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…

BY 2004, EVERY PRIMARY CARE TRUST (PCT) must have medicines management schemes in place. But what is medicines management and why do we need it? What are the key drivers for this agenda? What medicines management initiatives are currently underway? At the end of this article you should have a better understanding of MM and know where to look for further information.

What is Medicines Management?
Medicines management means different things to different people and covers a range of activities and tasks associated with the use of medicines. Think of the chain of events from when it is decided to prescribe a medicine, through supply and review to ensure it is effective and remains optimum treatment. Every person or process involved at each link in this chain is delivering a medicines management service - any break or weakness in the link may mean that the patient or the NHS will not get the best use from their medicine. In medicines management patients are partners in the use of their medicines and are empowered to take a far more active role in the management of their medication.

‘Medicines management aims to prevent, detect and address medicines-related problems and to achieve optimum use of medicines.’

‘Medicines management (MM) is a system of processes and behaviours that determines how medicines are used by patients and the NHS. Effective MM will place the patient as the primary focus, thus delivering better targeted care and better-informed individuals.

Why do we need Medicines Management?
The most common therapeutic intervention in the NHS is the use of medicines. An average PCT spends £18 million on medicines, which represents approximately 16% of its total expenditure.3 Most patients will benefit from appropriately prescribed medicines. However, evidence shows that not all patients benefit from medicines and some patients are caused harm or put at risk through inappropriate use or prescribing of medicines. The most expensive medicine is the one that the patient does not use! Evidence also shows that there is a huge amount of wasted medicines largely due to adverse effects from medicines but also through patient’s not understanding how to use their medicines or being prescribed medicines in a form that that they are unable to use. Some statistics relating to problems associated with poor medicines management are summarised below:

• As many as half of all patients with chronic conditions do not use their medicines appropriately
• Medication problems are implicated in 5-17% of hospital admissions.
• In hospital, 6-17% of older inpatients experience adverse drug reactions.
• Medication errors have been estimated to cost the NHS £500 million year in additional days spent in hospital.
• Some patients are not receiving medicines from which they would benefit and others are taking unnecessary medication (e.g. appropriate use of statins for patients with or at high-risk of heart disease).
• Each year approximately £100 million worth of unused medicines are returned to pharmacies.

What are the key drivers for Medicines Management?
There are four key drivers for medicines management:

• Value for money from medicines prescribing
• Medicines Partnerships
•Getting the right drug to the right patient at the right time
• Delivering measurable healthgain to the patient

1. Value for money from medicines prescribing
National Service Frameworks (NSFs) aim to drive up standards, improve health and reduce inequality of services and outcomes through medicines management and the appropriate use of health professionals to provide targeted advice and support. In addition the National Institute of Clinical Excellence (NICE) provides patients, health care professionals and the public with authoritative, robust and reliable guidance on the use of some medicines and treatments.

As a result of NSFs and NICE guidance, annual growth in prescribing is faster than the general increases in health spending. In 2002/03 the forecast increase in drugs spending was 11-13% compared to the planned increase in NHS spending for the same period of only 8.8%.3 The implementation of the Coronary Heart Disease NSF is the most significant factor driving increases in drugs spending – for example evidence in support of using statins to reduce mortality and morbidity in patients at high risk of heart disease or with existing heart disease is overwhelming and spending on statins increased by 33% in 2001/02.

Primary Care Trusts are finding it very difficult to control the growth in prescribing spending and need to ensure that prescribing is appropriately targeted and represents good value for money. The Audit Commission Report on Primary Care Prescribing3 found that a significant proportion of those taking statins were not in the high risk group (as defined in the NSF for Coronary Heart Disease), while large numbers of patients (up to 75% of men who have suffered angina, and 66% of men who have had heart attacks) who should be taking statins were not. The same audit also showed that review in some other areas ofprescribing could release funds to help manage the increase in prescribing required for the NSF Coronary Heart Disease.

Prescribing support at PCT and practice level is now commonplace and most if not all PCTs have a Prescribing Adviser or Head of Medicines Management who manages a multidisciplinary prescribing support team. Such teams will develop medicines management services that promote good management of prescribing and ensure that prescribing is appropriately targeted.

