume pharmacy have thrown away all your documents. They tend to stack up before a review, then only keep the successful drugs
• Remember that pharmacist speak to each other and consultants as well. The medics often tell us ‘the real deal’ and will often spin you a story to get something (a meal, a trip, etc)
• Do regular pharmacy lunches as this familiarises us with your product
• If your drug is not on formulary are pharmacy swapping? For example, are they substituting your agent for another that is on formulary (i.e.) PPI, statins, CCBs
• Find out how many D&Ts your formulary pharmacist sits on… remember whilst you may have difficulty tracking down D&T members, the FORMULARY PHARMACIST & DIRECTOR of PHARMACY are the two people that will definitely be on the D&T

This was a classic case of politics and maybe too aggressive repping having ruined not just one but probably future D&T applications.

Corporate Structure usually represents the line management of organisations Note that the Executive Team (four groups) have considerable concern as to the percep-tion of the organisation to the outside world, including local press, patient groups and issues surrounding complaints. The press advisor and legal affairs are key voices with regards the Chief Executive. Since April 1999, the CE was not only responsible for finance, but is now responsible for the quality of both patient care and the staff who are delivering it. Given that most CEs are not trained practitioners of any sort, the responsibility and accountability can only be delivered through clinical gover-nance. Of all the Executive Directors, the Medical Director and the Director of Operations are the two who have a significant impact on the role and performance of clinical staff and sup-port services. The Director of Nursing is one of the most far-reaching and diverse roles and will be a key target for stages of nurse prescribing, nurse consultants and nurse education. However, as is often the case, these individu-als are almost exclusively out of reach to most representatives from the Pharma industry.

The Director of Finance (DOF) has become one of the most commanding and dictating positions within the Trust. Directives on cost containment or budget reduction will have compulsory attainment. No argument. No dis-cussion. Directors of HR are interesting targets for the industry as most NHS Trusts & PCTs have staffing difficulties and Pharma companies, whilst realising this, have not yet been able to crack this problem. There are some fantastic examples, however, of collaborative working within pockets of the Trust. General Managers for the various Directorates (Medicine, Surgery, Woman and Children’s Services) have become very impor-tant with regard to interface logistics between the Executive Directors, their Trust Performance Targets and the patients on the wards who require care within the budget available from the DOF. Indeed, recently, one or two drugs and ther-apeutics decisions have been blocked or deferred by General Managers who hold sig-nificant budgetary power and can, to a certain extent, dictate commissioning resources for problematic drug use/costs. Director of Pharmacy holds many keys though these individuals have varying accessi-bility to the Pharma Industry. More important-ly, pharmacy staff working under this remit (formulary pharmacists, directorate pharma-cists and medical / drug information pharma-cists) have significant influence over medicines use within the hospital and subse-quent primary care interface. Pharmacists will be covered in further issues of the Matrix. Other Support Services such as Dieticians, Physiotherapists, Microbiologists will be tar-gets for those therapeutic areas in which they are directly or indirectly involved. Note some support services are now under PCT auspice for example, diabetes nurses and dieticians.

NHS Trusts have many Boards & Committees. Philosophically, they allow staff and man-agers who often do not have any line respon-sibility to each other to come together in some forum as dictated by the title of that Board. Operationally, they allow decisions to be made which often cross departments and multi-disciplinary staffing grades. These Boards and committees will either be advisory or policy making. It is not always clear which type a given group is! The CMB is a very important Board and acts as a filter to major decisions that may affect the Trust. Some therapeutic decisions may need to go, ‘through’ CMB although even this is varied and may not be clear to what extent the CMB, ‘need to know’. Modernisation Review Group do have all the NSF groups reporting progress along with Cancer Unit Steering Group. As the Government becomes more focused on per-formance than just audit, this will be a very important group. Remember that CHI (Commission of Health Improvement) are changing their role over this next year from an, ‘audit’ role to an, ‘inspection’ role. Their teeth have become larger and sharper and issues around cost, quality and performance will become more focussed than they have ever been before. This is both good and bad news for Pharma Companies. Whilst Drugs and Therapeutics Committees will become, ‘even more focused’ on evaluating new drugs, more and more groups will have an impact that will need con-sideration.

Case Study

A Trust comprising of three hospitals where a mixed variety of products were used for thrombo-embolic disease (DVT, PE, unstable angina) should see a concerted effort made to standardise practice across the hospitals. For historical reasons different heparins were being used for similar conditions. During this process a variety of Pharma Companies made contact with various individuals – but who were the key players? The review was Pharmacy led – but the lead consultants across three Directorates were crucial. Orthopaedics, General Surgery, Medicine and Obstetrics and Gynaecology and Cardiology. In each case, various companies targeted certain individuals but it became apparent that not one single representative had been able to see all the relevant clinical staff. Orthopaedic surgeons are never keen to use heparins – in fact to pursue the process Clinical Risk Management and Clinical Audit were both called upon to increase pressure and move issues in the right direction. Non of the Pharma companies had thought about this. Where does clinical evaluation for risk assessment in surgery occur? The answer lies very much in whether patients are blue-lighted in or whether they are elective. Patient access and consideration of where patients are eval-uated (as much as how they are evaluated) was key to producing well placed guidance on completion. Again, staff involved with clerking or ward staff involved in assessing risk were targeted by one company only and it helped them significantly. Post Grad Med Centre was key to meetings being held by individual directorates. Only one company was able to influence support at Directorate meetings so as to be at the right place at the right time. The Finance Director watched this process very closely. Significant financial data was provided throughout the process. As Haematology is key to the whole process, and there were significant issues addressing three sites and cross-political borders, only one company was able to bring some of these influences together in a short but very effective forum Medical education for nurses was addressed by all companies but most only one or two deliv-ered on promise. Some nursing staff reported favourable discussions regarding this to pharmacy. The creation of ward charts, protocols and lamin-ations was crucial in supporting the process. Clinical project sub-committee was key to aiding the audit process which actually helped the Trust achieve some of its audit targets – something which inevitably helps the CE of the Trust look favourably on those involved.

Pharma companies should bear issues like this in mind. We all have targets to reach. In the context of the Matrix, do any of your targets match ours? If you don’t know – find out!

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare Trust, PCG Formulary Advisor to Primary Care, Executive Board Member of the National Obesity Forum, the Pharmacist Representative of the Diabetes Local Services Action Group and if that isn’t enough Omar is a National UK Speaker.