Tramadol likely to be made Class C drug

by JoelLane 25. February 2013 14:00

Tramadol, a codeine analogue widely prescribed for chronic pain, is likely to become a legally controlled drug due to growing concern about its abuse.

According to the Advisory Council on the Misuse of Drugs (ACMD), tramadol overdoses – mostly without prescription – caused 154 deaths in 2011, compared to 87 deaths in 2009.

The ACMD recommends the Home Office should make it a Class C drug, with legal penalties of up to two years for possession and 14 years for supply.

Originally patented by Grünenthal, tramadol hydrochloride is now available in generic form under various brand names including Zydol, Zamadol and Marol.

The drug, a synthetic analogue of the opiate codeine, is prescribed for cancer pain, back pain and fibromyalgia.

In recent years it has been widely sold online without prescription, and is increasingly subject to addictive misuse.

While its dual action – it has both opioid and anti-depressant properties – make tramadol a potent euphoric, it also increases the risk of overdose leading to seizures, heart failure and serotonin poisoning.

The AMCD’s letter to the Home Office notes “an increasing number of reports within the NHS of tramadol’s misuse and harms”.

The letter also states that tramadol is being misprescribed, as it is more suitable for treating mild or moderate pain than severe or chronic pain; and there is evidence of prescription supplies being diverted for the black market.

It recommends that tramadol should be controlled as a Class C substance and be subject to Schedule III prescribing regulations; and anyone prescribing tramadol should receive training regarding its ‘dual action’, misuse and dangers.

Physiotherapist prescribing will take time, CSP says

by JoelLane 7. August 2012 11:09

football-injury Less than 1% of physiotherapists will initially be able to become independent prescribers, according to the Chartered Society of Physiotherapy (CSP).

New regulations enabling physiotherapists to prescribe drugs for a range of conditions have been welcomed by the profession, but the transition will not be rapid.

Only the best-qualified physiotherapists are eligible for the relevant training, so initial take-up will be limited.

Health Minister Lord Howe announced in July that new regulations would enable physiotherapists and podiatrists who gained suitable qualifications to prescribe for their patients.

This change, expected to become law by April 2013, was widely praised as a step towards integrated care of conditions such as chronic pain, asthma, rheumatic disorders, injuries and diabetic foot ulcers.

Dr Helena Johnson, CSP Chair, said that being able to prescribe would “hugely improve” the care therapists could provide, giving patients “a more streamlined and efficient service”.

However, a CSP spokesperson has since noted that only around 200 of its 51,000 members – those already involved in supplementary prescribing – will immediately be in a position to undertake the training necessary for independent prescribing.

A limited further number will be eligible for the training, but will require funding from their employers.

High-profile sports physiotherapist Dave Roberts commented: “It is going to take some time for physiotherapists, GPs and patients alike to get used to the new prescribing landscape.”

There would be concern from patients and from GPs about working together, he said – but “education” of all stakeholders should “counteract any tension”.

A BMA spokesperson said the new prescribing regulations would need to be “explained clearly and thoroughly” to all healthcare professionals.

Physiotherapists to become prescribers

by JoelLane 24. July 2012 17:05

gash-wound-on-arm Advanced physiotherapists and podiatrists are set to become prescribers by 2014.

New legislation will enable these clinic-based practitioners to prescribe drugs such as painkillers, asthma inhalers, steroid creams and antibiotics.

The relevant professional associations have welcomed the changes, which will significantly bridge the gap between primary and outpatient care.

Physiotherapists and podiatrists in the UK will be the first worldwide to prescribe medicines for their patients.

People with neuromuscular and foot disorders are often shuttled back and forth between specialist practitioners and GPs.

The new arrangements promise to simplify patient pathways and accelerate treatment of conditions such as chronic pain, asthma, arthritis and diabetic ulcers.

“Physiotherapists and podiatrists play a vital role in ensuring patients receive integrated care that helps them recover after treatment or manage a long-term condition,” said Health Minister Lord Howe.

“By introducing these changes, we aim to make the best use of their skills and allow patients to benefit from a faster and more effective service.”