Examples of MM services that achieve value for money in medicines prescribing:
• Formularies
• Disease management guidelines
• Care pathways

2. Patient partnerships
For the individual patient, medicines management is about working to achieve concordance. Concordance is a partnership between patient (and/or their carer/family) and health professional in which an agreement is reached about whether and how medicines are to be taken/used1. Concordance in medicines for patients can be achieved by:
• Informing patients about the drug and non-drug options available to treat their condition or disease.
• Involving patients in the choice of treatment and respecting their views and priorities
• Providing lifestyle advice to support any treatment
• Explaining how long they may need to take the medicine for explaining to patients how and when to take their medicine and how long the course of treatment is likely to be.
• Explaining the benefits of the drug treatment and any potential harms
• Informing patients of the benefits of regular review and the necessity of any monitoring
• Providing patients with an opportunity to comment on their medicines and their effectiveness

Examples of medicines management services that achieve patient partnerships:
• Patient information
• Patient support groups
• Disease management clinics
• Medication reviews

3. Getting the right drug to the right patient at the right time
The majority of health care is well intentioned but can be let down by inefficient or ineffective systems of delivery. Much work has been done following the ‘patient journey’ from the first consultation with a health care professional through to the delivery of a medical intervention. (It is important to remember that medicines management is only part of the care pathway or journey of the patient and that there will be number of other healthcare and social care professionals involved in the patient’s care.) Making sure that people can get medicines or pharmaceutical advice easily and, as far as possible, in a way, at a timeand at a place of their choosing is an essential component of medicines management and this will be best achieved by ensuring that as well as efficient systems there is effective communication between all professionals carers.

Some medicines management services may be developed around improving existing systems in the GP practice so that patients can have easier access to medical services. For example changing the appointments system so that all patients can see a doctor within 48 hours or improving the repeat prescribing system so that patients can collect a repeat prescription within 72 hours of ordering it.

Pharmacy in the Future5 and A Vision for Pharmacy in the new NHS6 describe how pharmacy systems and structures will provide patients with fast and convenient care that is tailored to individual patient needs and delivered to a consistently high standard. For example by 2004, electronic prescribing will reduce the scope for incomplete and illegible prescriptions and also by 2004, repeat dispensing will mean that patients will be able to get repeat prescriptions from a pharmacy, without having to contact their surgery each time. Evidence from pilots has shown that repeat dispensing reduces the amount of waste of medicines. Other models that are being developed will move the delivery focus of a particular type of care into another area, freeing up GP time. Examples of this are Patient Group Directions and Supplementary prescribing. Patient Group Directions (PGDs) are an alternative way of authorising the supply of medicines. PGDs can be used by pharmacistsor nurses to manage prescribing for some conditions or chronic diseases, for example emergency hormonal contraception, nicotine replacement therapy, asthma management. PGDs are normally drawn up by a doctor and counter signed by a pharmacist. Supplementary prescribing, allows professionals such as pharmacists to be responsible for the continuing care of patients who have been clinically assessed by an independent prescriber. By the end of 2003, the first pharmacists will be acting as supplementary prescribers.

Examples of medicines management services that get the right drug to the right patient at the right time:
• NHS Direct
• Out of hours services
•Supplementary prescribing
• Patient Group Directions
• Managing repeat prescribing systems
• Repeat dispensing services
• Electronic transmission of prescriptions

4. Delivering measurable healthgain to the patient
All medicines management services should show a measurable healthgain for both the patient and the NHS. Separate outcome mon-itoring and review processes will be required for different types of medicines management service. For example clinical audit or ePACT analysis would be used to measure how well a disease management guideline or NICE guideline had been implemented whereas patient feedback would be more useful to assess a new system for collecting repeat prescriptions, particularly patients perception of whether the service has made a difference to them.

Examples of medicines management services that measure healthgain for patients
• Clinical audit
• Medication review
• EPACT analysis
• Patient satisfaction surveys

What Medicines Management initiatives are currently underway?
This last section looks at some of the nationally funded initiatives around medicines management. In addition to the national initiatives there are numerous medicines management initiatives that are being funded locally by PCTs from the unified budget. It is beyond the scope of this article to look at the detail of these.

