Wednesday, 12 October 2016

European regulators give new medicines portal the go-ahead

EMA sets out plans for new online resource for patients, HCPs and academics

EMAThe EMA has given the green light for the development of a new online resource for patients, consumers, carers, healthcare professionals and academia.

The European medicines web portal will be a multilingual website offering “free, reliable and unbiased information” on all medicines authorised in the EU.

This will be provided for a medicines entire lifecycle, from clinical trial information to adverse drug reaction reports, aiming to make it more visible.

Around three-quarters of the 508 million people in the European Union have access to the internet at home, many of whom use it for medical and health information.

The go-ahead for the new portal was agreed at a meeting last week of the EMA Management Board and setting out its vision for the new website the board said it would “provide a unique source of information on all medicines authorised in the EU”.

“The website will help to position the EU medicines regulatory network as a core provider of free, unbiased, up-to-date, trustworthy, scientifically sound and validated online information on medicines, and will provide access to nationally authorised product information in a phased approach.”

The information it provides will, the EMA said, comply with the HONcode standard for trustworthy health information and be accessible on both mobile devices and desktops.

Once live it will replace the EudraPharm online medicines database that the EMA developed in 2006 and incorporate both the European Database of Adverse Drug Reaction Reports and the EU Clinical Trials Register.

It will also swallow up the forthcoming clinical data website, which will be launched later this month to make clinical study reports externally available.

The web portal is a requirement of the 2010 pharmacovigilance legislation that came into effect in 2012 and marked the biggest changes to European regulations since the EMA was set up in 1995.

The EMA Management Board noted in a ‘reflection paper‘ it signed off last week that the 2010 legislation also gave EU member states “the obligation to launch similar national medicines web portals”.

The next steps for the European web portal will see the EMA collaborate with EU member states and the European Commission to develop a delivery plan and start scoping IT solutions it will need to support the project.

Source PMLive

European regulators give new medicines portal the go-ahead

Friday, 23 September 2016

A digital NHS? An introduction to the digital agenda and plans for implementation (King's Fund)

In recent years, the digital agenda in health care has been the subject of an array of promises and plans, ranging from the Secretary of State’s challenge to the NHS to ‘go paperless’ to the commitment set out in the NHS’s Five Year Forward View to ‘harness the information revolution’. But have expectations been set too high? And is there sufficient clarity about the funding available to achieve this vision?





This report looks at the key commitments made and what we know about progress to date, grouped under three broad themes:

  • interoperable electronic health records

  • patient-focused digital technology

  • secondary use of data, transparency and consent.

It identifies barriers to further progress and opportunities for delivering on the digital agenda.

Key findings

  • Digital technology can transform how patients engage with services, drive improvements in efficiency and care co-ordination, and help people manage their health and wellbeing.

  • For historical reasons, the acute sector is furthest from achieving the goals set out under this agenda, in contrast to general practice where use of digital clinical systems is near-universal. Delivering large-scale digital transformation involves risks for NHS leaders (particularly in acute trusts); they should receive more support and tolerance from regulators and commissioners.

  • To maximise uptake, patients and the public need to be aware of the benefits of digitisation, while being reassured about data security and use.

  • Clinicians and frontline staff must be involved in designing and rolling out new technology.

Policy implications

  • Achieving the digital vision requires more realistic deadlines, given the backdrop of unprecedented financial and operational pressures facing NHS organisations. The government should adopt the Wachter review’s recommendations about extending the timetable to 2023.

  • In doing so, the government needs to take care to preserve the momentum that has been generated towards building local data-sharing arrangements and increasing the uptake of online services for patients.

  • Greater clarity is urgently needed about funding to support this agenda, including when the money already announced will be made available and how it can be accessed.

  • There is a risk that focusing too narrowly on cost savings and ‘going paperless’ could detract from the ultimate aim – to improve outcomes, efficiency and patient experience.

Source King’s Fund

Matthew Honeyman, Phoebe Dunn, Helen McKenna

A digital NHS? An introduction to the digital agenda and plans for implementation (King's Fund)

Tuesday, 20 September 2016

Pfizer launches app to help patients manage depression

Hopes the Moodivator app will complement treatment and support care teams

Pfizer moodivator appPfizer has launched a new mobile app for patients suffering from depression that it hopes will enable them to take a more active role in managing their condition.

The firm wants its new Moodivator app to complement treatment and says it can do so in a simple and efficient way.

