Record 'fake drugs' haul worth £16m by UK agency

Dangerous counterfeit and unlicensed medicines worth nearly £16m have been seized in a record haul by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Slimming pills, drugs for erectile dysfunction and cancer medicines were taken in a series of raids.

The MHRA said criminals were making money at the expense of people’s health and it was a growing problem.

Nearly 1,400 websites were closed as part of the operation.

Seven suspects are now under investigation.

Criminals involved in the illegal supply of medical products through the internet aren’t interested in your health, they are interested in your money

Alastair Jeffrey, MHRA head of enforcement

The seizures were part of Operation Pangea – an international clampdown on the illegal trade in fake medicines by 115 countries.

In the UK, 6.2 million doses or medical devices were seized, worth £15.8m. Internationally, £51.6m of goods were taken.

Items seized in the UK included:

• two million doses of erectile dysfunction drugs


• slimming drugs – some of which can increase the risk of heart attacks and strokes


• narcolepsy pills


• abortion pills


• diabetes medication


• hair-loss drugs


• cancer medicines, particularly for breast and prostate


• medical devices, including fake condoms and dental laboratories

“It’s amazing to me that people will buy those types of medicines over the internet,” said the MHRA’s head of enforcement, Alastair Jeffrey.

The drugs are not always used for their medical purposes.

Breast cancer drugs are used by some body builders to reduce their breast tissue, for example.

Many packs of narcolepsy pills were seized en route to universities, where students take them for “cognitive enhancement” – to stay awake around exam time.

Mr Jeffrey added: “Criminals involved in the illegal supply of medical products through the internet aren’t interested in your health, they are interested in your money and are able to get this by selling you a potentially dangerous product or by stealing you bank details.

“To protect your health, visit your GP, get a correct diagnosis and buy medicines from a legitimate High Street or registered pharmacy which can trade online.”

It is thought that people buying the drugs are made up of those who think they are buying genuine drugs and those who are getting hold of drugs a doctor would never prescribe.

The “vast majority” of the drugs came from India and China – neither country was involved in Operation Pangea.

It is unclear what the total size of the illegal drugs market in the UK is.

The MHRA said counterfeit medicines were the greatest source of profit “across the whole criminal spectrum” but insisted the UK was “way ahead of the game”.

Mr Jeffrey said criminal gangs were moving into the field because, compared with illegal narcotics, sentencing was low.

“It’s two years, it’s not a police priority, you can use the internet as a facilitator, the risk is low and the profits are very high,” he said.

He added there were “some indications” that terrorist groups were involved in “pharmaceutical crime” in the Middle East.

Source BBC News/Health http://www.bbc.co.uk/news/health-33183330

Record 'fake drugs' haul worth £16m by UK agency

Health and social care leaders set out next steps to transform NHS services and improve health outcomes using technology and data

Health and social care leaders will today (17 June) unveil detailed plans to make technology work harder and faster for patients and increase transparency across more services.

Building on the successes of the last 12 months which have seen 97% of GP practices offering patients the chance to book appointments, order repeat prescriptions and view a summary of their GP records online, the plans commit to giving patients full access to their entire digital health record in real time by 2018.

A third of all ambulances now share their records digitally with A&E doctors, providing them with speedy access to critical clinical information. Under these proposals, doctors and nurses will be able to access the most up to date lifesaving information wherever they are in England by 2018 for primary, urgent and emergency care services and by 2020 for all other NHS funded services.

To drive up quality and efficiency, MyNHS will be expanded to include new information on local NHS commissioners and care homes. This step builds on the popularity of the MyNHS site, which has attracted over 200,000 visits since it was launched in September last year.

To underpin this and support the NHS on its journey to harness the power of data and technology, the National Information Board (NIB), established by the Department of Health and chaired by NHS England’s National Director for Patients and Information, Tim Kelsey, will look at the feasibility of turning the entire NHS estate into a free Wi-Fi zone.

Wi-Fi would reduce the administrative burden on doctors, nurses and care staff, currently estimated to take up to 70% of a junior doctor’s day, freeing up more time to be spent with patients.

