A new first-in-class antibiotic has been recommended in the UK for treatment of severe Clostridium difficile infection (CDI).

New guidance from Public Health England recommends Dificlir (fidoxamicin) from Astellas for adults with severe CDI and high risk of recurrence, or for recurrent CDI.

This makes the drug available for those CDI patients who are at highest risk, including those with multiple conditions.

CDI, a bacterial infection, is predominantly hospital-acquired and is potentially fatal, with 27,000 cases in the UK each year leading to 3,000 deaths.

In clinical trials, Dificlir showed similar efficacy and safety to the current standard treatment, vancomycin, but more than halved the rate of recurrence.

Recurrence of CDI is the greatest problem encountered in treatment of the infection, occurring in up to 25% of patients within 30 days of treatment.

The NHS has identified CDI control as a key aspect of patient safety, with targets for reduction in cases that may be enforced by financial penalties.

The targets demand a reduction in CDI infections over 2013/2014 of 30% (on average) for acute trusts and 21% (on average) for CCGs.

Dr Simon Goldenberg, consultant microbiologist, said the new guidance was “a huge step forward in being able to improve the overall management of CDI,” offering a “very welcome” opportunity to “bring down rates of infection”.

Graziella Kontkowski, founder of the patient group C-diff Support, noted that while CDI rates have fallen in hospitals they have risen in the community. She described the new guidance as “good news for patients” that “will encourage a more rigorous approach to reducing both new and recurrent cases of the infection.”

NHS Chief Executive Sir David Nicholson has told the Health Select Committee he does not intend to resign over the Mid Staffs enquiry.

Nicholson, who led the Mid Staffordshire Foundation Trust for 10 months during the period when neglect and abuse of patients caused over 400 deaths, has blamed the Labour government for the abandonment of care.

With the endorsement of PM David Cameron, Nicholson also claimed he is what the NHS needs to see it through the critical period of reform.

An early day motion signed by 40 MPs has called on Nicholson to resign after the Francis report made it clear that he had failed to intervene in the regime at Stafford General Hospital when Chief Executive of the regional trust.

The Francis report made it clear that the trust’s focus on qualifying for Foundation trust status by slashing budgets and cutting staffing levels was the underlying reason for the Stafford General Hospital tragedy.

However, Nicholson – who started driving through Lansley’s NHS reforms on the ground long before the Health Act became law – avoided saying anything to the Health Select Committee that might lead them to doubt the safety of the reforms.

Instead, he placed the blame for the disaster on two policies that were specific to the Labour government: treatment access targets and infection control targets.

“There were a whole set of changes going on and a whole set of things we were being held accountable for from the centre, which created an environment where the leadership of the NHS lost its focus,” he argued.

Furthermore, he claimed, the NHS “is at maximum risk over the next few days”, when the old structures are dissolved and the new ones become fully operational, and he is the only person able to manage those risks.

Critics may suspect that Nicholson has won Cameron’s support by placing the blame on the Labour government and distracting attention from the threats to patient safety that are intrinsic to the current NHS reforms.

Was Stafford General Hospital the Potter’s Bar of NHS reform? Maxine Vaccine considers the lessons of a healthcare disaster for the future.

The testimonies of the Mid Staffordshire public enquiry make bleak reading. From 2005 to 2008, a hospital trust struggling to meet the financial targets demanded for Foundation Trust status and going through an organisational upheaval lost its grip on patient safety, cleanliness and basic care.

Bullying management forced out clinicians who opposed neglect of patients, resulting in an apathetic hospital where filth and suffering were considered the norm, where serious diseases went undiagnosed for months, and where meeting patients’ needs for hygiene and dignity was left to visiting family members.

Over a thousand preventable deaths are thought to have occurred. After years of campaigning by the families of the dead, a public enquiry took place in late 2009. Its final conclusions will be published in October 2012.

David Cameron and Andrew Lansley attended the Mid Staffs enquiry and declared that it proved the failure of Labour’s ‘target culture’. By encouraging bureaucratic control of the NHS, placing emphasis on process management rather than outcomes, and failing to make hospital trusts stand up to private sector competition, the Government had created a healthcare Chernobyl. The solution, they declared, was the ‘liberation’ of the NHS from targets, bureaucracy and protectionism.

