The NHS faces financial risks and worries over organisational success due to the lack of female leaders on Clinical Commissioning Groups, a new report has warned.

Releasing Potential: Women doctors and clinical leadership found women had experienced difficulties joining CCG leadership committees despite evidence showing gender diverse boards improve financial performance.

GP Penny Newman, report author, says the lack of diversity presents “a risk to developing the collaborative and inclusive leadership behaviour needed for organisations to succeed in a complex system”.

The report, funded by the National Leadership Council, was based on in-depth interviews with 26 leading female GPs and consultants with the outcomes tested on a further National Leadership Council workshop which included 43 female medical leaders and other experts.

Several interviewees said they had signalled an intention to take a senior role within CCGs but had experienced issues in joining. Previously, claims had been made of a ‘jobs for boys’ culture from female GPs following a similar study by Pulse. One interviewee even described one leadership committee as consisting of “clubs, gangs and mafia”, insisting there was “exclusion, inequity and disengagement of the rest of the profession”.

Research from the report said that female GPs were more likely to work with marginalised and vulnerable communities and were found to have qualities such as empathy, being able to question and admit vulnerability and offering support and development to others.

“While the number of female doctors continues to rise, there remains an unacceptably small proportion in leadership positions within the NHS,” said Dr Newman.

“Female doctors represent a valuable resource to the health service, both in terms of the style of working and individual talent.

“The NHS needs to enable them to achieve leadership positions through more flexible working and other initiatives to maximise the potential of the workforce and ultimately provide a better service for patients.”

The report follows an investigation by HSJ which revealed that 85% of CCGs were led by men.

A new report by the FDA highlights weaknesses in medical device quality in the US over the past decade.

The FDA’s report, Understanding Barriers to Medical Device Quality, stated that while revenues in the medical technology industry have grown over the last ten years, “serious adverse events” have outpaced this growth by 8% each year.

Failures in medical device design and manufacturing process control were found to account for more than half of all product recalls.

“While medical device flaws may vary by device, some sources of error are pervasive throughout the field,” the report reads.

“Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.”

The report was launched by the FDA’s Center for Devices and Radiological Health in order to understand and improve gaps in device quality, and outlines recommendations for both industry and federal regulators.

The analysis found that “nearly 60% of the adverse event reports” involved cardiovascular, in vitro diagnostics and general hospital/surgical equipment.

“Our efforts revealed that there are systemic gaps within the medical device industry's quality approach that result in these issues,” said the report. “Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.”

According to the FDA, medtech manufacturers are facing a series of challenges which are impeding device quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

Identified opportunities for improvement include postproduction monitoring and feedback, creating quality incentives, and improving design and engineering.

The report also cited steps for the FDA to incorporate, such as clarifying Agency requirements and learning from regulators of similar high-tech industries.

A similar initiative is underway in Europe to improve medical device regulatory assessment processes, with support from Eucomed.

As many as 238,000 pharmaceutical jobs may be lost in a decade in the US if President Obama’s proposed American Jobs Act is introduced, a new report warns.

The Act proposes that manufacturers of prescription drugs would pay rebates to the federal government for medicines used in both the Medicare and Medicaid health schemes and Medicare’s prescription drug benefit, known as Part D.

The report says that mandatory Part D rebates would see jobs cut, increase the cost of medication for the elderly and slow R&D with pharma absorbing the new charges.

This would result, it adds, in reduced payroll employment, reduced profits and possibly higher prices for other buyers.

President Obama introduced the bill in September, but faced stiff opposition from Republicans in the Senate who rejected the measure in the chamber vote.

The Office of Management and Budget (OMB) estimates that if the Act were introduced, the rebates would result in $135 billion paid to the federal government over the next ten years.

The report, published by the American Action Forum, a free-market policy think tank, says that “at a minimum, these additional rebates would constitute a direct, dollar-for-dollar reduction in revenue to the pharmaceutical industry”.