1. National Collaborative Medicines Management Services (MMS) Programme
The National Collaborative Medicines Management Services (MMS) programme is funded by the Department of Health and hosted by the National Prescribing Centre (NPC) in Liverpool

The programme uses a collaborative approach to achieve the overall goal of the MMS collaborative - ’to help optimise prescribing, plus the experience and health outcomes, for each patient, where medicines are involved’. The programme encourages team working and sharing of best practice and will help ensure that all PCTs have access to a range of appropriate medicines management services by 2004. It is delivered through four planned waves, where a wave is made up of a number of collaborative sites drawn from applications from PCTs. Each wave last approximately two years. To date 106 PCTs across England have participated in three waves. Medicines Management services developed through the programme have included use of GP clinical systems for medicines management, repeat prescribing systems, medication review, prescribing expenditure, clinical governance and making better use of the skills of local pharmacists. Applications are currently being considered for the fourth wave which will be made up of a further 40 sites. This wave will focus on repeat dispensing and closer co-operation with local hospitals.

2. Medicines Partnership
Medicines Partnership is a two-year Department of Health funded programme designed to involve patients as partners in prescribing decisions and support them in medicine taking, to improve health outcomes and satisfaction with care. To date the Medicines Partnership has been involved in a number of projects that aim to put patient partnerships into practice that have involved policy makers, professionals, patients and the public.

An example of the work that the Medicines Partnership is doing is its joint work with the National Medicines Management Collaborative Programme to produce a succinct, practical guide to medication review called ‘Room for Review.’9 The aim of the guide is to assist local organisations to improve the quality and patient-focus of their medication review, recognising that they are starting from very different points. Other areas that the Medicines Partnership has been involved in are supplementary prescribing and the NSFs for Diabetes and Renal Disease.

3. The Community Pharmacy Medicines Management Project
The Community Pharmacy Medicines Management Project is being sponsored by the Department of Health and five pharmacy organisations – The Pharmaceutical Services Negotiating Committee, the Royal Pharmaceutical Society of Great Britain, the Company Chemists Association and the Co-Operative Pharmacy Technician Panel. The project, which involves patient with coronary heart disease, is being conducted in nine pilot sites. Once patients have agreed to participate in the project, core base-line data is extracted from their medical records and sent to the pharmacy. The pharmacist then makes an appointment to see the patient and follows up any recommendations with the GP.

Conclusion
Medicines Management is now an accepted and important area of PCT activity. It means different things to different people but is principally involved in ensuring that patients and the NHS get the most benefit and the least harm from their medicines. There are a number of initiatives already underway with more to follow. Importantly the implementation of the Quality Outcomes Framework of the new GMS Contract for General Practice will ensure that good medicines management services are delivered. So too, the proposed new contract for community pharmacy will also encourage pharmacists to provide medicines management services.

Pf is delighted to speak with Dr Trevor Jones, Director General of the ABPI, to establish his perspective on the future of the industry. In the first of a two-part interview Dr Jones explains how Biotechnology is set to create a significant impact on the Pharmaceutical Industry.

Trevor, besides being Director General of the ABPI what other organisations do you work with?
As well as my position at the ABPI, and my seat as deputy chairman of Kings College London, I am also involved in venture capital. I am on the board of a company called Merlin, so every week I encounter new science – seeing new start up companies, and hearing about leading edge technology. I also chair one of these start up companies, where technology is being developed to take human stem cells from a foetal brain and grow them. They are then put back into the brains of patients who have suffered brain damage, for example from a stroke, in order for the growing cells to repair the damage from within. This is just one of the many emerging applications of Biotechnology.

The final aspect to my responsibilities is as the Chair of the UK Department of Health Advisory Group on Genetics, a group initially set up by Alan Milburn.

With most of the major traditional pharmaceutical companies showing considerable slow down in growth, do you think the Industry has developed as far as it can?
We are actually living in exciting times. The conventional approach to research will continue, but we can expect to see momentous leaps over the next few decades. The pharmaceutical industry is about 100 years old, and though it has been a huge century in terms of research and development, we are able to actually cure very little. We can only cure diseases of bacterial origin; with viral diseases we can only prevent them with vaccines. We have no cure for HIV, hepatitis, and many diseases of the brain and heart – we have spectacular drugs to alleviate symptoms but nothing to cure the diseases themselves.