It would also open up the possibility for ‘wearables’ to be used to monitor patients in hospital.  For example, over a fifth of patients with diabetes will have experienced a largely avoidable hypoglycemic episode whilst in hospital.  This technology can help patients and their doctors identify problems early.

Following Personalised Health and Care 2020 published by the National Information Board last November, today’s proposals mark a key moment in the journey to making technology work for patients.  Over the coming months the National Information Board and its partners will be engaging leaders and influencers from across the health and social care system to seek their views on the proposals before final publication in September.

Tim Kelsey, National Director for Patients and Information, said: “The NHS is embracing the offering of digital services to patients, with more than 55 million patients set to benefit from progress.

“As well as giving patients more choice and control, better use of technology can save money.  Letting people rebook online will help tackle the estimated £160 million that missed appointments cost the NHS each year.”

With over 50 million hits a month, NHS Choices will be the digital front door for online patient services as every citizen will soon be able to register for a GP; order prescriptions; access apps and digital tools; speak to their doctor online or via video link and view and take control of their full health record through a single online portal.

For people with long term conditions such as diabetes or asthma, devices, skin sensors or clothes which monitor health will be able to upload directly into patients’ records through this platform.

To help support the NHS’s National diabetes prevention programme, there will be a new online library of NHS approved digital tools, resources and apps that have a proven track record of effectiveness in helping people to live healthier lives. This follows the successful launch of the Mental Health Apps library on NHS Choices in March, which has since gathered over 47,000 hits.

HSCIC chief executive Andy Williams said: “The proposals announced today are a major step forward in using technology, data and information to transform the delivery of England’s health and social care services. The HSCIC looks forward to working with our partners to help local health and care organisations get the best out of these exciting new opportunities for the benefit of all patients.”

The roadmaps, which will be published in full on the National Information Board website over the coming days, are for discussion and further development with patients and the NHS and will be explored over a series of roadshows running throughout the summer. There will also be the opportunity to make comments and give feedback on the proposals via the website. The final roadmaps will be published in September at the Health and Care Innovation Expo in September.

The following proposals have also been put forward:

• By March 2016, the NHS 111 digital service will be integrated into the NHS endorsement of third party ‘apps’ and digital services that support patients and citizens in June 2015.


• By March 2016 an additional 150,000 citizens will be trained in digital skills.  Training resources and digital tools will be developed by August 2015.


• By March 2016 we will extend the information available to clinicians in the Summary Care Record to include if a patient has learning disabilities or suffers from dementia. This will improve the experience for these patients and prevent them/their carers having to repeat important information each time they interact with the NHS.

To watch the livestream of the National Information Board meeting, which is taking place at the Kings Fund Digital Health Congress 2015.

Source NHS England http://www.england.nhs.uk/2015/06/17/nib/

Health and social care leaders set out next steps to transform NHS services and improve health outcomes using technology and data

Genomics England - Successful bidders for Clinical Interpretation Services announced

Genomics England has today announced the four companies it has chosen to explore working with on the interpretation of the genomes of the first 8,000 patients participating in the 100,000 Genomes Project.

 

 

 

 

 

Genomics England continues to work with Illumina and are also expanding their partnership to explore a variety of bioinformatic challenges around sequencing and clinical interpretation.

Genomics England launched a ‘bake off’ for annotation and interpretation in the Spring of 2014 to determine the quality of offerings around the world.  The ‘bake off’ attracted 28 participants, each of whom was sent the genomes of 15 rare disease trio samples and 10 cancer/normal samples and asked to interpret them.  The submitted reports were then evaluated by a team within Genomics England.

This is an important milestone for the project. We are looking to provide high quality variant interpretation to assist clinicians within the NHS and these companies will enable us to deliver this service.

A group of 10 companies passed this ‘bake off’ stage.  These companies were then invited to take part in a tender to provide interpretation services in relation to the first 8,000 patients being treated within the 100,000 Genomes Project.  The focus of the tender was whether the companies could provide an automated service with limited amounts of manual intervention in view of the establishment of the Genomics England Clinical Interpretation Partnership (GeCIP) which will provide the latter.  Genomics England wished to appoint several providers so that it could learn from a variety of approaches in this fast moving area with the ideal being to appoint four providers to each provide reports on 2,500 patients, if this could be accommodated within the budget.  For some patients interpretation reports will be provided by multiple providers to compare performance. It is expected that this phase of the project will be completed within 12 months.