It also forecasts that hundreds of thousands of job losses would come from direct employment within the pharmaceutical industry and indirectly from suppliers.

After the rejection by the Senate, President Obama is now touring the US with the aim to increase support for the Act, which according to some economists, could actually create up two million jobs and see the economic growth by two percentage points.

A quarter of the NHS drugs spending of £4.1 billion last year went on just ten medicines, according to a new report.

IMS Health found that total prescribing costs in England, including primary care and community prescriptions, reached a record £12.86 billion in 2010, an increase of 4.8% from the previous year.

This total in English hospitals has increased by 7.7%.

The report, commissioned by the NHS, says that this growth is likely to be related to the introduction of new, more expensive treatments.

The top 10 drugs (Figure 1) were mainly biologics used to treat either autoimmune diseases or cancers.

The most expensive were two arthritis drugs, Abbott’s Humira (adalimumab), with an increase of 19% to £180.5 million, and Pfizer and Amgen’s Enbrel (etanercept), costing £179.6 million.

Novartis’ Lucentis (ranibizumab) treatment for eye disease cost £128.9 million, overtaking Roche’s breast cancer medicine Herceptin.

The report noted the difficulty in biologics, as they are unlikely to be copied and manufactured into generics, consequently costing for the NHS more for branded medication. Manufacturers are likely to make more innovative forms of existing drugs, which would also push prices up.

However, the primary care drugs bill, which takes up 66% of the £12.9 billion spending of medicines in the English NHS, is expected to decrease by £1 billion over the next four years due to a series of patent expiry dates.

A highly-skilled workforce is a must in today’s competitive business environment. But as many companies slash their budgets in the relentless pursuit of efficiencies, is employee training becoming yet another victim of austerity?

Companies that fail to invest in talent will undoubtedly learn the hard way that this is a short cut to failure. Chris Ross presents a crash course in the current market for training and development.

There are mixed views on whether companies’ training and development activities are taking a hit in the current global economy. Recent mid-year analysis in the US revealed that global spend on training this year has been around 7–9% higher than in 2010. But Training 2011, a study by UK market intelligence company Key Note, presents a different trend.

The report estimates that spending on off-the-job training by UK private and public sector employees fell by 3.2% in the year to April 2010 – and that spending on external trainers dropped by around 17% in the same period. The study reports that training investment most likely dropped further by around 2.5% up to April 2011, but forecasts a slight recovery of 1.5% by April 2012. These are worrying times.

Companies are desperately seeking to increase their capabilities as the markets in which they operate are changing; but to drive real growth, continued investment in talent is essential. The Chartered Institute of Personnel and Development (CIPD) says that whilst organisations will undoubtedly expect people to do more with less, they should not expect employees “to want to do more with less learning and talent development.”

Learning and Talent Development 2011, the CIPD’s annual survey report, revealed that resources and budgets for learning and development had decreased in two-fifths of organisations in the past year, whilst a third of companies had reduced their headcount.

The study showed that although most businesses have a training budget, in most cases these have not only suffered cutbacks, but are also expected to cover a broad range of activities and costs. Unsurprisingly, the majority of budgets cover items such as external courses and conferences (93%), hiring external consultants and trainers (83%) and books/training manuals (81%).

But for two-fifths of the organisations surveyed, the training budget is also expected to cover fixed costs and salaries for in-house trainers. Clearly, the battle to upskill the workforce is being played out in the most testing of circumstances.

 

The employment market

The employment market is certainly creating challenges for employers and candidates alike. Unemployment is rising as organisations continue to reduce their workforces – but those companies that are hiring are finding that many job applicants are not sufficiently skilled and are therefore unsuitable for employment.

Conversely, in a stagnant job market, those who are in employment appear reluctant to move. Talented individuals are staying put. But is enough being done to nurture and develop them? Or are they too likely to stagnate as opportunities fail to emerge?