How will these leaps be made?
In last the 5 to 10 years we have began to develop the ability to “unravel God’s software” - the genome. We are starting to develop a tool kit that allows us to understand how sometimes things in the body go wrong. The genome is a starting point – like having a dictionary, which explains the words that make up books. We can find mistakes in the book and use the dictionary to put them right. Looking at the structure of the genome tells us about its function.

When something goes wrong, we can compare different people and find out what it is, genetically, that makes some people develop problems. Then we can think about repairing it. So this genome revolution can only give us an understanding of conditions, which leads to understanding of function of genes, which will then lead to the development of better drugs.

However, these developments have been overplayed by many, as being instantly translatable into pharmaceuticals. The reality is, that practical applications of the technology is mostly years away.

Is genome science presently been used at all?
One application where it is already being used is at the stage of discovery. It can help in the under-standing of peoples’ responses to drugs, for example to answer questions such as: Why do some people get a side effect and others not? Why do some people get higher response at a certain dose than another? Why does a particular drug not even work at all in some cases? As we link their genetic make up to their response, we start to see why problems occur and can start to design molecules which are much more specific to that particular area. At the research and development stage, it can also allow you to eliminate products that frankly would have negative or variable effects. If a compound is too variable, we can look for a better, more predictable, reliable entity.

Where do you see this science being used in the next five to ten years?
The next activity will be to use genome science to screen out the things - such as carcinogenity or toxicity - that we presently have to use animals for. This will assist industry to develop cleverer, more specific drugs, and products more tailored to the majority of the population. One problem though, is that I can’t envisage the industry picking up all the smaller groups that these drugs don’t work for, so it may create a whole new series of rare disorders – the industry could get accused of neglecting the minorities.

Where this technology will be seen in the near future, say in the next five years or so, will be in using these techniques to select medicines more effectively – i.e. the right medicines for the right patient. An example is Warfarin, a well used anticlotting agent. We now know that for some people there is a genetic characteristic, which gives them a six fold increase in the potential to bleed when given Warfarin – if you can predict this, you can adjust the dose to lower the risk.

Another example is cholesterol- reducing drugs. There is more and more evidence that some work much better when you have certain genetic characteristics than others. Therefore we may potentially arrive at the situation where the doctor can screen patients genetically and then choose the right cholesterol- lowering drug for them. This will take away the concept that things are ‘me too’ - there will be specific products for specific patients according to their genetic profile.

This all seems some time away, are there any existing examples of genome screening presently been used to help patients?
A classical example actually already exists - the breast cancer drug, herceptin. If a woman has breast cancer, there are various genes that may be involved, but only a quarter of them have a particular gene and this drug hangs on to that, and stops that progression of the disease. This drug will therefore not work in three - quarters of the women that would have it – have to select that percentage. The women are therefore screened, and only receive herceptin if they have that particular gene. This saves a lot of money, and also prevents raising a patient’s hope that the drug will work if it will not.

Based on this what is your general prognosis for the industry?
VERY good! We work in an exciting industry that really adds value and changes people’s lives for the better. There are not many people who can say they work in such an environment. Harnessing the genome means that the quality of life we help to improve can only move from strength to strength.

James Thornhill is the MD of a selection and development consultancy which has been researching the difference between high and low performers in selling in partnership with the Chartered Institute of Marketing for the last 3 years. For more information see: http://www.hiperformers.coM

James Thornhill reviews new research that provides insight into what differentiates high performers from the rest, and how industry and individuals can profit from this.

MOST OF US, I believe, would feel we could learn something from high performers in the same role as ourselves. We may dispute the opinion of our manager (whether privately or publicly) about how we should improve our performance if we feel their opinion is biased. We may doubt the advice of a performance guru if their CV doesn’t appear to live up to their claims.

But somehow it is different with the high performer. When someone consistently sits year after year at the top of the sales ladder we tend to admire them for it. And when the company changes the job or the rewards system and they still come out on top again most of us would really like to know how they do it.