The scandal caused the wheels to come off New Labour’s NHS ‘modernisation’ programme. Forcing hospital trusts to meet stringent FT criteria under the pressure of external deadlines, letting financial management override clinical expertise, and running hospitals as businesses all suddenly seemed like not such good ideas. The market reforms devised by Alan Milburn significantly lost momentum under Alan Johnson, the Health Secretary who faced public horror as the Mid Staffs public enquiry unfolded.

Under the Coalition, Milburn has found a new political home. Foundation Trusts are once again the only game in town for NHS acute care. The primary engine of quality in acute care is now differential commissioning: CCGs will send their patients to the better hospitals, so the worse ones will go out of business. The only thing that might cause a good hospital (in clinical terms) to go out of business is if it fails to meet its financial targets – in other words, if it fails as a company.

Has Lansley learned the lessons of Mid Staffs? One could argue that his NHS Outcomes Framework, which replaces process targets with clinically defined patient outcome targets, is a positive legacy of that shameful era. But to have full confidence that the outcomes will be reliably achieved, you also have to believe that the ‘hidden hand’ of the market will keep patients safe from harm.

Or one could argue that, like the Potter’s Bar disaster, Stafford General Hospital proved that the free market and public services don’t mix. There was another public enquiry that showed cost-cutting and ‘productivity’ culture to be responsible for neglect of safety, leading to preventable suffering and death on an industrial scale.

Sir David Nicholson has warned that the Francis Report on the Mid Staffs enquiry is likely to clash with current NHS policy. In particular, it is expected to recommend that the DH take back ill-managed hospitals from FT control and restore them to the NHS – a policy that the Health and Social Care Act has rendered literally meaningless. Robert Francis may also say that Monitor and the CQC should be merged to place quality at the heart of regulation – but Monitor is now purely an economic regulator.

Writing in the Nursing Times, Peter Nolan commented: “The final Mid Staffs report will emphasise that the delivery of healthcare is driven and determined by politics, yet policy makers are prone to discuss healthcare in abstract terms such as efficiency, accessibility, choice and quality without specifying exactly what these mean in practice.”

What they mean in practice will determine whether the new NHS delivers better patient outcomes and patient safety – or merely proves that Foundation Trusts, as vehicles for the delivery of acute care, have no foundation and no trust.

Maxine’s views are not necessarily those of Pharmaceutical Field.

The NHS Commissioning Board Authority has taken on the key functions and expertise for patient safety from the National Patient Safety Agency (NPSA).

The move is an attempt to drive patient safety to the heart of the NHS whilst improving standards of care.

The Board will use the NPSA’s database of patient safety information to identify and correct important safety issues.

Working across different sectors, the Commissioning Board Authority aims to utilise patient incident data to assess risk, improve learning and overall safety.

Despite the switch, healthcare organisations should continue to report any patient safety incidents to the NPSA.

The conclusions of the Mid Staffordshire Foundation Trust public enquiry may conflict with NHS reform policy, according to NHS Chief Executive Sir David Nicholson.

Speaking at the Patient Safety Congress 2012, Nicholson said there was a “very real” likelihood that the Francis report would recommend tighter regulation of FTs to protect safety.

Nicholson himself recommended to the enquiry that FTs failing to maintain safety should be taken back under NHS control, in direct contradiction to Government policy for FTs.

The enquiry into the Mid Staffordshire care scandal, in which hundreds of patients are believed to have died unnecessarily, has provoked urgent questions about the regulation of acute care.

In his initial report, enquiry chair Robert Francis QC said: “the evidence shows that the Board’s focus on financial savings was a factor leading it to reconfigure its wards in an essentially experimental and untested scheme, whilst continuing to ignore the concerns of staff.”

The final Francis report, including recommendations for FT regulation, was expected in May but will now be published in October (subject to DH approval).

At the end of the enquiry, Francis said he would consider such recommendations as increasing the regulation of NHS managers and merging the Care Quality Commission with Monitor.

These recommendations would conflict with the current direction of NHS reform, whereby central regulation is stripped back and Monitor’s role is shifted to economic regulation.

Nicholson told the enquiry that the DH should have the power to strip FTs of their independence – but that also, the way to prevent a recurrence of breakdowns in patient care did not lie only in regulation.

The main solution lay in better data collection and communication between NHS organisations, health workers, patients and the public, he said.