The free iPhone app allows patients to set goals, track their moods using a simple scale and share their progress with their care team.

It also includes information about one of Pfizer‘s prescription treatments for depression, but the company says the app is not intended to take the place of doctors’ care or advice.

Susan Kornstein, professor of psychiatry at Virginia Commonwealth University School of Medicine, helped consult on the app’s design.

She said: “As awareness of the magnitude and severity of depression continues to mount, technology like the Moodivator app represents a new and exciting frontier for helping people with depression.

“The opportunity for patients to track and export their mood and goal progress in easy-to-read charts is also very useful, because the progress can then be shared with doctors to help inform care decisions.”

Depression is one of the most common mental disorders in the US and it’s estimated that one in 15 adults experiences at least one major depressive episode in any given year.

Source PMLive

Pfizer launches app to help patients manage depression

Thursday, 1 September 2016

Apps as medical devices - UK regulator updates its guidance

MHRA moves to help firms’ health apps comply with its rules

Mersey Burns iPhone health appThe UK’s regulator the MHRA has updated its guidance on whether a health app should be subject to medical device oversight.

A number of apps and pieces of stand-alone software that are already on the market have so far been classified as medical devices and consequently fall within the MHRA’s remit.

They include those that gather data from a person or a diagnostic device, such as diet, heartbeat, or blood glucose levels and then analyse and interpret the data to make a diagnosis, prescribe a medicine or recommend treatment.

John Wilkinson, MHRA’s director of medical devices, said: “We live in an increasingly digital world, both healthcare professionals, patients and the public are using software and stand-alone apps to aid diagnosis and monitor health.

“Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations.”

In the UK, as in the rest of Europe, software and apps that are defined as medical devices must gain a CE mark (kitemark) in line with the EU medical device directives to show they are ‘regulated and acceptably safe to use and also perform in the way the manufacturer/ developer intends them to’.

The first health app to be classified as a medical device was the Mersey Burns app (pictured above), which was developed by doctors at the Mersey Regional Burns and Plastic Surgery Unit. Other apps that also have a CE mark include OncoAssist and Airstrip’s patient monitoring apps.

The MHRA’s new guidance on health apps as medical devices is available in an interactive pdf that developers through its processes.

Releasing the guidance the MHRA stressed that apps that give incorrect diagnoses or prescribe inappropriate treatments could have severe and potentially life-threatening consequences.

Wilkinson added: “Patient safety is our priority. We continue to encourage people to report any safety or performance issues involving medical devices, including apps, to MHRA via our Yellow Card Scheme online.”

Source PMLive

Apps as medical devices - UK regulator updates its guidance

Tuesday, 16 August 2016

Multichannel: the essential European revolution

Boosting the digital component in Europe’s multichannel engagement strategy

IMS Health multichannel graphicThe mature markets of the US, Japan and Europe are still at the heart of growth for companies with innovative and protected products.

But with constrained budgets for sales forces and specialist doctors as customers, marketers must leverage state-of-the-art technology and information management systems to deliver rich content and services to their clients.

We see Europe significantly lagging behind the US and Japan in terms of the volume share and relative impact of digital contacts with prescribers. While digital by no means encompasses all of multichannel, it’s impossible to imagine a mature multichannel model without digital.

Although overall, traditional doctor engagement, that is, existing channels such as face-to-face rep interaction, is maintained, if not elevated in the US and Japan, in Europe we see the number of minutes of traditional engagement fall by almost 20%, whereas digital interaction increases by just a tiny fraction. European doctors, in line with their colleagues elsewhere, have moved online, but they aren’t communicating with companies digitally as much as they could.

In terms of digital share and impact, just four countries out of the 12 we looked at in Europe have a share of digital activity which exceeds 10% of all volume activity: Poland, Belgium, the UK and France. Poland, in fact, has a marginally higher share of digital contacts than the US, and is Europe’s digital pioneer.

Binary comparisons of the impact of digital versus traditional channels of promotion aren’t the way to assess a campaign’s multichannel impact. Nevertheless, a very significant disparity in the impact on doctors’ intentions to prescribe a product using digital or traditional communications is a warning that the process is not optimally effective.

The implications of our findings in terms of boosting digital as a component of a multichannel strategy are important for two reasons:

1. Europe’s leading markets aren’t necessarily digital pioneers

Other, smaller markets might be better markets to prove concepts, test approaches and build the case for a wider investment in digital.