So when we were asked to look at improving selection and development in Pharmaceutical companies it was natural for us to include a lot of face toface interviewing with high performers themselves. One role we investigated is the role of the business developer whose job it is to pave the way for representatives to sell and open the door or keep it open for new products and services.

Getting access to decision makers and influencers with the NHS is a key issue here particularly for drug companies where past behaviour has sometimes developed a climate of hostility towards new business developers. What did the high performing pharmaceutical business developers say?

Getting access to the customer and developing relationships
One said:”The job as I see it is to create a positive environment for our sales force to operate in. I have always seen it as selling the company as well as the product. One thing I do a lot of is corporate presentations. My colleagues were quite astonished at this at first.”

“You have to build relationships first, both with the organisation and its people. The products will come into it but they will come into it at the right time. It will never be in their face. You have to build some trust. You mustn’t go in there and slap them around the face with your product. Because when you ring them up again they will think ‘not on your Nellie. I am not having you back in here again’.”

“Some sales people will just turn up and expect the customer to see them. In the 8 years I have been doing this job I have never gone somewhere without making an appointment. If you don’t it devalues their time and yours. And if someone says to me just call in and see if I am here, I will say, I am sorry I haven’t got time to do that.”

“You have to know your customer too. I would feel I was doing a disservice to my customers if I didn’t make an effort to find out as much as I could about their environment. It is not their responsibility to train me. One rep asked me who are the board members on the PCG and I just wrote back and said this information is freely available on the internet.”

Solving their problems will help you with yours
Another high performer said: “Many of the people in the NHS trusts and the prescribing units are too worried about their jobs to think about placing orders with me. So I facilitate training workshops on structure change to help get the organisation settled and in a position to talk with me on business.

I do one a week for all the different sectors of the market. I could have 30 people there down to 6 or 8 for a small surgery and their staff. Subjects might include facilitation skills, chairing meetings, time management and personal development plans and appraisals. I also arrange for guest speakers to talk about drugs and case studies.

The company likes the credibility and it gives me access to the customers. I never have a problem getting access to key people. They ring me and ask if I can provide a workshop or help them with some problem. If I do a workshop I ask for a donation for charity.

Sales people have to try and start walking in their customer’s shoes. It’s when they can do this that they know what the customer wants and able to give it to them”.

Another high performer developed some simple business planning software and an accompanying book to be used by GP practices for preparing and writing business plans for fund holding GPs.

Focus on your performance rather than action
High performers represent a valuable source of learning and our research shows the reason ifsimple enough. High performers spend more time, about twice as much, thinking about their performance and performance issues than lower performers. They set themselves specific goals in relation to performance such as the number of new customers they want to sign up in a period and then work out what actions they need to take to achieve those goals.

They also spend more time reviewing their performance. One high performer would ring the sales office each Friday to check his calculations of sales for the week. He was rarely more than a pound or two adrift. “When I start on Monday morning”, he said, “I want to know exactly where I am and what I have to do to achieve my next target.”

Even if they don’t write down their plan, which many of them do, they have it in their head. First they work out their objectives including how they will measure them. Secondly they work out the actions necessary to achieve their objectives including when they will take them. Finally they will always be in touch with where they are on the plan by reviewing it regularly. So they will know what has been completed and what hasn’t.

So what can you do to learn from high performers
Not all high performers will be happy to give away their secrets but most will give you advice if you don’t waste their time. Work out your questions in advance and telephone them or invite them to lunch. Ask them how they solve the problem that you have. For example, how do you get new customers? How do you find out what the customer wants? How to avoid the customer concentrating on price?

If you are a sales manager or director you could organise a best practise workshop inviting the top performers to discuss what works best in the most important steps in the sales process such as Getting leads, Making Contact, Influencing the Sale and using the team.

In summary, what can you learn from high performers?
• Build relationships first, products come later.
• You have to demonstrate to the customer the value of moving to your company.
• Always try to look at everything from the customer’s viewpoint and not from the seller’s point of view. Try to ‘sit on their side of the table’.
• Find out what the customer wants first. A benefit is only a benefit if the customer wants it.
• When you offer a solution describe it in terms of the value from the customer’s point of view.