In the UK joint working is being encouraged to develop innovative services and propagate best practice. But in France, new legislation is placing significant barriers between pharma and its clients. Jérôme Guermonprez explains the implications for market access strategies in the country.

Across Europe pharmaceutical companies have been looking to underpin market access strategies with strong links to healthcare professionals. And while most pharmaceutical companies admit there are significant national differences that demand specific market access strategies, there has been a push, where possible, to leverage expertise, messaging and strategy to drive economies of scale.

Many organisations are now actively embarking upon innovative, cooperative working with regional decision-making bodies – such as the Clinical Commissioning Groups (CCG) in the UK; whilst doctors and pharmacists are increasingly involved in research projects, from clinical research to patient care, patient outcomes and procedures. Indeed, the UK’s amended Health and Social Care Bill strongly encourages pharmaceutical research, innovation and the use of scientific evidence in decision-making.

In France, the forthcoming radical overhaul of the drug regulatory system will significantly change relations between pharmaceutical companies, healthcare professionals, patient associations and physician associations. The “Reforme du Medicament” legislation aims to crack down on health practitioner conflicts of interest, restructure the country’s drug regulator and tighten the process for licensing drugs and for monitoring their effects once in use.

The proposed bill creates compliance requirements that far outstrip the UK anti-bribery laws and includes a number of significant changes which will directly affect the way pharmaceutical companies interact with opinion leaders across the French health service.

To minimise the risk of conflict of interest, the new legislation mirrors the US Sunshine Act by requiring pharmaceutical companies to disclose all financial relationships with healthcare professionals, patient associations and scientific experts.

With an emphasis on patient safety, the bill also requires far more detailed information and discussions about indications – from the provision of a helpline number on every drug packet to enable patients to report problems, to the creation of a government watch list of drugs under review.

It also demands pharmaceutical companies no longer undertake direct physician training but instead provide the funding for training to the government, which will then oversee independent training programmes.

 

Restricted access

Critically, from a market access perspective, the bill will prohibit individual medical representative visits to physicians within a hospital; visits must be collective to avoid any one-to-one relationships and ensure discussions are open and transparent.

The impact of this legislation – which is currently being discussed and should be passed by the French government by the end of 2011 – will be significant for pharmaceutical market access policies and demand companies gain new insight into key opinion leaders (KOL).

Under this new model, the industry will have to be incredibly careful about the type of relationships that are put in place with stakeholders; indeed, at least one pharmaceutical company has already announced it will no longer pay physicians directly in the future or invest directly in physician grants to avoid any regulatory compliance issues.

Furthermore, with many physicians likely to back away from any interaction with the pharmaceutical industry, at least in the short term, patient and physician associations will have a far greater role to play. Pharmaceutical companies will have to rapidly assess the way these associations and individual physicians respond to the new legislation and amend market access strategies accordingly.

 

Regional structure

This new challenge comes at a time when pharmaceutical companies are still adjusting to the major overhaul of the French healthcare system – which has seen the creation of 26 Regional Health Authorities (RHA).

While drug reimbursement is still set nationally as in the UK, since 2009, each region has found the responsibility to adapt national objectives to local or regional health and demographic problematic. Over the past year, each region has had to sign multiple year contracts between the  state and the region to deploy the health strategy.

As in the UK, over the past two years, pharmaceutical companies have realigned resources to create a regional approach based on a key account management (KAM) model. The regional structure has significantly broadened the number of stakeholders involved in decision-making, both financial and medical.

Furthermore, each RHA has a different demographic breakdown and health issues, creating very diverse goals for each region. This change has required a far greater insight into decision-makers and regional objectives; it has also demanded pharmaceutical companies use the KAM approach and strong CRM tools to drive synergies between teams at local, regional and national level.

Pharmaceutical companies in both France and the UK are now actively seeking in-depth insight into the KOLs within new regional structures. Information from the structure of the new organisations, including the multiple drug, technical and price commissions, to identifying specific members, roles and drivers is proving key to create the right regional messaging.

And with this regional, KAM-based model still in its infancy in France, pharmaceutical companies face a tough challenge to ensure the implications of the new medical reform legislation are incorporated.

Messaging, for example, must now be amended to include product safety, as well as quality and efficacy; while companies must ensure information is up to date to ensure changes in physician attitude to the pharmaceutical industry as a result of the new regulations are flagged to remove the chance of inappropriate or unwanted contact. CRM tools will also be essential to coordinate group visits to physicians to avoid any chance of the forbidden one-to-one interaction.