Likewise, less talented but generally reliable employees –the ‘safe pairs of hands’ that populate every organisation – are in many industries failing to receive adequate skills development, leading to an uncomfortable paradox: they are safe in their roles, but as their markets evolve they are not ‘fit for purpose’ to perform them.

In difficult times, the need for increased investment in human capital is significant. Training and talent development is a major priority for businesses large and small. In a market characterised by growing shareholder expectations and shrinking operational budgets, what are the options for training and developing the workforce?

Learning and Talent Development 2011 says that most companies are continuing the 2010 policy of “switching to more cost-effective development practices”. This has seen organisations reduce their use of external training service providers and instead increase in-house development programmes, internal knowledge-sharing events and coaching by line managers. In addition, the use of e-learning solutions continues to grow.

Technology-led learning tools are becoming increasingly popular across Europe. Training today, training tomorrow, a present-day analysis of learning trends across Europe by Cegos Group, says that uptake of solutions such as ‘serious games’, mobile learning and online learning has grown considerably. This, it says, is driven by an emerging younger demographic in the workplace, and widespread corporate objectives to reduce costs yet maintain productivity.

Learning solutions that are delivered in a medium that is more familiar to this emerging user-group, and that mirror the new “social, global and mobile environment”, are not only easier to integrate into employees’ daily activities, but are also considered more engaging and effective. According to Cegos Group’s 2011 survey, half of those trained in Europe have used informal learning tools such as videoconferencing, wikis, blogs, forums and podcasts.

 

Old school still rules

So the rise of e-based learning solutions is tipped to continue. But, despite rhetoric to the contrary, not at the expense of traditional learning tools. Face-to-face training remains popular – external courses, seminars and conferences continue to play a valuable educational role.

In heavily knowledge-based and technical industries such as life sciences, traditional methodologies remain both popular and effective. In medical markets, despite the obvious growth of e-learning tools, tried-and-tested lecture-style learning still appears to be the preferred option, with many participants choosing it as their favoured route for CPD.

The CIPD study shows that external conferences and events are rated as being among the most effective learning methods for leaders, potential leaders and middle management. Despite this, more than a third of companies (34%) have reduced their use of external events in the past year.

In other areas, classroom-style lectures are being replaced by individual one-to-one sessions that enable more individualised, targeted training. There has been significant growth in activities such as coaching and mentoring, which are being recognised as important tools to encourage individual accountability and nurture talent.

According to the CIPD survey, coaching takes place in more than four-fifths (86%) of companies polled, with its main objectives being to support performance management, prepare people for leadership roles and assist learning and development.

A third of companies employ coaches, while two-fifths hand responsibility for it to line managers. Only one-fifth use external consultants for coaching. Group training – such as team coaching sessions and collaborative workshops – is evolving to become more interactive, customised and flexible – giving facilitators the opportunity to adapt training quickly, based on employee feedback and needs.

 

The need for speed

Speed is emerging as a key consideration in companies’ training and development strategies. Businesses are becoming more impatient. They want their employees to develop quicker and to become more proficient and productive faster than ever before. Such corporate impatience is, in fact, often mirrored by learners themselves. Employees want the fast track to success and, where it exists, will choose the crash course over longer-term learning.

As a result, multimedia and web-based training tools have seen a real surge in uptake. The benefits are clear, but the approach is not without its challenges. The dropout rate in self-monitored online training is apparently high, with too many participants failing to complete courses.

Developers need to work hard to ensure that online courses are engaging and exploit the opportunities for interactivity and connectivity that the medium provides. Critics claim that too many courses appear little more than traditional training manuals that have been uploaded to an online format.

Clearly, as the global business environment continues to evolve in challenging times, training models and methodologies are having to adapt to meet changing needs. The emergence of collaborative, interactive and dynamic learning tools, enabled by rapid advances in technology, have opened up new opportunities for training and development – but it only really completes the circle of learning solutions available to the market.

Training is, after all, demand-driven and should be designed to meet the varying, and often individual, needs and tastes of its end users. As such, training managers should continue to consider the full suite of learning tools open to them – in dialogue with learners and their line managers, to find the most effective solutions to meet organisations’ and individuals’ objectives.