Subject to passing a test phase and agreeing a contract, Genomics England will engage with Congenica and Omicia in rare disease, Nanthealth in cancer, and Wuxi Nextcode in both rare disease and cancer for this stage of the project.  Lockheed Martin in partnership with Cypher Genomics has been appointed reserve bidder.  Each of the successful suppliers will have to provide the services within the Genomics England data centre, thus ensuring that the data does not leave the data centre.  It is expected that the services will commence from 1 August, 2015.

Genomics England intends to contract for its future requirements for clinical interpretation in early 2016 when it has learnt the lessons of the current pilot phase.

Dr Augusto Rendon, Director of Bioinformatics at Genomics England commented, “This is an important milestone for the project.  We are looking to provide high quality variant interpretation to assist clinicians within the NHS and these companies will enable us to deliver this service.  We look forward to working with each of the successful companies over the next year.”

Source Genomics England http://www.genomicsengland.co.uk/news/

Genomics England - Successful bidders for Clinical Interpretation Services announced

New pharmacy rules 'should reduce dispensing mistakes'

 

Seven patient deaths have been linked to mistakes made by high street chemists since 2009

Health ministers want to introduce an airline-style error reporting system for the UK’s high street pharmacies.

The government hopes it will provide more accurate information about the number of mistakes being made.

Voluntary reporting by pharmacists shows 10,000 medication errors a year, out of a billion prescriptions issued.

But academic research suggests that a quarter of a million patients are given the wrong medicine every year, with a million more so-called “near misses”.

Seven patient deaths have been linked to high street chemists since 2009.

There are 36,750 high street or community pharmacists in the UK. According to support groups, an increasing number of them are feeling stressed due to the pressure of ever-rising numbers of prescriptions.

Under the Medicines’ Act, pharmacists face criminal charges if they own up to making a mistake.

But under the system proposed by ministers, if they made a genuine mistake that harmed someone they would not face prosecution.

The Department of Health is currently considering a consultation about the proposed law change.

It said: “Encouraging pharmacists and their teams to come forward when they do make mistakes means that patients get better, safer care.

“Pharmacy professionals will learn from mistakes and prevent them from happening again.

“By decriminalising mistakes we will promote a more open culture of transparency.”

Dawn Britton, a 62-year-old from Bristol, died in 2013 after going into a hypoglycaemic coma.

Tammy Haskins is angry that no one has been prosecuted for her mother Dawn Britton’s death

She passed away weeks after her pharmacist wrongly dispensed diabetes drugs, instead of tablets for her Crohn’s Disease.

Her daughter Tammy Haskins told the BBC 5 live Investigates programme there was no point changing the law as no one had faced prosecution in her mother’s case.

“The CPS looked at it twice, and both times they said it was not in the public’s interest to prosecute,” she told the programme.

“I feel angry no one’s accountable for my mother’s death.”

The last NHS report into pharmacy dispensing errors, published in 2007 said that, in England and Wales, there were 113,953 “near misses” and 20,361 “dispensing errors.”

These figures represent 0.1% (near misses), and 0.02% (dispensing errors) of all prescriptions issued.

But in the same year another study in the International Journal of Pharmacy Practice which looked at 11 UK community pharmacies put the error rate for prescriptions dispensed to be as high as 3%.

‘Duty of care’

And voluntary reporting by pharmacists to the NHS under the current system shows only 10,000 medication mistakes a year, out of a billion prescriptions issued.

Pharmacists take the responsibility for the safe and correct supply of medicines to patients extremely seriously

Ash Soni, President, Royal Pharmaceutical Society

The Department for Health now wants to encourage candour by introducing a “no-fault” reporting system where blunders could be reported more freely.

But lawyers are sceptical that the changes would bring about significant improvements in safety.

Renu Daly from Neil Hudgell Solicitors represented Dawn Britton’s family.

“These proposals will have a very limited impact on the protection of the public, or on ensuring the safe supply of medication is better regulated,” she said.

“They will simply protect pharmacists from any kind of external scrutiny and accountability, and that would be a dangerous route to take.”