As in the US following the introduction of the Physician Payment Sunshine Act in 2009, pharmaceutical companies will also need help to meet their obligations to declare all activity with physicians.

 

What next?

It is tough to predict how the health service in France will respond to the new legislation over the next 12 months. For pharmaceutical companies there is no doubt that direct physician contact will decline and organisations will have to refocus efforts towards the increasingly influential patient associations and physician associations.

But for those organisations operating across Europe, the changes must demand very different approaches towards health service co-operation. As the UK market looks to drive service innovation and close ties with practitioners at every level, counterparts in France are being compelled to be transparent and improve patient safety. The concept of the global, or even pan–European, market access strategy looks ever less practical.

Jérôme Guermonprez is the Vice President and General Manager, France, Cegedim Relationship Management.

The world’s first RFID-based systems for counting and detecting surgical sponges, avoiding their accidental retention after surgery, have gained CE Mark approval.

The SmartSponge and SmartWand-DTX products from US patient safety specialist ClearCount are also the first RFID-based surgical products to gain approval for marketing in the EU.

ClearCount is currently pursuing commercial partners for European distribution of the two systems.

The SmartSponge is a Radio Frequency Identification (RFID) system that verifies sponge counts and detects sponges retained within the patient, uniquely identifying each sponge used during an operation.

Retained surgical items are estimated to occur in one of every 1,500 open abdominal or chest procedures, leading to serious complications including further surgery, infections and even death.

In the UK, nearly 800 missing or retained surgical swabs or instruments have been recorded by hospitals in a single year.

“CE Mark approval of our SmartSponge System and SmartWand-DTX represents a significant achievement and major milestone for our company,” said David Palmer, CEO of ClearCount.

“We have established a perfect safety record over the past two years in the United States. Our hospital customers have never experienced a retained surgical sponge while using our technology.”

Based in Pittsburgh, ClearCount Medical Solutions is a medical device company specialising in patient safety solutions. The company received the 2009 Wall Street Journal Technology Innovation Award.

Lundbeck has appointed Jens Peter Balling and Iman Barilero as vice presidents in its R&D organisation.

The new appointments follow Lundbeck’s recent consolidation of its R&D activities into one organisation, creating a new unit.

Peter Balling (pictured, right) has been appointed as Vice President of the new unit, which will focus on regulatory product support, patient safety and quality assurance of clinical research.

Barilero (pictured, below) will be responsible for increasing Lundbeck's strategic efforts to build and maintain constructive cooperation and dialogue with national and international regulatory authorities.

Anders Gersel Pedersen, Executive Vice President of R&D at Lundbeck, said: “The regulatory and safety areas are an increasingly important prerequisite for this. The creation of one new unit and the increased focus on the other gives us a strong position in these areas.”

Peter Balling joined Lundbeck in 2006 as divisional director of global pharmacovigilance, previously working at Novo Nordisk and Nycomed.

Barilero began work for Lundbeck in 2007, when she served divisional director of regulatory development, strategy and policy, with previous experience at Hoffmann-La Roche and Johnson & Johnson.

Search for careers at Lundbeck.

The NHS lacks specialist medical equipment to handle bariatric patients, according to a report published online in a BMA Group journal.

Lack of specially adapted equipment, and staff trained to use it, is a major cause of patient safety incidents involving obese people, the Postgraduate Medical Journal said.

The report analysed patient safety incident data from the National Patient Safety Agency, covering all incident reports relating to, or caused by, obesity over the period of three years from 2005 to 2008.

Of a total of 555 reported incidents, 389 were related to obesity. These incidents included ventilation problems, pressure sores and surgical errors. The consequences were considered significantly harmful in 14% of cases.

Of the incidents involving bariatric patients, 71 related to specialist equipment not being available or normal equipment failing with these patients.

The authors noted: “The majority of safety incidents associated with obesity were related to infrastructure, suggesting there is inadequate provision in place for the care of obese patients. While levels of harm were mostly low, the occurrence of incidents resulting in severe harm or death highlights the specific dangers associated with the care of the obese patient.

“Further planning and development of operation policies is needed to ensure the safe delivery of healthcare to patients in the future.”

Many medical equipment companies now specialise in manufacturing and/or supplying bariatric equipment in the UK.