Undoubtedly, however, the biggest demand from a business perspective is to nurture a skilled, talented and engaged workforce. To do this, companies must continue to invest in training and development, rather than chip away at training budgets for short-term efficiency gains.

The potential long-term impact of that approach is a disengaged, unmotivated and unproductive workforce that is not fit for purpose. And that really would be learning the hard way.

Data in this article have been sourced from Learning and Talent Development 2011, the Chartered Institute of Personnel and Development’s annual survey report. This is available for download from the CIPD website. Training today, training tomorrow, an analysis of learning trends across Europe and global comparisons, is available for download from the Cegos website.

The global market for telehealth services will pass $1 billion by 2016, a new business report has claimed.

In the 2011 edition of its report The World Market for Telehealth, medical electronics market research group InMedica forecasts that the telehealth market could reach $6 billion by 2020.

The report highlights the growing use of home monitoring systems to monitor vital signs, improving the control of long-term conditions such as diabetes, heart failure and COPD.

The leading market for telehealth systems is the US, the report notes, but there have been some large-scale trials in Europe – most notably in the UK, where more than 2,000 patients have received telehealth services.

“Many public healthcare systems now have targets to reduce both the number of hospital visits and the length of stay in hospital,” said Diane Wilkinson, Research Manager at InMedica. “This has led to a growing trend for healthcare to be managed outside the traditional hospital environment, and as a result, there is a growing trend for patients to be monitored in their home environment using telehealth technologies.

“What is apparent is the convergence of many different industries in this space, including telehealth companies, device manufacturers, healthcare agencies, service providers and telecommunication companies.”

The World Market for Telehealth – a Quantitative Market Assessment, 2011 Edition” provides an overview of the global telehealth market, analysing the sector’s business models, technologies, peripheral devices, major suppliers and market drivers/inhibitors.

InMedica is the medical research group of IMS Research, a leading supplier of market research and consultancy to the electronics industry.

The EMA’s approval system of comparing new drugs with placebos instead of against existing alternatives is flawed, according to a new report.

Written by the London School of Economics (LSE), the report argues that pharmaceutical companies should prove how their drugs differ with comparators to gain European approval, to guarantee that only the best drugs are funded.

The document suggests this will ease healthcare resources around the world, ensuring that only the most beneficial and safest drugs reach patients.

Researchers from the LSE said: “Comparative efficacy evidence should have a formal role in drug licensing decisions.”

They said that open dialogue between regulators, drugmakers and government agencies would “achieve better congruence between licensing and reimbursement requirements”.

As it currently stands, the EMA only requires significant comparison against a placebo rather than an existing therapy.

The researchers argued that the current method does not allow healthcare professionals to determine the health values of the new drug, resulting in “the widespread use of potentially less efficacious and unsafe drugs”, they warn.

“With this success comes an equally important additional need – to develop a systematic approach to evaluate the risks and benefits of these new therapies in the context of existing alternatives.”

Major inequalities in the numbers of patients approved to access certain cancer drugs have appeared across the UK, health campaigners have said.

Patients living in England are three times more likely to access key cancer drugs from their doctors than those in Scotland, and five times as likely as those in Wales, according to data presented by the Rarer Cancers Foundation (RCF).

Andrew Wilson, Chief Executive of the RCF, said: “A devastating divide has opened up with Scotland and Wales. A cancer drug does not become any less effective simply because it is prescribed on the other side of a border.”

Through the Freedom of Information Act, the RCF gathered data from health trusts across the country on the types of drugs approved by the Government’s cancer drugs fund.

Worth £200 million a year, the fund was established in England to access drugs approved by doctors, but is not currently available on the NHS.

Mr Wilson added: “The NHS should be there when you need it the most, regardless of where you live.

“People in Scotland and Wales will want to know why their chances of accessing a life-extending cancer drug are so much lower than their neighbours in England.”