About the author: James Thornhill is the MD of The Thornhill Consultancy, a selection and development consultancy, which has been researching the difference between high and low performers in selling in partnership with the Chartered Institute of Marketing for the last 3 years. The project launched the use of Biometric profiling to identify sales potential by analysing subtle differences in biology between humans from an hour long interview video recording. The research has created performance templates for different roles such as 'hunters and farmers' and for specific industries such as Pharmaceuticals. More than 75 major companies and 250 sales people have been involved in the research project to date.

Introduction
The new UK-wide General Medical Services (nGMS) contract begins in April 2004. This contract affects all practices – whether they are currently working under a GMS contract (about 62% of UKGPs) or a Personal Medical Services (PMS) contract. The implications of nGMS will be far reaching for all parties involved in primary care, and will allow practices and PCTs to re-shape the way services and care are delivered. The DoH’s goal for nGMS is to broaden the scope of patient services in primary care, with all this entails. This article focuses on how roles will change within General Practice, and the implications to you as a representative - who you should be targeting to write scripts and influence the writing of scripts , within the following areas:
• Minor illness
• Chronic diseases
• Health promotion
• Enhanced services

Minor Illness
Under nGMS, practices will be encouraged to offer a wider range of services, so GPs and nurses will be broadening their skills and moving away from our traditional views of their roles. However, a significant proportion of patients visiting their GP present with a minor illness. Described under ‘essential services’ within nGMS all practices are obliged to provide consultation slots to patients who believe they are ill, so this cohort of consultations will remain an aspect of general practice for all. Many practices have examined the best way to handle minor illnesses, and the traditional GP-led approach is making way fora broader range of options. This usually involves initial ‘triage’ by trained receptionists or practice nurses to determine the nature of the patient’s needs and the most appropriate healthcare professional (or other staff member) to deal with it. In this way, patients requiring simple procedures like an ECG., blood sample, etc may even be dealt with by a ‘healthcare assistant’ or trained member of the admin staff, allowing nurses to manage minor injuries, vaccinations, minor acute upper respiratory symptoms, minor dermatological conditions etc during their own morning surgery list, freeing up GP time for more complex problems.

Prescribing is very much part of the nurse remit in managing minor illnesses. If your product is aimed at treating minor illness, make sure you allow yourself to be ‘triaged’ when visiting your surgeries to find out who is the most important member of the healthcare team in dealing with the types of patients most likely to need your product! Don’t assume that the GP will continue to be your key customer.

Chronic Disease Management (CDM)
Last month’s PF article from Healthcare Partnership looked in detail at the new incentive scheme being introduced under nGMS – the ‘Quality & Outcomes Framework’(QOF). Over 60% of the available money paid out via the QOF scheme is for high-quality management of 10 defined chronic diseases. So, if your products are in any of the 10 incentivised QOF chronic disease areas, you need to know exactly what the QOF requires practices to focus on, and who will deliver the different aspects of care prescribed in the QOF.

My own personal experience, having worked with a number of practices looking at implementing the QOF under nGMS, is that the vast majority of CDM will be delegated to nursing staff, supported by a GP (with different GPs within group practices leading the CDM service in their own area of special interest), and increasingly with community pharmacists (for medication reviews) and other allied healthcare professionals (e.g. physios, podiatrists, ‘new leaf’ smoking cessation counsellors, etc) providing sessional support. Key aspects of CDM in the nGMS QOF include:

• Constructing/ maintaining a comprehensive patient register per disease area
• After diagnosis, initiating treatment in accordance with the most up-to-date guidelines (nGMS supersedes other guidance, even NSFs)
• Treating to target – which means aggressive not conservative management
• Recoding ‘exceptions’, i.e. patients who need to be excluded from the audit figures for a variety of reasons despite having the relevant condition
• Regular, scheduled patient monitoring and timely interventions to maintain symptom and target indicator control (e.g. at a disease-specific clinic)

General practice CDM is moving to a multi-professional integrated management approach allowing patients with long-term problems access to a local one-stop CDM shop. This will result in a lower initial rate of referral of certain conditions, and less hospital visits for patients once discharged from their consultant’s care. It will require better coordination between hospitals and practices, close working between hospitalbased nurse specialists and practice nurses, and integrated IT-based records. We can expect to see larger practices involving secondary care staff in primary care based CDM clinics, as happened under fundholding in the mid 1990s. Within practice nursing, we can expect an expansion of nurse practitioners (within larger practices, some will become specialised in specific disease areas) and more nurse prescribers, and more basic grade nurses or healthcare assistants to support them.