2. The reasons for being a digital pioneer are complex

A combination of doctors’ trust in digital channels, and a willingness of companies to expand their breadth of channel use is crucial.

Multichannel marketing can work very effectively in Europe, if the right circumstances are complemented with the right approach. There are three key success factors:

1. Successful integration

The first step in successful multichannel is to discard the notion that it is about measuring the success of traditional channels versus digital. Rather, there must be a critical mass of use of alternative channels, with a focus on the effectiveness of the overall integrated multichannel approach.

2. Reps must engage with the digital journey

Sales forces can see digital as a threat – a potential substitute for their activities. We found that many successful multichannel programmes engaged the reps in the roll-out of digital. These reps could see that digital channels could be used to broaden and extend their relationships with their doctors.

3. Content is king

Doctors are just like anyone else in the digital world – they will seek content that interests and is useful to them. If digital communications fail to provide that, or sell too overtly, they will be a turn-off, and without digital engagement, there’s no multichannel. Marketing departments, therefore, have to respond to a multichannel environment by upping their game. Digital provides a highly effective feedback loop on the content doctors value and use. This should be studied intensively.

Multichannel, and a true expression of orchestrated customer engagement, has a long way to go to reach maturity across Europe. However, the example of pioneer companies shows that careful choices and introductions of digital and multichannel initiatives can generate measurable impact and push customer engagement to a new level. Europe will emerge from this particular revolution with a transformed commercial model.

Source PMLive

Multichannel: the essential European revolution

Wednesday, 10 August 2016

Nurse-led technology helps to improve patient experience and outcomes

Hospitals in Manchester are using nurse-led technology to identify sepsis and other life-threatening conditions.

Jourey and Ingleby
 Catherine Jourey (left) and Sarah Ingleby use nurse-led technology daily. Picture: Neil O’Connor

Sarah Ingleby, lead nurse for the acute care and hospital at night teams at Central Manchester University Hospitals NHS Foundation Trust (CMFT), says the Patientrack electronic system has helped staff identify, manage and treat sepsis.

‘When a child comes in, you think ‘sepsis’ and then move on to other things. We need to think ‘sepsis’ every time. With this system, combined with clinical observations, it is less likely to slip through the net.’

Avoidable deaths

In the UK there are as many as 200,000 cases of sepsis, resulting in up to 60,000 deaths each year *. According to health secretary Jeremy Hunt, about 12,000 of these deaths may be avoidable.

In 2000, CMFT implemented early warning scores (EWS) to identify deteriorating patients. However, it was found that staff sometimes lacked the confidence to manage very sick patients and senior staff were not always alerted to deteriorating patients as quickly as they should have been.

‘There were different reasons why people were reluctant to escalate, such as “I think I’ve done everything I can” or “I want to escalate, but I don’t want to bother the doctor”,’ says Ms Ingleby.

Handheld devices

The trust introduced Patientrack in 2009, having considered many other systems. So how does it work in practice?

‘The observations are entered at the bedside using a handheld device,’ says Ms Ingleby. ‘If someone is a bit poorly, it bleeps the nurse in charge. If they get sicker it bleeps the junior doctor, if they become very sick it bleeps the senior doctor and critical care.

‘Therefore the nurse never has to leave a deteriorating patient to chase round looking for a doctor. She knows that the doctor will respond.’

Nurse training

Ms Ingleby is keen to stress that clinical judgement is also essential. ‘We cannot rely on electronic systems 100%. They are only one part of an overall approach.

‘You also need to make sure that staff have the correct level of expertise and critical care skills. That is why in every ward I have a nurse who has been on an acute illness management course.’

Nurses need to do more than simply respond to a bleep. ‘You have to be taught how to manage a person who may not trigger the EWS,’ she says. ‘For example, they may be on beta blockers so their heart rate might not be so fast even though they are dehydrated.’

Staff engagement

Several other trusts have installed the system. NHS Fife was the first health board in Scotland to introduce Patientrack at the Victoria Hospital, Kirkcaldy. And in March, cardiac arrests had fallen by two thirds after only 6 months of using the technology. It is also being hailed as a great success at Harrogate and District NHS Foundation Trust.

Patientrack has now been embedded in all inpatient areas in 55 wards in adult and children’s hospitals across Manchester.