Dr Helena Johnson, chair of the Chartered Society of Physiotherapy, commented that being able to prescribe would “hugely improve” the care therapists could provide, giving patients “a more streamlined and efficient service”.

The College of Podiatry said the changes would particularly benefit patients with foot wounds, infections and diabetic ulcers, for whom rapid access to medication can prevent hospital admissions.

The changes are expected to become law in April 2013, and physiotherapists and podiatrists will be able to become prescribers by 2014.

NHS needs to improve chronic pain management

by JoelLane 9. July 2012 15:25

child crying NHS services for management of chronic pain are inadequate to the needs of many patients, according to a report following the first UK ‘pain summit’.

The report, produced by a coalition of medical experts, identifies lack of clear guidelines, delayed referrals, long waiting times and suboptimal medication as problems affecting pain management services.

It recommends that the planned NICE quality standard on pain management include nationally agreed commissioning guidelines and a data strategy.

According to Beverly Collett, chair of the coalition, “chronic pain is not being taken seriously” though it impacts powerfully on general health.

Collett also argued that the conventional “analgesia staircase” was developed primarily for cancer patients and is less effective in patients with other types of chronic pain, who would benefit from a wider range of drug and non-drug therapies.

The report was produced by the Royal College of General Practitioners and the Faculty of Pain Medicine of the Royal College of Anaesthetists, together with the British Pain Society (a professional organisation) and the Chronic Pain Policy Coalition (an industry-sponsored group).

Chronic pain (persisting for more than three months) affects one in eight people in the UK, and has many causes.

According to the report, patients who would benefit from early intervention are often not referred to a specialist or face long waits for treatment, with reliance on suboptimal medication being the norm.

The report calls for:

• Clear national standards for the identification, assessment and initial management of chronic pain, forming the basis of the NICE quality standard.

• Nationally agreed commissioning guidelines to reduce service variation.

• A data strategy to collect and share information about the extent, severity and medical impact of chronic pain.

• Better education of medical students, clinicians and the public in pain management.

EC opens J&J and Novartis inquiry

by emma 24. October 2011 15:10

Pf Product News

An antitrust investigation into the contractual arrangements between Johnson & Johnson and the generic branches of Novartis has been opened by the European Commission.

The probe will analyse whether the agreement may have hindered the entry to market of generic versions of Fentanyl in The Netherlands.

Joaquín Almunia, Vice President of the Commission, who is in charge of competition policy, says that any such deals are a “restriction of competition that the Commission will not tolerate”.

If the Commission does find any irregularities, it would potentially represent a breach of EU antitrust rules, in particular Article 101 – which bans practices that restrict competition.

The European Commission says it pays “particularly close attention” to practices in the pharmaceutical industry after a previous inquiry showed that ‘originator’ companies may be paying generic manufacturers to delay the entry of cheaper generics on to the market.

“I regard this sector as a priority in terms of enforcement of competition rules given its importance for consumers and for governments' finances,” said Mr Almunia.

“Pharmaceutical companies are already rewarded for their innovation efforts by the patents they are granted.”

The duration of the investigation depends on a number of factors, the EC says, including the complexity of each case, the extent of co-operation and the exercise of the rights of defence.

Fentanyl is a strong pain killer for chronic pain.

Computer can detect pain, claims study

by emma 16. September 2011 13:28

MB Innovation news

A new computer learning software can detect when people are in pain, claims a new US study.

A team at Stanford University in California have claimed that data gathered from brain scans can teach the computer through patterns of brain activity to determine whether or not someone was experiencing pain with 80% accuracy.

Doctors currently rely on patients communicating their symptoms, which can be unreliable, or in some cases impossible, regarding the very young, very old, or those who are unconscious.

Dr Sean Mackey, head of the study, said: “People have been looking for a pain detector for a very long time”.

For the study, eight volunteers underwent brain scans whilst touching hot objects, and hotter objects that were painful to touch.

The computer, which used linear support vector machinery – algorithms invented in 1995 – used the data to recognise the differences in patterns of brain activity.

“We're hopeful we can eventually use this technology for better detection and better treatment of chronic pain.”