As the bullet points above describe, most aspects of nGMS chronic disease management do not require GP input, even to the extent that ongoing medication reviews which will be nurse or pharmacist led in future (there are 42 additional points within QOF for ‘medicines management’). Make sure you know how each of your practices is managing the chronic disease area you are focused on – so you spend time targeting the right people.

Health promotion
The QOF also incentives practices to offer effective services to prevent problems in the following areas:
• Cervical screening
• Child health surveillance
• Ante- and post-natal care
• Contraceptive services

Again, these services are increasingly delivered by non-GPs. If your products fall within these areas, be aware of any shift to the service being provided by nurses or allied healthcare professionals as the range of practice skill mix increases under nGMS, and with it the opportunity for GPs to delegate workload to more appropriately skilled colleagues.

Enhanced Services
A key method for PCTs to bring certain ‘secondary care’ services closer to patients is the commissioning aspect of nGMS for ‘enhanced services’. In many cases, these services will be delivered by General Practices, although the PCT has a range of service provider options should the skill/will/manpower not be available within practices. So, what types of ‘enhanced service’ might practices provide under nGMS? (www.doh.gov.uk/gmscontract/ guidance.htm for more detail of each enhanced service, and next month’s PF article by Healthcare Partnership)

– Flu/childhood vaccinations
– ‘Advanced’ minor surgery (joint injections, surgery)
– Services to support staff dealing with violent pts
–Anti-coagulation monitoring
– Enhanced care of the homeless
– intra-partum care
– minor injuries service
– coil fitting
– MS patients services
– Drug & alcohol services
– Specialised Sexual health services
– Near-patient testing
– Immediate/first-response care
– Specialised care of depressed patients
- Plus a range of locally-defined services not covered by the above

Clearly, some of these services are already widely available in practices, whilst others will require specialisation of nurses and GPs and a clear need for training and support. If your products are used in any of the areas mentioned above, be aware that PCTs must provide all of these services under nGMS within primary care. You need to know who has been commissioned to provide these services for each of your target PCTs, and who is doing the work and writing/influencing scripts within the units providing the service.

Summary
NGMS will expand the range of healthcare professionals working within primary care as the range of services on offer is expanded, and the quality of those services increases. The implications for the Pharmaceutical Industry are clear- local knowledge is required to identify the key influencers/prescribers in each practice and area of local service. It is no longer appropriate for you to assume that the GP is your key target – GPs may have delegated that role to someone else who now has the power of the pen. Pass this message on to your National Sales Managers and marketing colleagues so they can devise appropriate calling directives based around the new market conditions where delivery of care, and the writing of acute and chronic prescriptions, is no longer the sole domain if the GP in general practice.

Equally, enhanced services commissioning means some specialist representatives will spend more time in general practice in future, and may provide a range of opportunities to develop new customer groups.

NGMS is a critical issue to consider when writing your Business Plan for 2004, so make sure you do your research for each PCT and target practice, stay close to your customers and help them develop their services to your mutual benefit. A good business plan will highlight to your manager who you should be calling on to get maximum business, which in turn should inform senior managers’ calling priorities. Good luck in influencing all concerned!

World Contract Research Organisations (CROs) Market: Poised for strong growth despite challenges

CONTRACT RESEARCH ORGANISATION (CRO) revenues have been growing strongly as a result of drug developers’ need to reduce R&D costs while shortening product evaluation times. However, as demand for more efficient pre-clinical and clinical testing services has risen, so too have pressures on CROs as a result of heightened regulatory scrutiny and consolidation within the pharmaceutical industry. Additionally, CROs are also facing internal challenges including shrinking supplies of appropriately trained personnel and a diminishing group of attractive acquisition candidates. Although CROs are taking steps to improve their efficiency, these factors will mitigate future industry growth.