The Scottish Government stated that it would carefully consider the report.

“Scotland has robust, equitable and transparent arrangements for the introduction of newly-licensed clinically and cost-effective medicines through the Scottish Medicines Consortium and Healthcare Improvement Scotland which operate independently from the Scottish government,” said a spokeswoman for the Scottish Government.

“These arrangements include flexibility for additional factors to be taken into account in prescribing decisions”.

London & Essex Medicines Management
Cardiology Discussion Forum Hosted by iRx Solutions, July 2011

Pharmacists have the appetite for medicines commissioning

The NHS landscape is changing, the shape of medicines commissioning especially. At a time when the NHS – like other parts of the public sector – is in financial dire straits, the Government is driving a radical overhaul of the structure of health and social care services, in England at least. But incoming CGCs will be crying out of support around medicines management and commissioning. It’s time for pharmacy to step forward.

According to Stuart Saw, Director of Finance at NHS East London and the City Alliance, the recent listening exercise and “pause” of the Health and Social Care Bill’s journey through Parliament has not resulted in substantial changes to the direction of travel. “Irrespective of what people thought the pause might bring, the momentum was already there before the pause was called and it’s impossible to turn around,” he told guests at a cardiology discussion forum, held by iRx Solutions in London last month.

It is this momentum that will, in all probability, see the formation of some 500 Clinical Commissioning Groups, formerly known as GP Consortia, replacing around 150 Primary Care Trusts, which are to be abolished.

Omar Ali (pictured above right, with Jayesh Shah and Victoria Overland), a formulary pharmacist in the NHS, and one of three directors at iRx Solutions, suggests that these commissioning groups will be crying out for support around medicines management and commissioning, and believes that pharmacists have the necessary talent to fill the gap. “We have experienced firsthand how much sway pharmacists have as decision-makers within the NHS. This cultural change has happened over a number of years but has resulted in our profession being in a prime position to help deliver a new outcomes-focused healthcare system, which needs our expertise – and needs it urgently,” he said.

Mr Ali and fellow iRx Solutions directors, Victoria Overland and Jayesh Shah, also NHS pharmacists, came together in 2010 to consider how they could facilitate sharing of ideas and good practice among such influential pharmacists. Their vision: a suite of medicines-related solutions, including specialist education and medicines commissioning support, delivered by expert pharmacists to colleagues in ‘payer’ roles. Their recent cardiology discussion forum was a refreshing mix of good food, sponsored and non-sponsored presentations, and debate – attended by prescribing advisers, heads of medicines management and other pharmacy leaders.

Victoria Overland, who comes from a background as a commissioning pharmacist in primary care, says that pharmacists are now among the key decision-makers and are well placed to influence both prescribing and commissioning in the new NHS. “Therapy choices made by GPs,” she explains, “are currently supported by PCTs, which have a wealth of commissioning experience – balancing effectiveness and outcomes with the costs to the health economy. When the PCTs disband, this requirement for high-quality medicines commissioning support will still exist. What will be different about it is that Clinical Commissioning Groups will be making decisions that they feel best suit the needs of highly localised populations. We know that pharmacists have a great deal of experience in reviewing the efficacy and safety of medicines, and, crucially, their impact on healthcare budgets.”

So what did participants hear about at the discussion forum? Cardiology content was served up alongside presentations from Stuart Saw, who described the challenges being faced with the NHS reconfiguration, and Omar Ali, who gave an express tour of how value-based pricing of medicines might work in the future.

Helen Williams, Consultant Pharmacist for cardiovascular disease in south London, outlined how appropriate changes in drug therapy could support the Government’s QIPP – quality, innovation, productivity and prevention – agenda. Conversely, she questioned the wisdom of switching patients from certain branded angiotensin-receptor blockers (ARBs) to generic losartan. Ms Williams argued that some of the branded ARBs are due to come off patent in the near future and that the healthcare costs associated with switching therapies – not to mention the potential disruption for patients – might not be justified.