Tracking system improves catheter placing

by emma 9. September 2011 09:31

Weniger Röntgenstrahlung bei Katheter-Interventionen / Less radiation during catheter interventions

Two leading medtech companies have collaborated to provide a system that improves catheter placing during angiography procedures.

Siemens Healthcare has integrated the MediGuide navigation technology from St. Jude Medical into its new Artis zee angiography systems (pictured).

MediGuide makes it possible to place a catheter for angiography very accurately without continuous fluoroscopic tracking, thus reducing the radiation dose and amount of contrast agent needed.

The technology uses electromagnetic tracking to determine the catheter position during a minimally invasive intervention: a miniaturised sensor integrated into the catheter is located from positioning signals emitted by MediGuide transmitters in the Artis zee’s housing; then the position and orientation of the catheter are displayed in real time on previously-acquired fluoroscopic patient images from the patient.

In addition, the technology compensates for movements caused by respiration and heartbeat.

The technology is also available as an upgrade for a number of existing Artis zee systems.

“Siemens is the first to integrate MediGuide technology into its systems, demonstrating our ongoing commitment to lowering dose via our CARE initiative,” said Jane Whittaker, UK Angiography Business Manager at Siemens Healthcare.

The first interventions with the Artis zee and MediGuide technology have been carried out at the Heart Center in Leipzig, Germany.

“The low-radiation, precise localisation of the catheter tip onto the pre-recorded fluoroscopy image is a most impressive function, because the system is able to compensate the motion from heartbeat and breathing,” commented Prof. Dr. Gerhard Hindricks, Director of the Rhythmology Department.

“For my team and me, this is clearly the future in electrophysiology.”

Based in Minnesota, USA, St. Jude Medical specialises in devices for cardiac, neurological and chronic pain treatment. German-based company Siemens Healthcare is a global leader in diagnostic imaging.

FDA approves Lupin’s pain pill

by emma 1. September 2011 12:37

Pf product news

Lupin Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for Tramadol hydrochloride extended release tablets in the US.

Tramadol ER is the generic version of Ortho-McNeil’s Ultrum ER tablets, indicated for the management of moderate to moderately severe chronic pain in adults who require 24/7 treatment of their pain for an extended period of time.

The company said that it will be “shipping its Tramadol ER shortly”.

Mumbai-based Lupin Limited is a global pharmaceutical company producing both generic and branded formulations and APIs. Its Lupin Pharmaceuticals headquarters is based in Baltimore, Maryland, USA.

New app for spinal cord stimulation

by Joel 10. August 2011 17:37

Boston Scientific has introduced the first iPhone/iPad app for healthcare professionals using spinal cord stimulation (SCS) to treat chronic pain.

The new app is part of the Neuromodulation Learning Institute (NLI), Boston Scientific’s new education programme and online resource centre to help clinicians make the best use of SCS.

The NLI app features videos of surgical techniques and provides access to a textbook, Spinal Cord Stimulation: Percutaneous Implantation Techniques by Paul Kries and Scott Fishman.

The NLI programme offers a range of hands-on and web-based learning tools related to the use of Boston Scientific’s Precision Plus SCS system. It sponsors live opportunities to learn SCS techniques, and offers the world’s first SCS mobile simulator system, STIM Lab.

SCS involves using electrical impulses to block spinal cord signals to pain centres in the brain, relieving chronic pain symptoms.

“The NLI offers in-depth instruction on techniques critical to successful patient outcomes with SCS,” said Thomas Simopoulos, Director of the Interventional Pain Service at the Arnold Pain Management Center in Boston. He added: “The new iPhone/iPad app is an excellent tool for training current and prospective pain physicians on spinal cord stimulation.”

Michael Onuscheck, President of Boston Scientific’s Neuromodulation division, commented: “This unique training forum will benefit physicians and their patients who suffer from chronic pain by offering healthcare providers a comprehensive, single source of SCS information.”

Healthcare providers can download the NLI app for free and activate it by obtaining a passcode from their local Boston Scientific representative.

Neuromodulation app web 
                    
NLI app

Chronic pain: the hidden health issue

by Diana 2. July 2010 16:47

87529864 As NHS spending is cut, many areas of care will be ‘deprioritised’. Beginning Pf’s series focusing on different therapy areas, Alan Jones looks at one health issue that is currently low on the political agenda.