Outsourced research historically evolved from a need of drug developers to augment their in-house testing resources, particularly during times of quickly increasing workload when adding such capabilities would be a long and expensive process. As technology evolved, CROs became known for their ability to specialise in certain aspects of drug evaluation and add scientific and technological expertise that drug developers did not possess internally. Over the past several years, however, economic pressures on drug developers have grown and CROs are now seen as a key means to contain ever-expanding R&D costs and shorten time to market by virtue of their ability to achieve economies of scope and scale in the testing process. CROs’ ability to shorten testing times by as much as 30 percent are particularly important since manufacturers can lose $1 million or more in sales for each day a blockbuster drug is delayed. About 19 percent of all testing is now outsourced, accounting for worldwide CRO revenues of approximately $7.8 billion in 2002.

Despite Strong Growth, Challenges Abound
Mitigating these growth drivers, however, are a variety of factors that make the CRO business more challenging than ever. Chief among these are heightened regulatory scrutiny and pharmaceutical consolidation. Regulators around the world are increasingly asking for more detailed safety assessments on drug candidates. This is a result both of embarrassing recalls of unsafe products such as Redux and Pondimin as well as the preponderance of new drug candidates that address chronic and/or complicated conditions requiring more intensive study. In addition, regulators increasingly ask for details about the molecular effects of new scientific approaches. This requires more carefully designed studies evaluated by teams with greater expertise in specific therapeutic and scientific areas. At the same time, however, pharmaceutical firms are consolidating in an effort to enhance their own efficiency. When this happens, R&D projects are often re-evaluated and outsourced research may be temporarily suspended, resulting in cancellation of CRO contracts. This can wreak havoc with CRO staffing, as contract research companies are usually unable to re-deploy staffers to other projects quickly. In the past, such fluctuations have led to industry-wide cycles of staffing-up and staffing-down as CROs adjust their personnel levels to correspond to changing workload. The two leading CROs, Quintiles and Covance, have each eliminated hundreds of positions over the last several years.

While downsizing has saved CROs the cost of paying idle employees, it has had the unintended effect of causing a brain drain in the industry. Staffers seeking greater job security have left CRO positions for jobs in seemingly more stable pharmaceuticals and biotechnology companies. This is now resulting in CROs’ diminishing ability to staff projects with experienced scientists, potentially jeopardising quality of data and the CROs’ relationships with clients.

Looking Ahead
To address these challenges and pave the way for continued growth, CROs are taking a number of steps. These include continued geographical expansion, deepening of service offerings and enhancement of technological expertise.

Although more than half of all drug evaluation fees are earned in the U.S. and this share continues to grow, CROs continue to follow their pharmaceutical and biotech clients as they extend their global reach. In addition to positioning CROs to capture a greater share of client business, this also gives them access to low-cost clinical testing in areas such as Eastern Europe, Latin America and China. These cost savings can be passed along to clients, further enhancing CRO competitiveness. The largest contract research companies maintain worldwide networks of 30 or more offices. Many, however, are expanding their presence in Europe and Asia through alliances with and acquisitions of local providers. This is an important way of quickly accessing local expertise and relationships, which may otherwise take years to establish. Quintiles, Covance, ICON Clinical Research, Kendle, Pharmaceutical Product Development,PAREXEL and Omnicare have all taken this route.

Another strategy is deepening service offerings through acquisition of specialised providers and experts in various therapeutic areas. This has resulted in some CROs being able to offer a far more complete range of pre-clinical or clinical services than competitors, thus positioning them for strong future growth.

Lastly, CROs continue to upgrade their technical capabilities through the acquisition of time saving technologies such as voiceresponse data collection systems and web-based clinical trial platforms. Such enhancements position CROs as cutting-edge service providers who can deliver technological advantages not readily available clients on their own.

Background
Frost & Sullivan, an international consultancy firm, has been supporting clients’ growth for over four decades. Our market expertise covers a broad spectrum of industries, while our portfolio of advisory competencies include strategic consultancy, market intelligence and management training. Our mission is to work with our clients’ management teams to deliver market insights and to create value and drive growth through innovative approaches. Frost & Sullivan’s network of more than 500 consultants, industry experts, corporate trainers and support staff, spans the globe with 19 offices worldwide.