“We had nine years between simvastatin patent expiry and atorvastatin patent expiry and, as a result, we’ve saved millions,” she told attendees. She pointed out that the losartan patent expired in March 2010, adding: “We’ve got valsartan [expiring] this year and we’ve got candesartan and irbesartan next year. So I think we’ve missed the boat. If we wanted to make savings . . . from generic losartan, specifically, we needed to plan for it in 2008–09.”

Stable angina was also on the menu, with the profile of the condition set to be lifted following the publication of a new clinical guideline by the National Institute for Health and Clinical Excellence. Making clear that the NICE guideline was only in its draft form (when the discussion forum took place), Sotiris Antoniou, Consultant Pharmacist CV Medicine NE London CV & Stroke Network Barts & London NHS Trust, described the place in therapy of the range of medicines available for treating stable angina patients in the UK. He emphasised the need for clinicians, when interpreting NICE guidance, to “think about the whole patient” and his or her quality of life.

This is something that Jayesh Shah understands all too well from working as a medicines management pharmacist, supporting GP consortia. “With so many changes since the White Paper was published last year, there is a lot of confusion among both clinicians and managers,” he says. “But something we are certain about is that healthcare professionals care a great deal about their patients and want the best outcomes for them. So that’s our passion and driver, and meeting the ambitious goals of the QIPP agenda is also an imperative.”

According to Mr Shah, a healthy dialogue between pharmaceutical companies and pharmacists – “we need to think creatively about this relationship” – will help the industry to align its priorities with those of the evolving NHS. Omar Ali adds: “We are committed to working with the pharmaceutical industry to ensure all aspects of our educational events meet regulatory requirements. Moreover, iRx Solutions is committed to ensuring the quality of the content and speakers is exceptional. But we know that this kind of meeting is about more than the educational programme: both pharma and medicines management attendees see the value in time put aside for networking.”

Progress of the NHS reforms may have slowed, but it appears that momentum is building in at least one profession to tackle whatever the Government manages to push through Parliament. If the opinions of the team at iRx Solutions are anything to go by, pharmacists certainly have a bright future as decision-makers around medicines.

The directors are speaking on behalf of iRx Solutions not the NHS organisations by which they are currently employed. For more information on iRx Solutions, visit www.irxsolutions.co.uk.

Revenue generated from the outsourcing of contract manufacturing by the pharmaceutical industry will more than double between now and 2021, a new report forecasts.

Visiongain’s Pharmaceutical Contract Manufacturing: World Market Outlook 2011-2021 predicts the sector will reach $64.07 billion in 2016 after a compound annual growth rate (CAGR) of 8.7%.

Richard Lang, pharmaceutical industry analyst at Visiongain, says the sector will benefit from “a continued move to strategic outsourcing” by pharma.

The industry will increase the amount of manufacturing it outsources in the next decade to cover the costs of R&D and marketing, the report predicts.

The US accounted for 42% of total demand for contract manufacturing services in 2010, the report found, with demand expected to grow from developed market-based pharmaceutical companies over the next ten years. Growth in the biotechnology sector also presents a “significant new opportunities” for contract research organisations, the report says.

Currently, the production of active pharmaceutical ingredients (APIs) remained the biggest sector for the contract manufacturing industry with the report finding it accounted for almost three-quarters (71%) of the global market.

The report forecasts that API manufacturers in emerging markets will achieve increasing demand for their services, and that demand for generic and potent APIs will be one of the main drivers for growth during the next ten years.

“Industry will look more to long-term relationships with a few selected contract manufacturing organisations (CMOs) as the decade goes on,” Mr Lang said. “Becoming a full-service CMO or specialising in a niche area will best allow contract manufacturers to take advantage of these strategic partnerships.”

The report adds there are future opportunities for CMOs to expand through buying manufacturing facilities from pharma or acquiring smaller rival companies. Those which offer specialised manufacturing service will also benefit, it adds.