Despite the political mantra from the new coalition Government that healthcare spending will continue to rise in real terms over the next few years, the NHS is still heading for possibly a decade of austerity. Money will be extraordinarily tight. Even the £15/20bn QIPP efficiency savings are no longer real bottom line savings and, if they can be realised, will only cushion the NHS against rising demands from an ever-ageing population and the arrival of new technologies. It is the ‘robbing Peter to pay Paul’ strategy. Real difficult choices lie ahead and just as in the benefits system, where some payments will now be stopped, some NHS care may well have to be ‘deprioritised’.

With a much tighter financial envelope and growing demands, a new battle for priorities is likely. A first sign of this comes from the National Quality Board (NQB), which says that the Department of Health has been wrongly prioritising illnesses such as anxiety disorders and neglecting those such as Parkinson’s disease and back pain. As the NQB is now commissioning NICE to develop a range of new clinical standards in a number of therapy areas, there will be major implications for companies here at the national level.

At the local commissioner level, the priorities war will be fought between infinite demand and diminishing resources. The battle lines will be drawn around health needs assessment. It is thus worth remembering the ‘roadmap’ that payers use here. A commissioning cycle was launched at the outset of world class commissioning (see figure below), which essentially starts at the needs assessment stage at 10 o’clock in this diagram. If this is new to you, you too will need to start here in terms of payer account management and be able to demonstrate real burdens of disease in order to better align your clinical area against local NHS priorities.

It will certainly be much harder now to start at the bottom and work your way up, but if you have a National Service Framework (e.g. Renal) or a National Strategy (e.g. COPD) in your clinical area, much of the work may have already been done for you. If there is no such designated priority, it will be much more of a struggle for payers to put resources into your clinical area. Good prevalence and incidence data will be key, as will having a real epidemiological story to tell. Chronic pain is an excellent example of a low priority area.Pain Figure 1

The ‘story’ of chronic pain

It is some ten years since the Clinical Standards Advisory Group reported on care for patients with acute and chronic pain and on access and availability of services, but thereafter, for most of the Noughties, pain disappeared off the NHS radar, with the National Service Frameworks dominating priorities. Then, just over a year ago, it reappeared in the Chief Medical Officer’s 2008 Annual report. One brief chapter highlighted that some 7.8 million people are affected by pain and that chronic pain appears to be more common than ever with the numbers affected continuing to rise.

Chronic pain not only has a huge impact on both the sufferers and their families, but the burden to the economy as a whole is significant. People with chronic pain account for a significant proportion of GP appointments each year and are relatively high users of accident and emergency and outpatient services. However, in primary care, the provision of pain services appears to be very patchy. Significant numbers of chronic pain sufferers report inadequate control of their pain, while only 2% of them will see a specialist. It is the indirect costs, however, which lead to the biggest bill. In 1998, it was estimated that the cost to the UK of back pain alone was £12.3 billion and the main part of this cost (£10.7 billion) was due to work days lost, with chronic pain being the second most common reason for claiming incapacity benefit.

With chronic pain having a major impact on both people’s lives and the economy, Professor Liam Donaldson concluded that much more needed to be done to improve outcomes for patients. Picking up on this challenge, an All-Party Parliamentary Chronic Pain Group was established in May 2009 and, in November 2009, the APPG met with the then parliamentary-under-secretary for health to discuss the Department of Health’s progress towards implementing the pain recommendations in the Chief Medical Officer’s Annual report. Not much progress had been made and a BBC news report in March this year reported comments from a frustrated Chronic Pain Policy Coalition that perhaps it was time that chronic pain was recognised as a disease in its own right.

Europe meets to discuss the issue

Considering this background, it is significant that many of the UK protagonists in this area decamped to Brussels last month where they were joined by many more interested parties from across Europe. The symposium brought together over 150 people from 28 separate European countries to examine more closely the societal impact of pain and the implications for healthcare policy makers. Even the National Institute for Health and Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC) were represented. The symposium was organised by the European Federation of International Chapters (EFIC) of the International Association for the Study of Pain (IASP) and supported by Grünenthal GmbH.