According to the NHS National Reporting and Learning System, the vast majority of mistakes did not hurt anyone, but last year 1,200 people did suffer some harm because of a medication error.

In 2014 there were three deaths linked to community pharmacies. One of them was 83-year-old Edlie Masters.

Edlie Masters’ family argues that pharmacists should face prosecution for serious mistakes

He died when a pharmacist delivered a blood pressure drug to his house instead of paracetamol.

His son Leon said the government should leave the law alone.

“If you don’t have the threat of prosecution in place, it is giving pharmacists a right – ‘if I do make a mistake, nothing is going to happen to me’,” he explained.

“Accidents do happen, but they have a duty of care as well to you as a customer handing over prescriptions to you.”

Learning lessons

But Ash Soni, president of the Royal Pharmaceutical Society, insists the proposed law change will improve patient safety.

“Pharmacists take the responsibility for the safe and correct supply of medicines to patients extremely seriously,” he said.

“Sadly, mistakes occasionally happen and, when they do, we must be open with patients and do everything we can to stop them happening again.

“The proposed changes will increase accountability through greater reporting of errors and improve patient safety by sharing the learning from errors across the profession.”

Pharmacist Support chief executive Diane Leicester-Hallam said that more and more pharmacists are coming to her organisation for help.

“Around three quarters of all calls to our stress helpline, Listening Friends, relate to work,” she told the programme.

“Enquiries include pressures to meet targets, staffing levels and increasing numbers of prescriptions.”

Source BBC News/Health By Claire Savage 5 live Investigates http://www.bbc.co.uk/news/health-32832536

New pharmacy rules 'should reduce dispensing mistakes'

Quarter of skin cells 'on road to cancer'

More than a quarter of a middle-aged person’s skin may have already made the first steps towards cancer, a study suggests.

Analysis of samples from 55- to 73-year-olds found more than 100 DNA mutations linked to cancer in every 1 sq cm (0.1 sq in) of skin.

The team, at the Sanger Institute, near Cambridge, said the results were “surprising”.

Experts said prevention was the best defence against damage from the sun.

Skin cancer is one of the most common cancers.

Ultraviolet-radiation from sunlight bombards our skin and transforms it from healthy to cancerous tissue.

Seeds of cancer

Many of the mutations that culminate in skin cancer are already known, but the team wanted to know when they first started to appear.

The researchers analysed excess skin that had been removed from the eyelids of four patients.

They then drilled down deeply into the skin’s DNA to discover the very first steps being taken on the journey to cancer.

Dr Peter Campbell, the head of cancer genetics at Sanger, told the BBC News website: “The most surprising thing is just the scale, that a quarter to a third of cells had these cancerous mutations is way higher than we’d expect, but these cells are functioning normally.”

However, it would take multiple mutations – nobody is sure exactly how many – to culminate in a tumour.

The results, published in the journal Science, did show there were some subtle changes in the way the mildly mutated cells were behaving.

They were growing more quickly than other skin cells.

Dr Campbell said: “It certainly changes my sun worshipping, but I don’t think we should be terrified.

“It drives home the message that these mutations accumulate throughout life, and the best prevention is a lifetime of attention to the damage from sun exposure.”

The findings may be a warning to people trying to develop new cancer drugs, which often target the changes that make a cancer “unique”.

“We have not really had any insight into whether those cancerous changes occur in normal cells as well, a treatment that kills 20-30% of normal cells would potentially be a lot of collateral damage,” Dr Campbell said.

Dr Bav Shergill, from the British Association of Dermatologists, said: “Whilst the body’s immune system can prove quite effective at removing mutated cells, it is important to remember that some of cells aren’t removed and mutate into cancers.

“Prevention is the first line of defence; wearing protective clothing, seeking shade and choosing a sunscreen with an SPF [sun protection factor] of at least 30 are all good sun safety practices.”

Dr Alan Worsley, from Cancer Research UK, said: “Research like this could help uncover which specific mistakes are more likely to push a damaged skin cell into becoming a cancer.

“Although we all need some sun, avoid sunburn and skin damage when the sun is strong by spending time in the shade, covering up with clothing and using plenty of sunscreen with at least SPF 15 and four or more stars.”