‘Engagement of staff was key to getting this right but they were convinced very quickly,’ says Ms Ingleby. ‘It was the alerts and the fact that doctors are central to the system that got people on board.’

Over time the company has worked with staff to develop Patientrack’s use for a number of different assessments that have come from the wards.

Robust reporting system

The system is also popular with patients who like the fact that staff are automatically alerted when they are ill.

Ms Ingleby says there are other benefits. ‘There is a screen on every ward where you can see who has triggered an alert,’ she says. ‘If I come on night duty, I can go to a patient and say “I see you have been feeling poorly”. Also, critical care can send a patient to the ward and then keep an eye on the screen to see if the patient has got a bit sicker.’

She says all this is backed up with a robust reporting system. ‘I can see on the screen if someone has not responded. Response rates are reviewed each week and staff are held accountable.’

Data collection

Since Patientrack was introduced, the trust has seen a 50% reduction in cardiac arrests, reduced critical care length of stay and reduced risk of mortality for out of hours’ admissions. The length of stay for patients with sepsis has reduced by more than 50% and morbidity in emergency departments as a result of sepsis has also reduced.

Data are also being collected from several thousand observations on a daily basis, which means that CMFT can see how different wards are responding to patient needs and all sets of patients’ observations are maintained for the duration of their stay.

Ms Ingleby says: ‘6 months ago we reviewed our mortality over the 7-day week. There was no difference between weekdays and weekends, and we believe this is due to the fact that we now have systems working 24/7 to pull nurses and doctors to patients’ bedsides whenever they are needed.’

Ms Ingleby says she has no doubt that electronic observations will be introduced nationwide in the near future.

Bedside observations still vital

‘We have made such a big difference to the patient experience and to patient outcomes, you could never take it away. And when you speak to nurses, feedback is always “We love it. We know that patients are safer because they are always responded to quickly”.’

Ms Ingleby, however, does not think that nurses are going to be replaced by machines any time soon. ‘There has been some talk about automatically uploading blood pressure results, but I am not in favour of this,’ she says.

‘We should be at the bedside with our patients to check their pulse rate, to see if their skin is clammy. When you are doing clinical observations the hands-on bit is important so that you hold on to that level of understanding about your patients.’

* According to the National Confidential Enquiry into Patient Outcome and Death (NCEPOD) published in November 2015.



UK Sepsis Trust’s six most common signs

  1. Slurred speech or confusion

  2. Extreme shivering or muscle pain

  3. Passing no urine (in a day)

  4. Severe breathlessness

  5. Patients saying: ‘I feel like I might die’

  6. Skin mottled or discoloured

Source Nursing Standard

Nurse-led technology helps to improve patient experience and outcomes

Friday, 5 August 2016

Microsoft-backed doctors network expands in Europe

Among Doctors officially launches in the UK and Spain

Among Doctors online physician community

Online networking and collaboration network Among Doctors has launched in the UK and Spain.

The Athens-based online physician community is supported by the Microsoft Innovation Center and aims to connect doctors with colleagues across the globe.

Now officially launched, the Greek company says it started signing up UK doctors in January and says more than 10% of its users currently come from Britain.

Among Doctors’ difference from many of the online physician communities currently online is that it intends to remain independent from the pharmaceutical industry.

No part of the site will be sponsored, or observed by sponsors, the company notes, adding “no students, pharma, nurses or patients are allowed on the platform”. However, for doctors, access to the site is free.

Among Doctors has been live in public beta since November 2015 and already counts its first hundreds of doctors from over 38 countries, mostly in Europe, and 42 medical specialties.

The firm is funded with seed capital by angel investors. In April 2014, Among Doctors was awarded the 3rd prize at the Investors Pitch Showcase Contest by MIT Enterprise Forum of Greece.

Elena Barla, co-founder and CEO, said: “Doctors are increasingly interested in using social media for professional purposes, in order to network, share knowledge and get in touch with the international medical community.

“Knowledge should be shared across countries and economies, especially when it comes to saving lives. Among Doctors provides a global exclusive network of reliable, well-screened and quality profile licensed physicians, helping them exchange views and advice, as well as build their global referral base and network in a reliable and meaningful way.”

The online physician market has is becoming increasingly busy of late. In the last year Merck & Co reorganised its Univadis healthcare professional communities, Sermo continued its European expansion, Medscape opened doors on its first London office and new mobile-first community MedShr launched.

Source PMLive

Microsoft-backed doctors network expands in Europe