“Pain is a significant health problem that affects millions of people in Europe,” declared Giustino Varrassi, EFIC’s President at the symposium opening. He added: “And it must be addressed not only in terms of direct costs to national health care systems but also in terms of the wider societal costs, costs on welfare systems and the negative impact on the economy.”

Many speakers suggested that pain was simply not recognised as an important public health issue by national healthcare systems, whilst at the same time they were being overwhelmed by the high societal costs related to pain. Improving the situation would thus reduce not only healthcare expenses but also improve worklessness, increase productivity, reduce incapacity benefits and add to Exchequer revenues. There were suggestions that because of its high prevalence and impact on both patients and society, its treatment should be recognised as a health quality indicator for healthcare systems, and, further, that freedom of pain should be regarded as a universal human right, not because of the economic impact, but rather due to the tremendous human suffering resulting from it. It was described as a disease with no name and the ‘invisible disease’. And with chronic unresolved pain being a major problem all over the world, pain management must be made a much higher priority by governments and health providers.

A whole systems approach

A key take-home point from the conference was a real need for a ‘whole systems perspective’ on chronic pain. ‘Brick walls’ often exist between health and work systems, operating as parallel universes with mismatched agendas and conflicting targets. More integrated approaches are therefore needed.

As Professor Ceri Phillips from the University of Swansea said, “It is vital that pain and its management is moved higher up in the political agenda and featured more prominently in government policies. It is also essential for a joined-up cross-agency approach to be adopted, involving all those who have an interest in preventing ill-health, treating ill-health and rehabilitating those who have suffered from pain.”

The NICE speaker admitted that he was ‘embarrassed’ that the Institute hadn’t done much about pain, but that this was largely because health ministers have not asked them to look at chronic pain. For pharma, therefore, this might be a good route to take to achieve a higher priority for chronic pain with such clear clinical evidence of unmet need. Although the societal impact of pain is profound, possibly being as high as 1.5% GDP and consuming as much as 22% of healthcare expenditure, and chronic pain is such a serious healthcare problem, decision makers are simply not aware of the size of the problem. As mentioned in England, other clinical areas have had national service frameworks and yet healthcare costs seem comparable. Coronary heart disease costs the NHS £1.73bn a year, diabetes £1.77bn and chronic back pain £1.63 billion (but with £10.67 billion on informal care and societal costs). The results from an EU-wide survey on the impact of pain in the big five EU countries (including the UK) suggested that the typical pain patient in Europe was 48 years old, female and with low income and low educational attainment, implying that healthcare inequalities in managing chronic pain in lower socio economic groups and socially disadvantaged groups could be a further issue.

So where are we now?

Although more countries are collecting data on pain treatment/outcomes and direct/indirect costs, it appears that there is still insufficient focus on the impact of pain on work and work related activities, while a ‘bunker mentality’ to different budgets makes it difficult to take an integrated approach to pain treatment. Better education and implementation of pain guidelines is also key. However, some countries do appear to be investing in better care for patients, with one notable example being Scotland. The Scottish Government has recently made a commitment to recognise chronic pain as a long term condition and there is now a chronic pain Czar. Chronic pain managed clinical networks are also rolling out across the country.

For England, the unmet need in chronic pain continues to be great and it could be time that the Government looked at this area again. If chronic pain is going to be a disease in its own right, does it need a unique code? If it is going to be a basic human right, should it be in the Care Quality Commission’s essential standards of quality? If it is to move to a priority status, should this be suggested to the National Quality Board? It might also be a good idea for it to be incorporated into QOF. There is no doubt that chronic pain is a big public health issue and deserves to be a much higher priority, but at a time of healthcare recession and financial cuts it may continue to live in the shadows. Despite being common, chronic pain just isn’t very sexy. Perhaps the simplest answer is to call in Joanna Lumley.

Alan Jones is an occasional contributor to Pf. He commentates and presents widely on the ongoing reform within the NHS and its implications for pharma. He is also a consultant to Wellards, an independent healthcare policy analyst, adviser and NHS trainer. Email: alan.jones28@virgin.net.

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