Source BBC News/Health http://www.bbc.co.uk/news/health-32818285

Quarter of skin cells 'on road to cancer'

UK ramps up online access to GP services

Number of practices offering services like appointments via the internet tripled in first three months of 2015

 

Almost every GP surgery in England now offers a basic range of services online, according to new figures from NHS England.

This follows a spike in the number of GPs offering appointments, repeat prescriptions and access to summary information in medical records online, which tripled in the first three months of this year.

Beverley Bryant, director of digital technology for NHS England, said: “Many patients want the flexibility of booking services online so we are delighted that GPs have worked so hard to make this possible. There is more to come as we develop services that will increasingly help patients take more control of their health.”

Data from the Health and Social Care Information Centre (HSCIC) shows that over 97% of patients in England now have access to online services, a huge increase from the 3% in April 2014.

Dr Masood Nazir, GP and national clinical lead for NHS England’s PatientOnline programme, said: “Online services help to make patients’ lives easier and can reduce the paperwork for those in general practice. As GPs offer more online access we will continue to work closely with them to ensure they feel confident these services deliver real benefits for their patients.”

The government has ambitious plans to offer everyone in the UK online access to their full health records but, in addition to the inevitable questions about data security that will have to be answered, it will also have to overcome the ‘digital divide’.

There are still 10 million people who do not have access to the internet and 4 million of these people are the most socially and economically disadvantaged in the country.

Meanwhile, NHS England will put the emphasis on patients to go online. To use the GP services currently available via the internet NHS England is encouraging patients to ask their GP surgery to set-up their online access next time they visit.

Nevertheless, the announcement of greater online service coverage was welcomed by doctors leaders, who said moving administrative services online could ultimately lead to better patient care.

Dr Imran Rafi, chair of the Clinical Innovation and Research Centre at the Royal College of General Practitioners and lead for the RCGP Patient Online programme, said: “Services such as online appointment booking and online repeat prescription requests offer patients greater choice over how they interact with their GP practice – and it is very encouraging that the vast majority of patients now have some form of online access to their practice.

“We hope that Patient Online will make our patients’ lives easier and, in time, help to reduce the administrative burden on practices so that all members of the practice team are able to focus more of their time on frontline patient care.”

And, speaking to PMLiVE last year, life sciences minister George Freeman said both the NHS and pharma should be looking to digital technology to help the health service make the billions in savings needed over the coming years.

Source PMLive http://www.pmlive.com/blogs/digital_intelligence/archive/2015/may/uk_ramps_up_online_access_to_gp_services_741284

UK ramps up online access to GP services

NHS England chief: cash shortages could hit plans for seven-day health service

Simon Stevens, appearing with the PM at his NHS speech, warns that other changes could take priority at a time of funding shortfalls

 Health unions have threatened to strike over Cameron’s plans to create a seven-day-a-week health service if the initiative cuts existing payments for working antisocial hours. Photograph: Peter Byrne/P

The head of the NHS in England has warned that its financial problems could hamper the government’s plans to introduce a seven-day health service, as a former health minister said they were unachievable without a significant funding boost.

Simon Stevens, the chief executive of NHS England, warned that progress towards seven-day services may not be a priority because of cash shortages and the need to make other changes.

Analysis Seven-day NHS: seven questions answered

Everything you need to know about David Cameron plans for a 24/7 health service

His comments came as a former Liberal Democrat health minister, Norman Lamb, claimed that David Cameron’s plan could not be delivered within the service’s existing budget and would need even more money than the £8bn extra by 2020 the Conservatives have already pledged. Health unions have threatened strike action if workers’ benefits for working anti-social hours are cut.

Cameron used his first major speech since his re-election to guarantee care to patients “wherever they are and whenever they need it”.

Speaking at a GP surgery in the West Midlands on Monday, he promised more GPs, faster access to new drugs and treatments and a greater focus on mental health and healthy living. A GP access fund, which will ensure that 18 million patients will have access to a GP in the evenings and at weekends, will be expanded to ensure that more seven-day access will be available.

Cameron said: “It’s a shocking fact, but mortality rates for patients admitted to hospital on a Sunday can be 16% higher than on a Wednesday, while the biggest numbers of seriously ill patients arrive at the weekend when hospitals are least well equipped to handle them. So seven-day care isn’t just about a better service – it’s about saving lives.”

But Stevens, speaking alongside the prime minister, sounded a note of caution about Cameron’s pledge by pointing out that expanding NHS services when it was facing a £30bn budget gap would take time.

“We’ll need careful and disciplined phasing of our ambition to expand services – be it improved cancer care, mental health, primary care, seven-day services – all of which we want to do,” he said.

Stevens’s comments are significant, given the close relationship he enjoys with Cameron, the chancellor, George Osborne, and health secretary, Jeremy Hunt. All have backed Stevens’s blueprint for the service’s future, the NHS Five Year Forward View, and have pledged to find the £8bn of extra funding by 2020 he says is the minimum needed to keep the service sustainable.

Stevens’s public dampening-down of expectations follows concerns raised by health thinktanks that political parties’ promises made during the election to give patients easier access to key NHS services were not realistic.

Labour pledged to reinstate patients’ right to see a GP within 48 hours, despite a chronic and growing shortage of family doctors, for example. Dr Mark Porter, the leader of the British Medical Association, criticised the “outlandish and unrealistic election pledges” made by all the parties.

Speaking to the Guardian before Cameron’s speech, Lamb, a contender to succeed Nick Clegg as Liberal Democrat leader, said the plans could not be delivered in the current budget. “The idea that you can just achieve this without additional resources is just fanciful,” he said.

Lamb backed the ambition of a 24/7 NHS. “There’s a moral obligation to do this. The bottom line is that you can’t justify [having] different survival rates depending [on] whether you fall seriously ill on a weekday or at the weekend.”

But, he added, the extra capacity the NHS would need to become fully operational across all seven days – especially the extra staff involved – could not be achieved within the service’s budget, even though it has gone up by £3.1bn this year and will rise each year until 2020.

“No, the seven-day NHS can’t be delivered within existing resources. It needs additional resourcing. At the moment we are well staffed through five days but have a lower staffing ratio on the weekends, and that would have to change.”

Unison, the biggest health union, warned that it would ballot its members on strike action if a seven-day-a-week NHS operation was to be funded by cutting staff pay.

The Royal College of Nursing chief executive, Peter Carter, also warned that nurses would resist any changes to payments they receive for working outside office hours. Speaking to the Independent, Carter said: “The membership is quite clear: unsocial hours, weekend working, Christmas Day and bank holidays – they get a very modest higher level of remuneration. Any attack on that and I do fear it would result in industrial action.”

The health secretary, Jeremy Hunt, accused the unions of “jumping the gun”. He told BBC1’s Breakfast: “We haven’t made any proposals whatsoever about changing nurses’ terms and conditions … Eight days into a new government, I hope you’ll forgive me if I don’t negotiate on air about every single aspect of doctors’ and nurses’ conditions. That’s not our proposal.”

During the election campaign the Conservatives said they supported a plan produced by the NHS England chief executive, Simon Stevens, to fill a funding gap estimated at £30bn a year by 2020.

The BMA council chairman, Dr Mark Porter, said: “Crucially, the £8bn promised by the prime minister is the bare minimum needed for the NHS to simply stand still and will not pay for extra services.

“The real question for the government is how they plan to deliver additional care when the NHS is facing a funding gap of £30bn and there is a chronic shortage of GPs and hospital doctors, especially in acute and emergency medicine, where access to 24-hour care is vital.

“Without the answer to these questions this announcement is empty headline-grabbing and shows that, even after polling day, politicians are still avoiding the difficult questions and continuing to play games with the NHS.”

Hunt acknowledged that seven-day working would involve “some extra cost, which we will have to find”, but said it might be more cost-effective, for example, to boost capacity by using existing operating theatres at weekends, rather than building new facilities to use Monday to Friday.

Pressed on whether the government would be committing any extra money to the NHS, Hunt told BBC Radio 4’s Today programme: “If you look at what the prime minister is saying today he said ‘a minimum of £8bn’.”

Source The Guardian http://www.theguardian.com/society/2015/may/18/health-unions-threaten-to-strike-if-seven-day-nhs-means-pay-cuts

NHS England chief: cash shortages could hit plans for seven-day health service